Overall Survival with Ribociclib plus Letrozole in Advanced Breast Cancer.
Open accessAbstract
BACKGROUND: In a previous analysis of this phase 3 trial, first-line ribociclib plus letrozole resulted in significantly longer progression-free survival than letrozole alone among postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Whether overall survival would also be longer with ribociclib was not known. METHODS: Here we report the results of the protocol-specified final analysis of overall survival, a key secondary end point. Patients were randomly assigned in a 1:1 ratio to receive either ribociclib or placebo in combination with letrozole. Overall survival was assessed with the use of a stratified log-rank test and summarized with the use of Kaplan-Meier methods after 400 deaths had occurred. A hierarchical testing strategy was used for the analysis of progression-free survival and overall survival to ensure the validity of the findings. RESULTS: After a median follow-up of 6.6 years, 181 deaths had occurred among 334 patients (54.2%) in the ribociclib group and 219 among 334 (65.6%) in the placebo group. Ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole. Median overall survival was 63.9 months (95% confidence interval [CI], 52.4 to 71.0) with ribociclib plus letrozole and 51.4 months (95% CI, 47.2 to 59.7) with placebo plus letrozole (hazard ratio for death, 0.76; 95% CI, 0.63 to 0.93; two-sided P = 0.008). No new safety signals were observed. CONCLUSIONS: First-line therapy with ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole in patients with HR-positive, HER2-negative advanced breast cancer. Median overall survival was more than 12 months longer with ribociclib than with placebo. (Funded by Novartis; MONALEESA-2 ClinicalTrials.gov number, NCT01958021.).
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25 of 48 cited sources checked · 7 supported · 7 flagged · accuracy not yet measured
- Study design and conductcitation§ Discussion · p. 8
The trial's follow-up was long, with a median of 80 months.
“This trial has a long follow-up (median, 80 months). 19-23”
Quote in the paperNot a substantial claim3 of 5 sources checked- cites [19] 19. Johnston S, Martin M, Di Leo A, et al. MONARCH 3 final PFS: a randomized study of abemaciclib as initial therapy for advanced breast cancer. NPJ Breast Cancer 2019; 5: 5. source
The Results > Efficacy passage reports a median follow-up of 26.73 months at the final data cutoff, not 80 months. This directly contradicts the follow-up duration attributed to this trial. (LLM, conf=0.93)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured - cites [20] 20. Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptorpositive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol 2021; 32: 1015-24. source
The Discussion (pp. 7, 9) calls this an extended, long follow-up analysis, but gives the median follow-up as 56.3 months, not 80 months. The stated duration directly contradicts the claim's figure. (LLM, conf=0.92)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured - cites [21] 21. Rugo HS, Finn RS, Diéras V, et al. Palbociclib plus letrozole as first-line therapy in estrogen receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer with extended follow-up. Breast Cancer Res Treat 2019; 174: 719-29. source
The Efficacy section reports median follow-up of 37.6 months in the palbociclib–letrozole arm and 37.3 months in the placebo–letrozole arm, not 80 months. The Discussion calls the follow-up long relative to other phase 3 CDK4/6 inhibitor studies, but does not support the claimed duration. (LLM, conf=0.90)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured - cites [22] 22. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of preor perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Cancer Res 2021; 81: Suppl 4: PD2-04. abstract. source
- cites [23] 23. Cristofanilli M, Rugo HS, Im S-A, et al. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): updated analyses from PALOMA-3. J Clin Oncol 2021; 39: Suppl 15: 1000. abstract. source
- Findingown data§ ABSTRACT · p. 3
At the primary and updated analyses of MONALEESA-2, the overall survival data had not matured.
“Data for overall survival were immature at the time of the primary and updated analyses.”
Quote in the paperSubstantial claim1 of 2 sources checked- cites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. source
The Characteristic section states that overall survival results were not mature at the interim analysis, supporting the claim about the primary analysis. This 2016 paper does not report an updated analysis or establish whether overall survival data were still immature then. (LLM, conf=0.87)
Experimental — accuracy not yet measured - cites [17] 17. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of firstline ribociclib plus letrozole versus place- n engl j med 386;10 nejm.org March 10, 2022 bo plus letrozole in hormone receptorpositive, HER2-negative advanced breast cancer. Ann Oncol 2018; 29: 1541-7. source
- Premisecitation§ ABSTRACT · p. 3
Two ribociclib trials that enrolled some patients receiving first-line therapy demonstrated a significant overall survival benefit.
“To date, two trials evaluating ribociclib that included some patients receiving firstline therapy showed a significant overall survival benefit. 14-16”
Quote in the paperSubstantial claim2 of 3 sources checked- cites [14] 14. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med 2019; 381: 307-16. source
- cites [15] 15. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514-24. source
The Discussion (page unavailable) says that MONALEESA-3 and MONALEESA-7 both showed significant overall-survival benefits. The Overall Survival section documents patients receiving first-line treatment in MONALEESA-3, but our copy does not establish that MONALEESA-7 also enrolled first-line patients. (LLM, conf=0.82)
Experimental — accuracy not yet measured - cites [16] 16. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptorpositive, ERBB2-negative breast cancer that progressed on endocrine therapy MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6: 116-24. source
The Discussion (page not available) reports a statistically significant overall-survival improvement in one ribociclib trial, MONALEESA-7. The paper does not report significant overall-survival benefits for two ribociclib trials or establish that the trial it discusses included patients receiving first-line therapy; the References list MONALEESA-2 as a first-line trial but give no survival result for it. (LLM, conf=0.86)
Experimental — accuracy not yet measured
- Findingcitation§ ABSTRACT · p. 3
In the primary and updated analyses of MONALEESA-2, the hazard ratio for disease progression or death with ribociclib plus letrozole versus placebo plus letrozole was 0.57 (95% CI 0.46 to 0.70; P<0.001).
“In the primary and updated analyses of MONALEESA-2, progression-free survival was significantly longer with ribociclib plus letrozole than with placebo plus letrozole (median in updated analysis, 25.3 months vs. 16.0 months; hazard ratio for disease progression or death, 0.57; 95% confidence interval [CI], 0.46 to 0.70; P<0.001).”
Quote in the paperNot a substantial claim1 of 2 sources checked- cites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. source
The Efficacy of Ribociclib plus Letrozole section reports significantly longer progression-free survival with ribociclib plus letrozole in the primary interim analysis. It gives a hazard ratio of 0.56 (95% CI, 0.43 to 0.72), not the claimed 0.57 (95% CI, 0.46 to 0.70); our copy does not report the cited updated-analysis figures. (LLM, conf=0.88)
Experimental — accuracy not yet measured - cites [17] 17. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of firstline ribociclib plus letrozole versus place- n engl j med 386;10 nejm.org March 10, 2022 bo plus letrozole in hormone receptorpositive, HER2-negative advanced breast cancer. Ann Oncol 2018; 29: 1541-7. source
- Findingcitation§ ABSTRACT · p. 3
In the primary and updated analyses of MONALEESA-2, median PFS was 25.3 months with ribociclib plus letrozole versus 16.0 months with placebo plus letrozole.
“In the primary and updated analyses of MONALEESA-2, progression-free survival was significantly longer with ribociclib plus letrozole than with placebo plus letrozole (median in updated analysis, 25.3 months vs. 16.0 months; hazard ratio for disease progression or death, 0.57; 95% confidence interval [CI], 0.46 to 0.70; P<0.001).”
Quote in the paperNot a substantial claim1 of 2 sources checked- cites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. source
The Efficacy of Ribociclib plus Letrozole section reports significantly longer progression-free survival with ribociclib plus letrozole at the interim analysis. It does not report the claimed updated-analysis medians of 25.3 and 16.0 months; instead, the ribociclib median had not been reached and the placebo median was 14.7 months. No page numbers are available in our copy. (LLM, conf=0.90)
Experimental — accuracy not yet measured - cites [17] 17. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of firstline ribociclib plus letrozole versus place- n engl j med 386;10 nejm.org March 10, 2022 bo plus letrozole in hormone receptorpositive, HER2-negative advanced breast cancer. Ann Oncol 2018; 29: 1541-7. source
- Premisecitation§ ABSTRACT · p. 3
MONALEESA-3 showed significantly longer overall survival among postmenopausal patients receiving first- or second-line ribociclib plus fulvestrant compared with fulvestrant alone.
“In addition, the MONALEESA-3 trial showed significantly longer overall survival among postmenopausal patients with first- and second-line ribociclib plus fulvestrant than with fulvestrant alone. 15”
Quote in the paperSubstantial claim1 of 1 sources checked- cites [15] 15. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514-24. source
- Premisecitation§ ABSTRACT · p. 3
Higher CDK4 expression drives endocrine therapy resistance in HR-positive breast cancer patients.
“Increased expression of CDK4 has been shown to drive resistance to endocrine therapy in patients with HR-positive breast cancer. 4-7”
Quote in the paperSubstantial claim2 of 4 sources checked- cites [4] 4. Hosford SR, Miller TW. Clinical potential of novel therapeutic targets in breast cancer: CDK4/6, Src, JAK/STAT, PARP, HDAC, and PI3K/AKT/mTOR pathways. Pharmgenomics Pers Med 2014; 7: 203-15.
- cites [5] 5. Thangavel C, Dean JL, Ertel A, et al. Therapeutically activating RB: reestablishing cell cycle control in endocrine therapyresistant breast cancer. Endocr Relat Cancer 2011; 18: 333-45. source
The Results section on RB activation reports that blocking CDK4/6 curtailed cell-cycle progression in endocrine therapy-resistant breast cancer models. The Discussion links resistance to sustained cyclin D1–dependent kinase activity, but the paper does not show that increased CDK4 expression drives resistance in HR-positive patients. Its mechanistic evidence comes primarily from models, not a patient-level test of that claim. (LLM, conf=0.86)
Experimental — accuracy not yet measured - cites [6] 6. Shapiro GI. Cyclin-dependent kinase pathways as targets for cancer treatment. J Clin Oncol 2006; 24: 1770-83. source
- cites [7] 7. Miller TW, Balko JM, Fox EM, et al. ERα-dependent E2F transcription can mediate resistance to estrogen deprivation in human breast cancer. Cancer Discov 2011; 1: 338-51. source
The Results section on CDK4 reports that CDK4 knockdown or CDK4/6 inhibition suppressed hormone-independent growth in ER-positive breast cancer cell lines. The patient-tumor findings instead link an E2F activation signature—not higher CDK4 expression—to poorer response to aromatase inhibitors. The paper therefore supports a role for CDK4 in a resistance-related pathway, but does not show that increased CDK4 expression drives endocrine resistance in patients. (LLM, conf=0.88)
Experimental — accuracy not yet measured
- Findingcitation§ BACKGROUND · p. 2
In an earlier analysis of this phase 3 study, adding ribociclib to first-line letrozole yielded significantly longer progression-free survival than letrozole alone among postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer.
“In a previous analysis of this phase 3 trial, first-line ribociclib plus letrozole resulted in significantly longer progression-free survival than letrozole alone among postmenopausal patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer.”
- Also stated in: § ABSTRACT · p. 3 · plain
“In the primary and updated analyses of MONALEESA-2, progression-free survival was significantly longer with ribociclib plus letrozole than with placebo plus letrozole (median in updated analysis, 25.3 months vs. 16.0 months; hazard ratio for disease progression or death, 0.57; 95% confidence interval [CI], 0.46 to 0.70; P<0.001).”
Quote in the paperSubstantial claim1 of 2 sources checked- cites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. source
- cites [17] 17. Hortobagyi GN, Stemmer SM, Burris HA, et al. Updated results from MONALEESA-2, a phase III trial of firstline ribociclib plus letrozole versus place- n engl j med 386;10 nejm.org March 10, 2022 bo plus letrozole in hormone receptorpositive, HER2-negative advanced breast cancer. Ann Oncol 2018; 29: 1541-7. source
- Also stated in: § ABSTRACT · p. 3 · plain
- Premisecitation§ Discussion · p. 9
Those trials reported reductions in death risk of 29%, 28%, and 24%, respectively.
“These trials showed a 29%, 28%, and 24% lower risk of death, respectively.”
Quote in the paperSubstantial claim2 of 3 sources checked- cites [14] 14. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med 2019; 381: 307-16. source
- cites [15] 15. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514-24. source
- cites [16] 16. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptorpositive, ERBB2-negative breast cancer that progressed on endocrine therapy MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6: 116-24. source
- Premisecitation§ Discussion · p. 8
Earlier, three trials-MONALEESA-7, MONALEESA-3, and MONARCH 2-reported significant overall survival gains from adding a CDK4/6 inhibitor (ribociclib or abemaciclib) in broad HR-positive, HER2-negative advanced breast cancer populations.
“Previously, the MONALEESA-7, MONALEESA-3, and MONARCH 2 trials have shown a significant overall survival benefit with the addition of a CDK4/6 inhibitor (either ribociclib or abemaciclib) in broad groups of patients with HR-positive, HER2-negative advanced breast cancer. 14-16”
Quote in the paperSubstantial claim2 of 3 sources checked- cites [14] 14. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med 2019; 381: 307-16. source
- cites [15] 15. Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020; 382: 514-24. source
- cites [16] 16. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptorpositive, ERBB2-negative breast cancer that progressed on endocrine therapy MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6: 116-24. source
- Findingown data§ Overall Survival · p. 5
In the placebo group, median overall survival was 51.4 months (95% CI 47.2-59.7).
“A significant overall survival benefit was observed, with a median overall survival of 63.9 months (95% CI, 52.4 to 71.0) in the ribociclib group and 51.4 months (95% CI, 47.2 to 59.7) in the placebo group (hazard ratio for death, 0.76; 95% CI, 0.63 to 0.93; two-sided P = 0.008) (Fig. 1).”
Quote in the paperSubstantial claim - Findingown data§ Overall Survival · p. 5
Ribociclib plus letrozole produced a significant overall survival benefit compared with placebo plus letrozole.
“A significant overall survival benefit was observed, with a median overall survival of 63.9 months (95% CI, 52.4 to 71.0) in the ribociclib group and 51.4 months (95% CI, 47.2 to 59.7) in the placebo group (hazard ratio for death, 0.76; 95% CI, 0.63 to 0.93; two-sided P = 0.008) (Fig. 1).”
- Also stated in: § RESULTS · p. 2 · plain
“Ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole.”
- Also stated in: § CONCLUSIONS · p. 2 · plain
“First-line therapy with ribociclib plus letrozole showed a significant overall survival benefit as compared with placebo plus letrozole in patients with HR-positive, HER2-negative advanced breast cancer.”
Quote in the paperSubstantial claim- Rests on an assumption: The trial population is representative of the broader population of postmenopausal patients with HR-positive, HER2-negative advanced breast cancer.
- Also stated in: § RESULTS · p. 2 · plain
- Findingown data§ Overall Survival · p. 5
In the ribociclib group, median overall survival was 63.9 months (95% CI 52.4-71.0).
“A significant overall survival benefit was observed, with a median overall survival of 63.9 months (95% CI, 52.4 to 71.0) in the ribociclib group and 51.4 months (95% CI, 47.2 to 59.7) in the placebo group (hazard ratio for death, 0.76; 95% CI, 0.63 to 0.93; two-sided P = 0.008) (Fig. 1).”
Quote in the paperSubstantial claim - Findingown data§ Overall Survival · p. 5
The final OS analysis occurred after 400 deaths: 181 of 334 ribociclib patients (54.2%) and 219 of 334 placebo patients (65.6%).
“The final analysis of overall survival was performed after 400 deaths had occurred: 181 among 334 patients (54.2%) in the ribociclib group and 219 among 334 patients (65.6%) in the placebo group.”
Quote in the paperSubstantial claim - Findingown data§ Overall Survival · p. 5
On-treatment deaths occurred in 8 of 334 ribociclib patients and 3 of 330 placebo patients.
“Death during the treatment period occurred in 8 of 334 patients in the ribociclib group (in 2 from breast cancer, in 2 from respiratory failure, in 1 from pneumonia, and in 3 from other causes) and in 3 of 330 patients in the placebo group (in 2 from breast cancer and in 1 from subdural hematoma).”
Quote in the paperNot a substantial claim - Findingnone given§ RESULTS · p. 2
No new safety signals emerged.
“No new safety signals were observed.”
Quote in the paperNot a substantial claim - Findingown data§ Discussion · p. 8
In women who were postmenopausal and had HR-positive, HER2-negative advanced breast cancer receiving first-line therapy, adding ribociclib to letrozole significantly prolonged overall survival compared with letrozole alone.
“In our trial, the addition of ribociclib significantly prolonged overall survival as compared with letrozole alone when given to postmenopausal patients with HR-positive, HER2-negative advanced breast cancer exclusively as first-line therapy”
- Also stated in: § Discussion · p. 9 · boosted
“This analysis of the MONALEESA-2 trial showed a significant and clinically meaningful difference in overall survival of 12.5 months with first-line ribociclib plus letrozole as compared with placebo plus letrozole in postmenopausal patients with advanced HR-positive, HER2negative breast cancer”
Quote in the paperSubstantial claim - Also stated in: § Discussion · p. 9 · boosted
- Findingown data§ Discussion · p. 9
The median overall survival difference between ribociclib plus letrozole and placebo plus letrozole was 12.5 months in women who were postmenopausal and had HR-positive, HER2-negative advanced breast cancer.
“This analysis of the MONALEESA-2 trial showed a significant and clinically meaningful difference in overall survival of 12.5 months with first-line ribociclib plus letrozole as compared with placebo plus letrozole in postmenopausal patients with advanced HR-positive, HER2negative breast cancer”
Quote in the paperSubstantial claim - Findingown data§ Subsequent Therapy · p. 6
The most frequent subsequent antineoplastic therapy was endocrine therapy alone, used by 32.9% of ribociclib patients and 29.0% of placebo patients.
“Endocrine therapy alone was the most common subsequent antineoplastic therapy and was received by 32.9% of the patients in the ribociclib group and by 29.0% of those in the placebo group.”
Quote in the paperNot a substantial claim - Findingown data§ Discussion · p. 8
No new safety signals emerged after a median 20.2 months of treatment exposure in the ribociclib group.
“After a median of 20.2 months of treatment exposure in the ribociclib group, no new safety signals were revealed.”
Quote in the paperNot a substantial claim - Findingown data§ Discussion · p. 8
Adjusting for later CDK4/6 inhibitor use made the overall survival advantage larger.
“In addition, the overall survival benefit was further increased on adjustment for subsequent use of CDK4/6 inhibitors.”
Quote in the paperNot a substantial claim - Findingown data§ Discussion · p. 8
CDK4/6 inhibitors were used after the trial more often in the placebo group than in the ribociclib group (34.4% vs. 21.7%).
“Although subsequent use of CDK4/6 inhibitors in any line of therapy was more frequent in the placebo group than in the ribociclib group (34.4% vs. 21.7%)”
- Also stated in: § Safety · p. 8 · plain
“Receipt of any subsequent CDK4/6 inhibitor - no./total no. (%)† | 66/304 (21.7) | 109/317 (34.4) |”
Quote in the paperSubstantial claim - Also stated in: § Safety · p. 8 · plain
- Findingown data§ Subsequent Therapy · p. 6
Among 621 patients who discontinued the trial regimen, 179 (28.8%) received chemotherapy alone or combined as first subsequent therapy: 85/304 (28.0%) in the ribociclib group and 94/317 (29.7%) in the placebo group.
“In the intention-to-treat population, chemotherapy alone or in combination was received as the first subsequent therapy by 179 of 621 patients (28.8%) who discontinued the trial regimen (85 of 304 patients [28.0%] in the ribociclib group and 94 of 317 patients [29.7%] in the placebo group).”
Quote in the paperNot a substantial claim - Findingnone given§ Discussion · p. 8
Ribociclib's overall survival advantage was broadly consistent across patient subgroups.
“The overall survival benefit of ribociclib was generally consistent across patient subgroups.”
Quote in the paperNot a substantial claim - Findingown data§ Subsequent Therapy · p. 6
Median chemotherapy-free survival was 39.9 months with ribociclib and 30.1 months with placebo (HR 0.74; 95% CI 0.62-0.89).
“The median chemotherapy-free survival was 39.9 months in the ribociclib group and 30.1 months in the placebo group (hazard ratio for receipt of first subsequent chemotherapy or death, 0.74; 95% CI, 0.62 to 0.89) (Fig. S2).”
Quote in the paperNot a substantial claim - Findingown data§ Overall Survival · p. 5
At 72 months, Kaplan-Meier overall survival was 44.2% (95% CI 38.5-49.8) with ribociclib and 32.0% (95% CI 26.8-37.3) with placebo.
“The Kaplan-Meier estimate of overall survival at 60 months was 52.3% (95% CI, 46.5 to 57.7) in the ribociclib group and 43.9% (95% CI, 38.3 to 49.4) in the placebo group and at 72 months was 44.2% (95% CI, 38.5 to 49.8) and 32.0% (95% CI, 26.8 to 37.3), respectively (Table 1).”
Quote in the paperSubstantial claim - Findingown data§ CONCLUSIONS · p. 2
Median overall survival was over 12 months longer with ribociclib than with placebo.
“Median overall survival was more than 12 months longer with ribociclib than with placebo.”
Quote in the paperSubstantial claim - Findingown data§ Safety · p. 6
Adverse-event profiles in both groups matched those previously reported.
“Adverse-event profiles in both trial groups were consistent with previously reported results (Table S4).”
Quote in the paperNot a substantial claim - Findingown data§ Overall Survival · p. 5
The hazard ratio for death comparing ribociclib plus letrozole with placebo plus letrozole was 0.76 (95% CI 0.63-0.93; two-sided P=0.008).
“A significant overall survival benefit was observed, with a median overall survival of 63.9 months (95% CI, 52.4 to 71.0) in the ribociclib group and 51.4 months (95% CI, 47.2 to 59.7) in the placebo group (hazard ratio for death, 0.76; 95% CI, 0.63 to 0.93; two-sided P = 0.008) (Fig. 1).”
Quote in the paperSubstantial claim - Findingown data§ Subsequent Therapy · p. 6
Fewer ribociclib patients received subsequent CDK4/6 inhibitors in any line (66/304, 21.7%) than placebo patients (109/317, 34.4%).
“Subsequent use of CDK4/6 inhibitors, including palbociclib, abemaciclib, and ribociclib, in any line of therapy occurred in fewer patients in the ribociclib group (66 of 304 patients [21.7%]) than in the placebo group (109 of 317 patients [34.4%]) (Table 2).”
Quote in the paperSubstantial claim - Findingown data§ Subsequent Therapy · p. 6
Chemotherapy use or death before chemotherapy occurred in 229/334 ribociclib patients (68.6%) and 258/334 placebo patients (77.2%).
“Chemotherapy use or death before chemotherapy was reported in 229 of 334 patients (68.6%) in the ribociclib group and 258 of 334 patients (77.2%) in the placebo group.”
Quote in the paperNot a substantial claim - Findingown data§ Discussion · p. 8
The risk of death was 24% lower with ribociclib plus letrozole than with placebo plus letrozole in this trial population.
“with a risk of death that was 24% lower than that with placebo”
- Also stated in: § Discussion · p. 9 · plain
“with a 24% relative reduction in the risk of death”
Quote in the paperSubstantial claim - Also stated in: § Discussion · p. 9 · plain
- Findingown data§ Safety · p. 6
Grade 3 interstitial lung disease or pneumonitis occurred in 2 ribociclib patients (0.6%) and no placebo patients.
“Grade 3 interstitial lung disease or pneumonitis occurred in 2 patients (0.6%) in the ribociclib group and 0 patients in the placebo group.”
Quote in the paperNot a substantial claim - Findingown data§ Overall Survival · p. 5
At 60 months, Kaplan-Meier overall survival was 52.3% (95% CI 46.5-57.7) with ribociclib and 43.9% (95% CI 38.3-49.4) with placebo.
“The Kaplan-Meier estimate of overall survival at 60 months was 52.3% (95% CI, 46.5 to 57.7) in the ribociclib group and 43.9% (95% CI, 38.3 to 49.4) in the placebo group and at 72 months was 44.2% (95% CI, 38.5 to 49.8) and 32.0% (95% CI, 26.8 to 37.3), respectively (Table 1).”
Quote in the paperSubstantial claim - Findingown data§ Safety · p. 6
Neutropenia was the most frequent grade 3 or 4 adverse event of special interest, affecting 63.8% of ribociclib patients and 1.2% of placebo patients.
“The most common grade 3 or 4 adverse event of special interest was neutropenia, occurring in 63.8% of patients who received ribociclib and in 1.2% of those who received placebo.”
Quote in the paperNot a substantial claim - Findingown data§ Subsequent Therapy · p. 6
Median time to first subsequent chemotherapy was 50.6 months with ribociclib and 38.9 months with placebo (HR 0.74; 95% CI 0.61-0.91).
“The median time to first subsequent chemotherapy was 50.6 months in the ribociclib group and 38.9 months in the placebo group (hazard ratio for receipt of first chemotherapy, 0.74; 95% CI, 0.61 to 0.91) (Fig. S3).”
Quote in the paperNot a substantial claim - Premisecitation§ ABSTRACT · p. 3
In MONALEESA-7, premenopausal patients without prior endocrine therapy for advanced disease, who could have had up to one line of chemotherapy, had significantly longer overall survival with ribociclib plus endocrine therapy than with endocrine therapy alone.
“Among premenopausal patients who had not received previous endocrine therapy for advanced disease but may have received up to one line of chemotherapy for advanced disease in the MONALEESA-7 (Mammary Oncology Assessment of LEE011's [Ribociclib's] Efficacy and Safety-7) trial, overall survival was significantly longer with ribociclib plus endocrine therapy than with endocrine therapy alone. 14”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [14] 14. Im S-A, Lu Y-S, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med 2019; 381: 307-16. source
- Interpretationown data§ Patients and Treatment · p. 5
The trial participants resembled the overall breast cancer population in sex and age.
“Epidemiologic data explicitly for patients with HR-positive, HER2-negative metastatic breast cancer are quite limited; however, the patients in this trial were representative of patients with breast cancer overall with respect to sex and age (Table S2).”
Quote in the paperNot a substantial claim - Interpretationown data§ Discussion · p. 8
The results highlight a substantial benefit for ribociclib when used as initial therapy in advanced breast cancer.
“These findings underscore the substantial benefit of ribociclib as up-front therapy in patients with advanced breast cancer.”
Quote in the paperSubstantial claim
- The quote only partly states this claim. 3
- May combine two claims. 18
- Classified as probably not a substantial claim. 16
The quote only partly states this claim.
Findingcitation§ Discussion · p. 8Median survival to date in the ribociclib group was 63.9 months among women whose tumors were HR-positive and HER2-negative.
“as well as impressive median survival to date (63.9 months) among women with HR-positive, HER2-negative advanced breast cancer. 16,20,22-29”
Quote in the paperSubstantial claim5 of 10 sources checked- cites [16] 16. Sledge GW Jr, Toi M, Neven P, et al. The effect of abemaciclib plus fulvestrant on overall survival in hormone receptorpositive, ERBB2-negative breast cancer that progressed on endocrine therapy MONARCH 2: a randomized clinical trial. JAMA Oncol 2020; 6: 116-24. source
The Overall Survival section reports a median of 46.7 months for abemaciclib plus fulvestrant, not 63.9 months for ribociclib. The Discussion mentions ribociclib only in connection with a separate study’s survival hazard ratio; it gives no ribociclib median survival of 63.9 months. Page numbers are unavailable in our copy. (LLM, conf=0.88)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured - cites [20] 20. Slamon DJ, Neven P, Chia S, et al. Ribociclib plus fulvestrant for postmenopausal women with hormone receptorpositive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol 2021; 32: 1015-24. source
The Overall survival section (p. 3) reports median overall survival of 53.7 months in the ribociclib arm, not 63.9 months, at the October 2020 data cutoff. The Results summary (p. 1) gives the same 53.7-month figure. (LLM, conf=0.90)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured - cites [22] 22. Tripathy D, Im S-A, Colleoni M, et al. Updated overall survival (OS) results from the phase III MONALEESA-7 trial of preor perimenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Cancer Res 2021; 81: Suppl 4: PD2-04. abstract. source
- cites [23] 23. Cristofanilli M, Rugo HS, Im S-A, et al. Overall survival (OS) with palbociclib (PAL) + fulvestrant (FUL) in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC): updated analyses from PALOMA-3. J Clin Oncol 2021; 39: Suppl 15: 1000. abstract. source
- cites [24] 24. Bergh J, Jönsson P-E, Lidbrink EK, et al. FACT: an open-label randomized phase III study of fulvestrant and anastrozole in combination compared with anastrozole alone as first-line therapy for patients with receptor-positive postmenopausal breast cancer. J Clin Oncol 2012; 30: 1919-25. source
- cites [25] 25. Johnston SR, Kilburn LS, Ellis P, et al. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormonereceptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol 2013; 14: 989-98. source
The overall-survival figure in the Interpretation section (page unavailable) reports medians of 20.2, 19.4, and 21.6 months for the fulvestrant/anastrozole, fulvestrant/placebo, and exemestane groups, respectively. This trial had no ribociclib group and does not report a 63.9-month median survival for its patients. (LLM, conf=0.86)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured - cites [26] 26. Piccart M, Hortobagyi GN, Campone M, et al. Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2. Ann Oncol 2014; 25: 2357-62. source
- cites [27] 27. Ellis MJ, Llombart-Cussac A, Feltl D, et al. Fulvestrant 500 mg versus anastrozole 1 mg for the first-line treatment of advanced breast cancer: overall survival analysis from the phase II FIRST study. J Clin Oncol 2015; 33: 3781-7. source
The Results > Efficacy section reports median overall survival of 54.1 months with fulvestrant and 48.4 months with anastrozole, not a ribociclib outcome. A search for ribociclib and 63.9 months found no passage addressing the claimed survival figure; the paper's different treatment comparison does not establish a contrary ribociclib result. (LLM, conf=0.78)
Experimental — accuracy not yet measured - cites [28] 28. Mehta RS, Barlow WE, Albain KS, et al. Overall survival with fulvestrant plus anastrozole in metastatic breast cancer. N Engl J Med 2019; 380: 1226-34. source
- cites [29] 29. André F, Ciruelos EM, Juric D, et al. Alpelisib plus fulvestrant for PIK3CAmutated, hormone receptor-positive, human epidermal growth factor receptor2-negative advanced breast cancer: final overall survival results from SOLAR-1. Ann Oncol 2021; 32: 208-17. source
The Overall Survival section (page unavailable) reports median survival of 39.3 months with alpelisib plus fulvestrant and 31.4 months with placebo plus fulvestrant, not 63.9 months in a ribociclib group. Ribociclib studies appear in the References, but this paper does not report the claimed result. (LLM, conf=0.87)
Checked by a reasoning model — may be wrong.
Experimental — accuracy not yet measured
May combine two claims.
Premisecitation§ ABSTRACT · p. 3Use of CDK4/6 inhibitors such as ribociclib, abemaciclib, and palbociclib improved PFS in this population and led to regulatory approvals.
“The use of CDK4/6 inhibitors (ribociclib, abemaciclib, and palbociclib) improved progression-free survival in this patient population, leading to regulatory approvals. 9-13”
Quote in the paperSubstantial claim2 of 5 sources checked- cites [9] 9. Cristofanilli M, Turner NC, Bondarenko I, et al. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Lancet Oncol 2016; 17: 425-39. source
- cites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. source
The Results and Discussion report significantly longer progression-free survival with ribociclib plus letrozole than with placebo plus letrozole in postmenopausal women with HR-positive, HER2-negative advanced breast cancer. The paper describes CDK4/6 inhibition more broadly and cites palbociclib studies, but it does not establish a progression-free-survival benefit for abemaciclib or say that these findings led to regulatory approvals. (LLM, conf=0.88)
Experimental — accuracy not yet measured - cites [11] 11. Goetz MP, Toi M, Campone M, et al. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol 2017; 35: 3638-46. source
- cites [12] 12. Cardoso F, Paluch-Shimon S, Senkus E, et al. 5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5). Ann Oncol 2020; 31: 1623-49. source
In the guideline discussion following Methodology (page unavailable), the panel describes CDK4/6 inhibitors as beneficial for ER-positive/HER2-negative advanced breast cancer and recommends combining them with endocrine therapy. The passages found do not specifically document improved progression-free survival for all three named drugs or say that those results led to regulatory approvals. (LLM, conf=0.77)
Experimental — accuracy not yet measured - cites [13] 13. National Comprehensive Cancer Network. Metastatic breast cancer. 2020 (https://www . nccn . org/ patients/ guidelines/ content/ PDF/ stage\_iv\_breast - patient . pdf).
Couldn’t be matched to a paper in Crossref, so it can’t be checked.
Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingcitation§ Patients and Treatment · p. 5In the ribociclib group, median trial treatment exposure was 20.2 months (IQR 7.4-45.1), 7 months longer than at the primary PFS analysis.
“The median duration of exposure to trial treatment in the ribociclib group was 20.2 months (interquartile range, 7.4 to 45.1), which is 7 months longer than it was at the time of the primary analysis of progression-free survival. 10”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [10] 10. Hortobagyi GN, Stemmer SM, Burris HA, et al. Ribociclib as first-line therapy for HR-positive, advanced breast cancer. N Engl J Med 2016; 375: 1738-48. source
The Treatment section reports 13.0 months as the ribociclib group's median treatment exposure at the January 2016 cutoff, supporting the claim's reference to the earlier analysis. It does not report the later 20.2-month median, the 7.4–45.1-month interquartile range, or the increase to that later value. Page number is unavailable in our copy. (LLM, conf=0.86)
Experimental — accuracy not yet measured
May combine two claims. The quote only partly states this claim.
Premisecitation§ Discussion · p. 9PALOMA-3 found a 19% lower death risk that was not deemed significant.
“The PALOMA-3 trial showed a 19% lower risk of death, which was”
- Also stated in: § Discussion · p. 9 · plain
“not considered to be significant. 30”
Quote in the paperNot a substantial claim1 of 1 sources checked- cites [30] 30. Turner NC, Slamon DJ, Ro J, et al. Overall survival with palbociclib and fulvestrant in advanced breast cancer. N Engl J Med 2018; 379: 1926-36. Copyright © 2022 Massachusetts Medical Society. source
- Also stated in: § Discussion · p. 9 · plain
Probably not a substantial claim: may not pass S3 (load-bearing).
Findingown data§ Patients and Treatment · p. 5Median placebo exposure was 14.1 months (IQR 7.1-28.9).
“The median duration of exposure to placebo was 14.1 months (interquartile range, 7.1 to 28.9).”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown data§ Patients and Treatment · p. 5Black women made up only 2.5% of trial participants and were underrepresented.
“Unfortunately, only 2.5% of women in the trial were Black; thus, this demographic group was underrepresented in our trial.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Findingown data§ Patients and Treatment · p. 5Median follow-up from randomization to data cutoff was 80 months overall, with a minimum of 75 months.
“Among all patients, the median duration of follow-up (randomization to data cutoff) was 80 months (minimum, 75 months).”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Findingown data§ Patients and Treatment · p. 5At the final OS data cutoff, 30 of 334 ribociclib patients (9.0%) and 17 of 334 placebo patients (5.1%) were still on assigned treatment.
“At the data cutoff date for this final analysis of overall survival, 30 of 334 patients (9.0%) in the ribociclib group and 17 of 334 patients (5.1%) in the placebo group were still receiving ribociclib plus letrozole or placebo plus letrozole as assigned.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown data§ Discussion · p. 8Ribociclib's overall survival advantage started to appear around 20 months and grew with longer follow-up, as shown by survival at 5 and 6 years.
“The Kaplan-Meier analysis shows that the overall survival benefit of ribociclib began to emerge at approximately 20 months and continued to increase with longer follow-up, as indicated by survival at 5 years and 6 years.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown data§ Overall Survival · p. 6Exploratory subgroup analyses showed an OS benefit with ribociclib consistent with the overall population, but some subgroups had wide confidence intervals due to small numbers.
“The overall survival benefit with ribociclib in these subgroups was consistent with the results in the overall population; however, the small number of patients in some subgroups resulted in wide confidence intervals.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown data§ Subsequent Therapy · p. 6Adjusting for later CDK4/6 inhibitor use, placebo-group median overall survival was estimated at 50.5 months (95% CI 45.0-55.4) versus 51.4 months (95% CI 47.2-59.7) in the main analysis, with a death hazard ratio of 0.73 (95% CI 0.58-0.92).
“After adjustment for the subsequent treatment with a CDK4/6 inhibitor, the median overall survival in the placebo group was estimated to be 50.5 months (95% CI, 45.0 to 55.4), as compared with 51.4 months (95% CI, 47.2 to 59.7) in the main analysis (hazard ratio for death, 0.73; 95% CI, 0.58 to 0.92).”
Quote in the paperSubstantial claimMay combine two claims.
Findingown data§ Safety · p. 6Other key grade 3 or 4 adverse events of special interest were hepatobiliary toxicity (14.4% vs 4.8%) and prolonged QT interval (4.5% vs 2.1%) for ribociclib vs placebo.
“Additional key grade 3 or 4 adverse events of special interest in the ribociclib and placebo groups were hepatobiliary toxic effects (14.4% and 4.8%, respectively) and prolonged QT interval (4.5% and 2.1%, respectively).”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown data§ Safety · p. 6No grade 4 interstitial lung disease or pneumonitis events or related deaths occurred with ribociclib.
“No grade 4 adverse events or deaths related to interstitial lung disease or pneumonitis occurred in the ribociclib group.”
Quote in the paperNot a substantial claimMay combine two claims.
Findingown data§ Subsequent Therapy · p. 6After trial regimen discontinuation, subsequent antineoplastic therapy was given to 267 of 304 ribociclib patients (87.8%) and 286 of 317 placebo patients (90.2%).
“Among the patients who discontinued the trial regimen, subsequent antineoplastic therapies were received by 267 of 304 patients (87.8%) in the ribociclib group and 286 of 317 patients (90.2%) in the placebo group (Tables 2 and S3).”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductcitation§ Statistical Analysis · p. 4A rank-preserving structural failure time model was used in an OS sensitivity analysis to assess subsequent CDK4/6 inhibitor use in the placebo group after trial regimen discontinuation.
“The rankpreserving structural failure time (RPSFT) model was used in a sensitivity analysis of overall survival to assess the effects of subsequent administration of CDK4/6 inhibitors in the placebo group after discontinuation of the trial regimen. 18”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [18] 18. Robins JM, Tsiatis AA. Correcting for non-compliance in randomized trials using rank preserving structural failure time models. Commun Stat Theory Methods 1991; 20: 2609-31. source
Classified as probably not a substantial claim.
Study design and conductown data§ Statistical Analysis · p. 4Overall survival testing used a five-look group sequential design, but only if PFS results met prespecified significance conditions.
“Overall survival was to be tested under a five-look group sequential design only if progression-free survival results reached statistical significance according to the prespecified conditions in the protocol.”
Quote in the paperSubstantial claimClassified as probably not a substantial claim. May combine two claims.
Study design and conductnone given§ Trial Design and Patients · p. 3Investigators who gave treatment, analyzed data, or assessed outcomes, and all patients, did not know the group assignments.
“All the investigators who administered ribociclib or placebo, analyzed data, and assessed outcomes, as well as all the patients, were unaware of the trial-group assignments.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Premisecitation§ ABSTRACT · p. 3In preclinical work, ribociclib preferentially inhibits CDK4 and reaches high concentrations at clinically relevant doses.
“Preclinically, ribociclib has been shown to inhibit CDK4 preferentially and has also shown high drug concentrations at clinically relevant doses. 8”
Quote in the paperNot a substantial claim0 of 1 sources checked- cites [8] 8. Chen P, Lee NV, Hu W, et al. Spectrum and degree of CDK drug interactions predicts clinical performance. Mol Cancer Ther 2016; 15: 2273-81. source
May combine two claims.
Study design and conductreasoning§ Statistical Analysis · p. 4A hierarchical testing approach for PFS and OS controlled the familywise type I error at 2.5% and supported the findings' validity.
“A hierarchical testing strategy between progression-free survival and overall survival was used to control the familywise type I error rate at 2.5% and supported the validity of the findings.”
- Also stated in: § METHODS · p. 2 · plain
“A hierarchical testing strategy was used for the analysis of progression-free survival and overall survival to ensure the validity of the findings.”
Quote in the paperSubstantial claim- Also stated in: § METHODS · p. 2 · plain
Classified as probably not a substantial claim. May combine two claims.
Premisecitation§ ABSTRACT · p. 3CDK4 and CDK6 regulate cell-cycle progression and have a known role in promoting cancer growth.
“Cyclin-dependent kinases 4 and 6 (CDK4/6) play a key function in regulating cell-cycle progression and have a known role in promoting growth in cancer. 3”
Quote in the paperSubstantial claim0 of 1 sources checked- cites [3] 3. O'Leary B, Finn RS, Turner NC. Treating cancer with selective CDK4/6 inhibitors. Nat Rev Clin Oncol 2016; 13: 417-30. source
Classified as probably not a substantial claim.
Study design and conductnone given§ Trial Design and Patients · p. 3The trial prohibited crossover between groups until the final overall survival analysis had been completed.
“Crossover between the two groups was not allowed until the final analysis of overall survival was completed.”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown data§ Patients and Treatment · p. 5Four placebo-assigned patients did not receive their assigned placebo plus letrozole.
“Four patients assigned to the placebo group did not receive placebo plus letrozole as assigned.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown data§ Trial Design and Patients · p. 3The randomization was stratified by whether liver or lung metastases were present.
“Randomization was stratified according to the presence or absence of liver or lung metastases.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown data§ Trial Oversight · p. 4Safety data were reviewed by an independent data monitoring committee.
“An independent data monitoring committee assessed safety data.”
Quote in the paperNot a substantial claimMay combine two claims.
Study design and conductown data§ Trial Design and Patients · p. 3Participants were assigned randomly in equal numbers to ribociclib or placebo, both combined with letrozole.
“Patients were randomly assigned in a 1:1 ratio to receive either ribociclib (600 mg per day, administered orally once daily for 21 consecutive days, followed by 7 days off, for a complete cycle of 28 days) or a matching placebo. Patients in both groups received letrozole (2.5 mg per day on a continuous schedule).”
Quote in the paperSubstantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown data§ Trial Oversight · p. 4All patients gave written informed consent before enrollment.
“Before enrollment, all the patients provided written informed consent.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing).
Study design and conductown data§ Trial Oversight · p. 4Each site's institutional review board or an independent ethics committee approved the protocol and its amendments.
“The trial protocol and all amendments (available with the full text of this article at NEJM.org) were approved by the institutional review board at each site or by an independent ethics committee.”
Quote in the paperNot a substantial claimProbably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.
Study design and conductreasoning§ Trial Oversight · p. 4The study followed the Declaration of Helsinki and Good Clinical Practice guidelines.
“This trial was conducted in accordance with the provisions of the Declaration of Helsinki and Good Clinical Practice guidelines and was funded by Novartis.”
Quote in the paperNot a substantial claimMay combine two claims. The quote only partly states this claim.
Interpretationown data§ Discussion · p. 8Ribociclib recipients still showed a significant overall survival advantage even though placebo recipients more often received later CDK4/6 inhibitors.
“the ribociclib group had a significant overall survival benefit.”
Quote in the paperSubstantial claim
The paper relies on this without support.
The trial population is representative of the broader population of postmenopausal patients with HR-positive, HER2-negative advanced breast cancer.
“Epidemiologic data explicitly for patients with HR-positive, HER2-negative metastatic breast cancer are quite limited; however, the patients in this trial were representative of patients with breast cancer overall with respect to sex and age (Table S2).”
“Unfortunately, only 2.5% of women in the trial were Black; thus, this demographic group was underrepresented in our trial.”
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In MONALEESA-2, no numerical effect was observed in patients with liver metastases with the addition of ribociclib to letrozole.
“no numerical effect was observed in patients with liver metastases with the addition of ribociclib to letrozole in MONALEESA-2.19”
From Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3. (2024) · cites this paper as [19]
The exploratory subgroup table (p. 7) shows virtually identical median overall survival for patients with liver involvement: 37.7 months with ribociclib plus letrozole versus 38.1 months with placebo plus letrozole. But its hazard ratio for death is 0.81, a numerical result favoring ribociclib, so the broader assertion of no numerical effect is not fully supported. (LLM, conf=0.85)
Experimental — accuracy not yet measuredIn the MONALEESA-2 trial, the addition of ribociclib versus placebo to letrozole demonstrated a significant improvement in OS, with a median OS increase of 12.5 months (median OS 63.9 versus 51.4 months).
“In the MONALEESA-2 trial (n ¼ 668; 1 : 1 randomization; 6.6 years median follow-up), the addition of ribociclib versus placebo to letrozole demonstrated a significant improvement in OS, with a median OS increase of 12.5 months (median OS 63.9 versus 51.4 months).19”
From Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3. (2024) · cites this paper as [19]
The 13.1-month increase in median OS with abemaciclib + NSAI in MONARCH 3 was comparable with the 12.5-month improvement in median OS observed in the MONALEESA-2 trial.
“the 13.1-month increase in median OS (median OS 66.8 versus 53.7 months) was comparable with the 12.5-month improvement in median OS observed in the MONALEESA-2 trial.”
From Abemaciclib plus a nonsteroidal aromatase inhibitor as initial therapy for HR+, HER2- advanced breast cancer: final overall survival results of MONARCH 3. (2024) · cites this paper as [19]
This is the third pivotal trial to demonstrate a significant improvement in overall survival with ribociclib in a first-line setting.
“This is the third pivotal trial to demonstrate a significant improvement in OS with ribociclib in a first-line setting”
In MONALEESA-2, first-line ribociclib + letrozole in postmenopausal women demonstrated a significant 12.5-month improvement over letrozole alone, with median overall survival 63.9 vs 51.4 months (HR 0.76; 95% CI 0.63-0.93).
“In MONALEESA-2, first-line ribociclib + letrozole in postmenopausal women demonstrated a significant 12.5-month improvement over letrozole alone, with an mOS of 63.9 versus 51.4 months (HR 0.76; 95% CI 0.63–0.93; P = 0.008) [14].”
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Ribociclib as first-line therapy for HR-positive, advanced breast cancer
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Overall Survival with Fulvestrant plus Anastrozole in Metastatic Breast Cancer
Mehta, R. S., Barlow, W. E., Albain, K. S., Vandenberg, T. A., Dakhil, S. R., Tirumali, N. R., Lew, D. L., Hayes, D. F., Gralow, J. R., Linden, H. M., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1811714 · Cited by 126 · see citing works
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Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer
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Self-citationSlamon, D. J., Neven, P., Chia, S., et al. (2021) · Annals of Oncology · doi:10.1016/j.annonc.2021.07.011
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Ribociclib plus Endocrine Therapy in Early Breast Cancer
Slamon, D. J., Lipatov, O. N., Nowecki, Z. I., McAndrew, N. P., Kukiełka-Budny, B., Stroyakovskiy, D., Yardley, D. A., Huang, C., Fasching, P. A., Crown, J. P., et al. (2024) · New England Journal of Medicine · doi:10.1056/nejmoa2305488 · Cited by 431 · see citing works
Self-citationCyclin-dependent protein kinases and cell cycle regulation in biology and disease
Pellarin, I., Dall'Acqua, A., Favero, A., Segatto, I., Rossi, V., Crestan, N., Karimbayli, J., Belletti, B., & Baldassarre, G. (2025) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-024-02080-z · Cited by 323 · see citing works
Analysis of Breast Cancer Mortality in the US—1975 to 2019
Caswell-Jin, J. L., Sun, L. P., Munoz, D., et al. (2024) · JAMA · doi:10.1001/jama.2023.25881 · Cited by 284 · see citing works
The CDK4/6 inhibitor revolution — a game-changing era for breast cancer treatment
Morrison, L., Loibl, S., & Turner, N. C. (2023) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-023-00840-4 · Cited by 284 · see citing works
“91).”
Cardoso, F., Paluch–Shimon, S., Schumacher-Wulf, E., de Matos, L. V., Gelmon, K. A., Aapro, M., Bajpai, J., Barrios, C. H., Bergh, J. C. S., Bergsten-Nordström, E., et al. (2024) · The Breast · doi:10.1016/j.breast.2024.103756 · Cited by 260 · see citing works
Self-citationGoetz, M. P., Toi, M., Huober, J., Sohn, J., Trédan, O., Park, I. H., Campone, M., Chen, S.-C., Manso, L. M., Paluch-Shimon, S., et al. (2024) · Annals of Oncology · doi:10.1016/j.annonc.2024.04.013 · Cited by 238 · see citing works
Self-citationKalinsky, K. M., Accordino, M. K., Chiuzan, C. C., Mundi, P. S., Sakach, E. A., Sathe, C. M., Ahn, H., Trivedi, M. S., Novik, Y., Tiersten, A., et al. (2023) · Journal of Clinical Oncology · doi:10.1200/jco.22.02392 · Cited by 219 · see citing works
“censored) 13 (2) 4 (2) 1 (2) 1 (2) 1 (2) 60 (0) 21 (8) 11 (10) 5 (11) 3 (12) 2 (12) Placebo Plus ET (n = 59) Ribociclib Plus ET (n = 60)”
Overall Survival With Palbociclib Plus Letrozole in Advanced Breast Cancer
Slamon, D. J., Diéras, V., Rugo, H. S., Harbeck, N., Im, S.-A., Gelmon, K. A., Lipatov, O. N., Walshe, J. M., Martin, M., Chavez-MacGregor, M., et al. (2024) · Journal of Clinical Oncology · doi:10.1200/jco.23.00137 · Cited by 200 · see citing works
The Lancet Breast Cancer Commission
Coles, C. E., Earl, H. M., Anderson, B. O., Barrios, C. H., Bienz, M., Bliss, J. M., Cameron, D., Cardoso, F., Cui, W., Francis, P. A., et al. (2024) · The Lancet · doi:10.1016/s0140-6736(24)00747-5 · Cited by 198 · see citing works
Self-citationWang, J., Li, B., Luo, M., Huang, J., Zhang, K., Zheng, S., Zhang, S., & Zhou, J. (2024) · Signal Transduction and Targeted Therapy · doi:10.1038/s41392-024-01779-3 · Cited by 149 · see citing works
Hortobágyi, G. N., Łacko, A., Sohn, J., Cruz, F. M., Borrego, M. R., Manikhas, A., Park, Y. H., Stroyakovskiy, D., Yardley, D. A., Huang, C.-S., et al. (2024) · Annals of Oncology · doi:10.1016/j.annonc.2024.10.015 · Cited by 125 · see citing works
Self-citationOptimal targeting of PI3K-AKT and mTOR in advanced oestrogen receptor-positive breast cancer
Browne, I. M., André, F., Chandarlapaty, S., Carey, L., & Turner, N. C. (2024) · The Lancet Oncology · doi:10.1016/s1470-2045(23)00676-9 · Cited by 109 · see citing works
Self-citationSlamon, D. J., Fasching, P. A., Hurvitz, S. A., Chia, S., Crown, J. P., Martín, M., Barrios, C. H., Bardia, A., Im, S., Yardley, D. A., et al. (2023) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359231178125 · Cited by 105 · see citing works
“67 16–18 In the advanced setting, AEs associated with ribociclib are mostly asymptomatic, and patients reported improved or maintained QOL during treatment.”
BackgroundResultInfluentialSelf-citationPooled ctDNA analysis of MONALEESA phase III advanced breast cancer trials
André, F., Su, F., Solovieff, N., Hortobágyi, G. N., Chia, S., Neven, P., Bardia, A., Tripathy, D., Lu, Y.-S., Lteif, A., et al. (2023) · Annals of Oncology · doi:10.1016/j.annonc.2023.08.011 · Cited by 98 · see citing works
Self-citationNeven, P., Fasching, P. A., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S.-A., Petrakova, K., Bianchi, G. V., Martín, M., Nusch, A., et al. (2023) · Breast Cancer Research · doi:10.1186/s13058-023-01701-9 · Cited by 83 · see citing works
“…of the MONALEESA-2 (first line in combination with letrozole in postmenopausal patients) trial and MONALEESA-7 (first line in combination with NSAI in pre/perimeno-pausal patients) trial, which demonstrated a 63.9-and 58.7-month mOS, respectively, in patients treated with ribociclib + ET [14, 16].”
BackgroundResultInfluentialSelf-citationLópez-González, L., Cendra, A. S., Cendra, C. S., Cervantes, E. D. R., Espinosa, J. C., Pekarek, T., Fraile‐Μartinez, O., Montero, C. G., Rodriguez-Slocker, A. M., Jiménez-Álvarez, L., et al. (2024) · Medicina · doi:10.3390/medicina60010168 · Cited by 81 · see citing works
“The MONALEESA-2 trial [106] evaluated ribociclib as a first-line treatment for advanced HR+/HER2-breast cancer in postmenopausal women, showing a significant improvement in progression-free survival and overall survival.”
MethodEarly versus deferred use of CDK4/6 inhibitors in advanced breast cancer
Sonke, G. S., van Ommen‐Nijhof, A., Wortelboer, N., van der Noort, V., Swinkels, A. C. P., Blommestein, H. M., Páez, C. G., Mol, L., Beeker, A., Beelen, K. J., et al. (2024) · Nature · doi:10.1038/s41586-024-08035-2 · Cited by 83 · see citing works
Self-citationHiensch, A. E., Depenbusch, J., Schmidt, M. E., Monninkhof, E. M., Peláez, M., Clauss, D., Gunasekara, N., Zimmer, P., Belloso, J., Trevaskis, M., et al. (2024) · Nature Medicine · doi:10.1038/s41591-024-03143-y · Cited by 82 · see citing works
“Owing to therapeutic advances for patients with MBC, survival time has improved (it ranges from a median of 23 to 64 months, depending on tumor receptor status) 3–5 .”
BackgroundMethodSelf-citationGlaviano, A., Wander, S. A., Baird, R. D., Yap, K. C.-Y., Lam, H. Y., Toi, M., Carbone, D., Geoerger, B., Serra, V., Jones, R. H., et al. (2024) · Drug Resistance Updates · doi:10.1016/j.drup.2024.101103 · Cited by 85 · see citing works
CDK4 selective inhibition improves preclinical anti-tumor efficacy and safety
Palmer, C. L., Boras, B. W., Pascual, B., Li, N., Li, D., Garza, S. J., Huser, N. H., Yuan, J. T., Cianfrogna, J. A., Sung, T., et al. (2025) · Cancer Cell · doi:10.1016/j.ccell.2025.02.006 · Cited by 79 · see citing works
Precision therapeutics and emerging strategies for HR-positive metastatic breast cancer
Lloyd, M. R., Jhaveri, K. L., Kalinsky, K. M., Bardia, A., & Wander, S. A. (2024) · Nature Reviews Clinical Oncology · doi:10.1038/s41571-024-00935-6 · Cited by 73 · see citing works
“MONALEESA-2/3/7 also demonstrated significant improvements in median OS with ribociclib in the first-line setting 8,86,87 , whereas no significant improvement in OS was observed with palbociclib in an updated analysis of PALOMA-2 (53.9 months versus 51.2 months; HR 0.96, 95% CI 0.78 –1.18; P =…”
InfluentialDownton, T. D., Zhou, F. H., Segara, D., Jeselsohn, R. M., & Lim, E. (2022) · Drug Design Development and Therapy · doi:10.2147/dddt.s380925 · Cited by 68 · see citing works
Overall survival with abemaciclib in early breast cancer
Johnston, S. R. D., Martin, M., O’Shaughnessy, J., Hegg, R., Tolaney, S. M., Guarneri, V., Mastro, L. D., Campone, M., Sohn, J., Boyle, F. M., et al. (2025) · Annals of Oncology · doi:10.1016/j.annonc.2025.10.005 · Cited by 78 · see citing works
Self-citationRugo, H. S., Layman, R. M., Lynce, F. C., Liu, X., Li, B., McRoy, L., Cohen, A. B., Estévez, M., Curigliano, G., & Brufsky, A. (2025) · ESMO Open · doi:10.1016/j.esmoop.2024.104103 · Cited by 63 · see citing works
Im, S., Gennari, A., Park, Y. H., Kim, J. H., Jiang, Z., Gupta, S., Fadjari, T. H., Tamura, K., Mastura, M. Y., Abesamis-Tiambeng, M. L. T., et al. (2023) · ESMO Open · doi:10.1016/j.esmoop.2023.101541 · Cited by 60 · see citing works
“Median OS was >12 months longer in patients receiving ribociclib than in those receiving placebo.(55) The second discrepancy is for the PIK3CA inhibitor alpelisib (Table 2).”
BackgroundResultCDK4/6 inhibitor resistance in estrogen receptor positive breast cancer, a 2023 perspective
Zhou, F. H., Downton, T. D., Freelander, A., Hurwitz, J., Caldon, C. E., & Lim, E. (2023) · Frontiers in Cell and Developmental Biology · doi:10.3389/fcell.2023.1148792 · Cited by 55 · see citing works
“In contrast, only ribociclib in combination with an AI have reported an improvement in OS (Hortobagyi et al., 2022; Lu et al., 2022).”
BackgroundLuo, L., Yang, P., Mastoraki, S., Rao, X., Wang, Y., Kettner, N. M., Raghavendra, A. S., Tripathy, D., Damodaran, S., Hunt, K. K., et al. (2025) · Molecular Cancer · doi:10.1186/s12943-025-02226-9 · Cited by 58 · see citing works
Bidard, F., Kiavué, N., Jacot, W., Bachelot, T., Dureau, S., Bourgeois, H. P., Gonçalvès, A., Brain, E. G. C., Ladoire, S., Dalenc, F., et al. (2023) · Journal of Clinical Oncology · doi:10.1200/jco.23.00456 · Cited by 52 · see citing works
Palmieri, C., Linden, H. M., Birrell, S. N., Wheelwright, S. J., Lim, E., Schwartzberg, L. S., Dwyer, A. R., Hickey, T. E., Rugo, H. S., Cobb, P. W., et al. (2024) · The Lancet Oncology · doi:10.1016/s1470-2045(24)00004-4 · Cited by 50 · see citing works
Self-citationGoyal, R., Chen, H., Abughosh, S., Holmes, H. M., Candrilli, S. D., & Johnson, M. L. (2023) · Cancer · doi:10.1002/cncr.34675 · Cited by 47 · see citing works
“93]).(34) In the MONARCH‐3 trial, final OS results are not yet available; however, results from a recently published second interim analysis demonstrated that abemaciclib plus aromatase inhibitor had a significantly higher median OS compared with placebo plus aromatase inhibitor (67.”
ResultGrinshpun, A., Tolaney, S. M., Burstein, H. J., Jeselsohn, R. M., & Mayer, E. L. (2023) · npj Breast Cancer · doi:10.1038/s41523-023-00520-7 · Cited by 49 · see citing works
Esperança‐Martins, M., Roque, D., Barroso, T., Abrunhosa-Branquinho, A. N., Belo, D., Simas, N., & Costa, L. (2023) · Cancers · doi:10.3390/cancers15061796 · Cited by 49 · see citing works
“9 months with first-line hormone therapy and cyclin-dependent kinase inhibitors [76].”
BackgroundPavlovic, D., Nićiforović, D., Papic, D., Milojevic, K., & Marković, M. (2023) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359231205848 · Cited by 50 · see citing works
Kappel, C., Elliott, M. J., Kumar, V., Nadler, M. B., Desnoyers, A., & Amir, E. (2024) · Scientific Reports · doi:10.1038/s41598-024-53151-8 · Cited by 48 · see citing works
Jérusalem, G., Prat, A., Salgado, R., Reinisch, M., Saura, C., Ruíz-Borrego, M., Nikolinakos, P. G., Ades, F., Filian, J., Huang, N., et al. (2023) · The Breast · doi:10.1016/j.breast.2023.103580 · Cited by 46 · see citing works
Şahin, T. K., Rizzo, A., Güven, D. C., & Aksoy, S. (2025) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2025.102924 · Cited by 48 · see citing works
Jhaveri, K. L., & Marmé, F. (2023) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2023.102670 · Cited by 46 · see citing works
Provenzano, L., Dieci, M. V., Curigliano, G., Giuliano, M., Botticelli, A., Lambertini, M., Rizzo, G., Pedersini, R., Sirico, M., Verde, N. M. L., et al. (2025) · Annals of Oncology · doi:10.1016/j.annonc.2025.03.023 · Cited by 46 · see citing works
Ma, J., Chan, J. J., Toh, C. H., & Yap, Y. S. (2023) · npj Breast Cancer · doi:10.1038/s41523-023-00578-3 · Cited by 48 · see citing works
Self-citationLauro, V. D., Barchiesi, G., Martorana, F., Zucchini, G., Muratore, M., Fontanella, C., Arpino, G., Mastro, L. D., Giuliano, M., Puglisi, F., et al. (2022) · ESMO Open · doi:10.1016/j.esmoop.2022.100629 · Cited by 43 · see citing works
“In the MONALEESA-2 study, postmenopausal endocrine-sensitive HRþ/HER2 aBC patients were randomized to receive ribociclib or placebo in combination with letrozole.(3) HR-QoL was assessed using EORTC QLQ-C30 and BR23 questionnaires along with the EQ-5D-5L questionnaire at screening, every 8 weeks for the first 18 months…”
BackgroundMethodStanciu, I.-M., Paroșanu, A. I., & Niţipir, C. (2023) · Biomolecules · doi:10.3390/biom13091422 · Cited by 41 · see citing works
“The ribociclib group showed no grade 4 AEs or fatalities associated with interstitial lung disease or pneumonitis [37].”
BackgroundInfluentialAlbanell, J., Pérez-García, J. M., Gil‐Gil, M., Curigliano, G., Ruíz-Borrego, M., Comerma, L., Gibert, J., Bellet, M., Bermejo, B., Calvo, L., et al. (2022) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-22-1281 · Cited by 39 · see citing works
Senkus, E., Delaloge, S., Domchek, S. M., Conte, P., Im, S., Xu, B., Armstrong, A., Masuda, N., Fielding, A., Robson, M., et al. (2023) · International Journal of Cancer · doi:10.1002/ijc.34525 · Cited by 39 · see citing works
Self-citationTargeting oncogenic kinases: Insights on FDA approved tyrosine kinase inhibitors
Hussain, S., Mursal, M., Verma, G., Hasan, S. S., & Khan, M. F. (2024) · European Journal of Pharmacology · doi:10.1016/j.ejphar.2024.176484 · Cited by 41 · see citing works
Schäffler, H., Mergel, F., Pfister, K., Lukac, S., Fink, A., Veselinovic, K., Rack, B. K., Fink, V., Leinert, E., Dimpfl, M., et al. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms242216366 · Cited by 36 · see citing works
Self-citationGenetic Testing Enhances the Precision Diagnosis and Treatment of Breast Cancer
Yang, T.-L., Li, W., Huang, T., & Zhou, J. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms242316607 · Cited by 40 · see citing works
“A series of MONALEESA trials, including MONALEESA-2, MONALEESA-3, and MONALEESA-7 trials, proved the favored PFS of combining riboci-clib with the aromatase inhibitor [109–112].”
BackgroundTherapeutic evolution in HR+/HER2- breast cancer: from targeted therapy to endocrine therapy
Cao, L.-Q., Sun, H., Xie, Y., Patel, H. H., Bo, L., Lin, H., & Chen, Z. (2024) · Frontiers in Pharmacology · doi:10.3389/fphar.2024.1340764 · Cited by 37 · see citing works
Seize the engine: Emerging cell cycle targets in breast cancer
Fuentes‐Antrás, J., Bedard, P. L., & Cescon, D. W. (2024) · Clinical and Translational Medicine · doi:10.1002/ctm2.1544 · Cited by 38 · see citing works
“Their development has been focused on HR + BC, where underlying genomic (e.g. 24 These drugs are United States Food and Drug Administration (US FDA) and European Medicines Agency approved for the treatment of HR + /HER2 − –mBC in combination with endocrine therapy (ET), while abemaciclib is also…”
BackgroundMeegdes, M., Geurts, S. M. E., Erdkamp, F., Dercksen, M. W., Vriens, B. E. P. J., Aaldering, K. N. A., Pepels, M. J. A. E., van de Winkel, L., Peters, N. A. J. B., Tol, J., et al. (2023) · The Lancet Regional Health - Europe · doi:10.1016/j.lanepe.2022.100573 · Cited by 34 · see citing works
Mechanisms of endocrine resistance in hormone receptor-positive breast cancer
Gao, Y., Yu, Y., Zhang, M.-Q., Yu, W.-J., & Kang, L. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1448687 · Cited by 31 · see citing works
LncRNA EILA promotes CDK4/6 inhibitor resistance in breast cancer by stabilizing cyclin E1 protein
Cai, Z., Shi, Q., Li, Y., Jin, L., Li, S., Wong, L. L., Wang, J., Jiang, X., Zhu, M., Lin, J., et al. (2023) · Science Advances · doi:10.1126/sciadv.adi3821 · Cited by 32 · see citing works
Lobular Carcinoma of the Breast: A Comprehensive Review with Translational Insights
Batra, H. V., Mouabbi, J. A., Ding, Q., Şahin, A. A., & Raso, M. G. (2023) · Cancers · doi:10.3390/cancers15225491 · Cited by 31 · see citing works
“The first-line treatment in a metastatic setting is endocrine therapy with or without CDK4/6i, as shown by the MONARCH, MONALEESA, and PALOMA studies [210,214–216].”
BackgroundMethodRibociclib Plus Endocrine Therapy in Hormone Receptor–Positive/ ERBB2 -Negative Early Breast Cancer
Fasching, P. A., Stroyakovskiy, D., Yardley, D. A., Huang, C., Crown, J. P., Bardia, A., Chia, S., Im, S., Martín, M., Xu, B., et al. (2025) · JAMA Oncology · doi:10.1001/jamaoncol.2025.3700 · Cited by 36 · see citing works
Self-citationHR+/HER2– Advanced Breast Cancer Treatment in the First-Line Setting: Expert Review
Jerzak, K. J., Bouganim, N., Brezden‐Masley, C., Edwards, S. J., Gelmon, K. A., Henning, J., Hilton, J. F., & Sehdev, S. R. (2023) · Current Oncology · doi:10.3390/curroncol30060411 · Cited by 31 · see citing works
“…2A) Notably, the median OS in the control arms of MONALEESA-2 and PALOMA-2 were 51.4 months and 51.2 months, respectively, suggesting these trial populations were similar, yet the median OS in the treatment arms were strikingly different (63.9 months and 53.9 months, respectively) [14,15].”
InfluentialLee, J. S., Hackbart, H., Cui, X., & Yuan, Y. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms241411791 · Cited by 32 · see citing works
“MONALEESA-2 [6,7] Ribociclib plus letrozole 668 (1:1) 25.”
Hogstrom, J. M., Cruz, K. A., Selfors, L. M., Ward, M. N., Mehta, T. S., Kanarek, N., Philips, J., Dialani, V. M., Wulf, G. M., Collins, L. C., et al. (2023) · Journal of Biological Chemistry · doi:10.1016/j.jbc.2023.105021 · Cited by 28 · see citing works
Integrating radiation therapy with targeted treatments for breast cancer: From bench to bedside
Meattini, I., Livi, L., Lorito, N., Becherini, C., Bacci, M., Visani, L., Fozza, A., Belgioia, L., Loi, M., Mangoni, M., et al. (2022) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2022.102417 · Cited by 30 · see citing works
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“Although all first-line studies of different CDK4/6is combined with ET showed similar relative benefits in PFS, a significant improvement in OS has so far been reported for riboci-clib combined with ET in pre-and post-menopausal women in both the MONALEESA-7 and -2 trials [9,10].”
BackgroundGroheux, D., Vaz, S. C., Poortmans, P., Mann, R. M., Ulaner, G., Cook, G. J. R., Hindié, E., Woll, J. P. P., Jacene, H., Rubio, I. T., et al. (2024) · Breast · doi:10.1016/j.breast.2024.103806 · Cited by 30 · see citing works
“Randomized, multi-center trials across BC subtypes have demonstrated prolonged disease-free and overall survival for advanced breast cancer since the introduction of new systemic treatments [153 – 155], possibly changing the way that oligo-metastatic disease (OMD) may be managed in the future [156].”
BackgroundKim, S. Y., Yin, J., Bohlman, S., Walker, P., Dacic, S., Kim, C., Khan, H., Liu, S. V., Ma, P. C., Nagasaka, M., et al. (2022) · JTO Clinical and Research Reports · doi:10.1016/j.jtocrr.2022.100381 · Cited by 28 · see citing works
Masurkar, P. P., Damgacioglu, H., Deshmukh, A. A., & Trivedi, M. V. (2023) · PharmacoEconomics · doi:10.1007/s40273-023-01245-y · Cited by 28 · see citing works
Nabieva, N., & Fasching, P. A. (2023) · Cancers · doi:10.3390/cancers15061763 · Cited by 28 · see citing works
Real-world effectiveness of CDK 4/6 inhibitors in estrogen-positive metastatic breast cancer
Gehrchen, M. L., Berg, T., Garly, R., Jensen, M., Eßer-Naumann, S., Rønlev, J. D., Nielsen, H. M., Knoop, A. S., & Kümler, I. (2024) · BJC Reports · doi:10.1038/s44276-024-00070-w · Cited by 28 · see citing works
Buller, W., Pallan, L., Chu, T., & Khoja, L. (2023) · Journal of Oncology Pharmacy Practice · doi:10.1177/10781552231163121 · Cited by 27 · see citing works
“10,11 None of these agents have been directly compared in any setting and all remain acceptable fi rst line therapy options in metastatic disease.”
BackgroundTargeting sex steroid biosynthesis for breast and prostate cancer therapy
POUTANEN, M. H., Thulin, M. H., & Härkönen, P. L. (2023) · Nature reviews. Cancer · doi:10.1038/s41568-023-00609-y · Cited by 28 · see citing works
Cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors: existing and emerging differences
Johnston, S. R. D., Emde, A., Barrios, C. H., Srock, S., Neven, P., Martin, M., Cameron, D., Janni, W., & Gnant, M. (2023) · JNCI Cancer Spectrum · doi:10.1093/jncics/pkad045 · Cited by 29 · see citing works
Self-citationCell cycle plasticity underlies fractional resistance to palbociclib in ER+/HER2− breast tumor cells
Zikry, T. M., Wolff, S. C., Ranek, J. S., Davis, H. M., Naugle, A., Luthra, N., Whitman, A. A., Kedziora, K. M., Stallaert, W., Kosorok, M. R., et al. (2024) · Proceedings of the National Academy of Sciences · doi:10.1073/pnas.2309261121 · Cited by 26 · see citing works
“In fact, patients with ER+/HER2− breast cancer treated with abemaciclib or ribociclib, which have greater activity against CDK2 compared to the more CDK4/6 specific palbociclib, have improved responses (75–78).”
BackgroundPost-CDK 4/6 Inhibitor Therapy: Current Agents and Novel Targets
Ashai, N., & Swain, S. M. (2023) · Cancers · doi:10.3390/cancers15061855 · Cited by 25 · see citing works
“In the first-line setting, ribociclib combined with endocrine therapy showed an overall survival (OS) benefit [8,9].”
BackgroundKahraman, S., Erul, E., Seyyar, M., Gümüşay, Ö., Bayram, E., Demirel, B. Ç., Acar, Ö., Aksoy, S., Baytemür, N. K., Şahin, E., et al. (2023) · Future Oncology · doi:10.2217/fon-2022-1287 · Cited by 24 · see citing works
Nathan, S. D., Johri, S., Joly, J. M., et al. (2023) · Thorax · doi:10.1136/thorax-2023-220821 · Cited by 25 · see citing works
Tolaney, S. M., Punie, K., Carey, L. A., et al. (2024) · ESMO Open · doi:10.1016/j.esmoop.2024.103691 · Cited by 24 · see citing works
Kubeczko, M., Gabryś, D., Gawkowska‐Suwińska, M., Polakiewicz-Gilowska, A., Cortez, A. J., Krzywon, A., Woźniak, G., Latusek, T., Leśniak, A., Swiderska, K., et al. (2023) · Cancers · doi:10.3390/cancers15030690 · Cited by 27 · see citing works
“Given data on the overall survival benefits with CDK4/6i treatment [43], the addition of another treatment modality should not interfere with this therapy.”
BackgroundCardoso, F., Rihani, J., Harmer, V., Harbeck, N., Casas, A., Rugo, H. S., Fasching, P. A., Moore, A., de Courcy, J., Pathak, P., et al. (2023) · The Oncologist · doi:10.1093/oncolo/oyad207 · Cited by 27 · see citing works
Chiu, J. W. Y., Su, F., Joshi, M., Masuda, N., Ishikawa, T., Aruga, T., Zarate, J. P., Babbar, N., Balbin, O. A., & Yap, Y. S. (2023) · BMC Medicine · doi:10.1186/s12916-023-03017-z · Cited by 26 · see citing works
Self-citationAntonarelli, G., Salimbeni, B. T., Marra, A., Espósito, A., Locatelli, M., Trapani, D., Pescia, C., Fusco, N., Curigliano, G., & Criscitiello, C. (2023) · Critical Reviews in Oncology/Hematology · doi:10.1016/j.critrevonc.2023.104148 · Cited by 25 · see citing works
Thill, M., Zahn, M., Welt, A., Nusch, A., Zaiss, M. R., Engelken, K., Kaltenecker, G., Ringwald, K. G., Gratzke, K., Dille, S., et al. (2024) · International Journal of Cancer · doi:10.1002/ijc.35296 · Cited by 23 · see citing works
“…a distinct, yet nonsignificant benefit of abemaciclib and a significant benefit of ribociclib compared to ET alone in the first-line setting, 7 – 9 raises questions about the lack of an OS benefit for palbociclib and recommends yielding the interchangeable prescription to an individualized…”
Re, M. D., Crucitta, S., Omarini, C., Bargagna, I., Mongillo, M., Palleschi, M., Stucci, S., Meattini, I., D'Onofrio, R., Lorenzini, G., et al. (2022) · The Breast · doi:10.1016/j.breast.2022.10.005 · Cited by 23 · see citing works
Wekking, D., Leoni, V. P., Lambertini, M., Dessì, M., Pretta, A., Cadoni, A., Atzori, L., Scartozzi, M., & Solinas, C. (2023) · Cytokine & Growth Factor Reviews · doi:10.1016/j.cytogfr.2023.10.001 · Cited by 26 · see citing works
The Evolving Pathways of the Efficacy of and Resistance to CDK4/6 Inhibitors in Breast Cancer
Gomes, I., Abreu, C., Costa, L., & Casimiro, S. (2023) · Cancers · doi:10.3390/cancers15194835 · Cited by 23 · see citing works
“Median OS was also significantly prolonged (63.9 vs. 51.4 months, (HR 0.76, 95% CI 0.63–0.93, two-sided p = 0.008) [40]).”
InfluentialPascual, T., Fernández-Martínez, A., Agrawal, Y., Pfefferle, A. D., Chic, N., Brasó‐Maristany, F., González‐Farré, B., Paré, L., Villacampa, G. J., Saura, C., et al. (2024) · npj Breast Cancer · doi:10.1038/s41523-024-00625-7 · Cited by 22 · see citing works
“Among them, ribociclib, a CDK4/6 inhibitor, in combination with endocrine therapy (ET), has been shown to improve progression-freesurvival 14 – 16 andoverallsurvival 17 – 19 oversingleagentETin patients with metastatic HR + /HER2 − breast cancer, including Luminal B disease 20,21 .”
Gastrointestinal Metastases From Lobular Breast Carcinoma: A Literature Review
Kioleoglou, Z., Georgaki, E., Koufopoulos, N. I., Köstek, O., Volakakis, N., Dimitriadou, A., & Kokkali, S. (2024) · Cureus · doi:10.7759/cureus.65852 · Cited by 22 · see citing works
Prat, A., Solovieff, N., André, F., O’Shaughnessy, J., Cameron, D., Janni, W., Sonke, G. S., Yap, Y. S., Yardley, D. A., Partridge, A. H., et al. (2023) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-23-0561 · Cited by 22 · see citing works
Self-citationCortés, J., Hurvitz, S. A., O'Shaughnessy, J. A., et al. (2024) · Journal of Clinical Oncology · doi:10.1200/jco.23.02036 · Cited by 21 · see citing works
Self-citationTargeting HER2-low in metastatic breast cancer: an evolving treatment paradigm
Yang, C., Brezden‐Masley, C., Joy, A. A., Sehdev, S. R., Modi, S., Simmons, C. E., & Henning, J. (2023) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359231175440 · Cited by 21 · see citing works
Yıldırım, E. Ç., Atağ, E., Çoban, E., Unal, O. U., Çelebi, A., Keser, M., Uzun, M., Keskinkılıç, M., Şimşek, E. T., Sari, M., et al. (2023) · Breast · doi:10.1016/j.breast.2023.06.006 · Cited by 21 · see citing works
Al-Ziftawi, N. H., Elazzazy, S., Alam, M. F., Shafie, A. A., Hamad, A. A., Bbujassoum, S., & Ibrahim, M. I. M. (2023) · Frontiers in Oncology · doi:10.3389/fonc.2023.1203684 · Cited by 21 · see citing works
Vasseur, A., Cabel, L., Hego, C., Taka, W., Trabelsi‐Grati, O., Renouf, B., Lerebours, F., Loirat, D., Brain, E. G. C., Cottu, P. H., et al. (2024) · Oncogene · doi:10.1038/s41388-024-02986-6 · Cited by 22 · see citing works
“Three CDK4/6i (palbociclib, ribociclib and abemaciclib) [2 – 4] in combination with aromatase inhibitors [5] or fulvestrant (a selective estrogen receptor degrader) [6] have extended progression-free survival (PFS) and overall survival (OS) [7].”
BackgroundSánchez-Bayona, R., de, A. L., Gilarranz, Y. J., de Torre, A. S., Alva, M., Echavarría, I., Moreno, F., Tolosa, P., López, B. H., de Luna, A., et al. (2024) · Breast Cancer Research and Treatment · doi:10.1007/s10549-024-07324-8 · Cited by 22 · see citing works
Garrido-Castro, A. C., Graham, N., Ali, L. R., Herold, C. I., Desrosiers, J., Do, K., Parsons, H. A., Li, T., Goel, S., DiLullo, M. K., et al. (2025) · Journal for ImmunoTherapy of Cancer · doi:10.1136/jitc-2024-010430 · Cited by 20 · see citing works
“20 Similarly, MONALEESA-7 compared the addition of ribociclib or placebo to endocrine therapy (goserelin and either a non-steroidal aromatase inhibitor or tamoxifen) in pre-/perimenopausal women with previously untreated HR-positive/HER2-negative MBC, and showed a significant increase in rates of…”
Giugliano, F., Angelis, C. D., Pistilli, B., Viale, G., Bianchini, G., Giuliano, M., Malorni, L., Salimbeni, B. T., Espósito, A., Giordano, A., et al. (2025) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2025.102980 · Cited by 25 · see citing works
Lord, S. J., Daniels, B. J., Kiely, B. E., et al. (2022) · The Medical Journal of Australia · doi:10.5694/mja2.51687 · Cited by 20 · see citing works
Queiroz, M. M., Sacardo, K. P., Ribeiro, M. F., Gadotti, L. L., Saddi, R., Oliveira, L. J. D. C., Linck, R. D. M., Cruz, M. R. D. S., Barroso‐Sousa, R., Sahade, M., et al. (2023) · Cancer Treatment and Research Communications · doi:10.1016/j.ctarc.2023.100683 · Cited by 20 · see citing works
Petrelli, F., Dottorini, L., Menna, G. D., Borgonovo, K., Parati, M. C., Rea, C. G., Ghilardi, M., Ghidini, A., & Luciani, A. (2023) · The Breast · doi:10.1016/j.breast.2023.05.002 · Cited by 20 · see citing works
Regulation of the Cell Cycle by ncRNAs Affects the Efficiency of CDK4/6 Inhibition
Hu, Q., & Huang, T. (2023) · International Journal of Molecular Sciences · doi:10.3390/ijms24108939 · Cited by 20 · see citing works
Nicolini, A., & Ferrari, P. (2024) · Cancers · doi:10.3390/cancers16020466 · Cited by 22 · see citing works
“Clinical trials have shown a median PFS extending from 25.3 months with ribociclib [25,26] to 28.2 months with abemaciclib [27].”
BackgroundResultInfluentialAgarwal, N., Castellano, D., Alonso‐Gordoa, T., Arija, J. Á. A., Colomba, É., Gravis, G., Mourey, L., Oudard, S. M., Fléchon, A., González, M., et al. (2024) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-23-3436 · Cited by 20 · see citing works
Lin, C.-C. A., Chica-Parrado, M. D. R., Unni, N. G., Jaeger, E., Fang, Y. V., Guo, L. M., Napolitano, F., Luna, P., Harris, M., Chao, C. Y., et al. (2025) · Clinical Cancer Research · doi:10.1158/1078-0432.ccr-24-2307 · Cited by 19 · see citing works
Self-citationBreast Cancer Genomics: Primary and Most Common Metastases
Bennett, C., Carroll, C., Wright, C., Awad, B., Park, J. M., Farmer, M. B., Brown, E. (., Heatherly, A., & Woodard, S. A. (2022) · Cancers · doi:10.3390/cancers14133046 · Cited by 18 · see citing works
Kawai, M., Takada, M., Nakayama, T., Masuda, N., Shiheido, H., Cai, Z., Huang, Y., Kawaguchi, T., & Tanizawa, Y. (2022) · Breast Cancer Research and Treatment · doi:10.1007/s10549-022-06816-9 · Cited by 20 · see citing works
Advances in Endocrine Therapy for Hormone Receptor-Positive Advanced Breast Cancer
Ziyeh, S., Wong, L., & Basho, R. K. (2023) · Current Oncology Reports · doi:10.1007/s11912-023-01393-6 · Cited by 19 · see citing works
“MONALEESA-2 [22, 72] Postmenopausal women (N = 668) Ribociclib + letrozole 25.”
Background
- Authors
- Hortobagyi, G. N., Stemmer, S. M., Burris, H. A., Yap, Y.-S., Sonke, G. S., Hart, L., Campone, M., Petrakova, K., Winer, E. P., Janni, W., Conte, P., Cameron, D. A., André, F., Arteaga, C. L., Zarate, J. P., Chakravartty, A., Taran, T., Le Gac, F., Serra, P., & O’Shaughnessy, J.
- Affiliations
- From the Department of Breast Medical Oncology, University of Texas M.D. Anderson Cancer Center, Houston (G.N.H.), and Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center (C.L.A.), and Baylor University Medical Center, Texas Oncology, US Oncology (J.O.), Dallas — all in Texas; the Institute of Oncology, Davidoff Center, Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel (S.M.S.); Sarah Cannon Research Institute, Nashville (H.A.B.); the Department of Medical Oncology, National Cancer Centre Singapore, Singapore (Y.-S.Y.); the Department of Medical Oncology, Netherlands Cancer Institute and Borstkanker Onderzoek Groep Study Center, Amsterdam (G.S.S.); Florida Cancer Specialists, Sarah Cannon Research Institute, Fort Myers (L.H.); the Department of Medical Oncology, Institut de Cancérologie de l’Ouest–René Gauducheau, Saint-Herblain (M.C.), and the Department of Medical Oncology, Institut Gustave Roussy, Medical School, Université Paris-Saclay, Villejuif (F.A.) — both...
- The University of Texas MD Anderson Cancer Center (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2022-03-10
- Volume
- 386
- Issue
- 10
- Pages
- 942-950
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W4220709633
- Cited by
- 791
- References
- 30
- Citations by year
- 2026: 177 · 2025: 226 · 2024: 200 · 2023: 150 · 2022: 38
- FWCI
- 99.29
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (publishedVersion, other-oa)
- Funders
- Novartis Pharmaceuticals Corporation (N/A)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Advanced Breast Cancer Therapies
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Cancer Research › Breast Cancer Treatment Studies
- Health Sciences › Medicine › Oncology › PARP inhibition in cancer therapy
- Keywords
- ribociclib, letrozole, advanced breast cancer, hormone receptor-positive HER2-negative breast cancer, overall survival, first-line therapy, CDK4/6 inhibitors, postmenopausal women, progression-free survival
- MeSH terms
- Letrozole, Aged, Aminopyridines, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Female, Humans, Middle Aged, Neutropenia, Purines, Receptors, Estrogen, Survival Analysis, Erb-b2 Receptor Tyrosine Kinases, Intention to Treat Analysis, Neoplasm Grading
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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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