The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index; 25 of the 48 sources its claims cite were checked for support.
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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Claims the paper makes
34 Own result · 11 Own method · 7 Partly supported · 4 No full text of the sources · 3 Supported so far · 3 Own interpretation · 2 Supported · 2 Not supported · 2 No basis given · accuracy not yet measured
At least one cited source doesn’t support this claim or points to a different paper, and none confirmed it — see the verdicts below.
In the paper
“This trial has a long follow-up (median, 80 months). 19-23”
What the sources say
- Disputedcites [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. sourceExperimental — accuracy not yet measured
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.
- Disputedcites [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. sourceExperimental — accuracy not yet measured
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.
- Disputedcites [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. sourceExperimental — accuracy not yet measured
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.
- Not checked — no full text of the sourcecites [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
- Not checked — no full text of the sourcecites [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
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Disputed
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Data for overall survival were immature at the time of the primary and updated analyses.”
What the sources say
- Partly supportedcites [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. sourceExperimental — accuracy not yet measured
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)
- Not checked — no full text of the sourcecites [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
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“To date, two trials evaluating ribociclib that included some patients receiving firstline therapy showed a significant overall survival benefit. 14-16”
What the sources say
- Not checked — no full text of the sourcecites [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
- Partly supportedcites [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. sourceExperimental — accuracy not yet measured
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)
- Partly supportedcites [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. sourceExperimental — accuracy not yet measured
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)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“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).”
What the sources say
- Partly supportedcites [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. sourceExperimental — accuracy not yet measured
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)
- Not checked — no full text of the sourcecites [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
plaincorrelational- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Partly supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“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).”
What the sources say
- Partly supportedcites [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. sourceExperimental — accuracy not yet measured
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)
- Not checked — no full text of the sourcecites [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
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“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”
What the sources say
- Supportedcites [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 Abstract reports that MONALEESA-3 compared ribociclib plus fulvestrant with placebo plus fulvestrant as first- or second-line treatment and found a significant overall survival benefit. It describes the trial population as postmenopausal patients with advanced breast cancer. (LLM, conf=0.94)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Supported
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“Increased expression of CDK4 has been shown to drive resistance to endocrine therapy in patients with HR-positive breast cancer. 4-7”
What the sources say
- Not checked — no full text of the sourcecites [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.
- Partly supportedcites [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. sourceExperimental — accuracy not yet measured
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)
- Not checked — no full text of the sourcecites [6] 6. Shapiro GI. Cyclin-dependent kinase pathways as targets for cancer treatment. J Clin Oncol 2006; 24: 1770-83. source
- Partly supportedcites [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. sourceExperimental — accuracy not yet measured
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)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“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).”
What the sources say
- Supportedcites [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 Methods identify this as a phase 3 first-line trial in postmenopausal women with HR-positive, HER2-negative advanced breast cancer. The Discussion reports that, at the planned interim analysis, progression-free survival was significantly longer with ribociclib plus letrozole than with placebo plus letrozole. The claim's “letrozole alone” describes that placebo-plus-letrozole comparator. (LLM, conf=0.95)
- Not checked — no full text of the sourcecites [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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- Also stated in: § ABSTRACT · p. 3 · plain
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“These trials showed a 29%, 28%, and 24% lower risk of death, respectively.”
What the sources say
- Not checked — no full text of the sourcecites [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
- Supportedcites [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 Overall Survival section reports a 28% lower relative risk of death for ribociclib plus fulvestrant than for placebo plus fulvestrant (hazard ratio 0.72). The paper also reports hazard ratios of 0.71 and 0.76 for the other trials, corresponding to the cited 29% and 24% reductions, respectively. (LLM, conf=0.92)
- Supportedcites [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 hazard ratio of 0.757 for abemaciclib plus fulvestrant versus placebo plus fulvestrant, equivalent to approximately 24% lower risk of death. This supports the 24% figure attributed to MONARCH 2; this source is not being used to substantiate the other two trials’ figures. (LLM, conf=0.93)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The sources with a verdict support this claim; the rest weren’t checked yet, have no full text we could read, or their verdicts aren’t rated yet.
In the paper
“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”
What the sources say
- Not checked — no full text of the sourcecites [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
- Supportedcites [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 reports significant overall-survival benefits in MONALEESA-3 and MONALEESA-7 with ribociclib and in MONARCH 2 with abemaciclib. It identifies these as trials involving patients with hormone-receptor-positive, HER2-negative advanced breast cancer, while noting that the trial populations differed. (LLM, conf=0.93)
- Supportedcites [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 Key Points report that MONARCH 2 found significantly improved overall survival with abemaciclib plus fulvestrant versus placebo plus fulvestrant in patients with HR-positive, ERBB2-negative advanced breast cancer. The Discussion also calls the improvement statistically significant. This source supports the MONARCH 2 portion of the multi-trial claim; its participants had progressed on prior endocrine therapy. (LLM, conf=0.93)
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
- The quote only partly states this claim. 3
- It may state two separate claims as one. 18
- Probably not a substantial claim. 16
At least one cited source doesn’t support this claim or points to a different paper, and none confirmed it — see the verdicts below.
In the paper
“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”
What the sources say
- Disputedcites [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. sourceExperimental — accuracy not yet measured
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.
- Disputedcites [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. sourceExperimental — accuracy not yet measured
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.
- Not checked — no full text of the sourcecites [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
- Not checked — no full text of the sourcecites [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
- Not checked — no full text of the sourcecites [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
- Disputedcites [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. sourceExperimental — accuracy not yet measured
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.
- Not checked — no full text of the sourcecites [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
- Could not verifycites [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. sourceExperimental — accuracy not yet measured
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)
- Not checked — no full text of the sourcecites [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
- Disputedcites [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. sourceExperimental — accuracy not yet measured
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.
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
The quote only partly states this claim.
- Disputed
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“The use of CDK4/6 inhibitors (ribociclib, abemaciclib, and palbociclib) improved progression-free survival in this patient population, leading to regulatory approvals. 9-13”
What the sources say
- Not checked — no full text of the sourcecites [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
- Partly supportedcites [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. sourceExperimental — accuracy not yet measured
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)
- Not checked — no full text of the sourcecites [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
- Partly supportedcites [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. sourceExperimental — accuracy not yet measured
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)
- Not matchedcites [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.
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
The cited sources support only part of this claim — read each source’s verdict below.
In the paper
“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”
What the sources say
- Partly supportedcites [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. sourceExperimental — accuracy not yet measured
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)
plainn = 334- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
- Partly supported
Every source the paper cites for this claim was checked and supports it.
In the paper
“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”
What the sources say
- Supportedcites [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
The overall-survival figure (p. 1930) reports a stratified hazard ratio for death of 0.81, corresponding to a 19% lower estimated risk, with P=0.09. The Discussion also says the overall-survival finding did not reach significance in the intention-to-treat population. (LLM, conf=0.94)
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one. The quote only partly states this claim.
- Also stated in: § Discussion · p. 9 · plain
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“The median duration of exposure to placebo was 14.1 months (interquartile range, 7.1 to 28.9).”
plainn = 334- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Unfortunately, only 2.5% of women in the trial were Black; thus, this demographic group was underrepresented in our trial.”
plainn = 334- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“Among all patients, the median duration of follow-up (randomization to data cutoff) was 80 months (minimum, 75 months).”
plainn = 334- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
plainn = 334- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
hedgeddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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).”
hedged- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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).”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“No grade 4 adverse events or deaths related to interstitial lung disease or pneumonitis occurred in the ribociclib group.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: unclear — It is unclear whether the paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
A result the paper reports from its own data — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“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).”
plainn = 304- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
In the paper
“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”
What the sources say
- Not checked — no full text of the sourcecites [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
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
plainn = 243- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
In the paper
“Preclinically, ribociclib has been shown to inhibit CDK4 preferentially and has also shown high drug concentrations at clinically relevant doses. 8”
What the sources say
- Not checked — no full text of the sourcecites [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
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
- Also stated in: § METHODS · p. 2 · plain
In the paper
“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”
What the sources say
- Not checked — no full text of the sourcecites [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
boosteddirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Crossover between the two groups was not allowed until the final analysis of overall survival was completed.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Four patients assigned to the placebo group did not receive placebo plus letrozole as assigned.”
plainn = 4- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Randomization was stratified according to the presence or absence of liver or lung metastases.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“An independent data monitoring committee assessed safety data.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“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).”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“Before enrollment, all the patients provided written informed consent.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“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.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it.
What the paper did — it cites no source for this, so there is none to check. The quote shows it is in the paper.
In the paper
“This trial was conducted in accordance with the provisions of the Declaration of Helsinki and Good Clinical Practice guidelines and was funded by Novartis.”
plain- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: fails — The paper’s conclusions may not depend on it.
- Based: passes — The paper gives a reason why it holds.
Probably not a substantial claim. The paper’s conclusions may not depend on it. It may state two separate claims as one.
A conclusion the paper draws from its own results — it cites no other source for it, so there is none to check. The quote shows it is in the paper.
In the paper
“the ribociclib group had a significant overall survival benefit.”
plaindirect- Asserted: passes — The authors put it forward as true.
- Checkable: passes — It can be checked against evidence.
- Load-bearing: passes — The paper’s conclusions depend on it.
- Based: passes — The paper gives a reason why it holds.
It may state two separate claims as one. The quote only partly states this 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?
The source backs part of the claim, not all of it — or backs it for a different population, condition or comparison.
In the citing paper
“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]
Experimental — accuracy not yet measuredThe cited source says what the claim attributes to it.
In the citing paper
“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 cited source says what the claim attributes to it.
In the citing paper
“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]
The cited source says what the claim attributes to it.
In the citing paper
“This is the third pivotal trial to demonstrate a significant improvement in OS with ribociclib in a first-line setting”
The cited source says what the claim attributes to it.
In the citing paper
“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].”
Citations
Cites
Ribociclib as first-line therapy for HR-positive, advanced breast cancer
Hortobagyi, G. N., Stemmer, S. M., Burris, H. A., Yap, Y.-S., Sonke, G. S., Paluch-Shimon, S., Campone, M., Blackwell, K. L., André, F., Winer, E. P., et al. (2016) · New England Journal of Medicine · doi:10.1056/nejmoa1609709 · Cited by 2,039
Self-citationCristofanilli, M., Turner, N. C., Bondarenko, I., Ro, J., Im, S.-A., Masuda, N., Colleoni, M., DeMichele, A., Loi, S., Verma, S., et al. (2016) · The Lancet Oncology · doi:10.1016/s1470-2045(15)00613-0 · Cited by 1,827
MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer
Goetz, M. P., Toi, M., Campone, M., Sohn, J., Paluch-Shimon, S., Huober, J., Park, I. H., Trédan, O., Chen, S.-C., Manso, L., et al. (2017) · Journal of Clinical Oncology · doi:10.1200/jco.2017.75.6155 · Cited by 1,744
Self-citation5th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 5)
Cardoso, F., Paluch-Shimon, S., Senkus, E., Curigliano, G., Aapro, M. S., André, F., Barrios, C. H., Bergh, J., Bhattacharyya, G. S., Biganzoli, L., et al. (2020) · Annals of Oncology · doi:10.1016/j.annonc.2020.09.010 · Cited by 1,369
Self-citationOverall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer
Turner, N. C., Slamon, D. J., Ro, J., Bondarenko, I., Im, S.-A., Masuda, N., Colleoni, M., DeMichele, A., Loi, S., Verma, S., et al. (2018) · New England Journal of Medicine · doi:10.1056/nejmoa1810527 · Cited by 1,276
Self-citationTreating cancer with selective CDK4/6 inhibitors
O'Leary, B., Finn, R. S., & Turner, N. C. (2016) · Nature Reviews Clinical Oncology · doi:10.1038/nrclinonc.2016.26 · Cited by 1,137
Cyclin-Dependent Kinase Pathways As Targets for Cancer Treatment
Shapiro, G. I. (2006) · Journal of Clinical Oncology · doi:10.1200/jco.2005.03.7689 · Cited by 1,036
Overall survival with ribociclib plus endocrine therapy in breast cancer
Im, S.-A., Lu, Y.-S., Bardia, A., Harbeck, N., Colleoni, M., Franke, F., Chow, L., Sohn, J., Lee, K.-S., Campos-Gomez, S., et al. (2019) · New England Journal of Medicine · doi:10.1056/nejmoa1903765 · Cited by 1,001
Self-citationSledge, G. W., Toi, M., Neven, P., Sohn, J., Inoue, K., Pivot, X., Burdaeva, O., Okera, M., Masuda, N., Kaufman, P. A., et al. (2020) · JAMA Oncology · doi:10.1001/jamaoncol.2019.4782 · Cited by 991
Self-citationHortobagyi, G. N., Stemmer, S. M., Burris, H. A., Yap, Y. S., Sonke, G. S., Paluch-Shimon, S., Campone, M., Petrakova, K., Blackwell, K. L., Winer, E. P., et al. (2018) · Annals of Oncology · doi:10.1093/annonc/mdy155 · Cited by 876
Self-citation
Cited by
Sorted by citations
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 440
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 381
Analysis of Breast Cancer Mortality in the US—1975 to 2019
Caswell-Jin, J. L., Sun, L. P., Muñoz, D. F., Lü, Y., Li, Y., Huang, H., Hampton, J. M., Song, J., Jayasekera, J. C., Schechter, C. B., et al. (2024) · JAMA · doi:10.1001/jama.2023.25881 · Cited by 299
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 290
“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 276
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
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 229
“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
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 209
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 157
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 133
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 116
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 110
“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 101
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
“…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 92
“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 89
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 86
“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 87
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
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 82
“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 72
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 84
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 68
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 62
“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 58
“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 59
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 55
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
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 49
“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
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
“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 51
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
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
Şahin, T. K., Rizzo, A., Güven, D. C., & Aksoy, S. (2025) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2025.102924 · Cited by 48
Jhaveri, K. L., & Marmé, F. (2023) · Cancer Treatment Reviews · doi:10.1016/j.ctrv.2023.102670 · Cited by 49
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 48
Ma, J., Chan, J. J., Toh, C. H., & Yap, Y. S. (2023) · npj Breast Cancer · doi:10.1038/s41523-023-00578-3 · Cited by 49
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 44
“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
“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
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
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
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
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 45
“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 44
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 40
“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 36
Mechanisms of endocrine resistance in hormone receptor-positive breast cancer
Gao, Y., Yu, Y., Zhang, M., Yu, W., & Kang, L. (2024) · Frontiers in Oncology · doi:10.3389/fonc.2024.1448687 · Cited by 43
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
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 35
“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 38
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
“…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 33
“MONALEESA-2 [6,7] Ribociclib plus letrozole 668 (1:1) 25.”
Högström, J., 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
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
Ferro, A., Campora, M., Caldara, A., Lisi, D. D., Lorenzi, M., Monteverdi, S., Mihai, R., Bisio, A., Dipasquale, M., Caffo, O., et al. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13123611 · Cited by 31
“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
“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 29
Masurkar, P. P., Damgacioglu, H., Deshmukh, A. A., & Trivedi, M. V. (2023) · PharmacoEconomics · doi:10.1007/s40273-023-01245-y · Cited by 28
Nabieva, N., & Fasching, P. A. (2023) · Cancers · doi:10.3390/cancers15061763 · Cited by 29
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 29
Buller, W., Pallan, L., Chu, T., & Khoja, L. (2023) · Journal of Oncology Pharmacy Practice · doi:10.1177/10781552231163121 · Cited by 30
“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 31
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 30
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 31
“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
“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 26
Nathan, S. D., Johri, S., Joly, J. M., et al. (2023) · Thorax · doi:10.1136/thorax-2023-220821 · Cited by 25
Tolaney, S. M., Punie, K., Carey, L. A., et al. (2024) · ESMO Open · doi:10.1016/j.esmoop.2024.103691 · Cited by 24
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
“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
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 27
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 26
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 26
“…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
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
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 24
“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
“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
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
Self-citationCortés, J., Hurvitz, S. A., O’Shaughnessy, J., Delaloge, S., Iwata, H., Rugo, H. S., Neven, P., Kanagavel, D., Cohen, P., Paux, G., et al. (2024) · Journal of Clinical Oncology · doi:10.1200/jco.23.02036 · Cited by 24
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 22
Yıldırım, E. Ç., Atağ, E., Çoban, E., Ünal, O. Ü., Çelebi, A., Keser, M., Uzun, M., Keskinkılıç, M., Şimşek, E. T., Sarı, M., et al. (2023) · The Breast · doi:10.1016/j.breast.2023.06.006 · Cited by 22
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 23
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 24
“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 24
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
“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 26
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
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 21
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 21
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 23
Nicolini, A., & Ferrari, P. (2024) · Cancers · doi:10.3390/cancers16020466 · Cited by 23
“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
Lin, C.-C. A., Chica-Parrado, M. D. R., Unni, N. G., Jaeger, E., Fang, Y. V., Guo, L., 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
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
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
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
“MONALEESA-2 [22, 72] Postmenopausal women (N = 668) Ribociclib + letrozole 25.”
Background
Metadata
- 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 › Oncology › 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
About these checks
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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