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.).
Overview
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Claims the paper makes
25 of 48 cited sources checked · 7 supported · 7 flagged · 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
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- 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
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- 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)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesThe 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
Strength:plain· not yet calibratedCausal:correlational· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- 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
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passes- 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)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- 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)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesThe 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
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes- 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)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesThe 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)
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passes
- 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.
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesThe 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.
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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)
Strength:plain· not yet calibratedn = 334Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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)
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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).”
Strength:plain· not yet calibratedn = 334Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.”
Strength:plain· not yet calibratedn = 334Tests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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).”
Strength:plain· not yet calibratedn = 334Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.”
Strength:plain· not yet calibratedn = 334Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.”
Strength:hedged· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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.”
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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).”
Load-bearingStrength:hedged· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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).”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes? Load-bearing: unclear✓ Based: passesIt 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).”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably 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.”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably 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
Strength:plain· not yet calibratedCausal:direct· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably 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.”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesProbably 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.”
Strength:plain· not yet calibratedn = 4Tests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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).”
Load-bearingStrength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.”
Strength:plain· not yet calibratedTests✓ Asserted: passes✓ Checkable: passes✗ Load-bearing: fails✓ Based: passesProbably 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.”
Tests✓ Asserted: passes✓ Checkable: passes✓ Load-bearing: passes✓ Based: passesIt 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
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Items 501–600 of 760
What's new in surgical oncology breast
Brabender, D. E., Klimberg, V. S., & Sener, S. F. (2023) · Journal of Surgical Oncology · doi:10.1002/jso.27528 · Cited by 1
de Ligt, K. M., Koppert, L. B., de Rooij, B. H., van de Poll-Franse, L. V., Velikova, G., & Cardoso, F. (2024) · The Breast · doi:10.1016/j.breast.2024.103676 · Cited by 1
“Recent discoveries of new (combinations of) agents have substantially extended the median overall survival for HER2-positive and ER + /HER2-negative MBC from 2 to 3 to 5 years [17,18].”
BackgroundCyclin-dependent kinase 4/6 inhibitors in the treatment of advanced or metastatic breast cancer
Micha, J. P., Rettenmaier, M. A., Bohart, R. D., & Goldstein, B. H. (2024) · Journal of Oncology Pharmacy Practice · doi:10.1177/10781552241232701 · Cited by 1
Androgen receptor agonism in advanced oestrogen receptor-positive breast cancer
Chen, N., & Nanda, R. (2024) · The Lancet Oncology · doi:10.1016/s1470-2045(24)00080-9 · Cited by 1
Mullaguri, S. C., Mungamuri, S. K., Puligundla, K. C., Annamaneni, S., & Kancha, R. K. (2024) · Springer eBooks · doi:10.1007/978-981-97-1802-3_2 · Cited by 3
Kolyadina, I. V. (2024) · Tumors of female reproductive system · doi:10.17650/1994-4098-2024-20-1-89-103 · Cited by 1
Cáncer de mama luminal: estado del arte
Bravo-Garzón, M. A., Mantilla, W. A., Cervera, S., Caicedo, J. J., & Franco, S. X. (2023) · Medicina · doi:10.56050/01205498.2315 · Cited by 1
Savvidou, A., Theophanous-Kitiri, S., Zacharia, L. C., Constantinidou, A., & Petrou, C. C. (2024) · European Journal of Oncology Pharmacy · doi:10.1097/op9.0000000000000054 · Cited by 1
Cardiac safety of ribociclib evaluated with 24-hour rhythm Holter electrocardiogram
Yasin, A. İ., Uluganyan, M., İşleyen, Z. S., Topçu, A., Shbair, A. T., Şimşek, M., Beşiroğlu, M., Ersoy, Y. E., Türk, H. M., & Şeker, M. (2024) · Supportive Care in Cancer · doi:10.1007/s00520-024-08702-0 · Cited by 3
Zhang, Q., Zhang, P., Yan, M., Yan, X., Wang, X., Gu, Y., Qu, X., Li, S., Xu, G., Zhu, X., et al. (2024) · Therapeutic Advances in Medical Oncology · doi:10.1177/17588359241273026 · Cited by 1
Neuropilin-1: A Promising Therapeutic Target for Triple-Negative Breast Cancer
Al‐Zeheimi, N., & Adham, S. A. (2024) · IntechOpen eBooks · doi:10.5772/intechopen.1007394 · Cited by 1
Evolving treatment paradigms after CDK4/6 inhibitors in advanced breast cancer
Gnant, M., Balić, M., Singer, C. F., Rinnerthaler, G., Pfeiler, G., Suppan, C., Grünberger, B., Strasser‐Weippl, K., Castagnaviz, V., Heibl, S., et al. (2024) · memo - Magazine of European Medical Oncology · doi:10.1007/s12254-024-01012-5 · Cited by 1
Palliative Radiotherapy in Metastatic Breast Cancer Patients on CDK4/6 Inhibitors: Safety Analysis
Ceylan, F., Mehdiyev, M., Bi̇lgi̇n, B., Tenekeci, A. K., Yalçın, B., Akıncı, M. B., Dede, D. Ş., Şendur, M. A. N., Algın, E., & Yücel, Ş. (2025) · Cancers · doi:10.3390/cancers17030424 · Cited by 2
“In our study, during the 18-month follow-up period, the median PFS and OS were not reached, which is consistent with the literature [1,22–24].”
Bhatia, K. P., & Batra, A. (2025) · Springer eBooks · doi:10.1007/978-981-97-9847-6_15 · Cited by 2
CDK4/6 inhibition in early and advanced hormone receptor-positive, HER2-negative breast cancer
Yarlagadda, S. R., Andrade, M. D. O., & Nanda, R. (2025) · Expert Review of Anticancer Therapy · doi:10.1080/14737140.2025.2498994 · Cited by 1
Kang, Y., Han, B., Kong, Y., Liu, S., & Zhang, N. (2025) · BMC Cancer · doi:10.1186/s12885-025-14194-w · Cited by 1
“From the MONALEESA-2 and MONALEESA-7 trials, ribo-ciclib combined with letrozole showed absolute overall survival benefits compared to letrozole only (0.76, 0.63– 0.93; 0.76, 0.61–0.96) [49, 50].”
InfluentialLee, J., Lee, D.-W., Kim, M. H., Kim, J. H., Kim, J., Byun, J.-H., Lee, K. E., Kang, M. J., Koh, S.-J., Hong, S., et al. (2025) · The Breast · doi:10.1016/j.breast.2025.104500 · Cited by 1
“Additionally, it showed a relatively shorter median OS compared to that of other pivotal phase III trials with ribo-ciclib or abemaciclib [18,19].”
Kahraman, S., Hızal, M., Gümüşay, Ö., Başaran, G., Seyyar, M., Şahin, E., Çabuk, D., Yaşar, A., Bayoğlu, İ. V., Bayram, E., et al. (2025) · Turkish Journal of Clinics and Laboratory · doi:10.18663/tjcl.1639022 · Cited by 1
Huang, X., Varambally, S., Anderson, S. A., Bartow, B. B., Harada, S., Wei, S., Siegal, G. P., Khoury, K. E., & Yalnız, C. (2025) · Modern Pathology · doi:10.1016/j.modpat.2025.100841 · Cited by 1
Jerzak, K. J., Sehdev, S. R., Boileau, J.-F., Brezden‐Masley, C., Califaretti, N., Edwards, S. J., Gordon, J., Henning, J., LeVasseur, N., & Railton, C. (2025) · Current Oncology · doi:10.3390/curroncol32080444 · Cited by 2
Bacterial ubiquitin ligase engineered for small molecule and protein target identification
Ye, J. S., Majumdar, A., Park, B. C., Black, M. H., Hsieh, T., Osinski, A., Servage, K. A., Kulkarni, K., Naidoo, J., Alto, N. M., et al. (2026) · The EMBO Journal · doi:10.1038/s44318-025-00665-0 · Cited by 1
ASCO 2022 Breast Cancer Updates
Podrumar, A. I. (2022) · Journal of Medical and Radiation Oncology · doi:10.53011/jmro.2022.02.02 · Cited by 1
Masuyama, M., Masuda, N., Kawaguchi, H., Yamamoto, Y., Saji, S., Nakayama, T., Aogi, K., Anan, K., Ohtani, S., Sato, N., et al. (2023) · Cancer Medicine · doi:10.1002/cam4.6390
Cardiac Safety of Ribociclib Evaluated with 24-hour- Rhythm Holter ElectrocardiogramPreprint
Yasin, A. İ., Uluganyan, M., İşleyen, Z. S., et al. (2024) · Research Square · doi:10.21203/rs.3.rs-3911390/v1 · Cited by 1
Längeres Gesamtüberleben mit CDK-4/6-Hemmer in der Erstlinie bei fortgeschrittenem Brustkrebs
Klein, F. (2022) · Geburtshilfe und Frauenheilkunde · doi:10.1055/a-1798-3350
Cobain, E. F., & Hayes, D. F. (2022) · Journal of Clinical Oncology · doi:10.1200/jco.22.00702
Ganguly, S., & Gogia, A. (2022) · Cancer Research Statistics and Treatment · doi:10.4103/crst.crst_135_22
Kalinsky, K. M., & van den Heuvel, R. (2022) · doi:10.55788/32ff9e8a
Längeres Gesamtüberleben mit CDK-4/6-Hemmer in der Erstlinie bei fortgeschrittenem Brustkrebs
Klein, F. (2022) · Senologie - Zeitschrift für Mammadiagnostik und -therapie · doi:10.1055/a-1893-7315
Längeres Gesamtüberleben mit CDK-4/6-Hemmer in der Erstlinie bei fortgeschrittenem Brustkrebs
Klein, F. (2022) · Frauenheilkunde up2date · doi:10.1055/a-1950-9338
Владимировна, Л. Е., Tsareva, А. S., Kuznetsova, A. A., & Артамонова, Е. В. (2022) · Medical alphabet · doi:10.33667/2078-5631-2022-26-13-19
Silveira, C., Sousa, A. C., Corredeira, P., Martins, M., Sousa, A. R., Paula, A. D. C., Selenica, P., Brown, D. N., Golkaram, M., Kaplan, S., et al. (2022) · Biomolecules · doi:10.3390/biom12121818
“Based on the results of recent trials, ribociclib plus letrozole is currently considered the frontline treatment option in postmenopausal patients with advanced ER+/PR+/HER2breast cancer [53,54].”
ResultReal clinical practice patterns of palbociclib usage in Russian Federation
Фролова, М. А., & Stenina, M. B. (2022) · Meditsinskiy sovet = Medical Council · doi:10.21518/2079-701x-2022-16-22-4
2022 : nouvelles pratiques thérapeutiques en oncologie mammaire
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“Overall survival (OS) of patients in the intention-to-treat group in the ML-2 study [13].”
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Lüftner, D., Lux, M. P., Fehm, T. N., Welslau, M., Müller, V., Schütz, F., Fasching, P. A., Janni, W., Thomssen, C., Witzel, I., et al. (2023) · Senologie - Zeitschrift für Mammadiagnostik und -therapie · doi:10.1055/a-2079-8481
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“Ribociclib Ribociclib is currently approved for the treatment of HRpositive/HER2-negative mBC in combination with letrozole according to the MONALEESA-2 [46] and MONALEESA-7 [48], and with fulvestrant as established in the MONALEESA-3 trial [47], showing that the addition of ribociclib to endocrine therapy lead to ove…”
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Das metastasierte Mammakarzinom – ein Überblick zur Entwicklung der Therapiestandards 2024
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MONALEESA-2 Trial—A Beacon of Hope
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“[1] The cost of ribociclib in developing countries is prohibitive at present costing at least Rs. 57,000 per month in India.”
Determining QTc in acute care settings: What we (don’t) know
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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
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