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Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer

 Howard A Burris  ;  Arlene Chan  ;  Aditya Bardia  ;  J Thaddeus Beck  ;  Joohyuk Sohn  ;  Patrick Neven  ;  Debu Tripathy  ;  Seock-Ah Im  ;  Stephen Chia  ;  Francisco J Esteva  ;  Lowell Hart  ;  Juan Pablo Zarate  ;  Antonia Ridolfi  ;  Karen Rodriguez Lorenc  ;  Denise A Yardley 
 BRITISH JOURNAL OF CANCER, Vol.125(5) : 679-686, 2021-08 
Journal Title
Issue Date
Adult ; Aged ; Aged, 80 and over ; Aminopyridines / administration & dosage* ; Aminopyridines / adverse effects ; Antineoplastic Agents, Hormonal / administration & dosage* ; Antineoplastic Agents, Hormonal / adverse effects ; Antineoplastic Combined Chemotherapy Protocols / administration & dosage* ; Antineoplastic Combined Chemotherapy Protocols / adverse effects ; Breast Neoplasms / drug therapy* ; Breast Neoplasms / metabolism ; Double-Blind Method ; Drug Tapering ; Female ; Humans ; Middle Aged ; Purines / administration & dosage* ; Purines / adverse effects ; Receptor, ErbB-2 / metabolism ; Receptors, Estrogen / metabolism ; Receptors, Progesterone / metabolism ; Treatment Outcome ; Young Adult
Background: This pooled analysis of MONALEESA trials evaluated the safety of ribociclib plus endocrine therapy (RIB + ET) with a focus on dose reductions in first-line patients.

Methods: In the dose reduction analysis, data were pooled from MONALEESA-2 (all patients), MONALEESA-3 (patients receiving treatment as first-line ET) and MONALEESA-7 (patients receiving combination therapy with an NSAI as initial ET). Efficacy was analysed by ribociclib relative dose intensity (DI). Safety was analysed in all patients in the trials (except those receiving tamoxifen in MONALEESA-7) and those with/without ≥1 ribociclib dose reduction.

Results: Of 818 women who received first-line RIB + ET, 41.8% required ≥1 dose reduction due to AEs (most commonly, neutropenia). Median RIB relative DI in patients without and with dose reductions was 99.3% and 65.6% in MONALEESA-2, 98.4% and 67.8% in MONALEESA-3 and 98·0% and 66·3% in MONALEESA-7. Median PFS was 24.8, 24.9 and 29.6 months for patients who received ≤71% (30th percentile), 72-96% (60th percentile) and 97-100% (90th percentile) RIB relative DI, respectively. No new safety signals emerged in the pooled safety analysis.

Conclusions: This analysis provides reassuring data showing that the clinical benefit of RIB is preserved when dose modifications are undertaken to manage AEs.

Trial registration: MONALEESA-2 (NCT01958021) first posted October 8, 2013; MONALEESA-3 (NCT02422615) first posted April 21, 2015; MONALEESA-7 (NCT02278120) first posted October 29, 2014.
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1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
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