Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.

In the MONALEESA-3 Phase III trial of patients with hormone receptor-positive human epidermal growth factor receptor-negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL). Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs. Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62-1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61-1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60-1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57-1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57-1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58-1.12]) trended in favor of ribociclib vs placebo. In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.

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Déclaration de conflit d'intérêts

Declaration of competing interest Dr. Fasching has received grants from Novartis, grants from Biontech, personal fees from Novartis, Roche, Pfizer, Celgene, Daiichi-Sankyo, TEVA, AstraZeneca, Merck Sharp & Dohme, Myelo Therapeutics, Macrogenics, Eisai, Puma, grants from Cepheid, outside the submitted work; Dr. Chan has nothing to disclose; Dr. Beck has received grants for his institution from Novartis, outside the submitted work; Dr. De Laurentiis has received personal fees from Pfizer, Novartis, Roche, Celgene, Astra Zeneca, Eisai, Eli Lilly, Amgen, MSD, outside the submitted work; Dr. Esteva has received grants and personal fees from Novartis, Pfizer, Genentech/Roche, personal fees from Celltrion Healthcare, Seattle Genetics, grants from GlaxoSmithKline, outside the submitted work; Dr. Jerusalem has received personal fees from Novartis; grants, personal fees and non-financial support from Novartis, Roche, Pfizer, personal fees and non-financial support from Lilly, Amgen, BMS, Astra-Zeneca, personal fees from Celgene, Puma Technology, Daiichi Sankyo, AbbVie, outside the submitted work; Dr. Neven has nothing to disclose; Dr. Pivot has nothing to disclose; Dr. Bianchi has received personal fees from Novartis, Eli Lilly, outside the submitted work; Dr. Martin has received personal fees from Lilly, Pfizer, AstraZeneca, GlaxoSmithKline, Pharmamar, Taiho Oncology, grants and personal fees from Novartis, Roche-Genentech, outside the submitted work; Dr. Chandiwana reports other from Novartis, during the conduct of the study; Dr. Lanoue reports other from Novartis, during the conduct of the study; Dr. Ridolfi reports other from Novartis, during the conduct of the study; Dr. Wang has received personal fees and other from Novartis, outside the submitted work; Dr. Rodriguez Lorenc has received personal fees and other from Novartis, outside the submitted work; Dr. Nusch reports other from Novartis and Amgen, outside the submitted work.