TY - JOUR
T1 - Ribociclib plus fulvestrant for advanced breast cancer
T2 - Health-related quality-of-life analyses from the MONALEESA-3 study
AU - Fasching, Peter A.
AU - Beck, J. Thaddeus
AU - Chan, Arlene
AU - De Laurentiis, Michele
AU - Esteva, Francisco J.
AU - Jerusalem, Guy
AU - Neven, Patrick
AU - Pivot, Xavier
AU - Bianchi, Giulia V.
AU - Martin, Miguel
AU - Chandiwana, David
AU - Lanoue, Brad
AU - Ridolfi, Antonia
AU - Wang, Yingbo
AU - Rodriguez Lorenc, Karen
AU - Nusch, Arnd
N1 - Funding Information:
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.
Funding Information:
The authors thank the patients who participated in the study and their families. Medical writing assistance was provided by Mihaela Marina, PhD, of MediTech Media, Ltd., funded by Novartis Pharmaceutical Company.
Funding Information:
This study was funded by Novartis Pharmaceutical Company .
Publisher Copyright:
© 2020 The Authors
Copyright:
Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/12
Y1 - 2020/12
N2 - Purpose: 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). Methods: 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. Results: 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. Conclusions: In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.
AB - Purpose: 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). Methods: 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. Results: 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. Conclusions: In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.
KW - Breast cancer
KW - Metastatic
KW - Patient-reported outcomes
KW - Quality of life
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U2 - 10.1016/j.breast.2020.09.008
DO - 10.1016/j.breast.2020.09.008
M3 - Article
AN - SCOPUS:85092511474
VL - 54
SP - 148
EP - 154
JO - Breast
JF - Breast
SN - 0960-9776
ER -