Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study
Peter A. Fasching,
J. Thaddeus Beck,
Arlene Chan,
Michele De Laurentiis,
Francisco J. Esteva,
Guy Jerusalem,
Patrick Neven,
Xavier Pivot,
Giulia V. Bianchi,
Miguel Martin,
David Chandiwana,
Brad Lanoue,
Antonia Ridolfi,
Yingbo Wang,
Karen Rodriguez Lorenc,
Arnd Nusch
Affiliations
Peter A. Fasching
University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Department of Gynecology and Obstetrics, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen, Germany; Corresponding author. University Hospital Erlangen, Maximiliansplatz 2, Erlangen, 91054, Germany.
J. Thaddeus Beck
Highlands Oncology Group, Fayetteville, AR, USA
Arlene Chan
Breast Cancer Research Centre-Western Australia, Nedlands, WA, Australia
Michele De Laurentiis
Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”, Naples, Italy
Francisco J. Esteva
NYU Langone Health, New York, NY, USA
Guy Jerusalem
CHU de Liège, University of Liège, Liège, Belgium
Patrick Neven
Multidisciplinary Breast Centre, Universitair Ziekenhuis Leuven, Leuven, Belgium
Xavier Pivot
Institut Régional Du Cancer, Strasbourg, France
Giulia V. Bianchi
Fondazione IRCCS - Istituto Nazionale Dei Tumori, Milan, Italy
Miguel Martin
Instituto de Investigación Sanitaria Gregorio Marañón, Ciberonc Geicam, Universidad Complutense de Madrid, Madrid, Spain
David Chandiwana
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
Brad Lanoue
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
Antonia Ridolfi
Novartis Pharma SAS, Rueil-Malmaison, France
Yingbo Wang
Novartis Pharma AG, Basel, Switzerland
Karen Rodriguez Lorenc
Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA
Arnd Nusch
Practice for Haematology and Internal Oncology, Velbert, Germany
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.
