233P - Association of quality of life (QOL) with overall survival (OS) in patients (pts) with HR+/HER2− advanced breast cancer (ABC) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA-3 (ML-3) and ML-7 trials

Background

ML-3 and -7 demonstrated a significant OS benefit and maintenance/improvement of QOL with RIB + ET vs ET in pts with HR+/HER2− ABC. We evaluated the association of QOL with OS in ML-3 and -7.

Methods

In ML-3, postmenopausal pts were treated with RIB + fulvestrant (FUL) or FUL alone. This analysis included the NSAI cohort of ML-7, in which peri/premenopausal pts were treated with RIB + NSAI or NSAI alone. QOL was assessed with EORTC QLQ-C30. A responder analysis was performed based on published minimal clinically important differences in change from baseline to group pts as improvers/maintainers (responder) or non-improvers/non-maintainers (non-responder). The percentage of responders was summarized for each visit by treatment arm for pts who lived longer and pts who lived shorter (OS cutoffs: 39.2 mo for ML-3; 33.1 mo for ML-7).

Results

In ML-3 and -7, a greater percentage of pts living longer vs shorter had improved/maintained global health status (GHS), pain, fatigue, and diarrhea in either treatment (tx) group. In ML-7, a GHS benefit was seen for RIB vs PBO in pts living longer or shorter, with a greater benefit in pts living longer (Table). In ML-3, a tx benefit for RIB vs PBO in GHS was seen in pts living longer but was not observed in those living shorter; this trend was seen regardless of line of tx. There was a consistent benefit for RIB vs PBO for pain, fatigue, and diarrhea in ML-7 in pts living longer or shorter. In ML-3, a tx benefit was seen for RIB vs PBO for pain and diarrhea but was mainly in the second-line population for pts living longer. Table: 233P

Conclusions

In ML-3 and -7, pts living longer vs living shorter had more improved/maintained QOL over the course of tx. In both trials, RIB was generally associated with a greater percentage of pts with improvement/maintenance of GHS compared with ET alone, with greater tx benefit in pts living longer.

Clinical trial identification

MONALEESA-3; NCT02422615; MONALEESA-7; NCT02278120.

Editorial acknowledgement

Medical editorial assistance was provided by Casey Nielsen, PhD, of MediTech Media, and was financially supported by Novartis Pharmaceuticals Corporation.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

P.A. Fasching: Financial Interests, Personal, Advisory Board: Novartis, Roche, Pfizer, Celgene, Merck Sharp & Dohme, Macrogenics, Eisai, Puma, Lilly, AstraZeneca; Financial Interests, Personal, Other, Steering Board: Novartis; Financial Interests, Institutional, Research Grant: BioNTech, Novartis, Cepheid; Financial Interests, Personal, Invited Speaker, Lectures: Daiichi Sankyo, Merck Sharp & Dohme, Lilly. N. Harbeck: Financial Interests, Personal, Other, Consulting: Novartis, Lilly, Pfizer, AstraZeneca, Daiichi Sankyo, MSD, Pierre Fabre, Roche, Sandoz/Hexal, Seattle Genetics; Financial Interests, Personal, Invited Speaker, Lectures: Novartis, Lilly, Pfizer, AstraZeneca, Daiichi Sankyo, MSD, Pierre Fabre, Roche, Sandoz/Hexal, Seattle Genetics; Non-Financial Interests, Institutional, Member of the Board of Directors, Co-Director WSG: West German Study Group. G. Jerusalem: Financial Interests, Institutional, Research Grant: Novartis, Roche, Pfizer; Financial Interests, Personal, Other, not specified: Novartis, Roche, Pfizer, Lilly, Amgen, BMS, AstraZeneca, AbbVie, Daiichi Sankyo; Non-Financial Interests, Personal and Institutional, Other, not specified: Novartis, Roche, Pfizer, Lilly, Amgen, BMS, AstraZeneca, MedImmune, MerckKGA. M. De Laurentiis: Financial Interests, Personal, Invited Speaker, Honoraria: Pfizer, Novartis, Roche, AstraZeneca, Eli Lilly, Pierre Fabre; Financial Interests, Personal, Advisory Board, Honoraria: Pfizer, Novartis, Roche, AstraZeneca, Eli Lilly, Pierre Fabre. D. Tripathy: Financial Interests, Personal, Other, Consulting Fees: Novartis, Pfizer, GlaxoSmithKline, Polyphor, Sellas Life Sciences Group, Exact Sciences, Immunomedics; Financial Interests, Institutional, Research Grant, Contracted research and clinical research support: Novartis, Polyphor; Financial Interests, Personal, Other, Steering Committee: Pfizer, OncoPep; Non-Financial Interests, Personal, Advisory Board, Scientific Advisory Board (unpaid): Puma Biotechnology; Financial Interests, Personal, Invited Speaker, Fees for Lectures (educational): AstraZeneca. M. Martin: Financial Interests, Personal, Invited Speaker, Honoraria: Lilly, Pfizer; Financial Interests, Personal, Advisory Board, Honoraria: Lilly, Pfizer, AstraZeneca, Novartis, Roche-Genentech, GloxoSmithKline, PharmaMar, Taiho Oncology; Financial Interests, Institutional, Research Grant: Novartis, Roche-Genentech. D. Yardley: Financial Interests, Personal, Other, Consulting or advisory role (institution): Biotheranostics, Bristol Myers Squibb, Celgene, Daiichi Sankyo, Lilly, Eisai, Genetech, Roche, NanoString Technologies, Novartis; Financial Interests, Institutional, Research Grant, Research funding (institution): Daiichi Sankyo, Lilly, Eisai, Novartis, AbbVie, AstraZeneca, Clovis Oncology, Immunomedics, InventisBio, Lilly, MedImmune, Medivation, Merck, Oncothyreon, Pfizer, Syndax, Tesaro; Financial Interests, Personal and Institutional, Other, Travel, accommodations, expenses: Genentech, Roche, Novartis; Financial Interests, Personal, Speaker’s Bureau: Genentech, Roche, Novartis. P. Wheatley-Price: Financial Interests, Personal, Advisory Board, Lung Cancer Advisory Board: Roche, AbbVie, Takeda, Merck, BMS, Novartis, AstraZeneca, . A. Chan: Financial Interests, Personal, Invited Speaker, Honoraria: Amgen, Eisai, Novartis; Financial Interests, Personal, Other, Travel, accommodations, expenses: Amgen; Financial Interests, Institutional, Research Grant, Research funding: Eisai; Financial Interests, Personal, Advisory Role: Lilly; Financial Interests, Personal, Speaker’s Bureau: Prime Oncology. R. Villanueva Vazquez: Financial Interests, Personal, Invited Speaker, Honoraria: Novartis, Pfizer, Roche. A. Nusch: Financial Interests, Personal and Institutional, Advisory Role, Consulting/Advisory role: Novartis, Amgen; Financial Interests, Personal and Institutional, Other, Travel, accommodation, expenses: Novartis; Financial Interests, Institutional, Funding, Research funding: Novartis. E. Gu, H. Hu, A. Thuerigen: Financial Interests, Personal and Institutional, Full or part-time Employment: Novartis; Financial Interests, Personal and Institutional, Stocks/Shares: Novartis. P. Pathak: Financial Interests, Personal and Institutional, Full or part-time Employment: Novartis. A. Bardia: Financial Interests, Institutional, Research Grant: Genentech, Novartis, Pfizer, Merck, Sanofi, Radius Health, Immunomedics, Mersana, Innocrin; Financial Interests, Personal, Advisory Board, Advisory Board/Consulting: Biothernostics Inc., Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics, Spectrum Pharma, Taiho, Sanofi, Daiichi Pharma, Puma; Financial Interests, Institutional, Advisory Role, Consulting: Biothernostics Inc.; Financial Interests, Personal, Leadership Role, Steering Committee: Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics; Financial Interests, Personal, Other, Travel support: Pfizer, Novartis, Genentech, Merck, Radius Health, Immunomedics, Spectrum Pharma, Taiho, Sanofi. All other authors have declared no conflicts of interest.