456P - Quality of life (QOL) analysis from the phase II RIGHT choice study of first-line ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in aggressive HR+/HER2− advanced breast cancer (ABC)

Background

RIGHT Choice showed a statistically significant median progression-free survival benefit of ≈1 yr with first-line RIB + ET vs combo CT (HR, 0.54; P=0.0007) in patients (pts) with aggressive HR+/HER2− ABC. As QOL data provide information on real-life treatment (tx) benefit as well as impact tx choice and duration, a QOL analysis was performed.

Methods

Pre/perimenopausal pts with no prior systemic therapy for aggressive HR+/HER2− ABC were randomized 1:1 to RIB + ET or combo CT. The FACT-B scores were determined by a questionnaire administered at protocol-defined time points. The median time to deterioration (mTTD) in overall health status, nausea or pain was defined as a composite endpoint of time from randomization to either first occurrence of ≥10% deterioration in FACT-B scores with no later improvement or date of discontinuation due to progressive disease, death, or adverse events. Only pts with baseline and at least one post-baseline pt reported outcome assessment were included. Pts without events were censored at the last evaluation prior to the earliest of cutoff date, end of tx, start of new tx, or when lost to follow-up, or at consent withdrawal. Descriptive summary of change from baseline in FACT-B total score was also summarized.

Results

The composite endpoint of mTTD in overall health status was delayed with RIB + ET (N=111) vs combo CT (N=96;16.8 vs 10.6 mo; HR, 0.63; Table). The mTTD in subdomains of nausea (18.4 vs 10.4 mo; HR, 0.56) and pain (13.0 vs 10.4 mo; HR, 0.70) was also delayed in pts on RIB + ET vs combo CT. A numerical trend in change from baseline in FACT-B total scores during tx favoring RIB + ET over combo CT was observed.

Conclusions

This analysis suggests that first-line RIB + ET is associated with better QOL than combo CT for pts with aggressive HR+/HER2– ABC, providing supportive evidence for RIB + ET use in this pt population. Table: 456P

Clinical trial identification

NCT03839823.

Editorial acknowledgement

Editorial assistance in the writing of the abstract was provided by Shashank Tandon of MediTech Media.

Legal entity responsible for the study

Novartis Pharmaceuticals Corporation.

Funding

Novartis Pharmaceuticals Corporation.

Disclosure

Y. Eralp: Financial Interests, Personal, Advisory Role: Novartis, Merck, Sharp and Dohme, AstraZeneca; Financial Interests, Personal, Other, Educational fee: Gilead, Glaxo Smith Kline; Financial Interests, Personal and Institutional, Research Grant: Roche; Non-Financial Interests, Personal and Institutional, Other, Non-compansated educational program: Roche, Novartis; Non-Financial Interests, Personal and Institutional, Other, Non-compensated mentorship program: Boston Scientific; Financial Interests, Personal, Other, Satellite meeting fee: Roche. S. Im: Financial Interests, Personal and Institutional, Research Grant: AstraZeneca, Pfizer, Eisai, Roche, Daewoong Pharm, Boryung Pharm, Daiichi Sankyo; Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Hanmi, Pfizer, Eisai, Roche, Lilly, GSK, MSD , Daiichi Sankyo, Idience, Bertis. Y. Lu: Other, Personal and Institutional, Other, clinical trial study fee: Novartis ; Financial Interests, Personal and Institutional, Research Grant: Novartis; Financial Interests, Personal, Advisory Board: Novartis, Daiichi Sankyo; Financial Interests, Personal and Institutional, Invited Speaker: Novartis, Roche, Merck Sharp & Dohme, Pfizer, Eisai, AstraZeneca, Eli Lilly, Daiichi Sankyo; Financial Interests, Personal, Speaker, Consultant, Advisor, Consultation fee: Pfizer; Financial Interests, Personal, Other, Contracted research: Roche, Merck Sharp & Dohme, Pfizer; Financial Interests, Personal and Institutional, Other, clinical trial: AstraZeneca. Y.S. Yap: Financial Interests, Personal, Other, Honoraria: Novartis, Pfizer, Lilly/DKSH , Eisai, AstraZeneca, MSD, Inivata, Specialised Therapeutics, Roche; Non-Financial Interests, Personal, Other, Travel support: Lilly/DKSH ; Financial Interests, Personal, Other, Travel support: AstraZeneca; Financial Interests, Personal and Institutional, Research Grant: MSD. H.A. Azim: Financial Interests, Personal, Advisory Board, honoraria for advisory boards and lecturing: Novartis, Roche, Pfizer, MSD, BMS, ASZ, Lilly; Financial Interests, Personal, Invited Speaker, honoraria for advisory boards and lecturing: Novartis, Roche, Pfizer, MSD, BMS, ASZ, Lilly; Non-Financial Interests, Personal, Other, non financial support for supporting some educational activities for my in academic institution: Novartis, Roche, Pfizer, MSD, BMS, ASZ, Lilly. H. Hu, T. Delgar Alfaro, J. Wu, M. Gao: Financial Interests, Personal and Institutional, Full or part-time Employment: Novartis; Financial Interests, Personal, Stocks/Shares: Novartis. N.S. El Saghir: Financial Interests, Personal and Institutional, Invited Speaker, Honoraria: AstraZeneca, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Roche; Financial Interests, Personal and Institutional, Advisory Board, Honoraria: AstraZeneca, Lilly, MSD, Novartis, Pfizer, Pierre Fabre, Roche. All other authors have declared no conflicts of interest.