225PD - Impact of palbociclib plus letrozole on health related quality of life (HRQOL) compared with letrozole alone in treatment naïve postmenopausal pati...

Abstract

Background

Palbociclib plus letrozole significantly improved progression free survival (PFS) compared to letrozole alone in the phase III PALOMA-2 trial. QOL is a critical consideration when adding targeted agents to hormone therapy in metastatic breast cancer (MBC). We compared patient reported HRQOL in treatment naïve postmenopausal patients with ER + , HER2- MBC in PALOMA-2 (Pfizer: NCT01740427).

Methods

PALOMA-2 randomized patients 2:1 to palbociclib + letrozole (N= 444) or placebo + letrozole (N= 222). Patient reported outcomes were assessed at baseline, day 1 of cycle 2, 3 and day 1 of every other cycle from cycle 5 until end of treatment using the Functional Assessment of Cancer Therapy – Breast (FACT-B) questionnaire. FACT-B includes FACT-General (FACT-G) and BC-specific subscale (BCS). FACT-B produces five subscale scores: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional wellbeing (FWB), and a BC subscale (BCS), used to derive overall FACT-B, FACT-G, and Trial Outcome Index (TOI) scores. A higher score indicates a better QOL. Repeated measures mixed-effects analyses were performed to compare between treatments change from baseline in each subscale and FACT-B scores, controlling for baseline.

Results

Baseline scores were comparable between the two treatment arms for FACT-B (102 vs 103), FACT- G, TOI and each of the subscale scores. There were no significant differences between the treatment groups in change from baseline scores for PWB (-0.5 vs. -0.3; p= 0.414), SWB (-0.6 vs -0.7; p = 0.762), EWB (0.7 vs 0.5;p = 0.538) and FWB (0.2 vs 0.3;p = 0.707). Overall change from baseline scores was comparable for the BCS (0.19 vs 0.83; p =0.055), Trial Outcome Index (-0.1 vs 0.71; p= 0.325), FACT- G (-0.39 vs -0.53; p = 0.882) and FACT-B (-0.11 vs 0.22; p = 0.782) scores.

Conclusions

The addition of palbociclib to letrozole maintains HRQOL in treatment naïve postmenopausal patients with ER+ HER2- MBC and showed no significant difference compared to letrozole alone. This data adds favorably to the significant improvement in PFS seen in PALOMA-2.

Clinical trial identification

Pfizer: NCT01740427

Legal entity responsible for the study

Pfizer, Inc

Funding

Pfizer, Inc

Disclosure

H. Rugo: Institution receives research funding from Pfizer, Novartis, Lilly. V. Dieras: Consultant/Advisory role -Roche, Pfizer, Novartis Speaker's Bureau-Roche, Pfizer, Novartis. R. Finn: Consultant/Advisory role -Pfizer, Bayer, Novartis, Bristol Myers Squibb Institution receives research funding from Pfizer.

D. Slamon: Stock Ownership; Travel Accommodations or Expenses -PFizer Leadership; Stock Ownership; Travel Accommodations or Expenses- BioMarin. M. Miguel: Honraria - Amgen, Novartis Consultant/Advisory Role -Celgene; Novartis; Pfizer; Roche Pharma AG Research funding – Novartis.

J. Ettl: Consulting or Advisory Role; Travel Accommodations or Expenses - Pfizer, Roche, GSK, Teva, Novartis. A. Mori, D.R. Lu, H. Bhattacharyya, C.H. Bartlett, S. Iyer: Pfizer employee and stockholder

S. Johnston: Research Funding - Pfizer Consultant/Advisory Board - Astra Zeneca, Roche/Genetech, Novartis, Puma. N. Harbeck: Honararia-Amgen; Celgene, NanoString Technologies, Novartis; Pfizer, Roche.Consultant/Advisory Role -AstraZeneca, Celgene, Genomic Health, Novartis, Roche/Genentech, Sandoz, Wilex.Research Funding -Boehringer Ingelheim, Novartis, Pfizer, Roche/Genentech. All other authors have declared no conflicts of interest.