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

Date 09 October 2016
Event ESMO 2016 Congress
Session Breast cancer, metastatic
Topics Breast Cancer
Presenter Hope Rugo
Citation Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365
Authors H. Rugo1, V. Dieras2, K.A. Gelmon3, R. Finn4, D. Slamon5, M. Miguel6, P. Neven7, J. Ettl8, Y. Shparyk9, A. Mori10, D.R. Lu11, H. Bhattacharyya12, C.H. Bartlett13, S. Iyer14, S. Johnston15, N. Harbeck16
  • 1Medicine, UCSF Helen Diller Family Comprehensive Cancer Center, 94115 - San Francisco/US
  • 2Department Of Medical Oncology, Institut Curie, 75248 - Paris/FR
  • 3Medical Oncology, British Columbia Cancer Agency, V5Z 4E6 - Vancouver/CA
  • 4Medical Oncology, UCLA - School of Medicine, 90095 - Los Angeles/US
  • 5Hematology/oncology, UCLA Medical Center, Santa Monica, Santa Monica/US
  • 6Medical Oncology Service, Hospital General Universitario Gregorio Marañon, Madrid/ES
  • 7Oncology, University Hospitals Leuven - Campus Gasthuisberg, Leuven/BE
  • 8Oncology, Technische Universität München, München/DE
  • 9Department Of Chemotherapy, Lviv State Regional Treatment and Diagnostics Oncology Center, 79031 - Lviv/UA
  • 10Clinical Development, Pfizer, Milano/IT
  • 11Biostatistics, Pfizer, La Jolla/US
  • 12Statistics, Pfizer,Inc, New York/US
  • 13Global Medical, Pfizer,Inc, New York/US
  • 14Global Outcomes & Evidence, Pfizer, Inc, New York/US
  • 15Medical Oncology, Royal Marsden Hospital NHS Foundation Trust, London/GB
  • 16Breast Center, University of Munich, 81377 - Munich/DE



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).


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.


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.


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


Pfizer, Inc


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.