260P - Impact of palbociclib plus fulvestrant on patient reported general health status compared with fulvestrant alone in HR + , HER2- metastatic breast...

Date 10 October 2016
Event ESMO 2016 Congress
Session Poster display
Topics Breast Cancer
Presenter Sibylle Loibl
Citation Annals of Oncology (2016) 27 (6): 68-99. 10.1093/annonc/mdw365
Authors S. Loibl1, A. Demichele2, N.M. Turner3, M. Cristofanilli4, S. Loi5, S. Verma6, H. Bhattacharyya7, Z. Ke8, C. Giorgetti9, C.H. Bartlett10, S. Iyer11, M. Colleoni12, N. Masuda13, S. Im14, N. Harbeck15
  • 1Medicine And Research, German Breast Group (GBG) Forschungs GmbH, 63263 - Neu-Isenburg/DE
  • 2Medicine, University of Pennsylvania-Perelman Center for Advanced Medicine, 19104 - Philadelphia/US
  • 3Molecular Oncology, Royal Marsden Hospital NHS Foundation Trust, SW3 6JJ - London/GB
  • 4Feinberg School Of Medicine, Robert. H. Lurie Cancer Center of Northwestern University, Chicago/US
  • 5Division Of Cancer Medicine, Peter MacCallum Cancer Centre, 3002 - East Melbourne/AU
  • 6Tom Baker Cancer Centre, Department Of Oncology, University of Calgary, Calgary/CA
  • 7Statistics, Pfizer,Inc, New York/US
  • 8Biostatistics, Pfizer, Inc, La Jolla/US
  • 9Clinical Development, Pfizer, Inc, Milano/IT
  • 10Global Medical, Pfizer,Inc, New York/US
  • 11Global Outcomes & Evidence, Pfizer, Inc, New York/US
  • 12Medical Oncology, European Institute of Oncology (EIO), 20141 - Milan/IT
  • 13Surgery, National Hospital Organization Osaka National Hospital, 540-0006 - Osaka/JP
  • 14Internal Medicine, Seoul National University Hospital, Seoul/KR
  • 15Breast Center, University of Munich, 81377 - Munich/DE

Abstract

Background

The present analyses compares patient reported general health status between palbociclib plus fulvestrant and fulvestrant alone in HR + , HER2- metastatic breast cancer.

Methods

Patients in PALOMA -3 study (NCT 01942135; Turner et al. NEJM 2016) were randomized to palbociclib plus fulvestrant (n= 347) or placebo plus fulvestrant (n= 174). Patient-reported outcomes were assessed at baseline, on day 1 of each cycle until cycle 4 and every alternate cycle from cycle 6 until end of treatment using EQ-5D, a standardized measure of health status that consists of a descriptive system comprising 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression rated at 3 levels (no, some, or extreme problems) and a single index score for health status (range 0 [dead] to 1 [full health]) calculated using a standard algorithm. In addition, a visual analog scale (VAS) measured self-rated health status from ‘0’ (worst imaginable) to ‘100’ (best imaginable). Repeated measures mixed-effects analyses were performed to compare overall index and VAS scores between treatments, controlling for baseline.

Results

Completion rates at baseline were ≥85% in each group. The mean (SD) scores at baseline were comparable between palbociclib plus fulvestrant and fulvestrant alone for the VAS (72.9 [17.22] vs 70.3 [19.87]) and the EQ-5D index scores (0.73 [0.23]) vs (0.71 [0.23]). General health status assessed by VAS was found to be maintained from baseline and no significant difference in overall EQ-5D VAS scores was observed between the treatment arms. The proportion of patients reporting the presence of a problem at baseline was similar for palbociclib plus fulvestrant and fulvestrant, respectively: mobility (28% vs 32%), self-care (9% vs 9%), usual activities (38% vs 45%), pain (67% vs 67%), and anxiety/depression (52% vs 61%). The overall mean EQ-5D index scores on treatment was significantly greater (p 

Conclusions

Addition of palbociclib to fulvestrant was associated with significantly higher on treatment EQ-5D index scores compared to fulvestrant alone.

Clinical trial identification

NCT01942135

Legal entity responsible for the study

Pfizer

Funding

Pfizer, Inc

Disclosure

S. Loibl: Research and funding and honoraria to institution from GlaxoSmithKline; Novartis; Roche Pharma AG; Pfizer;Celgene, Amgen, and most other pharmaceutical companies. A. Demichele: Participant on Advisory Board sponsored by Pfizer. N.M. Turner: Consultant/ Advisory role and receives honoraria from AstraZeneca; Pfizer; Roche Pharma AG. M. Cristofanilli: honoraria - Agendia; Cynvenio Biosystems; Dompé Farmaceutici Consulting/Advisory role-Cynvenio Biosystems; Dompé Farmaceutici; Newomics Speaker's bureau- Agendia; NanoString Technologies. S. Loi: Affiliated Institute receives research funding from PharmaSea. S. Verma: Advisory Board Panel Member for Pfizer, Roche, AZ, Novartis,Amgen, Eisai,BMS, Eli Liily and Merck. H. Bhattacharyya: Pfizer employee and stockholder.

Z. Ke, C. Giorgetti, C.H. Bartlett: Pfizer Employee and Stockholder. S. Iyer: Employee and shareholder/stock options owner of Pfizer, Inc .M. Colleoni: Honararia - Novartis Advisory Role - Boehringer, Astra Zeneca, Pierre Fabre, Pfizer. N. Masuda: Personal Fees, Honararia; Research funding -Chugai, Astra zeneca, kyowa krin Research funding- Pfizer, Novartis, Eli Lilly. S-A. Im: Grant - Astra Zeneca Advisory Role- AZ, Roche, Novartis. N. Harbeck: Honoraria -Amgen; Celgene; NanoString Technologies; Novartis; Pfizer; Roche Consulting/Advosory role -AstraZeneca; Celgene; Genomic Health; Novartis; Roche/Genentech; Sandoz; Wilex Research funding -Boehringer Ingelheim; Novartis; Pfizer;