The present analyses compares patient reported general health status between palbociclib plus fulvestrant and fulvestrant alone in HR + , HER2- metastatic breast cancer.
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.
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
Addition of palbociclib to fulvestrant was associated with significantly higher on treatment EQ-5D index scores compared to fulvestrant alone.
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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;