Quality of life with palbociclib plus fulvestrant in previously treated hormone receptor-positive, HER2-negative metastatic breast cancer: patient-reported outcomes from the PALOMA-3 trial
Open Access
- 1 June 2016
- journal article
- research article
- Published by Elsevier BV in Annals of Oncology
- Vol. 27 (6), 1047-1054
- https://doi.org/10.1093/annonc/mdw139
Abstract
In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in hormone receptor-positive, HER2− endocrine-resistant metastatic breast cancer (MBC). This analysis compared patient-reported outcomes (PROs) between the two treatment groups. Patients were randomized 2 : 1 to receive palbociclib 125 mg/day orally for 3 weeks followed by 1 week off (n = 347) plus fulvestrant (500 mg i.m. per standard of care) or placebo plus fulvestrant (n = 174). PROs were assessed on day 1 of cycles 1–4 and of every other subsequent cycle starting with cycle 6 using the EORTC QLQ-C30 and its breast cancer module, QLQ-BR23. High scores (range 0–100) could indicate better functioning/quality of life (QoL) or worse symptom severity. Repeated-measures mixed-effect analyses were carried out to compare on-treatment overall scores and changes from baseline between treatment groups while controlling for baseline. Between-group comparisons of time to deterioration in global QoL and pain were made using an unstratified log-rank test and Cox proportional hazards model. Questionnaire completion rates were high at baseline and during treatment (from baseline to cycle 14, ≥95.8% in each group completed ≥1 question on the EORTC QLQ-C30). On treatment, estimated overall global QoL scores significantly favored the palbociclib plus fulvestrant group [66.1, 95% confidence interval (CI) 64.5–67.7 versus 63.0, 95% CI 60.6–65.3; P = 0.0313]. Significantly greater improvement from baseline in pain was also observed in this group (−3.3, 95% CI −5.1 to −1.5 versus 2.0, 95% CI −0.6 to 4.6; P = 0.0011). No significant differences were observed for other QLQ-BR23 functioning domains, breast or arm symptoms. Treatment with palbociclib plus fulvestrant significantly delayed deterioration in global QoL (P < 0.025) and pain (P < 0.001) compared with fulvestrant alone. Palbociclib plus fulvestrant allowed patients to maintain good QoL in the endocrine resistance setting while experiencing substantially delayed disease progression. NCT01942135.Funding Information
- Pfizer Inc.
This publication has 12 references indexed in Scilit:
- Palbociclib in Hormone-Receptor–Positive Advanced Breast CancerThe New England Journal of Medicine, 2015
- Determining issues of importance for the evaluation of quality of life and patient-reported outcomes in breast cancer: results of a survey of 1072 patientsBreast Cancer Research and Treatment, 2015
- The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 studyThe Lancet Oncology, 2015
- Impact of symptom burden on work-related abilities in patients with locally recurrent or metastatic breast cancer: Results from a substudy of the VIRGO observational cohort studyThe Breast, 2014
- The association of chemotherapy versus hormonal therapy and health outcomes among patients with hormone receptor-positive, HER2−negative metastatic breast cancer: experience from the patient perspectiveExpert Review of Pharmacoeconomics & Outcomes Research, 2014
- Addition of drug/s to a chemotherapy regimen for metastatic breast cancerEmergencias, 2010
- Uncertainty, lack of control and emotional functioning in women with metastatic breast cancer: a review and secondary analysis of the literature using the critical appraisal techniqueEuropean Journal of Cancer Care, 2010
- PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-positive human breast cancer cell lines in vitroBreast Cancer Research, 2009
- Discovery of a Potent and Selective Inhibitor of Cyclin-Dependent Kinase 4/6Journal of Medicinal Chemistry, 2005
- The European Organization for Research and Treatment of Cancer QLQ-C30: A Quality-of-Life Instrument for Use in International Clinical Trials in OncologyJNCI Journal of the National Cancer Institute, 1993