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.
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Date
2016-06-01ICR Author
Author
Harbeck, N
Iyer, S
Turner, N
Cristofanilli, M
Ro, J
André, F
Loi, S
Verma, S
Iwata, H
Bhattacharyya, H
Puyana Theall, K
Bartlett, CH
Loibl, S
Type
Journal Article
Metadata
Show full item recordAbstract
BACKGROUND: 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 AND METHODS: 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. RESULTS: 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. CONCLUSION: Palbociclib plus fulvestrant allowed patients to maintain good QoL in the endocrine resistance setting while experiencing substantially delayed disease progression. CLINICAL TRIAL REGISTRATION: NCT01942135.
Collections
Subject
Humans
Breast Neoplasms
Piperazines
Pyridines
Estradiol
Receptor, erbB-2
Receptors, Estrogen
Antineoplastic Combined Chemotherapy Protocols
Disease-Free Survival
Quality of Life
Adult
Aged
Middle Aged
Female
Drug-Related Side Effects and Adverse Reactions
Patient Reported Outcome Measures
Fulvestrant
Research team
Molecular Oncology
Molecular Oncology
Language
eng
Date accepted
2016-03-17
Citation
Annals of oncology : official journal of the European Society for Medical Oncology, 2016, 27 (6), pp. 1047 - 1054
Publisher
OXFORD UNIV PRESS