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

N. Harbeck*, S. Iyer, N. Turner, M. Cristofanilli, J. Ro, F. André, S. Loi, S. Verma, H. Iwata, H. Bhattacharyya, K. Puyana Theall, C. H. Bartlett, S. Loibl

*Corresponding author for this work

Research output: Contribution to journalArticle

69 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)1047-1054
Number of pages8
JournalAnnals of Oncology
Volume27
Issue number6
DOIs
StatePublished - Jun 18 2016

Keywords

  • Breast cancer
  • Endocrine resistance
  • Palbociclib
  • Patient-reported outcomes
  • Quality of life

ASJC Scopus subject areas

  • Hematology
  • Oncology

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    Harbeck, N., Iyer, S., Turner, N., Cristofanilli, M., Ro, J., André, F., Loi, S., Verma, S., Iwata, H., Bhattacharyya, H., Puyana Theall, K., Bartlett, C. H., & Loibl, S. (2016). 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. Annals of Oncology, 27(6), 1047-1054. https://doi.org/10.1093/annonc/mdw139