In the PALOMA-3 study, palbociclib plus fulvestrant demonstrated improved progression-free survival compared with fulvestrant plus placebo in HR+/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 intramuscularly 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-effects analyses were performed 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 vs 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,-1.5 vs 2.0, 95% CI:-0.6, 4.6; P=0.0011). No significant differences were observed for other QLQ-BR 23 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.
ClinicalTrials.gov identifier NCT01942135.
© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

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