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, 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

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.

Keywords: breast cancer; endocrine resistance; palbociclib; patient-reported outcomes; quality of life.

© The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.

Figures

Figure 1.
Figure 1.
Overall change from baseline in EORTC QLQ-C30 scores for global QoL and functional scales in the PRO analysis set. Changes from baseline in the patient-reported outcomes analysis population were determined using a repeated-measures mixed-effect model. Arrow denotes direction of improved outcome; changes >0 indicate improvement from baseline. EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items; PRO, patient-reported outcomes; QoL, quality of life. Asterisks denote that the change from baseline was statistically significantly different between treatment groups.
Figure 2.
Figure 2.
Time to deterioration in global QoL (A) and pain (B) in the PRO analysis set. Kaplan–Meier curves of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items (EORTC QLQ-C30) scores for the patient-reported outcomes analysis population. CI, confidence interval; NE, not estimable; TTD, time to deterioration; PRO, patient-reported outcomes; QoL, quality of life. Circles and pluses indicate patients censored.
Figure 3.
Figure 3.
Between-treatment comparison of changes from baseline in EORTC QLQ-C30 scores for symptom scales (A) and EORTC QLQ-BR23 scores for functional (B) and symptom (C) scales in the PRO analysis set. Changes from baseline in the patient-reported outcomes analysis population were determined using a repeated-measures mixed-effect model. EORTC QLQ-BR23, European Organization for Research and Treatment of Cancer Breast Cancer Module; EORTC QLQ-C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 items; PRO, patient-reported outcomes; QoL, quality of life. P values are shown only if significant between-group differences were observed. Asterisk denotes that question was only to be answered by patients who stated they had experienced hair loss, resulting in fewer patients responding to this question compared with other questions.

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Source: PubMed

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