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. (30th March 2016)

• Record Type: Journal Article
• Authors: 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.
• Is Part Of: Annals of oncology. Volume 27:Number 6(2016:Jun.)
• Page Start: 1047
• Page End: 1054
• Publication Date: 2016-03-30
• Subjects: endocrine resistance -- palbociclib -- patient-reported outcomes -- breast cancer -- quality of life; Oncology -- Periodicals; 616.992
• DOI: 10.1093/annonc/mdw139
• Languages: English
• ISSNs: 0923-7534

Abstract

Abstract : In treating HR+, HER2− metastatic breast cancer, novel agents that enhance endocrine therapy activity but do not worsen quality of life (QoL) are clinically desired. Patient-reported outcomes data from the PALOMA-3 study suggest palbociclib plus fulvestrant allow patients to maintain good QoL in the endocrine resistance setting while experiencing a substantially delayed disease progression. 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.