Harbeck, N; Iyer, S; Turner, N; Cristofanilli, M; Ro, J; Andre, F; Loi, S; Verma, S; Iwata, H; Bhattacharyya, H; Puyana Theall, K; Bartlett, C H; Loibl, S
Annals of oncology : official journal of the European Society for Medical Oncology / ESMO
2016Jun ; 27 ( 6 ) :1047-54.
PMID : 27029704
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Harbeck, N - Department of Obstetrics and Gynecology, Brustzentrum der Universitat Munchen, Munchen (LMU), Germany nadia.harbeck@med.uni-muenchen.de.
Iyer, S - Pfizer Inc, New York, USA.
Turner, N - Department of Molecular Oncology, Royal Marsden Hospital and Institute of Cancer Research, London, UK.
Cristofanilli, M - Department of Medical Oncology, Thomas Jefferson University, Philadelphia, USA.
Ro, J - Department of Medicine, National Cancer Center, Goyang-si, Korea.
Andre, F - Department of Medical Oncology, Institut Gustave Roussy, Villejuif, France.
Loi, S - Department of Oncology, Peter MacCallum Cancer Centre, East Melbourne, Australia.
Verma, S - Department of Medicine, Sunnybrook Odette Cancer Centre, Toronto, Canada.
Iwata, H - Department of Transfusion, Aichi Cancer Center Hospital, Nagoya, Japan.
Bhattacharyya, H - Pfizer Inc, New York, USA.
Puyana Theall, K - Pfizer Inc, Cambridge, USA.
Bartlett, C H - Pfizer Inc, New York, USA.
Loibl, S - Department of Oncology, German Breast Group Forschungs GmbH, Neu-Isenburg, Germany.
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, ??5.8% in each group completed ?? 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. CI - ??The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology.
keyword
breast cancer; endocrine resistance; palbociclib; patient-reported outcomes; quality of life
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