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Palbociclib plus endocrine therapy in older women with HR+/HER2- advanced breast cancer: A pooled analysis of randomised PALOMA clinical studies

Cited 30 time in Web of Science Cited 33 time in Scopus
Issue Date
2018-09
Citation
European Journal of Cancer, Vol.101, pp.123-133
Keywords
Advanced breast cancerAgeHR-positiveEndocrine treatmentHER2-negativeTumourLetrozoleFulvestrantPalbociclib
Abstract
Aim: Because incidence of breast cancer and comorbidities increase with age, it is important to determine treatment benefit in elderly patients. We evaluated outcomes with palbociclib plus endocrine therapy in patients aged >= 65 years. Methods: Data were pooled from three randomised studies (NCT00721409, NCT01740427 and NCT01942135) of women with HR+/HER2- advanced breast cancer (ABC). In PALOMA-1 (open-label) and PALOMA-2 (double-blind, placebo-controlled), treatment-naive patients received palbociclib plus letrozole or letrozole alone. In PALOMA-3 (double-blind, placebo-controlled), patients with endocrine-resistant disease received palbociclib plus fulvestrant or fulvestrant alone. Results: Among 528 patients treated with palbociclib plus letrozole and 347 treated with palbociclib plus fulvestrant, 218 (41.3%) and 86 (24.8%), respectively, were aged >= 65 years. Versus endocrine therapy alone, median progression-free survival was significantly improved in patients aged 65-74 years (hazard ratio [HR], 0.66; 95% confidence interval [CI], 0.45-0.97; P = 0.016) and >= 75 years (HR, 0.31; 95% CI, 0.16-0.61; P<0.001) receiving palbociclib plus letrozole and in patients aged 65-74 years (HR, 0.27; 95% CI, 0.16-0.48; P<0.001) receiving palbociclib plus fulvestrant; few patients aged >= 75 years received palbociclib plus fulvestrant (HR, 0.59; 95% CI, 0.19-1.8; P = 0.18). Patient-reported functioning and quality of life was maintained. No clinically relevant differences in palbociclib exposure were observed between age groups. Although myelosuppression was more common among patients aged >= 75 years, incidence of grade >= III myelosuppression was similar across age groups, and febrile neutropenia was uncommon (<= 2.4%); no new safety concerns were identified in older patients. Conclusions: Palbociclib plus endocrine therapy is an effective, well-tolerated treatment for older patients with ABC. (C) 2018 Published by Elsevier Ltd.
ISSN
0959-8049
URI
https://hdl.handle.net/10371/177318
DOI
https://doi.org/10.1016/j.ejca.2018.05.017
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College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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