• Hope S Rugo, Nicholas C Turner, Richard S Finn, Anil A Joy, Sunil Verma, Nadia Harbeck, Norikazu Masuda, Seock-Ah Im, Xin Huang, Sindy Kim, Wan Sun, Shrividya Iyer, Patrick Schnell, BartlettCynthia HuangCHPfizer Inc, 500 Arcola Rd, Collegeville, PA 19426, USA. Electronic address: cynthia.huang@pfizer.com., and Stephen Johnston.
• University of California San Francisco Helen Diller Family Comprehensive Cancer Center, 1600 Divisidero St, San Francisco, CA 94115, USA. Electronic address: hope.rugo@ucsf.edu.
• Eur. J. Cancer. 2018 Sep 1; 101: 123-133.

AimBecause 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.MethodsData 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-naïve 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.ResultsAmong 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.ConclusionsPalbociclib plus endocrine therapy is an effective, well-tolerated treatment for older patients with ABC.Copyright © 2018. Published by Elsevier Ltd.

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