Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first‑line treatment of ER+/HER2− advanced breast cancer (PALOMA‑1, TRIO‑18)

Finn, Richard S. and Boer, Katalin and Bondarenko, Igor and Patel, Ravindranath and Pinter, Tamas and Schmidt, Marcus and Shparyk, Yaroslav V. and Thummala, Anu and Voitko, Nataliia and Bananis, Eustratios and McRoy, Lynn and Wilner, Keith and Huang, Xin and Kim, Sindy and Slamon, Dennis J. and Ettl, Johannes (2020) Overall survival results from the randomized phase 2 study of palbociclib in combination with letrozole versus letrozole alone for first‑line treatment of ER+/HER2− advanced breast cancer (PALOMA‑1, TRIO‑18). Breast Cancer Research and Treatment, 183. pp. 419-428. ISSN 0167-6806 (print); 1573-7217 (online)

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Abstract

Purpose Palbociclib is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor, approved in combination with endocrine therapy for the treatment of women and men with hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer (HR+/HER2− ABC). In the phase 2, open-label, PALOMA-1 trial, palbociclib plus letrozole signifcantly prolonged progression-free survival (PFS) versus letrozole alone (hazard ratio, 0.488; 95% CI 0.319‒0.748; P=0.0004; median PFS, 20.2 vs 10.2 months, respectively) in postmenopausal women with estrogen receptor–positive (ER+)/HER2− ABC. Here, we present the fnal overall survival (OS) and updated safety results. Methods Postmenopausal women with ER+/HER2− ABC were randomized 1:1 to receive either palbociclib (125 mg/day, 3/1 schedule) plus letrozole (2.5 mg/day, continuous) or letrozole alone (2.5 mg/day, continuous). The primary endpoint was investigator-assessed PFS; secondary endpoints included OS and safety. Results A total of 165 patients were randomized. At the data cutof date of December 30, 2016 (median duration of follow-up, 64.7 months), the stratifed hazard ratio for OS was 0.897 (95% CI 0.623–1.294; P=0.281); median OS in the palbociclib plus letrozole and letrozole alone arms was 37.5 and 34.5 months, respectively. The median time from randomization to frst subsequent chemotherapy use was longer with palbociclib plus letrozole than letrozole alone (26.7 and 17.7 months, respectively). The most frequently reported adverse event in the palbociclib plus letrozole arm was neutropenia (any grade, 75%; grade 3 or 4, 59%). Conclusions Palbociclib plus letrozole treatment led to a numerical but not statistically signifcant improvement in median OS. Pfzer Inc (NCT00721409)

Item Type:	Article
Additional Information:	https://doi.org/10.1007/s10549-020-05755-7 Идентификационный номер: WOS:000549817500002 Идентификатор PubMed: 32683565
Uncontrolled Keywords:	Advanced breast cancer · ER+/HER2− · Letrozole · Overall survival · Palbociclib. KeyWords Plus:DEPENDENT KINASE 4/6; ENDOCRINE THERAPY; FULVESTRANT; ABEMACICLIB; RIBOCICLIB
Subjects:	Oncology
Divisions:	Departments > Department of Oncology and Medical Radiology
Depositing User:	Елена Шрамко
Date Deposited:	01 Apr 2021 14:37
Last Modified:	01 Apr 2021 14:37
URI:	http://repo.dma.dp.ua/id/eprint/6400

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