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
Richard S FinnJohannes Ettl

Abstract

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 significantly 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 final overall survival (OS) and updated safety results. 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. A total of 165 patients were randomized. At the data cutoff date of December 30, 2016 (median duration of follow-up, 64.7 months), the stratified 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 w...Continue Reading

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Citations

Sep 10, 2020·International Journal of Molecular Sciences·Michela PiezzoMichelino De Laurentiis
Apr 4, 2021·The Breast : Official Journal of the European Society of Mastology·Debora BasileFabio Puglisi
Jun 23, 2021·Bulletin du cancer·Florence CoussyPaul Cottu
Jul 3, 2021·Journal of Personalized Medicine·Vittoria BarberiAlessandra Fabi
Aug 8, 2021·Clinical & Translational Oncology : Official Publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico·E PanagiotouE Kotteas
Oct 9, 2021·Journal of Cutaneous Pathology·Riyad N H SeervaiJonathan L Curry
Oct 29, 2021·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Virginia F Borges

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