Expanded-Access Study of Palbociclib in Combination With Letrozole for Treatment of Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer

Clinical Breast Cancer
Vered StearnsAnil Abraham Joy

Abstract

Palbociclib is a cyclin-dependent kinase (CDK) 4 and 6 inhibitor that was conditionally approved in the United States (February 2015) and Canada (March 2016) with letrozole as initial endocrine-based therapy for postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer. A palbociclib expanded-access program (EAP) was initiated as an interim measure to provide drug access before commercial availability of drug. Eligible women were 18 years or older and postmenopausal with diagnosed metastatic HR-positive, HER2-negative breast cancer and were suitable candidates for letrozole therapy. Treatment continued until disease progression, unacceptable toxicity, withdrawal of consent, or commercial availability of palbociclib. We report combined safety data in both cohorts, and patient-reported outcomes in the Canadian cohort. From September 2014 to May 2016, a total of 334 patients were enrolled onto the EAP. With rapid regulatory approval and transfer to commercial supply, median duration of palbociclib treatment while on study was 77 days (range, 2-245 days). At least one dose reduction occurred in 24.3% of patients, and 3.6% of patients permanently disco...Continue Reading

Citations

Apr 18, 2018·Current Treatment Options in Oncology·Tomás ReinertMatthew J Ellis
Sep 19, 2019·BioDrugs : Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy·Matteo SantoniNicola Battelli
Aug 28, 2020·Journal of the Royal Society, Interface·Wei HeWilliam T Baumann
Jul 26, 2021·The Breast : Official Journal of the European Society of Mastology·L MoscettiF Piacentini

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