Long-term Pooled Safety Analysis of Palbociclib in Combination With Endocrine Therapy for HR+/HER2- Advanced Breast Cancer

Journal of the National Cancer Institute
Véronique DiérasRichard S Finn

Abstract

Palbociclib administered with endocrine therapy was tolerable when the overall incidence of toxicities was assessed separately for three PALOMA studies. This study analyzed pooled, longer-term PALOMA safety data longitudinally. Data were pooled from three randomized phase II and III studies (ClinicalTrials.gov: NCT00721409, NCT01740427, NCT01942135) of hormone receptor-positive/human epidermal growth factor receptor 2‒negative advanced breast cancer patients. Front-line patients were randomly assigned to receive letrozole with/without palbociclib (PALOMA-1) or letrozole plus palbociclib/placebo (PALOMA-2). In PALOMA-3, patients with prior endocrine resistance received fulvestrant plus palbociclib/placebo. The cumulative event rates of adverse events (AEs), reporting up to 50 months of treatment, were assessed over time. Patients who received endocrine therapy (n = 1343) were included in this pooled analysis (872 were also treated with palbociclib, and 471 were not). The most common AEs with palbociclib plus endocrine therapy were neutropenia and infections (any grade, 80.6% and 54.7%, respectively), which were higher than in the endocrine monotherapy arm (any grade, 5.3% and 36.9%). The most common hematologic AEs (≥15.0% in th...Continue Reading

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Citations

May 19, 2019·Current Treatment Options in Oncology·Conleth G Murphy
Jun 30, 2019·Annals of Oncology : Official Journal of the European Society for Medical Oncology·E L MayerH J Burstein
Sep 26, 2020·Insights Into Imaging·Rubina Manuela TrimboliFrancesco Sardanelli
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Oct 21, 2021·Clinical Pharmacology and Therapeutics·Albert L KrausJennifer M Tursi

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Clinical Trials Mentioned

NCT00721409
NCT01740427
NCT01942135
NCT02513394

Software Mentioned

PALOMA

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