Abemaciclib in Combination With Endocrine Therapy for Patients With Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer: A Phase 1b Study.
Abstract | BACKGROUND: PATIENTS AND METHODS: Women ≥18 years old with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) MBC were eligible for enrollment. Eligibility included measurable disease or non-measurable but evaluable bone disease by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1, Eastern Cooperative Oncology Group performance status 0-1, and no prior chemotherapy for metastatic disease. Adverse events were graded by the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 and tumor response were assessed by RECIST v1.1. RESULTS: Sixty-seven patients were enrolled and received abemaciclib 200 mg every 12 hours in combination with letrozole (Part A, n=20), anastrozole (Part B, n=16), tamoxifen (Part C, n=16), or exemestane (Part D, n=15). The most common treatment-emergent adverse events (TEAE) were diarrhea, fatigue, nausea, and abdominal pain. Grade 4 TEAEs were reported in five patients (one each with hyperglycemia, hypertension, neutropenia, procedural hemorrhage, and sepsis). There was no effect of abemaciclib or endocrine therapy on the pharmacokinetics of any combination study drug. Across all treated patients, the median progression-free survival was 25.4 months (95% confidence interval: 18.0, 35.8). The objective response rate was 38.9% in 36 patients with measurable disease. CONCLUSIONS:
Abemaciclib in combination with multiple endocrine therapy options exhibited manageable safety and promising antitumor activity in patients with HR+, HER2- MBC. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov/, identifier NCT02057133.
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Authors | Sara M Tolaney, Muralidhar Beeram, J Thaddeus Beck, Alison Conlin, E Claire Dees, Shannon L Puhalla, Brent N Rexer, Howard A Burris, Komal Jhaveri, Teresa Helsten, Carlos Becerra, Kevin Kalinsky, Kathleen N Moore, Allison M Manuel, Andrew Lithio, Gregory L Price, Sonya C Chapman, Lacey M Litchfield, Matthew P Goetz |
Journal | Frontiers in oncology
(Front Oncol)
Vol. 11
Pg. 810023
( 2021)
ISSN: 2234-943X [Print] Switzerland |
PMID | 35223458
(Publication Type: Journal Article)
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Copyright | Copyright © 2022 Tolaney, Beeram, Beck, Conlin, Dees, Puhalla, Rexer, Burris, Jhaveri, Helsten, Becerra, Kalinsky, Moore, Manuel, Lithio, Price, Chapman, Litchfield and Goetz. |
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