期刊
BLOOD
卷 133, 期 11, 页码 1201-1204出版社
AMER SOC HEMATOLOGY
DOI: 10.1182/blood-2018-11-886457
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资金
- Cancer Therapy Evaluation Program (CTEP)
- National Institutes of Health, National Cancer Institute [RO1CA18894, 1K24 CA201524-01]
- Alliance for Clinical Trials in Oncology Scholar award
- Translational Research Grants from Lymphoma Research Foundation
- V-Foundation
- Mantle Cell Lymphoma Research Initiative Award from the Leukemia & Lymphoma Society [MCL7001-18]
- Sarah Cannon Fund at the HCA Foundation
Single-agent ibrutinib is active in patients with previously treated mantle cell lymphoma (MCL); however, nearly half of all patients experience treatment failure during the first year. We previously demonstrated that prolonged early G1 cell cycle arrest induced by the oral, specific CDK4/6 inhibitor palbociclib can overcome ibrutinib resistance in primary human MCL cells and MCL cell lines expressing wild-type Bruton's tyrosine kinase (BTK). Therefore, we conducted a phase 1 trial to evaluate the dosing, safety, and preliminary activity of palbociclib plus ibrutinib in patients with previously treated mantle cell lymphoma. From August 2014 to June 2016, a total of 27 patients (21 men, 6 women) were enrolled. The maximum tolerated doses were ibrutinib 560 mg daily plus palbociclib 100 mg on days 1 to 21 of each 28-day cycle. The dose-limiting toxicity was grade 3 rash. The most common grade 3 to 4 toxicities included neutropenia (41%), thrombocytopenia (30%), hypertension (15%), febrile neutropenia (15%), and lung infection (11%). The overall and complete response rates were 67% and 37%, and with a median follow-up of 25.6 months, the 2-year progression-free survival was 59.4% and the 2-year response duration was 69.8%. A phase 2 multicenter clinical trial to further characterize efficacy is now ongoing.
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