A phase 2 study of epothilone B analog BMS‐247550 (NSC 710428) in patients with relapsed aggressive non‐Hodgkin lymphomas |
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| Authors: | Jane E. Churpek MD Barbara Pro MD Koen van Besien MD Justin Kline MD Kathy Conner RN James L. Wade III MD Fredrick Hagemeister MD Theodore Karrison PhD Sonali M. Smith MD |
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| Affiliation: | 1. Department of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center, Chicago, Illinois;2. Fox Chase Cancer Center, Philadelphia, Pennsylvania;3. Weill‐Cornell Medical Center, New York, New York;4. Decatur Memorial Hospital, Decatur, Illinois;5. The University of Texas MD Anderson Cancer Center, Houston, Texas;6. Department of Health Studies, University of Chicago Medical Center, Chicago, Illinois;7. Department of Medicine, Section of Hematology/Oncology, University of Chicago Medical Center, Chicago, IllinoisFax: (773) 702‐0963 |
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| Abstract: | BACKGROUND: The management of relapsed aggressive lymphomas remains problematic. Ixabepilone (BMS‐247550, epothilone B analog), a potent inhibitor of tubulin disassembly, has promising preclinical and early‐phase clinical activity in drug‐resistant malignancies. METHODS: This multicenter phase 2 clinical trial tested the activity and safety of ixabepilone in relapsed/refractory aggressive lymphoma patients with either chemosensitive (at least a partial response [PR] to most recent chemotherapy) or chemoresistant (less than PR to most recent chemotherapy) disease at 20 mg/m2 given intravenously weekly on days 1, 8, and 15 of a 28‐day cycle. RESULTS: Fifty‐one enrolled patients with a median age of 66 years received at least 1 dose of ixabepilone. Diffuse large B‐cell lymphoma (n = 25; 49%), mantle cell lymphoma (n = 16; 31%), and transformed follicular lymphoma (n = 5; 10%) were the most frequent histologies. Patients were heavily pretreated, with more than one‐quarter having received 4 or more prior therapies. The overall response rate was 27% (14 of 51 patients) with 12% (6 patients) experiencing complete responses and 16% (8 patients) with PRs. All responses were in patients with chemosensitive disease. The median time to response was 2 cycles with a median duration of response of 9.7 months. CONCLUSIONS: Ixabepilone was well‐tolerated, with neutropenia, peripheral sensory neuropathy, fatigue, and nausea as the major toxicities. Ixabepilone has modest single‐agent activity in patients with recurrent chemosensitive aggressive lymphomas. Cancer 2013. © 2013 American Cancer Society. |
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| Keywords: | non‐Hodgkin lymphoma aggressive refractory relapsed ixabepilone |
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