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- Title
Low-dose, single-agent temsirolimus for relapsed mantle cell lymphoma: a phase 2 trial in the North Central Cancer Treatment Group.
- Authors
Ansell, Stephen M.; Inwards, David J.; Rowland Jr, Kendrith M.; Flynn, Patrick J.; Morton, Roscoe F.; Moore Jr, Dennis F.; Kaufmann, Scott H.; Ghobrial, Irene; Kurtin, Paul J.; Maurer, Matthew; Alimer, Christine; Witzig, Thomas E.; Rowland, Kendrith M Jr; Moore, Dennis F Jr; Allmer, Christine
- Abstract
<bold>Background: </bold>The objective of this study was to test a low dose of (25 mg weekly) of the mammalian target of rapamycin kinase inhibitor temsirolimus for patients with relapsed mantle cell lymphoma (MCL).<bold>Methods: </bold>Patients with relapsed or refractory MCL were eligible to receive temsirolimus 25 mg intravenously every week as a single agent. Patients who had a tumor response after 6 cycles were eligible to continue drug for a total of 12 cycles or 2 cycles after complete remission and then were observed without maintenance.<bold>Results: </bold>Of 29 enrolled patients, 28 were evaluable for toxicity, and 27 were evaluable for efficacy. The median age was 69 years (range, 51-85 years), 86% of patients had stage IV disease, and 71% had > or = 2 extranodal sites. Patients had received a median of 4 prior therapies (range, 1-9 prior therapies), and 50% were refractory to the last treatment. The overall confirmed response rate was 41% (11 of 27 patients; 90% confidence interval [CI], 22%-61%) with 1 complete response (3.7%) and 10 partial responses (37%). The median time to progression in all eligible patients was 6 months (95% CI, 3-11 months), and the median duration of response for the 11 responders was 6 months (range, 1-26 months). Hematologic toxicities were the most common, with 50% (14 of 28 patients) grade 3 and 4% (1 of 28 patients) grade 4 toxicities observed. Thrombocytopenia was the most frequent cause of dose reduction.<bold>Conclusions: </bold>Single-agent temsirolimus at a dose of 25 mg weekly is an effective new agent for the treatment of MCL. The 25-mg dose level retained the antitumor activity of the 250-mg dose with less myelosuppression. Further studies of temsirolimus in combination with other active drugs for MCL and other lymphoid malignancies are warranted.
- Subjects
UNITED States; CANCER treatment; LYMPHOMA treatment; DRUG dosage; RAPAMYCIN; IMMUNOSUPPRESSIVE agents; ANTINEOPLASTIC agents; CLINICAL trials; COMPARATIVE studies; DRUG administration; DOSE-effect relationship in pharmacology; LYMPHOMAS; RESEARCH methodology; MEDICAL cooperation; RESEARCH; SURVIVAL analysis (Biometry); DISEASE relapse; EVALUATION research; TREATMENT effectiveness
- Publication
Cancer (0008543X), 2008, Vol 113, Issue 3, p508
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/cncr.23580