Journal of Clinical Oncology, 2005 ASCO Annual Meeting Proceedings.
Vol 23, No 16S (June 1 Supplement), 2005: 6591
© 2005 American Society of Clinical Oncology

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Abstract

Final report of a phase II study of oral cyclophosphamide, thalidomide, and prednisone (CTP) for patients with relapsed or refractory multiple myeloma: A Hoosier Oncology Group Trial: HEM01–21

Indiana Univ, Indianapolis, IN; Indiana Cancer Ctr, Indianapolis, IN

6591

Background: Well-tolerated, effective and simple regimens are warranted in multiple myeloma (MM). Both thalidomide and prolonged administration of low-dose chemotherapy inhibit angiogenesis, rather than direct cytotoxic effect observed with acute dosing schedule. Synergy observed with the combined use may decrease toxicity, while maintaining antimyeloma effect. Methods: The Hooseir Oncology Group conducted a phase II trial of oral regimen containing cyclophosphamide (50 mg BID for 21 days per 28-day course), thalidomide (200 mg/day) and prednisone (50 mg Q.O.D.); CTP, in patients with relapsed and refractory MM. Therapy was planned for a total of 12 courses. Primary endpoints were efficacy and tolerability of the regimen. With 5% error and 85% power, for expected response rate 30%, 12 responders among total of 37 patients were needed to pursue the trial further. Results: We report the final analysis of this study. Between November 2001 and June 2003, 37 patients were enrolled, 16 of whom had prior HDSCT and 22 had high dose steroid. Patient age ranged 49 to 87 (median 65) years. Two did not receive the study drugs due to progression and patient preference. Median follow up time was (95% CI 15.18–21.52) 18.37 months. Response was observed in 22 patients (63%); 7 (22%) CR, 2 (6%) nCR, and 13 (41%) partial response. Seven (22%) had stable disease, 3 (9%) had progression. Median time to best response was 3.7 (95% CI 2.9–10.9) months. Median time to progression was 13.24 months (95%CI 9.40 to 20.99). Median overall survival was 20.4+ months. The median number of treatment cycles was 7 (1–12). Major adverse effects included neutropenia (5 grade III and 5 grade IV), 4 grade III neuropathy, and 2 grade III Conclusions: The CTP oral regimen yielded high and durable response rate with acceptable toxicity profile and should be further explored in a larger patient cohort.

No significant financial relationships to disclose.

Abstract presentation from the 2005 ASCO Annual Meeting