ABSTRACT: The aim of this study was to determine the feasibility, efficacy and toxicity of the combined therapy consisting of cladribine (2-CdA), mitoxantrone and cyclophosphamide (CMC regimen) in patients with refractory or relapsed non-Hodgkin's lymphoma (NHL). Thirty six patients, 14 with mantle cell lymphoma (MCL), 10 with diffuse large B-cell lymphoma (DLBCL), 5 with follicular lymphoma (FL), 3 with small lymphocytic lymphoma (SLL), and 4 with T-cell lymphoma were enrolled to the study. The CMC protocol consisted of 2-CdA at a dose of 0.12 mg/kg in a 2-hour infusion on days 1 through 3, mitoxantrone 10 mg/m(2) i.v. on day 1 and cyclophosphamide 650 mg/m(2) i.v. on day 1. The CMC courses were repeated at intervals of 4 weeks. Thirty three patients were available for evaluation of response. Overall response rate (OR) was 58% (95% CI, 41--75%). Seven patients (21%; 95% CI, 7--35%) achieved a complete response (CR) and 12 patients (36%; 95% CI, 20--52%) achieved a partial response (PR). Seven of 19 patients with CR/PR are still in remission with a median follow-up of 3 months (range, 2-17 months). The median failure-free survival (FFS) was 5 months (range, 2-17 months). The median overall survival (OS) for the entire group was 9 months (range, 0.1-7 months). There was a significant difference in OS between responders and nonresponders after CMC therapy (log rank test, P = 0.015). When different disease status before CMC treatment was considered, a trend toward longer survival of recurrent patients was observed (log rank test, P = 0.08). Grade 3-4 neutropenia developed in 14 (39%) patients, and 16 episodes (15%) of grade 3-4 infections were observed. Grade 3-4 thrombocytopenia or anemia was seen in 9 patients (25%) and 10 patients (28%), respectively. The results of our study show that the CMC regimen is effective salvage therapy with acceptable toxicity in heavily pretreated patients with NHL including MCL and DLBCL.
Leukemia and Lymphoma 07/2007; 48(6):1092-101. · 2.58 Impact Factor