The efficacy and safety of the DICE regimen in combination with rh-endostatin (Endostar) in the treatment of recurrent or refractory diffuse large B-cell lymphoma: A prospective clinical trial / 肿瘤

ABSTRACT

Objective: To evaluate the efficacy and safety of the DICE regimen in combination with recombinant human endostatin (Endostar) in patients with recurrent or refractory DLBCL (diffuse large B-cell lymphoma). Methods: DICE regimen were given intravenously for 4 consecutive days, consisting of dexamethasone 10 mg/d, ifosfamide 1 g·m-2·d -1, cisplatin 25 mg·m-2·d-1, and etoposide 60 mg·m-2·d-1. Endostar were given at 7.5 mg/m2 (i.v.) on days 1-14. Cycles were repeated every 3 or 4 weeks. Results: Between January 2009 and September 2011, 15 patients with recurrent or refractory DLBCL were enrolled 11(73.3%) with primary refractory lymphoma and 4 (26.7%) with recurrent lymphoma. Two patients (13.3%) achieved a complete remission and 2 (13.3%) achieved a partial remission. The overall response rate was 26.7%. The clinical factors of gender (P = 0.011), International Prognostic Index (P = 0.033) and serum lactate dehydrogenase level (P = 0.011) had significant effects on overall response rate. The TTF (median time to treatment failure) and the OS (overall survival) time were 2 and 10 months, respectively. The one-year OS rate and the TTF rate were 46.7% and 26.7%, respectively. Myelosuppression was the major toxicity. WHO grade III/IV leukopenia and granulocytopenia were developed in 11 patients (78.6%). Conclusion: DICE regimen in combination with Endostar was well tolerated and its efficacy was mild in patients with recurrent or refractory DLBCL, probably due to these extremely poor prognostic patients. Copyright © 2013 by TUMOR.