[A phase II multicenter study to investigate R-ICE as a salvage therapy for relapsed diffuse large B-cell lymphoma]

To investigate the efficacy and safety of rituximab together with etoposide, carboplatin, and ifosfamide (R-ICE) as a salvage therapy for relapsed diffuse large B-cell lymphoma (DLBCL) after treatment with rituximab based first-line chemotherapy (R-Chemo).

DLBCL patients with complete remission (CR) or complete remission unconfirmed (CRu) after 6-8 cycles of R-Chemo treatment but relapsed for first time after stopping treatment were included in this study. Three cycles of R-ICE regimen were given to the patients [1st day: rituximab, 375 mg/m²; 2nd-4th day: ifosfamide, 1 600 mg/m²; 3rd day: carboplatin, area under the curve (AUC) =5 (maximum dosage: 800 mg), 2nd-4th day: etoposide, 100 mg/m²]. The primary endpoint was overall response rate (ORR). The secondary endpoints were the 2-year progression-free survival (PFS), 2-year overall survival (OS), and toxicity.

Thirty-two patients with median age at 55(range: 26-68) were recruited in this clinical study and the final analysis. After three cycles of R-ICE salvage treatment, 16 patients (50.0%) achieved CR or CRu and 9 patients (28.1 %) achieved partial remission (PR). The ORR was 78.1%. The 2-year PFS and OS were 40.8% and 60.7%, respectively. Nineteen patients (59.4%) had 3/4 grade adverse events. The ratios of leukopenia neutropenia, anemia and thrombocytopenia in patients with 3/4 grades were 37.5%, 15.6%, and 37.5%, respectively. No patient died.

R-ICE is an effective salvage therapy for R-Chemo relapsed DLBCL with manageable toxicities.