Salvage therapy with gemcitabine, ifosfamide, dexamethasone, and oxaliplatin (GIDOX) for B-cell non-Hodgkin's lymphoma: A consortium for improving survival of lymphoma (CISL) trial

Summary: Background: We investigated response rates to and toxicities of gemcitabine, ifosfamide, dexamethasone, and oxaliplatin (GIDOX) for the treatment of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL). Patients and Methods: Patients with recurrent or refractory diffuse large B-cell lymphoma or mantle cell lymphoma (DLBCL) were eligible for enrollment in this study. Treatment consisted of gemcitabine 1,000 mg/m² intravenously (i.v.) on Days 1 and 8, ifosfamide 2,000 mg/m² i.v. on Day 1, dexamethasone 40 mg orally on Days 1-4, and oxaliplatin 130 mg/m ² i.v. on Day 2, every 21 days. The primary goal of treatment was to establish a response rate after three cycles. Afterwards, patients could proceed to high-dose chemotherapy followed by autologous stem cell transplantation (HDC-ASCT) or receive up to six treatment cycles. Results: Twenty-seven eligible patients were evaluated for toxicity and response. The median age of the patients was 54 years (range, 18-75 years), and most had DLBCL. After three cycles, there were four CR (15%) and 10 PR (37%) for an overall response rate (RR) of 52%. Among a total of 88 GIDOX cycles, grade 3 and 4 neutropenia occurred in 33% and 16% of the cycles, respectively. Likewise, grade 3 and 4 thrombocytopenia occurred in 14% and 16% of the cycles, respectively. Two patients (2%) experienced febrile neutropenia, while seven patients (26%) proceeded to HDC-ASCT. Conclusions: GIDOX is an active salvage regimen for aggressive B-cell NHL and can be tolerated by patients with acceptable toxicity.