A multicenter phase II trial of etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin for patients with primary refractory/relapsed aggressive non-Hodgkin's lymphoma

Purpose: We investigated the efficacy and toxicity of the etoposide, methylprednisolone, high-dose cytarabine, and oxaliplatin (ESHAOx), in which oxaliplatin (Ox) was substituted for cisplatin in the ESHAP [etoposide (E), methylprednisolone (S), high-dose cytarabine (HA), and cisplatin (P)] regimen, for patients with refractory/relapsed aggressive non-Hodgkin's lymphoma (NHL). Materials and methods: The ESHAOx consisted of E (40 mg/m² on days 1-4), S (500 mg on days 1-5), HA (2 g/m² on day 5), and Ox (130 mg/m² on day 1) every 3 weeks to a maximum of six cycles. Responses were assessed every three cycles. Results: Twenty-seven patients were enrolled (19 with relapsed and 8 with refractory; 10 with an IPI score of 3-5). The overall response rate was 63% [95% confidence interval (95% CI) 45-81%], including eight complete remissions (CR) and one unconfirmed CR (33%). The median duration of response was 9.9 months (95% CI 5.7-14.2 months). After a median follow-up of 18.6 months, the median progression-free and overall survival was 5.3 months (95% CI 3.9-6.7 months) and 15.1 months (95% CI 9.4-20.9 months), respectively, with a 1-year survival rate of 61.5%. Most common grade 3/4 hematologic toxicities were neutropenia (56%) and thrombocytopenia (35%), whereas no patient experienced grade 3/4 renal or neurotoxicity. Conclusion: The efficacy and toxicity profiles suggested that the ESHAOx can be an alternative option for patients with refractory/relapsed aggressive NHL.