R-ESHAP as salvage therapy in patients with relapsed or refractory diffuse large B-cell lymphoma: A prospective phase II study.

Abstract

e18549 Background: Patients with refractory or relapsed diffuse large B-cell lymphoma (DLBCL) are usually managed by salvage chemotherapy. However, standard regimen remains uncertain. Moreover, the benefit of adding rituximab is not well established. The aim of this study was to determine the efficacy and the safety of R-ESHAP (rituximab, etoposide, methylprednisolone, cytarabine and cisplatin) as salvage therapy in patients with relapsed or refractory DLBCL. Methods: Patients received at least 2 cycles of R-ESHAP. For patients with chemo-sensitive disease after R-ESHAP, high dose therapy and autologous stem cell transplantation (ASCT) were recommended. Results: A total of 31 patients were enrolled. Eight patients (26%) were diagnosed with refractory disease which was defined as lack of complete response on previous chemotherapy. All patients received CHOP regimen as their initial chemotherapy and 8 patients had rituximab combination. The median cycle of R-ESHAP salvage chemotherapy was four. Thirty patients responded to chemotherapy with an overall response rate of 96.8%. The complete and partial response rates were 58.1% and 38.7%, respectively. Hematological toxicity was common, but manageable. Grade 3/4 neutropenia occurred in 68% of the patients and 10 patients (32%) developed neutropenic fever. Twelve patients (39%) had grade 3/4 of thrombocytopenia and anemia. With a median follow-up of 25.8 months, the overall survival (OS) and progression-free survival (PFS) rates at 2 years were 70% and 49%, respectively. Patients with refractory disease had a significantly poorer 2-year PFS rate compared with those with relapsed disease (25% vs. 58%, P = 0.02). Patients with B symptoms had an adverse impact on both PFS (43% vs. 55%, P = 0.03) and OS (36% vs. 78%, P = 0.02). None of patients treated with ASCT died and had an insignificant higher 2-year OS rate compared with those without ASCT (100% vs. 65%, P = 0.16). Conclusions: Our study showed R-ESHAP was an effective salvage chemotherapy regimen with tolerable toxicities in patients with relapsed or refractory DLBCL. The prognosis for patients with refractory disease and B symptoms was poor and the treatment in this cohort needs to be optimized.