Single Agent Gemcitabine As a Salvage Regimen in Patients with Relapsed/Refractory Hodgkin's Lymphoma after Autologous Stem Cell Transplantation

Abstract

The aim of this study was to evaluate the efficacy and safety of gemcitabine as a salvage regimen in patients with relapsed or refractory Hodgkin's lymphoma after autologous stem cell transplantation (ASCT). Fifteen patients were enrolled. All patients had received ≥ 2 prior chemotherapy regimens, had an ECOG performance status ≤ 2, had adequate organ function and had undergone ASCT. Patients received intravenous gemcitabine (1000 mg/m2) on days 1 and 15, every 4 weeks. The median age was 26 years (range, 18-44) and 8 (53%) were female. Eight (53%) had primary refractory disease. All had previous platinum-based salvage chemotherapy (IIVP, 7; ICE, 5; DHAP, 3). All (100%) had relapsed/refractory disease following ASCT as their last treatment. Eleven (73%) had refractory/progressive disease after ASCT. None had previous brentuximab vedotin treatment. Median number of previous lines of chemotherapy was 2 (range, 2-3). Median number of gemcitabine cycles administered to the patients was 4 (range, 2-6). Treatment response was assessed with PET-CT in majority of the patients before and 2-3 cycles after gemcitabine, and those patients who demonstrated a response continued to receive a maximum of 6 courses of gemcitabine or bridged to allogeneic SCT. Of 15 patients, 1 (7%) had complete response, 5 (33%) had partial response and the remaining patients had refractory/progressive disease with an overall response rate of 40%. The median time to progression for responding patients was 3 months (range, 2-7 months). Two patients were successfully bridged to allogeneic SCT. Main toxicity was hematological. Grade ≥ 3 hematologic toxicity occurred in 8 patients: thrombocytopenia (40%), neutropenia (33%) and anemia (7%). Three patients had grade 4 thrombocytopenia and 2 had grade 4 neutropenia. Dose reduction was necessary in 3 patients and treatment cycle postponed in 2 patients because of hematological toxicity. Five patients (33%) needed G-CSF support. Two patients developed febrile neutropenia. No treatment-related deaths occurred. Gemcitabine was shown to be an active salvage regimen in patients with relapsed/refractory Hodgkin's lymphoma after ASCT, producing an overall response rate of 40%. Although, the median PFS time was short, some patients can be bridged to allogeneic SCT. Hematological toxicity was common. DisclosuresOff Label Use: Gemcitabine in Hodgkin's Lymphoma.