O2-1-2 - Feasibility Study of a Gemcitabine Combined Regimen in Heavily Pre-Treated Patients with Non-Hodgkin Lymphomas

Abstract

Background: Prognosis of relapsed or refractory non-Hodgkin lymphomas (NHL) remains poor. We conducted a feasibility study of a new salvage regimen containing gemcitabine for patients with relapsed or refractory NHL who received at least two or more regimens including standard salvage chemotherapy.Methods: This was a single institute clinical study approved by the Institutional Review Board of Aichi Cancer Center. Written informed consent was obtained from each patient. Subjects were patients diagnosed as relapsed or refractory NHL from 2006 to 2012. The regimen (Mit-GDP ± R) consisted of mitoxantrone, gemcitabine, dexamethasone and cisplatin. Rituximab was administered for patients if tumor cells showed the positivity of CD20 antigen.Results: A total of 8 patients [(diffuse large B-cell lymphomas (n = 5), mantle cell lymphoma (n = 1) and peripheral T-cell lymphomas not otherwise specified (n = 2)] were enrolled. The median age was 62.5 years. The median number of previous treatment was 3 (range: 2-5) and five patients had a history of previous autotransplant. Five patients had refractory diseases and all patients of B-NHL received prior rituximab combined therapy. The median days from prior treatment to the start of Mit-GDP ± R were 53.5 days. After receiving the Mit-GDP ± R regimen (median 2 cycles, range; 1-4), three patients obtained objective responses including three complete responses (CR, 37.5%). The median time to treatment failure was 2 months and the median duration of CR was 60 months (range: 13-73 months). Major grade 3 hematological and non-hematological toxicities were febrile neutropenia (37.5%) and nausea (12.5%). Non-hematological Grade 4 and 5 toxicities were not observed until now.Conclusions: The Mit-GDP ± R regimen showed a modest efficacy with acceptable toxicities in heavily pre-treated NHL patients. This regimen may be considered for some subset of patients who have failed after standard salvage therapy.