Gemcitabine as a single agent in the treatment of relapsed or refractory aggressive non-Hodgkin's lymphoma

Purpose: A multicenter phase II trial was conducted to evaluate the efficac y and toxicity of gemcitabine in patients with relapsed or refractory aggre ssive nonHodgkin's lymphomas(NHL) Patients and Methods: Thirty-one patients with B-cell intermediate or high- grade NHL (Working Formulation) were enrolled onto the study, The median ag e was 61 years, with a Karnofsky performance statue of less than or equal t o 80% in 65% of patients, Forty-eight percent held stage III or IV (Ann Arb or Classification) at study entry, Pretreatment consisted of one, two, or t hree chemotherapeutic regimens in nine, 11, and 11 patients, respectively. Gemcitabine 1,250 mg/m(2) was administered intravenously over 30 minutes on days 1,8, and 15 of a 28-day schedule. Results: Thirty patients were assessable for efficacy, and 31 were assessab le for toxicity. No complete responses were observed, hut six patients show ed a partial response, 11 stable disease, and 13 progressive disease. The o verall response rate was 20% (95% confidence interval, 8% to 39%) for asses sable patients and 19% (95% confidence interval, 8% to 34%) for the intent- to-treat analysis. The median duration of partial response was 6 months (ra nge, 3.7 to 15+ months), Nonhematologic World Health Organization grade 3 t oxicity included hepatic toxicity in four patients and infection in two, He matologic toxicity was observed as grade 3 anemia in three patients, grade 3 leukopenia in two patients, grade 3/4 neutropenia in two patients, and gr ade 3/4 thrombocytopenia in six patients, Conclusion: The present schedule of gemcitabine displays modest efficacy an d mild toxicity in pretreated aggressive NHL. J Clin Oncol 17:3786-3792, (C ) 1999 by American Society of Clinical Oncology.