Value of gemcitabine treatment in heavily pretreated Hodgkin's disease patients

Background and Objectives. To assess the efficacy and the toxic profile of gemcitabine, a novel pyrimidine antimetabolite active against several solid tumors, we carried out a study in heavily pretreated Hodgkin's disease (HD) patients. Design and Methods. From May 1997 to January 1999, 14 pretreated patients (10 relapsed and 4 refractory to previous treatments) were enrolled in a phase II trial and treated with gemcitabine. The drug was given on days 1, 8 and 15 of a 28-day schedule at a dose of 1,200 mg/m(2) intravenously for a total of 6 cycles. Results. Two (14%) patients achieved complete remission (CR) and 4 (29%) had partial responses (PR), giving an overall response rate of 43%. In the relapsed subset there was an overall response rate of 50% with 2 CR and 3 PR. Among the refractory patients there was only 1 PR (25%). Both patients who had relapsed after autologous bone marrow transplant achieved a response (1 CR and 1 PR). No major toxic effects were recorded. Interpretation and Conclusions. These data suggest that gemcitabine is an effective drug with a low toxicity profile in patients with heavily pretreated HD. Further trials using gemcitabine in combination with other conventional drugs are needed. (C) 2000, Ferrata Storti Foundation.