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 pha
se II trial and treated with gemcitabine. The drug was given on days 1, 8 a
nd 15 of a 28-day schedule at a dose of 1,200 mg/m(2) intravenously for a t
otal of 6 cycles.
Results. Two (14%) patients achieved complete remission (CR) and 4 (29%) ha
d partial responses (PR), giving an overall response rate of 43%. In the re
lapsed 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 e
ffective drug with a low toxicity profile in patients with heavily pretreat
ed HD. Further trials using gemcitabine in combination with other conventio
nal drugs are needed. (C) 2000, Ferrata Storti Foundation.