Gemcitabine in the treatment of relapsed and refractory Hodgkin's disease

Background: Patients with refractory Hodgkin's disease or relapsing after high-dose therapy and autografting have a poor prognosis. Here, we present our experiences with gemcitabine in this setting. Patients and Methods: We treated 14 patients with relapsed or refractory Hodgkin's disease with gemcitabine. The treatment was given on a compassionate use basis, off-label and not according to a study protocol. Patients were 17 - 46 years of age. 1 patient had stage IA disease, 2 patients had stage IIIB disease and 11 patients had stage IVB disease. 9 patients had received radiotherapy. 8 patients had been autografted and 1 patient auto- and allografted. Gemcitabine was administered at a starting dose of 1 g/m(2) on days 1 and 8 every 3 weeks in combination with steroids. Results: The median follow-up period was 10 months. Hematological toxicity grade 3 - 4 occurred in 12 patients leading to dose reductions. 1 patient died of neutropenic sepsis. No other non-hematological toxicities were observed. The response rate was 64% with 6 patients achieving complete remission (CR) and 3 patients partial remission (PR). The median time to treatment failure was 9 months, and survival was 11 months. Responses were seen in previously transplanted patients and in patients refractory to previous treatment. The so far longest responder has been in CR for over 68 months. Conclusion: Gemcitabine is an effective treatment for Hodgkin's disease. Heavily pretreated patients often require dose reductions.