Gemcitabine and cisplatin in refractory malignant lymphoma

Objective: We performed a pilot study to evaluate the effect of the high-dose gemcitabine-cisplatin combination in a brief weekly regimen in the treatment of primary refractory diffuse large cell lymphoma with high or high-intermediate clinical risk. Methods: Thirty patients refractory to first-line anthracycline-based chemotherapy were treated with a combination of gemcitabine (1.5 g/m(2) i.v.) and cisplatin (50 mg/m(2) i.v.) on days 1, 8, 22, 29, 42 and 49. No further treatment was administered. Results: Complete response rate was 53%; and only two relapses have been observed at the last follow-up. Thus actuarial disease-free survival at the 3-year follow-up was: 87% (95% confidence interval, CI: 70-93%) and overall survival 53% ( 95% CI: 44-63%). Toxicity was mild, and treatment was well tolerated. No treatment-related death was observed. Conclusions: The gemcitabine-cisplatin combination appears to be promising in the treatment of refractory lymphoma patients, with a low toxicity. However, a longer follow-up is needed to confirm the results. In our opinion, prolonged chemotherapy (6-8 cycles) did not improve outcome. At present, we are testing if the use of monoclonal antibodies ( anti-CD20) employed as maintenance therapy may improve disease-free survival and overall survival. Copyright (C) 2004 S. Karger AG, Basel.