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

A multicentre phase II trial was conducted to evaluate the efficacy and tox icity of gemcitabine in patients with refractory or relapsed indolent non-H odgkin's lymphoma. Thirty-six patients were enrolled onto the study, includ ing 11 cases of mantle cell lymphoma (MCL), 10 cases of chronic lymphocytic leukaemia (CLL)/lymphocytic lymphoma, nine cases of follicular lymphoma, f our cases of lymphoplasmacytic lymphoma and two cases of T-cell lymphoma. G emcitabine 1 g/m(2) was administered as a 30-min infusion on d 1, 8 and 15 of a 28-d schedule, up to a maximum of six cycles. Complete responses were observed in two patients with MCL, and partial responses were observed in s even patients, including three patients with CLL/lymphocytic lymphoma, two patients with T-cell lymphoma, one patient with MCL and one patient with fo llicular lymphoma. Minor responses were observed in three patients, includi ng two patients with MCL and one patient with CLL. The median duration of r esponse was 150 d and the overall progression-free survival was 342 d. Haem atological toxicity was observed as grade 3-4 leucopenia in 12 patients (33 %) and grade 3-4 thrombocytopenia in 18 patients (50%). Severe non-haematol ogical toxicity included one case of fatal veno-occlusive disease, one case of thrombotic microangiopathy leading to terminal renal failure, one case of capillary leak syndrome, one case of myocardial infarction and drug-indu ced fever in two patients. These data suggest that gemcitabine displays act ivity in patients with MCL and CLL/lymphocytic lymphoma. Haematological tox icity was frequent in these heavily treated patients. Severe non-haematolog ical toxicity was significant and should be taken into account in the desig n of future trials.