Liposomal daunorubicin in the treatment of relapsed or refractory non-Hodgkin's lymphoma

Purpose: To assess the efficacy and toxicity of liposomal daunorubicin admi nistered as a two-hour intravenous infusion to patients with relapsed or re fractory non-Hodgkin's lymphoma (NHL). Patients and methods: Eligible patients had relapsed or refractory NHL with measurable or evaluable disease, and low grade, select intermediate grade, or mantle cell pathologic types. Prior exposure to an anthracycline or ant hracenedione was allowed. Liposomal daunorubicin at a dose of 100 mg/m(2) w as given intravenously over a minimum of 120 minutes every 3 weeks, as a si ngle agent. Results: Thirty-three patients were accrued: twenty-three (70%) had low-gra de histologies; six (18%) had intermediate-grade histologies (follicular la rge-cell and diffuse small cleaved); and four (12%) patients had mantle-cel l lymphoma. Eighteen (55%) had received two or more prior regimens; fourtee n (42%) received a prior anthracycline. A median of six cycles of liposomal daunorubicin were administered (range 1-15). Of 31 patients evaluable for response, 2 complete and 10 partial remissions were documented for a major response rate of 39% (95% confidence interval (CI): 22%-58%). The median du ration of response was 19.5 months (range 4.3-41.1+). Six responders (50%) had received a prior anthracycline; one responder had mantle-cell histology . The major toxicities were grade 3 or 4 neutropenia in 26 patients (79%), mild to moderate nausea in 22 (67%), and fatigue in 16 (48%). Conclusions: Liposomal daunorubicin at 100 mg/m(2) every three weeks has ac tivity in patients with relapsed or refractory NHL, including patients with prior exposure to an anthracycline. Further studies of liposomal daunorubi cin in combination with other agents are warranted.