Combination immunotherapy of relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma with rituximab and interferon-alpha-2a

Rituximab and IFN have each demonstrated single-agent activity in patients with low-grade non-Hodgkins lymphoma (NHL), A single-arm, multicenter, Phas e II trial was conducted to assess the safety and efficacy of combination t herapy with rituximab and IFN-alpha-2a in 38 patients with relapsed or refr actory, low-grade or follicular, B-cell NHL, IFN-alpha-2a [2,5 or 5 million units (MIU)I was administered s,c., three times weekly for 12 weeks. Start ing on the fifth week of treatment, rituximab was administered by i,v, infu sion (375 mg/m(2)) weekly for 4 doses. All 38 patients received four comple te infusions of rituximab and were evaluable for efficacy, although 11 pati ents (29%) did not receive all 36 injections of IFN, The mean number of IFN -alpha-2a injections was 31 doses; the mean total units received were 141 M IU (maximum, 180 MIU), The study treatment was reasonably well tolerated wi th no unexpected toxicities stemming from the combination therapy. No grade 4 events were reported. Frequent adverse events during the treatment perio d included asthenia (35 of 38 patients), chills (31 of 38), fever (30 of 38 ), headache (28 of 38), nausea (23 of 38), and myalgia (22 of 38), The over all response rate was 45% (17 of 38 patients); 11% had a complete response, and 34% had a partial response. The Kaplan-Meier estimates for the median response duration and the median time to progression in responders are 22.3 and 25.2 months, respectively. Further follow-up is needed to determine wh ether this treatment combination leads to a significantly longer time to pr ogression than single-agent treatment with rituximab.