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

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

Thomas A Davis, David G Maloney, Antonio J Grillo-Lopez, Christine A White, Michael E Williams, George J Weiner, Sue Dowden and Ronald Levy
Clinical cancer research, Vol.6(7), pp.2644-2652
07/2000
PMID: 10914705

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Abstract

Rituximab and IFN have each demonstrated single-agent activity in patients with low-grade non-Hodgkin's lymphoma (NHL). A single-arm, multicenter, Phase II trial was conducted to assess the safety and efficacy of combination therapy with rituximab and IFN-alpha-2a in 38 patients with relapsed or refractory, low-grade or follicular, B-cell NHL. IFN-alpha-2a [2.5 or 5 million units (MIU)] was administered s.c., three times weekly for 12 weeks. Starting on the fifth week of treatment, rituximab was administered by i.v. infusion (375 mg/m2) weekly for 4 doses. All 38 patients received four complete infusions of rituximab and were evaluable for efficacy, although 11 patients (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 MIU (maximum, 180 MIU). The study treatment was reasonably well tolerated with no unexpected toxicities stemming from the combination therapy. No grade 4 events were reported. Frequent adverse events during the treatment period 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 overall 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 whether this treatment combination leads to a significantly longer time to progression than single-agent treatment with rituximab.
Lymphoma, Follicular - drug therapy Humans Middle Aged Antibodies, Monoclonal - adverse effects Antineoplastic Combined Chemotherapy Protocols - adverse effects Antibodies, Monoclonal - therapeutic use Male Antineoplastic Agents - therapeutic use Recombinant Proteins Time Factors Antineoplastic Agents - adverse effects Adult Female Lymphoma, B-Cell - drug therapy Antibodies, Monoclonal, Murine-Derived Lymphoma, Follicular - pathology Interferon-alpha - therapeutic use Rituximab Disease Progression Immunotherapy - adverse effects Interferon-alpha - administration & dosage Disease-Free Survival Antibodies, Monoclonal - administration & dosage Antineoplastic Combined Chemotherapy Protocols - therapeutic use Lymphoma, B-Cell - pathology Aged Interferon-alpha - adverse effects Infusions, Intravenous Neoplasm Staging

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