Purpose Interleukin-4 (IL-4) is a pleiotropic cytokine that has in vitro antiproliferative activity against non-Hodgkin's lymphoma (NHL). This phase II study was conducted to learn the efficacy and toxicity of IL-4 on patients with relapsing or resistant NHL.
Patients and Methods Patients with relapsed or refractory indolent or aggressive NHL were eligible to receive either 2.5 or 5.0 μg/kg of subcutaneous IL-4 daily for 28 days of a 42-day cycle. Patients with a response and acceptable toxicity after two cycles were eligible to continue treatment for a total of six cycles followed by observation without maintenance.
Results Forty-one patients were enrolled and were assessable for toxicity; two patients were ineligible after histology review, leaving 39 patients for the analysis of tumor response. The median age was 65 years (range 34-79 years), and 56% were stage 4. The overall response rate was 13% (5 of 39), with one complete response and four partial responses. All five responders were in the 5.0 μg/kg group, the median time to progression in all patients was 84 days, and the median duration of response for the responders was 8.3 months (range 7.4-15.7 months). Edema was noted in 66% (27 of 41) and was the most common toxicity.
Conclusions Agents that target the IL-4 receptor can have therapeutic benefit in patients with relapsed or refractory NHL.
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