A randomized Phase II study of interleukin-2 with and without beta-interferon for patients with advanced non-small cell lung cancer: An Eastern Cooperative Oncology Group study (PZ586)

Abstract Interleukin-2 (IL-2) and beta-interferon (β-IFN) are biologic agents with antitumor activity observed in preclinical models. Some studies of patients with advanced non-small cell lung cancer treated with IL-2 report relatively long survival, despite low response rates. Seventy-six evaluable patients with stage IV non-small cell lung cancer were treated in a randomized Phase II study with either IL-2 alone or IL-2 plus β-IFN. Patients received either IL-2 at 6×10 6 Cetus units/m 2 3 days weekly or the combination of IL-2 at 5×10 6 Cetus units/m 2 plus β-IFN at 6×10 6 units/m 2 , both given 3 days weekly. Both biologic agents were administered by intravenous bolus injection on an outpatient basis. Objective responses were observed in 3/76 (4%) patients. Grade 4 toxicity occurred in 3/39 patients treated with IL-2 alone, and in 4/37 patients treated with IL-2 plus β-IFN. An additional lethal respiratory toxicity occurred in a patient who received IL-2 plus β-IFN. The median survival of all patients treated on this study was 33 weeks. Despite producing only a 4% objective response rate, IL-2 appears to have a favorable impact on survival comparable to chemotherapy. The role for this immune therapy in the management of non-small cell lung cancer requires further study.