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)

• Published in: Lung cancer 1999-09, Vol.25 (3), p.199-206
• Main Authors: Tester, William J., Kim, Kyung Mann, Krigel, Robert L., Bonomi, Philip D., Glick, John H., Asbury, Robert F., Kirkwood, John M., Blum, Ronald H., Schiller, Joan H.
• Format: Article
• Language: English
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - mortality; Adenocarcinoma - pathology; Adult; Aged; Antineoplastic agents; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - therapeutic use; Beta-interferon; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - mortality; Carcinoma, Non-Small-Cell Lung - pathology; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - mortality; Carcinoma, Squamous Cell - pathology; Drug Therapy, Combination; Female; Humans; Immunotherapy; Injections, Intravenous; Interferon-beta - administration & dosage; Interferon-beta - therapeutic use; Interleukin-2; Interleukin-2 - administration & dosage; Interleukin-2 - therapeutic use; Lung Neoplasms - drug therapy; Lung Neoplasms - mortality; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Neoplasm Staging; Non-small cell lung cancer; Pharmacology. Drug treatments; Retrospective Studies; Survival Rate; Treatment Outcome
• ISSN: 0169-5002; 1872-8332
• DOI: 10.1016/S0169-5002(99)00054-9

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.