Outpatient biochemotherapy with interleukin-2 and interferon alfa-2b in patients with metastatic malignant melanoma: Results of two phase II cytokineworking group trials

Purpose: The Cytokine Working Group performed a randomized phase II trial o f two outpatient biochemotherapy regimens to identify an outpatient regimen with high antitumor activity and less toxicity than inpatient regimens whi ch might be compared with chemotherapy or inpatient biochemotherapy regimen s in future phase III trials. Patients and Methods: Eighty-one patients with metastatic malignant melanom a received dacarbazine 250 mg/m(2)/d intravenously (IV) and cisplatin 25 mg /m(2)/d IV on days 1, 2, and 3, plus interferon (IFN) alfa-2b 5 mU/m(2) sub cutaneously (SC) on days 6, 8, 10, 13, and 15, given every 28 days. Interle ukin-2 (IL-2) was given daily on days 6 to 10 and 13 to 15. In group 1, IV IL-2 was given at 18.0 MU/m(2), and in group 2, SC IL-2 was given at 5.0 mU /m(2) Results: In group 1 (IV IL-2), there were five complete responses (CRs) and 11 partial responses (PRs) among 44 patients (objective response rate [ORR ], 36%; 95% confidence interval [CI], 22% to 51%). In group 2 (SC IL-2), th ere was one CR and five PRs among the 36 patients (ORR, 17%; 95% CI, 4% to 29%). The median survival was 10.7 months in group 1 and 7.3 months in grou p 2. Eleven patients in group 1 and four patients in group 2 remain alive a s of the last follow-up. Toxicities in both groups were similar. No patient required hospitalization for neutropenic fever. Conclusion: Biochemotherapy has activity in these outpatient regimens with acceptable toxicity. The antitumor activity observed with the IV IL-2 regim en seems similar to that of inpatient biochemotherapy regimens. If inpatien t biochemotherapy regimens develop an established roll in the management of melanoma, future phase III trial comparisons with this outpatient IV IL-2 regimen would be appropriate. (C) 2001 by American Society of Clinical Onco logy.