Single-agent interleukin-2 in the treatment of metastatic melanoma: A systematic review

SummaryBackgroundThe aim of this systematic review was to determine the role of single-agent interleukin-2 in the treatment of adults with metastatic melanoma. Outcomes of interest include objective and complete response rates, duration of response, toxicity and quality of life.MethodsA systematic review of the literature was conducted to locate randomized controlled trials, meta-analyses, and systematic reviews published between 1985 and 2006.ResultsData from three randomized controlled trials demonstrate that single-agent interleukin-2, when given in high-doses, elicited objective response rates of 5–27% with complete responses in 0–4% of patients. High-dose interleukin-2, administered as a single-agent or in combination with lymphokine-activated killer cells, demonstrates complete response rates ranging from 0% to 11% and has shown consistent observations of long-term responses that range from 6 to 66+ months (median 27 months).Non-comparative phase II trials of high-dose single-agent interleukin-2 have consistently reported objective response rates of 10–33% with complete response rates ranging from 0% to 15%. Complete responders in those trials also demonstrate long-term responses ranging from 1.5 to 148 months (median 70 months). No other therapy for metastatic melanoma offers the possibility for a durable complete remission.ConclusionThis systematic review suggests that patients with a good performance status (ECOG 0–1), a normal lactate dehydrogenase level, less than three organs involved or cutaneous and/or subcutaneous metastases, have the highest probability of responding and achieving a durable complete response. This carefully selected group of patients should be considered for treatment with high-dose interleukin-2.