RT Journal Article SR Electronic T1 Treatment of Metastatic Melanoma Using Interleukin-2 Alone or in Conjunction with Vaccines JF Clinical Cancer Research JO Clin Cancer Res FD American Association for Cancer Research SP 5610 OP 5618 DO 10.1158/1078-0432.CCR-08-0116 VO 14 IS 17 A1 Smith, Franz O. A1 Downey, Stephanie G. A1 Klapper, Jacob A. A1 Yang, James C. A1 Sherry, Richard M. A1 Royal, Richard E. A1 Kammula, Udai S. A1 Hughes, Marybeth S. A1 Restifo, Nicholas P. A1 Levy, Catherine L. A1 White, Donald E. A1 Steinberg, Seth M. A1 Rosenberg, Steven A. YR 2008 UL http://clincancerres.aacrjournals.org/content/14/17/5610.abstract AB Purpose: To identify prognostic factors associated with survival beyond 4 years and overall response in patients with metastatic melanoma treated with high-dose bolus i.v. interleukin-2 (IL-2) given either alone or in combination with a variety of melanoma vaccines. Study Design: 684 consecutive patients with metastatic melanoma received high-dose bolus i.v. IL-2 either alone or in conjunction with a variety of melanoma vaccines. Treatments occurred between August 1, 1985 and January 1, 2006. Results: The overall objective response rate was 13% for patients receiving IL-2 alone and 16% for patients who received IL-2 with vaccine. In patients treated with IL-2 alone (n = 305) and IL-2 with vaccine (n = 379), having an objective response was associated with survival beyond 4 years (P < 0.0001). No pretreatment factors could be identified that were strongly associated with increased rate of objective response or long-term survival in patients receiving IL-2 alone. In patients receiving IL-2 with vaccines, there were increased response rates in patients with s.c. or cutaneous disease only and lower response rates with visceral disease only. Patients who received the gp100:209-217(210M) peptide plus IL-2 showed a strong trend to increased objective responses compared with IL-2 alone (22% versus 12.8%; P = 0.01) and also compared with patients who received a variety of vaccines that did not include this immunogenic peptide (13.8%; P = 0.009). Conclusion: IL-2 can produce a modest response rate in patients with metastatic melanoma including patients with durable complete responses. S.c. or cutaneous disease only and vaccination with gp100:209-217(210M) peptide was associated with significant increase in response rates.