| Abstract: |
Purpose: High-dose interferon alfa-2b (IFN alpha 2b) is the only established adjuvant therapy of resectable high-risk melanoma. GM2-KLH/QS-21 (GMK) is a chemically defined vaccine that is one of the best developed of a range of vaccine candidates for melanoma. A single-institution phase III trial conducted at Memorial Hospital served as the impetus for an intergroup adjuvant E1694/S9512/C509801 trial, which recently completed enrollment of 880 patients. To build on the apparent benefit of IFN alpha 2b in resectable high-risk American Joint Committee on Cancer [AJCC) stage IIB or III melanoma, this phase II study was designed to evaluate the combination of GMK and IFN alpha 2b. The E2696 trial was undertaken to evaluate the toxicity and other effects of the established adjuvant high-dose IFN alpha 2b regimen in relation to immune responses to GMK and to evaluate the potential clinical and immunologic effects of the combined therapies, Patients and Methods: This trial enrolled 107 patients with resectable high- or very high-risk melanoma (AJCC stages IIB, III, and IV). Results: The results demonstrate that IFN alpha 2b does not significantly inhibit immunoglobulin M or G serologic responses to the vaccine and that the combination of high-dose IFN alpha 2b and GMK is well tolerated in this patient population. Conclusion: Cox analysis of the results of the combination with IFN alpha 2b show improvement in the relapse-free survival of patients with very high-risk melanoma (including those with resectable M-1, disease). J Clin Oncol 19:1430-1436. (C) 2001 by American Society of Clinical Oncology. |
