UICC World Cancer Congress 2006

Objective:The adjuvant treatment of IIB stage melanoma with IFNa remains questionable, therefore new approaches such as GM-CSF therapy are of interest. We evaluated 10-year survival and immunologic effects of postoperative immunotherapy with GM-CSF in stage II melanoma patients. Methods: From July 1993 through September 1994, 30 patients (pts) with stage T4N0M0 of skin melanoma were enrolled. 15 pts were treated with low-doses of GM-CSF (1 mcg/kg, s.c., three days per week, every other day) for 1 year after surgical excision of the primary tumor (study group). Results were compared with 15 pts who received no adjuvant treatment after surgery (control group). All patients had ECOG performance status of 0. The median age was 41.2 years in the study group and 47.1 years in the control group. The male/female ratio was 1:2 in both groups. Results: 3-year overall survival was 84.6% in study group and 66.5% in control group. The time to progression was 422.7 days in the study group and 356.5 days in the control group. 10-year overall survival was 76.9 (10/13) and 50.0% (7/14) in study and control group, respectively. Low dose GM-CSF is efficacy in adjuvant setting for high-risk melanoma pts. Immunologic correlative studies will be presented at the meeting.