ADJUVANT THERAPY OF STAGE III AND IV MALIGNANT MELANOMA USING GM-CSF.  L. E. Spitler¹, M. L. Grossbard², M. S. Ernstoff³, G. Silver¹, M. Jacobs¹, F. A. Hayes⁴, and S.J. Soong⁵.  Northern California Melanoma Center¹, San Francisco, CA, USA, Massachusetts General Hospital², Boston, MA, USA, Dartmouth Hitchcock Medical Center³, Lebanon, NH, USA, Immunex R & D Corp.⁴, Seattle, WA, USA, UAB Comprehensive Cancer Center⁵, Birmingham, AL, USA

An open-label, Phase II trial of rhGM-CSF (Leukine) as surgical adjuvant therapy was conducted in patients with malignant melanoma who were at very high risk for recurrence.  Eligible patients were those with a) lymph node metastasis of melanoma with a mass Ï 3 cm or more than 4 positive nodes or b) spread of melanoma beyond regional lymph nodes.  Administration of the GM-CSF was required to begin within 60 days of the last evidence of tumor.  rhGM-CSF was administered daily subcutaneously at 125 µg/m² for 14 days followed by 14 days off treatment and was continued until recurrence or until the patient had been tumor-free for 1 year.  Results follow:

      *The median survival time has not been reached, so this is a model-based

        estimate.

      **Median survival not yet reached at median follow-up of 17 months; Kaplan-

          Meier is not able to estimate the median survival for this group.

We conclude that surgical adjuvant therapy with GM-CSF appears to provide clinical benefit and that these encouraging results warrant analysis in a prospective randomized trial.