Study Supports Possible Use of Sargramostim as a Potential Adjuvant Therapy for High-Risk Melanoma Patients

Results from an adjuvant trial in high-risk melanoma patients demonstrated that a majority of patients treated with granulocyte-macrophage colony-stimulating factor, or sargramostim (Leukine), achieved disease-free and/or overall survival. These findings from a phase II study show that 60% of the 45 high-risk patients enrolled in the trial experienced disease-free survival and 64% of patients achieved overall survival at 21 months.

"Previous findings suggest that sargramostim may be a potential adjuvant therapy for high-risk melanoma patients," said E. George Elias, MD, PhD, director of Maryland Melanoma Center. "The percentage of patients who achieved disease-free and overall survival in this trial provides further evidence that sargramostim may prove to be a viable treatment option for this patient population and that further study in phase III trials are needed."

In this trial, adjuvant therapy with sargramostim and a synergistic cytokine, interleukin (IL)-2, was generally well-tolerated in patients with high-risk melanoma following potentially curative surgery. Each patient received 2 years of adjuvant therapy: year 1 with sargramostim and IL-2 and year 2 with only sargramostim. Toxicities were mild to moderate, and no hospitalizations were required.