Sargramostim Appears to Achieve Long-Term Survival in Patients With High-Risk Malignant Melanoma: Presented at ASCO

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Title: Sargramostim Appears to Achieve Long-Term Survival in Patients With High-Risk Malignant Melanoma: Presented at ASCO
URL: http://www.pslgroup.com/dg/223062.htm
Doctor's Guide
June 5, 2008

By Ed Susman

CHICAGO -- June 5, 2008 -- A combination of interleukin 2 (IL-2) and the recombinant granulocyte-macrophage colony-stimulating factor sargramostim appears to extend survival in patients with advanced malignant melanoma.

"After 2 years with this outpatient treatment, about 60% of our patients are still alive and are doing well," said George Elias, MD, Maryland Melanoma Center, Baltimore, Maryland.

"Granulocyte macrophage colony stimulating factor and IL-2 are 2 cytokines with distinct mechanism of action that are synergistic, and it seemed logical to investigate the combination as adjuvant therapy in patients with high-risk malignant melanoma," said Dr. Elias here at the American Society of Clinical Oncology (ASCO) 44th Annual Meeting.

He reported on 45 patients who had either stage III malignant melanoma with lymph node involvement or stage IV malignant melanoma with resectable distant metastases.

"These are patients for whom recurrence of disease is a very high risk, and our aim was to try and prevent the recurrence by stimulating the immune system," he explained in a presentation on June 3.

Sargramostim creates added stimulus for IL-2 to seek out and destroy cancer cells, hopefully before those cells can mature into tumours, Dr. Elias said. In addition to these 2 drugs, patients were also given doses of autologous vaccine derived from their own cancer to prime the immune system.

Sargramostim 125 mcg/m² daily was administered subcutaneously for 14 days. IL-2 was given in a dose of 9 million IU/m² for 4 consecutive days followed by no treatment for 10 days.

"Our patients found this regimen to be less toxic [than previous treatments]. There was no need to perform the administration in an intensive care unit as with other regimens," he said. "This was a well tolerated regimen. We believe that it improves survival."

Other adjuvant treatments have achieved 2-year survival rates of about 25% in this high-risk population, Dr. Elias said.

Phase 3 studies are currently being conducted under the auspices of the European Organisation for Research and Treatment of Cancer (EORTC).

Previous adjuvant trials with IL-2 or with interferon have had large drop-out rates due to adverse effects, and some treatments are contraindicated in elderly patients.

Dr. Elias said that while he reported on 45 patients, he has treated 55 patients in his ongoing work.

Funding for this study was provided by Bayer Corporation.

[Presentation title: GM-CSF & IL-2 +- Autologous Whole Cell Vaccine as Adjuvant Therapy in Cutaneous Melanoma: A Phase II Clinical Trial. Abstract 20007]

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