Recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) administered for 3 years as adjuvant therapy of stages II(T4), III, and IV melanoma.

Abstract

A hypothesis generating study was conducted to evaluate the safety and efficacy of prolonged (3 y) administration of granulocyte-macrophage colony-stimulating factor (GM-CSF, sargramostim) as surgical adjuvant therapy in patients with melanoma at high risk of recurrence. Ninety-eight evaluable patients with stages II(T4), III, or IV melanoma were given prolonged treatment with GM-CSF after surgical resection of disease. The GM-CSF was administered subcutaneously in 28-day cycles, such that a dose of 125 microg/m2 was delivered daily for 14 days followed by 14 days rest. Treatment cycles continued for 3 years or until disease recurrence, which could not be surgically excised. Patients were evaluated for toxicity, disease-free survival, and melanoma-specific survival. Prolonged administration of GM-CSF was well tolerated; grade 1 or 2 side effects occurred in 82% of the patients. There were no grade 3 or 4 treatment-related side effects. Two patients developed acute myelogenous leukemia after completion of 3 years of GM-CSF administration. With a median follow-up of 5.3 years, the median melanoma-specific survival has not yet been reached. The 5-year melanoma-specific survival rate was 60%. The current study has expanded the preliminary evidence on GM-CSF as adjuvant therapy of patients with melanoma who are at high risk for recurrence.

• Authors: Lynn E Spitler, Robert W Weber, Robert E Allen, John Meyer, Scott Cruickshank, Edeltraut Garbe, Hui-Yi Lin, Seng-jaw Soong
• Journal: Journal of immunotherapy (Hagerstown, Md. : 1997) (J Immunother) 2009 Jul-Aug Vol. 32 Issue 6 Pg. 632-7 ISSN: 1537-4513 [Electronic] United States
• PMID: 19483646 (Publication Type: Case Reports, Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Adjuvants, Immunologic
• Cancer Vaccines
• Recombinant Proteins
• sargramostim
• Granulocyte-Macrophage Colony-Stimulating Factor

Topics

• Adjuvants, Immunologic (administration & dosage, adverse effects)
• Aged
• Cancer Vaccines (therapeutic use)
• Chemotherapy, Adjuvant
• Combined Modality Therapy
• Disease-Free Survival
• Female
• Granulocyte-Macrophage Colony-Stimulating Factor (administration & dosage, adverse effects)
• Humans
• Kaplan-Meier Estimate
• Male
• Melanoma (drug therapy, pathology, surgery)
• Middle Aged
• Neoplasm Recurrence, Local (prevention & control)
• Neoplasm Staging
• Recombinant Proteins
• Skin Neoplasms (drug therapy, pathology, surgery)
• Survival Rate