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. Journal of immunotherapy (Hagerstown, Md. : 1997) [J Immunother] Journal article | | Title | 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. | | Author(s) | Spitler LE, Weber RW, Allen RE, Meyer J, Cruickshank S, Garbe E, Lin HY, Soong SJ | | Institution | *Northern California Melanoma Center, Saint Mary's Medical Center daggerNorthern California Melanoma Center, St Francis Memorial Hospital, San Francisco double daggerCruickshank and Associates, Santa Barbara, CA parallelDepartment of Medicine, University of Alabama paragraph signBiostatistics Department, 153 Wallace Tumor Institute, Birmingham, AL section signBremen Institute for Prevention Research and Social Medicine, Bremen, Germany. | | Source | J Immunother 2009 May 28. | | 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 mug/m 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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19483646 |
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