Adjuvant therapy of stage III and IV malignant melanoma using granulocyte-macrophage colony-stimulating factor.

Abstract

PURPOSE:

To evaluate granulocyte-macrophage colony-stimulating factor (GM-CSF) as surgical adjuvant therapy in patients with malignant melanoma who are at high risk of recurrence.

PATIENTS AND METHODS:

Forty-eight assessable patients with stage III or IV melanoma were treated in a phase II trial with long-term, chronic, intermittent GM-CSF after surgical resection of disease. Patients with stage III disease were required to have more than four positive nodes or a more than 3-cm mass. All patients were rendered clinically disease-free by surgery before enrollment. The GM-CSF was administered subcutaneously in 28-day cycles, such that a dose of 125 microg/m(2) was delivered daily for 14 days followed by 14 days of rest. Treatment cycles continued for 1 year or until disease recurrence. Patients were evaluated for toxicity and disease-free and overall survival.

RESULTS:

Overall and disease-free survival were significantly prolonged in patients who received GM-CSF compared with matched historical controls. The median survival duration was 37.5 months in the study patients versus 12.2 months in the matched controls (P <.001). GM-CSF was well tolerated; only one subject discontinued drug due to an adverse event (grade 2 injection site reaction).

CONCLUSION:

GM-CSF may provide an antitumor effect that prolongs survival and disease-free survival in patients with stage III and IV melanoma who are clinically disease-free. These results support institution of a prospective, randomized clinical trial to definitively determine the value of surgical adjuvant therapy with GM-CSF in such patients.

• Authors: L E Spitler, M L Grossbard, M S Ernstoff, G Silver, M Jacobs, F A Hayes, S J Soong
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 18 Issue 8 Pg. 1614-21 (Apr 2000) ISSN: 0732-183X [Print] United States
• PMID: 10764421 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)

Chemical References

• Granulocyte-Macrophage Colony-Stimulating Factor

Topics

• Aged
• Combined Modality Therapy
• Disease-Free Survival
• Female
• Granulocyte-Macrophage Colony-Stimulating Factor (adverse effects, therapeutic use)
• Humans
• Life Tables
• Lymphatic Metastasis
• Male
• Melanoma (mortality, pathology, surgery, therapy)
• Skin Neoplasms (pathology, surgery, therapy)
• Survival Rate