title: Adjuvant therapy of stage III and IV malignant melanoma using granulocyte-macrophage colony-stimulating factor.
abstract: OBJECTIVE
  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.
  
  
  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).
  
  
  CONCLUSIONS
  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.affiliation: Northern California Melanoma Center, San Francisco, CA, USA. lynn@drspitler.com
authors.forename: L E
authors.initials: LE
authors.lastname: Spitler
authors.forename: M L
authors.initials: ML
authors.lastname: Grossbard
authors.forename: M S
authors.initials: MS
authors.lastname: Ernstoff
authors.forename: G
authors.initials: G
authors.lastname: Silver
authors.forename: M
authors.initials: M
authors.lastname: Jacobs
authors.forename: F A
authors.initials: FA
authors.lastname: Hayes
authors.forename: S J
authors.initials: SJ
authors.lastname: Soong
mesh_terms: D000368:Aged; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D015993:Life Tables; D008207:Lymphatic Metastasis; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D012878:Skin Neoplasms / Q000473:pathology / Q000601:surgery / Q000628:therapy*; D015996:Survival Rate
chemical_list: D016178:Granulocyte-Macrophage Colony-Stimulating Factor