title: Granulocyte-macrophage colony-stimulating factor alone or with dacarbazine in metastatic melanoma: a randomized phase II trial.
abstract: The potential antitumoral effect of granulocyte-macrophage colony-stimulating factor (GM-CSF) led us to evaluate GM-CSF alone or with dacarbazine (DTIC) in metastatic melanoma in first line randomized phase II. Treatment was arm A: GM-CSF: 5 microg kg(-1), bid, 14 consecutive days every 21 days and arm B: GM-CSF: 5 microg kg(-1), bid, day 2 to day 19 every 21 days and DTIC: 800 mg m(-2), day 1 of each cycle. 32 patients (pts) were included, 15 pts in arm A and 17 in arm B. All pts had visceral metastatic sites. 9 had only one metastatic site. The median number of cycles given was 2 in arm A and 3 in arm B. 100% and 89.4% of the planned dose of GM-CSF was given in arm A and arm B respectively. No objective response was obtained. 19 pts experienced at least WHO grade 3 toxicity. All pts had fever, 29 had a decrease in performance status and 23 had pain. Grade 3 toxicity were fever (38.7%), decrease in performance status (32.3%), pain (19.4%) and dyspnoea (12.5%). In this study, GM-CSF alone or in association with DTIC did not induce any antitumoral activity with subsequent toxicity.
authors.affiliation: Department of Medicine, Institut Bergonié, Regional Cancer Center, Bordeaux, France.
authors.forename: A
authors.initials: A
authors.lastname: Ravaud
authors.forename: M
authors.initials: M
authors.lastname: Delaunay
authors.forename: C
authors.initials: C
authors.lastname: Chevreau
authors.forename: V
authors.initials: V
authors.lastname: Coulon
authors.forename: M
authors.initials: M
authors.lastname: Debled
authors.forename: C
authors.initials: C
authors.lastname: Bret-Dibat
authors.forename: F
authors.initials: F
authors.lastname: Courbon
authors.forename: N
authors.initials: N
authors.lastname: Gualde
authors.forename: B
authors.initials: B
authors.lastname: Nguyen Bui
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003606:Dacarbazine / Q000008:administration & dosage; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D003606:Dacarbazine; D016178:Granulocyte-Macrophage Colony-Stimulating Factor