title: Sequential administration of GM-CSF (Sargramostim) and IL-2 +/- autologous vaccine as adjuvant therapy in cutaneous melanoma: an interim report of a phase II clinical trial.
abstract: Granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-2 (IL-2) are 2 cytokines with distinct mechanisms of action that complement one another in the adjuvant management of melanoma. Forty-five patients with high-risk melanoma were enrolled in an open-label, single-arm, phase II clinical trial to examine the safety, tolerability, and effectiveness of this combination. After potentially curative surgery, each patient received 12 months of GM-CSF 125 microg/m2/d subcutaneously (SC) for 14 days followed by IL-2, 9 million IU/m2/d SC for 4 days (given every other cycle from months 7-12), followed by 10 days of no treatment. In addition, patients who had tumors yielding an adequate number of live cells received autologous melanoma vaccines. For months 13-24, patients received only GM-CSF 250 microg/m2 twice weekly. This is an interim analysis based on the 45 enrolled patients with a median of 15.9 months follow-up (range, 1-50 months). Thirty-two patients are alive: 9 of 13 with stage IV resected melanoma, 16 of 25 with stage III disease, and 7 of 7 with stage II disease. Twelve died of the disease, and one due to stroke. Adjuvant use of sequential GM-CSF and IL-2 +/- autologous vaccine was well tolerated with good patient compliance and seemed to benefit high-risk patients with surgically resected melanoma.
authors.affiliation: The Maryland Melanoma Center at the Weinberg Cancer Institute, Franklin Square Hospital Center, Baltimore, MD 21237, USA. george.elias@medstar.net
authors.forename: E George
authors.initials: EG
authors.lastname: Elias
authors.forename: John L
authors.initials: JL
authors.lastname: Zapas
authors.forename: Edward C
authors.initials: EC
authors.lastname: McCarron
authors.forename: Sandra L
authors.initials: SL
authors.lastname: Beam
authors.forename: Joanne H
authors.initials: JH
authors.lastname: Hasskamp
authors.forename: W Joel
authors.initials: WJ
authors.lastname: Culpepper
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D019496:Cancer Vaccines / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage* / Q000627:therapeutic use; D006801:Humans; D007376:Interleukin-2 / Q000235:genetics*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000601:surgery; D008875:Middle Aged; D011994:Recombinant Proteins; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000601:surgery
chemical_list: D019496:Cancer Vaccines; D007376:Interleukin-2; D011994:Recombinant Proteins; C081222:sargramostim; D016178:Granulocyte-Macrophage Colony-Stimulating Factor