title: Combination chemotherapy with or without s.c. IL-2 and IFN-alpha: results of a prospectively randomized trial of the Cooperative Advanced Malignant Melanoma Chemoimmunotherapy Group (ACIMM).
abstract: The purpose of this randomized trial was to evaluate the efficacy of combination chemoimmunotherapy compared with chemotherapy alone. A total of 124 patients were randomized to receive intravenous cisplatin (35 mg m(-2), days 1-3), carmustine (150 mg m(-2), day 1, cycles 1 and 3 only), dacarbacine (220 mg m(-2), days 1-3) and oral tamoxifen (20 mg m(-2), daily) in combination with (n=64) or without (n=60) sequential subcutaneous IL-2 and IFN-alpha. In those patients who received sequential immunotherapy, each cycle of chemotherapy was followed by outpatient s.c. IL-2 (10 x 10(6) IU m(-2), days 3-5, week 4; 5 x 10(6) IU m(-2), days 1, 3, 5, week 5) and s.c. IFN-alpha (5 x 10(6) IU m(-2), day 1, week 4; days 1, 3, 5, week 5). The overall response rate of patients treated with the combination of chemotherapy and IL-2/IFN-alpha was 34.3% with seven complete responses (10.9%) and 15 partial responses (23.4%). In patients treated with chemotherapy, only, the overall response rate was 29.9% with eight complete responses (13.3%) and 10 partial responses (16.6%). There was no significant difference in median progression free survival (0 months vs 4 months) and in median overall survival (12 months vs 13 months) for combined chemoimmunotherapy and for chemotherapy, respectively.
authors.affiliation: European Institute for Tumor Immunology and Prevention (EUTIP), Gotenstr. 152, 53175 Bonn, Germany. SekrProfAtzpodien@yahoo.de
authors.forename: J
authors.initials: J
authors.lastname: Atzpodien
authors.forename: K
authors.initials: K
authors.lastname: Neuber
authors.forename: D
authors.initials: D
authors.lastname: Kamanabrou
authors.forename: M
authors.initials: M
authors.lastname: Fluck
authors.forename: E B
authors.initials: EB
authors.lastname: Bröcker
authors.forename: C
authors.initials: C
authors.lastname: Neumann
authors.forename: T M
authors.initials: TM
authors.lastname: Rünger
authors.forename: G
authors.initials: G
authors.lastname: Schuler
authors.forename: P
authors.initials: P
authors.lastname: von den Driesch
authors.forename: I
authors.initials: I
authors.lastname: Müller
authors.forename: E
authors.initials: E
authors.lastname: Paul
authors.forename: T
authors.initials: T
authors.lastname: Patzelt
authors.forename: M
authors.initials: M
authors.lastname: Reitz
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000494:pharmacology*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002330:Carmustine / Q000008:administration & dosage; D002945:Cisplatin / Q000008:administration & dosage; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007279:Injections, Subcutaneous; D016898:Interferon-alpha / Q000008:administration & dosage / Q000494:pharmacology*; D007376:Interleukin-2 / Q000008:administration & dosage / Q000494:pharmacology*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology; D008875:Middle Aged; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology; D013629:Tamoxifen / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D016898:Interferon-alpha; D007376:Interleukin-2; D013629:Tamoxifen; D003606:Dacarbazine; D002945:Cisplatin; D002330:Carmustine