title: Randomized trial of dacarbazine versus bleomycin, vincristine, lomustine and dacarbazine (BOLD) chemotherapy combined with natural or recombinant interferon-alpha in patients with advanced melanoma.
abstract: This randomized phase II study was designed to compare the efficacy and tolerability of dacarbazine (DTIC) and bleomycin, vincristine, lomustine and DTIC (BOLD) combined with natural interferon-alpha (nIFN-alpha) or recombinant interferon-alpha2b (rIFN-alpha2b) in patients with advanced melanoma. The treatment arms were: A, DTIC plus nIFN-alpha; B, BOLD plus nIFN-alpha; C, DTIC plus rIFN-alpha2b; D, BOLD plus rIFN-alpha2b. One hundred and eight patients were randomized, of whom 106 were eligible to be analysed for efficacy. Overall, 56% of patients had abdominal visceral and/or bone involvement. The response rates were 8% (2/25) in arm A, 13% (4/31) in arm B, 12% (3/25) in arm C and 24% (6/25) in arm D. The differences were not statistically significant by the usual chi-squared test. However, when analysed using the Cochran-Armitage trend test, the one-sided P values were close to significant (0.085 and 0.033). All of the eight complete responses occurred in patients with soft tissue and/or lung metastases and the BOLD regimens produced six of them. There were no significant differences in survival (arm A, 11.1 months; arm B, 9.8 months; arm C, 9.1 months; arm D, 7.5 months; P=0.62). BOLD was more toxic than DTIC. With the present sample size, there were no statistically significant differences in efficacy between the arms, but there was a trend towards a higher response rate with BOLD plus rIFN-alpha2b. Patients with soft tissue or lung metastases may achieve more complete responses with BOLD regimens.
authors: Department of Oncology, University of Tampere and Tampere University Hospital, Tampere, Finland. meri-sisko.vuoristo@fimnet.fi
authors: Meri-Sisko
authors: MS
authors: Vuoristo
authors: Marjo
authors: M
authors: Hahka-Kemppinen
authors: Leena-Maija
authors: LM
authors: Parvinen
authors: Seppo
authors: S
authors: Pyrhönen
authors: Hanna
authors: H
authors: Seppä
authors: Merja
authors: M
authors: Korpela
authors: Pirkko
authors: P
authors: Kellokumpu-Lehtinen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001761:Bleomycin / Q000008:administration & dosage / Q000627:therapeutic use; D003606:Dacarbazine / Q000008:administration & dosage / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007370:Interferon Type I / Q000627:therapeutic use*; D016898:Interferon-alpha / Q000627:therapeutic use*; D008130:Lomustine / Q000008:administration & dosage / Q000627:therapeutic use; D008297:Male; D008545:Melanoma / Q000188:drug therapy*; D008875:Middle Aged; D009362:Neoplasm Metastasis; D011994:Recombinant Proteins; D012878:Skin Neoplasms / Q000188:drug therapy*; D016019:Survival Analysis; D016896:Treatment Outcome; D014750:Vincristine / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D000970:Antineoplastic Agents; D007370:Interferon Type I; D016898:Interferon-alpha; D011994:Recombinant Proteins; D001761:Bleomycin; D014750:Vincristine; D008130:Lomustine; D003606:Dacarbazine