ORIGINAL ARTICLESRandomized trial of dacarbazine versus bleomycin, vincristine, lomustine and dacarbazine (BOLD) chemotherapy combined with natural or recombinant interferon-α in patients with advanced melanomaVuoristo, Meri-Siskoa; Hahka-Kemppinen, Marjob; Parvinen, Leena-Maijac; Pyrhönen, Seppoc; Seppä, Hannad; Korpela, Merjae; Kellokumpu-Lehtinen, PirkkoaAuthor Information aDepartment of Oncology, University of Tampere and Tampere University Hospital, Tampere, Finland bDepartment of Oncology, Helsinki University Central Hospital, Helsinki, Finland cDepartment of Oncology, Turku University Hospital, Turku, Finland dDepartment of Oncology, Kuopio University Hospital, Kuopio, Finland eDepartment of Oncology, Oulu University Hospital, Oulu, Finland Sponsorship: The Medical Research Fund of Tampere University Hospital, the Finnish Cancer Society and the Finnish Association of Oncology provided financial support for this work. Correspondence and requests for reprints to Meri-Sisko Vuoristo, Department of Oncology, Tampere University Hospital, PO Box 2000, Fin-33521 Tampere, Finland Tel: +358-3-3116 3451; fax: +358-3-3116 3009; e-mail: [email protected] Received 2 July 2004 Accepted (after revision) 13 December 2004 Melanoma Research: August 2005 - Volume 15 - Issue 4 - p 291-296 Buy 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-α (nIFN-α) or recombinant interferon-α2b (rIFN-α2b) in patients with advanced melanoma. The treatment arms were: A, DTIC plus nIFN-α; B, BOLD plus nIFN-α; C, DTIC plus rIFN-α2b; D, BOLD plus rIFN-α2b. 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-α2b. Patients with soft tissue or lung metastases may achieve more complete responses with BOLD regimens. © 2005 Lippincott Williams & Wilkins, Inc.