title: Treatment of metastatic malignant melanoma with dacarbazine plus tamoxifen, or vindesine plus tamoxifen: a prospective randomized study.
abstract: This study aimed to verify whether the advantage in terms of response rate and survival of dacarbazine plus tamoxifen over dacarbazine alone in metastatic malignant melanoma reported in a previous randomized trial was due to a specific interaction of dacarbazine with tamoxifen. A total of 125 patients with locoregional or disseminated malignant melanoma were randomized to receive dacarbazine (250 mg/m(2) days 1-5 every 3 weeks) plus tamoxifen (arm A) or vindesine (3 mg/m(2) every week for 6 weeks, then every 2 weeks) plus tamoxifen (arm B). Of the 125 randomized patients, 57 and 59 were evaluable in arm A and B, respectively. The complete response rates were the same (2% versus 2%) and the complete plus partial response rates were similar (11% versus 14%) in the two groups. There was no significant difference in survival. Neither response or survival correlated with gender. In conclusion, when combined with tamoxifen, dacarbazine does not have a specific effect on response or survival compared with vindesine. The lower response rate to dacarbazine plus tamoxifen (11%) than that reported in the previous trial (28%) might be explained by actual differences in patient and/or participating centre accrual characteristics in the presence of apparently identical eligibility criteria.
authors.affiliation: Medical Oncology Institution of Parma, Parma, Italy. giorgio.cocconi@tin.it
authors.forename: G
authors.initials: G
authors.lastname: Cocconi
authors.forename: R
authors.initials: R
authors.lastname: Passalacqua
authors.forename: S
authors.initials: S
authors.lastname: Foladore
authors.forename: P
authors.initials: P
authors.lastname: Carlini
authors.forename: L
authors.initials: L
authors.lastname: Acito
authors.forename: E
authors.initials: E
authors.lastname: Maiello
authors.forename: M
authors.initials: M
authors.lastname: Marchi
authors.forename: V
authors.initials: V
authors.lastname: Gebbia
authors.forename: S
authors.initials: S
authors.lastname: Di Sarra
authors.forename: M
authors.initials: M
authors.lastname: Beretta
authors.forename: M
authors.initials: M
authors.lastname: Bacchi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D003606:Dacarbazine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D015996:Survival Rate; D013629:Tamoxifen / Q000008:administration & dosage; D016896:Treatment Outcome; D014751:Vindesine / Q000008:administration & dosage
chemical_list: D013629:Tamoxifen; D003606:Dacarbazine; D014751:Vindesine