title: Long-term survival benefit after adjuvant treatment of cutaneous melanoma with dacarbazine and low dose natural interferon alpha: A controlled, randomised multicentre trial.
abstract: In a prospective, controlled, randomised, multicentre study 252 patients with totally resected cutaneous melanoma (248 in stage II-III and 4 in stage IV) were either treated with two doses of dacarbazine (DTIC) followed by a 6-month treatment with 3 MU thrice weekly of highly purified natural interferon-alpha (n = 128; arm A) or received no adjuvant treatment (n = 124; arm B). Treatment was well tolerated. After a median follow-up of 8.5 years ITT analysis showed that the difference in survival was statistically significant with respect to melanoma-related deaths (HR = 0.65, CI = 0.46-0.97, p = 0.022) and close to significance with respect to overall survival (HR 0.71, CI 0.49-1.00, p = 0.052). The risk reduction of melanoma-associated death, calculated by Cox proportional hazards modelling, after adjusting for identified predictive variables, was almost 50% (p = 0.002). The overall efficacy of the treatment appeared to be mainly attributable to effects observed in patients with deep and/or metastasizing tumours (HR 0.60, CI 0.40-0.90, p = 0.013).
authors.affiliation: Department of Dermatology, Academic Medical Centre, Minden, Germany. rudolf.stadler@klinikum-minden.de
authors.forename: Rudolf
authors.initials: R
authors.lastname: Stadler
authors.forename: Thomas
authors.initials: T
authors.lastname: Luger
authors.forename: Thomas
authors.initials: T
authors.lastname: Bieber
authors.forename: Ulrike
authors.initials: U
authors.lastname: Köhler
authors.forename: Ruthild
authors.initials: R
authors.lastname: Linse
authors.forename: Kristin
authors.initials: K
authors.lastname: Technau
authors.forename: Roland
authors.initials: R
authors.lastname: Schubert
authors.forename: Katja
authors.initials: K
authors.lastname: Schroth
authors.forename: Feredoun
authors.initials: F
authors.lastname: Vakilzadeh
authors.forename: Matthias
authors.initials: M
authors.lastname: Volkenandt
authors.forename: Harald
authors.initials: H
authors.lastname: Gollnick
authors.forename: Harald
authors.initials: H
authors.lastname: Von Eick
authors.forename: Fredrik
authors.initials: F
authors.lastname: Thoren
authors.forename: Orjan
authors.initials: O
authors.lastname: Strannegård
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D017024:Chemotherapy, Adjuvant; D003606:Dacarbazine / Q000008:administration & dosage; D005260:Female; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage; D008297:Male; D008545:Melanoma / Q000188:drug therapy / Q000401:mortality*; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000401:mortality / Q000556:secondary; D009367:Neoplasm Staging; D011446:Prospective Studies; D012878:Skin Neoplasms / Q000188:drug therapy / Q000401:mortality*; D015996:Survival Rate
chemical_list: D016898:Interferon-alpha; D003606:Dacarbazine