title: Results of a phase II trial with cystemustine at 90 mg/m(2) as a first- or second-line treatment in advanced malignant melanoma: a trial of the EORTC Clinical Studies Group.
abstract: From May 1991 to January 1996, 54 patients with advanced malignant melanoma were enrolled into a phase II trial testing the new nitrosourea cystemustine, administrated intravenously as a 15 min infusion every 2 weeks at 90 mg/m2 for three cycles followed by 60 mg/m2. Out of the 54 enrolled patients, 10 were Ineligible, leaving 44 fully evaluable patients (World Health Organization criteria). Twenty one patients had already received first-line palliative chemotherapy and/or immunotherapy. The median age was 62 years (range 30-74 years) and the median performance status was 0 (grade 0, 19 patients; grade 1, 21 patients; grade 2, 4 patients). Five patients with partial responses (lasting 16-29 weeks, mean duration 24 weeks), nine with stable disease and 28 showing progression were observed, giving an overall response rate of 11% (confidence interval 3.8-24.6%). Toxicity was mild and consisted mainly of neutropenia (39% grade III-IV), thrombocytopenia (42% grade III-IV); febrile aplasia was rare. Cystemustine administered to this schedule appears to have limited clinical activity and acceptable toxicity in untreated or second-line advanced malignant melanoma.
authors.affiliation: Centre Jean Perrin, Hôtel Dieu, and Inserm U, Clermont-Ferrand, France.
authors.forename: H
authors.initials: H
authors.lastname: Cure
authors.forename: P
authors.initials: P
authors.lastname: Souteyrand
authors.forename: R
authors.initials: R
authors.lastname: Ouabdesselam
authors.forename: H
authors.initials: H
authors.lastname: Roche
authors.forename: A
authors.initials: A
authors.lastname: Ravaud
authors.forename: M
authors.initials: M
authors.lastname: D'incan
authors.forename: P
authors.initials: P
authors.lastname: Viens
authors.forename: P
authors.initials: P
authors.lastname: Fargeot
authors.forename: M A
authors.initials: MA
authors.lastname: Lentz
authors.forename: P
authors.initials: P
authors.lastname: Fumoleau
authors.forename: A
authors.initials: A
authors.lastname: Hanauske
authors.forename: P
authors.initials: P
authors.lastname: Chollet
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000627:therapeutic use; D005260:Female; D006801:Humans; D007167:Immunotherapy; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary / Q000628:therapy; D008875:Middle Aged; D009367:Neoplasm Staging; D009607:Nitrosourea Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D009607:Nitrosourea Compounds; C051263:N'-(2-chloroethyl)-N-(2-(methylsulfonyl)ethyl)-N'-nitrosourea; D003606:Dacarbazine