title: [Fotemustine: a pilot phase II trial in sarcoma of the soft tissues].
abstract: Fotemustine has been administered to 10 patients with metastatic or redux soft sarcoma in a phase II pilot study. The main inclusion criteria were: at least one measurable site, Karnofsky index (KI) higher than 60%, no specific treatment within the last 4 weeks, correct haematological status. Induction treatment comprised fotemustine 100 mg/m2 D1-D8-D15 in a 1 h intravenous infusion protected from light, followed by a 5-week rest period. In patients with no progressive disease, maintenance treatment comprised fotemustine 100 mg/m2 D1 q 3 weeks, until progression or toxicity. Patients characteristics were: 9 M/1 F; median age: 51 years [26-66]; median KI 90% [60-100]; median number of previous drugs: 5 [2-8]; 6 patients had two or more metastatic sites and one patient had developed a sarcoma following chest radiotherapy. Evaluation was carried out in weeks 4 and 8, following the first fotemustine injection. One case of minor response and one case of stabilisation were observed, but they were of short duration. The main toxicity was haematological with delayed leucopenia and thrombopenia (nadir: week 6). In patients who have undergone previous chemotherapy, fotemustine is not efficient according to the first step of the Gehan statistical guidelines.
authors.affiliation: Institut Gustave-Roussy, IGR, Villejuif, France.
authors.forename: M
authors.initials: M
authors.lastname: Spielmann
authors.forename: J
authors.initials: J
authors.lastname: Berille
authors.forename: D
authors.initials: D
authors.lastname: Khayat
authors.forename: J P
authors.initials: JP
authors.lastname: Bizzari
authors.forename: C
authors.initials: C
authors.lastname: Jacquillat
authors.forename: T
authors.initials: T
authors.lastname: Tursz
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D009607:Nitrosourea Compounds / Q000627:therapeutic use*; D009943:Organophosphorus Compounds / Q000627:therapeutic use*; D010865:Pilot Projects; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology / Q000556:secondary; D012983:Soft Tissue Neoplasms / Q000188:drug therapy* / Q000556:secondary
chemical_list: D000970:Antineoplastic Agents; D009607:Nitrosourea Compounds; D009943:Organophosphorus Compounds; C054368:fotemustine
vernacular_title: Fotémustine: essai pilote de phase II dans l'indication sarcomes des parties molles.