title: A phase II study of cisplatin and continuous infusion of vindesine in metastatic head and neck squamous cell cancer.
abstract: The chemotherapeutic treatment of recurrent and/or metastatic squamous cell carcinoma (SCC) of the head and neck (H & N) has a very dismal prognosis, with survival usually not exceeding 1 year. Reported objective response rates vary between 3% and 70%. This difference appears largely attributable to the heterogeneity of the patient populations included in most published Phase II studies in H & N cancer. They usually include together initially metastatic, recurrent, and post primary treatment metastatic disease patients. These patients respond differently to chemotherapy. Because of this situation, we decided to study a more homogeneous patient population consisting of metastatic patients only. Cisplatin (CDDP) and vindesine (VDS) are active agents in H & N SCC. As VDS has a cycle-specific activity, the therapeutic index may be increased if it is administered in a continuous infusion (CI) schedule. Thirty-three patients with metastatic H & N (69% biopsy proven) were treated with a combination regimen including CDDP (100 mg/m2) day 1 and VDS 0.6 to 1 mg/m2 for 96 hours of CI. Thirty-one patients were evaluable for response: five had a complete response (CR; 16%) and 11 had a partial response (PR; 36%) with an overall rate response of 52% (95% confidence limit: 33% to 70%). Median duration of CR was 6.4 months (3 to 19 months) and 4.4 months for PR (3 to 6 months). A decrease in the leukocytes was the main toxicity encountered with this regimen. This combination regimen containing CDDP and CI VDS was well tolerated and active in H & N SCC. The incorporation of an active vinca-alkaloid in neoadjuvant regimens should be considered.
authors.affiliation: Department of Medicine, Institut Gustave-Roussy-Villejuif, France.
authors.forename: E
authors.initials: E
authors.lastname: Tellez-Bernal
authors.forename: G
authors.initials: G
authors.lastname: Recondo
authors.forename: T
authors.initials: T
authors.lastname: Guillot
authors.forename: M
authors.initials: M
authors.lastname: Benhamed
authors.forename: C
authors.initials: C
authors.lastname: Domenge
authors.forename: J
authors.initials: J
authors.lastname: Izzo
authors.forename: E
authors.initials: E
authors.lastname: Cvitkovic
authors.forename: J P
authors.initials: JP
authors.lastname: Armand
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001424:Bacterial Infections / Q000209:etiology; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary; D002945:Cisplatin / Q000008:administration & dosage*; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000401:mortality; D006801:Humans; D007262:Infusions, Intravenous; D007958:Leukocyte Count / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D012008:Recurrence; D012074:Remission Induction; D015996:Survival Rate; D014751:Vindesine / Q000008:administration & dosage*
chemical_list: D002945:Cisplatin; D014751:Vindesine