title: Vinorelbine and cisplatin in metastatic squamous cell carcinoma of the oesophagus: response, toxicity, quality of life and survival.
abstract: BACKGROUND
  Vinorelbine and cisplatin are active against squamous cell oesophageal carcinoma. The purpose of this phase II study was to evaluate the efficacy and safety of vinorelbine plus cisplatin in previously untreated patients with metastatic squamous cell oesophageal carcinoma and to estimate the progression-free survival, overall survival and quality of life (QoL) of the patient population.
  
  
  METHODS
  Seventy-one eligible patients were entered into a study of vinorelbine 25 mg/m2 on days 1 and 8 plus cisplatin 80 mg/m2 on day 1, every 3 weeks. Degree of dysphagia relief was monitored and QoL was measured using the EORTC QLQ-C30.
  
  
  RESULTS
  All eligible patients were assessed for response and 24 achieved a confirmed partial response (33.8%; 95% confidence interval 23-46); the median duration of response was 6.8 months, progression-free survival was 3.6 months and median survival of the whole group was 6.8 months. Toxicity was mainly related to neutropenia (grade 3/4 in 41% of patients). At cycle 2, 43% of the patients reported at least a moderate improvement in global health status/QoL and 25% experienced a large improvement.
  
  
  CONCLUSIONS
  Vinorelbine plus cisplatin represents a well-tolerated active palliative regimen for patients with advanced squamous cell carcinoma of the oesophagus. This combination may offer a better therapeutic index than cisplatin-5-fluorouracil.
authors.affiliation: Department of Medical Oncology, Centre Alexis Vautrin, Vandoeuvre-lès-Nancy, France. t.conroy@nancy.fnclcc.fr
authors.forename: T
authors.initials: T
authors.lastname: Conroy
authors.forename: P L
authors.initials: PL
authors.lastname: Etienne
authors.forename: A
authors.initials: A
authors.lastname: Adenis
authors.forename: M
authors.initials: M
authors.lastname: Ducreux
authors.forename: B
authors.initials: B
authors.lastname: Paillot
authors.forename: J
authors.initials: J
authors.lastname: Oliveira
authors.forename: J F
authors.initials: JF
authors.lastname: Seitz
authors.forename: E
authors.initials: E
authors.lastname: Francois
authors.forename: E
authors.initials: E
authors.lastname: Van Cutsem
authors.forename: D J T
authors.initials: DJ
authors.lastname: Wagener
authors.forename: F
authors.initials: F
authors.lastname: Kohser
authors.forename: S
authors.initials: S
authors.lastname: Daamen
authors.forename: M
authors.initials: M
authors.lastname: Praet
authors.forename: T
authors.initials: T
authors.lastname: Gorlia
authors.forename: B
authors.initials: B
authors.lastname: Baron
authors.forename: J
authors.initials: J
authors.lastname: Wils
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000556:secondary*; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004938:Esophageal Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality*; D016629:Esophagectomy / Q000379:methods; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D016015:Logistic Models; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D010166:Palliative Care; D011788:Quality of Life; D018570:Risk Assessment; D018709:Statistics, Nonparametric; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine