title: A multicenter phase II study of cisplatin and docetaxel (Taxotere) in the first-line treatment of advanced ovarian cancer: a GINECO study.
abstract: OBJECTIVE
  A multicenter phase II study to evaluate the antitumor effect and safety of docetaxel in combination with cisplatin as first-line chemotherapy for advanced ovarian cancer.
  
  
  METHODS
  Enrolled in the study were 45 patients who were to receive six courses of docetaxel 75 mg/m(2) plus cisplatin 75 mg/m(2) every 21 days with hydration and steroid prophylaxis after initial debulking surgery. Imaging techniques and radiography were used to assess clinical tumor response, and second-look surgery was required for patients with complete clinical responses and for those without clinically measurable disease.
  
  
  RESULTS
  The overall clinical response rate in 29 patients with clinically measurable disease was 58% (41% complete response). A complete pathologic response was seen in 9 of 34 patients who underwent second-look laparotomy, while microscopic disease was found in 10 patients. The median time to progression was 14.4 months (95% CI 8.4-20.4 months), with a median overall survival of 43 months (95% CI 21.1-65.0 months). Patients received a median number of six cycles at a dose intensity of 98%. Grade 3-4 neutropenia was seen in 80% of patients, but was manageable. No patients withdrew because of fluid retention.
  
  
  CONCLUSIONS
  The combination of docetaxel with cisplatin confers high clinical and pathologically verified tumor response rates and is well tolerated in the first-line management of advanced ovarian cancer.
authors.affiliation: Department of Medical Oncology, Institut Curie, 26 rue d'Ulm, 75005 Paris, France. veronique.dieras@curie.net
authors.forename: Véronique
authors.initials: V
authors.lastname: Diéras
authors.forename: Jean Paul
authors.initials: JP
authors.lastname: Guastalla
authors.forename: Jean Marc
authors.initials: JM
authors.lastname: Ferrero
authors.forename: Hervé
authors.initials: H
authors.lastname: Curé
authors.forename: Béatrice
authors.initials: B
authors.lastname: Weber
authors.forename: Philippe
authors.initials: P
authors.lastname: Winckel
authors.forename: Alain
authors.initials: A
authors.lastname: Lortholary
authors.forename: Françoise
authors.initials: F
authors.lastname: Mayer
authors.forename: Désiré
authors.initials: D
authors.lastname: Paraiso
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Magherini
authors.forename: Eric
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D002945:Cisplatin