title: Gemcitabine combined with cisplatin as first-line treatment in patients with epithelial ovarian cancer: a phase II study.
abstract: OBJECTIVE
  This phase II study was performed to evaluate the activity and toxicity of gemcitabine plus cisplatin as first-line treatment of advanced epithelial ovarian cancer.
  
  
  METHODS
  Chemonaive patients with histologically or cytologically confirmed FIGO stage III or IV epithelial ovarian carcinoma were enrolled. Patients received cisplatin 75 mg/m(2) on Day 1 and gemcitabine 1250 mg/m(2) on Days 1 (after cisplatin) and 8 of a 21-day cycle.
  
  
  RESULTS
  Of the 42 female patients (median age 60 years) enrolled, 81% had a Zubrod performance status of 0 or 1. Among the 37 response-evaluable patients, there were 5 (13.5%) pathological complete responses (CRs), 16 (43.2%) pathological partial responses (PRs), and 3 (8.1%) clinical PRs, for an overall response rate of 64.9% (95% CI: 47.4-79.8%) and a pathological response rate of 56.8%. Per an intent-to-treat analysis, the overall response rate was 57.1% (95% CI: 41.0-72.3%). After a median follow-up time of 15.8 months, the median survival was 24.0 months and median progression-free survival was 13.4 months. Grade 3/4 neutropenia and thrombocytopenia occurred in 69.0 and 33.3% of patients, respectively, with no febrile neutropenia or hemorrhage. Grade 3/4 nausea and vomiting occurred in 35.7% and grade 3 alopecia in 21.4% of the patients. One patient died due to a toxicity-related death (dyspnea).
  
  
  CONCLUSIONS
  Gemcitabine plus cisplatin is active and feasible as first-line treatment of advanced epithelial ovarian cancer. Further clinical trials adding gemcitabine to first-line treatment seem warranted.
authors.affiliation: Hôpital Boucicaut Cerc, ARTAC-Cerc, 78 Rue de la Convention, 75015, Paris, France. ktl_louis@lilly.com
authors.forename: D
authors.initials: D
authors.lastname: Belpomme
authors.forename: I
authors.initials: I
authors.lastname: Krakowski
authors.forename: M
authors.initials: M
authors.lastname: Beauduin
authors.forename: T
authors.initials: T
authors.lastname: Petit
authors.forename: J L
authors.initials: JL
authors.lastname: Canon
authors.forename: J
authors.initials: J
authors.lastname: Janssens
authors.forename: S
authors.initials: S
authors.lastname: Gauthier
authors.forename: A
authors.initials: A
authors.lastname: De Pauw
authors.forename: V
authors.initials: V
authors.lastname: Moreau
authors.forename: L
authors.initials: L
authors.lastname: Kayitalire
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine