title: Gemcitabine plus carboplatin compared with carboplatin in patients with platinum-sensitive recurrent ovarian cancer: an intergroup trial of the AGO-OVAR, the NCIC CTG, and the EORTC GCG.
abstract: OBJECTIVE
  Most patients with advanced ovarian cancer develop recurrent disease. For those patients who recur at least 6 months after initial therapy, paclitaxel platinum has shown a modest survival advantage over platinum without paclitaxel; however, many patients develop clinically relevant neurotoxicity, frequently resulting in treatment discontinuation. Thus, an alternative regimen without significant neurotoxicity was evaluated by comparing gemcitabine plus carboplatin with single-agent carboplatin in platinum-sensitive recurrent ovarian cancer patients.
  
  
  METHODS
  Patients with platinum-sensitive recurrent ovarian cancer were randomly assigned to receive either gemcitabine plus carboplatin or carboplatin alone, every 21 days. The primary objective was to compare progression-free survival (PFS).
  
  
  RESULTS
  Three hundred fifty-six patients (178 gemcitabine plus carboplatin; 178 carboplatin) were randomly assigned. Patients received a median of six cycles in both arms. With a median follow-up of 17 months, median PFS was 8.6 months (95% CI, 7.9 to 9.7 months) for gemcitabine plus carboplatin and 5.8 months (95% CI, 5.2 to 7.1 months) for carboplatin. The hazard ration (HR) for PFS was 0.72 (95% CI, 0.58 to 0.90; P = .0031). Response rate was 47.2% (95% CI, 39.9% to 54.5%) for gemcitabine plus carboplatin and 30.9% (95% CI, 24.1% to 37.7%) for carboplatin (P = .0016). The HR for overall survival was 0.96 (95% CI, 0.75 to1.23; P = .7349). While myelosuppression was significantly more common in the combination, sequelae such as febrile neutropenia or infections were uncommon. No statistically significant differences in quality of life scores between arms were noted.
  
  
  CONCLUSIONS
  Gemcitabine plus carboplatin significantly improves PFS and response rate without worsening quality of life for patients with platinum-sensitive recurrent ovarian cancer.
authors.affiliation: Klinik für Gynäkologie und Geburtshilfe, Campus Kiel, Universitätsklinikum Schleswig-Holstein, Michaelisstr 16, D-24105 Kiel, Germany. jpfisterer@e-mail.uni-kiel.de
authors.forename: Jacobus
authors.initials: J
authors.lastname: Pfisterer
authors.forename: Marie
authors.initials: M
authors.lastname: Plante
authors.forename: Ignace
authors.initials: I
authors.lastname: Vergote
authors.forename: Andreas
authors.initials: A
authors.lastname: du Bois
authors.forename: Hal
authors.initials: H
authors.lastname: Hirte
authors.forename: Angel J
authors.initials: AJ
authors.lastname: Lacave
authors.forename: Uwe
authors.initials: U
authors.lastname: Wagner
authors.forename: Anne
authors.initials: A
authors.lastname: Stähle
authors.forename: Gavin
authors.initials: G
authors.lastname: Stuart
authors.forename: Rainer
authors.initials: R
authors.lastname: Kimmig
authors.forename: Sigrid
authors.initials: S
authors.lastname: Olbricht
authors.forename: Tien
authors.initials: T
authors.lastname: Le
authors.forename: Janusz
authors.initials: J
authors.lastname: Emerich
authors.forename: Walther
authors.initials: W
authors.lastname: Kuhn
authors.forename: James
authors.initials: J
authors.lastname: Bentley
authors.forename: Christian
authors.initials: C
authors.lastname: Jackisch
authors.forename: Hans-Joachim
authors.initials: HJ
authors.lastname: Lück
authors.forename: Justine
authors.initials: J
authors.lastname: Rochon
authors.forename: Annamaria Hayden
authors.initials: AH
authors.lastname: Zimmermann
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Eisenhauer
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000494:pharmacology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002945:Cisplatin / Q000494:pharmacology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D016190:Carboplatin; D002945:Cisplatin; D000093542:Gemcitabine