title: Weekly paclitaxel as a single agent or in combination with carboplatin or weekly topotecan in patients with resistant ovarian cancer: the CARTAXHY randomized phase II trial from Groupe d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO).
abstract: BACKGROUND
  Platinum rechallenge or weekly topotecan in combination have not been evaluated in randomized trials for resistant recurrent ovarian cancer (ROC).
  
  
  METHODS
  Patients with ROC after first- or second-line treatment including a platinum and taxane and progression within 6 months were randomized to weekly paclitaxel (wP, 80 mg/m(2)/week) alone or in combination with carboplatin (C, area under the curve of 5 mg/ml/min every 4 weeks) or weekly topotecan (wT, 3 mg/m(2)/week). Primary end point was progression-free survival (PFS) comparing wP and combination therapy.
  
  
  RESULTS
  Patients (n = 165) received a median three cycles in each arm. Nonhematologic toxicity was not different, except increased hypersensitivity reactions with wP + C. Grade 3-4 hematologic toxic effects with wP, wP + C, and wP + wT, respectively, were neutropenia in 13%, 54%, and 42%; febrile neutropenia in 0%, 4%, and 5%; and anemia in 6%, 19%, and 29%. Response rates were 35%, 37%, and 39%, and median PFS times were 3.7, 4.8, and 5.4 months, respectively. PFS was not significantly different among the treatment arms [hazard ratio (HR) 0.922; 95% confidence interval (CI) 0.765-1.111; P = 0.46] or between monotherapy and combination therapy (HR 0.951; 95% CI 0.686-1.318; P = 0.76).
  
  
  CONCLUSIONS
  Combination chemotherapy in platinum-resistant ROC was more toxic than weekly paclitaxel and did not significantly prolong PFS.
authors.affiliation: Oncology Department, Centre Catherine de Sienne, Nantes, France.
authors.forename: A
authors.initials: A
authors.lastname: Lortholary
authors.forename: R
authors.initials: R
authors.lastname: Largillier
authors.forename: B
authors.initials: B
authors.lastname: Weber
authors.forename: L
authors.initials: L
authors.lastname: Gladieff
authors.forename: J
authors.initials: J
authors.lastname: Alexandre
authors.forename: X
authors.initials: X
authors.lastname: Durando
authors.forename: B
authors.initials: B
authors.lastname: Slama
authors.forename: J
authors.initials: J
authors.lastname: Dauba
authors.forename: D
authors.initials: D
authors.lastname: Paraiso
authors.forename: E
authors.initials: E
authors.lastname: Pujade-Lauraine
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality; D017239:Paclitaxel / Q000008:administration & dosage; D016019:Survival Analysis; D019772:Topotecan / Q000008:administration & dosage
chemical_list: D019772:Topotecan; D016190:Carboplatin; D017239:Paclitaxel