title: Biweekly gemcitabine and cisplatin in platinum-resistant/refractory, paclitaxel-pretreated, ovarian and peritoneal carcinoma.
abstract: OBJECTIVE
  Synergism between gemcitabine and cisplatin is supported by preclinical and clinical data. The present study explores the efficacy of a biweekly regimen in platinum-resistant/refractory, paclitaxel-pretreated ovarian and peritoneal cancer.
  
  
  METHODS
  50 paclitaxel-pretreated patients with platinum-resistant/refractory ovarian or peritoneal carcinoma who had previously received paclitaxel chemotherapy, were treated with six cycles of gemcitabine 1000 mg/m(2) followed by cisplatin 40 mg/m(2) on days 1 and 15, repeated every 4 weeks.
  
  
  RESULTS
  The median platinum-free interval (PFI) was 4 months while the median number of previous treatment lines was 2. Chemotherapy was well tolerated. Objective responses were observed in 31.5% of evaluable patients (n=35). CA125 response was observed in 68% of patients with elevated CA125 (n=41). Median overall survival (OS) was 13.2 months (95% Confidence Interval, CI: 10.2-16.2) while progression-free survival (PFS) was 4.9 months (95%CI: 3.5-6.4). A PFI of less than 3 months was associated with lower objective response rates (15.8% versus 50%, p=0.03).
  
  
  CONCLUSIONS
  Biweekly gemcitabine and cisplatin is feasible for patients with platinum-resistant ovarian or peritoneal cancer and is associated with a favorable toxicity profile. In a population with recent exposure to platinum, a PFI of less than 3 months was the major factor influencing response to chemotherapy.
authors.affiliation: Department of Clinical Therapeutics, University of Athens, Medical School, 31 Komninon st, Haidari, 12462 Athens, Greece.
authors.forename: George
authors.initials: G
authors.lastname: Bozas
authors.forename: Aristotle
authors.initials: A
authors.lastname: Bamias
authors.forename: Vassiliki
authors.initials: V
authors.lastname: Koutsoukou
authors.forename: Eleni
authors.initials: E
authors.lastname: Efstathiou
authors.forename: Dimitra
authors.initials: D
authors.lastname: Gika
authors.forename: Christos A
authors.initials: CA
authors.lastname: Papadimitriou
authors.forename: Meletios A
authors.initials: MA
authors.lastname: Dimopoulos
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000494:pharmacology; D010534:Peritoneal Neoplasms / Q000188:drug therapy*; D011446:Prospective Studies; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D017239:Paclitaxel; D002945:Cisplatin; D000093542:Gemcitabine