title: A phase II study of gemcitabine plus cisplatin in previously untreated advanced ovarian cancer.
abstract: BACKGROUND
  The primary objective was the evaluation of the effects of gemcitabine plus cisplatin on the overall response rate (ORR) of patients with advanced ovarian cancer; the secondary assessments included toxicity, time to progressive disease (TtPD) and the duration of response.
  
  
  METHODS
  Chemonaive patients with stage III/IV ovarian cancer received gemcitabine 1250 mg/m2 (d 1,8) and cisplatin 75 mg/m2 (d 1), every 21 days for a maximum of six cycles.
  
  
  RESULTS
  Between March 1999 and June 2003, 28 patients (median age 52 years, range 23-72) had received chemotherapy. Of 26 assessable patients, the ORR was 57.7% (95% CI, 42.7%-83.6%) based on four complete responses and eleven partial responses, six patients experienced stable disease, while five had progressive disease. The median survival was 28.1 months (95% CI, 11.4-33.4 months), the median TtPD was 10.5 months (95% CI, 1.4-44.2 months) and the median duration of response was 24.3 months (95% CI, 12.3-33.4 months). The most common grade 3/4 toxicities were nausea/vomiting (15.2%) and neutropenia (10.7%). There was no grade 3 or 4 thrombocytopenia.
  
  
  CONCLUSIONS
  Gemcitabine plus cisplatin exhibited activity in advanced ovarian cancer with an acceptable toxicity profile.
authors.affiliation: Instituto Nacional de Cancerología, Av. San Fernando # 22 Del. Tlalpan, México.
authors.forename: Dolores
authors.initials: D
authors.lastname: Gallardo
authors.forename: German
authors.initials: G
authors.lastname: Calderillo
authors.forename: Alberto
authors.initials: A
authors.lastname: Serrano
authors.forename: Francisco
authors.initials: F
authors.lastname: Alexander
authors.forename: Gerardo
authors.initials: G
authors.lastname: Rodríguez
authors.forename: Leonel
authors.initials: L
authors.lastname: Pérez
authors.forename: Jaime
authors.initials: J
authors.lastname: de la Garza
authors.forename: Luis
authors.initials: L
authors.lastname: Orate-Ocaña
authors.forename: Jorge
authors.initials: J
authors.lastname: Otero
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; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D002945:Cisplatin; D000093542:Gemcitabine