title: Combination chemotherapy with irinotecan and cisplatin in pretreated patients with unresectable or recurrent gastric cancer.
abstract: BACKGROUND
  The combination of irinotecan (CPT-11) and cisplatin (CDDP) is an active regimen for metastatic gastric cancer in the first-line setting. The objective of this retrospective study was to clarify its efficacy and safety in patients with prior chemotherapy for advanced or recurrent gastric cancer.
  
  
  METHODS
  Patients in the study fulfilled the following selection criteria: (1) histologically proven gastric cancer with metastatic lesions; (2) performance status of 2 or less; (3) age of 75 years or younger; (4) at least one prior chemotherapy regimen without CPT-11 or CDDP; (5) adequate bone marrow, liver, and kidney function; (6) normal cardiac function; (7) no other severe medical conditions; (8) no other active malignancy; and (9) the provision of written informed consent. The treatment consisted of CPT-11 (70 mg/m2) on day 1 and day 15 and CDDP (80 mg/m2) on day 1; repeated every 4 weeks.
  
  
  RESULTS
  Thirty-two patients were recruited, and 28 were assessable for clinical response. There were eight partial responses, resulting in a response rate of 28%. Median time to progression was 104 days (range, 24-863 days) and median overall survival time was 283 days from the initiation of this therapy. The incidences of grade 4 neutropenia, grade 3 or higher infection, and diarrhea were 69%, 9%, and 3%, respectively. Other adverse reactions were mild. No treatment-related deaths occurred.
  
  
  CONCLUSIONS
  A combination of CPT-11 and CDDP may be active and feasible for gastric cancer patients with prior chemotherapy. Further studies with larger numbers of patients are needed to clarify this regimen's significance in the second-line setting.
authors.affiliation: Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Ueda
authors.forename: Shuichi
authors.initials: S
authors.lastname: Hironaka
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Akira
authors.initials: A
authors.lastname: Fukutomi
authors.forename: Takayuki
authors.initials: T
authors.lastname: Yoshino
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Onozawa
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives*; D002945:Cisplatin / Q000008:administration & dosage*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D012189:Retrospective Studies; D016879:Salvage Therapy / Q000379:methods; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D016019:Survival Analysis
chemical_list: D000077146:Irinotecan; D002945:Cisplatin; D002166:Camptothecin