title: Feasibility study of biweekly CPT-11 plus CDDP for S-1- and paclitaxel-refractory, metastatic gastric cancer.
abstract: BACKGROUND
  To confirm the feasibility and efficacy of biweekly irinotecan (CPT-11) plus cisplatin (CDDP) as third-line chemotherapy, the response rate (RR), overall survival and toxicity were evaluated in patients who had been treated with S-1 as a first-line and paclitaxel as a second-line chemotherapy for metastatic gastric cancer.
  
  
  METHODS
  The eligibility criteria of our study were: i) pathologically-confirmed adenocarcinoma of the stomach, ii) primary non-resectable or recurrent tumors, iii) Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 2 or less, iv) age less than 75 years, v) adequate hepatic, renal and bone marrow functions and vi) patients had received S-1 as a first-line and paclitaxel as a second-line chemotherapy and both regimens had failed. The treatment consisted of CPT-11 (60 mg/m2) and CDDP (30 mg/m2) on day 1 and day 15, repeated every 4 weeks.
  
  
  RESULTS
  Twenty-six patients were enrolled in this study. All the treatment was administered at the out-patient clinic except the first course for the initial 4 patients. The overall RR was 23.1% in all and 30.0% in the patients with target tumors (6 partial response, 11 stable disease, 7 progressive disease, 2 non-evaluable). Overall grade 3/4 toxicity was observed in 5 patients (19.2%) including pancytopenia, neutropenia, anemia, anorexia and elevation of AST/ALT. The time-to-treatment failure and the median survival time were 95 and 299 days, respectively.
  
  
  CONCLUSIONS
  Biweekly CPT-11 plus CDDP was feasible for S-1- and paclitaxel-refractory metastatic gastric cancer, with moderate activity and favorable toxicity. This regimen was safely performed at the out-patient clinic as third-line chemotherapy.
authors.affiliation: Department of Gastrointestinal Surgery, Kanagawa Cancer Center, Yokohama, Japan. tatsu-yo@js8.so-net.ne.jp
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Yoshida
authors.forename: Takaki
authors.initials: T
authors.lastname: Yoshikawa
authors.forename: Akira
authors.initials: A
authors.lastname: Tsuburaya
authors.forename: Osamu
authors.initials: O
authors.lastname: Kobayashi
authors.forename: Shinichi
authors.initials: S
authors.lastname: Hasegawa
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Osaragi
authors.forename: Motonori
authors.initials: M
authors.lastname: Sairenji
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D004338:Drug Combinations; D018432:Drug Resistance, Multiple; D019008:Drug Resistance, Neoplasm; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D010094:Oxonic Acid / Q000494:pharmacology; D017239:Paclitaxel / Q000494:pharmacology; D011725:Pyridines / Q000494:pharmacology; D013274:Stomach Neoplasms / Q000188:drug therapy*; D005641:Tegafur / Q000494:pharmacology
chemical_list: D004338:Drug Combinations; D011725:Pyridines; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D017239:Paclitaxel; D002945:Cisplatin; D002166:Camptothecin