title: Salvage chemotherapy of biweekly irinotecan plus S-1 (biweekly IRIS) in previously treated patients with advanced gastric cancer.
abstract: OBJECTIVE
  This phase II trial first describes the combination chemotherapy of biweekly irinotecan plus S-1 (biweekly IRIS) for pretreated advanced gastric cancer (AGC) patients.
  
  
  METHODS
  Patients who had previously been treated with greater than or equal to one regimen were enrolled. They received S-1 35 mg/m(2) twice daily on days 1-14 and irinotecan 150 mg/m(2) on days 1 and 15, every 4 weeks. The primary endpoint was overall survival (OS).
  
  
  RESULTS
  Among the 38 patients enrolled, 18 patients were treated as second line, and the remaining 20 patients were enrolled as third- or fourth line. A total of 208 cycles were administered with the median being four cycles (range 1-16). The median OS was 8.7 months [95% confidence interval (CI) 7.5-10.3], and the median progression-free survival was 6.3 months (95% CI 5.3-7.3). Low serum albumin (<3.5 mg/dL) was an independent adverse prognosticator for survival. Overall response rate was 17% (95% CI 4-30%). The major grade 3/4 toxicities were neutropenia (26%) and diarrhea (18%).
  
  
  CONCLUSIONS
  Biweekly IRIS showed the moderate activity as salvage treatment in AGC. Considering high neutropenia and gastrointestinal toxicity, patient selection should be warranted; serum albumin may be a predictive factor for treatment decision.
authors.affiliation: Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea.
authors.forename: Hong Jae
authors.initials: HJ
authors.lastname: Chon
authors.forename: Sun Young
authors.initials: SY
authors.lastname: Rha
authors.forename: Hyung Soon
authors.initials: HS
authors.lastname: Park
authors.forename: Sang Joon
authors.initials: SJ
authors.lastname: Shin
authors.forename: Hyo Song
authors.initials: HS
authors.lastname: Kim
authors.forename: Jae Kyung
authors.initials: JK
authors.lastname: Roh
authors.forename: Sung Hoon
authors.initials: SH
authors.lastname: Noh
authors.forename: Hyun Cheol
authors.initials: HC
authors.lastname: Chung
authors.forename: Hei-Cheul
authors.initials: HC
authors.lastname: Jeung
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000031:analogs & derivatives; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000008:administration & dosage; D018579:Patient Selection; D016879:Salvage Therapy / Q000379:methods*; D012709:Serum Albumin / Q000378:metabolism*; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D013534:Survival; D005641:Tegafur / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D004338:Drug Combinations; D012709:Serum Albumin; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D000077146:Irinotecan; D002166:Camptothecin