title: A phase II study of irinotecan and docetaxel combination chemotherapy for patients with previously treated metastatic or recurrent advanced gastric cancer.
abstract: OBJECTIVE
  Irinotecan (I) and docetaxel (D), each of which has a unique mechanism of action, were recently introduced in the treatment of patients with advanced gastric cancer (AGC). We have evaluated the efficacy and safety of the ID combination for AGC patients after failure of fluoropyrimidine- or platinum-based chemotherapy.
  
  
  METHODS
  Patients with relapsed or progressive AGC after prior fluoropyrimidine- or platinum-based chemotherapy were treated with I (160 mg/m(2), 90 min) followed by D (65 mg/m(2), 1 h) every 3 weeks. Because of the unacceptable toxicity among the first ten patients, the doses were reduced for I (120 mg/m(2)) and D (50 mg/m(2)) every 3 weeks.
  
  
  RESULTS
  Forty-nine patients, of median age 53 years (range, 27-68 years), were treated with 170 cycles of chemotherapy (median, 2 cycles; range, 1-12 cycles). Three patients achieved complete response and seven achieved partial response, resulting in an overall response rate (ORR) of 20.4% [95% confidence interval (CI), 9.1-31.7%], with a median duration of 7.1 months (range: 2.1-69.1 months). ORR was 60% (95% CI, 29.6-90.3%) for the higher dose and 10.3% (95% CI, 0.7-19.8%) for the lower dose. Median time to progression for all patients was 2.7 months (95% CI, 1.7-3.8 months) and the median overall survival was 8.9 months (95% CI, 6.6-11.3 months). Grade 3/4 toxicities included neutropenia (90%), febrile neutropenia (50%), asthenia (40%), and diarrhea (10%) with the higher dose and neutropenia (71%), febrile neutropenia (11%), diarrhea (24%), and asthenia (24%) with the lower dose. There were two possible treatment-related deaths.
  
  
  CONCLUSIONS
  The combination of irinotecan and docetaxel, once every three weeks shows anti-tumor activity but is not feasible as a second-line treatment for AGC patients after failure of fluoropyrimidine- or platinum-based chemotherapy due to the high rate of toxicities.
authors.affiliation: Department of Medicine, Division of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Songpa Gu, Seoul, South Korea.
authors.forename: Sun Jin
authors.initials: SJ
authors.lastname: Sym
authors.forename: Heung Moon
authors.initials: HM
authors.lastname: Chang
authors.forename: Hye Jin
authors.initials: HJ
authors.lastname: Kang
authors.forename: Sung Sook
authors.initials: SS
authors.lastname: Lee
authors.forename: Min-Hee
authors.initials: MH
authors.lastname: Ryu
authors.forename: Jae-Lyun
authors.initials: JL
authors.lastname: Lee
authors.forename: Tae-Won
authors.initials: TW
authors.lastname: Kim
authors.forename: Jeong Hwan
authors.initials: JH
authors.lastname: Yook
authors.forename: Sung Tae
authors.initials: ST
authors.lastname: Oh
authors.forename: Byung Sik
authors.initials: BS
authors.lastname: Kim
authors.forename: Yoon-Koo
authors.initials: YK
authors.lastname: Kang
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000556:secondary; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001247:Asthenia / Q000139:chemically induced; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018450:Disease Progression; D000077143:Docetaxel; D005260:Female; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D000077146:Irinotecan; D008297:Male; D008875:Middle Aged; D012074:Remission Induction; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D002166:Camptothecin