title: Randomized, open-label, phase III study comparing irinotecan with paclitaxel in patients with advanced gastric cancer without severe peritoneal metastasis after failure of prior combination chemotherapy using fluoropyrimidine plus platinum: WJOG 4007 trial.
abstract: OBJECTIVE
  This phase III study compared treatment with weekly paclitaxel and biweekly irinotecan in patients with advanced gastric cancer refractory to treatment with fluoropyrimidine plus platinum.
  
  
  METHODS
  Patients were randomly assigned to receive either paclitaxel (80 mg/m(2) on days 1, 8, and 15, every 4 weeks) or irinotecan (150 mg/m(2) on days 1 and 15, every 4 weeks). Primary end point was overall survival (OS), and secondary end points were progression-free survival (PFS), response rate, adverse events, and proportion of patients who received third-line chemotherapy.
  
  
  RESULTS
  Of 223 patients, 219 were eligible for analysis. Median OS was 9.5 months in 108 patients allocated to the paclitaxel group and 8.4 months in 111 patients allocated to the irinotecan group (hazard ratio [HR], 1.13; 95% CI, 0.86 to 1.49; P = .38). Median PFS was 3.6 months in the paclitaxel group and 2.3 months in the irinotecan group (HR, 1.14; 95% CI, 0.88 to 1.49; P = .33). Response rate was 20.9% in the paclitaxel group and 13.6% in the irinotecan group (P = .24). Common grade 3 to 4 adverse events were neutropenia (paclitaxel group, 28.7%; irinotecan group, 39.1%), anemia (21.3%; 30.0%), and anorexia (7.4%; 17.3%). Treatment-related deaths occurred in two patients (1.8%) in the irinotecan group. Third-line chemotherapy was administered in 97 patients (89.8%) after paclitaxel treatment and in 80 patients (72.1%) after irinotecan treatment (P = .001).
  
  
  CONCLUSIONS
  No statistically significant difference was observed between paclitaxel and irinotecan for OS. Both are reasonable second-line treatment options for advanced gastric cancer.
authors.affiliation: Shuichi Hironaka, Chiba Cancer Center, Chiba; Shinya Ueda and Isamu Okamoto, Kinki University, Osakasayama; Hirofumi Yasui, Shizuoka Cancer Center, Shizuoka; Tomohiro Nishina, National Hospital Organization Shikoku Cancer Center, Matsuyama; Masahiro Tsuda, Hyogo Cancer Center, Akashi; Takehiko Tsumura, Osaka Red Cross Hospital; Naotoshi Sugimoto, Osaka Medical Center for Cancer and Cardiovascular Diseases; Shinya Tokunaga, Osaka City General Hospital; Kazumasa Fujitani, Osaka National Hospital, Osaka; Hideki Shimodaira, Tohoku University Hospital, Sendai; Toshikazu Moriwaki and Ichinosuke Hyodo, University of Tsukuba, Tsukuba; Taito Esaki, National Kyushu Organization Kyushu Cancer Center, Fukuoka; Michitaka Nagase, Jichi Medical University, Shimono; Kensei Yamaguchi, Saitama Cancer Center, Saitama; Takashi Ura, Aichi Cancer Center Hospital, Nagoya; Yasuo Hamamoto, Tochigi Cancer Center, Utsunomiya; Satoshi Morita, Yokohama City University Graduate School of Medicine, Yokohama; and Narikazu Boku, St Marianna University School of Medicine, Kawasaki, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Hironaka
authors.forename: Shinya
authors.initials: S
authors.lastname: Ueda
authors.forename: Hirofumi
authors.initials: H
authors.lastname: Yasui
authors.forename: Tomohiro
authors.initials: T
authors.lastname: Nishina
authors.forename: Masahiro
authors.initials: M
authors.lastname: Tsuda
authors.forename: Takehiko
authors.initials: T
authors.lastname: Tsumura
authors.forename: Naotoshi
authors.initials: N
authors.lastname: Sugimoto
authors.forename: Hideki
authors.initials: H
authors.lastname: Shimodaira
authors.forename: Shinya
authors.initials: S
authors.lastname: Tokunaga
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Moriwaki
authors.forename: Taito
authors.initials: T
authors.lastname: Esaki
authors.forename: Michitaka
authors.initials: M
authors.lastname: Nagase
authors.forename: Kazumasa
authors.initials: K
authors.lastname: Fujitani
authors.forename: Kensei
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Takashi
authors.initials: T
authors.lastname: Ura
authors.forename: Yasuo
authors.initials: Y
authors.lastname: Hamamoto
authors.forename: Satoshi
authors.initials: S
authors.lastname: Morita
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
authors.forename: Narikazu
authors.initials: N
authors.lastname: Boku
authors.forename: Ichinosuke
authors.initials: I
authors.lastname: Hyodo
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000855:Anorexia / Q000139:chemically induced; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D000077146:Irinotecan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D010984:Platinum / Q000008:administration & dosage; D011446:Prospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy*; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D010984:Platinum; D000077146:Irinotecan; D017239:Paclitaxel; D005472:Fluorouracil; D002166:Camptothecin