title: Second-line chemotherapy with biweekly paclitaxel after failure of fluoropyrimidine-based treatment in patients with advanced or recurrent gastric cancer: a report from the gastrointestinal oncology group of the Tokyo cooperative oncology group, TCOG GC-0501 trial.
abstract: OBJECTIVE
  A multicenter trial was conducted to evaluate the efficacy and safety of paclitaxel every 2 weeks in patients with advanced or recurrent gastric cancer who had previously received fluoropyrimidine-based chemotherapy.
  
  
  METHODS
  The subjects were patients with gastric cancer who had disease progression or recurrence while receiving fluoropyrimidine-based chemotherapy. All patients had adequate major organ functions with an Eastern Cooperative Oncology Group performance status (PS) of 0-2. Paclitaxel 140 mg/m(2) was administered intravenously on days 1 and 15 of a 4-week cycle. The primary endpoint was the response rate. Secondary endpoints were progression-free survival (PFS), overall survival and safety.
  
  
  RESULTS
  Response was assessable in 40 of 41 enrolled patients. Their median age was 63 (range: 48-77) years, and PS was 0 in 22 patients, 1 in 13 and 2 in 5. Previous treatment included S-1 (1 M tegafur-0.4 M gimestat-1 M otastat potassium) monotherapy in 32 patients and S-1-based combination therapy in 5. The median number of administered courses of paclitaxel was 3.5 (1-14). The response rate was 17.5% (95% confidence interval: 7.3-32.8%, partial response: 7, stable disease: 21, progressive disease: 10 and not evaluable: 2). The disease control rate was 70.0%, the median PFS was 111 days and the median overall survival was 254 days. Major adverse events of Grade 3 or 4 were neutropenia (27.5%), anemia (12.5%), diarrhea (2.5%) and sensory neuropathy (2.5%).
  
  
  CONCLUSIONS
  Biweekly paclitaxel seemed to be one of the useful chemotherapies after failure of fluoropyrimidine-based treatment in patients with advanced or recurrent gastric cancer.
authors.affiliation: Department of Gastroenterology, Kitasato University East Hospital, 2-1-1 Asamizodai, Sagamihara, Kanagawa 228-8520, Japan. koizumi@med.kitasato-u.ac.jp
authors.forename: Wasaburo
authors.initials: W
authors.lastname: Koizumi
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Akiya
authors.forename: Atsushi
authors.initials: A
authors.lastname: Sato
authors.forename: Kensei
authors.initials: K
authors.lastname: Yamaguchi
authors.forename: Toshikazu
authors.initials: T
authors.lastname: Sakuyama
authors.forename: Norisuke
authors.initials: N
authors.lastname: Nakayama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanabe
authors.forename: Katsuhiko
authors.initials: K
authors.lastname: Higuchi
authors.forename: Tohru
authors.initials: T
authors.lastname: Sasaki
authors.forename: Takashi
authors.initials: T
authors.lastname: Sekikawa
mesh_terms: D000368:Aged; D000855:Anorexia / Q000139:chemically induced; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D019008:Drug Resistance, Neoplasm; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects*; D010523:Peripheral Nervous System Diseases / Q000139:chemically induced; D011743:Pyrimidines / Q000008:administration & dosage; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D014041:Tokyo; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D011743:Pyrimidines; D017239:Paclitaxel