title: Phase II study of S-1 monotherapy in paclitaxel- and cisplatin-refractory gastric cancer.
abstract: OBJECTIVE
  S-1 is a fourth-generation oral fluoropyrimidine that was developed to mimic the effects achieved with protracted continuous infusion of 5-fluorouracil (5-FU). This phase II study evaluated the efficacy and safety of S-1 salvage chemotherapy in patients with paclitaxel- and cisplatin-refractory gastric cancer. The primary end point was progression-free survival; secondary end points were overall survival, safety, and clinical benefit.
  
  
  METHODS
  Patients were eligible for the study if they had histologically documented gastric adenocarcinoma previously treated with paclitaxel and cisplatin, age > or = 18 years, Eastern Clinical Oncology Group performance status < or =2, adequate organ function, and no evidence of gastrointestinal obstruction or passage disturbance. Patients were treated with a dose of S-1 based on body surface area (BSA) as follows: BSA < 1.25 m(2), 80 mg/day; 1.25 < or = BSA < 1.5 m(2), 100 mg/day; BSA > or= 1.5 m(2), 120 mg/day. The total dose was divided in two and administered twice daily for 4 weeks followed by a 2-week rest period.
  
  
  RESULTS
  Of the 53 patients enrolled in this study, 49 were evaluable. A total of 190 chemotherapy cycles were administered, and the median number of cycles was 2. Five patients (9.4%) had a partial response, and 18 (34%) had stable disease. Median progression-free survival and overall survival were 4.9 and 10.4 months, respectively. Grade 3/4 hematological toxicities included neutropenia in six patients (11%) but no cases of febrile neutropenia were found. Most of the non-hematological toxicities were diarrhea, asthenia, and mucositis, but none reached grade 3 or grade 4 in severity. Improvement of pain was observed in 17 patients (32.1%).
  
  
  CONCLUSIONS
  S-1 monotherapy provides active and safe salvage chemotherapy for patients with advanced gastric cancer who have been previously treated with paclitaxel and cisplatin.
authors.affiliation: Division of Hemato-Oncology, Department of Internal Medicine, Center for Biomedical Human Resources, Chonnam National University Medical School, Kwangju, Korea.
authors.forename: Sung-Ji
authors.initials: SJ
authors.lastname: Lee
authors.forename: Sang-Hee
authors.initials: SH
authors.lastname: Cho
authors.forename: Ju-Young
authors.initials: JY
authors.lastname: Yoon
authors.forename: Jun-Eul
authors.initials: JE
authors.lastname: Hwang
authors.forename: Woo-Kyun
authors.initials: WK
authors.lastname: Bae
authors.forename: Hyun-Jeong
authors.initials: HJ
authors.lastname: Shim
authors.forename: Ik-Joo
authors.initials: IJ
authors.lastname: Chung
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000401:mortality; D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use; D002945:Cisplatin / Q000627:therapeutic use; D018572:Disease-Free Survival; D004338:Drug Combinations; D005260:Female; D005334:Fever / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D010094:Oxonic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D017239:Paclitaxel / Q000627:therapeutic use; D010146:Pain / Q000188:drug therapy / Q000209:etiology; D016879:Salvage Therapy; D012720:Severity of Illness Index; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000401:mortality; D015996:Survival Rate; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D000972:Antineoplastic Agents, Phytogenic; D004338:Drug Combinations; C079198:S 1 (combination); D005641:Tegafur; D010094:Oxonic Acid; D017239:Paclitaxel; D002945:Cisplatin