title: Salvage chemotherapy for pretreated gastric cancer: a randomized phase III trial comparing chemotherapy plus best supportive care with best supportive care alone.
abstract: OBJECTIVE
  When designing this trial, there was no evidence that salvage chemotherapy (SLC) in advanced gastric cancer (AGC) resulted in substantial prolongation of survival when compared with best supportive care (BSC). However, SLC is often offered to pretreated patients with AGC for anecdotal reasons.
  
  
  METHODS
  Patients with AGC with one or two prior chemotherapy regimens involving both fluoropyrimidines and platinum and with an Eastern Cooperative Oncology Group performance status (PS) 0 or 1 were randomly assigned in a ratio of 2:1 to SLC plus BSC or BSC alone. Choice of SLC-either docetaxel 60 mg/m(2) every 3 weeks or irinotecan 150 mg/m(2) every 2 weeks-was left to the discretion of investigators. Primary end point was overall survival (OS).
  
  
  RESULTS
  Median OS was 5.3 months among 133 patients in the SLC arm and 3.8 months among 69 patients in the BSC arm (hazard ratio, 0.657; 95% CI, 0.485 to 0.891; one-sided P = .007). OS benefit for SLC was consistent in most of the prospectively defined subgroups, including age, PS, number of prior treatments, metastatic sites, hemoglobin levels, and response to prior chemotherapy. SLC was generally well tolerated, and adverse events were similar in the SLC and BSC arms. We found no median OS difference between docetaxel and irinotecan (5.2 v 6.5 months; P = .116).
  
  
  CONCLUSIONS
  To our knowledge, this is the largest phase III trial comparing SLC plus BSC with BSC alone in AGC. In pretreated patients, SLC is tolerated and significantly improves OS when added to BSC.
authors.affiliation: Gyeongsang NationalUniversity Hospital, Jinju, Korea.
authors.forename: Jung Hun
authors.initials: JH
authors.lastname: Kang
authors.forename: Soon Il
authors.initials: SI
authors.lastname: Lee
authors.forename: Do Hyoung
authors.initials: DH
authors.lastname: Lim
authors.forename: Keon-Woo
authors.initials: KW
authors.lastname: Park
authors.forename: Sung Yong
authors.initials: SY
authors.lastname: Oh
authors.forename: Hyuk-Chan
authors.initials: HC
authors.lastname: Kwon
authors.forename: In Gyu
authors.initials: IG
authors.lastname: Hwang
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Lee
authors.forename: Eunmi
authors.initials: E
authors.lastname: Nam
authors.forename: Dong Bok
authors.initials: DB
authors.lastname: Shin
authors.forename: Jeeyun
authors.initials: J
authors.lastname: Lee
authors.forename: Joon Oh
authors.initials: JO
authors.lastname: Park
authors.forename: Young Suk
authors.initials: YS
authors.lastname: Park
authors.forename: Ho Yeong
authors.initials: HY
authors.lastname: Lim
authors.forename: Won Ki
authors.initials: WK
authors.lastname: Kang
authors.forename: Se Hoon
authors.initials: SH
authors.lastname: Park
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; 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; D003131:Combined Modality Therapy; D000077143:Docetaxel; D019008:Drug Resistance, Neoplasm; D005260:Female; D006801:Humans; D000077146:Irinotecan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D017671:Platinum Compounds / Q000008:administration & dosage; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011743:Pyrimidines / Q000008:administration & dosage; D056910:Republic of Korea; D018570:Risk Assessment; D012307:Risk Factors; D016879:Salvage Therapy; D013274:Stomach Neoplasms / Q000401:mortality / Q000628:therapy*; D043823:Taxoids / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017671:Platinum Compounds; D011743:Pyrimidines; D043823:Taxoids; D000077143:Docetaxel; D000077146:Irinotecan; D002166:Camptothecin