title: [Trastuzumab in combination with chemotherapy versus chemotherapy alone for first-line treatment of HER2-positive advanced gastric or gastroesophageal junction cancer: a Phase III, multi-center, randomized controlled trial, Chinese subreport].
abstract: OBJECTIVE
  To evaluate the efficacy and safety of trastuzumab in combination with chemotherapy versus chemotherapy alone in the first-line treatment of HER-2-positive advanced gastric or gastro-oesophageal junction cancer.
  
  
  METHODS
  Fifteen Chinese research centers are involved in the BO18255 (ToGA) study. Patients with gastric or gastro-oesophageal junction cancer were eligible for inclusion if their tumor showed overexpression of HER-2 protein by immunohistochemistry +++ or FISH-positive. Patients were randomly assigned in a 1:1 ratio to receive a chemotherapy regimen consisting of capecitabine or 5-FU plus cisplatin or chemotherapy in combination with intravenous trastuzumab. The primary endpoint was overall survival.
  
  
  RESULTS
  Eighty-five Chinese patients were enrolled in this study, of whom 84 were included in the primary analysis: trastuzumab plus chemotherapy (FP/H) (n = 36) and chemotherapy alone (FP)(n = 48). The median follow-up was 15.2 months in the FP/H group and 14.2 months in the FP group. The median survival time was 12.6 months in the FP/H group compared with 9.7 months in the FP group [hazard ratio 0.72, 95%CI (0.40; 1.29)]. Grade 3/4 adverse events were higher in the FP/H(63.9%)than FP (47.9%) groups, including neutropenia, vomiting and nausea. Two mild cardiac adverse events occurred in the FP/H group. Severe adverse events occurred in 3 cases of both two groups, respectively.
  
  
  CONCLUSIONS
  Addition of trastuzumab to chemotherapy is well tolerated and shows improved survival in Chinese patients with advanced gastric or gastro-oesophageal junction cancer. These results are consistent with the results of ToGA whole population trial. Trastuzumab in combination with chemotherapy can be considered as a new option for patients with HER-2-positive advanced gastric or gastro-oesophageal junction cancer.
authors.affiliation: Department of Gastroenterology, Peking University Cancer Hospital & Institute, Beijing 100142, China. lin100@medmail.com.cn
authors.forename: Lin
authors.initials: L
authors.lastname: Shen
authors.forename: Jian-ming
authors.initials: JM
authors.lastname: Xu
authors.forename: Feng-yi
authors.initials: FY
authors.lastname: Feng
authors.forename: Shun-chang
authors.initials: SC
authors.lastname: Jiao
authors.forename: Li-wei
authors.initials: LW
authors.lastname: Wang
authors.forename: Jin
authors.initials: J
authors.lastname: Li
authors.forename: Zhong-Zhen
authors.initials: ZZ
authors.lastname: Guan
authors.forename: Shu-kui
authors.initials: SK
authors.lastname: Qin
authors.forename: Jie-jun
authors.initials: JJ
authors.lastname: Wang
authors.forename: Shi-ying
authors.initials: SY
authors.lastname: Yu
authors.forename: Ya-jie
authors.initials: YJ
authors.lastname: Wang
authors.forename: Ye-ning
authors.initials: YN
authors.lastname: Jin
authors.forename: Min
authors.initials: M
authors.lastname: Tao
authors.forename: Lei-zhen
authors.initials: LZ
authors.lastname: Zheng
authors.forename: Liang-xi
authors.initials: LX
authors.lastname: Pan
mesh_terms: D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D002681:China; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004938:Esophageal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004943:Esophagogastric Junction; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D012074:Remission Induction; D012189:Retrospective Studies; D013274:Stomach Neoplasms / Q000188:drug therapy* / Q000473:pathology; D015996:Survival Rate; D000068878:Trastuzumab; D014839:Vomiting / Q000139:chemically induced
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D000069287:Capecitabine; D002945:Cisplatin; D003841:Deoxycytidine; D005472:Fluorouracil; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; C508053:ERBB2 protein, human