title: Post-operative imatinib in patients with intermediate or high risk gastrointestinal stromal tumor.
abstract: OBJECTIVE
  This study aims to determine whether adjuvant treatment with imatinib improves recurrence-free survival (RFS) in Chinese patients undergoing complete resection of localized primary gastrointestinal stromal tumor (GIST) compared with those not receiving adjuvant therapy. We also sought a correlation between c-KIT mutations and RFS.
  
  
  METHODS
  Patients who had undergone complete tumor resection with intermediate or high risk of recurrence were enrolled in a single-center, non-randomized, prospective study. Patients either received adjuvant imatinib therapy (400 mg once-daily) for 3 years or did not. Mutation analyses of c-KIT were performed on available archival tumor samples.
  
  
  RESULTS
  105 patients were enrolled: 56 in the treatment group and 49 in the control group. Median follow-up was 45(43.1-46.9) months. RFS at 1, 2 and 3 years were higher in the treatment group than in the control group (100% vs. 90% at 1 year; 96% vs. 57% at 2 years; 89% versus 48% at 3 years, P < 0.001, HR = 0.188). Subgroup analyses showed that adjuvant therapy significantly decreased the risk of recurrence in patients whether at high risk or at intermediate risk compared with control patients (3-year RFS: 95% vs. 72%, in intermediate risk; 85% versus 31% in high risk; P < 0.001). In addition, imatinib adjuvant treatment decreased the risk of death (P = 0.025, [corrected] HR = 0.254).
  
  
  CONCLUSIONS
  Adjuvant imatinib can improve 1-, 2- and 3-year RFS rates in patients at intermediate or high risk of recurrence after complete tumor resection.
  
  
  BACKGROUND
  ChiCTR-TCC-00000582.
authors.affiliation: Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Department of GI Oncology, Peking University School of Oncology, Beijing Cancer Hospital & Institute, 52 Fucheng Road, Haidian District, Beijing 100142 China.
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.forename: J F
authors.initials: JF
authors.lastname: Gong
authors.forename: A W
authors.initials: AW
authors.lastname: Wu
authors.forename: L
authors.initials: L
authors.lastname: Shen
mesh_terms: D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D044466:Asian People; D001549:Benzamides; D017024:Chemotherapy, Adjuvant; D002681:China; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005743:Gastrectomy; D046152:Gastrointestinal Stromal Tumors / Q000188:drug therapy* / Q000401:mortality* / Q000601:surgery; D006801:Humans; D000068877:Imatinib Mesylate; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009154:Mutation; D010879:Piperazines / Q000008:administration & dosage / Q000627:therapeutic use*; D016016:Proportional Hazards Models; D011446:Prospective Studies; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D019009:Proto-Oncogene Proteins c-kit / Q000235:genetics*; D011743:Pyrimidines / Q000008:administration & dosage / Q000627:therapeutic use*; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D000068877:Imatinib Mesylate; D019009:Proto-Oncogene Proteins c-kit