title: Adjuvant therapy with imatinib mesylate after resection of primary high-risk gastrointestinal stromal tumors in Japanese patients.
abstract: BACKGROUND
  Imatinib mesylate, a small-molecule tyrosine kinase inhibitor, is currently used for adjuvant therapy of patients who have undergone resection of high-risk gastrointestinal stromal tumors (GISTs). There are no data concerning the efficacy and safety of postoperative adjuvant therapy with imatinib for Japanese or East Asian patients with GIST.
  
  
  METHODS
  A single-arm, open-label, multicenter trial was conducted in 17 hospitals in Japan. The eligibility criteria included histologically proven primary high-risk GISTs with macroscopic complete resection. Patients were treated with imatinib at a dose of 400 mg/day for 1 year after surgery. The primary endpoint was recurrence-free survival as assessed by Kaplan-Meier analysis. The secondary endpoints were overall survival and safety. This study was registered with ClinicalTrials.gov, number NCT00171977.
  
  
  RESULTS
  A total of 64 patients were enrolled between September 2004 and July 2006. The median age of the patients was 59.5 years. Forty-nine (76.6%) patients completed the 1-year treatment, whereas 15 (23.4%) patients did not complete the treatment owing to recurrence, toxicities, and consent withdrawal. At the median follow-up period of 109 weeks, 20 patients had recurrence. The 3-year recurrence rate was 42.7% (95% confidence interval 29.2-56.3%), which exceeded the expected recurrence rate in this trial. The recurrence-free and overall survival rates at 2 years were 71.1 and 93.7%, respectively. The most frequent adverse drug reaction of any grade was eyelid edema (48.4%), followed by neutropenia (40.6%), leukopenia (39.1%), nausea (39.1%), rash (37.5%), and peripheral edema (37.5%), most of which were mild and manageable.
  
  
  CONCLUSIONS
  Adjuvant therapy with imatinib at 400 mg/day for 1 year is well tolerated by Japanese patients and possibly reduces the risk of early recurrence of high-risk GISTs.
authors: Department of Surgery, Niigata University Medical and Dental Hospital, 1-754 Asahimachi-dori, Chuo-ku, Niigata, 951-8520, Japan. kandat@med.niigata-u.ac.jp
authors: Tatsuo
authors: T
authors: Kanda
authors: Toshirou
authors: T
authors: Nishida
authors: Norihito
authors: N
authors: Wada
authors: Osamu
authors: O
authors: Kobayashi
authors: Masakazu
authors: M
authors: Yamamoto
authors: Akira
authors: A
authors: Sawaki
authors: Narikazu
authors: N
authors: Boku
authors: Masato
authors: M
authors: Koseki
authors: Toshihiko
authors: T
authors: Doi
authors: Yasushi
authors: Y
authors: Toh
authors: Yoshihiro
authors: Y
authors: Kakeji
authors: Toshiro
authors: T
authors: Sugiyama
authors: Yoshito
authors: Y
authors: Komatsu
authors: Shojiro
authors: S
authors: Kikuchi
authors: Kyoji
authors: K
authors: Ogoshi
authors: Hitoshi
authors: H
authors: Katai
authors: Kazuhito
authors: K
authors: Miyachi
authors: Seiichi
authors: S
authors: Hirota
authors: Atsushi
authors: A
authors: Ohtsu
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D001549:Benzamides / Q000008:administration & dosage* / Q000009:adverse effects; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D064420:Drug-Related Side Effects and Adverse Reactions / Q000139:chemically induced / Q000145:classification / Q000503:physiopathology*; D005260:Female; D046152:Gastrointestinal Stromal Tumors / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D006801:Humans; D000068877:Imatinib Mesylate; D007564:Japan; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011184:Postoperative Period; D047428:Protein Kinase Inhibitors / Q000009:adverse effects; D011743:Pyrimidines / Q000008:administration & dosage* / Q000009:adverse effects; D012008:Recurrence; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D047428:Protein Kinase Inhibitors; D011743:Pyrimidines; D000068877:Imatinib Mesylate