title: Neoadjuvant imatinib in patients with locally advanced non metastatic GIST in the prospective BFR14 trial.
abstract: BACKGROUND
  The role of surgery in the management of patients with advanced gastrointestinal stromal tumors (GIST) in the era of imatinib mesylate (IM) remains debated. We analyzed the outcome of patients with non metastatic locally advanced primary GIST treated with IM within the prospective BFR14 phase III trial.
  
  
  METHODS
  The database of the BFR14 trial was searched for patients with no metastasis at time of inclusion. Patients treated for recurrent disease were excluded. Twenty-five of 434 patients met these criteria.
  
  
  RESULTS
  Fifteen of 25 patients (60%) had a partial response to IM. Nine of the 25 patients (36%) underwent surgical resection of their primary tumor after a median of 7.3 months of IM treatment (range 3.4-12.0). Per protocol patients received continuous IM treatment in the post resection period, in an adjuvant setting. With a median follow-up of 53.5 months, there was a significant improvement in progression-free survival (PFS) and overall survival (OS) for patients who underwent surgical resection versus those who did not (median not reached vs 23.6 months, p = 0.0318 for PFS and median not reached vs 42.2 months, p = 0.0217 for OS). In the group of patients who underwent resection followed by IM, the 3-year PFS and OS rates were 67% and 89% respectively
  
  
  CONCLUSIONS
  Following neoadjuvant IM for non metastatic locally advanced GIST 9 of 25 patients (36%) were selected for resection of the primary tumor. OS and PFS figures were close to those of localised intermediate or high risk GIST (70% at 5 years) in the subgroup of operated patients, while the outcome of the non-operated subgroup was similar to that of metastatic GIST.
authors.affiliation: Department of Medicine, Institut Roussy, Villejuif, France.
authors.forename: Aurore
authors.initials: A
authors.lastname: Blesius
authors.forename: Philippe A
authors.initials: PA
authors.lastname: Cassier
authors.forename: François
authors.initials: F
authors.lastname: Bertucci
authors.forename: Jerome
authors.initials: J
authors.lastname: Fayette
authors.forename: Isabelle
authors.initials: I
authors.lastname: Ray-Coquard
authors.forename: Binh
authors.initials: B
authors.lastname: Bui
authors.forename: Antoine
authors.initials: A
authors.lastname: Adenis
authors.forename: Maria
authors.initials: M
authors.lastname: Rios
authors.forename: Didier
authors.initials: D
authors.lastname: Cupissol
authors.forename: David
authors.initials: D
authors.lastname: Pérol
authors.forename: Jean-Yves
authors.initials: JY
authors.lastname: Blay
authors.forename: Axel
authors.initials: A
authors.lastname: Le Cesne
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D001549:Benzamides; D017326:Clinical Trials, Phase III as Topic; D003131:Combined Modality Therapy; D018450:Disease Progression; D005260:Female; D005500:Follow-Up Studies; D046152:Gastrointestinal Stromal Tumors / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery; D006801:Humans; D000068877:Imatinib Mesylate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate