708P - Real-life management of advanced gastrointestinal stromal tumors (GIST) treated with imatinib in France

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
GIST
Presenter Olivier Bouché
Authors O. Bouché1, A. Le Cesne2, M. Rios3, L. Chaigneau4, B. Bui5, P. Xavier6, J. Blay7
  • 1Hopital Robert Debré, Reims/FR
  • 2Institut Gustave Roussy, 94805 - VILLEJUIF/FR
  • 3Oncologie, Centre Alexis Vautrin, Vandoeuvre-lès-Nancy/FR
  • 4Oncologie, Hopital Jean Minjoz, Besancon/FR
  • 5Oncology, Institute Bergoni, FR-33076 - Bordeaux CEDEX/FR
  • 6Oncology, Novartis, 92505 - Rueil Malmaison/FR
  • 7University Claude Bernard Lyon I, Centre L, 69373 - Lyon cedex /FR

Abstract

Introduction

GISTs are rare tumors of the gastrointestinal tract. Imatinib has been approved for the treatment of Kit+ unresectable or metastatic GIST since 2002. However, information is lacking in the real-life, non-trial setting on the efficacy, use, and safety of imatinib, and the quality of life of imatinib-treated patients. The EPIGIST study was set up in 2006 in France to obtain this information.

Method

EPIGIST is a multicenter, observational, longitudinal follow-up cohort study conducted in France on patients diagnosed with a Kit + unresectable or metastatic GIST, treated with imatinib for the first time, between its market introduction and 2011. Sites were selected at random from a national file of oncologists, gastroenterology surgeons, and gastroenterologists. The intended follow-up period was 3 years. A clinical case report form was completed at enrollment and at each visit.

Results

31 sites enrolled at least one patient. A total of 164 patients were enrolled, 151 were analyzed. Median age at diagnosis was 60 years (range: 21–86 years), sex ratio was predominantly male (58%). The commonest locations of the primary GIST at diagnosis were stomach (46%) and small intestine (37%). 85 (56%) analyzed patients had localized disease at diagnosis, and 42 (49%) were at high risk of relapse according to Miettinen's classification; 60 (70%) had developed metastatic disease by the time imatinib therapy was instituted (median 13 months after diagnosis; range 0–135 months). The starting dose of imatinib for 148 (98%) patients was 400 mg/day. The estimated 4-year overall survival was 60.7% (95% CI: [51.4%; 68.8%]), with a median follow-up of 4 years. Adverse events disorders were gastrointestinal (70%), general disorders and administration site conditions (70%), eye (38%), musculoskeletal and connective tissue (35%), and skin and subcutaneous tissue (34%).

Conclusion

The EPIGIST observational study confirms that the results of the clinical studies are maintained in the real-life setting. The indications for imatinib have been recently extended to include the adjuvant treatment of patients at significant risk of relapse following resection of Kit+ GIST. This population is not described in this study.

Disclosure

O. Bouché: Consulting fees from Novartis and Pfizer.

A. Le Cesne: Honorary Grants from Novartis, Pfizer, Pharmamar.

P. Xavier: Employment full time Novartis.

J. Blay: Research grants: Novartis, Roche, GSK, Pfizer, Pharmamar Consulting fees: Novartis, Roche, GSK, Pfizer, Pharmamar.

All other authors have declared no conflicts of interest.