MALIGNANT GASTROINTESTINAL STROMAL TUMORS TREATED WITH IMATINIB IN FRANCE- EFFICACY IN REAL LIFE
Author(s)
Blay JY1, Bouché O2, Cucherat M3, Goldberg M4, Grosclaude P5, Sambuc R6, Bisot-Locard S7, Deschaseaux C7, Sailly J81Centre Léon Bérard, Lyon, France, 2Robert Debré Hospital, Reims, France, 3Laennec University, Lyon, France, 4INSERM, Villejuif, France, 5Tarn Cancer registry, Albi, France, 6University of Aix-Marseille II, Faculty of Medicine, Marseille, France, 7Novartis Pharma, Rueil malmaison, France, 8CRESGE, Wattignies, France
OBJECTIVES: GISTs are rare tumors of the GI tract. In France, their incidence is estimated to be 9-12/106 inhabitants/year. Imatinib has been approved to treat unresectable and/or metastatic Kit-positive GISTs since 2002, but information on routine use, safety and efficacy in unselected “real life” setting is lacking. An observational cohort (EPIGIST) in France was designed to provide data on survival, safety and treatment patterns and quality of life. METHODS: EPIGIST is a nationwide multi-center, observational study on GIST patients treated with Imatinib between the availability on the French Market and the end of the 2008. Centers were randomly selected in national files of oncologists, gastrointestinal surgeons and specialists. The planned follow-up duration was three years. A case report form had to be completed at inclusion and during each follow-up visits. Quality of life was assessed using QLQ-C30 and SF36 questionnaires. RESULTS: Thirty on 51 selected centers enrolled at least one patient and 139 patients were included (as of June 2009). The median age of disease onset was 58 years (range 21 – 86). 42% were metastatic at diagnosis. Primary tumors were most often stomach (48%), or bowel (34%). At diagnosis 86% of patients had a tumor size over 5 cm. 68% of patients had surgery of the primary tumor before starting Imatinib. 68% of patients were considered as high risk of relapse according the Miettinen classification. For 99% of the patients, Imatinib was given at an initial dosage of 400 mg, 1% at 300 mg. Compliance was superior to 90% for 99% of patients. With a median follow-up of 2.1 years, two-years overall survival from first treatment with Imatinib was 83.9% (CI95%: [74.5%-90.1%]). CONCLUSIONS: EPIGIST is still an ongoing survey. Current results confirm previous published data on survival in GIST treated with Imatinib in an unselected cohort of patients outside of a clinical trial.
Conference/Value in Health Info
2009-10, ISPOR Europe 2009, Paris, France
Value in Health, Vol. 12, No. 7 (October 2009)
Code
PCN10
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Oncology