Imatinib failure-free survival (IFS) in patients with localized gastrointestinal stromal tumors (GIST) treated with adjuvant imatinib (IM): The EORTC/AGITG/FSG/GEIS/ISG randomized controlled phase III trial.

• DOI: 10.1200/jco.2013.31.15_suppl.10500
• Publication Date: 2020-03-11T15:44:51Z
• Authors: Paolo Giovanni Ca...; Axel Le Cesne; Andres Poveda Vel...; Dusan Kotasek; Piotr Rutkowski; Peter Hohenberger; Elena Fumagalli; Ian Robert Judson; Antoine Italiano; Javier Martin Broto; Alessandro Gronchi; Angelo Paolo Dei Tos; Sandrine Marreaud; Winette T.A. Van ...; John Raymond Zalc...; Saskia Litière; Jean-Yves Blay
• Keywords: Clinical endpoint; Interim analysis; CD117

10500 Background: In 2004 we launched an open-label randomized trial with adjuvant IM for 2 yrs in localized, surgically resected, high/intermediate-risk GIST. Methods: Pts were between of IM, 400 mg daily, and no further therapy after surgery. The primary end-point was OS, while RFS, RFI toxicity secondary end-points. Main eligibility criteria were: age >18 yrs, PS 0-2, localized CD117-positive GIST, intermediate or high risk according to the 2002 Consensus classification, R0 R1 surgical margins, previous medical therapy. stratified by risk, tumor site margins. An accrual pts planned, then escalated 900. Given prognostic improvement advanced GIST pts, 2009 study IDMC authorized change into IFS, whose failure defined as time when a different tyrosine kinase inhibitor (TKI) is started. We report on planned interim analysis carried out 115 events new end-point, significance level 1.5%. Hazard ratios (HR) p-values adjusted stratification factors. Results: 908 2005 2008, 454 observation arm; 835 eligible. 17% treated stopped early due refusal. With median follow-up 4.7 5-yr IFS 87% IM-arm vs 84% control arm (HR=0.80, 98.5% CI [0.51; 1.26], p=0.23); RFS 66% at 3 69% 63% 5 (p<0.001); OS 100% 99%. Among 528 high-risk local pathology, 79% 73% (p=0.11), 77% (p=0.44) amongst 336 centrally reviewed pathology. Conclusions: This confirms that has overt impact short-term freedom from relapse. subgroup, non-statistically significant trend favor observed terms IFS. setting, i.e. survival free any first employed TKI, designed incorporate resistance, currently main factor adversely affecting prognosis pts. Clinical information: NCT00103168.