Time to secondary resistance (TSR) after interruption of imatinib (IM) in advanced GIST: Updated results of the prospective French Sarcoma Group randomized phase III trial on long-term survival.

Abstract

10015 Background: We previously demonstrated that interruption of IM treatment after 1, 3, and 5 yrs in responding patients (pts) with advanced GIST are associated with rapid relapse. The impact of IM interruption on secondary resistance and overall survival (OS) with longer-term follow-up was unclear. METHODS This prospective multicenter BFR14 study was initiated in June 2002 and closed for accrual in July 2009. Pts with GIST free of progression after 1, 3 or 5 yrs of IM 400 mg/day were randomly assigned to continue (C arm) or interrupt (I arm) IM. Reintroduction of IM (same dose) upon progression was allowed for pts in the I group. Primary endpoint was Progression Free Survival (PFS). Secondary endpoints included OS and time to secondary resistance (TSR) defined as time to progression under IM treatment (i.e. first progression in the C arm and progression after reintroduction of IM in the I arm). RESULTS As of January 2011, 434 pts were included in this trial. Fifty-eight, 50 and 27 non progressive pts at 1, 3 and 5 yrs were randomized and median follow-up from randomization were 74, 47 and 18 months, respectively. Results are summarized in the table. PFS was significantly lower in the I arms than in C arms. IM reintroduction allowed tumor control in 94% (49/52) of pts. The rates of pts with relapse at 2 yrs post-randomisation decreases with the duration of treatment: 38%, 20% and 0% of pts randomised after 1, 3 and 5 yrs of IM treatment in the C arm. No difference for TSR or OS is observed between the 2 arms. CONCLUSIONS Reintroduction of IM allowed tumor control in almost all pts. IM interruption had no impact on TSR The rate of secondary resistance decreases with longer duration of IM treatment. [Table: see text].

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@article{Cesne2011TimeTS, title={Time to secondary resistance (TSR) after interruption of imatinib (IM) in advanced GIST: Updated results of the prospective French Sarcoma Group randomized phase III trial on long-term survival.}, author={Axel le Cesne and Isabel Ray-Coquard and Binh Bui Nguyen and Antoine A. Adenis and M. A. Jimenez Rios and François Bertucci and Florence Duffaud and Didier Cupissol and Christine Chevreau and Emmanuelle Bompas and Angela Cioffi and Sylvie Chabaud and David P{\'e}rol and Jean-Yves Blay}, journal={Journal of clinical oncology : official journal of the American Society of Clinical Oncology}, year={2011}, volume={29 15_suppl}, pages={10015} }