Interruption of imatinib (IM) in GIST patients with advanced disease: Updated results of the prospective French Sarcoma Group randomized phase III trial on survival and quality of life

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Abstract
9031 Background: IM (Gleevec/Glivec; Novartis Pharma) the first-line treatment (Tx) for advanced GIST, must be given continuously until disease progression (PD) or intolerance (Blay et al, ASCO 2004). The impact on overall survival (OS) of IM discontinuation in responding patients (pts) and its reintroduction at progression is unknown. Methods: This prospective multicenter BFR14 study was initiated in June 2002. After 1 year of IM 400mg/day, 58 pts free from progression were randomly offered to continue or interrupt Tx until PD. Pts allocated to the interruption (I) arm could restart IM (same dose) in case of PD. Primary endpoint was progression-free survival (PFS); secondary endpoints were OS, quality of life (QoL), secondary response after IM re-introduction, identification of molecular determinants of response. Survival data were compared using the log-rank test. Results: Patient characteristics were well balanced between the two arms. Current median follow-up after randomization is 21 months (range 12–29). 21/32 pts (66%) in arm I versus 4/26 pts (15%) in continuous (C) arm experienced PD. IM interruption was significantly associated with reduced PFS (P-4) with a median of 6 months (95% CI, 3–9) for arm I. IM reintroduction allowed tumor control (OR or SD) in 11/14 evaluated pts (79%). One-year OS rates were 89% and 87% for arms I and C, respectively (P = 0.46), with no significant difference in QoL. Conclusions: A statistically significant increase in the rate of PD was observed when IM was interrupted (experimental arm). IM re-introduction was safe and allows further tumor control in the majority of the randomized pts. At the time of the present analysis, no impact of IM discontinuation on OS could be detected. Updated results including mutational analysis will be presented at the meeting. No significant financial relationships to disclose.

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