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Authors: Joensuu H et al. Reviewed By: Dr. Vincent Tam Abstract: ASCO 2011 Abstract 1 Date posted: June 2011

Twelve versus 36 months of adjuvant imatinib as treatment of operable GIST with a high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO). Authors: Joensuu H et al. Reviewed By: Dr. Vincent Tam Abstract: ASCO 2011 Abstract 1 Date posted: June 2011.

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Authors: Joensuu H et al. Reviewed By: Dr. Vincent Tam Abstract: ASCO 2011 Abstract 1 Date posted: June 2011

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  1. Twelve versus 36 months of adjuvant imatinib as treatment of operable GIST with a high risk of recurrence: Final results of a randomized trial (SSGXVIII/AIO) Authors: Joensuu H et al. Reviewed By: Dr. Vincent Tam Abstract: ASCO 2011 Abstract 1 Date posted: June 2011

  2. Thank you for downloading this update. Please feel free to use it for educational purposes. Please acknowledge OncologyEducation.ca and Dr. Vincent Tam when using these slides.

  3. Study Design N= 400 (1:1 randomization) Stratification: 1) R0 resection, no tumor rupture 2) R1 resection, tumor rupture Primary Outcome: RFS Treatment A: IMATINIB 400mg daily x 12 months R Treatment B: IMATINIB 400mg daily x 36 months

  4. INCLUSION CRITERIA • Histologically confirmed GIST, KIT-positive • High risk of recurrence according to the Modified Consensus Criteria: • Tumor diameter > 10cm or • Tumor mitosis count >10/50 HPF or • Size >5cm and mitosis count >5/50 HPF or • Tumor rupture spontaneously or at surgery

  5. RESULTS* * Intention-to-treat analysis

  6. TOXICITY

  7. STUDY COMMENTARY • Well designed adjuvant study which demonstrated a statistically significant increase in RFS and OS with 36 months of imatinib • Higher rate of discontinuing imatinib prior to complete course in 36 month arm due to adverse events, but also due to “other reasons” possibly related to patients not willing to take a drug for years without any evidence of disease • Is there additional benefit of continuing imabinib beyond 36 months, perhaps indefinitely?

  8. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • The standard of care for adjuvant treatment of GIST at high risk of recurrence is now 3 years of imatinib

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