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Joensuu H, Eriksson M, Sundby Hall K, et al. JAMA. 2012;307(12):1265–1272

One vs Three Years of Adjuvant Imatinib for Operable Gastrointestinal Stromal Tumor A Randomized Trial. Joensuu H, Eriksson M, Sundby Hall K, et al. JAMA. 2012;307(12):1265–1272. SSGXVIII/AIO: Design. An open-label Phase III study. N=400. Imatinib for 12 months. Follow-up. Random

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Joensuu H, Eriksson M, Sundby Hall K, et al. JAMA. 2012;307(12):1265–1272

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  1. One vs Three Years of Adjuvant Imatinib for Operable Gastrointestinal Stromal TumorA Randomized Trial Joensuu H, Eriksson M, Sundby Hall K, et al. JAMA. 2012;307(12):1265–1272

  2. SSGXVIII/AIO: Design An open-label Phase III study N=400 Imatinib for 12 months Follow-up Random Assignment 1:1 Imatinib for 36 months Follow-up Stratification: 1) R0 resection, no tumor rupture 2) R1 resection or tumor rupture Joensuu H et al. JAMA 2012;307(12):1265–1272

  3. SSGXVIII/AIO: Methods Endpoints1 Treatment1 Imatinib • 400 mg/d (12 vs 36 months) Primary • RFS Secondary • Treatment safety • OS • GIST-specific survival Key inclusion criteria1 • Histologically confirmed GIST, KIT-positive • High risk of recurrence according to the modified consensus criteria2,3 • Tumor size >10 cm or • Tumor mitosis count >10/50 HPF or • Size >5 cm and mitosis count >5/50 HPF or • Tumor rupture before surgery or at surgery • HPF, high-power field of the microscope. • Joensuu H et al. JAMA 2012;307(12):1265–1272 • Fletcher CD et al. Hum Pathol 2002;33:459–465 • Joensuu H. Hum Pathol2008;39:1411−1419.

  4. SSGXVIII/AIO: Patient Disposition *Three patients who withdrew consent were excluded Joensuu H et al. JAMA 2012;307(12):1265–1272

  5. SSGXVIII/AIO: Baseline Characteristics (ITT Population) *Per 50 high power fields **Available for 366 (92%) out of the 397 tumors Joensuu H et al. JAMA 2012;307(12):1265–1272

  6. SSGXVIII/AIO: Baseline Characteristics (ITT Population) Joensuu H et al. JAMA 2012;307(12):1265–1272

  7. SSGXVIII/AIO: RFS Events and Deaths (ITT Population) Median follow-up time: 54 months (from the date of randomization to the date of data cut-off, Dec 31, 2010) Joensuu H et al. JAMA 2012;307(12):1265–1272

  8. SSGXVIII/AIO: Recurrence-Free Survival (ITT Population) 36 Months of imatinib 3-year survival : 36 months, 86.6% 12 months, 60.1% 5-year survival : 36 months, 65.6% 12 months, 47.9% Percentage 12 Months of imatinib HR, 0.46 (95% CI, 0.32-0.65) Log-rank P<.001 Time Since Randomisation, y No. of patients Joensuu H et al. JAMA 2012;307(12):1265–1272

  9. SSGXVIII/AIO: RFS in Efficacy Population 36 Months of imatinib 3-year survival : 36 months, 88.1% 12 months, 62.1% 5-year survival : 36 months, 67.4% 12 months, 50.3% Percentage 12 Months of imatinib HR, 0.46 (95% CI, 0.31-0.68) Log-rank P<.001 Time Since Randomisation, y No. of patients Excluded: consent withdrawn, no GIST at pathology review, or overt metastases at study entry Joensuu H et al. JAMA 2012;307(12):1265–1272

  10. SSGXVIII/AIO: RFS in Subgroups Favors 36 mo of Imatinib Favors 12 mo of Imatinib 0.1 10 1.0 Joensuu H et al. JAMA 2012;307(12):1265–1272 HR (95% CI)

  11. SSGXVIII/AIO: Overall Survival (ITT Population) 36 Months of imatinib 12 Months of imatinib 3-year survival : 36 months, 96.3% 12 months, 94.0% 5-year survival : 36 months, 92.0% 12 months, 81.7% Percentage HR, 0.45 (95% CI, 0.22-0.89) Log-rank P = .02 Time Since Randomisation, y No. of patients Joensuu H et al. JAMA 2012;307(12):1265–1272

  12. SSGXVIII/AIO: Treatment Safety • Cardiac AEs and second malignancies were low and comparable in both treatment arms Joensuu H et al. JAMA 2012;307(12):1265–1272

  13. SSGXVIII/AIO: Conclusions • Compared with 1 year of treatment, 3 years of adjuvant imatinib significantly improves RFS and OS for patients with GIST who are at a high risk of recurrence after surgery • Adjuvant imatinib is relatively well tolerated; severe adverse events are infrequent • This trial has established 3 years of 400 mg imatinib as the new standard of care for adjuvant treatment of patients with high-risk GIST • Both the US Food and Drug Administration and European commission approved label updates that include 3-year duration for adjuvant treatment of KIT+ GIST patients • The National Comprehensive Cancer Network updated recommendations to include 3 years of adjuvant imatinib therapy as the new standard of care for KIT+ GIST patients Joensuu H et al. JAMA 2012;307(12):1265–1272

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