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I. Ray-Coquard, N. Bin Bui, A. Adenis, M. Rios, F. Bertucci, S. Chabaud, D. Pérol,

Risk of relapse with imatinib (IM) at 5 years in advanced GIST patients: Results of the prospective BFR14 randomized phase III study comparing interruption versus continuation of IM at 5 years of treatment: A French Sarcoma Group study. I. Ray-Coquard, N. Bin Bui, A. Adenis, M. Rios,

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I. Ray-Coquard, N. Bin Bui, A. Adenis, M. Rios, F. Bertucci, S. Chabaud, D. Pérol,

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  1. Risk of relapse with imatinib (IM) at 5 years in advanced GIST patients: Results of the prospective BFR14 randomized phase III study comparing interruption versus continuation of IM at 5 years of treatment: A French Sarcoma Group study. I. Ray-Coquard, N. Bin Bui, A. Adenis, M. Rios, F. Bertucci, S. Chabaud, D. Pérol, J. Y. Blay, A. Le Cesne for the French Sarcoma Group

  2. STUDY DESIGN

  3. Objectives Main endpoint Progression-free survival (PFS) Secondary endpoints Overall survival (OS) Response to imatinib re-start in the STOP arm Time to secondary resistance (TSR) in both arms

  4. Summary of study steps • 1 year randomization From May 03 to March 04, 58 patients were randomized (32 in the STOP group). STOP group: 1-year PFS: 31% [CI95% , 16-47] CONT group: 1-year PFS: 85% [CI95%, 64-94] • 3 years randomization From June 05 to May 07, 50 patients were randomized (25 in the STOP group). STOP group : 1-years PFS : 32% [CI95% ; 15-50] CONT group : 1-years PFS : 92% [CI95% ; 72-98] • May 2007: amendment to address similar question after 5 years of imatinib treatment.

  5. 5 years randomization, statistical methods Since, Nov 07, 24 patients have been randomized (13 in the STOP group). Statistical consideration:in order to stop the study earlier ASAP in case of excess of relapses in the Stop arm : a Bayesian approach (study endpoint every 3 months) Bayesian Principle: Progression rate considered as a random parameter. Distribution updated at each analysis conditionally to previous data Probability of progression rate > in the STOP arm vs. CONT arm is estimated. If Prob (STOP > CONT) > 0.95: progression rate in STOP group is considered as statistically higher than in the CONT group. Adamina, M., G. Tomlinson, and U. Guller. "Bayesian statistics in oncology: a guide for the clinical investigator"; Cancer 115.23 (2009): 5371-81. Berry, D. A. "Bayesian clinical trials"; Nat.Rev.Drug Discov. 5.1 (2006): 27-36.

  6. Results (1)

  7. Results (2) • Density probability function • Date • Feb 2009: • STOP group: 1 prog / 6 • CONT group: 0 prog / 4 • Prob (STOP > CONT): p = 0.641 • Aug 2009: • STOP group: 3 prog / 10 • CONT group: 0 prog / 8 • Prob (STOP > CONT): p = 0.887 • May 2010: • STOP group: 7 prog / 11 • CONT group: 0 prog / 10 • Prob (STOP > CONT): p = 0.987

  8. Results (3) Median follow-up : 11.9 months STOP group : median PFS : 12.6 months (CI95% = 8.6;21.8) CONT group : median not reached Log-rank test: p value = 0.0317

  9. Conclusions • Imatinib stop at 5 yrs resulted in a higher rate of progression than imatinib maintenance in patients with advanced GIST in response or stabilized with imatinib. • Imatinib has to be given continuously until PD or intolerance in the population of non progressing advanced or metastatic GIST.

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