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What is the Optimal A pproach to CLL, BR vs. FCR/FR?

What is the Optimal A pproach to CLL, BR vs. FCR/FR?. Michael J. Keating MD Anderson Cancer Center Presented by: Richard R. Furman Weill Cornell Medical College. Bendamustine Bifunctional Antineoplastic Agent. CH 3. N. ClH 2 C. N. N. CO 2 H. Purine-like Benzimidazole Ring. ClH 2 C.

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What is the Optimal A pproach to CLL, BR vs. FCR/FR?

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  1. What is the Optimal Approach to CLL, BR vs. FCR/FR? Michael J. Keating MD Anderson Cancer Center Presented by: Richard R. Furman Weill Cornell Medical College

  2. BendamustineBifunctional Antineoplastic Agent CH3 N ClH2C N N CO2H Purine-like Benzimidazole Ring ClH2C Alkylating Group Available in Germany, 1971-1992 Unique in vitro anti-tumor profile Rummel M, J Clin Oncol. 2005;23:3383.

  3. Fludarabine + Prednisone (1983 – 1993)Progression Free Survival Median PFS: 26 months Proportion

  4. Long Term Outcomes for FR:CALGB 9712 Survival Months

  5. Chlorambucilvs. Bendamustine in Untreated CLL: Progression-Free Survival Knauf WU. JCO. 2009; 27:4378

  6. GCLLSG CLL2M:BR in Untreated CLL Treatment: • Bendamustine 90 mg/m2 days 1,2 (cycles 1-6) • Rituximab: 375 mg/m2 (cycle 1) 500 mg/m2 (cycles 2-6) Study Characteristics: • 117 patients • No age limit (median=64; range 34-78) • 73.5% received all 6 cycles Fischer K. JCO 2012; 30:3209.

  7. CLL2M: BR in Untreated CLL: Event Free Survival median EFS = 33.9 months Fischer K. JCO 2012; 30:3209.

  8. CLL2M: BR in Untreated CLL: Response Rates Fischer K. JCO 2012; 30:3209.

  9. BR: Adverse Events, Grades 3+4 (pts)

  10. Phase III Trial of FC + / - Rituximab in Untreated CLL: GCLLSG CLL8 Trial Fludarabine 25 mg/m2, d1-3 Cyclophosphamide 250 mg/m2, d1-3 RANDOMI ZE F O L L O W U P • Untreated • No age restriction • Active CLL requiring therapy x 6 cycles Fludarabine 25 mg/m2, d1-3 Cyclophosphamide 250 mg/m2, d1-3 Rituximab 500 mg/m2, d1 (375 mg/m2 initial dose) (n = 817) • Primary endpoint: PFS • No age limit • 74% of patients received all 6 courses of FCR Hallek M. Lancet 2010; 376:1164

  11. FCR vs. FC in Untreated CLL:GCLLSG CLL8 Trial Hallek M. Lancet 2010; 376:1164

  12. GCLLSG CLL8: FCR vs. FCProgression Free Survival Median PFS: FCR 57 months FC33 months Median follow-up: 5.9 years 1.0 0.8 0.6 Cumulative Survival 0.4 0.2 0.0 Fischer K. ASH 2012.

  13. CLL8: Adverse Events (pts) Hallek M. Lancet 2010; 376:1164

  14. Response Comparison

  15. AE Comparison

  16. Patient Comparison

  17. Patient Comparison

  18. FCR300:First-line Outcomes Department of Leukemia UT MD Anderson Cancer Center Houston, TX

  19. Response to FCR(NCI-WG: 300 Patients)

  20. FCR300: PFS and OS P<.0001 Proportion Surviving PFS OS Months

  21. FCR300: PFS by IGHV Mutation Status Group Events Total IGHV-M 33 82 IGHV-UM 114 131 Unknown 39 87 Proportion Progression-free P<.0001 Months

  22. FCR vs. BR: The Tally

  23. CLL10 GCLLSG:Randomized Trial of FCR vs. BRASH 2013? fludarabine 25 mg/m2d1-3cyclophosphamide 250 mg/m2d1-3 rituximab 375 mg/m2C1, d1 500 mg/m2C2-6, d1 Primary Endpoint: PFS @ 2 yr Untreated CLL (N = 564) Randomize bendamustine 90 mg/m2d1,2 rituximab 375 mg/m2 C1, d1 500 mg/m2 C2-6, d1

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