Selecting Therapy in CLL
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A presentation on selecting first line therapy in CLL and how that influences subsequent therapy selection.
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Selecting Therapy in CLL
- 1. CLL: Past, Present, and Future Jeff Sharman M.D. Medical Director Hematology Research US Oncology http://cll-nhl.com
- 2. CLL: Management in a TKI World • • • • • Historical perspectives FCR – The rise and fall Choosing first line therapy in 2014 Management of relapsed disease Ibrutinib considerations
- 3. CLL: Management in a TKI World • • • • • Historical perspectives FCR – The rise and fall Choosing first line therapy in 2014 Management of relapsed disease Ibrutinib considerations
- 4. Chlorambucil
- 5. Fludarabine
- 8. Improved Outcomes with FCR (2008)
- 9. German CLL8 – FC vs FCR (2003)
- 11. MDA Long Term Follow Up
- 13. So what is the problem?
- 14. FCR not so popular….
- 15. Patterns of Care (FCR in Front Line) • Age < 65 = 45% FCR • Age 65-75 = 32% FCR • Age > 75 = 20% FCR
- 16. Clinical trials versus real life • MDA FCR Median Age – 57 years old • German CLL8 (FC vs FCR) – 61 years old • Real life – Age 71 at diagnosis – Age 74 at first treatment
- 17. Age Matters • Decreased Renal Function – Clears fludarabine • Decreased Marrow Reserves – Prolonged cytopenias – MDS / AML • Infectious Complications – Really nasty gross stuff
- 18. MDA Long Term follow up
- 19. Death within 12 months of first line therapy • MDA = 1% • German CLL8/10 study = 3-4% • Registry Studies = 10%
- 20. Case Study • 72 year old retired lumber yard worker – Lymphocytosis c/w CLL stage I, but over 2 years progressive adenopathy and hemoglobin down to 10 – Deletion 13q but unmutated IgVH • Entered onto FCR vs PCR study – Stopped FCR after cycle 3 due to myelotoxicity – Has maintained remission for six years • Multiple treatment complications – Pulmonary aspergillosis – Received > 50 units PRBC’s over next two years – Now has MDS
- 21. Where will FCR fit in the next five years? ”We’re going to get rid of FCR”
- 23. German CLL10 Study FCR versus BR CIRS < 7, Creatinine Clearance > 70, no 17P deletion FCR BR ORR 97.8% 97.8% CR 47% 38% MRD Negative 71% 66% 2 Year PFS 85% 78%
- 24. German CLL10 Study FCR versus BR CIRS < 7, Creatinine Clearance > 70, no 17P deletion FCR BR G3/4 Neutropenia 82% 56% G3/4 Infection 47% 26% Induction Death 4% 2% Complete 6 cycles 70% 80%
- 25. CLL10 Summary • FCR works a little better, but considerably more toxic than BR • No clear winner as gains in response offset by increased toxicity
- 26. What about the elderly?
- 27. Complement 1 Chlorambucil +/- Ofatumumab Chlorambucil Clb-Ofatumumab PFS (mo) 13 22 ORR 69% 82% CR 1% 12% MRD 4% 12%
- 29. CLL: Management in a TKI World • • • • • Historical perspectives FCR – The rise and fall Choosing first line therapy in 2014 Management of relapsed disease Ibrutinib considerations
- 30. Choosing first line therapy in 2014 FCR BR Age & Comorbidity Obi
- 31. CLL: Management in a TKI World • • • • • Historical perspectives FCR – The rise and fall Choosing first line therapy in 2014 Management of relapsed disease Ibrutinib considerations
- 34. What is “one prior therapy?”
- 35. MRD in CLL8 Study Post 3 cycles End of Treatment
- 36. MRD: Depth = Duration
- 38. CLL: Beyond FISH
- 40. CLL – Evolution in Real Time A: Pre-Chlorambucil B: Pre FCR C: Post FCR D: Pre Ofatumumab E: Post Ofatumumab
- 41. CLL: Management in a TKI World • • • • • Historical perspectives FCR – The rise and fall Choosing first line therapy in 2014 Management of relapsed disease Ibrutinib considerations
- 42. Clinical Challenges • Initial lymphocytosis • Interruptions (surgery / other) • Adherence • Copayments • Adventures in medical decision making • Progressions
- 43. Clinical Challenges • Initial lymphocytosis • Interruptions (surgery / other) • Adherence • Copayments • Adventures in medical decision making • Progressions
- 44. Compartment Effect: Decreased Nodes with Lymphocytosis
- 46. Clinical Challenges • Initial lymphocytosis • Interruptions (surgery / other) • Adherence • Copayments • Adventures in medical decision making • Progressions
- 48. Long Term Drug Problems?
- 49. Clinical Challenges • Initial lymphocytosis • Interruptions (surgery / other) • Adherence • Copayments • Adventures in medical decision making • Progressions
- 50. Clinical Challenges • Initial lymphocytosis • Interruptions (surgery / other) • Adherence • Copayments • Adventures in medical decision making • Progressions