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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
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•
•
•
•
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
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
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”
22.
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
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
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
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