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Monitoring CML Treatment: Addressing the Issues for the Community Hematologist/Oncologist

Monitoring CML Treatment: Addressing the Issues for the Community Hematologist/Oncologist . Hagop M. Kantarjian, MD Chairman; Professor, Department of Leukemia University of Texas, MD Anderson Cancer Center Houston, Texas Jorge E. Cortes, MD Chair, CML Section, Division of Cancer Medicine

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Monitoring CML Treatment: Addressing the Issues for the Community Hematologist/Oncologist

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  1. Monitoring CML Treatment: Addressing the Issues for the Community Hematologist/Oncologist Hagop M. Kantarjian, MD Chairman; Professor, Department of Leukemia University of Texas, MD Anderson Cancer Center Houston, Texas Jorge E. Cortes, MD Chair, CML Section, Division of Cancer Medicine University of Texas, Department of Leukemia, MD Anderson Cancer Center Houston, Texas Ronjay Rakkhit, MD Oncology Consultants Houston, Texas William S. Velasquez, MD Allopathic & Osteopathic Physicians Internal Medicine Hematology & Oncology Houston, Texas

  2. CML: Epidemiology • It accounts for 0.34% of all cancers, 3.6% of hematologic malignancies, and 0.08% of all cancer mortality.[a] • 5050 new cases were estimated in the United States in 2009, and 470 people with CML were estimated to die in the same time period.[a] • From 2003 to 2007, age-adjusted incidence rates of the disease were 2.0 per 100,000 men and 1.1 per 100,000 women.[b] a. Jemal A, et al. CA Cancer J Clin. 2009;59:225-249. b. NCI/SEER. Available at: http://seer.cancer.gov/statfacts/html/cmyl.html

  3. CML: Pathophysiology • Myeloproliferative disorder of the primitive hematopoietic stem cell[a] • Arises from a translocation t(9;22)(q34;q11), known as the Philadelphia chromosome[a] • Resulting bcr-abl1 fusion gene codes for a constitutively active tyrosine kinase[a,b] a. Kantarjian H, et al. Blood. 1993;82:691-703. b. Quintás-Cardama A, Cortés JE. Blood. 2009;113:1619-1630.

  4. CML: Advent of Imatinib • Most cases are diagnosed in the chronic phase (CP).[a] • Before the advent of imatinib therapy, the median survival was approximately 3-4 years.[b] • The advent of imatinib changed the natural history of CML.[c] a. Faderl S, et al. N Engl J Med. 1999;341:164-172. b. Kantarjian H, et al. Cancer. 2008;113(suppl):1933-1952. c. Weisberg E, et al. Nat Rev Cancer. 2007;7:345-356.

  5. CML: FDA-Approved Second-line TKIs Weisberg E, et al. Nat Rev Cancer. 2007;7:345-356.

  6. CML: IRIS Trial 5- and 8-Year Follow-up[a] • At 8 years, estimated overall survival was 85%, and 93% when only CML-related deaths were considered.[b] a. Druker BJ, et al. N Engl J Med. 2003;355:2408-2417. b. Deininger M, et al. ASH 2009. Abstract 1126.

  7. Bone Marrow Analysis in the Community Setting Appropriate in Patients With Suspected CML at Diagnosis?

  8. Bone Marrow Analysis in the Community Setting Appropriate and Important in Patients With Suspected CML at Diagnosis May Provide Information About Additional Chromosomal Abnormalities and Number of Blasts

  9. Patients With Newly Diagnosed CML-CP Nilotinib vs Imatinib: Phase 3 ENESTnd Trial • Rate of progression to AP/BC CML • Nilotinib 300 mg BID: 0.7% (P = .006 vs imatinib) • Nilotinib 400 mg BID: 0.4% (P = .003 vs imatinib) • Imatinib 400 mg QD: 4.2% *P < .0001 vs imatinib†P < .001 vs imatinib Larson RA, et al. ASCO 2010. Abstract 6501.

  10. Patients With Newly Diagnosed CML-CP Dasatinib vs Imatinib: Phase 3 DASISION Trial Kantarjian H, et al. ASCO 2010. LBA6500.

  11. Optimal Monitoring in the Community Practice Which Method, When, and How Often?

  12. Frequent Monitoring Importance and Rationale • Identify patient with suboptimal response early • Do not wait until the patient loses hematologic response • Intervene early • Optimize dose • Change therapy • Increase probability of good response and long-term favorable outcome Patients With Cytogenetic Relapse Typically Respond Better to Second-Generation TKIs Than Patients With Hematologic Relapse.

  13. Imatinib Failure Operational Criteria CCA = clonal chromosome abnormalities Baccarani M, et al. J Clin Oncol. 2009;27:6041-6051.

  14. Patient in CCyR With Rising Q-PCR Intervene or Just Monitor and Continue With The Same Treatment?

  15. Patient in CCyR With Rising Q-PCR Value of Any Intervention Is Unknown; Keep Monitoring

  16. Compliance Major Effect on Response Marin D, et al. J Clin Oncol. 2010;28:2381-2388.

  17. Patient in CCyR With Rising Q-PCR If Dose Is Reduced Earlier, Try Optimizing Dose

  18. Monitoring CML Proposed Approach Kantrajian H, et al. Blood. 2008;111:1774-1780.

  19. Role of Allogeneic Transplant Today Second-, Third-, or Occasionally First-line Therapy?

  20. Role of Allogeneic Transplant Today Rarely a First-line Therapy Even in Patients in Accelerated or Blastic Phase or Those Who Failed to Respond to Imatinib (Except in Patients With T315I Mutation)

  21. Patients With T315I Mutation Emerging Therapies • Omacetaxine (homoharringtonine) • AP24534 • DCC230326

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