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  1. CML in China Qian Jiang, MD Peking University People's Hospital, Peking University Institute of Hematology 2013-2-22

  2. CML in China 江倩 北京大学人民医院 北京大学血液病研究所 2013-2-22

  3. Outline • Current status of CML in China • TKI treatment for CML patients: experience from single center • Transplant in the TKI era: experience from single center • Therapeutic choices for CML patients based on financial constraints

  4. Outline • Current status of CML in China • TKI treatment for CML patients: experience from single center • Transplant in the TKI era: experience from single center • Therapeutic choices for CML patients based on financial constraints

  5. Incidence of CML • Annual incidence: 0.4/100,000 population • Median age at diagnosis: 40 years • Male: Female = 1.4 - 2.3 : 1 • Disease phase at diagnosis: - CP: 80% - 90% - AP and BP: 10% - 20% Kim DW, et al. Leuk Res. 2010;34:1459-71 Wang JX, et al. Zhonghua Xue Ye Xue Za Zhi. 2009;30:721-5.

  6. National insurance coverage of CML therapies in China • Hydroxyurea: fully covered • Interferon: partial covered • Transplant: partial covered,¥30,0000- ¥500,000 • Imatinib: not covered in the majority of regions - partial covered in a few provinces and cities - available through GIPAP, at least ¥70,000 each year • Dasatinib & Nilotinib: not covered - available through access program, at least ¥90,000 each year

  7. Treatment Patterns Asia CML Study Alliance (ACSA) developed a survey to assess current CML treatment patterns in the Asia-Pacific region between Nov 2008 and April 2009. Kim DW, et al. Leuk Res. 2010;34:1459-71

  8. Number of patients who received imatinib treatment by year ECP LCP AP BP Data from CCF

  9. Number of patients who received 2nd generation TKIs treatment by year Nilotinib Dasatinib • Dasatinib and nilotinib were approved as the second-line options • after imatinib failure in China. • Most patients received 2nd generation TKIs in advanced phase. • 2nd TKIs were used as a first-line therapy only for clinical trials. Data from CCF & BMS

  10. Number of patients who underwent transplantat by year Transplantation is preferred for CML patients with TKI failure, in advanced phase, or those who can not afford TKI treatment. Case number Data from Chinese Hematopoietic Stem Cell Transplantation Register Group

  11. Outline • Current status of CML in China • TKI treatment for CML patients: experience from single center • Transplant in the TKI era: experience from single center • Therapeutic choices for CML patients based on financial constraints

  12. Imatinib therapy for newly diagnosed patients in chronic phase: response rates Median follow-up was 34 months (range, 4-118 months). Estimated rate at 12 months at 48 months CCR n=172 86.0% 93.7% MMR n=165 34.1% 72.1% CMR n=165 12.2% 49.7% Data from Peking University People's Hospital

  13. Imatinib therapy for newly diagnosed patients in chronic phase: EFS, PFS and OS Probability of EFS, PFS and OS • Median time to event was 9 months. • Median time to AP/BP was 12 months. • Median time to dead was 7 months. Total n=172Estimated rate at 48 months EFS event n=20 87.7% PFS AP/BP n=11 93.2% OS dead n=4 81.9% 98.8% (considering only CML related deaths) Data from Peking University People's Hospital

  14. Imatinib therapy for interferon-failure patients in chronic phase: EFS, PFS and OS Probability of EFS, PFS and OS Total n=56 At 10 years EFS event n=21 61.0% PFS AP/BP n=8 84.8% OS dead n=6 87.8% 90.1% (considering only CML related deaths) Months Data from Peking University People's Hospital

  15. Imatinib versus nilotinib for newly diagnosed patients in chronic phase: CCR rate P=0.003 P=0.039 28 27 27 31 31 30 Data from Peking University People's Hospital

  16. Imatinib versus nilotinib for newly diagnosed patients in chronic phase: molecular response BCR-ABL mRNA reduction P=0.027 P=0.003 P=0.055 3m 6m 12m Data from Peking University People's Hospital

  17. Imatinib versus nilotinib for newly diagnosed patients in chronic phase: event and progression The superior rate of responses has not yet translated into improvements in EFS, PFS and OS. n=5 n=2 n=8 n=3 Data from Peking University People's Hospital

  18. Dasatinib as a second- or third-line therapy for imatinib-failure patients CP n=27 AP n=16 BP n=27 CP n=27 AP n=18 BP n=40 Data from Peking University People's Hospital

  19. Outline • Current status of CML in China • TKI treatment for CML patients: experience from single center • Transplant in the TKI era: experience from single center • Therapeutic choices for CML patients based on financial constraints

  20. Imatinib versus transplant for patients with CP CML <1 year after diagnosis: Flow chart of study 348 pts with CP CML <55 years old prospectively assigned to receive imatinib or an HLA-identical sibling transplant from April, 2001 to March, 2010. Jiang Q et al. ASH 2011 Abstract No. 162

  21. Imatinib therapy was associated with better outcomes than transplantin patients with CP CML <1 year after diagnosis EFS PFS Survival RR=3.62 (95% CI, 1.95–6.72) P<0.0001 RR=5.30 (95% CI, 2.40–11.71) P<0.0001 RR=41.84 (95% CI, 5.66–309) P<0.0001) • No 5-year TRM in the imatinib cohort compared to 17% in the • transplant cohort. • 5-year CIFs of progression were comparable in both cohorts. • More MMR and CMR were in the transplant cohort. Jiang Q et al. ASH 2011 Abstract No. 162

  22. Imatinib versus transplant for previously imatinib-untreated AP CML patients PFS rate at 6 years 95.2% 48.3% OS rate at 6 years 83.3% 51.4% A cohort study was designed to compare the outcomes of imatinib vs. allo-HSCT for AP CML from April 2001 to Sep 2008, 132 pts were enrolled. EFS rate at 6 years 71.8% 39.2% Jiang Q, et al. Blood. 2011. 17;117:3032-40.

  23. Independent adverse prognostic factors prior to treatmentfor both OS and PFS • CML duration ≥ 12 months • hemoglobin < 100 g/L • peripheral blood blasts ≥ 5% In an attempt to determine whether choice of therapy contributed to the survival differences, we categorized the entire cohort into 3 groups: - low-risk (no factor): n = 40 - intermediate-risk (any factor): n = 59 - high-risk (at least two factors): n = 33 Jiang Q, et al. Blood. 2011. 17;117:3032-40.

  24. EFS, OS and PFS in low-risk AP CML patients by therapy Absence of significant differences between the two groups. Jiang Q, et al. Blood. 2011. 17;117:3032-40.

  25. EFS, OS and PFS in intermediate-risk AP CML patients by therapy • EFS & OS did not differ in terms of therapy mode. • More relapse developed in the imatinib group. Jiang Q, et al. Blood. 2011. 17;117:3032-40.

  26. EFS, OS and PFS in high-risk AP CML patients by therapy Allo-HSCT was significantly superior to imatinib. Jiang Q, et al. Blood. 2011. 17;117:3032-40.

  27. Conclusions • Allo-HSCT is superior to imatinib, conferring significant survival advantages to high- and intermediate-risk patients. • We recommend those patients receive an early transplant after achieving a second CP with imatinib. Jiang Q, et al. Blood. 2011. 17;117:3032-40.

  28. Conclusions (Cont’d) • Outcomes of imatinib and allo-HSCT were equally good in low-risk patients with CML in AP. • For low-risk patients, imatinib may remain the primary option so long as MRD is carefully monitored, and allo-HSCT should be considered if there is evidence of imatinib resistance. Jiang Q, et al. Blood. 2011. 17;117:3032-40.

  29. TKIs versus transplant for previously TKI-untreated BP CML patients by therapy OS OS PFS EFS EFS Allo-HSCT was significantly superior to TKIs. Data from Peking University People's Hospital

  30. Outline • Current status of CML in China • TKI treatment for CML patients: experience from single center • Transplant in the TKI era: experience from single center • Therapeutic choices for CML patients based on financial constraints

  31. What will be the first option for CP CML patients in China? • TKIs, a life-long therapy, are used mainly through partially paid patient access program. • 2nd generation TKIs are more expensive than imatinib, not covered by insurance and approved by SFAD only for a second-line therapy for imatinib-failure patients. • So, imatinib will be the mainstay choice as a first-line option for CML.

  32. What is the role of transplant in the TKI era for CML in China? • Transplant offers the possibility of a cure with less cost than TKIs therapy. • One-off transplant versus the expense of lifetime TKI therapy. • So, transplant perhaps will remain a first choice for a few young CP CML patients with an HLA-identical donor and a second-line option following imatinib for those who can’t afford a long-term 2nd generation TKI therapy.

  33. What is our next move? • To find ways to make TKIs more widely available to more CML patients and increase accessibility of affordable therapeutic approaches. • To improve CML management according to international guidelines by routine cytogenetic and molecular monitoring. • To identify early signs of resistanceto TKIsand enable a timelyswitch to alternative therapies.