1 / 8

Kantarjian H et al. Proc ASCO 2011;Abstract 6510.

Dasatinib or Imatinib (IM) in Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Two-Year Follow-Up from DASISION. Kantarjian H et al. Proc ASCO 2011;Abstract 6510. DASISION Study Design. Dasatinib 100 mg QD (n = 259). R. Follow-up. 5 yrs. Imatinib 400 mg QD (n = 260).

vivek
Download Presentation

Kantarjian H et al. Proc ASCO 2011;Abstract 6510.

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Dasatinib or Imatinib (IM) in Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase (CML-CP): Two-Year Follow-Up from DASISION Kantarjian H et al. Proc ASCO 2011;Abstract 6510.

  2. DASISION Study Design Dasatinib 100 mg QD (n = 259) R Follow-up 5 yrs Imatinib 400 mg QD (n = 260) Primary Endpoint: Confirmed CCyR by 12 months Secondary/Other Endpoints: Rates of CCyR and MMR; times to confirmed CCyR and MMR; time in confirmed CCyR; PFS; OS Kantarjian H et al. Proc ASCO 2011;Abstract 6510.

  3. DASISION: Cumulative CCyR Rates by Months of Treatment (ITT Population) 100 90 80 70 60 50 40 30 20 10 0 Dasatinib 100 mg QD Imatinib 400 mg QD 86 86 85 82 79 73 73 59 CCyR (%) 6 12 18 24 Months Kantarjian H et al. Proc ASCO 2011;Abstract 6510.

  4. DASISION: Cumulative Incidence of MMR Dasatinib 100 mg QD Imatinib 400 mg QD By 24 months64% By 12 months46% p < 0.0001 MMR (%) 46% 28% Months With permission from Kantarjian H et al. Proc ASCO 2011;Abstract 6510.

  5. DASISION: Transformation to AP/BP CML (ITT Population) Dasatinib 100 mg QD Imatinib 400 mg QD 100 6 4 2 0 5.8 5.0 Patients (%) 3.5 2.3 6/259 13/260 9/259 15/260 On study Including follow-up beyond discontinuationa a Yearly evaluations after discontinuation are currently stipulated by the protocol; additional information on patient status may be provided by the investigators at other times. Kantarjian H et al. Proc ASCO 2011;Abstract 6510.

  6. DASISION: Difference in Adverse Event Rates for Dasatinib and Imatinib Rate difference (dasatinib–imatinib) with exact 95% CI Favors dasatinib Favors imatinib Fluid retentionSuperficial edemaPleural effusionMyalgiaNauseaVomitingDiarrheaFatigueHeadacheRash NeutropeniaThrombocytopeniaAnemia Any grade Grade 3/4 -40 -20 0 20 40 Patients w/QTc intervals 450 msec - 500 msec: Dasatinib 2%, Imatinib 4% Median QTc interval change from baseline: Dasatinib 3.0 msec, Imatinib 8.2 msec With permission from Kantarjian H et al. Proc ASCO 2011;Abstract 6510.

  7. Conclusions • 24-month follow-up of patients with newly diagnosed CML-CP in the DASISION trial continues to demonstrate • High rate of CCyR with dasatinib • Higher and faster rate of MMR with dasatinib over imatinib • Few patients transformed to AP/BP CML • 6 on dasatinib, 13 on imatinib • Dasatinib was associated with fewer discontinuations due to toxicity (data not shown) • Frequency of many of the most common nonhematologic AEs were comparable or lower than imatinib • Most cytopenias occurred within the first year • Longer follow-up continues to support the use of dasatinib 100 mg once daily as first-line treatment of newly diagnosed CML-CP Kantarjian H et al. Proc ASCO 2011;Abstract 6510.

  8. Investigator Commentary: DASISION Study of Dasatinib versus Imatinib in Newly Diagnosed CML-CP The primary endpoint of DASISION was confirmed complete cytogenetic response (CCyR) at 12 months. Now with 18-month follow-up, the response rates were clearly higher for dasatinib compared to imatinib. So the relevance of this follow-up is that this is an endpoint at 18 months that would clearly define failure of imatinib if CCyR is not reached. With this clinically relevant endpoint, the second-generation TKI dasatinib is clearly better than imatinib as up-front therapy for CML-CP. Generally, I will use a second-generation TKI up front, with my selection based on comorbidities. If I have patient who has congestive heart failure who I know is prone to pleural effusions, I might not choose dasatinib. If I have a diabetic patient, who can’t eat around the time that he or she receives nilotinib, I might not choose nilotinib for that patient. I don’t believe one can say at this point that if you want to use a second-generation TKI you can choose on the basis of efficacy. We have nothing to suggest, at this point, that one is better than the other. The toxicity profiles are slightly different, and nilotinib is administered BID, whereas dasatinib has the advantage of being once a day. Susan M O'Brien, MD

More Related