Kantarjian HM et al. Blood 2008;112:Abstract 635.

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Kantarjian HM et al. Blood 2008;112:Abstract 635. Development and Validation of a New Prognostic Model for Myelodysplastic Syndrome (MDS) That Accounts for Events Not Considered by the International Prognostic Scoring System (IPSS) Kantarjian HM et al. Blood 2008;112:Abstract 635.

Introduction The IPSS risk model provides survival projections for patients with de novo MDS who are managed with supportive measures alone. Patients with MDS who have received investigational treatments require a prognostic stratification model that can be applied at intervals after diagnosis and adjusts for the following factors: Impact of prior therapy Secondary forms of disease Proliferative chronic myelomonocytic leukemia (CMML) Adverse cytogenetic subsets (chromosome 7 abnormalities [abn], having three cytogenetic abn) Current study objectives: To develop a new MDS risk model that accounts for subsets not included in IPSS, that refines prognostic subsets, and that applies at any point during the course of MDS. Source: Kantarjian HM et al. Blood 2008;112:Abstract 635.

New MDS Prognostic Model Retrospective Study Design Study Group (n=958) Eligibility (n=1,915) Patients with MDS referred to the MD Anderson Cancer Center from 1993 to 2005 (including CMML, secondary MDS, and MDS with prior therapy) Multivariate analyses of prognostic factors to identify adverse independent factors as continuous and categorical values Test Group (n=957) Validation of new proposed model Source: Kantarjian HM et al. Blood 2008;112:Abstract 635.

Weighted Points of Prognostic Factors Coefficient Score Points Hemoglobin (g/dL) <12.0 0.274 2 Age (yrs) 60 - 64 ≥65 0.179 0.336 1 Platelets (x 109/L) <30 30 - 49 50 - 199 0.418 0.270 0.184 3 Marrow blast % 5 - 10 11 - 29 0.222 0.260 Source: Kantarjian HM et al. Blood 2008;112:Abstract 635.

Weighted Points of Prognostic Factors (continued) Coefficient Score Points White blood cells (x 109/L) >20 0.258 2 Karyotype (chromosome 7 or ≥3 abn) 0.479 3 Prior transfusion Yes 0.107 1 Performance status ≥2 0.267 Source: Kantarjian HM et al. Blood 2008;112:Abstract 635.

Segregation of Patients (Pts Segregation of Patients (Pts.) into Prognostic Groups in New MDS Prognostic Model Study Group (n=958) Test Group (n=957) Risk Score No. Pts. Median Survival Low 0 - 4 157 54 mos 159 45 mos Intermediate 1 5 - 6 229 25 mos 228 23 mos Intermediate 2 7 - 8 233 14 mos 244 13 mos High ≥9 341 6 mos 326 Application of new model’s prognostic scores within the four IPSS risk groups was highly prognostic in each. Application of IPSS scores within the four risk groups of the new model was not prognostic. Source: Kantarjian HM et al. Blood 2008;112:Abstract 635.

Prognosis for Patients in Multiple MDS Subsets According to the New Prognostic Model Median Survival (mos)/1 yr Survival (%) Disease Low Int. 1 Int. 2 High CMML (n=176) 33 mos 19 mos 12 mos 8 mos MDS - prior therapy (n=702) 38 mos MDS - no prior therapy (n=507) 56 mos 36 mos 14 mos 9 mos Secondary MDS (n=571) 43 mos 16 mos 6 mos Decitabine trial 20071 three-arm (n=124) Not reached2 42 mos 13 mos Postdecitabine failure (n=59) (% 1 yr survival) 100% 54% 41% 18% 1 Kantarjian et al. Blood 2007;110:42 [Abstract 115]. 2 100% at 3 years Source: Kantarjian HM et al. Blood 2008;112:Abstract 635.

Summary and Conclusions A new prognostic model was developed and validated for MDS that accounts for all MDS or CMML cases regardless of prior therapy. The model was demonstrated to be superior to IPSS. The model was highly prognostic in a group of patients (n=507) with newly diagnosed MDS (as per the original IPSS groups). The new prognostic model was used to demonstrate an improved survival with decitabine compared to the expected (historical) survival calculated with the new risk model. Median survival vs historical control: Overall (20 mos vs 13 mos), Low-intermediate-1 risk (44 mos vs 30 mos) and Intermediate-2-high risk (15 mos vs 10 mos). Additional validations are necessary in independent MDS populations. Source: Kantarjian HM et al. Blood 2008;112:Abstract 635.