Emerging New Prognostic Scoring Systems in Myelodysplastic Syndromes 2012

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1 Emerging New Prognostic Scoring Systems in Myelodysplastic Syndromes 2012 Arjan A. van de Loosdrecht, MD, PhD Department of Hematology VU University Medical Center VU-Institute of Cancer and Immunology (V-ICI) Cancer Center Amsterdam (CCA) Amsterdam, The Netherlands NvvH Utrecht 4 October 2012

2 Literature: MDS 2012 Greenberg P et al., Blood 2012; [June 27; epub ahead of print] Schanz J et al., J Clin Oncol 2012; 20; Bejar R et al., J Clin Oncol 2012; [August 8; epub ahead of print] Backbone literature: Schanz J et al., J Clin Oncol 2011; 29: Bejar R et al., N Engl J Med 2011; 364: Westers TM et al., Leukemia 2012; feb 6 [epub ahead of print]

3 The Myelodysplastic Syndromes MDS; a heterogeneous spectrum of myeloid disorders characterized by: Ineffective hematopoiesis Dysplastic cells in peripheral blood and BM Low blood cell counts ([pan-] cytopenia) progression to acute myeloid leukemia (AML)

4 Diagnostic approach to MDS 2012 Diagnostic tool Diagnostic value Priority Peripheral blood smear Bone marrow aspirate Evaluation of dysplasia in one or more cell lines Enumeration of blasts Evaluation of dysplasia in one or more myeloid cell lines Enumeration of blasts Enumeration of ring sideroblasts Mandatory Mandatory Bone marrow biopsy Assessment of cellularity, CD34+ cells, and fibrosis Mandatory Cytogenetic analysis FISH Flow cytometry immunophenotyping SNP-array Mutation analysis of candidate genes* Detection of acquired clonal chromosomal abnormalities that can allow a conclusive diagnosis and also prognostic assessment Detection of targeted chromosomal abnormalities in interphase nuclei following failure of standard G- banding Detection of abnormalities in erythroid, immature myeloid, maturing granulocytes, monocytes, immature and mature lymphoid compartments Detection of chromosomal defects at a high resolution in combination with metaphase cytogenetics Detection of somatic mutations that can allow a conclusive diagnosis and also reliable prognostic evaluation Mandatory Recommended Recommended Suggested (likely to become a diagnostic tool in the near future) Suggested (likely to become a diagnostic tool in the near future) Malcovati L, et al., ELN guidelines 2012 (submitted); Loosdrecht AA van de, et al., Nederlandse richtlijnen voor diagnostiek en behandeling 2012 (in preparation)

5 Minimal diagnostic criteria in MDS A. Prerequisite Criteria constant cytopenia in one or more cell lineages exclusion of all other hematopoietic or non-hematopoietic disorders B. MDS-related (Decisive) Criteria dysplasia in > 10% of all cells in one of the lineages, or > 15% ring sideroblasts (iron stain) 5 19% blast cells in bone marrow smears typical chromosomal abnormality (karyotyping or FISH) FISH = fluorescence in situ hybridization. Valent P et al., Leuk Res 2007 Loken MR, Loosdrecht AA van de et al., Leuk Res 2008 Platzbecker U et al., Leuk Res 2012

6 Recurrent chromosomal abnormalities that provide presumptive evidence of primary MDS Abnormality -7 or (7q) -5 or (5q) i(17q) or t(17p) -13 or (13q) (11q) (12p) or t(12p) (9q) idic(x)(q13) t(11;16)(q23;p13.3) t(3;21)(q26.2;q22.1) t(1;3)(p36.3;q21.2) t(2;11)(p21;q23) inv(3)(q21q26.2) t(6;9)(p23;q34) Malcovati L, et al., ELN guidelines 2012 (submitted); Loosdrecht AA van de, et al., Nederlandse richtlijnen voor diagnostiek en behandeling 2012 (in prep)

7 Minimal diagnostic criteria in MDS consensus (Vienna 2006) C. Co-criteria abnormal phenotype of bone marrow cells by flow cytometry molecular signs of a monoclonal cell population o HUMARA assay, gene profiling, point mutation analysis o markedly and persistently reduced colony-formation (CFU-assay) Valent P et al., Leuk Res 2007;31: Loosdrecht AA van de et al., Leuk Res 2008;32:205-7 Loken MR, Loosdrecht AA van de et al., Leuk Res 2008;32:5-17 Loosdrecht AA van de et al., Blood 2008;111; Loosdrecht AA van de et al., Haematologica 2009;94: Platzbecker U et al., Leuk Res 2012;36: Westers TM et al., Leukemia 2012;Feb 6 Della Porta M et al., Haematologica 2012;Feb 7

8 Major differences between FAB and WHO classification in MDS AML if bone marrow blasts > 20% (FAB: RAEB-t) 2. MDS and Auer rods with bone marrow blasts < 20% RAEB-2 3. Lineage dysplasia if 10% of cells are dysplastic 4. RCUD (RA, RN, RT) 5. Refractory anemia with ringed sideroblasts 6. Refractory cytopenia with multilineage dysplasia 7. MDS-U 8. MDS associated with isolated del(5q) 9. RAEB-1 and RAEB-2 according to blast % and uni- and/or multilineage dysplasia 10. New category: myelodysplastic/myeloproliferative diseases 11. Specific cytogenetic abnormalities: t(8;21), inv(16), t(15;17), and < 20% blasts AML 12. ICUS [discussed] Nimer SD et al., Blood 2008;111: Vardiman JM et al., Blood 2009;114:937

9 WHO-2008 and Overall Survival in MDS Classification based on morphology! Cazzola, Haematologica 2011;96:349

10 International Prognostic Scoring System (IPSS) in myelodysplastic syndromes Prognostic variable Bone marrow blasts (%) Score < Cytogenetics Good Intermediate Poor Cytopenias* *Hb < 10 g/dl; 6.2 mmol/l; platelets < 100 x 10 9 /L; ANC < 1.8 x 10 9 /L ANC = absolute neutrophil count. Greenberg P, et al. Blood. 1997;89:

11 Cumulative survival of MDS patients by IPSS Survival (%) Survival Low (n = 267) Int-1 (n = 314) Int-2 (n = 179) High (n = 56) AML evolution (%) AML evolution Low (n = 235) Int-1 (n = 295) Int-2 (n = 171) High (n = 58) Time (years) Time (years) Greenberg P, et al. Blood. 1997;89:

12 WHO-classification-based Prognostic Scoring System (WPSS and refined-wpss) Variable WHO RA, RARS, 5q- RCMD+/-RS RAEB-1 RAEB-2 Karyotype good intermediate poor -- Trf/Hb* no/(hb>8/9 g/dl) regular (Hb<8/9 g/dl) m f Malcovati L et al., J Clin Oncol 2007;25; Haematologica 2011;96:

13 Time-dependent prognostic scoring system: validation cohort WPSS WPSS at diagnosis WPSS time-dependent Malcovati L et al., J Clin Oncol 2007;25; Haematologica 2011;96:

14 Emerging new prognositic scoring system: IPSS-revised for Myelodysplastic syndromes 11 countries; n=7012 Inclusion: -primary untreated MDS -BM blasts 30%; PB blast 19% -WBC 12; ANC 8 -Vienna cohort for validation of the model Greenberg PL, et al., Blood 2012 (June 27: epub ahead of print)

15 International Prognostic Scoring System (IPSSrevised) in myelodysplastic syndromes Prognostic variable Cytogenetics Very Good Good Inter Poor Very Poor BM Blast % 2% >2-<5% 5-10% >10 % Hemoglobin g/dl; mmol/l Platelets <100 ANC 0.8 <0.8 8-<10 5-<6.2 <50 <8 <5 Greenberg PL, et al., Blood 2012 (june 27: epub ahead of print) Schanz J, et al., J Clin Oncol 2012

16 Underestimation of poor risk cytogenetics in the IPSS - data of 2351 patients Schanz J et al, J Clin Oncol 2011

17 Survival and evolution to AML: cytogenetic profiling Schanz J, et al, J Clin Oncol 2012

18 Survival of the new cytogenetic subgroups in MDS Schanz J, et al, J Clin Oncol 2012

19 Redistribution of the new cytogenetic subgroups IPSS vs new cytogenetic scoring proposal Greenberg PL, et al., Blood 2012 (June 27: epub ahead of print) Schanz J, et al., J Clin Oncol 2012

20 Design of a cytogenetic scoring system for MDS Schanz J et al, J Clin Oncol 2012

21 IPSS-revised cytogenetic subgroups Greenberg PL, et al., Blood 2012 (june 27: epub ahead of print)

22 International Prognostic Scoring System (IPSSrevised) in myelodysplastic syndromes Prognostic variable Cytogenetics Very Good Good Inter Poor Very Poor BM Blast % 2% >2-<5% 5-10% >10 % Hemoglobin g/dl; mmol/l Platelets <100 ANC 0.8 <0.8 8-<10 5-<6.2 <50 <8 <5 Greenberg PL, et al., Blood 2012 (June 27: epub ahead of print) Schanz J, et al., J Clin Oncol 2012

23 Survival and leukemic free survival: IPSS-revised Hb tresholds: >10; >8 to 10; 8 g/dl Greenberg PL, et al., Blood 2012 (june 27: epub ahead of print)

24 Survival and leukemic free survival: IPSS-revised; BM blasts Greenberg PL et al., 2012 (IPSS-R; submitted; with permission)

25 Refinements of the IPSS-R beyond the IPSS New marrow blast categories 2, >2 - <5, 5-10, >10-30% Refined cytogenetic abnormalities and risk groups 16 (vs 7) specific abnormalities 5 (vs 3) subgroups Evaluation of depth of cytopenias clinically and statistically relevant cutpoints used Inclusion of differentiating [provisional] features* AGE, Performance Status, serum ferritin, LDH, Beta-2- microglobulin** Prognostic model with 5 (vs 4) risk categories improved predictive power Greenberg PL, et al., Blood 2012 (june 27: epub ahead of print)

26 IPSS-revised 5 scores Greenberg PL, et al., Blood 2012 (june 27: epub ahead of print)

27 Revised International Prognostic Scoring System (IPSS-R) for MDS Greenberg PL et al., Blood 2012 (June 27 epub ahead of print)

28 Clinical effects of point mutations in myelodysplastic syndromes Bejar R et al., NeJM 2011;364:2496

29 OS according to IPSS and mutational status Bejar R et al., NeJM 2011;364:2496

30 Validation of a prognostic model and the impact of mutational status in lower risk MDS Bejar R et al., J Clin Oncol 2012: August 6 [epub ahead of print]

31 Validation of a prognostic model and the impact of mutational status in lower risk MDS Bejar R et al., J Clin Oncol 2012: August 6 [epub ahead of print]

32 Validation of a prognostic model and the impact of mutational status in lower risk MDS Bejar R et al., J Clin Oncol 2012: August 6 [epub ahead of print]

33 Minimal diagnostic criteria in MDS consensus (Vienna 2006) C. Co-criteria abnormal phenotype of bone marrow cells by flow cytometry molecular signs of a monoclonal cell population o HUMARA assay, gene profiling, point mutation analysis o markedly and persistently reduced colony-formation (CFU-assay) Valent P et al., Leuk Res 2007;31: Loosdrecht AA van de et al., Leuk Res 2008;32:205-7 Loken MR, Loosdrecht AA van de et al., Leuk Res 2008;32:5-17 Loosdrecht AA van de et al., Blood 2008;111; Loosdrecht AA van de et al., Haematologica 2009;94: Platzbecker U et al., Leuk Res 2012;36: Westers TM et al., Leukemia 2012;Feb 6 Della Porta M et al., Haematologica 2012;Feb 7

34 Standardization of flow cytometry in MDS: ELNet 2012 Westers TM et al., Leukemia 2012; Feb 6 Van de Loosdrecht AA et al., Leuk and Lymph 2012 [epub ahead of print]

35 Antigen expression during neutrophil differentiation: the concept MYELOBLAST PROMYELOCYTE MYELOCYTE METAMYELOCYTE BAND/ NEUTROPHIL 10 3 CD13 CD CD11b 10 1 CD16 Adapted from: A Orfao, ELNet Flow MDS 2008, Amsterdam

36 Antigen expression during neutrophil differentiation: the concept MYELOBLAST PROMYELOCYTE MYELOCYTE METAMYELOCYTE BAND/ NEUTROPHIL CD15 CD13 CD64 MPO CD CD33 CD65 CD CD11b 10 1 CD34 CD16 CD10 HLA-DR CD117 CD54 Adapted from: A Orfao, ELNet Flow MDS 2008, Amsterdam

37 Severe dyspoiesis as reflected by a high FCSS is associated with worse overall survival in MDS n=152 p<0.001 Alhan et al., 2012 (Manuscript in preparation) Greenberg et al., Blood 2012 [June 27 epub ahead of print]

38 The FCSS can identify MDS patients within the revised-ipss low risk group with a worse prognosis n=66 p=0.04 Alhan et al., 2012 (Manuscript in preparation) Greenberg et al., Blood 2012 [June 27 epub ahead of print]

39 The FCSS identifies MDS patients within the revised-ipss good risk cytogenetic group with a worse prognosis n=101 p<0.05 Alhan et al., 2012 (Manuscript in preparation) Greenberg et al., Blood 2012 [June 27 epub ahead of print]

40 Conclusions: diagnostics and prognostics in MDS 2012 A full diagnostic screen should be assessed by patients with cytopenia according to ELN guidelines MDS should be categorized according to WHO2008 Each patient should be assessed according to the WPSS/IPSS-revised prognostic scoring systems Mutational status and flow cytometric aberrancies may be of additional prognostic value

41 Validation of a prognostic model and the impact of mutational status in lower risk MDS Bejar R et al., J Clin Oncol 2012: August 6 [epub ahead of print]

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