Mielofibrosi: inquadramento dei fattori prognostici

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1 Mielofibrosi: inquadramento dei fattori prognostici Francesco Passamon, Division of Hematology University Hospital, Fondazione Macchi Varese, Italy

2 Reduced survival in PMF and causes of death Median OS 69 m (95% CI, 61-76) 13% 4% 4% 5% 10% 14% 19% 33% 31% 50% Cervantes F et al, Blood 2009;113:

3 The InternaHonal PrognosHc Scoring System (IPSS) at PMF Diagnosis years 22% Probability years 29% 4 years 28% 2.2 years 21% Years 95 % CI Low 95 % CI Intermediate 1 95 % CI Intermediate % CI High Risk Categories/score LR 0 Int- 1 1 Risk factors (all aqributed 1 point): Int- 2 2 Age > 65 years Hb < 10 g/dl WBC > 25 x10 9 /L PB Blasts 1% HR 3 ConsVtuVonal symptoms Cervantes F et al, Blood 2009;113:

4 The Dynamic InternaHonal PrognosHc Scoring System (DIPSS) during the follow- up of PMF Not reached 14.2 years 4 years 1.5 years Risk factors: Age > 65 years (1 point) Hb < 10 g/dl (2 points) WBC > 25 x10 9 /L (1 point) PB Blasts 1% (1 point) ConsVtuVonal symptoms (1 point) Risk categories/score LR 0 Int Int HR 5-6 PassamonV F et al, Blood 2010;115:1703-8

5 What about post- ET/PV Myelofibrosis? IPSS in post- ET/ post- PV MF: no stavsvcally significant difference between LR, Int- 1 R, Int- 2 R n.s. P=0.008 Candidate predictors for shortened OS: age >65 y, Hb <10 g/dl, Plt < /L, being on hydroxycarbamide treatment at MF diagnosis, unfavorable karyotype Candidate predictor for progression to AML: Plt < /L Hernandez- Boluda JC et al, Haematologica 2014;99(4):e55-7; PassamonV F et al, Blood 2008;111(7):3383-7; Dingli D et al, Cancer 2006;106(9):1985-9

6 MYSEC- PM: A New PrognosHc Model in Secondary Myelofibrosis 16 centers, 718 pts (364 PET- MF, 354 PPV- MF), Med F- up 2.4 y Training cohort: 493 pts ValidaVon cohort: 225 pts Risk factors: Points:! Age >65 y 3! Time to SMF >15 y 2! History of thrombosis 2! ConsVtuVonal symptoms 2! Hemoglobin <10 g/dl 1! CirculaVng blasts 1% 2 LR Med OS nr Int- R Med OS 7.9 y HR Med OS 3.8 y Risk categories/sum of points: LR 0-2 Int- R 3-6 HR >6 P< PassamonV F et al, Abs presented at ASH 2014 #1826

7 Baseline spleen volume and impact on OS: pooled analysis of the COMFORT studies The risk of death increased by 14% for each addihonal 5 dl in spleen volume at baseline (HR = 1.14; 95% CI, ); or by 9% (HR = 1.09; 95% CI, ) in MV model adjusvng for treatment, study, and IPSS risk alone] Median normal spleen volume, 200 cm 3 ; median MF value of spleen volume in COMFORT2: 2408 cm 3 (24 dl) Vannucchi AM et al, Abs presented at ASH 2013 #2820

8 Frequency of CytogeneHc AbnormaliHes in PMF 36% 6% 3.2% 1% 1.4% 1.8% 3.5% 5% 2.8% 2 % 2.3 % 7 % 64% Normal karyotype Sole 20q- Sole 13q- Sole +9 Sole Chrom. 1 trans/dup. Other indeterminate risk sole abns. Two abns. excluding unfavorable Two abns. including unfavorable Complex karyotype Sole + 8 Sole - 7/7q- Other high- risk sole abns.i(17q), inv (3), - 5/5q-, 12p-, 11q23 rearrangements Caramazza D et al, Leukemia 2011;25(1):82-8

9 Impact of CytogeneHcs on OS and LFS in PMF Unfavorable karyotype Complex Sole or two including +8, - 7/7q-, i(17q), inv (3), - 5/5q-, 12p-, 11q23 rearrangements Favorable karyotype Normal All others 5- yr survival for unfavorable vs favorable karyotype: 8 vs 51% (HR: 3.1) 5- yr leukemic transformahon rates for unfavorable vs favorable karyotype: 46 vs 7% (HR: 5.5) Caramazza D et al, Leukemia 2011;25(1):82-8

10 An Integrated Score: the DIPSS- plus Risk factors DIPSS int- 1 DIPSS int- 2 DIPSS HR Unfav cytogenevcs PLT <100 x10 9 /L Transfusion dep. 1 point 2 points 3 points 1 point 1 point 1 point Risk Categories/score LR 0 Int- 1 1 Int HR years 8% 6.6 years 22% 2.9 years 45% 1.3 years 25% Gangat N et al, J Clin Oncol 2011;29(4):392-7

11 High risk cytogenehc profile recognizes LR IPSS pahents with worse survival ConvenHonal unfavorable karyotype: o Complex, sole or two including +8, - 7/7q-, i(17q), inv (3), - 5/5q-, 12p-, 11q23 abn New strahficahon: o Very high: MK, inv(3), i(17q), - 7/7q-, 11q or 12p) o High (complex without MK, two abnormalives not included in VHR, 5q-, +8, other autosomal trisomies except +9, and other sole abn) o Intermediate (sole 20q-, 1q dup., other translocavon, - Y) o Low (normal, sole 13q- or +9) In the DIPSS- plus, 7% of LR- IPSS pavents had an unfavorable karyotype, upgrading their risk Risk re- assignment also in the new cyto strata Caramazza D et al, Leukemia 2011;25:82-8; J Clin Oncol. 2011;29:392-7; Tefferi A et al, ASH meeting 2014, abstract 631

12 MutaHonal profile of MF pahents (483 EU, 396 Mayo) 382 pts (79.1%) had >1 mut 154 pts (32.5%) had >2 mut 31 pts (6.4%) had >3 mut Vannucchi AM et al, Leukemia 2013;27(9):1861-9

13 MutaHons in any one of ASXL1, EZH2, SRSF2, IDH1/2 is associated with reduced survival Median survival EU series HMR 81 m LMR 148 m HR= 2.29 (95%CI: ) HMR (High Molecular Risk): at least one mutavon in any one of ASXL1, EZH2, SRSF2, IDH1/2 LMR (Low Molecular Risk): no mutavon in the 4- gene set Vannucchi AM et al, Leukemia 2013;27(9):1861-9

14 Overall Survival by Number of Mutated Genes N. Mut Genes Mean Survival y (range) ( ) ( ) ( ) 1mut LMR (No mut) P< mut In a Cox mulvvariable analysis adjusted for IPSS, the HR for OS for 2 or more mutavons was 2.4 (95% CI= ) Guglielmelli P et al, Leukemia 2014;28(9):

15 CALR/MPL/JAK2 mutahons in PMF 25% Frequency PrognosHc relevance 8% 9% 32% ASXL1 mutavon 18% spliceosome mutavon 32% abnormal karyotype CALR mut P< % JAK2V617F CALR MPL Triple negative Triple neg. JAK2 mut MPL mut Type 1 vs Type 2 CALR mut MutaHonal status N Med OS CALR mut y 1 P< JAK2 mut y MPL mut y 2 Triple negaeve y Tefferi A et al, Leukemia 2014;28(7): Tefferi A et al, Leukemia 2014;28(7):

16 PrognosHc Significance of Phenotypic Driver MutaHons in 617 PMF pts N = 140 (22.7%) N = 25 (4.0%) N = 53 (8.6%) N = 399 (64.7%) CALR- mutant pts have a berer OS than: - JAK2V617F- mutant pts (HR 2.3, P <0.001) - MPL- mutant pts (HR 2.6, P <0.009) - Triple- negavve pts (HR 6.2, P <0.001) Rumi E et al, Blood 2014;124(7):1062-9

17 CALR & ASXL1 mutahonal status: impact on OS CALR+ASXL y 17% P< y 61% CALR- ASXL1+ CALR- ASXL1- / CALR+ASXL y 22% CALR- ASXL1+ Med OS 4 y LR + Int- 1 R P< CALR+ASXL1- Med OS 20 y CALR- ASXL1- / CALR+ASXL1+ Med OS 9 y CALR- ASXL1+ Med OS 2.3 y Int- 2 R + HR CALR+ASXL1- Med OS 4.8 y P< CALR- ASXL1- / CALR+ASXL1+ Med OS 4.1 y Tefferi A et al, Leukemia 2014; 28(7):

18 MIPSS Molecular based IPSS Training cohort: 588 pts ValidaVon cohort: 398 pts Risk factors: Points:! age >60 years 1.5! consvtuvonal symptoms 0.5! hemoglobin <100g/L 0.5! platelets <200x10 9 /L 1.0! TN 1.5! JAK2 or MPL mut. 0.5! ASXL1 and SRSF2 mut. 0.5 Risk categories/sum of points: LR Int Int HR =>4 Vannucchi et al; ASH 2014 # 405

19 Is the (D)IPSS enough for clinical decision making? IPSS at diagnosis PMF Diagnosis LR Int- 1 R Int- 2 R HR Med OS 11.2 y Med OS 7.9 y Med OS 4 y Med OS 2.2 y DIPSS during f- up LR over Hme: 85% alive at 20 y But what if: Thrombocytopenia? RBC transfusion need? Unfavorable karyotype? Int- 1 R over Hme: Med OS 14.2 y Adverse molecular feature(s)? Dismal prognosis ophons: SCT when possible (age, comorbidives, donor) RuxoliVnib may prolong survival and improve QoL FDA and EMA approved Experimental treatment! Karyotyping & Molecular profiling for post- SCT MRD

20 IPSS/DIPSS: risk factors readily available in rouvne clinical pracvce, important prognosvc informavon Secondary MF? MYSEC- PM Conclusions CytogeneVc and molecular profiling may add valuable prognosvc informavon, especially in the lower IPSS/DIPSS risk categories Integrated scoring systems: e.g., MutaVon- Enhanced InternaVonal PrognosVc Scoring System JAK- inhibitor treatment era: validavon/adaptavon of (clinical) prognosvc scoring systems in this sewng would be important

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