Il trattamento del Mieloma su stratificazione di rischio: è oggi possibile?
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1 Il trattamento del Mieloma su stratificazione di rischio: è oggi possibile? Francesca Gay, MD Divisione Ematologia 1 AO Città della Salute e della Scienza, Torino, Italy Focus sul MM 2014 Cagliari, Maggio min 30m
2 Survival improvement Where we come from Median age 61 5-year OS with MP: 24% where we are now Median age 59 5-year OS with TT3: 73% OS OS CR duration P< P< years years years Myeloma Trialists Collaborative Group JCO 1998;16:3832 Usmani SZ, et al. Leukemia 2012,10:1038
3 Biological events Korde N, et al Blood 2011
4 Different molecular mechanisms in early and late stage disease.treatment targeted to the subtype of the disease. Morgan G J, and Kaiser M F Hematology 2012;2012:
5 PREDICTIVE vs PROGNOSTIC markers Marker Informative on example Prognostic Predictive Outcome risk stratification Outcome w specific th Individualized treatment ISS stage, Del17, t(4;14), LDH level TRAF bortezomib response 1 Cereblon IMIDs resistance 2 TRAF: TNF receptor associated factor; IMIDs: immunomodulatory drugs 1. Keats JJ, et al. Cancer Cell 2007;12: Zhu YX, at al. Blood 2011;118: Chng WJ et al, Leukemia 2014,
6 What is the best riskstratification?
7 RISK STRATIFICATION several prognostic markers! Marker Informative on example Host Fitness to receive Age, frailty therapy Tumor byology Genetic aberration (FISH) GEP signatures burden ISS Stage response Degree Duration ISS, international Staging System; FISH, fluorescent in situ Ibridization, GEP, gene expression profile,
8 ISS Tumor related markers t(4;14) LDH del17 Greipp PR, JCO 2005; 23(15) , Gkotzamanidou, M et al. Clin Lymphoma Myeloma Leuk. 2011, Avet Loiseau H, JCO 2013, 31:2806-9
9 Tumor response Analysis of 1175 elderly patients OS Stringent CR OS Molecular CR OS CR % SMR 50 VGPR PR % Medians: NR No SMR P = months months Gay F et al. Blood. Blood. 2011;117: Paiva et al. Blood. 2008;112: Ladetto M, et al. ASH 2011 Abstract 827
10 Importance of achieving durable CR Hoering et al. Blood 2009;114: )
11 Parameters RISK FACTORS not just one staging! Combined genetic-iss models GRADE 1 Low-Risk ISS I/II No t(4;14), 17p13 del +1q21 GRADE 2 Std-Risk GRADE 3 High-Risk ISS II/III and Others t(4;14) * or Age<55 years 17p13 del Median OS >10 years 7 years 2 years % Patients 20% 60% 20% ISS, international Staging System; OS, overall survival; *Survival of t(4;14) patients is improved with the use of bortezomibbased therapy; Chng WJ et al, Leukemia 2014,
12 RISK FACTORS not just one staging! Combined genetic-iss-ldh models Score Definition Absence of adverse factors (neither high LDH, nor ISS 3, nor t (4;14) and/or del 17p) Presence of only 1 adverse factor (either high LDH or ISS3 or t (4;14) and/or del 17p) Presence of high LDH plus ISS 3 in the absence of t(4;14) and/or del 17p Presence of t (4;14) and/or del 17 in addition to either ISS 3 or high LDH Overall population Outcome (4 years OS) 57 % 89 % 32 % 73 % 6 % 68 % 5 % 24 % Moreau P asbtract ASH 2012
13 RISK STRATIFICATION why? Prognosis Research Optimize patient management and outcome Comprehensive evaluation
14 Can we recommend riskadapted therapy?
15 RISK ADAPTED THERAPY in CURABLE DISEASES GOOD PROGNOSIS LESS INTENSIVE THERAPY BAD PROGNOSIS HIGH-DOSE THERAPY
16 RISK ADAPTED THERAPY Tansplant eligible Not Tansplant eligible Mayo Clinic Proceedings , DOI: ( /j.mayocp )
17 RISK ADAPTED THERAPY in CURABLE DISEASES GOOD PROGNOSIS LESS INTENSIVE THERAPY BAD PROGNOSIS HIGH-DOSE THERAPY But MM is INCURABLE
18 Outcome improved in standard risk VTD, VMP, VMPT by FISH PFS TT3 by GEP EFS P< TT3/Low-risk TT2/Low-risk OS P=0.02 TT3/High-risk TT2/High-risk OS TT3/Low-risk TT2/Low-risk 40 TT3/High-risk 20 0 TT2/High-risk Cavo M, et al. ASH 2010;116:781 Barlogie B, et al. IMW Paris 2011:96 VTD, bortezomib-thalidomide-dexamethasone; VMP, bortezomib-melphalan-prednisone; VMPT, VMP plus thalidomide; TT, total therapy; FISH, fluorescence in situ hybridization; GEP, gene expression profile; PFS, progression-free survival; EFS, event-free survival; OS, overall survival
19 Can we optimize patients management? May be
20 Getting to Minimal Residual Disease (MRD): New Definitions for CR Newly diagnosed CR Stringent CR Molecular/Flow CR Cure? 0.0 Bortezomib Lenalidomide Combinations Courtesy of Dr S. Lonial
21 Tumour burden Treatment Strategy Continuous therapy Prolongs PFS Improve Quality of lyfe Combinational therapy Increases CR rate Time Safe Consolidation and Maintenance to improve outcome
22 Impact of genetic evolution Morgan G, et al ASH 2012
23 Early vs late intensification Sensitive disease CR rate 56% PFS 5 yr OS 5 yr Progression Combination therapy + maintenance 2nd-line 3rd-line Progression Single agent or non-novel drug combo 2nd-line 3rd-line 5thline 4thline CR rate 2% PFS 5 mo Resistant disease OS 9 mo Usmani SZ, et al. Leukemia 2012:1 [Epub]; Kumar SK, et al. Leukemia 2012;26:149
24 How: young fit patients
25 Current standard inductions for young patients Induction regimen Bortezomib- Dexamethasone 1 (223 patients) Bortezomib- Cylophosphamide- Dexamethasone 2 (63 patients) Dexamethasone 3 (413 patients) Bortezomib-Doxorubicin- Bortezomib- Thalidomide- Dexamethasone 4 (241 patients) Bortezomib- Lenalidomide- Dexamethasone 5 (66 patients) Schedule Four 21-day cycles Bor: 1.3 mg/m 2, d Dex: 40 mg, d 1-4, 9-12 Four 28-day cycles Bor: 1.3 mg/m 2 d or 1.5 mg/m 2 d Cycl: 300 mg/m 2 d Dex: 40 mg d 1-4, 9-12, Three 28-day cycles Bor: 1.3 mg/m 2 d Dox: 9 mg/m2 d 1-4 Dex. 40 mg d 1-4, 9-12, Three 21-day cycles Bor: 1.3 mg/m 2 d Thal: 100 mg/d for the first 14 days and 200 mg/d thereafter Dex: 40 mg/d on 8 of the first 12 days, but not consecutively; total of 320 mg per cycle Eight 28-day cycles Bor: 1.3 or 1 mg/m 2 d Len: 15 or 25 mg d 1-21 Dex: 40 or 20 mg d 1-2, 4-5, 8-9, DLT: Bor: 1.3mg/m 2, Len: 25 mg, Dex: 20 mg Response post-induction (%) PFS OS CR/nCR VGPR 15* 38 3 yr 3 yr 12* yr 3 yr yr 5 yr yr 3 yr yr 1.5 yr 1 Harousseau JL, et al. JCO 2010;28:4621; 2 Reeder CB, et al. Blood 2010;115:3416; 3 Sonneveld P, et al. JCO. 2012;30:2946; 4 Cavo M, et al. Lancet. 2010;376:2075; 5 Richardson PG, et al. Blood 2010; 116:679; CR, complete response; ncr, near complete response; PFS, progression-free survival; OS, overall survival; NA, not available; * CR rate only
26 VAD - ASCT Median follow-up 75 months EFS Single vs double ASCT 100 VAD - ASCT Median follow-up 62 months EFS VAD - ASCT - T maint no random Median follow-up 41 months Median 30 months Double ASCT Median 25 months P=0.03 Single ASCT OS 75 Median 35 months 50 Double ASCT 25 Median 23 months P= Single ASCT OS ASCT Single Double PFS median 24 mo 31 mo Median 48 months P=0.01 Cochrane: Median 58 months Double ASCT Single ASCT Median 67 months Median 71 months P= Koreth M, et al. NEJM 2003;349:2495 Cavo M, et al. JCO 2007;25:2434 Double ASCT Single ASCT no study was sufficiently informative for treatment decisions - no trial integrated "novel agents" 5 yr 55% 70% Sonneveld P, et al. JCO 2012;30:2946 Cochrane Database Syst Rev Oct 17
27 Consolidation improves response VTD 1 TD 2 before after CR: 15% 49% before after CR: 40% 47% before after VTD 2 R 5 before after V 3 (n)cr: 20% 45% before after VTD 4 CR: 33% 52% CR: 49% 61% before after VGPR: 58% 69% V:Bortezomib (Velcade) T:Thalidomide D:Dexamethasone R:Lenalidomide (Revlimid) Percentage 1 Ladetto M, et al. JCO 2010;28: ; 2 Cavo M, et al. Blood 2012 Epub; 3. Mellqvist UH, et al. Blood Leleu X, et al. Leukemia Attal M, et al. NEJM 2012;366:
28 Lenalidomide maintenance IFM CALGB Median follow-up 45 months PFS Median follow-up 34 months PFS Median 41 months Median 46 months Median 23 months Median 27 months P<0.001 OS OS 3 yr 3 yr 3 yr 3 yr P=0.03 Attal M, et al. NEJM 2012;366:1782 McCarthy PL, et al. NEJM. 2012;366:1770
29 How: Elderly patients
30 Standard therapies AEs and discontinuation Grade 3-4 AEs (%) Discontinuation for toxicity (%) PFS OS MPT % at 3 yr 69% at 3 yr VMP twice-weekly % at 2 yr 68% at 3 yr VMP once-weekly % at 3 yr 87% at 3 yr RD high-dose Dex % at 2 yr 78% at 2 yr Rd low-dose Dex % at 2 yr 88% at 2 yr 1 Waage A, et al. ASCO 2010; 2 San Miguel JF, et al. N Engl J Med 2008; 3 Bringhen S, et al. Blood. 2010; 4 Rajkumar SV, et al. Lancet Oncol 2010 AE, adverse events; PFS, progression free survival; OS, overall survival; MPT, melphalan-prednisone-thalidomide; VMP, bortezomib-melphalan-prednisone; RD, lenalidomide plus high-dose dexamethasone; Rd, lenalidomide plus low-dose dexamethasone.
31 IMID-based combination PFS All Patients 60% Reduced Risk of Progression Years of Age 69% Reduced Risk of Progression Median PFS Median PFS 100 MPR-R MPR MP 31 months 14 months 13 months 100 MPR-R MPR MP Not reached 14.7 months 12.4 months Patients (%) HR P < HR P < HR P = HR P = Time (Months) Time (Months) Palumbo A, NEJM 2011 MPR-R: melphalan-prednisone-lenalidomide lenalidomide continuous treatment; MPR: melphalan-prednisone-lenalidomide; MP: melphalan-prednisone
32 IMID-based combination PFS and OS Rd continuous vs Rd18 vs MPT Significant PFS advantage for Rd continuous vs Rd 18 vs MPT ( Rd continuous vs MPT: HR=0.72; p= ) Significant PFS advantage for Rd continuous vs Rd 18 vs MPT ( Rd continuous vs MPT: HR=0.78, p= ) Facon T, ASH 2013 meeting Abstract
33 Patients (%) PI-Based combination OS VMPT VT Maintenance Off therapy years OS Median OS 0.75 VMPT-VT VMP 61% Not reached 51% 60.6 months Palumbo A, ASH 2012 meeting Abstract Time (months) HR 0.70, 95% CI, , P = 0.01
34 Overall survival Landmark analysis 1.00 Age < 75 years 1.00 ISS CR HR 0.60, 95% CI, , p= HR 0.66, 95% CI, , p = HR 0.45, 95% CI, , p = Age 75 years 1.00 ISS VGPR/PR HR 0.76, 95% CI, , p =.36 HR 0.64, 95% CI, , p =.22 HR 0.80, 95% CI, , p = VMPT VT maint. VMPT VT maint. VMPT VT maint. Off therapy Off therapy Off therapy VMP No maint. VMP No maint. VMP No maint.
35 How can we improve? Tomorrow
36 PRAMEF12 NRAS USH2A ASXL2 NCKAP5 PLS1 ACOT12 PCDHB6 CDKAL1 COL9A1 TIAM2 LRRC69 TRPM3 Whole Genome Sequencing New genomic frontier 1,2 1 0,8 Early mutation not in late sample New mutations in late sample PD4301 0,6 0,4 0,2 %MutLate %MutEarly 0 Early Tumor Late Tumor Early Tumor Late Tumor EARLY LATE (Munshi NC et al, ASH 2012 Abs. 276)
37 Carfilzomib, Lenalidomide, Dexamethasone (CRd) Patients (%) 53 newly diagnosed transplant eligible and ineligible MM patients enrolled at 4 US centers CRd Cycles 1-8 C: 20/27/36 mg/m 2, d 1,2,8,9,15,16 R: 25 mg/m 2, d 1-21 d: 40 mg (cycles 1-4) 20 mg (cycles 5-8), d 1,8,15,22 For ASCT eligible: Stem cell collection after cycle 4 M AI N T E N A N C E CRd Cycles 9-24 C: 20/27/36 mg/m2, d 1,2, 15,16 R: 25 mg/m2, d 1-21 d: 20 mg, d 1,8,15,22 R E C O M M E N D E D R (off protocol) Cycles 25+ L: 25 mg/day on days 1-21 Progression-free survival Median follow-up 13 months (range 1-20) 1-year rate 97% 2-year rate 92% Best response Median 12 cycles (range 1-25) PR VGPR ncr scr CRd, cyclophosphamide-lenalidomide-dexamethasone; R, lenalidomide; ASCT, autologous stem cell transplantation; PR, partial response; VGPR, very good partial response; CR, complete response; scr, stringent complete response. Jakubowiak AJ, et al. Blood 2012.
38 Patients (%) Patients (%) Carfilzomib, Cyclophosphamide, Dexamethasone (CCyd) 58 newly diagnosed elderly MM patients enrolled at 10 Italian centers CCyd Cycles 1-9 C: 20 mg/m 2 d 1,2 followed by 36 mg/m 2 d 8,9,15,16,22 (cycle 1); 36 mg/m 2 d 1,2,8,9,15,16,22 (cycle 2-9); Cy: 300 mg/m 2 d 1,8,15 d: 40 mg d 1,8,15,22 Progression-free survival M A I N T E N A N C E C Until progression/intolerance C: 36 mg/m 2 d 1,2,15,16 Best response year rate 86% Cycle 2 Cycle 6 Cycle 9 Time (months) CCyd, cyclophosphamide-cyclophosphamide-dexamethasone; C, carfilzomib; PR, partial response; VGPR, very good partial response; CR, complete response; scr, stringent complete response; ncr, near complete response. Bringhen S, et al. EHA scr scr/ncr/cr VGPR PR
39 Bortezomib in patients with t(4;14) VD induction in t(4;14) pts VD vs VAD induction in t(4;14) pts Avet-Loiseau H et al. JCO 2010;28:
40 Predictive markers in MM Cereblon primary teratogenic thalidomide targe Depletion resistance to Lenalidomide and Pomalidomide Acquired CRNB deletion resistance to Lenalidomide and Pomalidomide TRAF gene mutation causing inactivation of TRAF results in constitutive activation of NF-KB PIs target the NF-KB pathway
41 Conclusions 1 Risk stratification based on host and tumor factor Early is better than late Good prognosis major benefit Best available treatment Prospective collection of risk-assignement in clinical trials retrospective evaluation
42 Predictive markers Conclusions 2 Genomic driven therapy Newer agents/combo Risk stratification in the trial design in order to specifically answer questions on treatment within each risk group.
43 Thank you
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