Frontline Induc.on Therapy in 2017 Alan K Burne+
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1 Frontline Induc.on Therapy in 2017 Alan K Burne+ Ravenna, October 2017
2 Standard of Care Induc5on: 7+3 Ara-C / Daunorubicin Consolida5on: High Dose Ara-C (3g doses) Total of 4 courses. Myeloabla5ve allogral for young high risk groups
3 2017 marks the 44 th anniversary of 3+7 DNR 45 mg/m 2, D 1-3 Ara-C 100 mg/m 2, D 1-7 Yates JW et al, Cancer Chemother Rep 1973
4 Changes in outcome with Eme: remission rates Age (years) Pre < 15 39% 82% 90% 92% 92% 93% % 73% 76% 79% 83% 85% % 52% 47% 58% 60% 65% 70 18% 36% 40% 48% 47% 62% All 34% 66% 70% 74% 77% 79%
5 Changes in Early Mortality Time Period 30 day mortality % 12% % 10% 60 day mortality p= % 8% % 8% % 7% All non-apl pa5ents aged enrolled in trials for younger pa5ents
6 SAB a promising new treatment for AML in the elderly? Treatment Number of pts CR rate Induction deaths DAT % 30% 23% SAB % 15% 24% Resistant disease p= Wheatley K et al.
7 Beyond 3+7 : Which InducEon Treatment? A) Daunorubicin/Ara-C (3+7) B) Idarubicin/Mitoxantrone + Ara-C C) Which dose of Ara-C D) Above + a third drug E) An alterna5ve nucleoside analogue F) Addi5on of an immuno-conjugate
8 Might some anthracyclines be be+er than others? Mitoxantrone 8-12 mg/m 2 compared to DNR mg/m 2 superior CR rate in some studies 1,2 but not in others 3 Idarubicin mg/m 2 compared to DNR mg/ m 2 superior CR rate and possibly longer OS 4 1 Lowenberg et al, JCO 1998; 2 Arlin et al, Leukemia1990; 3 Mandelli et al, JCO 2009; 4 Berman et al, Cancer 1997
9 Daily Ara-C Dose? A) 100mg/m 2 /day B) 200mg/m 2 /twice daily C) 1.0g/m 2 /day D) 3.0g/m 2 /day
10 Daunorubicin Dose A) 45mg/m 2 B) 60mg/m 2 C) 90mg/m 2
11 ECOG E1900 (90mg vs 45mg) Fernandez et al, NEJM 2009
12 DA 90mg vs 45mg in younger paeents from Fernandez et al, NEJM 2009;361: AML15 AML15 (all) mo
13 Korean Study Lee et al, Blood 2011
14 HOVON-SAKK-AMLSG STUDY Löwenberg et al, NEJM 2009
15 Randomised Trials of Escalated Daunorubicin E1900 trial: CR 70% vs 57%/ OS 38% vs 23% HOVON trial: CR 64% vs 54%/ OS: no difference Korean Trial: CR: 82% vs 72%/OS: 47% vs 35%
16 Randomised Trials of Escalated Daunorubicin E1900 trial: CR 70% vs 57%/ OS 38% vs 23% -benefit in <50 s, intermediate cytogene5cs HOVON trial: CR: 64% vs 54%/ OS: no difference - benefit in yrs/ trend in CBF subgroup (35% vs 23%) Korean Trial: CR 82% vs 72%/OS 47% vs 35% - OS benefit due to intermediate risk (51% vs 34% )
17 Who Benefits from 90mg vs 45mg Patel JP, Gonen M, Figueroa ME, et al. Prognos5c relevance of integrated Gene5c profiling in acute myeloid leukemia. N.Engl J Med. 2012; 366 (12): DNMT3A, NPM1, and MLL-PTD Luskin MR, Lee J-W, Fernandez HF et al., Benefit of high dose daunorubicin in AML induc5on extends across cytogene5c and molecular groups: updated analysis of E1900 Blood 2016 Blood <50 years, not adverse cytogeneecs, not FLT3, MLL-PTD and NMP1c if no FLT3
18 AML17: 90mg/m 2 vs 60mg/m 2 : OS
19 AML17: 90mg/m 2 vs 60mg/m 2 : OS by Risk Group
20 AML17: 90mg/m 2 vs 60mg/m 2 : StraEfied Analysis of survival
21 AML17 FLT3 Mutants: Dauno 90 vs. 60: Update
22 AddiEon of a Third drug A) Etoposide B) Cladrabine / Fludarabine/ Clofarabine C) Gemtuzumab Ozogamicin (GO) mylotarg D) FLAG-Ida
23 Addition of Cladrabine to DA: (A) overall and (B) leukemiafree survival. Holowiecki J et al. JCO 2012;30: by American Society of Clinical Oncology
24 DA vs D-Clofarabine OS (n=806)
25 DClo vs FLAG-Ida for high risk
26 Mylotarg (gemtuzumab ozogamicin) First an5body-targeted chemotherapeu5c agent for the treatment of relapsed acute myeloid leukemia in older pa5ents IgG4 ane-cd33 CH 3 HO NH O OCH 3 O OH DNA minor groove binding I O CH 3 OCH 3 O O S OCH 3 Linker O Me Me NHN S Me CH S 3 O O CH 3 O OH HN CH 3 CH 2 HO O O N CH OCH 3 3 O HO O H O NH O OCH 3 Calicheamicin derivative
27 GO+IC: meta-analysis of RCT Trial GO dose/sched InducEon Chemo No. of paeents Median age (years) CG Risk (MRC) MRC AML15 ADE,DA, FLAG-Ida 3 mg/m 2 d (15-71) All NCRI AML16 DA, DClo (51-84) All SWOG-0106 GOELAMS AML2006/IR ALFA mg/m 2 d4 3 mg/m 2 d1,4,7 DA (3+7) (18-60) All DA (3+7) (18-60) Inter DA (3+7) (50-70) Inter/Adv Hills RK et al. Lancet Oncol.
28 Results: Survival post remission
29 Overall Survival: Favourable, Intermediate CytogeneEcs
30 Overall Survival: Adverse
31 CBF Subset: Results of regression analysis Variable listed in order of importance Hazard raeo 95% Confidence Interval P-value GO to 0.71 < Performance status (per category) to Age (per 10 years) to Ara-C consolida5on to Male sex to
32 GO for CBF in course 1 or course 2?
33 Mylotarg: Remaining Issues Op5mum dose Schedule Use in consolida5on Use in APL Availability/ approval
34 AML17: GO 6mg vs 3mg (n=788)
35 Role for Transplant? The Mylotarg Impact
36 FLAG-Ida
37 AML 15 PaEents <60 yrs: Remission Rates DA vs ADE ADE vs FLAG-Ida DA(90) Overall (%) Course % of remi+ers
38 ADE vs FLAG-Ida
39 2 or 4 courses? FLAG v ADE/Ara-C
40 2 or 4 courses? ADE/DA
41 ADE/DA vs FLAG-Ida 4 courses p-value adjusted for age, WBC, cytogene5cs, secondary disease p=0.004
42 NCRI AML19 (2015-) DA + GO3 R I S K R DA + molecule Ara-C ± molecule Ara-C ± molecule Non- APL R DA + GO3x2 FLAG-Ida + GO3 FLAG-Ida + GO3x2 A S S E S S M E N T R DA alone FLAG-Ida + molecule FLAG-Ida alone R Ara-C ± molecule Ara-C ± molecule Molecule vs not Ara-C ± Molecule molecule vs not Molecule vs not Course 1 Course 2 Sibling RIC to SCT if >35 Course 3 Course 4 Poor risk at any point to high risk options
43 ImplementaEon of MRD Specificity and sensi5vity? Does it tell us more than we already know. Is it prognos5c or is it predic5ve? Is it treatment dependent? What are the indirect costs? monitor vs no monitor
44 MRD: CumulaEve Incidence of Relapse
45 AddiEon of ConsolidaEon in MRD +ve
46 AddiEon of ConsolidaEon in MRD-ve
47 OS: Standard Risk (N=699) Freeman S. et al
48 OS Standard Risk Censored at SCT Freeman S. et al
49 Conclusions There is beoer than 3+7 available Daunorubicin 60mg dose is op5mal for most Addi5on of mylotarg; cladrabine; and/or FLAG-Ida may be superior The efficacy of induc5on determines OS when intensive therapy use. MRD status may clarify post induc5on choices
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