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ZZ.PI > KK.Vyx > Flashcards

KK.Vyx Flashcards

1
Q

Patients w MRC who presented wo antecedent heme disorder

A

78%

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2
Q

how does MRC present?

A

As denovo AML with MDS related cytogenetic changes OR

As multilineage dysplasia

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3
Q

% of patients with MRC presenting with AHD

A

22%

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4
Q

Common unfavorable cytogenetic risk group in AML

A

del 5, del 7

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5
Q

24-35% of all AML cases

A

AML MRC

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6
Q

definition of MRC?

A

> 20% blasts in PB / Marrow and Any of the following:

MDS, Non MDS (MRC + Multilineage dysplasia)

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7
Q

Multilineage dysplasia

A

Dysplasia in >50% of cells in at least 2 myeloid lines, UNLESS an NPM1 mutation or Biallelic mutation of CEBPA is present.

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8
Q

MRC Characteristics?

A

Complex karyotype - 3 or more abnormalities

Unbalanced Abnormalities

Balanced Abnormalities

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9
Q

Trial?

A

309 patients aged 60-75

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10
Q

Primary endpoint

A

OS

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11
Q

Phase 3 study patients?

A

20% T Aml
54% MRC w/ documented history
25% MRC No documented history

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12
Q

FLT3 in 5 yr analysis

A

16% in Vyxeos Arm

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13
Q

Prior HMA exposure?

A

41% patients treated with Vyxeos had prior HMA exposure

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14
Q

Most frequently reported hemorraghic event

A

Epistaxis

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15
Q

Primary end point

A

mOS 9.6 vs 5.9

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16
Q

Hazard Ratio

A

0.69

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17
Q

1 yr survival

A

42% vs 28%

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18
Q

5yr survival

A

18% vs 8%

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19
Q

At 5 years mOS in 60-69 was?

A

9.6 vs 6.9

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20
Q

At 5 years mOS in 70-75 was?

A

8.9 vs 5.6

21
Q

In phase 3 % of patients achieving CR+CRi?

A

48% vs 33%

22
Q

% of patients achieving CR only?

A

38% vs 26%

23
Q

At 5 yrs mOS in patients achieving CR+CRi was?

A

21.7 mos vs 10.4 mos

Post Hoc analysis

small non randomized group 125

24
Q

Overall rate of HSCT

A

35% vs 25%

25
Q

How can we do a transplant better?

Does it matter what induction / consolidation therapy used when taking a patient to transplant?

A

TBD

26
Q

Median OS in patients who received HSCT

A

Not reached vs 10.3 months

27
Q

Median OS in patients achieving CR or CRi

A

Not reached vs 11.7 mos

28
Q

MRD negativity? assessed after Vyxeos induction

A

Real World:
Germany 64% by Flow 36 patients
Italy 38%
France 57% Flow NGS qPCR

29
Q

Patients w CR or CRi but no transplant

A

med OS for those in CR: 19.2 vs 8.4 mo
med OS for those in CR+CRi: 14.7 vs 7.6

30
Q

30/60 day mortality

A

30: 6 vs 11%
60: 14 vs 21%

31
Q

Outpatient Admin?

A

64% IPOP then admitted day 6 (n=22) Kubal Study
58% IPOP eventually admitted (n=12)
Deutch Study

32
Q

Overall incidence of hemorrhagic events was ___in the Vyxeos arm and ___in the control arm

A

74%, 56%

33
Q

Grade 3 or greater events occurred in ____

A

12% of Vyxeos treated patients.

34
Q

Fatal treatment emergent CNS hemorrhage not in the setting of progressive disease occurred in ___

A

2%

35
Q

Unbalanced Abnormalities

A

del 7
del 5
17q
del 13, 11q, 12p

36
Q

Balanced abnormalities

A

t 11;16
t 3;21
t 1;3

37
Q

CPX is an integrated proposition

A

To include:
Induction
Consolidation
Transplant

38
Q

% patients transplanted in Viale A

A

10%

39
Q

De Novo AML Mutations

A

NPM1, CEBPA, FLT3 ITD, Inv 16, t(8;21)
aberrations involving 11q23

40
Q

Secondary type AML mutations
stAML

A

RUNX1, EZH2, SRSF2, STAG2, ZRSR2, SF3B1, ASXL1, U2AF1

41
Q

2016 WHO classification of secondary AML

A

categorizes secondary AML together with de novo AML with myelodysplasia or related karyotypes

42
Q

Potential uses for AML MRD

A

1-Deep quantification of antileukemic efficacy
2.Early relapse detectionand intervention during sequential monitoring
3.Therapeutic assignment
4. Patient selection for clinical trials
5. As surrogate endpoint fo OS for regulatory approval

43
Q

AML is a _____

A

Collection of myeloid malignancies which can have changing clonal proportions over time.

44
Q

best test for MRD

A

Not at this time. Optimal would be a on size fits all approach to MRD monitoring.

45
Q

MRD monitoring best for?

A

APL, CML, MM
single variants expressed at the transcript level - CML (bcr-abl)
MM with distinct cell surface phenotypes

46
Q

In the German Experience patients achieving a CR+CRi had an MRD detected by flow of

A

64%

47
Q

in the Italian experience those achieving CR+CRi achieved a MRD detected by wt-1 mrd and mfc of

A

55% and 38% respectively

48
Q

In the french experience patients with CR +CRi MRD by flow,ngs,pcr

A

MRD of 57%

ZZ.PI (6 decks)

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