Biomarker Testing Flashcards

1
Q

Up to ___% BTC are HER2 Positive?

A

30%

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2
Q

T/F? HER 2 Testing may not be routine?

A

T

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3
Q

____ Drives tumor growth

A

HER2 overexpression

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4
Q

IHC uses ______ as a sample type and tests for ________

A

Tissue and Protein Overexpression

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5
Q

ISH uses_____ as a sample type and tests for_______

A

Tissue or liquid (biopsy), and Gene amplification

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6
Q

NGS uses _________ as a sample type and tests for ____________

A

Tissue or liquid, and Gene amplification,
gene alterations and activating mutations

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7
Q

What test uses labeled antibodies added to tissue sample (biopsy specimen)?

A

IHC

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8
Q

IHC 0 for a biopsy specimen

A

No reactivity in any tumor cell

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9
Q

IHC 1+ for a biopsy specimen

A

Tumor cell cluster (>5 tumor cells) faint stain. Membranous reactivity.

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10
Q

IHC 2 + for a biopsy specimen

A

Tumor cell cluster (>5 tumor cells) weak to moderate complete, basolateral or lateral membranous activity

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11
Q

IHC 3+ for a biopsy specimen

A

Tumor cell cluster (>5 tumor cells) weak to STRONG complete, basolateral or lateral membranous activity

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12
Q

IHC 2+ is…

A

Equivocal, reflex FISH on same specimen OR: New IHC test on new specimen if original specimen is unavailable

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13
Q

IHC 0 or 1+

A

HER2 negative

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14
Q

IHC 3+

A

HER2 positive

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15
Q

IHC 0 on surgical resection specimen

A

No reactivity in <10% tumor cells

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16
Q

IHC1+ on surgical resection specimen

A

faint/barely perceptible membranous reactivity >10% tumor cells

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17
Q

IHC2+ on surgical resection specimen

A

Weak to moderate complete, basolateral or lateral membranous activity in >10% of tumor cells.

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18
Q

IHC3+ on surgical resection specimen

A

Strong, complete, basolateral or lateral membranous in >10 tumor cells

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19
Q

ISH can detect chromosome abnormalities such as:

A

Copy number and Structural alterations (eg. Gene rearrangements)

20
Q

During ISH a probe targeting a specific _____ or _____ sequence is added to a sample

A

mRNA or DNA

21
Q

ISH results are reported as

A

Positive or Negative for HER2 amplification

22
Q

FOR GEA: Reflex FISH testing results can be either:

A

HER2/CEP17 Ratio <2
HER2/CEP17 Ratio >2 (HER2 Positive)

23
Q

FOR GEA: If HER2/CEP17 ratio <2.0 and CEP17 <3.0/cell then_______

A

HER2 Negative

24
Q

FOR GEA: If HER2/CEP17 ratio <2.0 and CEP17 >3.0/cell and HER2 <4.0/cell then

A

HER 2 Negative

25
Q

FOR GEA: If HER2/CEP17 ratio <2.0 and CEP17 >3.0/cell and HER2>6.0/cell then

A

HER2 Positive

26
Q

Test used in Sequencing millions of DNA and RNA fragments in a single test

A

NGS

27
Q

In addition to HER2 amplification. NGS can detect

A

HER2 Activating mutations

28
Q

HER2 gene alteration detected by NGS do not necessarily indicate________

A

HER2 Overexpression

29
Q

Within an NGS report, the HER2 gene amplification is often referred to as____

A

ERBB amplification

30
Q

Comprehensive molecular testing is recommended for patients with BTC who are_____

A

Not candidates for surgery, who have metastatic disease or who are candidates for systemic therapy

31
Q

Adults with _______, _______,_______,________, HER positive BTC may be eligible for treatment with Zanidatamab

A

Previously treated, unresectable, locally advanced or metastatic.

32
Q

Among patients with IHC2+/IHC3+ , ISH amplifiedf tumors, the confirmed ORR was_________

A

52%

33
Q

Among patients with IHC 2+, ISH amplified tumors the confirmed ORR was _______

A

6%

34
Q

Median Duration of response

A

12.9 months

35
Q

Median time to response

A

1.8 months

36
Q

Mutations in IDH1 and IDH2 induce____

A

Gain of function activity.

37
Q

FGFR receptors are________ and play a role in______________

A

Transmembrane, cell proliferation, survival, migration and angiogenesis

38
Q

FGFR ________, __________, __________ have been reported in BTC’s

A

Fusions, Rearrangements, Translocations

39
Q

dMMR (Deficient mismatch repair) can promote__________

A

MSI (Microsatellite instability)

40
Q

MSI is characterized by___________

A

A high frequency of mutations that occur in repeated sequences known as Microsatellites.

41
Q

MSI-H/dMMR tumors are susceptible to treatment with ____________________

A

Immune checkpoint inhibitors such as PD1 and PD-L1

42
Q

Tumor Mutational Burden (TMB-H)

A

Tumors with a high mutational burden harbor >10 mutations per megabase of DNA

43
Q

As with MSI-H/dMMR tumors, responses to immune checkpoint inhibitors have been shown to be ___________ in TMB-H cancers compared to non TMB-H cancers.

A

Higher

44
Q

Therapeutic targets in BTC also include

A

G12C, KRAS, RET gene fusions, BRAF mutations, NTRK Gene fusions.

45
Q

HER2 is a biomarker found in approx ______% patients with BTC

A

30%