Biomarker Testing

Question 1

Up to ___% BTC are HER2 Positive?

Answer 1

30%

Question 2

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

Answer 2

T

Question 3

____ Drives tumor growth

Answer 3

HER2 overexpression

Question 4

IHC uses ______ as a sample type and tests for ________

Answer 4

Tissue and Protein Overexpression

Question 5

ISH uses_____ as a sample type and tests for_______

Answer 5

Tissue or liquid (biopsy), and Gene amplification

Question 6

NGS uses _________ as a sample type and tests for ____________

Answer 6

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

Question 7

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

Answer 7

IHC

Question 8

IHC 0 for a biopsy specimen

Answer 8

No reactivity in any tumor cell

Question 9

IHC 1+ for a biopsy specimen

Answer 9

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

Question 10

IHC 2 + for a biopsy specimen

Answer 10

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

Question 11

IHC 3+ for a biopsy specimen

Answer 11

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

Question 12

IHC 2+ is…

Answer 12

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

Question 13

IHC 0 or 1+

Answer 13

HER2 negative

Question 14

IHC 3+

Answer 14

HER2 positive

Question 15

IHC 0 on surgical resection specimen

Answer 15

No reactivity in <10% tumor cells

Question 16

IHC1+ on surgical resection specimen

Answer 16

faint/barely perceptible membranous reactivity >10% tumor cells

Question 17

IHC2+ on surgical resection specimen

Answer 17

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

Question 18

IHC3+ on surgical resection specimen

Answer 18

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

Question 19

ISH can detect chromosome abnormalities such as:

Answer 19

Copy number and Structural alterations (eg. Gene rearrangements)

Question 20

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

Answer 20

mRNA or DNA

Question 21

ISH results are reported as

Answer 21

Positive or Negative for HER2 amplification

Question 22

FOR GEA: Reflex FISH testing results can be either:

Answer 22

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

Question 23

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

Answer 23

HER2 Negative

Question 24

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

Answer 24

HER 2 Negative

Question 25

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

Answer 25

HER2 Positive

Question 26

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

Answer 26

NGS

Question 27

In addition to HER2 amplification. NGS can detect

Answer 27

HER2 Activating mutations

Question 28

HER2 gene alteration detected by NGS do not necessarily indicate________

Answer 28

HER2 Overexpression

Question 29

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

Answer 29

ERBB amplification

Question 30

Comprehensive molecular testing is recommended for patients with BTC who are_____

Answer 30

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

Question 31

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

Answer 31

Previously treated, unresectable, locally advanced or metastatic.

Question 32

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

Answer 32

52%

Question 33

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

Answer 33

6%

Question 34

Median Duration of response

Answer 34

12.9 months

Question 35

Median time to response

Answer 35

1.8 months

Question 36

Mutations in IDH1 and IDH2 induce____

Answer 36

Gain of function activity.

Question 37

FGFR receptors are________ and play a role in______________

Answer 37

Transmembrane, cell proliferation, survival, migration and angiogenesis

Question 38

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

Answer 38

Fusions, Rearrangements, Translocations

Question 39

dMMR (Deficient mismatch repair) can promote__________

Answer 39

MSI (Microsatellite instability)

Question 40

MSI is characterized by___________

Answer 40

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

Question 41

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

Answer 41

Immune checkpoint inhibitors such as PD1 and PD-L1

Question 42

Tumor Mutational Burden (TMB-H)

Answer 42

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

Question 43

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.

Answer 43

Higher

Question 44

Therapeutic targets in BTC also include

Answer 44

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

Question 45

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

Answer 45

30%