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Biomarkers > Biomarkers and Biomarker Testing > Flashcards

Biomarkers and Biomarker Testing Flashcards

1
Q

What are the Guideline Sources for Biomarker Testing?

Hint: CAN

A

College of American Pathologists/Intl. Assc. for the Study of Lung Cancer/Assc. for Molecular Pathology (CAP/IASLC/AMP)

American Society of Clinical Oncology (ASCO)

National Comprehensive Cancer Network (NCCN)

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2
Q

What is a Diagnostic Biomarker?

A

Biomarker used to detect or confirm presence of a disease or condition of interest or to identify individuals with a subtype of the disease

Is there an illness? What type of disease is it?

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3
Q

What is a Monitoring Biomarker?

A

Biomarker measured serially for assessing status of a disease or medical condition or for evidence of exposure to (or effect of) a medical product or an environmental agent

What is the status or extent of a disease or medical condition?

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4
Q

What is a Predictive Biomarker?

A

Biomarker used to identify individuals who are more likely than similar individuals without the biomarker to experience a favorable or unfavorable effect from exposure to a medical product or an environmental agent

What is the likelihood of response to a treatment?

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5
Q

What is a Prognostic Biomarker?

A

Biomarker used to identify likelihood of a clinical event, disease recurrence, or progression in patients who have the disease or medical condition of interest

What is the likelihood of a particular clinical outcome?

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6
Q

What is the difference between an Actionable Biomarker and an Emerging Biomarker?

A

Actionable biomarkers can be targeted by FDA approved products whereas products targeting emerging biomarkers are still under investigation

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7
Q

Actionable Biomarker(s) for Targeted Therapy with TKIs?

Hint: RAMEN-R

A 
RET
ALK
MET
EGFR
NTRK
-
ROS1
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8
Q

Actionable Biomarker(s) for Combined BRAF and MEK Inhibitors?

A

BRAF

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9
Q

Actionable Biomarker(s) for Immune Checkpoint Inhibitors?

A

PD-L1 Expression Levels (immune checkpoint protein that inhibits T-cell activation)

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10
Q

Emerging Biomarker(s) for NSCLC?

HINT: TEK

A

TMB
ERBB2 (HER2)
KRAS

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11
Q

True or False; the presence of a known activating mutation in KRAS identifies patients who are unlikely to benefit from further molecular testing?

A

True

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12
Q

What is the incidence of KRAS mutations in NSCLC patients?

A

25 - 35%

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13
Q

True or False; NCCN, CAP/IASLC/AMP, and ASCO recommend expanded testing of KRAS as an emerging biomarker

A

True

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14
Q

True or False; Adhering to guideline-recommended biomarker testing improves outcomes

A

True

11% decreased risk for all -cause mortality

22% decreased risk for all-cause mortality at 1 year for those with Stage IV initial diagnosis

8% increase in median OS

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15
Q

True or False; Many patients do not receive biomarker testing and targeted therapy

Hint: Academic and Government vs. Community

A

True; only 22% of patients are tested for all four guideline-recommended actionable biomarkers in community practices and 55% of patients with actionable mutations do not receive targeted therapy

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16
Q

What are the four guideline-recommended actionable biomarkers?

Hint: BEAR

A

BRAF
EGFR
ALK
ROS1

17
Q

What are the seven biomarkers recommended by NCCN guidelines?

Hint BEAR REM

A

BRAF
EGFR
ALK
ROS1

MET
ERBB2
RET

Note: KRAS is not on this list

18
Q

Name five biopsy methods

A

Sputum cytology, thoracentesis, needle biopsy, bronchoscopy, surgery

19
Q

Under what situations does the NCCN recommend the use of a liquid biopsy?

Hint: Two

A
  1. The patient is not medically fit for invasive tissue sampling
  2. The is insufficient tissue for molecular analysis and follow-up tissue-based analysis will be done if a genetic abnormality is not identified by liquid biopsy
20
Q

Name some of the Pros and Cons of Liquid Biopsy

Hint: Consider Method, Tumor Heterogeneity, Sample Collection, Sample Requirements, Sample Integrity

A

Pros: Minimally invasive blood sample, captures tumor heterogeneity

Cons: Helps when insufficient tissue is available or when patient is unfit for biopsy, not all tumors shed cfDNA, requires fast turnaround to maintain sample integrity

21
Q

Name some of the Pros and Cons of Tissue Biopsy

Hint: Consider Method, Tumor Heterogeneity, Sample Collection, Sample Requirements, Sample Integrity

A

Pros: Tissue comes directly from the primary tumor or metastatic sites (Gold Standard)

Cons: Collecting adequate sample size, invasive with possible complications (esp. if tumor is inaccessible)

22
Q

True or False; Tissue and liquid biopsy have reasonable concordance (agreement or consistency) across multiple biomarkers?

23
Q

Name five methodologies used to assess NSCLC biomarkers

Hint: SNIP-F

A 
Sanger sequencing
NGS
Immunohistochemistry (IHC)
PCR
-
Flourescence in situ hybridization (FISH)
24
Q

Immunohistochemistry (IHC) can detect ___ biomarker(s) at a time and (can / cannot) be used to assess for a KRAS mutation.

A

One

Cannot

25
Q

Flourescence in situ hybridation (FISH) can detect ___ biomarker(s) at a time and (can / cannot) be used to assess for a KRAS mutation.

A

One

Cannot

26
Q

PCR can detect ___ biomarker(s) at a time and (can / cannot) be used to assess for a KRAS mutation.

A

One; exception is multiplex PCR

Can

27
Q

Sanger sequencing (can / cannot) be used for a KRAS mutation but requires ___% tumor cells to get accurate results.

A

Can

25 - 30%

28
Q

NGS (does / does not) require selection of biomarkers of interest prior to testing and (can / cannot) be used to assess for a KRAS mutation.

A

Does not

Can

29
Q

True or False; molecular tests (Sanger sequencing, NGS, PCR) can be used to assess for a KRAS mutation

30
Q

Which of the following test(s) go through clinical trials for FDA approval to receive indications for specific therapies?

Lab-developed test (LDT)
Companion Diagnostic (CDx)
A

Companion Diagnostic (CDx); may have a higher standard for analytical and clinical validity due to FDA regulation

31
Q

True or False; there are a few CDx tests approved to test for KRAS in patients with NSCLC

A

False; however, some CDx’s are approved for KRAS testing in colorectal samples to include KRAS G12C.

32
Q

Identify five formats for reporting of KRAS G12C results on a biomarker testing results form

A 
Codon: 12
Exon: 2
Amino acid: NP_203524.1; pGly12Cys
Nucleotide change: GGT -> TGT; c.34G>T
Variant ID: COSM516
33
Q

Which one of the following describes KRAS in its active state and which one describes KRAS in its inactive state.

KRAS G12C - GDP
KRAS G12C - GTP

A

GDP - Inactive
GTP - Active

Hint: Phosphorylation “activates” so tri-phosphate is active, and di-phosphate is inactive

34
Q

KRAS G12C accounts for nearly ___ of all KRAS mutations, making it one of the most prevalent drivers of mutations in NSCLC

A

Half, or 44%

35
Q

What is a truncal mutation?

Hint: Trunk

A

Mutation that is theoretically present in every cancer cell, or at the trunk of the cancer evolutionary tree

36
Q

True or False; KRAS mutations occur in smokers (current and former) as well as non-smokers

37
Q

True or False; KRAS G12C is mutually exclusive from other actionable and emerging mutations and patient status does not seem to change over time

38
Q

Which payer type does not require Prior Authorization and no Patient Cost-Sharing?

Original Medicare
Medicare Advantage
Commercial

A

Original Medicare; but patients may be responsible for an office visit co-pay

Biomarkers (4 decks)

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