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Cancer Pharmacology > Systemic Clinical Cancer Treatment (2) > Flashcards

Systemic Clinical Cancer Treatment (2) Flashcards

1
Q

What are the primary curative cancers for systemic treatment?

A

Leukaemia
Lymphomas
Germ cell tumours

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2
Q

What is adjuvant and neoadjuvant chemotherapy?

A

Improve chances of cure before and after surgery or radiotherapy

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3
Q

What is palliative treatment?

A

Reduce tumour burden
Symptom control, increase quality of life
Increase survival

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4
Q

What is an objective way to assess the benefit of a therapy?

A

Volume changes in tumours

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5
Q

What ways can you assess survival to assess the benefit of therapy?

A

Overall survival
Progression free survival
Relapse free survival

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6
Q

What 3 ways can you assess cancer treatment benefit?

A

Survival
Objective response
Health related quality of life

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7
Q

How can you use healthy related quality of life to assess cancer treatment benefit?

A

Objectively assess symptoms, always want a drug which makes the patient as comfortable as possible

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8
Q

What is a complete response?

A

Disappearance of all target lesions

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9
Q

What is partial response?

A

A least a 30% decrease in the sum of diameters of target lesions

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10
Q

What is a progressive disease?

A

At least a 20% increase in the sum of diameters of target lesions

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11
Q

What is stable disease?

A

Neither sufficient shrinkage to qualify for a partial response nor sufficient increase to qualify for progressive disease

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12
Q

What is objective response rate?

A

= complete response + partial response

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13
Q

What is disease control rate?

A

= complete response + partial response + stable disease

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14
Q

How quickly can you determine objective response rate?

A

In weeks or months of starting treatment

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15
Q

How do you conduct a clinical trial?

A

Not everyone will get treatment at the same time but they have to have the treatment for the same amount and finish at the same time

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16
Q

What statistical model is used to calculate survival analysis?

A

Kaplan-Meier

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17
Q

What is the hazard ratio?

A

It estimates over the period of time of the study the chances of a patient dying of one therapy compared to the other

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18
Q

How is health related quality of life measured?

A

Patients reported outcomes
Objectively measuring symptom improvement and its impact
Takes into account the toxicities of the treatment

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19
Q

What is primary or inherent resistance?

A

No response seen, tumour continues to grow and spread

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20
Q

What is secondary resistance?

A

Initial response but then regrowth of the tumour either while the patient is still on the same medicine or after it has stopped

21
Q

How does circulating free tumour DNA (ctDNA) work?

A

The tumour leaks DNA out into the blood and you can sequence this and identify copy number changes, gene mutations and abnormalities

22
Q

What are the benefits of ctDNA

A

Because it is a blood test it is non-invasive and is repeatable
Able to detect new tumours a lot earlier than CT scans

23
Q

How many patients with NSCLC develop EGFR resistance?

A

50%

24
Q

What 3rd generation drug targets EGFR and EGFR resistance mutations?

A

Osimertinib

25
Q

Of 10,000 chemicals in pre-clinical trials, approximately how many make it to clinical trials and how many are approved?

A

Clinical Trials - 5

Approved - 1

26
Q

How many patients are involved in phase I clinical trials?

A

40-50

27
Q

What is the main reason for phase I clinical trials?

A

To get a safe dose optimum

28
Q

Who take part in phase I clinical trials?

A

Cancer patients who remain fit but have exhausted all other options

29
Q

What are the outcomes of phase I clinical trials?

A

If the drug is safe or if it has unacceptable toxicities
The dose is chosen
Anti-cancer efficacy

30
Q

What two doses do they generate?

A

Maximal tolerated dose

Biologically effective dose

31
Q

What is the biologically effective dose based on?

A

Pharmacokinetics

Pharmacodynamic biomarker

32
Q

Why is biologically effective dose used sometimes?

A

Targeted drugs tend to have less side effects than cytotoxic chemotherapies and therefore you use this dose instead of the really high dose

33
Q

What is pharmacokinetics?

A

Measure the concentration of the drug in the plasma or tissue

34
Q

Why are pharmacodynamic biomarkers used?

A

To make sure the drug is hitting the right target

may involve a biopsy

35
Q

How many patients are involved in phase II clinical trials?

A

50-100

36
Q

What is the main aim for phase II clinical trials?

A

To access the potential efficacy
Determine which cancer type it targets based on pre-clinical work and phase I results
Confirm safety, side effects and dose
Is the drug more effective than the current standard of care?

37
Q

How is the potential efficacy measured?

A

measuring short term changes in tumour volume

38
Q

How can you analyse changes in tumour volume?

A

Waterfall plots - compare against the current standard of care

39
Q

How many patients are involved in phase III clinical trials?

A

hundreds - thousands

40
Q

What is the main aim of phase III clinical trials?

A

To get the survival benefit of the drug by testing:

  • overall survival
  • progression free survival
  • relapse free survival
  • symptom control, quality of life
41
Q

What is phase IV clinical trials?

A

Licensing for clinical use involving assessment of all trials
Reimbursement approval from some healthcare systems, including the NHS

42
Q

What do they consider when healthcare systems complete reimbursement approval?

A

Comparative clinical effectiveness

Comparative cost effectiveness

43
Q

What is a biomarker?

A

A parameter that can be objectively measured in a patient or their disease that will provide information regarding a defined biological process or clinical outcome

44
Q

What types of biomarkers are there?

A 
Screening biomarkers 
Diagnostic biomarkers
Pharamacodynamic biomarkers 
Predictive biomarkers 
Prognostic biomarkers
45
Q

What are the stages of biomarker development?

A

Discovery -> Qualification -> Validation -> Implementation

46
Q

What is the qualification component of biomarker development?

A

Building up evidence that the biomarker does what it is meant to do

47
Q

What is the validation component of biomarker development?

A

The technical process of developing the assay which makes the biomarker and make sure it works on all materials e.g. blood and tissue

48
Q

Why are predictive biomarkers needed?

A

Clinical effectiveness

Cost effectiveness

Cancer Pharmacology (13 decks)

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