To see all protocols that comply with the WHO Essential Medicine List 

There is a great deal of variability in the recommended studies for monitoring patients on immunotherapy. There are no studies evaluating the necessity of the various investigations recommended for monitoring immunotherapy. Several societies recommend extensive panels of tests done on an every cycle basis, whereas modern randomised trials have substantially reduced the breadth and frequency of such testing. The recommendations of eviQ are thus to be considered in view of this great variability, local expertise and experience. Institutional guidelines should also be consulted.

Below is a summary of the available recommendations:

Baseline investigations:

ASCOr ESMOr SITCr

FBC

Electrolytes (Na, K, Ca, CO2)

Creatinine

AST, ALT, alkaline phos, GGT

Total bilirubin

CK

Glucose

LDH and aldolase

TSH, fT4

LH, FSH

Testosterone or oestrogen

Hep B, C, EBV, CMV, HIV serology

Latent TB screen

Troponin

FBC

Renal function tests

Electrolytes

Liver function tests

Glucose

LDH

ESR

Pancreatic tests

Hormonal axis tests [TFT in case of anti-PD-1/PD-L1 and all (TFT, adrenal function tests and gonadotropin hormonal tests) in the case of anti-CTLA4 and combination immunotherapy].

FBC

CMP

TSH, fT4

Total CK

HbA1c

Fasting lipid profile

Hep B, C, CMV, HIV serology

Latent TB screen

Troponin

Consider:

8am cortisol

8am ACTH

BNP

Monitoring with blood tests for immune related toxicities when on immunotherapy:

irAE ASCOr ESMOr SITCr
Hepatitis

AST, ALT and bilirubin prior to each infusion and/or weekly if G1 abnormality develops

AST, ALT and bilirubin prior to every cycle of treatment Liver function testing prior to each cycle of treatment
Thyroiditis TSH and FT4 every 4-6 weeks

TSH and FT4 before every infusion or at least once a month (in the case of 2-weekly infusions)

Anti-CTLA4 +- anti-PD-1:

・ TFTs every cycle

・ TFTs 4-6wkly after C4

Note - late endocrine dysfunction can occur

Anti-PD-1/Anti-PD-L1

・ TFTs every cycle for first 3 months then every second cycle thereafter

TSH and fT4 before each cycle

Diabetes BSL every treatment cycle during induction for 12 weeks, then every 3- 6 weeks “Regular” BSL monitoring BSL before each cycle
Renal dysfunction Serum creatinine prior to every cycle

Serum sodium, potassium, creatinine and urea prior to every infusion

Serum creatinine should be monitored at “intervals” throughout the treatment course

Cardiac

No clear evidence – some centres continue troponin testing through the initial period of therapy

  Troponin I or T weekly for 6 weeks

Hypophysitis/

adrenal insufficiency
If symptomatic - ACTH, cortisol (AM), TSH, FT4, electrolytes and consider evaluating LH, FSH, and testosterone levels in males or estrogen in premenopausal females with fatigue, loss of libido, and mood changes

If symptomatic - ACTH, cortisol (AM or random if unwell and treatment cannot be delayed), TSH/FT4, LH, FSH, oestradiol if premenopausal, testosterone in men, IGF-1, prolactin

Routine monitoring with early morning ACTH and cortisol levels should be considered (every month for 6 months, then every 3 months for 6 months then every 6 months for 1 year)

Pancreatitis Only if symptomatic - amylase and lipase Only if symptomatic - amylase and lipase  
Haematological toxicities  If symptomatic - FBC + smear + others If symptomatic - FBC + smear + others

FBC should be monitored at “intervals” during treatment, and periodically in long-term survivors who are no longer receiving treatment

ESMO general guidelines:r

  • Every infusion (q2-3 weekly) for first 12 weeks
  • Then, every second infusion (q4-6 weekly)
  • Then, first 3 months after cessation for treatment continue with every 4-6 wks
  • Then, thereafter, every 3 months

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First approved:
Review due:

The currency of this information is guaranteed only up until the date of printing, for any updates please check:

https://www.eviq.org.au/p/3549

25 May 2019