Treatment: cancer immunotherapy (anti-PD-1, anti-PD-L1, anti-CTLA-4)

Fasting laboratory tests, 10 to 15 days before the first infusion

• FBC with platelets
• Serum electrolytes
• Serum creatinine with eGFR
• Full liver function tests: AST
• ALT
• GGT
• Alkaline phosphatase
• Bilirubin
• Fasting plasma glucose
• TSH (free T4 as a reflex test if TSH abnormal)
• 8 am serum cortisol (away from any corticosteroid therapy)
• Troponin
• Creatine kinase (CK)
• NT-proBNP
• Lipid profile
• Hepatitis B serology (HBsAg, anti-HBc, anti-HBs)
• Hepatitis C serology
• HIV serology
• HbA1c
• Free T4 straight away with the TSH (anti-CTLA-4 or combination)if neededThe SFE asks for TSH and free T4 together at every check ^[2]; TNCD asks for free T4 only if TSH is abnormal ^[3]. Useful above all under anti-CTLA-4, where hypophysitis predominates ^[3]. Outside the reflex-test setting, not reimbursed in France unless a central cause is suspected ^[4].
• LH, FSH, testosterone (men); FSH (postmenopausal women)if neededRecommended by the SFE to screen for hypophysitis ^[2]; absent from the TNCD tests ^[3].
• Serum β-hCG (woman of childbearing potential)if neededWoman of childbearing potential ^[3].

Urine tests

• Urine protein:creatinine ratio (spot sample)
• Urine microscopy and culture
• Not a laboratory test: baseline ECG (copy given to the patient), chest imaging, oxygen saturation.

Before each infusion

• FBC with platelets
• Serum electrolytes
• Serum creatinine with eGFR
• Full liver function tests: AST
• ALT
• GGT
• Alkaline phosphatase
• Bilirubin
• Urine protein:creatinine ratio (spot sample)
• Urine microscopy and culture

At each cycle for 6 months, then every 2 cycles

• Fasting plasma glucose
• TSH (free T4 as a reflex test if TSH abnormal)
• Free T4 straight away with the TSH (if anti-CTLA-4 or combination)if neededThe SFE ^[2], ASCO ^[9], the German S3 ^[5], SITC ^[6] and the ESE ^[7] measure free T4 with TSH; TNCD only if TSH is abnormal ^[3]. Hypophysitis, especially under anti-CTLA-4, may leave TSH normal or low ^[3,9]. Outside the reflex-test setting, not reimbursed in France unless a central cause is suspected ^[4].
• 8 am serum cortisol
• Testosterone (men)if neededRecommended by the SFE at every check for 6 months ^[2]; absent from TNCD follow-up ^[3].

During the first 4 cycles, then every 3 months

• Troponin (same laboratory as the baseline value)
• Not a laboratory test: ECG at the same frequency as troponin; examination of the skin and mucous membranes before each infusion.

• Patient looks seriously ill: call the emergency medical service (SAMU); hydrocortisone without waiting for the cortisol result.

Laboratory tests the same day

• Plasma glucose
• Serum electrolytes (sodium, potassium)
• Serum cortisol, whatever the time (note the time and any corticosteroid intake)
• ACTH, on the same sample as the cortisol (if possible)if needednon-French guidelineDistinguishes primary adrenal insufficiency (high ACTH) from hypophysitis (low or normal ACTH); to be taken at the same time as cortisol, without delaying hydrocortisone ^[2,9].
• TSH (free T4 as a reflex test if TSH abnormal)
• Free T4 straight away with the TSH (write "suspected central hypothyroidism")if neededHeadache, severe fatigue, hyponatraemia or another sign of hypophysitis: TSH may remain normal or low despite thyrotroph deficiency, hence the free T4 measurement ^[2,9]. Covered by the French laboratory fee schedule (NABM) straight away if suspicion of a central cause is stated on the prescription (procedure 1211) ^[4].
• Serum creatinine with eGFR
• AST
• ALT
• GGT
• Alkaline phosphatase
• Bilirubin
• FBC with platelets
• Troponin, CK (chest pain, dyspnoea, palpitations, muscle weakness)if neededSuspected myocarditis or myositis: urgent specialist advice and suspension of immunotherapy ^[3].
• Stool culture, Clostridioides difficile testing (if diarrhoea)if neededAn infectious colitis must be ruled out before any corticosteroid therapy according to TNCD ^[3], SITC ^[6] and eviQ in Australia ^[11]. Sampling does not delay a treatment judged necessary ^[6].
• Serum lipase (if abdominal pain or vomiting)if needednon-French guidelineTo look for pancreatitis: SITC ^[6] and eviQ ^[11] reserve this test for symptoms, like ASCO ^[9]. An isolated rise without symptoms is not treated ^[11]; hence no routine measurement during treatment.

At 1 month, 3 months and 6 months after stopping

• TSH (free T4 as a reflex test if TSH abnormal)
• 8 am serum cortisol
• AST
• ALT
• GGT
• Alkaline phosphatase
• Bilirubin

Every month for 6 months

• Urea
• Serum creatinine with eGFR

Between 6 and 12 months after stopping

• Troponin
• Not a laboratory test: ECG between 6 and 12 months after stopping.