Clinical characteristics and treatment-related biomarkers associated with response to high-dose interleukin-2 in metastatic melanoma and renal cell carcinoma: retrospective analysis of an academic community hospital’s experience

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Table 1 Institutional guidelines - relative and absolute criteria for discontinuation of IL-2 therapy

System	Relative criteria	Absolute criteria
Cardiac	Sinus tachycardia, HR 120 – 130	Sinus tachycardia, HR >130
		EKG Ischemia
		Atrial Fibrillation
		Frequent PVCs, bigeminy, ventricular arrhythmia
		Elevated cardiac enzymes
Dermatologic		Moist desquamation
Gastrointestinal	Diarrhea >1000cc/shift	Refractory vomiting
	Diarrhea >1000cc/shift	Unrelenting abdominal pain
	Abdominal distension	Unrelenting abdominal pain
Hemodynamic		Hypotension requiring pressors
Hemorrhage	Guiac-positive stool, sputum or emesis	Frank blood in stools, sputum or emesis
	Platelets 30,000 – 50,000/mm³	Frank blood in stools, sputum or emesis
	Platelets 30,000 – 50,000/mm³	Platelets < 30,000/mm³
Infectious		Strong clinical suspicion or documented
Neurologic		Mental status changes
Neurologic		Disorientation, vivid dreams, emotional lability
Pulmonary	Resting dyspnea	>4 L oxygen needed for saturations >95%
	Crackles present in >1/3 but <1/2 chest	Crackles present in >1/2 chest
	Crackles present in >1/3 but <1/2 chest	40% oxygen mask for saturations >95%
	3 – 4 L oxygen for saturations > 95%	40% oxygen mask for saturations >95%
	3 – 4 L oxygen for saturations > 95%	Intubation
Renal	Urine output 80 – 160 mL/8 hour	Urine <80 mL/8 hour
		Urine < 10 mL/hour
		Creatinine ≥ 3 mg/dL
	Urine 10 – 20 mL/hour
	Creatinine 2.5 – 2.9 mg/dL
Weight Gain	15% over baseline

In the occurrence of any relative criteria the dose is held, corrective action taken and patient re-assessed at next scheduled time. Discontinue therapy if ≥ 3 relative criteria occur or for any one absolute criteria. Discontinue therapy if pressors are needed for hypotension, neurological changes or the scheduled dose has been held on 3 occasions.
HR = heart rate, EKG = electrocardiogram, PVC = premature ventricular contraction).