National Cancer Institution (NCI) Toxicity Criteria

Transcription

1 National Cancer Institution (NCI) Toxicity Criteria Toxicity Grade Blood/Bone Marrow WBC? <1.0 PLT WNL normal <25.0 Hgb WNL normal <6.5 Granulocytes/ Bands? <0.5 Lymphocytes? <0.5 Haemorrhage None mild, no transfusion gross, 1-2 units gross, 3-4 units massive, >4 units (clinical) transfusion per transfusion per transfusion per episode episode episode Infection None mild moderate severe life-threatening Gastrointestinal Nausea able to eat reasonable intake intake significantly decreased but can eat Vomiting 1 episode in 24 hrs 2-5 episodes in 24 hrs no significant intake episodes in 24 >10 episodes in 24 hrs, hrs or requiring parenteral support Diarrhoea increase of 2-3 increase of 4-6 increase of 7-9 increase of?10 stools/day over stools/day, or stools/day, or stools/day or grossly pre-rx nocturnal stools, or incontinence, or bloody diarrhoea, or moderate cramping severe cramping need for parenteral support Stomatitis painless ulcers, painful erythema, painful erythema, requires parenteral or erythema, or mild oedema, or ulcers, oedema, or ulcers, enteral support soreness but can eat and cannot eat NCI Toxicity Criteria Page 1 of 6

2 Liver Bilirubin WNL --- ULN-1.5 x ULN > x ULN >3.0 x ULN Transaminase (SGOT, SGPT) WNL >ULN-2.5 X ULN > X ULN > X ULN >20.0 x ULN Alkaline Phosphatase or 5'nucleotidase WNL >ULN-2.5 X ULN > X ULN > x ULN >20.0 x ULN Liver -- (clinical) no from baseline precoma hepatic coma Kidney, Bladder Creatinine WNL >ULN-1.5 x ULN > x ULN > x ULN >6.0 x ULN Proteinuria no 1 + or < 0.3 g% or or > 1.0 g% nephrotic syndrome or < 3 g/l g% or 3-10 g/l or > 10 g/l Haematuria negative micro only gross, no clots gross + clots requires transfusion Alopecia no loss mild hair loss pronounced or total loss Pulmonary with dyspnoea on dysp noea at normal dyspnoea at rest abnormality in PFTs significant exertion level of activity NCI Toxicty Criteria Page 2 of 6

3 Heart Cardiac recurrent or requires treatment requires monitoring; dysrhythmias transient, requiring persistent, no or hypotension, no therapy therapy required or ventricular tachycardia, or fibrillation Cardiac function normal mild CHF, Severe or refractory decline of resting decline of resting responsive to CHF ejection fraction by ejection fraction by therapy less than 20% of more than 20% of baseline value baseline value Cardiac -- non-specific T-wave angina without acute myocardial ischaemia flattening ST and T - wave evidence of infarction s suggesting infarction ischaemia Cardiac -- asymptomatic pericarditis (rub, symptomatic tamponade; drainage pericardial effusion, no chest pain, ECG effusion; drainage urgently required intervention required s) required Blood Pressure Hypertension recurrent or requires therapy hypertensive crisis transient increase by persistent increase greater than 20 mm by greater than 20 Hg (D) or to mm Hg (D) or to >150/100 if >150/100 if previously WNL. previously WNL. No treatment No treatment required required Hypotension s requiring no requires fluid requires therapy and requires therapy and therapy (including replacement or other hospitalisation; hospitalisation for >48 transient orthostatic therapy but not resolves within 48 hrs after stopping the hypotension) hospitalisation hrs of stopping the agent agent NCI Toxicty Criteria Page 3 of 6

4 Neurological sensory mild paresthesias, loss of deep tendon reflexes mild or moderate objective sensory loss; moderate severe objective sensory loss or paresthesias that --- paresthesias interfere with function subjective weakness; mild objective objective weakness paralysis motor no objective weakness without with impairment of findings significant function impairment of function cortical mild somnolence or moderate severe somnolence, coma, seizures, toxic agitation somnolence or agitation, confusion, psychosis agitation disorientation, or hallucinations slight intention tremor, locomotor ataxia cerebellar necrosis cerebellar incoordination, dysmetria, slurred dysdiadochokinesia speech, nystagmus mood no mild anxiety or moderate anxiety or severe anxiety or suicidal ideation depression depression depression mild moderate or severe unrelenting and --- headache but transient severe constipation mild moderate severe ileus >96 hrs hearing tinnitus hearing loss deafness not hearing loss on interfering with correctable audiometry only function but correctable with hearing aid vision symptomatic blindness subtotal loss of vision NCI Toxicty Criteria Page 4 of 6

5 Skin scattered macular or scattered macular or generalized exfoliative dermatitis papular eruption or papular eruption or symptomatic or ulcerating dermatitis erythema that is erythema with macular, papular, or asymptomatic pruritus or other vesicular eruption associated symptoms Allergy transient rash, drug urticaria, drug fever serum sickness, anaphylaxis fever <38 C, 100.4? F =38 C, 100.4?F mild bronchospasm bronchospasm, req parenteral meds Fever in absence of infection C C >40.0 C for less than 24 hrs >40.0 C (104.0 F) for more than 24 hrs or fever accompanied by hypotension Local pain pain and swelling, with inflammation or phlebitis ulceration plastic surgery indicated Weight gain/loss <5.0% % %?20.0% --- Metabolic Hyperglycaemia < >500 or ketoacidosis Hypoglycaemia > <30 Amylase WNL <1.5 x N x N x N >5.1 x N Hypercalcaemia < ?13.5 Hypocalcaemia > ?6.0 Hypomagnesaemi > ?0.5 a NCI Toxicty Criteria Page 5 of 6

6 Coagulation Fibrinogen WNL x N x N x N?0.24 x N Prothrombin time WNL x N x N x N >2.00 x N Partial thromboplastin time WNL x N x N x N >3.00 x N NCI Toxicty Criteria Page 6 of 6