NCI (National Cancer Institute) Common Toxicity Criteria Version 1

advertisement
National Cancer Institute (NCI) Common Toxicity Criteria Version 1
Page 1 of 4
NCI (National Cancer Institute) Common Toxicity Criteria Version 1
Category
Toxicity
Grade0
Grade1
Slight
None incoordination,
dysdiadokinesis
No
Mild anxiety,
change depression
NEUROLOGICAL
Cerebellar
NEUROLOGICAL
Mood
NEUROLOGICAL
Headache
None
NEUROLOGICAL
Constipation
None or
no
Mild
change
NEUROLOGICAL
Hearing
None or Asymptomatic
no
hearing loss on
change audiometry only
NEUROLOGICAL
Vision
Mild
None or
no
-change
Scattered macular
None or
or papular rash or
no
erythema that is
change
asymptomatic
SKIN
SKIN
ALLERGY
ALLERGY
None
Transient rash,
drug fever<38°
FEVER/NO
INFECTION
FEVER/NO
INFECTION
None
37.1 - 38.0°
http://www.accessdata.fda.gov/scripts/cder/onctools/toxcrit1.cfm
Grade2
Intention tremor,
dysmetria, slurred
speech, nystagmus
Moderate anxiety,
depression
Moderate or severe,
transient
Grade3
Grade4
Locomotor ataxia cerebellar necrosis
Severe anxiety,
depression
Severe,
unrelenting
Suicidal ideation
--
Moderate
Severe
Ileus > 96 hrs
Tinnitus
Hearing loss
interfering with
function,
Deafness not correctable
correctable with
aid
--
Symptomatic
subtotal loss
Blindness
Scattered macular or
papular rash or
erythema with pruritis
or other symptoms
Generalized
symptomatic
Exfoliative or ulcerating
macular, papular, dermatitis
or vesicular rash
Serum sickness,
Urticaria, drug fever =
bronchospasm
38° mild
Anaphylaxis
requiring
bronchospasm
parenteral meds
>40° for > 24 hrs or
38.1 - 40.0°
>40° for < 24 hrs fever accompanied by
hypotension
7/9/2007
National Cancer Institute (NCI) Common Toxicity Criteria Version 1
TISSUE
LOCAL
Pain & swelling with
inflammation or
Ulceration
phlebitis
Plastic surgery indicated
< 5.0% 5.0 - 9.9%
10.0 - 19.9%
>20%
--
< 116
>64
WNL
< 10.6
>8.4
>1.4
None or
no
change
116 - 160
55 - 64
< 1.5 x N
10.6 - 11.5
8.4 - 7.8
1.4 - 1.2
161 - 250
40 - 54
1.5 - 2.0 x N
11.6 - 12.5
7.7 - 7.0
1.1 - 0.9
251 - 500
30 - 39
2.1 - 5.0 x N
12.6 - 13.5
6.9 - 6.1
0.8 - 0.6
>500 or ketoacidosis
< 30
>5.1 x N
>13.5
< 6.0
< 0.5
Asymptomatic
with abnl PFT's
Dyspnea on
significant exertion
Dyspnea with
normal activity
Dyspnea at rest
Asymptomatic,
transient requires
no Rx.
Asymptomatic,
resting ejection
fraction Ø'd by
<20% of baseline
Recurrent or
persistent Requires no
Rx.
Asymptomatic,
resting ejection
fraction Ø'd by >20%
of baseline
Asymptomatic, ST/T
wave changes
suggesting ischemia
Pericarditis - rub,
chest pain, ECG
changes
Requires Rx.
Requires monitoring; or
hypotension; or vent.
tachycardia/fibrillation
Mild CHF,
responds to Rx.
Severe, refractory CHF
None
METABOLIC
METABOLIC
METABOLIC
METABOLIC
METABOLIC
METABOLIC
WEIGHT
GAIN/LOSS
Hyperglycemia
Hypoglycemia
Amylase
Hypercalcemia
Hypocalcemia
Hypomagnesemia
PULMONARY
Pulmonary
CARDIAC
Dysrhythmias
None
CARDIAC
Function
WNL
WEIGHT GAIN/LOSS
CARDIAC
Ischemia
None
CARDIAC
Pericardial
None
BLOOD PRESSURE
Hypertension
Page 2 of 4
Pain
Nonspecific Twave flattening
Asymptomatic
effusion, no Rx.
required
Asymptomatic,
transient _ by >20
None or
mm (D) or to
no
>150/100 if
change
previously WNL.
No Rx.
Angina without
evidence for
infarction
Symptomatic
effusion,
drainage required
Recurrent/persistent _
by >20 mm (D) or to
Requires Rx.
>150/100 if
previously WNL. No
Rx.
Acute myocardial
infarction
Tamponade; drainage
urgently required
Hypertensive crisis
Changes not
http://www.accessdata.fda.gov/scripts/cder/onctools/toxcrit1.cfm
7/9/2007
National Cancer Institute (NCI) Common Toxicity Criteria Version 1
BLOOD PRESSURE
Hypotension
NEUROLOGICAL
Sensory
NEUROLOGICAL
Motor
BLOOD/BONE
MARROW
BLOOD/BONE
MARROW
BLOOD/BONE
MARROW
BLOOD/BONE
MARROW
BLOOD/BONE
MARROW
Page 3 of 4
requiring Rx.
None or
Requires fluids or
(includes transient
no
other Rx. but not
orthostatic
change
hospitalized
hypotension)
Requires Rx. and Requires therapy and
hospitalization; hospitalization for >48 h
resolves within after stopping agent
Severe objective
None or Mild paresthesias, Mild or moderate
sensory loss or
no
loss of deep
objective sensory loss; paresthesias that -change tendon reflexes
moderate paresthesias interfere with
function
Mild objective
None or Subjective
Objective
weakness, no
no
weakness, no
weakness with Paralysis
significant loss of
change objective findings
loss of function
function
WBC (x1000/mm3) >4.0
3.0-3.9
2.0-2.9
1.0-1.9
< 1.0
PLT (x1000/mm3) WNL
75.0-WNL
50.0-74.9
25.0-49.9
< 25.0
Hgb (gm/dl)
10.0-WNL
8.0-10.0
6.5-7.9
< 6.5
ANC (x1000/mm3) >2.0
1.5-1.9
1.0-1.4
0.5-0.9
< 0.5
Lymph
(x1000/mm3)
>2.0
1.5-1.9
1.0-1.4
0.5-0.9
< 0.5
HEMORRHAGE
Hemorrhage
None
INFECTION
Infection
None
Mild, no Tx.per
episode
Mild
None
Able to eat
Gross, 3-4 units
Tx. per episode
Severe
Unable to eat Ø
intake
Massive, >4 units Tx.
per episode
Life-threatening
GASTROINTESTINAL Nausea
Gross, 1-2 units Tx.
per episode
Moderate
Able to eat reasonable
intake
GASTROINTESTINAL Vomiting
None
1 emesis/24 h
2-5 emeses/24 h
6-10 emeses/24 h
GASTROINTESTINAL Diarrhea
None
_ of 2-3 stools/d
over pre-Rx
_ of 4-6 stools/d
moderate cramping
nocturnal stools
>10 emeses/24 h or
parenteral support
_ of 7-9 stools/d _ of >10 stools/d
severe cramping parenteral support
incontinence
grossly bloody stools
Erythema,
Painful erythema,
Painful
WNL
http://www.accessdata.fda.gov/scripts/cder/onctools/toxcrit1.cfm
--
Parenteral or enteral
7/9/2007
National Cancer Institute (NCI) Common Toxicity Criteria Version 1
WNL
WNL
painless ulcers,
mild soreness
-< 2.5 x N
edema, ulcers can eat erythema, edema, support
ulcers cannot eat
< 1.5 x N
1.5-3.0 x N
>3.0 x N
2.6-5.0 x N
5.1-20.0 x N
>20.0 x N
WNL
< 2.5 x N
2.6-5.0 x N
-< 1.5 x N
1+ or <0.3 gm%
(<3 gm/L)
Microscopic
Mild hair loss
-1.5-3.0 x N
2-3+ or 0.3-1.0 gm%
(3-10 gm/L)
Gross, no clots
Near or total hair loss
GASTROINTESTINAL Stomatitis
None
HEPATIC
HEPATIC
HEPATIC
RENAL/BLADDER
Bilirubin
SGOT/SGPT
Alk
Phos/5'Nucleotidase
Clinical
Creatinine
RENAL/BLADDER
Proteinuria
RENAL/BLADDER
ALOPECIA
Hematuria
Alopecia
-WNL
No
change
Neg.
No loss
NEUROLOGICAL
Cortical
None
COAGULATION
COAGULATION
Fibrinogen
WNL
Protrombin time
WNL
Partial
WNL
thromboplastin time
HEPATIC
COAGULATION
Page 4 of 4
5.1-20.0 x N
>20.0 x N
Precoma
3.1-6.0 x N
4+ or >1.0 gm%
(>10 gm/L)
Gross + clots
-Severe
somnolence,
Mild somnolence, Moderate
agitation,
agitation
somnolence, agitation confusion,
disorientation,
hallucinations
0.99 - 0.75 x N
0.74 - 0.5 x N
0.49 - 0.25 x N
1.01 - 1.25 x N
1.26 - 1.5 x N
1.51 - 2.0 x N
Hepatic coma
>6.0 x N
1.01 - 1.66 x N
>3.0 x N
http://www.accessdata.fda.gov/scripts/cder/onctools/toxcrit1.cfm
1.67 - 2.33 x N
2.34 - 3.0 x N
Nephrotic syndrome
Requires Tx.
--
Coma, seizures, toxic
psychosis
< 0.24 x N
>2.0 x N
7/9/2007
Download