The Common Toxicity Criteria (CTC) define adverse events following cancer therapy. It was designed for use in clinical trials of different therapeutic regimens. Criteria are given for the severity of coagulation disorders as a result of the cancer therapy.
Types of coagulation complications:
(1) disseminated intravascular coagulation (DIC)
(2) fibrinogen
(3) prothrombin time (PT)
(4) activated partial thromboplastin time (aPTT)
(5) thrombotic microangiopathy: thrombotic thrombocytopenic purpura (TTP) or hemolytic uremic syndrome (HUS)
Grade 0: normal or no change
|
Parameter |
Finding |
Grade |
|
fibrinogen |
>= LLN |
0 |
|
|
>= 75% and < 100% LLN |
1 |
|
|
>= 50% and < 75% LLN |
2 |
|
|
>= 25% and < 50% LLN |
3 |
|
|
< 25% LLN |
4 |
|
fibrinogen (protocol) |
>= LLN |
0 |
|
|
< 20% decrease of pretreatment value or LLN |
1 |
|
|
>= 20% to < 40% decrease |
2 |
|
|
>= 40% to < 70% decrease |
3 |
|
|
< 50 mg |
4 |
|
PT |
<= ULN |
0 |
|
|
> ULN to <= 1.5 times ULN |
1 |
|
|
> 1.5 ULN to <= 2.0 ULN |
2 |
|
|
> 2 times ULN |
3 |
|
aPTT |
<= ULN |
0 |
|
|
> ULN to <= 1.5 times ULN |
1 |
|
|
> 1.5 ULN to <= 2.0 ULN |
2 |
|
|
> 2 times ULN |
3 |
where:
• ULN = upper limit of normal reference range
• LLN = lower limit of normal reference range
• BMT = bone marrow transplant studies
• Fibrinogen (protocol), Grade 4: A > 70% decrease would seem a possible criterion.
|
Parameter |
Finding |
Grade |
|
DIC |
none |
0 |
|
|
lab findings without no bleeding |
3 |
|
|
lab findings and bleeding |
4 |
|
TTP/HUS |
none |
0 |
|
|
schistocytosis without clinical findings |
1 |
|
|
schistocytosis with elevation in creatinine (<= 3 times ULN) |
2 |
|
|
schistocytosis with elevation in creatinine (> 3 times ULN) without dialysis |
3 |
|
|
schistocytosis with renal failure requiring dialysis; encephalopathy present |
4 |
where:
• Laboratory findings for DIC include increased fibrin split products and/or D-dimer, reduction in platelet count, reduction in fibrinogen, and consumption of coagulation factors.
• For TTP/HUS must have microangiopathic changes on the peripheral blood smear, with schistocytes, helmet cells and red blood cell fragments.
• The criteria have 2 forms for reporting TTP/HUS, one of which appears to be for BMT studies. I have combined both into 1 form.
Specialty: Hematology Oncology
