Table 1.
VCOG-CTCAE v1.1 grading criteria applied to both pretreatment and toxicity-related clinical and laboratory abnormalities in cats with relapsed low-grade alimentary lymphoma receiving rescue cyclophosphamide after failing chlorambucil treatment
| Parameter | Grade 1 | Grade 2 | Grade 3 | Grade 4 |
|---|---|---|---|---|
| Weight loss | <10% from baseline; intervention not indicated | 10–15% from baseline; nutritional dietary modification indicated | >15% of baseline | – |
| Anorexia | Coaxing or dietary change required to maintain appetite | Oral intake altered (⩽3 days) without significant weight loss; oral nutritional supplements/appetite stimulants may be indicated | Of >3 days’ duration; associated with significant weight loss (⩾10%) or malnutrition; IV fluids, tube feeding or force feeding indicated | Life-threatening consequences; TPN indicated; >5 days’ duration |
| Vomiting | <3 episodes in 24 h, medical intervention not indicated | 3–10 episodes in 24 h; <5 episodes/day for ⩽48 h; parenteral fluids (IV or SC) indicated ⩽48 h; medications indicated | Multiple episodes >48 h and IV fluids or PPN/TPN indicated >48 h | Life-threatening (eg, hemodynamic collapse) |
| Diarrhea | Increase of up to two stools per day over baseline; no increase in frequency; however, consistency decreased over baseline | Increase of 3–6 stools per day over baseline; medications indicated; parenteral (IV or SC) fluids indicated ⩽48 h; not interfering with ADL | Increase of >6 stools per day over baseline; incontinence >48 h; IV fluids >48 h; hospitalization; interfering with ADL | Life-threatening (eg, hemodynamic collapse) |
| Lethargy | Mild lethargy over baseline; diminished activity from pre-disease level, but able to function as an acceptable pet | Moderate lethargy causing some difficulty with performing ADL; ambulatory only to the point of eating, sleeping and consistently defecating and urinating in acceptable areas | Compromised, severely restricted in ADL; unable to confine urinations and defecation to acceptable areas; will consume food if offered in place | Disabled, must be force fed and helped to perform ADL |
| Dehydration | Increased oral fluids indicated; dry mucous membranes; <skin turgor | Parenteral (IV or SC) fluids indicated <48 h | IV fluids indicated >48 h | Life-threatening (eg, hemodynamic collapse) |
| Fever | 103.5–104°F (39.7–40°C) | >104–105.8°F (40–41°C), transient (<6 h), not requiring hospitalization | >105.8–107.6°F (41–42°C), prolonged (>6 h); requiring hospitalization | >107.6ºF (42ºC) |
| Ascites | Clinical or diagnostic observations only; intervention not indicated | Symptomatic; medical intervention indicated | Severe clinical signs; invasive intervention indicated | Life-threatening consequences; urgent operative intervention indicated |
| PCV | 25% to <LLN | 20 to <25% | 15 to <20% | <15% |
| Neutropenia | 1500 μl–¹ to <LLN | 1000−1499 μl–¹ | 500−999 μl–¹ | <500 μl–¹ |
| Thrombocytopenia | 100,000 μl–¹ to <LLN | 50,000−99,000 μl–¹ | 25,000−49,000 μl–¹ | <25,000 μl–¹ |
| BUN | >1–1.5 × baseline; >ULN to 1.5 × ULN | >1.5–3 × baseline; >1.5–2.0 × ULN | >3 × baseline; >2.0–3 × ULN | >3 × ULN |
| Creatinine | >1–1.5 × baseline; >ULN to 1.5 × ULN | >1.5–3 × baseline; >1.5–2.0 × ULN | >3 × baseline; >2.0–3 × ULN | >3 × ULN |
| ALT | >ULN to 1.25 × ULN | >1.25–1.5 × ULN, transient (<2 weeks) | >1.5–2.0 × ULN | >2 × ULN |
| ALP | >ULN to 1.25 × ULN | >1.25–1.5 × ULN, transient (<2 weeks) | >1.5–2.0 × ULN | >2 × ULN |
| Potassium, high | >ULN–5.5 mmol l–¹ | >5.5–6.0 mmol l–¹ | >6.0–7.0 mmol l–¹ | >7.0 mmol l–¹ |
| Bilirubin | >ULN to 1.5 × ULN | >1.5–3.0 × ULN | >3.0–10 × ULN | >10 × ULN |
| Glucose, high | >ULN–200 mg dl–¹ | >200–250 mg dl–¹ | >250–500 mg dl–¹ | >500 mg dl–¹ |
| Thyroid function, hyperthyroidism | Asymptomatic; clinical or diagnostic observations only; intervention not indicated | Symptomatic; thyroid suppression therapy indicated; limiting ADL | Severe clinical signs; limiting ADL, hospitalization indicated | Life-threatening consequences; urgent intervention indicated |
| Potassium, low | <LLN–3.0 mmol l–¹ | – | <3.0–2.5 mmol l–¹ | <2.5 mmol l–¹ |
| Calcium, low | <LLN–8.0 mg dl–¹; ionized: <LLN–0.9 nmol l–¹ | <8.0–7.0 mg dl–¹; ionized: <0.9–0.8 nmol l–¹ | <7.0–6.0 mg dl–¹; ionized: <0.8–0.7 nmol l–¹ | <6.0 mg dl–¹; ionized: <0.7 nmol l–¹ |
| Albumin, low | <LLN–2.0 g dl–¹ | <2.0–1.5 g dl–¹ | <1.5 g dl–¹ | – |
VCOG–CTCAE = Veterinary Cooperative Oncology Group – common terminology criteria for adverse events; IV = intravenous; TPN = total parenteral nutrition; SC = subcutaneous; PPN = partial parenteral nutrition; ADL = activities of daily living (eating, sleeping, defecating and urinating); PCV = packed cell volume; LLN = lower limit of normal; BUN = blood urea nitrogen; ULN = upper limit of normal; ALT = alanine aminotransferase; ALP = alkaline phosphatase