Severe enteropathy has been reported among patients with stage ll/lll colon cancer treated with fluorouracil with or without oxaliplatin.
A study by Kuebler et alr published results of 1857 patients treated with weekly bolus fluorouracil and leucovorin (FL; "Roswell Park Regimen") or the same regimen plus oxaliplatin (FLOX). There were 5 deaths related to enteropathy, and 71% of patients resumed treatment with fluorouracil after recovery.
Bowel wall injury (BWI)
79 patients (4.3%) developed a syndrome of bowel wall injury (BWI, small or large) characterised by hospitalisation for the management of severe diarrhoea or dehydration, and radiological or endoscopic evidence of bowel thickening or ulceration. These adverse events were more common in FLOX 64% (51 patients) than FL 35.4% (28 patients) (p<0.01).
Enteric sepsis (ES)
Enteric sepsis characterised by grade 3 or greater diarrhoea and grade 4 neutropenia with or without proven bacteraemia occurred in 22 patients treated with FLOX and 8 patients treated with FL (p=0.01).
Severe gastrointestinal toxicity usually occurred during the third or fourth week on the first cycle, required hospitalisation and was managed by fluids, antidiarrhoeals and antibiotics.
- age over 60 years: patients over 60 years were at higher risk for BWI when treated with FLOX (6.7%) versus FL (2.9%) (p<0.01)
- female patients had a higher incidence of BWI with FLOX (9.1%) than FL (3.9%) (p<0.01).