32512
document
Severe enteropathy among patients with stage II/III colon cancer treated on a randomized trial of bolus 5-fluorouracil/leucovorin plus or minus oxaliplatin : a prospective analysis . BACKGROUND Cases of severe gastrointestinal toxicity were monitored prospectively during NSABP C-07 , a randomized clinical trial of adjuvant therapy for patients with stage II/III colon cancer . METHODS Patients were treated with weekly bolus 5-fluorouracil ( 5-FU ) and leucovorin ( FL ; " Roswell Park Regimen " ) or the same regimen plus oxaliplatin ( FLOX ) . RESULTS Of 1857 patients , 79 ( 4.3 % ) developed a syndrome of bowel wall injury ( BWI , small or large ) characterized by hospitalization for the management of severe diarrhea or dehydration and radiographic or endoscopic evidence of bowel wall thickening or ulceration . Fifty-one ( 64.6 % ) of these adverse events occurred in patients treated with FLOX and 28 ( 35.4 % ) in those treated with FL ( P < .01 ) . Enteric sepsis ( ES ) , characterized by grade 3 or greater diarrhea and grade 4 neutropenia with or without proven bacteremia occurred in 22 patients treated with FLOX , versus 8 in those treated with FL ( P = .01 ) . Patients > 60 years were at higher risk for BWI after treatment with FLOX ( 6.7 % ) versus treatment with FL ( 2.9 % , P < .01 ) . Female patients had a higher incidence of BWI with FLOX ( 9.1 % ) than with FL ( 3.9 % , P < .01 ) . Severe gastrointestinal toxicity usually occurred during the third or fourth week on the first cycle of therapy , required hospitalization , and was managed with fluids , antidiarrheals , and antibiotics . There were 5 deaths ( 0.3 % ) due to enteropathy , 2 related to ES and 3 related to both BWI and ES . Seventy-one percent of patients resumed treatment with FL after recovery . CONCLUSIONS Patients treated with adjuvant FL should be closely monitored for diarrhea and aggressively managed , especially if oxaliplatin has been added to the regimen . Society .
32513
Intervention_Pharmacological
bolus 5-fluorouracil/leucovorin plus or minus oxaliplatin
32514
Intervention_Pharmacological
bolus 5-fluorouracil ( 5-FU ) and leucovorin
32515
Intervention_Pharmacological
same regimen plus oxaliplatin ( FLOX ) .
32516
Intervention_Pharmacological
FLOX
32517
Intervention_Pharmacological
FLOX
32518
Intervention_Pharmacological
FL
32519
Intervention_Pharmacological
FLOX
32520
Intervention_Pharmacological
FL
32521
Intervention_Pharmacological
FLOX
32522
Intervention_Pharmacological
FL
32523
Intervention_Pharmacological
FL
32524
Outcome_Physical
syndrome of bowel wall injury ( BWI , small or large )
32525
Outcome_Physical
severe diarrhea or dehydration and radiographic or endoscopic evidence of bowel wall thickening or ulceration
32526
Outcome_Adverse-effects
adverse events
32527
Outcome_Physical
Enteric sepsis ( ES )
32528
Outcome_Physical
grade 3 or greater diarrhea and grade 4
32529
Outcome_Adverse-effects
neutropenia
32530
Outcome_Physical
with or without proven bacteremia
32531
Outcome_Physical
higher risk for BWI
32532
Outcome_Physical
higher incidence of BWI
32533
Outcome_Physical
Severe gastrointestinal toxicity
32534
Outcome_Mortality
deaths
32535
Outcome_Adverse-effects
diarrhea
32536
Participant_Condition
patients with stage II/III colon cancer
32537
Participant_Condition
patients with stage II/III colon cancer .