Capecitabine as Adjuvant Treatment for Stage III Colon Cancer
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- 0.316 · how far apart the two teachers sit on this one work
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score_only:v0-immature-baseline· verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it
Abstract
BACKGROUND: Intravenous bolus fluorouracil plus leucovorin is the standard adjuvant treatment for colon cancer. The oral fluoropyrimidine capecitabine is an established alternative to bolus fluorouracil plus leucovorin as first-line treatment for metastatic colorectal cancer. We evaluated capecitabine in the adjuvant setting. METHODS: We randomly assigned a total of 1987 patients with resected stage III colon cancer to receive either oral capecitabine (1004 patients) or bolus fluorouracil plus leucovorin (Mayo Clinic regimen; 983 patients) over a period of 24 weeks. The primary efficacy end point was at least equivalence in disease-free survival; the primary safety end point was the incidence of grade 3 or 4 toxic effects due to fluoropyrimidines. RESULTS: Disease-free survival in the capecitabine group was at least equivalent to that in the fluorouracil-plus-leucovorin group (in the intention-to-treat analysis, P<0.001 for the comparison of the upper limit of the hazard ratio with the noninferiority margin of 1.20). Capecitabine improved relapse-free survival (hazard ratio, 0.86; 95 percent confidence interval, 0.74 to 0.99; P=0.04) and was associated with significantly fewer adverse events than fluorouracil plus leucovorin (P<0.001). CONCLUSIONS: Oral capecitabine is an effective alternative to intravenous fluorouracil plus leucovorin in the adjuvant treatment of colon cancer.
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The record
- Venue
- New England Journal of Medicine
- Topic
- Colorectal Cancer Treatments and Studies
- Field
- Medicine
- Canadian institutions
- Ottawa Regional Cancer Foundation
- Funders
- —
- Keywords
- CapecitabineMedicineFluorouracilHazard ratioInternal medicineColorectal cancerRegimenClinical endpointBolus (digestion)Adverse effectGastroenterologyOncologyAdjuvantSurgeryConfidence intervalChemotherapyCancerRandomized controlled trial
- Has abstract in OpenAlex
- yes