Three randomized trials have shown chemoradiotherapy to be superior to either chemotherapy alone or radiation alone in terms of improved survival. Among three randomized trials of chemoradiotherapy comparing different chemotherapeutic agents, no chemotherapy regimen was superior to 5-FU in combination with radiation. These data support the use of chemoradiotherapy as standard practice for medically suitable patients. Outside of a clinical trial, 5-FU is the preferred chemotherapeutic agent to combine with radiotherapy, however, the optimal mode and duration of 5-FU delivery is unclear.
Although different from the regimens actually used in the trials, common protocols give 5-FU either by continuous infusion at a dose of 200 mg/m2/day during radiation, or bolus injection of 500 mg/m2/day on days 1 through 3 and the last three days of radiation, usually without subsequent maintenance treatment. This practice guideline does not make a recommendation for bolus 5-FU infusion over continuous 5-FU infusion despite the fact that the majority of the studies examined used bolus infusion as the treatment modality of choice. However, there is empirical evidence showing an enhancement of radiotherapy effects with continuous 5-FU infusion compared with bolus 5-FU infusion. Consequently, for any positive benefit that is seen with bolus 5-FU infusion, at least equivalent or greater benefit can be expected with continuous 5-FU infusion. The dose of radiation treatment ranges from 45 Gy to 54 Gy, given at 1.8 Gy per fraction over five to six weeks.
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