European Organization for Research and Treatment of Cancer

A larger study performed by the European Organization for Research and Treatment of Cancer (EORTC) randomized 218 patients who had undergone curative resection of a cancer of the pancreatic head or periampullary region (including distal common bile duct, papilla of Vater, or duodenum) to receive either adjuvant chemoradiation or no further treatment (8). The treatment regimen differed somewhat from that used in the GITSG study. Radiation was again given in a split-course design. However, in this European study, 5-FU concurrently with radiotherapy was administered as a continuous infusion (25 mg/kg/day) for zero to five days at the start of each course of radiation, and no additional chemotherapy was given afterward. Survival data for the 114 patients with pancreatic head cancer showed a trend toward improved median survival in the treatment arm (17.1 vs. 12.6 months), although this difference did not achieve statistical significance (P=0.099). Both two- and five-year actuarial survival rates were better in patients receiving chemoradiation; again, these differences were not statistically significant (37% vs. 23% at two years, and 20% vs. 10% at five years, respectively) (Table 1). On these bases, the EORTC study investigators concluded that adjuvant 5-FU-based chemoradiation as an adjuvant treatment for this group of patients should not be given routinely.

However, several important caveats need to be highlighted in interpreting this study. First, similar to the GITSG trial, a substantial proportion of patients (approximately 20%) randomized to the treatment arm never ended up receiving therapy. Second, the trial included a number of early-stage patients with very small tumors; almost 16% of those with pancreatic head tumors were a pathologic stage T1. Both of these factors could conceivably have contributed to the lack of a statistically significant survival difference seen in this study. Third, because the study

TABLE 1 Comparison of Gastrointestinal Tumor Study Group and European Organization for Research and Treatment of Cancer Randomized Phase III Trials

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