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Abstract

The Gastrointestinal Tumor Study Group (GITSG) previously demonstrated a significant survival advantage for patients who receive adjuvant combined radiation and chemotherapy following curative resection of pancreatic cancer.1 Median survival in the group randomized to control was 10.9 months, compared with 21.0 months for those randomized to treatment. GITSG registered 30 additional patients, who received the adjuvant therapy to demonstrate that the results of the randomized trial could be replicated. Characteristics of registered patients were similar to those of patients in the randomized phase, with the exception of an improved performance status. The registered patients had median survival time of 18 months. Ten patients were alive at 18.9 to 42.4 months (median, 25.0). Two-year actuarial survival was 46% (95% confidence interval [CI], 0.28, 0.65) compared with 43% (95% CI, 0.25, 0.63) for 21 patients randomized to treatment and 18% (95% CI, 0.08, 0.36) for 22 patients randomized to control. Based on the original study and the confirmatory findings, the combined use of radiation therapy and fluorouracil as adjuvant therapy after curative resection is effective and is preferred to no adjuvant therapy.