Intraoperative and conformal external‐beam radiation therapy with protracted 5‐fluorouracil infusion in patients with locally advanced pancreatic carcinoma

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Abstract
BACKGROUND Chemoradiotherapy is widely used for patients with locally advanced pancreatic carcinoma. The purpose of this study was to clarify the efficacy and feasibility of chemoradiotherapy with more intensive radiotherapy in these patients, using a combination of intraoperative radiotherapy (IORT), conformal external‐beam radiaotherapy (EBRT), and protracted 5‐fluorouracil (5‐FU). METHODS Thirty patients with unresectable locally advanced pancreatic carcinoma were enrolled in this Phase II study. The treatment consisted of IORT (25 grays [Gy]), followed by EBRT (40 Gy in 20 fractions, 5 times per week), and concurrent protracted 5‐FU infusion (200 mg/m2), beginning 2–4 weeks after IORT. The authors evaluated the efficacy and adverse effects of this treatment by following up patients for 12.0–28.1 months. Survival from the date of IORT was calculated using the Kaplan–Meier method. RESULTS In 11 of the 30 patients, metastatic spread was detected in the abdominal cavity at laparotomy. The full EBRT dose was administered in 28 of the 30 patients. Of the remaining 2 patients, EBRT was terminated at 8 Gy due to progression of brain metastasis and another patient did not receive EBRT or chemotherapy due to massive ascites after IORT. The overall response rate for primary pancreatic tumor on dynamic computed tomography scan was 23.3% (7 partial responses). Grade 3 or 4 toxicity (according to the National Cancer Institute Common Toxicity Criteria) was observed in 15 of the 28 patients who received the full irradiation dose (53.6%). These included anorexia, nausea, emesis, fatigue, leukopenia, and/or elevation of transaminase levels. There were no directly treatment‐related deaths, but 1 patient died of hepatic failure related to late effects of irradiation after 25.6 months. The median survival time of the 30 patients was 7.8 months and the 2‐year survival rate was 8.1%. The median survival time of the 19 patients without metastatic spread in the abdominal cavity was 12.9 months and that of the 11 patients with metastatic spread was 5.8 months. CONCLUSIONS The present regimen of chemoradiotherapy is not superior to conventional chemoradiotherapy (EBRT and 5‐FU) for patients with locally advanced pancreatic carcinoma. Cancer 2003;97:1346–52. © 2003 American Cancer Society. DOI 10.1002/cncr.11165