THE ROLE OF RADIOTHERAPY IN THE MANAGEMENT OF EXTRAHEPATIC BILE-DUCT CANCER - AN ANALYSIS OF 145 CONSECUTIVE PATIENTS TREATED WITH INTRALUMINAL AND OR EXTERNAL-BEAM RADIOTHERAPY/

Purpose: To determine the feasibility of high dose radiotherapy and to evaluate its role in the management of extrahepatic bile duct (EHBD) cancer. Methods and Materials: Between 1983 and 1991, 145 consecutive patients with EHBD cancer were treated by low dose rate intraluminal I r-192 irradiation (ILRT) either alone or in combination with external beam radiotherapy (EBRT), Among the primarily irradiated, 77 patients unsuitable for surgical resection, 54 were enrolled in radical radioth erapy, and 23 received palitative radiotherapy. Fifty-nine received po stoperative radiotherapy, and the remaining 9 preoperative radiotherap y. The mean radiation dose was 67.8 Gy, ranging from 10 to 135 Gy, Int raluminal Ir-192 irradiation was indicated in 103 patients, and 85 of them were combined with EBRT, Expandable metallic biliary endoprosthes is (EMBE) was used in 32 primarily irradiated patients (31 radical and 1 palliative radiotherapy) after the completion of radiotherapy. Resu lts: The 1-, 3-, and 5-year actuarial survival rates for all 145 patie nts were 55%, 18%, and 10%, for the 54 patients treated by radical rad iotherapy (mean 83.1 Gy), 56%, 13%, and 6% [median survival time (MST) 12.4 months], and for the 59 patients receiving postoperative radioth erapy (mean 61.6 Gy), 73%, 31%, and 18% (MST 21.5 months), respectivel y. Expandable metallic biliary endoprosthesis was useful for the early establishment of an internal bile passage in radically irradiated pat ients and MST of 14.9 months in these 31 patients was significantly lo nger than that of 9.3 months in the remaining 23 patients without EMBE placement (p < 0.05). Eighteen patients whose surgical margins were p ositive in the hepatic side bile duct(s) showed significantly better s urvival compared with 15 patients whose surgical margins were positive in the adjacent structure(s) (44% vs, 0% survival at 3 years, p < 0.0 01). No survival benefit was obtained in patients given palliative or preoperative radiotherapy, Gastroduodenal complications increased in t hose receiving doses of 90 Gy or more, and serious biliary bleeding wa s experienced in three preoperatively irradiated patients, Complicatio ns in other patients were tolerable. Conclusions: High-dose radiothera py, consisting of ILRT and EBRT, appears to be feasible in the managem ent of EHBD cancer, and it offers a survival advantage for patients no t suited for surgical resection and patients with positive margins in the resected end of the hepatic side bile duct, Expandable metallic bi liary endoprosthesis assists the internal bile flow and may lengthen s urvival after high dose radiotherapy.