PII S0360-3016(02)02952-8 CLINICAL INVESTIGATION Bile Ducts ROLE OF POSTOPERATIVE RADIOTHERAPY IN THE MANAGEMENT OF EXTRAHEPATIC BILE DUCT CANCER SUZY KIM, M.D.,* SUN WHE KIM, M.D., † YONG JOO BANG, M.D., ‡ DAE-SEOG HEO, M.D., ‡ AND SUNG WHAN HA, M.D.* § Departments of *Therapeutic Radiology, † General Surgery, and ‡ Internal Medicine, Seoul National University College of Medicine; § Institute of Radiation Medicine, Medical Research Center, Seoul National University, Seoul, South Korea Purpose: To analyze the outcome of postoperative radiotherapy (RT) or chemoradiation for patients with extrahepatic bile duct cancer who had undergone either curative or palliative surgery, and to identify the prognostic factors for these patients. Methods and Materials: Between March 1982 and December 1994, 91 patients with extrahepatic bile duct cancer underwent RT at the Department of Therapeutic Radiology, Seoul National University Hospital. Of these patients, 84 were included in this retrospective study. The male/female ratio was 3.7:1 (66 men and 18 women). The median age of the patients was 58 years (range 33–76). Gross total surgical resection was performed in 72 patients, with pathologically negative margins in 47 and microscopically positive margins in 25. Twelve patients underwent surgical exploration and biopsy or subtotal resection with palliative bypass procedures. All the patients received >40 Gy of external beam RT after surgery. Concurrent 5-fluorouracil was administered during external beam RT in 71 patients, and maintenance chemotherapy was performed in 61 patients after RT completion. The minimal follow-up of the survivors was 14 months, and the median follow-up period for all the patients was 23 months (range 2–75). Results: The overall 2- and 5-year survival rate was 52% and 31%, respectively. The 2- and 5-year disease-free survival rate was 48% and 26%, respectively. On univariate analysis using the Kaplan-Meier product limit method, the use of chemotherapy, performance status, N stage, size of residual tumor, stage, and tumor location were significant prognostic factors. However, on multivariate analysis using Cox’s proportional hazard model, N stage (N0 vs. N1 and N2, p  0.02) was the only significant prognostic factor. Conclusion: Long-term survival can be expected in patients with extrahepatic bile duct cancer who undergo radical surgery and postoperative chemoradiation. Regional lymph node metastasis is a poor prognostic factor for these patients. © 2002 Elsevier Science Inc. Extrahepatic bile duct cancer, Surgery, Radiotherapy, Chemotherapy. INTRODUCTION Extrahepatic bile duct (EHBD) cancer is a rare tumor. Of the extrahepatic biliary tumors, approximately 60% occur at the gallbladder and 40% within the extrahepatic biliary tree. The tumor is locally invasive, and distant metastasis is rare at presentation (1). Maximal surgical resection is the treat- ment of choice for EHBD cancer (2, 3). Many patients present with unresectable disease; and in resected patients, gross or microscopic residual disease is common (4). Ra- diotherapy (RT) has been used as an adjuvant treatment with curative intent in patients with positive margins after gross total resection and as palliative treatment of unresect- able biliary tract cancer. In this study, the outcome of postoperative RT was ret- rospectively analyzed for patients with EHBD cancer who had undergone either curative or palliative surgery and prognostic factors were identified. METHODS AND MATERIALS Study population Between March 1982 and December 1994, 91 patients with pathologically confirmed localized EHBD cancer un- derwent RT at the Department of Therapeutic Radiology, Seoul National University Hospital. Of these, 7 patients were excluded from this retrospective study: 5 patients had received a radiation dose of 20 Gy, and 2 patients were lost to follow-up just after treatment. Therefore, 84 patients with pathologically verified cholangiocarcinoma were en- tered into the study. The male/female ratio was 3.7:1 (66 men and 18 women). Reprint requests to: Sung Whan Ha, M.D., Department of Therapeutic Radiology, Seoul National University College of Medicine, 28 Yongon-dong, Chongno-gu, Seoul 110-744 South Korea. Tel: +82-2-760-2524; Fax: +82-2-742-2073; E-mail: swha@snu.ac.kr Received Aug 13, 2001, and in revised form Apr 23, 2002. Accepted for publication May 15, 2002. Int. J. Radiation Oncology Biol. Phys., Vol. 54, No. 2, pp. 414 – 419, 2002 Copyright © 2002 Elsevier Science Inc. Printed in the USA. All rights reserved 0360-3016/02/$–see front matter 414