Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo 113-8655, Japan.
World J Gastroenterol. 2012 May 21;18(19):2364-70. doi: 10.3748/wjg.v18.i19.2364.
To determine the efficacy of external beam radiotherapy (EBRT), with or without intraluminal brachytherapy (ILBT), in patients with non-resected locally advanced hilar cholangiocarcinoma.
We analyzed 64 patients with locally advanced hilar cholangiocarcinoma, including 25 who underwent resection (17 curative and 8 non-curative), 28 treated with radiotherapy, and 11 who received best supportive care (BSC). The radiotherapy group received EBRT (50 Gy, 30 fractions), with 11 receiving an additional 24 Gy (4 fractions) ILBT by iridium-192 with remote after loading. ILBT was performed using percutaneous transhepatic biliary drainage (PTBD) route. Uncovered metallic stents (UMS) were inserted into non-resected patients with obstructive jaundice, with the exception of four patients who received percutaneous transhepatic biliary drainage only. UMS were placed endoscopically or percutaneously, depending on the initial drainage procedure. The primary endpoints were patient death or stent occlusion. Survival time of patients in the radiotherapy group was compared with that of patients in the resection and BSC groups. Stent patency was compared in the radiotherapy and BSC groups.
No statistically significant differences in patient characteristics were found among the resection, radiotherapy, and BSC groups. Three patients in the radiotherapy group and one in the BSC group did not receive UMS insertion but received PTBD alone; cholangitis occurred after endoscopic stenting, and patients were treated with PTBD. A total of 16 patients were administered additional systemic chemotherapy (5-fluorouracil-based regimen in 9, S-1 in 6, and gemcitabine in 1). Overall survival varied significantly among groups, with median survival times of 48.7 mo in the surgery group, 22.1 mo in the radiotherapy group, and 5.7 mo in the BSC group. Patients who underwent curative resection survived significantly longer than those who were not candidates for surgery (P = 0.0076). Cumulative survival in the radiotherapy group was significantly longer than in the BSC group (P = 0.0031), but did not differ significantly from those in the non-resection group. Furthermore, the median survival time of patients in the radiotherapy group who were considered for possible resection (excluding the seven patients who were not candidates for surgery due to comorbid disease or age) was 25.9 mo. Stent patency was evaluated only in the 24 patients who received a metallic stent. Stent patency was significantly longer in the radiotherapy than in the BSC group (P = 0.0165). Biliary drainage was not eliminated in any patient. To determine the efficacy of ILBT, we compared survival time and stent patency in the EBRT alone and EBRT plus ILBT groups. However, we found no significant difference in survival time between groups or for stent patencies. Hemorrhagic gastroduodenal ulcers were observed in 5 patients (17.9%), three in the EBRT plus ILBT group and two in the EBRT alone group. Ulcers occurred 5 mo, 7 mo, 8 mo, 16 mo, and 29 mo following radiotherapy. All patients required hospitalization, but blood transfusions were unnecessary. All 5 patients recovered following the administration of anti-ulcer medication.
Radiotherapy improved patient prognosis and the patency of uncovered metallic stents in patients with locally advanced hilar cholangiocarcinoma, but ILBT provided no additional benefits.
确定未切除的局部晚期肝门部胆管癌患者行外照射放疗（EBRT）联合或不联合腔内近距离放疗（ILBT）的疗效。
我们分析了 64 例局部晚期肝门部胆管癌患者，包括 25 例行切除术（17 例根治性和 8 例非根治性）、28 例接受放疗和 11 例接受最佳支持治疗（BSC）的患者。放疗组接受 EBRT（50Gy，30 次），其中 11 例接受额外的 24Gy（4 次）铱-192 后装腔内近距离放疗。ILBT 通过经皮肝穿刺胆道引流（PTBD）途径进行。非梗阻性黄疸的未切除患者插入未覆盖金属支架（UMS），但有 4 例患者仅接受经皮肝穿刺胆道引流。UMS 根据初始引流程序经内镜或经皮插入。主要终点是患者死亡或支架阻塞。与切除组和 BSC 组相比，放疗组患者的生存时间。比较放疗和 BSC 组的支架通畅率。
切除组、放疗组和 BSC 组患者的一般特征无统计学差异。放疗组 3 例和 BSC 组 1 例患者未置入 UMS，但单独接受 PTBD；内镜支架置入后发生胆管炎，患者接受 PTBD 治疗。共有 16 例患者接受了额外的全身化疗（9 例为 5-氟尿嘧啶为基础的方案，6 例为 S-1，1 例为吉西他滨）。各组总生存时间差异显著，手术组中位生存时间为 48.7 个月，放疗组为 22.1 个月，BSC 组为 5.7 个月。接受根治性切除术的患者生存时间明显长于不能手术的患者（P=0.0076）。放疗组的累积生存率明显长于 BSC 组（P=0.0031），但与未切除组无显著差异。此外，在被认为可能切除的放疗组患者中（排除因合并症或年龄而不适合手术的 7 例患者），中位生存时间为 25.9 个月。仅对接受金属支架的 24 例患者进行了支架通畅性评估。放疗组的支架通畅率明显长于 BSC 组（P=0.0165）。任何患者的胆道引流均未消除。为了确定 ILBT 的疗效，我们比较了单纯 EBRT 组和 EBRT 联合 ILBT 组的生存时间和支架通畅率。然而，我们发现两组之间的生存时间或支架通畅率均无显著差异。5 例（17.9%）患者出现出血性胃十二指肠溃疡，其中 EBRT 联合 ILBT 组 3 例，单纯 EBRT 组 2 例。溃疡发生在放疗后 5 个月、7 个月、8 个月、16 个月和 29 个月。所有患者均需住院治疗，但无需输血。所有 5 例患者均在接受抗溃疡药物治疗后康复。
放疗改善了局部晚期肝门部胆管癌患者的预后和未覆盖金属支架的通畅率，但 ILBT 没有带来额外的益处。
