Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.
Hepatology. 2023 May 1;77(5):1540-1549. doi: 10.1097/HEP.0000000000000046. Epub 2023 Jan 3.
The effectiveness of gemcitabine-based adjuvant chemotherapy is unclear in cholangiocarcinoma. We investigated the role of adjuvant gemcitabine plus cisplatin (GemCis) in a homogeneous group of high-risk patients with resected, lymph node-positive extrahepatic cholangiocarcinoma.
Adenocarcinoma of perihilar or distal bile duct with regional lymph node metastasis who underwent curative-intent surgery (R0/R1) was eligible. Patients were randomized to receive GemCis (gemcitabine 1000 mg/m2, cisplatin 25 mg/m2 on days 1 and 8) or capecitabine (1250 mg/m2 twice daily on days 1-14) every 3 weeks for 8 cycles. Primary endpoint was disease-free survival. Secondary endpoints were overall survival and safety. All p values are 1 sided and were considered significant if <0.1. Between July 2017 and November 2020, 101 patients (50 in the GemCis and 51 in the capecitabine group) were included in the intention-to-treat population. Perihilar and distal bile ducts were the primary sites in 45 (44.6%) and 56 (55.4%) patients, respectively, and 32 (31.7%) had R1 resections. Median (1-sided 90% CI) follow-up duration was 33.4 (30.5-35.8) months. In the GemCis and capecitabine group, 2-year disease-free survival rates were 38.5% (29.5%-47.4%) and 25.1% (17.4%-33.5%) [HR=0.96 (CI, 0.71-1.30), p=0.430], and median overall survival was 35.7 months (29.5-not estimated) and 35.7 months (30.9-not estimated) [HR=1.08 (CI, 0.71-1.64), 1-sided p=0.404], respectively. Grade 3-4 adverse events occurred in 42 (84.0%) and 8 patients (16.0%) in the GemCis and capecitabine groups, respectively. No treatment-related deaths were reported.
In resected lymph node-positive extrahepatic cholangiocarcinoma, adjuvant GemCis did not improve survival outcomes compared with capecitabine.
吉西他滨为基础的辅助化疗在胆管癌中的疗效尚不清楚。我们研究了在接受根治性手术（R0/R1）的淋巴结阳性肝外胆管癌的同质高风险患者中，辅助吉西他滨加顺铂（GemCis）的作用。
适合的患者为肝门或远端胆管腺癌，伴区域淋巴结转移，接受根治性手术（R0/R1）。患者被随机分为 GemCis（吉西他滨 1000mg/m2，顺铂 25mg/m2，第 1 和第 8 天）或卡培他滨（1250mg/m2，每天 2 次，第 1-14 天）每 3 周 8 个周期。主要终点是无病生存期。次要终点是总生存期和安全性。所有 p 值均为单侧，如果 <0.1，则认为有统计学意义。2017 年 7 月至 2020 年 11 月，101 例患者（GemCis 组 50 例，卡培他滨组 51 例）被纳入意向治疗人群。45 例（44.6%）和 56 例（55.4%）患者的主要部位分别为肝门和远端胆管，32 例（31.7%）为 R1 切除。中位（单侧 90%CI）随访时间为 33.4（30.5-35.8）个月。在 GemCis 组和卡培他滨组中，2 年无病生存率分别为 38.5%（29.5%-47.4%）和 25.1%（17.4%-33.5%）[HR=0.96（CI，0.71-1.30），p=0.430]，中位总生存期分别为 35.7 个月（29.5-未估计）和 35.7 个月（30.9-未估计）[HR=1.08（CI，0.71-1.64），单侧 p=0.404]。GemCis 组和卡培他滨组分别有 42 例（84.0%）和 8 例（16.0%）患者发生 3-4 级不良事件。未报告与治疗相关的死亡。
在淋巴结阳性肝外胆管癌患者中，辅助 GemCis 并未改善与卡培他滨相比的生存结果。
