Liver and Bile

Hepatology. 2023;77(5):1540–9

Jeong H, Kim KP, Jeong JH, Hwang DW, Lee JH, Kim KH, Moon DB, Lee MA, Park SJ, Chon HJ, Park JH, Lee JS, Ryoo BY, Yoo C

Adjuvant gemcitabine plus cisplatin versus capecitabine in node-positive extrahepatic cholangiocarcinoma: The STAMP randomized trial


Background and aims: The effectiveness of gemcitabine-based adjuvant chemotherapy is unclear in cholangiocarcinoma. The authors investigated the role of adjuvant gemcitabine plus cisplatin (GemCis) in a homogeneous group of high-risk patients with resected, lymph node-positive extrahepatic cholangiocarcinoma.
Approach and results: 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 end point was disease-free survival. Secondary end points 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% confidence interval [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%) (hazard ratio [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.

Conclusions: In resected lymph node-positive extrahepatic cholangiocarcinoma, adjuvant gemcitabine plus cisplatin did not improve survival outcomes compared with capecitabine.

Prof. Dr. C. Yoo or Prof. Dr. B.-Y. Ryoo, Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea,
E-Mail: yooc@amc.seoul.kr or E-Mail: ryooby@amc.seoul.kr

DOI: 10.1097/hep.0000000000000046

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