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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Liver and Bile

Model to predict major complications following liver resection for HCC in patients with metabolic syndrome

Hepatology. 2023;77(5):1527–39

Berardi G, Ratti F, Sposito C, Nebbia M, D’Souza DM, Pascual F, Dogeas E, Tohme S, D’Amico FE, Alessandris R, Simonelli I, Del Basso C, Russolillo N, Moro A, Fiorentini G, Serenari M, Rotellar F, Zimmitti G, Famularo S, Ivanics T, Hoffman D, Onkendi E, Essaji Y, Lopez Ben S, Caula C, Rompianesi G, Chopra A, Abu Hilal M, Torzilli G, Sapisochin G, Corvera C, Alseidi A, Helton S, Troisi RI, Simo K, Conrad C, Cescon M, Cleary S, Kwon CHD, Ferrero A, Ettorre GM, Cillo U, Geller D, Cherqui D, Serrano PE, Ferrone C, Mazzaferro V, Aldrighetti L, Kingham TP

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Liver and Bile

Acute severe non-A-E-hepatitis of unknown origin in children – A 30-year retrospective observational study from North-West Germany

J Hepatol. 2023;78(5):971–8