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Can I read Adjuvant gemcitabine plus cisplatin versus capecitabine in node-positive extrahepatic cholangiocarcinoma: the STAMP randomized trial on EtoBox?
Adjuvant gemcitabine plus cisplatin versus capecitabine in node-positive extrahepatic cholangiocarcinoma: the STAMP randomized trial by Hyehyun Jeong; Kyu-pyo Kim; Jae Ho Jeong; Dae Wook Hwang; Jae Hoon Lee; Ki-Hun Kim; Deok-Bog Moon; Myung Ah Lee; Se Jun Park; Hong Jae Chon; Jin-hong Park; Ji Sung Lee; Baek-Yeol Ryoo; Changhoon Yoo is a Medicine article available to read on EtoBox.
What is Adjuvant gemcitabine plus cisplatin versus capecitabine in node-positive extrahepatic cholangiocarcinoma: the STAMP randomized trial about?
## Background and Aims: 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. ## 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/m^2^, cisplatin 25 mg/m^2^ on days 1 and 8) or capecitabine (1250 mg/m^2^ 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
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- Author
- Hyehyun Jeong; Kyu-pyo Kim; Jae Ho Jeong; Dae Wook Hwang; Jae Hoon Lee; Ki-Hun Kim; Deok-Bog Moon; Myung Ah Lee; Se Jun Park; Hong Jae Chon; Jin-hong Park; Ji Sung Lee; Baek-Yeol Ryoo; Changhoon Yoo
- Publisher
- Ovid Technologies (Wolters Kluwer Health)
- Published
- 2023
- Language
- EN
- Field
- Medicine (Health Sciences)