Comparison of 5-Fluorouracil/Leucovorin and Capecitabine as Adjuvant Therapies in Biliary Tract Cancer

Q: What was the purpose of the study comparing capecitabine and 5-fluorouracil/leucovorin?

To compare the efficacy and safety of capecitabine versus 5-fluorouracil/leucovorin as adjuvant treatments after curative resection in patients with biliary tract cancer.

Q: How were efficacy outcomes evaluated in the two treatment groups?

Recurrence-free survival and overall survival were investigated between the capecitabine and FL groups, including analyses before and after propensity score matching.

Q: What did the study find about safety and adverse events?

Severe adverse events did not differ significantly overall, but overall adverse events were significantly more frequent with capecitabine, both before and after propensity score matching.

Sep 23, 2026

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Biliary tract cancer after curative resection has poor prognosis and persistent high recurrence rates. This retrospective study compared capecitabine versus 5-fluorouracil/leucovorin as adjuvant chemotherapy in patients treated between 2011 and 2023. Recurrence-free survival and overall survival were evaluated alongside adverse events in a cohort of 263 patients, including analyses before and after propensity score matching. Results showed no significant differences in RFS and OS initially, while capecitabine improved overall survival after matching, with higher overall adverse event rates.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages11

Reading Time28 min

AccessFree to download

Abstract

Background

Methods

Results

Conclusion

Introduction

Epidemiology and clinical challenges

Prior trials and guideline context

Capecitabine rationale

Journal of Gastroenterology and Hepatology ORIGINAL ARTICLE-BILIARYAND PANCREATIC OPEN ACCESS Comparison of 5-Fluorouracil/Leucovorin and Capecitabine as Adjuvant Therapies in Biliary Tract Cancer Tae Seung Lee1 | Young Hoon Choi2,3 | Jun Yeol Kim1 | Myeong Hwan Lee1 | Kyu-Hyun Paik2 | In Rae Cho1 | Woo Il Kwon4 | Sang Hyub Lee1 | In Seok Lee2 | Myung Ah. Lee2 | Jin-Young Jang4 | Ji Kon Ryu1 | Yong-Tae Kim1 | Woo Hyun Paik1 1Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea | 2Department of Internal Medicine, College of Medicine, Catholic University of Korea, Seoul, South Korea | 3Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea | 4Department of Surgery and Cancer Research Institute, Seoul National University College of Medicine, Seoul, Republic of Korea Correspondence: Woo Hyun Paik ([iatrus@hanmail.net](iatrus@hanmail.net)) Received: 30 November 2024 | Revised: 1 April 2025 | Accepted: 23 June 2025 Funding: The authors received no specific funding for this work. Keywords: 5-fluorouracil/leucovorin | adjuvant | biliary tract cancer | capecitabine ABSTRACT Background: The prognosis ofbiliary tract cancer (BTC) is poor, and recurrence rates remain high even after curative resection. This study aimed to compare the efficacy and safety of capecitabine and 5-fluorouracil/leucovorin (FL) as adjuvant treatments following curative resection in patients with BTC. Methods: We retrospectively reviewed the medical records of patients with BTC (including gallbladder and extrahepatic and intrahepatic bile duct cancers) who underwent curative surgical resection and adjuvant chemotherapy between 2011 and 2023. The recurrence-free survival, overall survival, and adverse events were investigated between the two groups. Results: Of the 263 patients, 85 and 178 received capecitabine and FL, respectively. The recurrence-free survival and overall survival did not show statistically significant differences between the capecitabine and FL groups. After propensity score matching, the capecitabine group showed significantly longer overall survival (median, NA [52 − NA] vs. 43 months [32 − NA], p = 0.032) . Although severe adverse events did not differ between both groups (29.4% vs. 20.2%, p = 0.135), overall adverse events, including anemia, thrombocytopenia, hand–foot syndrome, and skin color change, were significantly more frequent in the capecitabine group (90.6% vs. 57.9%, p < 0.001). After propensity score matching, severe adverse events (30.3% vs. 14.5%, p = 0.032) and overall adverse events (90.8% vs. 65.8%, p < 0.001) were significantly more frequent in the capecitabine group. Conclusion: In patients with curatively resected BTC, capecitabine demonstrated superior efficacy in prolonging overall survival, whereas FL had a more favorable safety profile with fewer adverse events. | Abbreviations: 5-FU, 5-fluorouracil; BTC, biliary tract cancer; FL, 5-fluorouracil/leucovorin; OS, overall survival; RFS, recurrence free survival. Tae Seung Lee and Young Hoon Choi contributed equally as first authors. The paper is not based on a previous communication to a society or meeting. | | --- | | This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made.
© 2025 The Author(s). Journal of Gastroenterology and Hepatology published by Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd. | 2324 Journal of Gastroenterology and Hepatology, 2025; 40:2324–2334 [https://doi.org/10.1111/jgh.17044](https://doi.org/10.1111/jgh.17044) 1 | Introduction Biliary tract cancer (BTC) comprises

FAQs

What was the purpose of the study comparing capecitabine and 5-fluorouracil/leucovorin?

To compare the efficacy and safety of capecitabine versus 5-fluorouracil/leucovorin as adjuvant treatments after curative resection in patients with biliary tract cancer.

How were efficacy outcomes evaluated in the two treatment groups?

Recurrence-free survival and overall survival were investigated between the capecitabine and FL groups, including analyses before and after propensity score matching.

What did the study find about safety and adverse events?

Severe adverse events did not differ significantly overall, but overall adverse events were significantly more frequent with capecitabine, both before and after propensity score matching.

Sep 23, 2026

Uploaded by Mimi