Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Aug;31(8):4896-4904.
doi: 10.1245/s10434-024-15117-y. Epub 2024 Mar 5.

Adjuvant Chemoradiation in Resected Biliary Adenocarcinoma: Evaluation of SWOG S0809 with a Large National Database

Dana A Dominguez  1 , Paul Wong  1   2 , Yi-Jen Chen  3 , Gagandeep P Singh  1 , Yuman Fong  1 , Daneng Li  4 , Philip H G Ituarte  1 , Laleh G Melstrom  5
Affiliations

Adjuvant Chemoradiation in Resected Biliary Adenocarcinoma: Evaluation of SWOG S0809 with a Large National Database

Dana A Dominguez et al. Ann Surg Oncol. 2024 Aug.

Abstract

Background: There is a paucity of evidence supporting the use of adjuvant radiation therapy in resected biliary cancer. Supporting evidence for use comes mainly from the small SWOG S0809 trial, which demonstrated an overall median survival of 35 months. We aimed to use a large national database to evaluate the use of adjuvant chemoradiation in resected extrahepatic bile duct and gallbladder cancer.

Methods: Using the National Cancer Database, we selected patients from 2004 to 2017 with pT2-4, pN0-1, M0 extrahepatic bile duct or gallbladder adenocarcinoma with either R0 or R1 resection margins, and examined factors associated with overall survival (OS). We examined OS in a cohort of patients mimicking the SWOG S0809 protocol as a large validation cohort. Lastly, we compared patients who received chemotherapy only with patients who received adjuvant chemotherapy and radiation using entropy balancing propensity score matching.

Results: Overall, 4997 patients with gallbladder or extrahepatic bile duct adenocarcinoma with available survival information meeting the SWOG S0809 criteria were selected, 469 of whom received both adjuvant chemotherapy and radiotherapy. Median OS in patients undergoing chemoradiation was 36.9 months, and was not different between primary sites (p = 0.841). In a propensity score matched cohort, receipt of adjuvant chemoradiation had a survival benefit compared with adjuvant chemotherapy only (hazard ratio 0.86, 95% confidence interval 0.77-0.95; p = 0.004).

Conclusion: Using a large national database, we support the findings of SWOG S0809 with a similar median OS in patients receiving chemoradiation. These data further support the consideration of adjuvant multimodal therapy in resected biliary cancers.

Keywords: Bile duct cancer; Chemoradiation; Cholangiocarcinoma; Gallbladder cancer; SWOG 0809.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Overall survival of the ‘SWOG-like’ cohort stratified by primary tumor site
Fig. 2
Fig. 2
Overall survival in the ‘SWOG-like’ cohort stratified by a nodal status and b resection margin status
Fig. 3
Fig. 3
Multivariable Cox proportional hazards model of propensity matched cohorts comparing patients who received chemotherapy only with those who received chemotherapy and radiation (n = 2303)
See this image and copyright information in PMC

References

    1. Ahn DH, Bekaii-Saab T. Biliary cancer: intrahepatic cholangiocarcinoma vs. extrahepatic cholangiocarcinoma vs. gallbladder cancers: classification and therapeutic implications. J Gastrointest Oncol. 2017;8(2):293–301. doi: 10.21037/jgo.2016.10.01. - DOI - PMC - PubMed
    1. Jarnagin WR, Ruo L, Little SA, Klimstra D, D’Angelica M, DeMatteo RP, et al. Patterns of initial disease recurrence after resection of gallbladder carcinoma and hilar cholangiocarcinoma: implications for adjuvant therapeutic strategies. Cancer. 2003;98(8):1689–1700. doi: 10.1002/cncr.11699. - DOI - PubMed
    1. Vogel A, Bridgewater J, Edeline J, Kelley RK, Klümpen HJ, Malka D, et al. Biliary tract cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. Ann Oncol. 2023;34(2):127–140. doi: 10.1016/j.annonc.2022.10.506. - DOI - PubMed
    1. Primrose JN, Fox RP, Palmer DH, Malik HZ, Prasad R, Mirza D, et al. Capecitabine compared with observation in resected biliary tract cancer (BILCAP): a randomised, controlled, multicentre, phase 3 study. Lancet Oncol. 2019;20(5):663–673. doi: 10.1016/S1470-2045(18)30915-X. - DOI - PubMed
    1. Nakachi K, Ikeda M, Konishi M, Nomura S, Katayama H, Kataoka T, et al. Adjuvant S-1 compared with observation in resected biliary tract cancer (JCOG1202, ASCOT): a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet. 2023;401(10372):195–203. doi: 10.1016/S0140-6736(22)02038-4. - DOI - PubMed

LinkOut - more resources