Retrospective Cohort Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Apr 15, 2023; 15(4): 677-688
Published online Apr 15, 2023. doi: 10.4251/wjgo.v15.i4.677
Role of adjuvant chemotherapy on recurrence and survival in patients with resected ampulla of Vater carcinoma
Se Jun Park, Kabsoo Shin, In-Ho Kim, Tae Ho Hong, Younghoon Kim, Myung-ah Lee
Se Jun Park, Kabsoo Shin, In-Ho Kim, Myung-ah Lee, Division of Medical Oncology, Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul 06591, South Korea
Tae Ho Hong, Department of General Surgery, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul 06591, South Korea
Younghoon Kim, Department of Pathology, The Catholic University of Korea, Seoul St. Mary’s Hospital, Seoul 06591, South Korea
Author contributions: All authors helped to perform the research; Park SJ was involved in manuscript writing, drafting conception and design, acquisition of data, performing procedures, and data analysis; Shin KS, Kim IH, Hong TH, and Kim Y contributed to writing the manuscript; Lee MA contributed to writing the manuscript, drafting conception and design, performing procedures, and data analysis; all authors have read and approved the final manuscript.
Institutional review board statement: The study conformed to Korean regulations and the Declaration of Helsinki. Ethical approval was provided by the Institutional Review Board (IRB) of The Catholic University of Korea, Seoul St. Mary’s Hospital (approval ID: KC21RISI0518).
Informed consent statement: Patients were not required to give informed consent to the study because the analysis used anonymous clinical data that were obtained after each patient agreed to treatment by written consent. We received Institutional Review Board approval to conduct our study without consent process.
Conflict-of-interest statement: All the authors report no relevant conflicts of interest for this article.
Data sharing statement: The datasets used in this study are available from the corresponding author upon request.
STROBE statement: The authors have read the STROBE Statement—checklist of items, and the manuscript was prepared and revised according to the STROBE Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Myung-ah Lee, MD, PhD, Professor, Division of Medical Oncology, Department of Internal Medicine, The Catholic University of Korea, Seoul St. Mary’s Hospital, 222 Banpo-daero, Secho-gu, Seoul 06591, South Korea. angelamd@catholic.ac.kr
Received: December 24, 2022
Peer-review started: December 24, 2022
First decision: February 10, 2023
Revised: February 20, 2023
Accepted: March 22, 2023
Article in press: March 22, 2023
Published online: April 15, 2023
Processing time: 108 Days and 23.1 Hours
Abstract
BACKGROUND

Owing to rarity of disease and lack of prospective studies, data supporting the role of adjuvant chemotherapy in ampulla of Vater (AoV) carcinoma is limited.

AIM

To evaluate whether adjuvant chemotherapy cases for AoV carcinoma had better disease-free survival (DFS) rates than cases of observation following curative surgery.

METHODS

We retrospectively analyzed the association between adjuvant chemotherapy and DFS and overall survival (OS) in patients with stage IB-III AoV carcinoma who underwent curative surgical resection. Fluorouracil-based adjuvant chemotherapy was administered after surgery at the discretion of the physician. Adjusted multivariate regression models were used to evaluate the association between adjuvant chemotherapy and survival outcomes.

RESULTS

Of the total 104 patients who underwent curative surgery, 52 received adjuvant chemotherapy. Multivariate analysis revealed that higher histologic grade [hazard ratio (HR) = 2.24, P = 0.046], advanced tumor stage (HR = 1.85, P = 0.030), and vascular invasion (HR = 2.14, P = 0.010) were associated with shorter DFS. Adjuvant chemotherapy improved DFS compared to the observation group (HR = 0.50, P = 0.015) and tended to be associated with a longer OS, although the difference was not statistically significant (HR = 0.58, P = 0.098).

CONCLUSION

Among patients with resected AoV carcinoma, the adjuvant chemotherapy group was not associated with a significant survival benefit compared to the observation group. However, on multivariate analysis adjusting for prognostic factors, adjuvant chemotherapy following surgery was an independent prognostic factor for DFS in patients with resected AoV carcinoma. Further studies are needed to investigate the effectiveness of adjuvant chemotherapy according to histologic phenotype.

Keywords: Ampulla of Vater carcinoma; Adjuvant chemotherapy; Prognosis; Recurrence

Core Tip: To date, there is no standard adjuvant treatment for patients with ampulla of Vater (AoV) carcinoma after surgical resection. In this study, we evaluated the effectiveness and safety of adjuvant fluorouracil-based chemotherapy. Of 104 patients investigated, 52 were received 5-fluorouracil-based adjuvant chemotherapy and 52 were observed without any adjuvant treatment. Adjuvant chemotherapy could improve disease-free survival in patients with AoV cancer following surgery, but overall survival was not associated with adjuvant chemotherapy. Treatment related adverse events were manageable. Further studies are warranted to identify patients with resected AoV cancer who might benefit from adjuvant chemotherapy.