Retrospective Study
Copyright ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Jan 15, 2020; 12(1): 83-91
Published online Jan 15, 2020. doi: 10.4251/wjgo.v12.i1.83
Multi-institutional retrospective analysis of FOLFIRI in patients with advanced biliary tract cancers
Jonathan D Mizrahi, Valerie Gunchick, Kabir Mody, Lianchun Xiao, Phanikeerthi Surapaneni, Rachna T Shroff, Vaibhav Sahai
Jonathan D Mizrahi, Lianchun Xiao, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX 77005, United States
Valerie Gunchick, Vaibhav Sahai, Department of Internal Medicine, University of Michigan, Ann Arbor, MI 48109, United States
Kabir Mody, Phanikeerthi Surapaneni, Division of Medical Oncology, Mayo Clinic Cancer Center, Jacksonville, FL 32224, United States
Rachna T Shroff, University of Arizona Cancer Center, University of Arizona, Tucson, AZ 85724, United States
Author contributions: Sahai V, Shroff RT and Mody K designed the research study; Mizrahi JD, Gunchick V, Mody K, Surapaneni KP, Shroff RT and Sahai V collected the data; Xiao L, Mizrahi JD, Gunchick V and Sahai V analyzed and interpreted the data; Mizrahi JD, Gunchick V and Sahai V wrote the manuscript; All authors have read and approve the final manuscript.
Institutional review board statement: The study was reviewed and approved by the individual Institutional Review Boards at MD Anderson Cancer Center, University of Michigan and Mayo Clinic.
Informed consent statement: Informed consent was waived as patient data were collected and de-identified for analysis.
Conflict-of-interest statement: The authors report no conflicts of interest relevant to this article.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (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:
Corresponding author: Jonathan D Mizrahi, MD, Academic Fellow, Division of Cancer Medicine, the University of Texas MD Anderson Cancer Center, 1515 Holcombe Blvd Unit 463, Houston, TX 77030, United States.
Received: May 8, 2019
Peer-review started: May 10, 2019
First decision: July 31, 2019
Revised: August 9, 2019
Accepted: September 12, 2019
Article in press: September 12, 2019
Published online: January 15, 2020

Gemcitabine plus platinum is the standard of care first-line treatment for advanced biliary tract cancers (BTC). There is no established second-line therapy, and retrospective reviews report median progression-free survival (PFS) less than 3 mo on second-line therapy. 5-Fluorouracil plus irinotecan (FOLFIRI) is a commonly used regimen in patients with BTC who have progressed on gemcitabine plus platinum, though there is a paucity of data regarding its efficacy in this population.


To assess the efficacy of FOLFIRI in patients with biliary tract cancers.


We retrospectively identified patients with advanced BTC who were treated with FOLFIRI at MD Anderson, University of Michigan and Mayo Clinic in Jacksonville. Data were collected on patient demographics, BTC subtype, response per RECIST v1.1, progression and survival.


Ninety-eight patients were included of which 74 (75%) had metastatic and 24 (25%) had locally advanced disease at the time of treatment with FOLFIRI. The median age was 60 (range, 22-86) years. The number of patients with extrahepatic cholangiocarcinoma, gall bladder cancer and intrahepatic cholangiocarcinoma were 10, 17 and 71, respectively. FOLFIRI was used as 1st, 2nd, 3rd or 4th – Nth lines in 8, 50, 36 and 4 patients, respectively. Median duration on FOLFIRI in the entire cohort was 2.2 (range, 0.5-8.4) mo. The median PFS and overall survival were 2.4 (95% confidence interval (CI): 1.7-3.1) and 6.6 (95%CI: 4.7-8.4) mo, respectively. Median PFS for patients treated with FOLFIRI in 1st, 2nd, 3rd or 4th – Nth lines were 3.1, 2.5, 2.3 and 1.5 mo, respectively. Eighteen patients received concurrent bevacizumab (n = 13) or EGFR-targeted therapy (n = 5) with FOLFIRI, with a median PFS of 2.7 mo (95%CI: 1.7-5.1).


In this largest multi-institution retrospective review of 98 patients with BTC treated with FOLFIRI, efficacy appears to be modest with outcomes similar to other cytotoxic chemotherapy regimens.

Keywords: Biliary tract neoplasms, Fluorouracil, Irinotecan, Cholangiocarcinoma, Retrospective studies

Core tip: We retrospectively analyzed patients with advanced biliary tract cancers treated with 5-fluorouracil plus irinotecan at three institutions, MD Anderson, University of Michigan and Mayo Clinic in Jacksonville. We identified 98 patients with a median age of 60 years, most (72%) of whom had intrahepatic cholangiocarcinoma. Fifty and 36 patients were treated in the second and third-line settings, respectively. The median progression-free survival and overall survival were 2.4 (95%CI: 1.7-3.1) and 6.6 (95%CI: 4.7-8.4) mo, respectively.