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
Research background

Advanced biliary tract cancers (BTC) are aggressive malignancies without an established standard of care after progression on first-line combination chemotherapy with gemcitabine plus cisplatin. Fluoropyrimidine-based therapies, such as 5-fluorouracil plus either oxaliplatin (FOLFOX) or irinotecan (FOLFIRI) are commonly used in this setting. There is limited data on the efficacy of such regimens in patients with BTCs, particularly in the patients who have progressed on first-line therapy.

Research motivation

There is a significant need for evidence-based treatment of patients with advanced BTCs who have previously progressed of first-line systemic chemotherapy. Only small, primarily single-institution analyses have been published about the role of FOLFIRI in this population. We sought to combine the experiences of multiple institutions to provide the largest dataset with this regimen.

Research objectives

Our study assessed the efficacy of FOLFIRI in patients with BTC by measuring progression-free survival and overall survival.

Research methods

We retrospectively identified patients with advanced, unresectable BTC who were treated with FOLFIRI at three institutions: MD Anderson, University of Michigan and Mayo Clinic in Jacksonville. We collected data on survival, response per RECIST v1.1, patient demographics and tumor characteristics.

Research results

Ninety-eight patients were included in our analysis, most of whom were treated in the second and third-line setting. Median duration on FOLFIRI was 2.2 mo. Median progression-free survival was 2.4 mo (95%CI: 1.7-3.1), and median overall survival was 6.6 mo (95%CI: 4.7-8.4).

Research conclusions

The efficacy of FOLFIRI for patients with BTCs appears to be modest with survival outcomes that are similar to historical controls of other retrospectively examined second-line cytotoxic therapy options.

Research perspectives

Based on this multi-institutional analysis, FOLFIRI seems to have a limited role in the treatment of patients with BTCs, though there are no prospective studies that have assessed this regimen in this patient population. The recently reported results of the randomized phase III ABC-06 trial demonstrating an increase in OS with modified FOLFOX plus active symptom control compared to active symptom control alone likely makes this a more appealing treatment option for most patients who have progressed on gemcitabine plus cisplatin.