Retrospective Study
Copyright ©The Author(s) 2018. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Nov 15, 2018; 10(11): 421-430
Published online Nov 15, 2018. doi: 10.4251/wjgo.v10.i11.421
Comparison of efficacy and safety between standard-dose and modified-dose FOLFIRINOX as a first-line treatment of pancreatic cancer
Huapyong Kang, Jung Hyun Jo, Hee Seung Lee, Moon Jae Chung, Seungmin Bang, Seung Woo Park, Si Young Song, Jeong Youp Park
Huapyong Kang, Jung Hyun Jo, Hee Seung Lee, Moon Jae Chung, Seungmin Bang, Seung Woo Park, Si Young Song, Jeong Youp Park, Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, Seodaemun-gu, Seoul 03722, South Korea
Author contributions: Kang H and Park JY led the study design; the study was supervised by Park JY. Kang H, Jo JH, Lee HS, Chung MJ, Bang S, Park SW, Song SY, and Park JY were contributed to the collection and assembly of data; Kang H did the data analysis; all authors interpreted the analyzed data; Kang H and Park JY wrote the manuscript; all authors reviewed every version of the manuscript and approved the final manuscript.
Institutional review board statement: This study was approved by the Institutional Review Board of Yonsei University Health System (Approval number: 4-2017-0757) and carried out in accordance with the Declaration of Helsinki.
Informed consent statement: The institutional review board waived the need for consent for this study due to its retrospective design.
Conflict-of-interest statement: All authors declare no conflicts-of-interest related to this article.
Data sharing statement: No additional data are available.
Open-Access: This 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: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Jeong Youp Park, MD, PhD, Associate Professor, Division of Gastroenterology, Department of Internal Medicine, Yonsei University College of Medicine, 50-1 Yonsei-ro, Seodaemun-gu, Seoul 03722, South Korea. sensass@yuhs.ac
Telephone: +82-2-22281982 Fax: +82-2-3936884
Received: August 6, 2018
Peer-review started: August 7, 2018
First decision: August 31, 2018
Revised: September 7, 2018
Accepted: October 10, 2018
Article in press: October 10, 2018
Published online: November 15, 2018
Processing time: 101 Days and 12.5 Hours
Abstract
AIM

To directly compare the efficacy and toxicity of standard-dose FOLFIRINOX (sFOLFIRINOX) and modified-dose FOLFIRINOX (mFOLFIRINOX, 75% of standard-dose) for pancreatic cancer.

METHODS

One hundred and thirty pancreatic cancer patients who received sFOLFIRINOX (n = 88) or mFOLFIRINOX (n = 42) as their first-line chemotherapy from January 2013 to July 2017 were retrospectively reviewed. For efficacy analysis, the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were evaluated and compared using Pearson’s chi-square test, Kaplan-Meier plot and log-rank test. The adverse events (AEs) were evaluated, and severe (≥ grade 3) AEs rates of the two groups were compared for toxicity analysis.

RESULTS

The mFOLFIRINOX group included more female patients (30.7% vs 57.1%; P = 0.004) and older patients [age (median), 57 vs 63.5; P = 0.018] than the sFOLFIRINOX group. In the efficacy analysis, the ORR and DCR were not significantly different between the two groups (ORR: 39.8% vs 35.7%; P = 0.656; DCR: 80.7% vs 83.3%; P = 0.716). The median PFS and OS were also not different between the groups (PFS: 8.7 mo vs 8.1 mo, P = 0.272; OS: 13.9 mo vs 13.7 mo, P = 0.476). In the safety analysis with severe AEs, the rates of neutropenia (83.0% vs 66.7%; P = 0.044), anorexia (48.9% vs 28.6%; P = 0.029) and diarrhea (13.6% vs 0.0%; P = 0.009) were markedly lower in the mFOLFIRINOX group.

CONCLUSION

mFOLFIRINOX showed comparable efficacy but better safety compared to sFOLFIRINOX. If clinically necessary, initiating FOLFIRINOX with 75% of the standard-dose can alleviate toxicity concerns without compromising efficacy.

Keywords: Dose modification; Adverse event; Pancreatic cancer; Adenocarcinoma; FOLFIRINOX; Chemotherapy

Core tip: Although the efficacy of FOLFIRINOX for pancreatic cancer has been well demonstrated, its relatively high toxicity rate is an important concern. We aimed to directly compare the efficacy and toxicity of standard-dose FOLFIRINOX and modified-dose FOLFIRINOX (mFOLFIRINOX, 75% of standard-dose) for pancreatic cancer. One hundred and thirty patients with pancreatic cancer (standard: 88 vs modified: 42) were reviewed retrospectively. Response rates, progression-free survival, and overall survival were not different between both groups. However, severe adverse events such as neutropenia, anorexia and diarrhea were significantly lower in the mFOLFIRINOX group. If clinically necessary, initiating FOLFIRINOX with 75% of the standard-dose can alleviate toxicity concerns without compromising efficacy.