Observational Study
Copyright ©The Author(s) 2021. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Apr 15, 2021; 13(4): 295-304
Published online Apr 15, 2021. doi: 10.4251/wjgo.v13.i4.295
Clinical efficacy and safety of second line and salvage aflibercept for advanced colorectal cancer in Akita prefecture
Taichi Yoshida, Kentaro Takahashi, Kengo Shibuya, Osamu Muto, Yuko Yoshida, Daiki Taguchi, Kazuhiro Shimazu, Koji Fukuda, Fuminori Ono, Kyoko Nomura, Hiroyuki Shibata
Taichi Yoshida, Daiki Taguchi, Kazuhiro Shimazu, Koji Fukuda, Hiroyuki Shibata, Department ofClinical Oncology, Akita University Graduate School of Medicine, Akita 010-8543, Japan
Kentaro Takahashi, Department ofGastroenterological Surgery, Nakadori General Hospital, Akita 010-8577, Japan
Kengo Shibuya, Department ofGastroenterology, Akita Kousei Medical, Akita 010-0948, Japan
Osamu Muto, Yuko Yoshida, Department ofMedical Oncology, Akita Red Cross Hospital, Akita 010-1495, Japan
Fuminori Ono, Department ofSurgery, Omagari Kousei Medical Center, Akita 014-0027, Japan
Kyoko Nomura, Department ofEnvironmental Health Science and Public Health, Akita University Graduate School of Medicine, Akita 010-8543, Japan
Author contributions: Yoshida T drafted the article; all authors contributed to development of the study protocol, data collection, and analysis, and revision of the manuscript for important intellectual content.
Institutional review board statement: This study was conducted in accordance with the Declaration of Helsinki. The protocol was approved by the Institutional Review Board at Akita University, November 2018 (#2070).
Informed consent statement: Informed consent was not obtained from all participants, as it was not required due to the retrospective and observational nature of the study design.
Conflict-of-interest statement: The authors declare that they have no conflicts of interest.
Data sharing statement: No additional date is available.
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: http://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Hiroyuki Shibata, MD, PhD, Professor, Department of Clinical Oncology, Akita University Graduate School of Medicine, Hondo 1-1-1, Akita 010-8543, Japan. hiroyuki@med.akita-u.ac.jp
Received: December 28, 2020
Peer-review started: December 28, 2020
First decision: January 17, 2021
Revised: January 28, 2021
Accepted: March 11, 2021
Article in press: March 11, 2021
Published online: April 15, 2021
Research background

We usually use angiogenesis inhibitors (AIs) for chemotherapy in metastatic colorectal cancer (CRC). Aflibercept (AFL), one of the AIs, has been shown to be effective in second-line treatment by the ‘VELOUR’ study.

Research motivation

We can choose three Ais-bevacizumab, ramucirumab, and AFL-for treating with second-line chemotherapy. No means of choosing among the three AIs has been established because of the absence of direct comparisons.

Research objectives

We researched whether AFL is a treatment option for second-line chemotherapy with CRC in the ordinary clinical setting in Akita, Japan.

Research methods

Medical records including age, sex, primary tumor location, RAS and BRAF status, metastatic sites, cycles of prior chemotherapies, survival time after initial AFL administration, etc. were collected from each institution. We investigated the efficacy and safety for AFL via a statistical approach.

Research results

Time to AFL treatment failure was 123 d in the second-line group and 71 d in the salvage therapy group. The median survival time post-AFL was 673 d in the second-line group and 396 d in the salvage therapy group. Adverse events of grade ≥ 3 occurred in 8 patients (36%) in the second-line group and 9 patients (47%) in the salvage therapy group.

Research conclusions

Our study indicated that the efficacy and safety was the same as in the VELOUR study and that AFL contributes survival benefit similarly in both the second-line and salvage therapy settings. Patients with unresectable metastatic CRC should consider receiving AFL, regardless of number of treatment cycles.

Research perspectives

AFL is a promising agent, along with chemotherapy, for CRC. Further study should verify whether AFL will be affected by sequential therapy; for example, investigating the particular regimen used as first-line therapy before AFL administration.