Retrospective Study
Copyright ©The Author(s) 2019. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Oct 15, 2019; 11(10): 857-865
Published online Oct 15, 2019. doi: 10.4251/wjgo.v11.i10.857
Retrospective review of total neoadjuvant therapy
Laila Babar, Veli Bakalov, Stephen Abel, Obaid Ashraf, Gene Grant Finley, Moses S Raj, Kristina Lundeen, Dulabh K Monga, Alexander V Kirichenko, Rodney E Wegner
Laila Babar, Veli Bakalov, Obaid Ashraf, Department of Internal Medicine, Allegheny General Hospital, Pittsburgh, PA 15212, United States
Stephen Abel, Alexander V Kirichenko, Rodney E Wegner, Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, PA 15212, United States
Gene Grant Finley, Moses S Raj, Kristina Lundeen, Dulabh K Monga, Department of Medical Oncology, Allegheny General Hospital, Pittsburgh, PA 15212, United States
Author contributions: Babar L and Wegner R designed the study; Babar L, Bakalov V, and Abel S performed the statistical analysis; Babar L wrote the paper; Ashraf O, Finley GG, Raj MS, Lundeen K, Monga DK, Kirichenko AV, and Wegner R contributed to the scientific review; Wegner R was the faculty mentor for this project.
Institutional review board statement: The IRB has reviewed this information and finds that this protocol does not fall under the purview of the IRB as it does not meet the definition of human subject research according to the federal code of regulations: 45 CFR 46.102(f).
Informed consent statement: As the data used was accessed via a public national database with deidentified patients, there was no need for informed consent.
Conflict-of-interest statement: The authors have no conflict of interest to report.
Data sharing statement: Data from this manuscript will be available upon request.
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: http://creativecommons.org/licenses/by-nc/4.0/
Corresponding author: Laila Babar, MD, Doctor, Resident Physician, Department of Internal Medicine, Allegheny General Hospital, 320 E North Ave, Pittsburgh, PA 15212, United States. laila.babar@ahn.org
Telephone: +1-412-6520419
Received: February 27, 2019
Peer-review started: February 27, 2019
First decision: April 11, 2019
Revised: May 1, 2019
Accepted: September 12, 2019
Article in press: September 12, 2019
Published online: October 15, 2019
Processing time: 231 Days and 15 Hours
ARTICLE HIGHLIGHTS
Research background

Locally advanced rectal cancer (LARC) treatment has been evolving for several years, specifically to improve standard of living after treatment. Total neoadjuvant treatment (TNT) has been gaining favor in recent years as it allows for better sphincter preservation and an overall improved quality of life. Our study analyzes the use of TNT over a 10-year period and compares the overall survival (OS) to that of patients treated with traditional neoadjuvant chemoradiation.

Research motivation

The focus of our study was to evaluate the OS in patients with LARC when treated with either TNT or traditional chemoradiation. It compared the two modes of treatment, which will help clinicians decide between the two modalities. It also sets up the stage for ongoing and future clinical trials that aim to study the benefit of using one modality over the other.

Research objectives

The main objective of our research was to analyze differences in OS in patients treated with TNT or traditional chemoradiation. We did not find a statistically significant difference in OS between the two modalities. An equivocal OS allows researchers to further design clinical trials comparing both treatment options prospectively and establish stronger guidelines that will further help clinicians decide what treatment will benefit their patients most.

Research methods

This was a retrospective review of data extracted from the national cancer database. We queried the National Cancer Data Base to find patients with LARC, stages II and III, who were treated with either TNT or traditional chemoradiotherapy. The standard of care, currently, utilizes a combination of adjuvant chemoradiation and surgery, followed by postoperative multi-agent chemotherapy. We analyzed the differences in OS between the two arms as our primary goal. For our secondary goal, we established what patient characteristics were likely to be associated with TNT use. These characteristics included age, race, gender and comorbidity score.

Research results

Using univariate and multivariate cox regressions, we analyzed our data for both primary and secondary goals. There was no statistically significant difference in OS between the two arms. We also found that patients with stage III disease, higher nodal involvement or treatment within recent years were more likely to have been treated with TNT. Patients in both arms had poor OS with higher comorbidity score, older age, African American race and female gender. Our results further solidify the theory that TNT is non inferior to traditional chemoradiotherapy, and thus must be studied in more detail with prospective trials.

Research conclusions

OS is similar in patients treated with either TNT or traditional chemoradiation. TNT has been associated with better quality of life. As OS is similar to that of neoadjuvant chemoradiation, using TNT may be preferable, to allow for a better standard of living. The 5-year OS is similar for both TNT and traditional chemoradiation. First, in patients with LARC, TNT and neoadjuvant chemoradiation have similar rates of OS. Second, TNT use may be linked to a better quality of life however more studies are needed in this area. There were no new methods as this was a retrospective review of a national database. There was no new phenomenon found as this was a retrospective analysis of an existing database. We queried the database to establish differences in OS for patients treated with two different chemoradiation protocols. Our retrospective analysis showed that the rate of OS was equivocal in patients treated with either TNT or traditional chemoradiation. It will allow clinicians and researchers to further compare the two modalities and may increase the treatment options available to patients suffering from LARC.

Research perspectives

New techniques that allow for radiation treatment to be completed prior to surgery, such as TNT, have yielded non- inferior results and therefore must be studied in greater detail. Future research should aim to conduct prospective clinical trials comparing TNT to traditional chemoradiation. This will help clinicians better decide what treatment is best suited to their patient population. Clinical trials exploring the survival, quality of life and toxicities associated with both TNT and neoadjuvant chemoradiation will help further the research in this field and provide concrete answers to many of the questions raised.