Retrospective Cohort Study
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Gastrointest Oncol. Sep 15, 2022; 14(9): 1711-1726
Published online Sep 15, 2022. doi: 10.4251/wjgo.v14.i9.1711
Consolidation chemotherapy with capecitabine after neoadjuvant chemoradiotherapy in high-risk patients with locally advanced rectal cancer: Propensity score study
Xue-Qing Sheng, Hong-Zhi Wang, Shuai Li, Yang-Zi Zhang, Jian-Hao Geng, Xiang-Gao Zhu, Ji-Zhong Quan, Yong-Heng Li, Yong Cai, Wei-Hu Wang
Xue-Qing Sheng, Hong-Zhi Wang, Shuai Li, Yang-Zi Zhang, Jian-Hao Geng, Xiang-Gao Zhu, Yong-Heng Li, Yong Cai, Wei-Hu Wang, Department of Radiation Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China
Xue-Qing Sheng, Department of Radiation Oncology, Peking University People's Hospital, Beijing 100044, China
Ji-Zhong Quan, Department of Radiation Oncology, Jilin Guowen Hospital, Gongzhuling 136199, Jilin Province, China
Author contributions: Wang WH and Cai Y are responsible for the manuscript conceptualization; Sheng XQ, Wang HZ, Zhang YZ and Geng JH are responsible for the methodology; Sheng XQ and Wang HZ are responsible for the formal analysis; Sheng XQ, Li S and Wang HZ are responsible for the investigation; Wang WH, YL, Cai Y and Zhu XG collect the resources; Sheng XQ, Li S, Zhang YZ and Geng JH do the data curation; Sheng XQ write the original draft; Wang WH and Cai Y are responsible for the reviewing and editing; Li YH and Quan JZ are responsible for the supervision; Li S, Wang HZ, Geng JH, and Zhu XG do the project administration.
Supported by Beijing Municipal Science and Technology Commission, No. Z181100001718192; Capital’s Funds for Health Improvement and Research, No. 2020-2-1027 and No. 2020-1-4021; National Natural Science Foundation, No. 82073333.
Institutional review board statement: The study was approved by the Ethics Committee of Peking University Cancer Hospital review board, No. 2021YJZ62.
Informed consent statement: Informed consent from patients was waived by the Ethics Committee of Peking University Cancer Hospital review board.
Conflict-of-interest statement: All authors report no relevant conflict of interest for this article.
Data sharing statement: The datasets used and/or analyzed during the current study are available from the corresponding authors on reasonable request.
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: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Wei-Hu Wang, MD, Chief Physician, Department of Radiation Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Fucheng Road, Beijing 100142, China. wangweihu88@163.com
Received: April 29, 2022
Peer-review started: April 29, 2022
First decision: July 6, 2022
Revised: July 14, 2022
Accepted: August 9, 2022
Article in press: August 9, 2022
Published online: September 15, 2022
Abstract
BACKGROUND

The effects of consolidation chemotherapy (CC) in neoadjuvant therapy in locally advanced rectal cancer (LARC) have been explored. However, the optimal neoadjuvant chemoradiotherapy (NCRT) and surgery interval, regimen, and cycles of chemotherapy remains unclear.

AIM

To evaluate the effects of one to two cycles of CC with capecitabine on high-risk patients with LARC without extending NCRT and surgery interval.

METHODS

We retrospectively evaluated high-risk patients with LARC, who were defined as having at least one of the following factors by magnetic resonance imaging: depth of invasion beyond the muscularis propria of more than 5 mm (cT3c-cT3d), T4, meso-rectal fascia or extramural vascular invasion positive, and treatment date between January 2015 and July 2019 in our center. Patients were divided into the CC and non-CC group according to whether they received CC (capecitabine 1000 mg/m2 twice daily from days 1 to 14 every 21 d) after NCRT. Propensity score matching (PSM) and inverse probability of treatment weight (IPTW) were used to balance the differences between the two groups. The main outcome was the complete response (CR) rate.

RESULTS

A total of 265 patients were enrolled: 136 patients in the CC group and 129 patients in the non-CC group. The median interval was 70 d (range, 37-168). The CR rate was 24.3% and 16.3% (P = 0.107) in the CC and non-CC groups’ original samples, respectively. After PSM and IPTW, the CR rate in the CC group was higher than that in non-CC group (27.6% vs 16.2%, P = 0.045; 25.9% vs 16.3%, P = 0.045). The median follow-up was 39.8 mo (range, 2.9-74.8), and there were no differences in 3-year non-regrowth disease-free survival nor overall survival in the original samples (73.2% vs 71.9%, P = 0.913; 92.3% vs 86.7%, P = 0.294), PSM (73.2% vs 73.5%, P = 0.865; 92.5% vs 89.3%, P = 0.612), and IPTW (73.8% vs 72.1%, P = 0.913; 92.4% vs 87.4%, P = 0.294). There was also no difference in grade 2 or higher acute toxicity during neoadjuvant therapy in the two groups (49.3% vs 53.5%, P = 0.492).

CONCLUSION

One to two cycles of CC with capecitabine after NCRT was safe and increased the CR rate in high-risk LARC but failed to improve the long-term outcomes.

Keywords: High-risk locally advanced rectal cancer, Neoadjuvant chemoradiotherapy, Capecitabine, Consolidation chemotherapy, Complete response

Core Tip: This is the first study to explore the effects of one to two cycles of consolidation chemotherapy with capecitabine after neoadjuvant chemoradiotherapy (NCRT) in magnetic resonance imaging-defined high-risk patients with locally advanced rectal cancer without extending NCRT and surgery interval. After propensity score-matching and inverse probability of treatment weighting, the complete response rate increased. Although it showed no significant difference in long-term results, this relatively low-toxicity program deserves further exploration.