Neoadjuvant chemotherapy (CAPOX) alone for low- and intermediate-risk stage II/III rectal cancer: Long-term follow-up of a prospective single-arm study

Yu Shen; Qingbin Wu; Wenjian Meng; Mingtian Wei; Xiangbing Deng; Ziqiang Wang

doi:10.1016/j.ejso.2023.107115

Neoadjuvant chemotherapy (CAPOX) alone for low- and intermediate-risk stage II/III rectal cancer: Long-term follow-up of a prospective single-arm study

Eur J Surg Oncol. 2023 Dec;49(12):107115. doi: 10.1016/j.ejso.2023.107115. Epub 2023 Oct 11.

Authors

Yu Shen¹, Qingbin Wu¹, Wenjian Meng¹, Mingtian Wei², Xiangbing Deng³, Ziqiang Wang⁴

Affiliations

¹ Colorectal Cancer Center, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, China.
² Colorectal Cancer Center, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, China. Electronic address: mtweiyy15@scu.edu.cn.
³ Colorectal Cancer Center, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, China. Electronic address: 247940362@qq.com.
⁴ Colorectal Cancer Center, Department of General Surgery, West China Hospital, Sichuan University, Chengdu, China. Electronic address: wangziqiang@scu.edu.cn.

PMID: 37839296
DOI: 10.1016/j.ejso.2023.107115

Abstract

Background: Stratified treatment has been recommended for rectal cancer. Our previous multicenter randomized trial showed that low-/intermediate-risk rectal cancer patients did not benefit much from neoadjuvant chemoradiotherapy. In our phase II study, we found that stage II/III rectal cancer patients with low-/intermediate risks can be managed by neoadjuvant chemotherapy alone and achieve a good response. The current study aimed to report the long-term survival outcomes in the expanded phase II trial.

Method: Consecutive patients diagnosed with mid-low stage II/III rectal cancer with low/intermediate risk factors were included. Four cycles of neoadjuvant chemotherapy (CAPOX) were given, and MRI was used for tumour response detection. The primary endpoint was disease-free survival. The secondary endpoints were tumour response to NCT, tumour-related death, and overall survival.

Results: This study enrolled 121 eligible patients. The good tumour response rate based on MRI was 82.6 %, with a pathological complete response (pCR) rate of 18.3 %. The disease-free survival rate was 82.6 %, and the overall survival rate was 96.7 % after a median follow-up time of 40 months. Two patients (1.7 %) suffered local recurrence, and 15 patients (12.4 %) suffered distant metastasis. The median disease-free survival and overall survival were 37 (9-60) and 40 (16-60) months, respectively. Tumour longitudinal length reduction and tumour regression grade on MRI were identified as predictors for poor tumour response to neoadjuvant chemotherapy.

Conclusion: In stage II/III rectal cancer patients with low-/intermediate risks, neoadjuvant chemotherapy alone may result in an acceptable tumour response and disease-free survival. Tumour response might be predicted early.

Keywords: Long-term follow-up outcomes; Low- and intermediate-risk rectal cancer; Neoadjuvant chemotherapy; Tumour response evaluation.

Publication types

Clinical Trial, Phase II

MeSH terms

Antineoplastic Combined Chemotherapy Protocols / therapeutic use
Chemoradiotherapy
Follow-Up Studies
Humans
Neoadjuvant Therapy*
Neoplasm Staging
Prospective Studies
Rectal Neoplasms* / drug therapy
Rectal Neoplasms* / pathology
Treatment Outcome