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Comparing neoadjuvant therapy followed by local excision to total mesorectal excision in the treatment of early stage rectal cancer: a systematic review and meta-analysis of randomised clinical trials

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Abstract

Introduction

Total mesorectal excision (TME) is the standard-of-care in early, clinical stage (cT2-3 N0 M0) rectal cancer. Local excision (LE) may be an alternative after adequate response to neoadjuvant therapy (NAT), with either long-course chemoradiotherapy (nCRT) or short-course radiotherapy (SCRT), as a means of preserving the rectum and potentially obviating the morbidity of TME.

Methods

A systematic review was performed according to PRISMA guidelines for studies that randomly assigned patients with cT2-3 N0 M0 rectal cancer to either NAT + LE or TME that reported radiologic, oncologic, surgical, and morbidity outcomes.

Results

A total of 4 RCTs comprise 462 patients (232 patients receiving NAT + LE; nCRT n = 205; SCRT n = 27) and 230 undergoing TME, respectively. NAT compliance was 98.86%. The rate of early completion TME in the NAT + LE group was 22.3%, while the proportion of patients achieving durable organ preservation was 75.4% at mean follow-up of 5.6 years. There was no difference in disease-free survival (DFS) (HR [hazard ratio] 1.19; 95% CI 0.95, 1.49; p = 0.13) or overall survival (OS) (HR 0.94; 95% CI 0.72, 1.23; p = 0.63]) according to the assigned treatment arm. The local recurrence rate (LRR) (HR 1.22; 95% CI 0.5–3.02; p = 0.66) and distant metastases (HR 0.92; 95% CI 0.45, 1.90; p = 0.82) were also comparable between the groups. There was a significant reduction in major (OR 0.45; 95% CI 0.21, 0.95; p = 0.04) and minor morbidity (OR 0.45; 95% CI 0.24, 0.85; p = 0.01) for patients undergoing NAT + LE. Overall stoma formation was decreased in the NAT + LE group (OR 0.03; 95% CI 0.0, 0.23; p ≤ 0.00001).

Conclusion

NAT + LE reduces adverse effects of TME, without any compromise in oncological outcomes, and the potential for an organ preserving strategy should be discussed with patients with T2-3N0 rectal cancers prior to treatment.

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Data availability

The authors acknowledge that all data is available within the sited studies, all materials and analysis are available within the manuscript. Any further information is available upon request.

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  1. Paul Lynch and Odhrán K. Ryan contributed equally to this manuscript and are designated as co-first authors.

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  1. Department of Colorectal Surgery, St. Vincent’s University Hospital, Elm Park, Dublin 4, Ireland

    Paul Lynch, Odhrán K. Ryan, Mark Donnelly, Éanna J. Ryan, Matthew G. Davey, Ian S. Reynolds, Ben Creavin, Ann Hanly, Rory Kennelly, Seán T. Martin & Des C. Winter

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Contributions

Study concepts: ÉJR, ISR, BC, AH, RK, STM, DCW, Study design: ÉJR, ISR, BC, AH, RK, STM, DCW, Data acquisition: PL, OKR, MD, MGD, Quality control of data and algorithms: PL, OKR, MD, MGD, Data analysis and interpretation: PL, OKR, MD, MGD, Statistical analysis: PL, OKR, MD, MGD, Manuscript preparation: PL, OKR, MD, Manuscript editing: OKR, MD, ÉJR, Manuscript review: ÉJR, ISR, BC, AH, RK, STM, DCW.

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Lynch, P., Ryan, O.K., Donnelly, M. et al. Comparing neoadjuvant therapy followed by local excision to total mesorectal excision in the treatment of early stage rectal cancer: a systematic review and meta-analysis of randomised clinical trials. Int J Colorectal Dis 38, 263 (2023). https://doi.org/10.1007/s00384-023-04558-8

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