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Non-Operative Management Versus Total Mesorectal Excision for Locally Advanced Rectal Cancer with Clinical Complete Response After Neoadjuvant Chemoradiotherapy: a GRADE Approach by the Rectal Cancer Guidelines Writing Group of the Italian Association of Medical Oncology (AIOM)

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Journal of Gastrointestinal Surgery Aims and scope

Abstract

Background

The standard approach for locally advanced rectal cancer (LARC) is neoadjuvant chemoradiotherapy (nCRT) followed by total mesorectal excision (TME). After nCRT 20% of patients achieve a clinical complete response (pCR) and could be treated with a non-operative management (NOM).

Methods

The panel of the Italian Association of Medical Oncology (AIOM) Guidelines on rectal cancer applied the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach addressing the following question: Should NOM vs. TME be used for patients with rectal cancer with clinical complete response after nCRT? Five outcomes were identified: disease-free survival (DFS), mortality, local recurrence, colostomy rate, and functional outcomes.

Results

Nine studies were included in the analysis. A higher risk of disease recurrence was observed in the NOM group compared to the TME group (RR = 1.69, 95% CI 1.08, 2.64) on the other hand, we observed a slightly positive but not significant effect on mortality of NOM (RR = 0.82, 95% CI 0.46, 1.45). Patients in the NOM group were more likely to experience local recurrence (RR = 5.37, 95% CI 2.56, 11.27) and patients in the TME group were more likely to have a permanent colostomy (RR = 0.15, 95% CI 0.08, 0.29). Only one study evaluated functional outcomes. The overall certainty of evidence was rated as very low.

Conclusions

NOM was found to correlate with a higher risk of local recurrence which did not translate in worse OS and a lower colostomy rate. Due to the paucity of evidences, no recommendations are possible. NOM remains an experimental treatment; thus, patients managed with NOM should be enrolled in clinical trials with a dedicated follow-up schedule.

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Authors and Affiliations

  1. Department of Surgical, Oncological and Gastroenterological Sciences, University of Padova, Via Giustiniani 2, 35121, Padua, Italy

    Giulia Capelli & Gaya Spolverato

  2. Mario Negri Institute for Pharmacological Research, IRCCS, Milan, Italy

    Irene De Simone, Michela Cinquini & Ivan Moschetti

  3. Veneto Institute of Oncology, IOV-IRCCS, Padua, Italy

    Sara Lonardi

  4. University Hospital of Pisa, Pisa, Italy

    Gianluca Masi

  5. “Federico II” University of Napoli, Naples, Italy

    Chiara Carlomagno

  6. San Giovanni Calibita Fatebenefratelli Hospital, Rome, Italy

    Domenico Corsi

  7. University Hospital of Modena, Modena, Italy

    Gabriele Luppi

  8. Agostino Gemelli Hospital, Rome, Italy

    Maria Antonietta Gambacorta & Brunella Barbaro

  9. CNAO (Centro Nazionale di Adroterapia Oncologica) Foundation, Pavia, Italy

    Francesca Valvo

  10. CRO (Centro di Riferimento Oncologico) IRCCS, Aviano, Italy

    Renato Cannizzaro

  11. S. Martino University Hospital, IRCCS, Genoa, Italy

    Federica Grillo

  12. Department of Surgical Sciences, University of Cagliari, Cagliari, Italy

    Angelo Restivo

  13. San Raffale Giglio Hospital, Cefalù, Palermo, Italy

    Marco Messina

  14. Sant’Andrea Hospital, La Spezia, Italy

    Alessandro Pastorino, Carlo Aschele & Salvatore Pucciarelli

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  1. Giulia Capelli
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Correspondence to Gaya Spolverato.

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Capelli, G., De Simone, I., Spolverato, G. et al. Non-Operative Management Versus Total Mesorectal Excision for Locally Advanced Rectal Cancer with Clinical Complete Response After Neoadjuvant Chemoradiotherapy: a GRADE Approach by the Rectal Cancer Guidelines Writing Group of the Italian Association of Medical Oncology (AIOM). J Gastrointest Surg 24, 2150–2159 (2020). https://doi.org/10.1007/s11605-020-04635-1

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