Localised rectal cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
- Study type
- Clinical guideline
- Study name
- ESMO Localised Rectal Cancer 2025
- Design
- ESMO clinical guideline with levels of evidence (I to V) and grades of recommendation (A to E); replaces the 2017 version (Ann Oncol 2017;28(suppl 4):iv22-iv40)
- Source
- Ann Oncol · 2025
In plain words
This is the latest European (ESMO) guideline for rectal cancer that has not spread to distant organs. Its key points for patients: a pelvic MRI is essential to work out how high-risk the tumour is; for high-risk tumours, all of the chemotherapy and radiotherapy is usually given before surgery; if the tumour disappears completely after treatment, it may be possible to keep the rectum and have regular check-ups (every 3 months for the first 2 years) instead of surgery; and for tumours with a DNA repair defect (dMMR/MSI-H), 6 months of immunotherapy with dostarlimab is recommended, although this use is not yet officially approved by the European and US drug regulators.
Key guideline recommendations
- I, A; ESCAT: I-B
MSI and/or MMR status should be assessed in all patients at diagnosis using the biopsy sample.
- I, A
MRI is a mandatory part of staging to stratify patients for risk-adapted treatment. The recommended high-risk criteria are: cT4a or cT4b, mesorectal fascia involvement (MRF+), cN2 (4 or more suspicious nodes), extramural venous invasion (EMVI+) and enlarged lateral lymph nodes of 7 mm or more [I, A].
- I, A
For tumours of the middle or lower third, when surgery is planned, total neoadjuvant therapy (TNT) should be offered to patients with high-risk features.
- I, A
Radiotherapy should be given as long-course chemoradiotherapy (50 to 50.4 Gy in 25 to 28 fractions with capecitabine or infusional 5-FU) or short-course radiotherapy (25 Gy in 5 fractions) [I, A]. Consolidation or induction chemotherapy (CAPOX or FOLFOX) should be given for 3 to 4.5 months [I, A]. If irinotecan is used, it should be given according to the PRODIGE 23 trial protocol [I, A].
- II, A; ESCAT: I-B
Patients with dMMR or MSI-H locally advanced rectal tumours of the upper, middle or lower third should receive dostarlimab with a planned treatment duration of 6 months. (This use is not EMA- or FDA-approved.)
- I, A / II, A
For tumours of the middle or lower third, when organ preservation is the goal, a "watch and wait" strategy is recommended in patients with a clinical complete response [I, A]. For all dMMR or MSI-H rectal tumours, watch and wait is recommended in patients with a clinical complete response after PD-1 inhibitor treatment [II, A].
- I, A
In watch and wait, discussing with the patient the importance of adhering to close follow-up is mandatory [V, A]. Follow-up should include MRI, endoscopy and digital rectal examination every 3 months for the first 2 years and every 6 months thereafter [I, A].
- II, D
Postoperative ctDNA status is currently not recommended for adjuvant treatment decisions.
Study population
Patients with localised and locally advanced (non-metastatic) rectal cancer: diagnosis, staging and risk assessment, radiotherapy and chemoradiotherapy, total neoadjuvant therapy (TNT), neoadjuvant chemotherapy, dMMR/MSI-H tumours, surgery, watch and wait, adjuvant treatment and follow-up. Metastatic rectal cancer is covered in the ESMO guideline for metastatic colorectal cancer.
Clinical significance and place in guidelines
This guideline (May 2025) replaced the 2017 ESMO rectal cancer guideline and brought TNT, organ preservation and immunotherapy for dMMR tumours into the formal recommendations. The dostarlimab recommendation is based on the trials of Cercek et al. (NEJM 2022 and 2025) and is explicitly flagged as not approved by the EMA/FDA.
Limitations
Many of the organ-preservation recommendations depend on high-quality MRI, endoscopy and an experienced multidisciplinary team; the dostarlimab recommendation is based on single-arm phase 2 studies (level of evidence II).
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.