كتاب
Localized rectal Cancer
- Executive Summary
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Strength of the recommendation |
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l From diagnosis, a dedicated multidisciplinary team (MDT) of expert medical oncologists, radiologists, surgeons, radiation oncologists and pathologists should attend regular meetings to discuss patients |
Good practice statement. |
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l A full medical history and physical examination, including digital rectal examination (DRE), complete blood count, liver and renal function tests and measurement of serum CEA, should be carried out |
Good practice statement. |
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l Preoperative colonoscopy to the caecal pole and MRI are recommended to determine tumour level. Tumor height must be defined: low = 0 to <5 from anal verge , mid 5 to <10 cm, upper >10 cm. |
Strong |
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l ERUS (if available) is recommended for T staging of localized tumors in cases of cT1 versus cT2. |
Conditional |
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l MRI (rectal protocol) is mandatory as part of the staging work-up to stratify for risk-adapted treatment |
Strong |
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l MRI reports should include description of tumour infiltration depth, node status, lateral lymph nodes, EMVI status and MRF status
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Strong |
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l The recommended high-risk criteria are cT4a or cT4b, involved or threatened mesorectal fascia (MRF+), cN2 (4 uspicious nodes), EMVI + and lateral lymph node enlargement of 7 mm .
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Strong |
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l Contrast-enhanced CT of the chest and abdomen is recommended for distant staging (if possible) |
Strong |
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l Fertility risk discussion is recommended in appropriate patients.
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Good practice statement. |
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MANAGEMENT OF LOCALISED DISEASE |
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RT and CRT |
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For lower or middle third tumours when surgery is intended: |
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l Preoperative RT followed by LE cannot generally be recommended in patients with cT2 N0 tumours <4 cm but may be considered for selected patients (e.g. elderly or frail patient at high surgical risk). |
Conditional |
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l Neoadjuvant SCRT or CRT (not TNT) is recommended for patients with cT2 N+, cT3 N0 or cT3 N1 tumours. |
Strong
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For lower or middle third tumours when watch-and-wait approach is intended: |
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l SCRT or CRT is recommended for patients with cT1-cT2 N0 tumours.
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Strong
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Total neoadjuvant therapy (TNT). |
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l RT should be offered as long-course CRT (50-50.4 Gy in 25-28 fractions with concomitant capecitabine or infusional 5-FU) or SCRT (25 Gy in five fractions) |
Strong |
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l Consolidation or induction chemotherapy (CAPOX or FOLFOX) should be administered for 4-6 cycles (i.e. 3-4.5 months) |
Strong
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l If FOLFIRINOX regimen is used, it may be administered in line with the protocol of the PRODIGE 23 trial (indications and doses), see Annex. |
Conditional
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For upper third tumours: |
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l TNT should be offered to patients with cT4 or involved or threatened MRF. |
Strong
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l CRT or SCRT should be considered if TNT is not feasible. |
Strong
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l TNT should be offered to patients with high-risk criteria. |
Strong
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For lower or middle third tumours when watch-and-wait approach is intended: |
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l TNT is recommended for patients with high-risk criteria and patients with cT2 N+ or cT3 any N |
Strong |
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l Upfront CRT followed by consolidation chemotherapy is recommended to increase the likelihood of cCR. |
Strong
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Neoadjuvant Chemtherapy |
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l When considering neoadjuvant chemotherapy, the inclusion criteria of the PROSPECT study should be used (T2 N+, T3 any N, distance to the CRM ≥3 mm, continence-preserving surgery possible). |
Strong
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l Neoadjuvant chemotherapy should comprise 3 months of CAPOX or FOLFOX . |
Strong
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For upper third tumours: |
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l Neoadjuvant chemotherapy is recommended for patients with cT2 N+ or cT3 any N disease. |
Strong
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l Neoadjuvant chemotherapy is recommended for patients with cT4 any N disease. |
Strong
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For lower or middle third tumours when surgery is intended: |
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l Neoadjuvant chemotherapy is recommended for patients with cT2 N+, cT3 N0 or cT3 N1 disease. |
Strong
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l Salvage RT is recommended in case of intolerance to, or progression on, neoadjuvant chemotherapy. |
Strong
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Strong |
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l In case of a cCR, biopsies are not recommended to determine a watch-and-wait approach, as their value in this setting is unclear. |
Strong |
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Surgery |
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l PME and TME are the recommended surgical procedures for rectal cancer |
Strong |
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l Open surgery and minimally invasive approaches are both recommended as they lead to similar oncological results |
Strong
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l A distance of >1 mm from tumour to CRM and other organs is recommended. In case of MRF + or T4b, beyond TME surgery is recommended. |
Strong
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l The distal mesorectal margin should be >5 cm. |
Strong |
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l A distal resection margin of >1 cm is recommended. |
Strong |
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l Lateral lymph nodes with a short axis of >7 mm should be resected after neoadjuvant treatment |
Strong |
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For upper third tumours: |
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l PME and TME are both equally recommended. |
Strong |
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l LE is recommended as an alternative to PME or TME for low-risk tumours (pT1 without unfavourable pathological features). |
Strong |
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For lower or middle third tumours when surgery is intended: |
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l TME is the recommended surgical procedure. |
Strong |
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l LE should be considered as an alternative to TME for low-risk tumours (pT1 without unfavourable pathological features). |
Strong |
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For lower or middle third tumours when watch-and-wait approach is intended: |
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l Surgery, with the resection method depending on clinical assessment, is recommended for patients who do not achieve a cCR following CRT or TNT |
Strong |
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l In case of local (endorectal) regrowth after a watch-and-wait procedure, salvage resection should be offered to all patients. |
Strong |
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Watch and wait approach |
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l For lower or middle third tumours, a watch-and-wait strategy is recommended in patients with cCR when organ preservation is intended. |
Strong |
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l Discussion with patients about the importance of adherence to strict follow-up investigations is mandatory. |
Good Practice Statement
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l Follow-up examinations should comprise MRI, endoscopy and DRE every 3 months for the first 2 years and every 6 months thereafter. CT scans of the chest and abdomen should be carried out every 6 months for the first 2 years and annually thereafter. |
Strong |
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Adjuvant therapy |
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For upper third tumours: |
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Adjuvant Chemotherapy with a fluoropyrimidine and (potentially) oxaliplatin should be offered (according to clinical risk assessment) following PME or TME alone. |
Strong |
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In patients who did not receive preoperative RT, adjuvant CRT should be offered in case of CRM positivity, pT4b, pN2 with extracapsular spread close to the MRF or poor-quality TME. |
Strong |
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For lower or middle third tumours after surgery: |
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l Adjuvant therapy with a fluoropyrimidine and (potentially) oxaliplatin should be offered (according to clinical risk assessment) following TME alone. |
Strong |
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l Adjuvant therapy with a fluoropyrimidine and (potentially) oxaliplatin is recommended after neoadjuvant CRT or SCRT. |
Strong |
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l In patients who did not receive preoperative RT, adjuvant CRT should be offered in case of CRM positivity, pT4b, pN2 with extracapsular spread close to the MRF or poor-quality TME. |
Strong |
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For lower or middle third tumours for watch-and-wait approach: |
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l An adjuvant fluoropyrimidine oxaliplatin combination can be offered on a case-by-case basis after RT or fluoropyrimidine-based CRT in patients achieving cCR with initial cN+ disease |
Conditional |
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l Post-neoadjuvant systemic treatment following TNT (irrespective of surgical or nonsurgical local approach) cannot be generally recommended due to toxicity considerations. This approach should be discussed individually within an MDT. |
Conditional |
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FOLLOW-UP, LONG-TERM IMPLICATIONS AND SURVIVORSHIP |
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l Proactive surveillance for local recurrence can be considered in patients at high risk of recurrence (e.g. involved CRM). |
Good practice statement.
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l Clinical assessment should be carried out every 3 months for 2 years |
Good practice statement.
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l Serum CEA measurements can be recommended every 3-4 months for the first 3 years. |
Good practice statement.
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l Annual (minimum) CT scan of the chest, abdomen and pelvis can be recommended after the first 2 years for detection of distant metastases. |
Good practice statement.
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l A completion colonoscopy is recommended within the first year (preferably after 6 months) if not carried out at the time of diagnostic work-up (e.g. if an obstruction was present) |
Good practice statement.
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l Medical history and colonoscopy with resection of colonic polyps can be recommended every 5 years up to the age of 75 years |
Good practice statement.
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l Long-term side-effects of treatment should be monitored |
Good practice statement.
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