Introduction
Levels of evidence:
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I. Evidence from at least one large randomized, controlled trial of good methodological quality (low potential for bias) or meta-analyses of well-conducted randomized trials without heterogeneity |
II. Small randomized trials or large randomized trials with a suspicion of bias (lower methodological quality) or meta-analyses of such trials or of trials with demonstrated heterogeneity |
III. Prospective cohort studies |
IV. Retrospective cohort studies or case–control studies |
V. Studies without control group, case reports, experts opinions |
Grades of recommendation
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A. Strong evidence for efficacy with a substantial clinical benefit, strongly recommended |
B. Strong or moderate evidence for efficacy but with a limited clinical benefit, generally recommended |
C. Insufficient evidence for efficacy or benefit does not outweigh the risk or the disadvantages (adverse events, costs, etc.), optional |
D. Moderate evidence against efficacy or for adverse outcome, generally not recommended |
E. Strong evidence against efficacy or for adverse outcome, never recommended |
Diagnosis
Staging
ERUS | CT scan | HR MRI | |
---|---|---|---|
T stage (early tumors) | + Small T1–2 tumors | – | + Assesses the depth of spread accurately to within 1 mm of histopathology assessments |
T stage (advanced tumors) | – | + | + T3 substaging (a–b/c–d) |
CRM status | – | – | + (≤1 mm from tumor to the MRF is considered as positive) |
EMVI status | – | + | + |
N stage | ± (only perirectal lymph nodes) | – | ± |
Management of local disease
Early rectal cancer: cT1/cT2 and cN0
Resectable locally advanced rectal cancer: cT3–T4 any cN+
Surgery: open and laparoscopic
Preoperative chemoradiation (CRT) or short-course radiotherapy (SCRT)
Total neoadjuvant treatment (Induction chemotherapy followed by CRT)
Study | No. of Pt | Induction chemotherapy | CRT regimen | Adjuvant chemotherapy | pCR (%) | Outcomes |
---|---|---|---|---|---|---|
GCR-3 [26]
| 108 | – | CAPOX | CAPOX × 4 cy | 13 | 5-year DFS = 62% 5-year OS = 77% |
CAPOX × 4 cy | CAPOX | – | 14 | 5-year DFS = 64% 5-year OS = 74% | ||
Maréchal [27]
| 57 | – | 5FU | – | 34 | Closed prematurely |
FOLFOX × 2 cy | 5FU | – | 32 | |||
EXPERT [25]
| 105 | CAPOX × 12wks | Capecitabine | Capecitabine × 12 wks | 20 | 3-year DFS = 68% 3-year OS = 83% |
CONTRE [28]
| 39 | FOLFOX × 8 cy | Capecitabine | – | 33 | R0 = 100% |
Schou [29]
| 85 | CAPOX × 2 cy | Capecitabine | – | 23 | 5-year DFS = 63% 5-year OS = 67% |
Office visit and CEA | Every 3–6 months for 2 years, then every 6 months until 5 years |
CT chest/abdomen/pelvis | Annually for 5 yearsa
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Colonoscopy | 1 year after preoperative colonoscopy (or 3–6 months after surgery if colon not preoperatively “cleared”)b
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Proctoscopy (± ERUS) | Every 6–12 monthsc for patients who underwent resection with anastomosis or every 6 months for patients undergoing local excision for 3–5 years |
Adjuvant therapy
Are there any subgroups who may benefit from adjuvant chemotherapy?
Adjuvant treatment after immediate radical standard surgery (TME)
Unresectable disease: cT4
Follow-up
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A clinical encounter with a physician every 3 to 6 months for the first 3 years, and every 6 months during years 4 and 5.
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Serum carcinoembryonic antigen (CEA) level at each follow-up visit for at least the first 3 years.
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Annual computed tomography of the chest, abdomen, and pelvis for 5 years.
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Full colonoscopy one year after surgery to exclude new lesions, or 3–6 months after surgery if colon not preoperatively complete studied. Further colonoscopy frequency depends on the results of the 1-year colonoscopy, with repeat examination in 3 years for patients without adenomas and 1 year for patients with adenomas. Patients at higher risk for local recurrence may be considered for proctosigmoidoscopy every six months for three to five years. Higher-risk patients may include those who have undergone low anterior resection and not received pelvic radiation therapy, those with poorer-risk tumors (T2 or poor differentiation) who underwent local excision, those with positive margins (≤1 mm), and those with T4 or N2 rectal cancers.