ESMO Minimum Clinical Recommendations for diagnosis, treatment and follow-up of rectal cancer

K. M. Tveit

Ullevaal University Hospital, Oslo, Norway


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The crude incidence of rectal cancer in the European Union is approximately 35% of the total colorectal cancer incidence, i.e. 15–25 cases/100 000 per year.
The mortality is 4–10 cases/100 000 per year with the lower figures valid for females, the higher for males.


    Diagnosis
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Diagnosis is based on a clinical rectal examination including rigid proctoscopy with biopsy for histopathological examination. Tumors with distal extension to 15 cm or less (as measured by rigid proctoscopy) from the anal margin are classified as rectal, more proximal tumors as colonic.


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Complete history and physical examination, complete blood count, liver and renal function tests, chest X-ray and computed tomography (CT) or magnetic resonance (MR) or ultrasound of liver should be performed. In fixed tumors, CT or MR of the pelvis should be done.
Complete colonoscopy should be done.
Histopathological examination should include a surgical specimen with proximal, distal and circumferential margins and regional lymph nodes (it is recommended that at least 12 nodes are examined).
TNM staging system should always be used. In addition Dukes’ staging system (A, B, C, D) may be used (Table 1):


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Table 1.
 

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Resectable cases
Preoperative radiotherapy. Preoperative radiotherapy (e.g. 25 Gy, 5 Gy/fraction followed by immediate surgery) reduces local recurrence [I, A], and may improve survival compared with surgery alone and is recommended unless there is a very low risk of local failure.
Surgical procedure. Total mesorectal excision is strongly recommended as the method gives a low local recurrence rate (<10%) [II, A]. Whenever possible a low anterior resection should be employed.
Postoperative radio/chemotherapy. Postoperative radiotherapy (e.g. 50 Gy) with concomitant 5-fluorouracil (5-FU)-based chemotherapy is recommended [III, B] for patients with T3 and T4 (i.e. Dukes’ B2 and B3) tumors and for patients with nodal involvement (N1–2, i.e. Dukes’ C1–3), if preoperative radiotherapy has not been given. 5-FU-based chemotherapy may be continued for 2–4 months following radiotherapy.

Primary non-resectable cases and local recurrences

Patients with fixed tumors or with local recurrence (if radiotherapy was not given in the primary situation) should receive preoperative radiotherapy with or without concomitant chemotherapy [II, A].
Attempted radical surgery should take place 4–8 weeks after radiotherapy [II, A].

Locally advanced and disseminated disease

In selected cases, treatment may include surgery of isolated liver or lung metastases [II, A], surgical stenting [III, A] or radiotherapy should be considered as palliative procedures [II, A].
First-line palliative chemotherapy should be started early and consists of 5-FU in various combinations and schedules, e.g. infusional regimens. Frequently used schedules include 5-FU (425 mg/m2) + low-dose leucovorin (20 mg/m2) days 1–5, q4 weeks. Combination with oxaliplatin or irinotecan may be considered.
Second-line chemotherapy should be considered for selected patients with maintained good performance status.


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Follow-up serves to identify patients in need of salvage surgery or palliative care and to prevent second colorectal cancers. There is no proof that regular follow-up after successful treatment improves the outcome of patients with rectal cancer. Provisional recommendations are as follows: history and rectosigmoidoscopy (with endosonography if available) every 6 months for 2 years [V, D]; history and colonoscopy with resection of colonic polyps every 5 years [I, B]; clinical, laboratory and radiological examinations are of unproven benefit and should be restricted to patients with suspicious symptoms [A].


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Levels of Evidence [I–V] and Grades of Recommendation [A–D] as used by the American Society of Clinical Oncology are given in square brackets. Statements without grading were considered justified standard clinical practice by the expert authors and the ESMO faculty.


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Coordinating author for the ESMO Guidelines Task Force: K. M. Tveit, Ullevaal University Hospital, Oslo, Norway.

Approved by the ESMO Guidelines Task Force: August 2002.

Correspondence to:

ESMO Guidelines Task Force

ESMO Head Office

Via La Santa 7

CH-6962 Viganello-Lugano

Switzerland


    References
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 Incidence
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 Staging and risk assessment
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 References
 
1. MacFarlane JK, Ryall RD, Heald RJ. Mesorectal excision for rectal cancer. Lancet 1993; 341: 457–460.[ISI][Medline]

2. Kapiteijn E, Marijnen CAM, Nagtegaal ID et al. Preoperative radiotherapy in combination with total mesorectal excision improves local control in resectable rectal cancer. Report from a multicenter randomized trial. For the Dutch Colorectal Cancer Group and other cooperative investigators. N Engl J Med 2001; 345: 638–646.[Abstract/Free Full Text]

3. Colorectal Cancer Collaborative Group. Adjuvant radiotherapy for rectal cancer: a systematic overview of 8507 patients from 22 randomised trials. Lancet 2001; 358: 1291–1304.[CrossRef][ISI][Medline]

4. Jeffery GM, Hickey BE, Hider P. Follow-up strategies for patients treated for non-metastatic colorectal cancer. Cochrane Database Syst Rev 2002; 1: CD002200.[Medline]

5. Beets-Tan R, Beets G, Vliegen R et al. Accuracy of magnetic resonance imaging in prediction of tumour-free resection margin in rectal cancer surgery. Lancet 2001; 357: 497–504.[CrossRef][ISI][Medline]