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

Abstract

• 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 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. • 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):Table 1TNMStageExtension toModified Dukes’TisN0M00Carcinoma in situ–T1N0M0IMucosa or submucosaAT2N0M0IMuscularis propriaB1T3N0M0IISubserosa/perirectal tissueB2T4N0M0IIPerforation into perirectal tissue orinvasion of other organsB3T2N1M0/T2N2M0IIIT2, N1: 1–3/N2: ≥4 lymph nodesC1T3N1M0/T3N2M0IIIT3, N1: 1–3/N2: ≥4 lymph nodesC2T4N1M0IIIT4, N1: 1–3/N2: ≥4 lymph nodesC3Any T any NM1IVDistant metastasesD Open table in a new tab • 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. • 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]. • 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. • 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 andrectosigmoidoscopy (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 unprovenbenefit and should be restricted to patients with suspicious symptoms [A]. Levels of Evidence [I–V] and Grades of Recommendation [A–D] as used by the American Society of Clinical Oncology are givenin square brackets. Statements without grading were considered justified standard clinical practice by the expert authors and the ESMO faculty. 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