NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE 1 Guideline title SCOPE Colorectal cancer: diagnosis and management of colorectal cancer 1.1 Short title Colorectal cancer 2 The remit The Department of Health has asked NICE: To prepare a clinical guideline on the diagnosis and management of patients with all stages of primary colorectal cancer. This excludes any population screening and surveillance of high-risk groups, including patients with a family history and patients with inflammatory bowel disease.' 3 Clinical need for the guideline 3.1 Epidemiology a) Colorectal cancer is the third most common cancer in the UK, with approximately 32,300 new cases diagnosed and 14,000 deaths in England and Wales each year. Around half of people diagnosed with colorectal cancer survive for at least 5 years after diagnosis. b) Occurrence of colorectal cancer is strongly related to age, with 83% of cases arising in people older than 60 years. It is anticipated that as our elderly population increases, colorectal cancer will increase in prevalence. Colorectal cancer draft scope for consultation 18 February to 18 March 2009 Page 1 of 9
3.2 Current practice a) There are variations in: the management of locally advanced disease the management of patients presenting with stage 4 disease the management of symptomatic primary colorectal cancer the role of sequenced therapies combining surgery, ablation, chemotherapies and biological agents in advanced disease. b) Patients with poor performance status, who are therefore at a greater risk of treatment-related morbidity and mortality, are increasingly being considered for radical interventions. These interventions may be curative but their impact needs to be balanced against the overall prognosis of the patient. c) The costs of the radical therapies for colorectal cancer have increased significantly over the past decade, posing a major health economics challenge. d) A clinical guideline will help to address these issues and offer guidance on best practice. 4 The guideline The guideline development process is described in detail on the NICE website (see section 6, Further information ). This scope defines what the guideline will (and will not) examine, and what the guideline developers will consider. The scope is based on the referral from the Department of Health. If we are to produce a high-quality guideline within the allotted time it will not be possible to cover the entire care pathway described by the remit (see section 2). Therefore we intend to focus on clinical issues: for which there is uncertainty or disagreement on best practice Colorectal cancer draft scope for consultation 18 February to 18 March 2009 Page 2 of 9
that will have the most significant impact on the clinical service and on the management of patients with colorectal cancer that could improve health outcomes and/or make better use of health resources that could help to avoid unlawful discrimination and reduce health equalities. A list of the prioritised clinical questions has been developed using advice from the Guideline Development Group chair and clinical lead, attendees at the NICE colorectal cancer stakeholder workshop and registered stakeholders. We acknowledge that there will be some important topics that are not part of the final prioritised list. These will go on to a holding list for future consideration within any update, and the final guideline will make this clear to the reader. The areas that will be addressed by the guideline are described in the following sections. 4.1 Population 4.1.1 Groups that will be covered a) Adults (18 years and older) with newly diagnosed adenocarcinoma of the colon. b) Adults with newly diagnosed adenocarcinoma of the rectum. c) Adults with relapsed adenocarcinoma of the colon. d) Adults with relapsed adenocarcinoma of the rectum. e) No patient subgroups needing special consideration have been identified. 4.1.2 Groups that will not be covered a) Patients with anal cancer. b) Children (younger than 18) with colorectal cancer. Colorectal cancer draft scope for consultation 18 February to 18 March 2009 Page 3 of 9
c) Patients with primary or secondary lymphoma of colon and rectum. d) Patients with pure small cell carcinoma of colon and rectum. e) Patients with carcinoid tumours of colon and rectum. f) Patients with high grade neuroendocrine tumours of colon and rectum. g) Patients with adenocarcinoma with some neuroendocrine differentiation. h) Patients with gastrointestinal stromal tumours (GIST) or sarcoma of colon and rectum. 4.2 Healthcare setting a) Primary care. b) Secondary care. c) Tertiary care in cancer centres, and regional centres for specialties such as stenting, hepatic surgery, thoracic surgery, endorectal therapies, radiotherapy and ablation therapies. 4.3 Clinical management 4.3.1 Key clinical issues that will be covered a) Effective diagnostic modalities in establishing a diagnosis of colorectal cancer in patients referred with suspicious symptoms (considering effectiveness of methods in terms of sensitivity and specificity). b) Tumour staging system for defining treatment at all stages of disease in patients with colorectal cancer. c) Effective diagnostic modalities in determining which patients with rectal cancer are suitable for local resection. Colorectal cancer draft scope for consultation 18 February to 18 March 2009 Page 4 of 9
d) Second-line treatment for patients who have received first-line treatment for colorectal cancer and are a) stable or b) progressing. e) Curative treatment for patients with stage 1 or polyp cancer (such as TEMS, endoscopic mucosal resection, radical surgery or contact radiotherapy). f) Treatment for patients presenting as emergencies with the symptoms of colorectal cancer (such as radical surgery with curative intent, defunctioning stoma or endoscopic stenting). g) The sequence of local and systemic treatments in patients with locally-advanced colorectal cancer to achieve cure, prolong life without cure, or to improve quality of life (such as surgery, stenting, radiotherapy and chemotherapy). h) The sequence of local and systemic treatments in patients with synchronous metastatic disease to achieve cure, prolong life without cure, or to improve quality of life. i) Effectiveness of a) pre-operative radiotherapy and b) chemoradiotherapy in treating patients with rectal cancer. j) For patients with stage 2 and 3 rectal cancer, the indications for giving adjuvant chemotherapy after surgery. k) For patients with high-risk stage 2 colorectal cancer, the indications for giving adjuvant chemotherapy after surgery. l) The sequence of ablation, surgery, regional therapy and systemic therapy, to achieve cure or long-term survival in patients with apparently incurable metastatic disease. m) Imaging methods to determine the extent of metastases in patients with colorectal cancer. n) Clinical indications for performing liver metastasectomy in patients with colorectal cancer metastasized to the liver. Colorectal cancer draft scope for consultation 18 February to 18 March 2009 Page 5 of 9
o) Clinical indications for performing extrahepatic metastasectomy in patients with colorectal cancer. p) Chemotherapy for patients with advanced and metastatic disease (update of NICE technology appraisal guidance 93). q) Methods and frequencies of follow up after potentially curative treatment for primary colorectal cancer. r) Methods and frequencies of follow up after potentially curative treatment for metastatic colorectal cancer. s) We think it is important that patient issues should be represented on the list of priority topics investigated by this guideline. What in your view are the information and support issues specific to patients with colorectal cancer and their carers/families that the guideline should focus on? 4.3.2 Clinical issues that will not be covered a) Population screening. b) Surveillance of high-risk groups, including patients with a family history of colorectal cancer and patients with inflammatory bowel disease. 4.4 Economic aspects Developers will take into account both clinical and cost effectiveness when making recommendations involving a choice between alternative interventions. A review of the economic evidence will be conducted and analyses will be carried out as appropriate. The preferred unit of effectiveness is the quality-adjusted life year (QALY), and the costs considered will usually only be from an NHS and personal social services (PSS) perspective. Further detail on the methods can be found in 'The guidelines manual' (see Further information ). Colorectal cancer draft scope for consultation 18 February to 18 March 2009 Page 6 of 9
4.5 Status 4.5.1 Scope This is the consultation draft of the scope. The consultation dates are 18 February to 18 March 2009. 4.5.2 Timing The development of the guideline recommendations will begin in May 2009. 5 Related NICE guidance 5.1 Published guidance 5.1.1 NICE guidance to be updated This guideline will update and replace the following NICE guidance. Irinotecan, oxaliplatin and raltitrexed for advanced colorectal cancer (review). NICE technology appraisal guidance 93 (2005). Available from www.nice.org.ukta93. 5.1.2 Other related NICE guidance Cetuximab for the treatment of metastatic colorectal cancer following failure of oxaliplatin-containing chemotherapy terminated appraisal. NICE technology appraisal 150 (2008). See www.nice.org.uk/ta150. Bevacizumab and cetuximab for the treatment of metastatic colorectal cancer. NICE technology appraisal guidance 118 (2007). Available from www.nice.org.uk/ta118 Laparoscopic surgery for the treatment of colorectal cancer (review). NICE technology appraisal guidance 105 (2006). Available from www.nice.org.uk/ta105 Capecitabine and oxaliplatin in the adjuvant treatment of stage III (Dukes' C) colon cancer. NICE technology appraisal guidance 100 (2006). Available from www.nice.org.uk/ta100 Referral guidelines for suspected cancer. NICE clinical guideline 27 (2005). Available from www.nice.org.uk/cg027 Colorectal cancer draft scope for consultation 18 February to 18 March 2009 Page 7 of 9
Improving supportive and palliative care for adults with cancer. Cancer service guidance (2004). Available from: www.nice.org.uk/csgsp Improving outcomes in colorectal cancers: manual update. Cancer service guidance (2004). Available from www.nice.org.uk/csgcc Selective internal radiation therapy for colorectal metastases in the liver. NICE interventional procedure guidance 93 (2004). Available from www.nice.org.uk/ipg93 Radiofrequency ablation for the treatment of colorectal metastases in the liver. NICE interventional procedure guidance 92 (2004). Available from www.nice.org.uk/ipg92 Capecitabine and tegafur uracil for metastatic colorectal cancer. NICE technology appraisal guidance 61 (2003). Available from www.nice.org.uk/ta61 5.2 Guidance under development NICE is currently developing the following related guidance (details available from the NICE website). Cetuximab for the first line treatment of metastatic colorectal cancer. NICE technology appraisal guidance. Publication expected April 2009. Irinotecan for the adjuvant treatment of colon cancer. NICE technology appraisal guidance. Publication date to be confirmed. Bevacizumab in combination with oxaliplatin and either 5FU or capecitabine for the treatment of metastatic colorectal cancer. NICE technology appraisal guidance. Publication date to be confirmed. 6 Further information Information on the guideline development process is provided in: How NICE clinical guidelines are developed: an overview for stakeholders' the public and the NHS The guidelines manual. Colorectal cancer draft scope for consultation 18 February to 18 March 2009 Page 8 of 9
These are available from the NICE website (www.nice.org.uk/guidelinesmanual). Information on the progress of the guideline will also be available from the NICE website (www.nice.org.uk). Colorectal cancer draft scope for consultation 18 February to 18 March 2009 Page 9 of 9