Improving Outcomes in Colorectal Cancer

GOOD PRACTICE

Guidance on Commissioning Cancer Services

Improving Outcomes in Colorectal Cancer The Manual

Purpose ot this document This booklet is intended to help Chief Executives of Health Authorities and NHS Trusts review and identify ways to improve services for colorectal cancer.

Contact Point

Triona Norman NHS Executive Health Services Directorate Wellington House London SE1 8UG

Further copies

Department of Health PO Box 410 Wetherby LS23 7LL

Date of Issue

November 1997

Other Relevant publications

A Policy Framework for Commissioning Cancer Services NHSE 1995 Guidance for Purchasers: Improving Outcomes in Breast Cancer NHSE 1996

Catalogue number

Improving Outcomes in Colorectal Cancer: The Manual 97CV0119 Improving Outcomes in Colorectal Cancer: Research Evidence 97CC0120

Guidance on Commissioning Cancer Services

Improving Outcomes in Colorectal Cancer The Manual

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Contents Foreword Introduction Key Recommendations Background

7 11 15 16

The Topic Areas 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Patient-centred Care Access to Appropriate Services Multi-disciplinary Team Primary Diagnosis and Pre-operative Evaluation Surgery and Histopathology Radiotherapy in Primary Disease Adjuvant Chemotherapy Follow-up Recurrent and Advanced Disease Palliative Care

21 24 29 33 36 40 42 44 48 51

Appendices 1. 2. 3.

Developing the Guidance: the Process People and Organisations Involved in Production of the Guidance Glossary of Terms

54 56 69

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Foreword The first guidance document on breast cancer was well received and this, the second in the series, has been produced using the same method and approach. Like breast cancer, colorectal cancer is responsible for about 10% of all new cases of cancer in the UK population overall. Colorectal cancer is second only to lung cancer in importance as a cause of cancer death, with about 12% of all cancer deaths (breast cancer causes 9%); however, patients with colorectal cancer tend to be older than those with breast cancer. Outcomes in colorectal cancer in the UK appear, if the Eurocare Study1 is to be accepted, to be worse than in many comparable countries, a similar situation to that for breast cancer. This second cancer guidance report deals, therefore, with an important type of cancer, but one which has not enjoyed the same public, political, and professional profile that has been accorded to breast cancer. Less, perhaps, can be expected from the public in terms of their appreciation of the importance of symptoms that might result in the diagnosis of this disease. There is almost certainly less understanding too amongst health professionals, including health managers, about the clinical and health service issues that might be associated with improving outcomes for patients with this disease. Many reasons might account for this, the chief of which is that public interest in breast cancer was stimulated during the late 1980s by the introduction of national population screening for women aged between 50 and 65. The screening programme for breast cancer established new services, setting high standards of quality control and creating pressure to extend the same systematic approach to symptomatic services. Colorectal cancer, by contrast, is a disease for which there is currently no national screening programme, and historically little pressure to develop services. There has been a plethora of publications on breast cancer, ranging from the House of Commons Select Committee Report to referral guidelines for primary care, which have created a climate of knowledge and expectation. This is not the case for colorectal cancer, where the changes necessary to generate improvements in outcomes are less understood. This picture is beginning to change for three main reasons. First, progress is being made across the country in implementing the Calman/Hine cancer policy, addressing the commoner cancers in particular. Secondly, recently published research suggests there may now be a sufficient scientific basis for population screening for colorectal cancer, an issue which is being actively reviewed in accordance with national policy for assessing potential new screening programmes. Thus this issue is not dealt with in this report. Thirdly, national clinical guidelines for this disease have now been published by the Royal College of Surgeons of England, the Association of

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Coloproctology of Great Britain and Ireland, and the Scottish Cancer Therapy Network/Scottish Cancer Co-ordinating and Advisory Committee. These are of considerable importance amongst relevant professional groups. It might be argued that there is a greater need for authoritative guidance on services for colorectal cancer. However, and significantly for those who have had the task of producing this report, the evidence base for the relationship between services and outcomes for colorectal cancer is thinner than for breast cancer. There is less clarity about some crucial issues about which good research was available for breast cancer; follow-up is one example. For this reason this document, with its emphasis on the careful appraisal of research evidence, is not always able to offer as clear-cut recommendations as some people may have hoped to see. Breast cancer, conveniently perhaps, presents to health services in ways which are relatively easy to define, and its primary management is almost always elective. Colorectal cancer, by contrast, presents in more varied ways, and patients may be referred by a variety of routes. About one-fifth of patients with this disease are treated as emergencies. The quality of diagnostic services was one of the important themes in the breast guidance, as it is in this document. Whilst the importance of good histopathology and imaging is common to both, there is a crucial and specific requirement in large bowel cancer for adequate endoscopy facilities. These are necessary for diagnosis in symptomatic patients and for the surveillance of patients at high risk. The adequacy of endoscopy services will need active consideration if and when any programme of population screening is to be implemented. Treatment issues are inevitably important to the improvement of outcomes. Qualitative issues in surgery are more influential than in breast cancer, for rectal cancer in particular. The effective deployment of multi-modality therapy is common to both, with proven roles for radiotherapy and chemotherapy. The recommendations in this guidance document take account of the increasing evidence of benefit from pre-operative radiotherapy in rectal cancer, therapy which will necessitate changes in clinical practice in many areas, although not necessarily an absolute increase in the amount of radiotherapy given for this disease. The importance of clinical trials in answering crucial questions about the roles of different treatment combinations is emphasised. This contrast between breast and colorectal cancer makes the very important point that although these guidance documents follow a consistent style and format, differences in the nature of the diseases and their management inevitably lead to different recommendations. These may be encompassed within different topic areas. One of the potentially controversial aspects of the breast report was its recommendation that a minimum of 100 cases per year should be the threshold for a modern specialist breast service. This recommendation was based on four strands of evidence: against low volume work; in favour of specialists (and by implication multi-disciplinary work); of wider professional consensus; and the cost-effectiveness of convening a full specialist team. There was confidence that breast work could be concentrated in the hands of the designated specialist team.

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There is not the same body of evidence on which to base an equivalent recommendation in colorectal cancer. Evidence of a volume effect in colorectal surgery is simply not there in most studies. Evidence of the benefits of specialisation is patchy, and there is currently no professional consensus on a caseload figure. The notion of cost-effectiveness in formulating a specialist team clearly applies, but because of the varied presentations of this disease, it may not be possible to centralise its management completely. There are problems, too, in regarding colon and rectal cancer as if they present the same service organisational and clinical problems. A lively debate is in progress about the nature of optimum surgery in rectal cancer. Strong evidence exists that with thorough and accurate histopathology, it is possible to assess surgical results on an ongoing basis in a way that correlates with important outcomes, such as local recurrence and survival. The variability of outcomes relates in part to the quality of the surgery carried out. Does it matter, therefore, which surgeons treat these patients, or how much of this type of surgery they perform? These questions are dealt with in this report in recommendations about the nature and role of specialist teams in the management of patients who have, or may have, this disease. One particular facet of the answers to these questions does carry broad professional agreement, namely the importance of audit. Through this means it will be possible to establish which surgeons achieve good results. This justifies our making what will inevitably be a somewhat controversial recommendation that surgery, particularly for rectal cancer, should be concentrated in the hands of surgeons who carry out sufficient potentially curative resections to allow the meaningful audit of their results. This clearly would not be possible for single figure numbers. The only figure suggested in the literature is that from Hermanek and Hohenberger2 which proposes an average of between one and two radical resections for colorectal cancer per month as a minimum. Such a workload would begin to provide results for proper audit. This approach also requires careful and accurate recording of key histopathological features. In the absence of an evidence base for a more definitive recommendation, this provides a logical way forward.

Professor Robert Haward Chairman of the Cancer Guidance Sub-group of the Clinical Outcomes Group.

1

World Health Organisation, International Agency for Research on Cancer, European Commission. Survival of cancer patients in Europe: the Eurocare Study. Lyon: IARC Scientific Publications No. 132, 1995.

2

Hermanek P, Hohenberger W. The importance of volume in colorectal cancer surgery. European Journal of Surgical Oncology 1996; 22: 213-215.

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Introduction Aims This guidance is intended to help the commissioning, planning, and developing of colorectal cancer services. It was produced on the initiative of the Chief Medical Officer’s Clinical Outcomes Group, to follow on from the Calman and Hine Report, A Policy Framework for Commissioning Cancer Services1 and forms part of the Department of Health strategy as set out in Executive Letter EL(96)15, paragraph 8 and Annex C. This is the second in a series of guidance documents on site-specific cancers; the first was on breast cancer. It is designed to help those commissioning cancer services - including general practitioners - to focus on those aspects of colorectal cancer services which are likely to have a significant impact on health outcomes. It can be used to guide choices between providers and to provide the basis for improving the quality of their services. The information it contains will also be of interest to health care providers and to patients.

Why guidance is needed Colorectal cancer causes 17,000 deaths per annum in England and Wales.2 There is evidence of significant variations both in the process3,4 and outcomes5,6 of colorectal cancer care across the country. Cross-country comparisons reveal that the rates of survival for people with diagnosed colorectal cancer in England are lower than in several other European countries.7 Implementation of this guidance will make a significant contribution to reducing unjustifiable variations in provision of care, improving quality, and enhancing a broad range of health outcomes. The recommendations represent a set of priorities, not a shopping list of everything to be commissioned or all relevant health care activities. By focusing on components of provision which are most relevant to patient outcomes, considering the resource implications of change, and by giving information on anticipated health benefits of implementing the recommendations, the manual will help commissioners concentrate on areas most likely to make a difference. This is neither a set of mandatory instructions nor clinical practice guidelines. Many of the recommendations made here may already have been implemented in some places; the guidance can be used to identify gaps in local provision and to check on the appropriateness of existing services. It is not anticipated that all the proposals described will be achieved in all areas; some may be easy to implement, while others will be used as goals at which to aim. Health authorities will need to identify which of these to prioritise, taking into account the quality and configuration of existing local services and the resources

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available. It might seem reasonable to prioritise on the basis of the likely impact of change - as far as this may be judged from the evidence - but this too depends on the degree to which the current service differs from that which is recommended. The topic areas covered vary widely and the evidence suggests that change in some areas will have more impact than in others. The amount and strength of supporting evidence available also varies, partly reflecting the fact that research has tended to focus on some issues more than others. Unanswered questions and areas of uncertainty remain. Some of these are being studied in clinical trials, in which all units should be encouraged to participate in order to contribute to improvements in knowledge about the best way to treat colorectal cancer. It is anticipated that this guidance will be updated when significant new evidence becomes available. Local circumstances will necessitate modifications in the way this guidance is implemented. For example, services suitable for sparsely populated areas, where access can be difficult, may be different from those provided in cities. Cultural and ethnic differences may also affect appropriate provision. Local people and GPs should be involved in discussions about the configuration of services and the nature of the care to be provided.

How the guidance was produced The guidance is a result of an extensive, explicit and rigorous multi-stage process which was developed by a sub-group of the Chief Medical Officer’s Clinical Outcomes Group chaired by Professor Haward of Leeds University (Appendix 1). A wide range of professional, policy and patient groups was involved in generating proposals for recommendations which were then critically appraised in the light of research evidence (Appendix 2). Finally, the material was synthesised and refined, taking account of the resource implications. The first stage of the production process for colorectal cancer guidance took place at a two-day event at which a large group of relevant health care professionals, people with personal experience of colorectal cancer, commissioners, and academics from around the country, met to put forward structured proposals based on their experience and knowledge of the research (Appendix 2.2). These proposals were then sent to a wide range of referees, including clinicians, academics, representatives of health authorities, the Department of Health, patient organisations, and relevant charities, many of whom made detailed comments and suggestions (Appendix 2.3). Systematic reviews of the research literature, and where appropriate, meta-analyses of the results, were then carried out or commissioned by the NHS Centre for Reviews and Dissemination (CRD) at the University of York (Appendix 2.4). This process culminated in the production of two large sources of information. One had a practical or operational focus, while the other concerned detailed research evidence on effectiveness. The guidance draws on both these sources, with added input from commissioners, patients, and experts in the particular fields who gave advice. It was written by the NHS Centre for Reviews and Dissemination (Appendix 2) with editorial input from the Cancer Guidance Sub-group of the Clinical Outcomes Group (Appendix 2.1) and informed by focus groups of commissioners (Appendix 2.5).

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The final ten topic areas represent a refinement of material which had originally been presented in fifteen proposals. The production of this guidance was funded by the NHS Executive.

The organisation of the guidance material The guidance material is divided into two documents, in which the ten topic areas are discussed in the same order for ease of cross-reference. This order is intended to be a logical sequence of issues and does not reflect priorities. The first document (The Manual) is based on all the available sources of information. Each topic area includes five sections, summarising (A) the recommendations, (B) potential benefits of implementing them, (C) the strength of the supporting evidence, (D) how implementation may be measured, and (E) the resource implications of implementing the recommendations. The second document (The Research Evidence) is a summary of relevant systematic reviews of research. It includes tables with information about individual studies and is fully referenced. The recommendations are also published as a four page summary which will be widely distributed, particularly in primary care.

The Topic Areas 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Patient-centred care Access to appropriate services Multi-disciplinary team Primary diagnosis and pre-operative evaluation Surgery and histopathology Radiotherapy in primary disease Adjuvant chemotherapy Follow-up Recurrent and advanced disease Palliative care

The Research Evidence In order to ensure that the guidance is anchored in the research evidence, the research literature was reviewed and critically appraised. The reliability and quality of evidence which supports the recommendations is graded throughout the document as follows:8 A. B. C.

Evidence derived from randomised controlled trials or systematic reviews of randomised trials. Evidence from non-randomised controlled trials or observational studies. Professional consensus.

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It should be recognised that the quality of research evidence forms a continuum. It is categorised here for convenience but there is overlap between categories. Most of the published research on colorectal cancer focuses on clinical evaluations of treatment; relatively little direct research has been carried out on the organisation and delivery of services. In addition, for many service delivery issues, randomised controlled trials (categorised here as the highest quality evidence) are not feasible. Therefore, research designs which might be regarded as of relatively poor quality for evaluating a clinical intervention may be the most reliable available for assessing the effectiveness of service delivery.

References

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1.

Expert Advisory Group on Cancer. A Policy Framework for Commissioning Cancer Services. Department of Health, 1995.

2.

OPCS: Mortality statistics, Cause, 1993. London: HMSO, Series DH2 No. 22, 1995.

3.

Wessex Colorectal Cancer Audit, Progress Report No.3. Winchester: Institute of Public Health Medicine, 1996.

4.

MacFarlane JK, Ryall RDH, Heald RJ. Mesorectal excision for rectal cancer. Lancet, 1993, 341: 457-460.

5.

McArdle CS, Hole D. Impact of variability among surgeons on post-operative morbidity and mortality and ultimate survival. British Medical Journal, 1991, 302: 1501-1505.

6.

Consultant Surgeons and Pathologists of the Lothian and Borders Health Board. Lothian and Borders large bowel cancer project: immediate outcome after surgery. British Journal of Surgery, 1995, 82: 888-890.

7.

World Health Organisation, International Agency for Research on Cancer, European Commission. Survival of cancer patients in Europe: the Eurocare Study. Lyon: IARC Scientific Publications No. 132, 1995.

8.

Mann T. Clinical Guidelines: using clinical guidelines to improve patient care within the NHS. Leeds: NHS Executive, 1996.

Key Recommendations The guidance puts forward recommendations in ten areas. It is unlikely that all of these can be implemented in the short term. We have identified six key recommendations which, if implemented as a whole, will make a major contribution to improving quality of care. Each of these is treated more fully under the relevant topic section.

Patient focus (Topic 1) Patients should be offered full verbal and written information about their condition and about any treatment that may be offered. They should have continuing access to a member of the core team who can offer guidance and support.

Multi-disciplinary teams (Topic 3) Management of cancer care by multi-disciplinary teams which work to agreed protocols is likely to facilitate the implementation of recommendations in this report and improve the quality and co-ordination of care. These teams would include clinicians with up-to-date knowledge of diagnosis and treatment of colorectal cancer, and specialised nursing staff who can support and advise patients.

Endoscopy facilities (Topics 2 and 4) Adequate endoscopy facilities should be provided to help ensure accurate and timely diagnosis. Quality of diagnostic procedures - particularly colonoscopy completion and complication rates - should be monitored and staff given additional training when necessary to improve standards.

Surgery for rectal cancer (Topic 5) Surgery for rectal cancer should be concentrated in the hands of surgeons who can demonstrate good results, particularly in terms of low recurrence rates. Surgeons should monitor their performance by working closely with histopathologists.

Improved pathology reporting (Topic 5) Pathology reporting should be sufficiently detailed to give comprehensive feedback on the adequacy of surgery, particularly for rectal cancer. Reports on surgical specimens should include data on the size, type, grade and Dukes’ stage of tumour, and the involvement of lymph nodes and surgical margins. This information is important to guide treatment decisions, for routine collection of data on case-mix by cancer registries, and for monitoring long-term outcomes.

Adjuvant therapies (Topics 6 and 7) Pre-operative radiotherapy should be available for patients with rectal cancer. Adjuvant chemotherapy can improve survival in some groups of patients and should be more widely available. Large scale, nationally or internationally co-ordinated randomised controlled trials should be supported in order to determine the best management of patients with colorectal cancer.

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Background The size of the problem: incidence and mortality rates Colorectal (large bowel) cancer is responsible for over 19,000 deaths per year in the United Kingdom (17,000 in England and Wales, 1,700 in Scotland and 450 in Northern Ireland).1-3 Its incidence is 48 per 100,000 per year, rising sharply with age. In people below the age of 45, the annual registration rate is 2 per 100,000, but among those aged 75 and above, the rate reaches 300 per 100,000 per year. The median age of patients at diagnosis is just under 70 years.1 Taking into account the background mortality due to other causes, data from some of the best European cancer registries suggest that 5-year survival rates for colorectal cancer in England and Scotland are worse than in many other parts of Europe.4 Denmark, the Netherlands, Finland, France, Germany, Italy, Spain and Switzerland all report significantly better outcomes for colon cancer, rectal cancer or both. However, selection bias may exaggerate the size of these differences.

The disease: characteristics and prognosis Colorectal refers to any part of the large bowel, but the cancer can be described in terms of the specific anatomical area affected. About two-thirds of tumours occur in the colon and the remainder in the rectum and rectosigmoid. Colon cancer occurs at roughly equal rates in both men and women, but rectal cancer is more common in men. Most of these tumours are believed to evolve from polyps which may be present for some years before malignancy develops. The rate of progression of the disease is very variable; in some patients, the tumour grows slowly and can remain asymptomatic for many years, while in others it may be more aggressive.5 The most common presenting symptoms are blood on, or mixed with, stools; change in bowel habit; anaemia; weight loss; nausea and anorexia; and abdominal pain. These symptoms are often not clear-cut. They may not become apparent until the cancer is far advanced and they can have a variety of other causes, leading to problems with diagnosis. Patients survive, on average, for three years after diagnosis.5 The prognosis and type and effectiveness of treatment depend largely on the degree to which the cancer has spread. Spread is usually described in terms of Dukes’ stage, modified to allow for inclusion of metastatic spread (Table 1).

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Table 1: Colorectal cancer staging* Dukes’ Stage (modified)

Definition

Approximate frequency at diagnosis

5-year survival

A

Cancer localised within the bowel wall

11%

83%

B

Cancer which penetrates the bowel wall

35%

64%

C

Cancer spread to lymph nodes

26%

38%

D

Cancer with distant metastases (most often in the liver)

29%

3%

Populations at increased risk Around 5% of patients suffer from genetic syndromes associated with an exceptionally high risk of colorectal cancer and 1% have bowel disease that increases susceptibility. In general, the risk is greater for people with a family history of the disease. However, around 75% of patients have neither a positive family history nor any condition known to predispose them to developing colorectal cancer.6 (Figure 1)

Figure 1: Risk factors associated with new cases of colorectal cancer IBD 1% FAP 1% HNPCC 5%

FH 15-20%

“Sporadic” “Average Risk” - 75%

P Risk Factors “Sporadic” FH HNPCC FAP IBD

*

= = = = =

aged 50 and older with no special risk factors positive family history hereditary non-polyposis colorectal cancer familial adenomatous polyposis inflammatory bowel disease

Frequency and survival statistics based on data from 777 patients derived from St Vincent’s Hospital colorectal cancer database, Dublin. (Mulcahy, 1997, personal communication). Note that stage frequency and survival figures vary widely between published series from different centres.

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Prevention Possible links between colorectal cancer and lifestyle have been the subject of considerable research. There is increasingly convincing evidence that the risk of colorectal cancer is lower when the diet is high in vegetables and that physical activity can reduce the risk of colon cancer.7

Surveillance and Screening At present, there are no established screening services for the general population, although individuals who belong to groups known to be at exceptionally high risk may receive regular surveillance. Screening policy is currently being reviewed by the Chief Medical Officer’s National Screening Committee in the light of three major randomised controlled trials showing significant survival benefits from screening older members of the population.8-10

Treatment Surgery, radiotherapy and chemotherapy have all been shown to improve long-term survival and reduce recurrence in certain groups of patients. Surgery to remove the tumour is the principal first line treatment for approximately 80% of cases. These, mainly elderly, patients are likely to remain in hospital for two to three weeks, after which about 40% will remain disease-free in the long term. In about 20% of cases, the disease is too far advanced at initial presentation for any curative intervention; most of these patients die within a few months.5,11 Chemotherapy as an adjuvant to surgery is offered to a minority of patients (4% in Yorkshire, 1989-93).11 Adjuvant radiotherapy may be used to treat rectal cancers, but again only a minority of patients receive it. Surgery, chemotherapy, or radiotherapy may also be used as part of palliative treatment for patients with advanced disease. The role of chemotherapy and radiotherapy in adjuvant and palliative treatment is discussed in the relevant sections of this Guidance. Their use both as adjuvant therapy and in palliation, although clear in some areas, needs further evaluation through well organised national clinical trials.

Costs Colorectal cancer accounts for more hospital in-patient expenditure than cancer of any other site, and for between 10 and 20% of palliative care provision. Overall costs to the NHS per average district (population 250,000) have been estimated to be just over £1 million per year at 1991 prices. Over half of this cost is for surgery. Palliative care is the next largest contributor, accounting for 28% of the total bill, and follow-up accounts for nearly 10%.5

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Figure 2: Colorectal cancer: clinical services Patients PATIENTCENTRED CARE (Topic 1)

Symptomatic

ACCESS (Topic 2) PRIMARY DIAGNOSIS (Topic 4)

Non-specific symptoms: referred via other specialties

RADIOTHERAPY (Topic 6)

SURGERY (Topic 5)

diagnostic procedures as necessary

colon cancer (67%)

multi-disciplinary review

? radiotherapy

inoperable cancer (20%)

surgery (80%) palliative surgery (10%)

multi-disciplinary review CHEMOTHERAPY (Topic 7)

FOLLOW-UP (Topic 8) RECURRENT & ADVANCED DISEASE (Topic 9) PALLIATIVE CARE (Topic 10)

High Risk (5%)

(75%)

rectal cancer (33%) TEAM (Topic 3)

Emergency (20%)

?chemotherapy (up to 30%)

follow-up disease-free (35%)

recurrence (35%)

disease-free