Scope for the development of a clinical guideline on the diagnosis and treatment of lung cancer |
National Institute for Clinical Excellence
Scope
1. Guideline title
Lung cancer: diagnosis and treatment
Short title
Lung Cancer
2. Background
The National Institute for Clinical Excellence ('NICE' or 'the Institute') has
commissioned the National Collaborating Centre for Acute Care to develop a
clinical guideline on lung cancer for use in the NHS in England and Wales.
This follows referral of the topic by the Department of Health and National
Assembly for Wales (see Appendix). The guideline will provide recommendations
for good practice that are based on the best available evidence of clinical
and cost effectiveness.
The Institute's clinical guidelines support the
implementation of National Service Frameworks (NSFs) in those aspects of care
where a Framework has been published. The statements in each NSF reflect the
evidence that was used at the time the Framework was prepared. The clinical
guidelines and technology appraisals published by the Institute after an NSF
has been issued will have the effect of updating the Framework. This guideline
will support current national initiatives outlined in the 'NHS Cancer Plan'i
, the Calman Hine reportii , 'Manual of Cancer Service Standards
for England'iii and 'All Wales Minimum Standards for Lung Cancer
Services'iv . The cancer service guidance entitled 'Supportive and
Palliative Care for People with Cancer', which is currently in development by
the Institute, will also be of relevance to those using this guideline.
3. Clinical need for the guideline
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3.1. |
Primary lung cancer is a major public health problem. During 1998 in England and Wales there were 32,502 new cases of lung cancer and 29,400 deaths registered.v |
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3.2. |
Although the total number of people diagnosed with lung cancer is falling, the rate of decrease is very small and is among men only. Furthermore, it masks the fact that numbers continue to rise in women, a problem that is expected to grow in future due to increased tobacco consumption among teenage girls.vi |
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3.3. |
Lung cancer is usually divided into two types, which respond differently to different treatment modalities. Among those with a histological diagnosis, non-small cell lung cancer (NSCLC) accounts for 80% of all cases of lung cancer with small cell lung cancer (SCLC) accounting for the remaining 20%. |
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3.4. |
The five-year survival rate for lung cancer sufferers is 5% in England and Walesvii , lower than the rates in many European and North American countries thus suggesting that there may be scope for improvement in the diagnosis and treatment of lung cancer.viii |
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3.5. |
It is estimated that a large number of lung cancer patients are not diagnosed early enough and/or are not referred to a specialist team and thus do not receive treatment adequate treatment. |
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3.6. |
The management and treatment of lung cancer depends on the accurate typing (i.e., making a histological diagnosis) and staging of the cancer. Staging is critical for developing a treatment strategy and determining patient survival. Staging aims to estimate the tumour size and whether the cancer remains localised. Higher histological diagnosis rates are associated with greater survival rates, but these diagnostic rates have typically been lower in the UK than in other European countries, especially among patients over 65 years of age.ix |
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3.7. |
Evidence suggests that the standards of management vary widely across the UK as manifested in wide variations in surgical resection rates.x It may be the case that more patients may benefit from surgery and existing guidelines in this area call for improved accuracy of the selection process of lung cancer patients suitable for surgery.xi |
4. The guideline
The areas that will be addressed by the guideline are described in the
following sections 4.1 to 4.4.
The guideline development process is described in detail in
three booklets that are available from the NICE website (see 'Further
Information', Section 6). 'The Guideline Development Process - Information for
Stakeholders' describes how organisations can become involved in the
development of a guideline.
4.1. Population
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4.1.1. |
Groups that will be covered The guideline will be relevant to adults over the age of 18 years who are suspected as having, or are diagnosed with, lung cancer. |
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4.1.2. |
Groups that will not be covered The guideline will not cover: |
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4.1.2.1. |
Patients with mesothelioma |
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4.1.2.2. |
Patients with lung metastases from cancer arising from outside the lung |
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4.1.2.3. |
The prevention of lung cancer. |
4.2. Healthcare setting
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4.2.1. |
The guideline will offer guidance on care provided in primary care, secondary care, outpatient and day treatment services, tertiary care, specialist services and the interface with the voluntary and social services where relevant. |
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4.2.2. |
The guideline will be relevant to multidisciplinary teams involved in the diagnosis and care of patients with suspected or diagnosed lung cancer. These teams may include, for example, general physicians and nurses, respiratory physicians, palliative care physicians, clinical and medical oncologists, thoracic surgeons, geriatricians, cellular pathologists, radiologists, radiographers, occupational therapists, specialist nurses, physiotherapists, dieticians, pharmacists and clinical psychologists. |
4.3. Clinical management
The guideline will address diagnosis, staging and treatment.
Where there are issues specific to lung cancer, it will also address
palliative care , psychological impact and day-to-day functioning as follows:
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4.3.1. |
Diagnosis: The guideline will provide guidance on diagnosis including early diagnosis, diagnostic methods, and staging. The guideline will cover: |
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4.3.1.1. |
Early diagnosis, ie, guidance for primary care on early diagnosis, for example diagnostic significance of symptoms. |
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4.3.1.2. |
Key symptoms and signs upon which a patient should be referred to a specialist lung cancer team or physician. |
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4.3.1.3. |
Factors encouraging patients to present to healthcare services sooner, where evidence exists. |
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4.3.1.4. |
Diagnostic methods, for example: :
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4.3.1.5. |
Staging, including the use of:
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4.3.1.6. |
Identifying both the impact of lung cancer on the patient's psychological and daily activities, and the need for referral to allied or other health professionals for further assessment if required. |
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4.3.2. |
Treatment The guideline will provide guidance on: |
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4.3.2.1. |
Modalities used in treating lung cancer while taking account of their effect on quality of life, any adverse events associated with them and the patient's individual circumstances, eg, co-morbidities and personal preferences. |
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4.3.2.2. |
The impact of co-morbidities (e.g., COPD, cardiovascular and cerebrovascular disease) and prognostic factors (e.g., weight loss, performance status, biochemical markers) in determining suitability for radical treatment. |
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4.3.2.3. |
Specific treatment modalities, for example: |
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Non small cell lung cancer (NSCLC) |
Small cell lung cancer (SCLC) |
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Surgery |
The most effective type of surgery for NSCLC (including pneumonectomy, lobectomy, sleeve resection, chest wall resection, and video-assisted thorascopic surgery) and on what factors it depends. The criteria (including co-morbidities, pulmonary function, and stage of cancer) upon which patients are selected for surgery. |
The role of surgery for SCLC. |
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Radiotherapy |
The effectiveness of radical radiotherapy (either CHART or conventional) as a primary treatment for NSCLC. The role and dosage of palliative radiotherapy. |
The role of thoracic radiotherapy in the treatment of SCLC. Whether prophylactic cranial irradiation should be routinely used, and if so, for which patients. |
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Chemotherapy |
The role of chemotherapy and more particularly, how many cycles of chemotherapy patients should receive, whether dose intensification improves outcomes, and whether it is possible to reduce the risk of fatal toxic events. The role and nature of second line chemotherapy. This will take into account, the Institute's existing technology appraisal on docetaxel, paclitaxel, gemcitabine and vinorelbine . |
The role of chemotherapy and more particularly, how many cycles of chemotherapy patients should receive, whether dose intensification improves outcomes, and whether it is possible to reduce the risk of fatal toxic events. The role and nature of second line chemotherapy. |
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Combination Treatment |
The use of combination treatment (any two or more of the above modalities), whether radiotherapy should be concurrent or sequential where combination therapy is used, and the place of brachytherapy (endobrochial radiotherapy). |
The use of combination treatment (any two or more of the above modalities), whether radiotherapy should be concurrent or sequential where combination therapy is used, and the place of brachytherapy (endobrochial radiotherapy). |
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Endobronchial Therapies |
Endobronchial therapies, including, brachytherapy, stenting (including SVC stenting), laser therapy, cryotherapy, and diathermy. |
Endobronchial therapies, including, brachytherapy, stenting (including SVC stenting), laser therapy, cryotherapy, and diathermy. |
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4.3.2.4. |
Guidance on referral to physiotherapy, occupational therapy or other allied health therapies for treatment to maximise day-to-day functional independence and quality of life, both in the short term and during palliative care. |
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4.3.2.5. |
Guidance on the provision of information and psychological support for patients and carers with respect to results of diagnostic tests, treatment options, preparation for treatment and palliative care, in aspects specific to lung cancer.
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4.3.3. |
Palliative Care The guidance will make reference to NICE 'Supportive
and Palliative care Cancer Service Guidance' currently in production. |
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4.3.3.1. |
Diagnostic information needed in order to optimise palliative treatment decisions. |
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4.3.3.2. |
Palliative interventions for:
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4.3.3.3. |
How palliative interventions and care, specific to lung cancer, can be delivered effectively. |
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4.3.3.4. |
The use of corticosteroids and anabolic steroids in palliative care of lung cancer. |
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4.4. Audit support within guideline
The guideline will include several key review criteria for audit, which will
enable objective measurements to be made of the extent and nature of local
implementation of this guidance, particularly its impact upon practice and
outcomes for patients.
5. Status
This is Version 2b of this Scope. It was drafted by the National Collaborating
Centre for Acute Care andapproved by the Institute for consultation. Following
consultation with stakeholders it was modified for consultation with the
Institutes Guidelines Advisory Committee Panel before it is formally signed
off by the Institute. It will then be posted on the Institute's website and
the development of the guideline is expected to begin in May 2002.
6. Further information
Information on the guideline development process is provided in:
Guideline Development Process: Information for the Public and the NHS
Guideline Development Process: Information for Stakeholders
Guideline Development Process - Information for National Collaborating Centres and Guideline Development Groups
These booklets are available as pdf files from the NICE website (www.nice.org.uk).
Information of the progress of the guideline will also be available on the
website.
7. References
iDepartment of Health. The NHS Cancer Plan: a
plan for investment: a plan for reform, 2000.
iiNHS Executive. A policy framework for commissioning cancer
services; improving the quality of cancer services - a report by the expert
advisory group on cancer to the Chief Medical Officers of England and Wales,
1995.
iiiNHS Executive. Manual of cancer service standards. London:
Department of Health, 2000.
ivCancer Services Coordinating Group. Lung cancer services: all
Wales minimum standards. National Assembly for Wales, 2000.
vCancer Trends in England and Wales: 1950-1999 (ISBN: 0 11 621393
0).
viImperial Cancer Research Fund and Cancer Research Campaign.
viiCancer Research Campaign.
viiiBerrino F et al. (eds) Survival of cancer patients in Europe:
the EUROCARE STUDY. Lyon: International Agency for Research on Cancer, 1995.
ixGuidance on Commissioning Cancer Services (NYCRIS).
xRoyal College of Physicians of London (Peake MD, Thompson S, eds)
National audit of lung cancer in the UK 1999; cancer treatment policies and
their effects on survival. Key sites study No 2: Lung Cancer Northern and
Yorkshire Cancer Registry and Information Service (NYCRIS) 1999.
xiBritish Thoracic Society and Society of Cardiothoracic Surgeons
of Great Britain and Ireland Working Party. Guidelines on the selection of
patients with lung cancer for surgery. Thorax 56: 89-108,
2001.
xiiNational Institute for Clinical Excellence. Guidance on the use
of docetaxel, paclitaxel,gemcitabine and vinorelbine for the treatment of
non-small cell lung cancer. Technology Appraisal Guidance No. 26. London:
National Institute for Clinical Excellence, June 2001.
Appendix - Remit from the Department of Health and National Assembly for Wales
"To prepare clinical guidelines for the NHS in England and Wales for the diagnosis and treatment of lung cancer. This is to supplement the existing service guidance published by DH in 1998 and this commission replaces the earlier commission to update that guidance".