Diagnosis and treatment of lung cancer: summary of updated NICE guidanceBMJ 2011; 342 doi: https://doi.org/10.1136/bmj.d2110 (Published 27 April 2011) Cite this as: BMJ 2011;342:d2110
- D R Baldwin, consultant respiratory physician1,
- B White, consultant neurosurgeon1,
- M Schmidt-Hansen, researcher2,
- A R Champion, centre manager2,
- A M Melder, senior researcher3
- on behalf of the Guideline Development Group
- 1Nottingham University Hospitals NHS Trust, Nottingham NG5 1PB, UK
- 2National Collaborating Centre for Cancer, Cardiff CF10 3AF, UK
- 3Centre for Clinical Effectiveness, Southern Health, Clayton, Victoria 3168, Australia
- Correspondence to: Dr D R Baldwin, Consultant Respiratory Physician, Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals, City Campus, Hucknall Road, Nottingham, NG5 1PB
Each year in the United Kingdom over 35 000 people die from lung cancer, 4000 more than from breast and bowel cancer combined,1 and survival remains lower than in other developed countries.2 Inequality exists in the UK in the delivery of treatment with curative intent3 as well as in delivery of active treatments generally. All healthcare professionals involved at any stage of the care pathway have important roles to play in tackling these inequalities. Thus the 2005 guidance from the National Institute for Health and Clinical Excellence (NICE) on the diagnosis and treatment of lung cancer was updated to advise healthcare professionals of important advances in management and to ensure patients have a supported, informed choice of the treatment that will help them most. This article summarises the recommendations from the updated NICE guideline on the diagnosis and treatment of lung cancer.4
NICE recommendations are based on systematic reviews of best available evidence and explicit consideration of cost effectiveness. When minimal evidence is available, recommendations are based on the Guideline Development Group’s experience and opinion of what constitutes good practice. Evidence levels for the recommendations are given in italic in square brackets.
Early diagnosis and referral
Ensure that patients have the best chance of early diagnosis by prompt attention to warning symptoms and promotion of public awareness of these (box).
Referral (recommendations retained from 2005)
Offer urgent referral for a chest radiography when a patient presents with:
-Any of the following unexplained or persistent (lasting more than three weeks) symptoms or signs: cough, chest or shoulder pain, dyspnoea, hoarseness, weight loss, chest signs, finger clubbing, features suggestive of metastasis from a lung cancer (for example, in the brain, bone, liver, or skin), or cervical or supraclavicular lymphadenopathy
If chest radiography or chest computed tomography suggests lung cancer (including pleural effusion and slowly resolving consolidation), offer an urgent referral to a member of the lung cancer multidisciplinary team, usually a chest physician. If the chest x ray film is normal but there is a high suspicion of lung cancer, offer urgent referral to a member of the lung cancer multidisciplinary team, usually the chest physician
Offer an urgent referral to a member of the lung cancer multidisciplinary team, usually the chest physician, while awaiting the result of chest radiography, if any of the following are present:
-Persistent haemoptysis in smokers and former smokers older than 40 years
-Signs of superior vena caval obstruction (swelling of the face or neck with fixed rise in jugular venous pressure)
[All the points in this box are based on case series and expert opinion]
Communication (New recommendation)
Find out what the patients knows, provide accurate and easy to understand verbal and written information at appropriate times in the pathway, and support patients and carers as they receive information. Consider the use of purpose designed decision aids. Document the discussions clearly, and offer patients a copy. Share information among healthcare professionals, including any advanced decision. If the patient does not wish to confront some concerns, this should be respected.
Ensure that a clinical nurse specialist in lung cancer is available at all stages of care to support patients and carers.
[Both of the above are based on limited and poor quality phase 1 studies, cross sectional surveys, and expert opinion]
Diagnosis and staging (New recommendation)
Choose investigations that give the most information about diagnosis and staging with least risk to the patient. Think carefully before performing a test that gives only a diagnosis when information on staging is also needed to guide treatment (fig 1⇓).
Ensure that positron emission tomography with computed tomography (PET-CT) and needle biopsy guided with endobronchial ultrasonography or endoscopic ultrasonography are available in every cancer network. Audit the local test performance of endobronchial and endoscopic ultrasonography and of transbronchial needle aspiration without ultrasonography guidance.
For modern chemotherapy, tumours must be classified accurately, so ensure that diagnostic samples are adequate to permit pathological subtyping and measurement of predictive markers.
If computed tomography (CT) scans show peripheral lesions, do PET-CT, followed by either definitive treatment or transthoracic biopsy, but take a biopsy specimen from any nodes that show uptake of fluorodeoxyglucose. However, if initial CT scans show enlarged (≥10 mm short axis) mediastinal nodes, take a biopsy specimen from the nodes rather than the primary lesion as the extent of disease in the nodes will have the most bearing on treatment.
Assessment of the mediastinal lymph nodes requires a different approach depending on the size of nodes and hence the probability of malignancy.
-For nodes >20 mm maximum short axis on CT scans, the preferred options are neck ultrasonography or non-guided transbronchial needle aspiration (during standard bronchoscopy).
-If neck nodes are seen on CT scans, offer neck ultrasonography as the first test.
-For lymph nodes 10-20 mm maximum short axis, offer as the first test one of: PET-CT; transbronchial needle aspiration guided with endobronchial ultrasonography; fine needle aspiration guided with endoscopic ultrasonography; or transbronchial needle aspiration without ultrasonography guidance. These patients have an intermediate probability of mediastinal malignancy and are potentially suitable for treatment with curative intent.
Consider magnetic resonance imaging or CT of the head in patients selected for treatment with curative intent, especially in stage III disease.
[The above five recommendations are based on studies ranging from low to high quality, including systematic reviews, and case series. Recommendations for mediastinal sampling are based on expert opinion and health economic evaluation]
Treatment with curative intent for non-small cell lung cancer (New recommendation)
Ensure that the patient is fit enough for such treatment by using a trimodality approach to risk assessment (fig 2⇓):
-Operative mortality—Consider using a global risk score such as Thoracoscore5 to estimate the risk of death. Ensure that the patient is aware of this risk before consenting for surgery.
-Cardiovascular morbidity—Minimise this by ensuring early optimal cardiovascular treatment, avoiding surgery within 30 days of myocardial infarction, obtaining a cardiology opinion for patients with active cardiac conditions (including stents) or three or more cardiovascular risk factors, and considering revascularisation, if indicated, before lung cancer surgery.
-Lung function and exercise testing—Offer preoperative spirometry (and transfer factor when breathlessness is disproportionate or the patient has other lung disease) combined with segment counting to estimate postoperative lung function; however, patients may still be offered resection if their predicted postoperative values are <30% of the predicted value and if they accept the risk of dyspnoea. Consider using shuttle walk testing or cardiopulmonary exercise testing to clarify the risk of dyspnoea in patients with borderline fitness.
[Based on medium quality retrospective and some prospective studies of risk scores and exercise testing]
Encourage patients to stop smoking, advising that it reduces pulmonary complications, and help them by providing smoking cessation aids. Do not postpone surgery to allow patients to stop. [Based on low quality observational studies]
Treatment modalities for non-small cell lung cancer
For patients who are medically fit and suitable for treatment with curative intent, offer lobectomy (either open or thoracoscopic) as the treatment of first choice. For patients with borderline fitness and smaller tumours (≤3 cm diameter with no lymph node involvement), consider parenchymal sparing lung surgery (segmentectomy or wedge resection) if a complete resection can be achieved. (New recommendation.)
Offer radical radiotherapy to patients with stage I, II, or III non-small cell lung cancer who have good performance status (are active and capable of self care) and whose disease can be treated with radiotherapy without undue risk of normal tissue damage. (The GDG recognised that radiotherapy techniques have advanced considerably since the 2005 guideline and that centres would reasonably wish to offer new techniques that have the advantage of reducing the risk of damage to normal tissue.)
Patients receiving radical radiotherapy should be part of a national quality assurance programme. (New recommendation.)
[All of the above are based on a Cochrane systematic review and expert opinion]
Offer postoperative chemotherapy except for tumours less than 4 cm in diameter without nodal disease. (New recommendation.)
Do not offer neo-adjuvant chemotherapy. (New recommendation.)
Combined modality treatment (which comprises different treatments, such as surgery, radiotherapy, and chemotherapy, in combination either concurrently or sequentially) offers improved survival compared with single modality treatment. Thus consider chemoradiotherapy when surgical treatment is not possible.
[All of the above are based on medium to high quality evidence from randomised controlled trials, a systematic review, a case series, and expert opinion]
Treatment of small cell lung cancer (New recommendation)
Arrange an assessment by a thoracic oncologist within one week of deciding to recommend treatment.
For patients with limited disease, offer concurrent chemoradiotherapy or, if a patient is unable to tolerate this, sequential chemoradiotherapy.
Consider surgery in patients with early stage small cell lung cancer (tumours ≤3 cm diameter without nodal disease).
For patients with extensive disease, offer platinum based combination chemotherapy if they are fit enough.
For patients with relapsed disease, offer second line combination chemotherapy, informing those who did not respond to first line treatment that there is little evidence that further chemotherapy will be of benefit; offer radiotherapy to treat local symptoms.
[All the above are based on low to high quality randomised controlled trials and systematic reviews for chemotherapy and radiotherapy and on cases series and phase 2 studies for surgery]
Offer prophylactic cranial irradiation to all patients if their disease has not progressed with first line treatment [Based on high to low quality randomised controlled trials]
Refer to NICE’s technology appraisal 184 on the use of topotecan.9
Management of endobronchial obstruction (New recommendation)
The table⇓ describes the available endobronchial treatments.
For patients with large airway involvement, monitor clinically and radiologically for potential obstruction so that external beam radiotherapy or endobronchial treatment can be given early.
Every cancer network should ensure that patients have rapid access to a team capable of providing interventional endobronchial treatments.
[Both of the above are based on one medium quality randomised controlled trial, case series, and expert opinion]
Treatment of established cerebral metastasis (New recommendation)
Consider palliative, whole brain radiotherapy for patients with symptomatic brain metastases and good performance status (0 or 1 (out of 5) on the World Health Organization’s scale for performance status). [Based on a low quality quality randomised controlled trials and retrospective study]
Follow-up (New recommendation)
Offer all patients an initial specialist follow-up appointment within 6 weeks of completing treatment to discuss ongoing care. Offer regular appointments thereafter, rather than relying on patients requesting appointments when they experience symptoms.
Offer protocol driven follow-up by a lung cancer clinical nurse specialist and ensure patients know how to contact her/him.
[Both of the above are based on low quality retrospective studies and expert opinion]
It is important to overcome a nihilistic approach that has existed in the past towards lung cancer, and may still exist. Thus this guideline aims to help healthcare professionals and patients understand that a modern approach to early presentation, assessment, and treatment can improve survival and mortality. Another barrier to implementation of this guideline is the perception of limited resources preventing rapid access to diagnostic tests. This can often be overcome by enthusiastic and dedicated healthcare teams that realise that tests that have to be done at some stage in the pathway may as well be prioritised and done quickly. A dedicated team is essential. The capacity to provide certain diagnostic tests (such as endobronchial ultrasonography) needs to be increased, and again this depends on enthusiastic clinicians. Access to lung cancer clinicians willing to deliver state of the art treatment to patients with borderline fitness or with tumours that are difficult to treat (such as by resection) can be limited, and all cancer networks must have sufficient clinicians. Although radiotherapy capacity is being increased in the UK, it will remain limited in the near future.
Further information on the guidance
Evidence of inconsistent practice prompting guideline update
Inequality exists in the quality of the diagnostic approach for lung cancer, including adherence to the previous NICE guidance, delivery of treatment with curative intent, and delivery of active treatment. The National Lung Cancer Audit has shown that histological confirmation rates vary from as low as 25% to over 85%; only 75% of patients have computed tomography before bronchoscopy (NICE recommendations from 2005); surgical resection rates vary from less than 5% to over 25%’ and active treatment rates (surgery, chemotherapy, or radiotherapy) vary from 10% to 80%.3 It is thought that the updating of the NICE guidance with implementation tools such as the development of directly derived quality standards will encourage better practice. Other initiatives such as the National Awareness and Early Diagnosis Initiative will encourage the public and patients to present earlier and will provide more opportunity for patients to receive the most effective, guideline driven care.
Since the publication of the 2005 NICE guideline, important improvements have been made in the selection of patients for treatment, and the range of treatments available is ever increasing. The central role of the multidisciplinary team in ensuring that patients are correctly selected for these treatments is now embedded in clinical practice, as is the role of the clinical nurse specialist as the key worker. The key topics covered in this partial update seek to ensure that:
All multidisciplinary teams apply efficient and appropriate methods to accurately diagnose and stage patients (supported by a new algorithm)
Fitness assessment is an objective process (supported by a new algorithm)
As many patients as possible are offered treatment with curative intent, after accurate staging and fitness assessments, and assessment by surgeons and clinical oncologists for lung sparing operations and radical radiotherapy
Patients receive information and support throughout the pathway through effective communication and follow-up
Patients with small cell lung cancer are offered the most effective treatment approach.
The overall aim is to ensure that all healthcare professionals are aware of the important advances in the management of lung cancer and that patients can see that clear patient centred guidelines exist. The update was unable to include the fast developing area of chemotherapy for non-small cell lung cancer owing to NICE’s recent, previous, and ongoing technology appraisals.
This guidance was developed by the National Collaborating Centre for Cancer (NCC-C) in accordance with NICE guideline development methods.10 A Guideline Development Group was established by the National Collaborating Centre for Cancer, which incorporated healthcare professionals, patient and carer members, and NCC-C staff. The GDG identified relevant clinical questions, collected and appraised clinical evidence, and evaluated the cost effectiveness of proposed interventions where possible. The draft guideline underwent a rigorous reviewing process during which stakeholder organisations were invited to comment; the GDG took all comments into consideration when producing the final version of the guideline.
NICE has produced four different versions of the guideline: a full version containing all the evidence, the process undertaken to develop the recommendations, and all the recommendations; a quick reference guide; a version containing a list of all the recommendations, known as the “NICE guideline”; and a version for patients and the public. All these versions are available from the NICE website (www.nice.org.uk/CG121). Further updates of the guidance will be produced as part of the NICE guideline development programme.
What factors predict successful outcome in treatment with curative intent? Studies should include fitness parameters and functional imaging
For patients with non-bulky single zone N2 (subcranial or ipsilateral paratracheal) disease, how do outcomes compare for surgery with or without multimodality treatment? Outcomes should include mortality and five year survival
What are the benefits of pulmonary rehabilitation, optimisation of drug treatment, and enhanced recovery programmes before and after surgery? Outcomes should include mortality, survival, pulmonary complications, pulmonary function, and quality of life (including assessment by EQ-5D, a standardised instrument for measuring health outcome (www.euroqol.org/eq-5d/what-is-eq-5d.html)
How effective is dose escalation in radiotherapy with curative intent, including stereotactic body irradiation? Outcomes should include mortality, pulmonary complications, pulmonary function, and validated quality of life measures (including assessment by EQ-5D)
Using randomised controlled trials, what is the value of imaging modalities and other interventions in monitoring response and recurrent disease?
Cite this as: BMJ 2011;342:d2110
This is one of a series of BMJ summaries of new guidelines based on the best available evidence; they highlight important recommendations for clinical practice, especially where uncertainty or controversy exists.
Contributors: All authors contributed to the conception and drafting of this article and to revising it critically. They have all approved this version. The guarantors are DRB, BW, ARC, and John Graham (director at the National Collaborating Centre for Cancer, which developed the guideline).
Funding: The National Collaborating Centre for Cancer was commissioned and funded by the National Institute for Health and Clinical Excellence to write this summary.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: MS-H and AMM had support from the National Collaborating Centre for Cancer for the submitted work; DRB and BW received payment for attendance at committees and for travelling and accommodation costs in accordance with NICE policy; there are no other relationships or activities that could appear to have influenced the submitted work.
Provenance and peer review: Commissioned; not externally peer reviewed.