NICE Pathways bring together all NICE guidance, quality standards and other NICE information on a specific topic.

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1 bring together all NICE guidance, quality standards and other NICE information on a specific topic. are interactive and designed to be used online. They are updated regularly as new NICE guidance is published. To view the latest version of this pathway see: Pathway last updated: 21 June 2016 This document contains a single pathway diagram and uses numbering to link the boxes to the associated recommendations. All rights reserved

2 Page 2 of 11

3 1 High suspicion of lung cancer No additional information 2 CT scan and spirometry CT scan Offer patients with known or suspected lung cancer a contrast-enhanced CT scan of the chest, liver and adrenals 1. For patients where the contrast-enhanced CT scan is unable to image the liver, NICE has produced guidance on SonoVue (sulphur hexafluoride microbubbles) contrast agent for contrast-enhanced ultrasound imaging of the liver (NICE diagnostics guidance 5). Spirometry Perform spirometry, measure T L CO if disproportionate breathlessness or other lung pathology. 3 Factors to consider when choosing tests for diagnosis and staging Choose investigations that give the most information with the least risk. Think carefully about performing tests that give only diagnostic pathology when information on staging is needed to guide treatment. Take adequate samples without unacceptable risk to the patient to permit detailed pathological diagnosis including tumour sub-typing and measurement of predictive markers. Biopsy enlarged mediastinal nodes ( 10 mm maximum short axis on CT) or other lesions in preference to primary lesion if determination of stage affects treatment. Offer fibreoptic bronchoscopy to patients with central lesions on CT where nodal staging does not influence treatment. Enlarged lymph nodes ( 10 mm maximum short axis on CT) may be simultaneously sampled with TBNA (non-ultrasound-guided) if required for diagnosis. Do not use MRI routinely to stage the primary tumour in NSCLC. Page 3 of 11

4 1 This recommendation was outside the scope of the 2011 update but the GDG recognised that many centres include the lower neck when performing CT scans for the diagnosis of lung cancer. The GDG also recognised that contrast medium should only be given with caution to patients with known renal impairment. Page 4 of 11

5 Where necessary use MRI to assess the extent of disease for patients with superior sulcus tumours. Offer EBUS-guided TBNA for biopsy of paratracheal and peri-bronchial intra-parenchymal lung lesions. Reserve sputum cytology for patients with centrally placed nodules or masses who are unable to tolerate bronchoscopy or other invasive tests. Quality standards The following quality statements are relevant to this part of the pathway. 6. Investigations 7. Tissue diagnosis 4 Peripheral lesion with low probability of mediastinal malignancy (nodes < 10 mm) Offer PET-CT as the preferred first test after CT showing a low probability of mediastinal malignancy (lymph nodes < 10 mm maximum short axis on CT) for patients who are potentially suitable for treatment with curative intent. Offer CT- or ultrasound-guided transthoracic needle biopsy to patients with peripheral lung lesions when treatment can be planned on the basis of this test. EBUS-TBB for peripheral lung lesions NICE has published interventional procedures guidance on EBUS-TBB for peripheral lung lesions with normal arrangements for clinical governance, consent and audit. 5 Peripheral or central lesion with intermediate probability of mediastinal malignancy (nodes mm) Offer PET-CT, or EBUS-guided TBNA, or EUS-guided FNA, or non-ultrasound-guided TBNA as the first test for patients with an intermediate probability of mediastinal malignancy (lymph Page 5 of 11

6 nodes between 10 and 20 mm maximum short axis on CT) who are potentially suitable for treatment with curative intent. Confirm negative results obtained by non-ultrasound-guided TBNA using EBUS-guided TBNA, EUS-guided FNA or surgical staging. Confirm negative results obtained by EBUS-guided TBNA and/or EUS-guided FNA using surgical staging if clinical suspicion of mediastinal malignancy is high. Consider combined EBUS and EUS for initial staging of the mediastinum as an alternative to surgical staging. Interventional procedures NICE has produced guidance on EBUS-TBNA for mediastinal masses with normal arrangements for consent, audit and clinical governance. 6 Peripheral or central lesion with high probability of mediastinal malignancy (nodes > 20 mm) Offer neck ultrasound with sampling of visible lymph nodes or non ultrasound-guided TBNA to patients with a high probability of mediastinal malignancy (lymph nodes > 20 mm maximum short axis on CT). If neck ultrasound is negative, follow with non-ultrasound-guided TBNA, EBUS-guided TBNA or EUS-guided FNA. If non-ultrasound-guided TBNA is negative follow with EBUS-guided TBNA or EUS-guided FNA. Confirm negative results obtained by non-ultrasound-guided TBNA using EBUS-guided TBNA, EUS-guided FNA or surgical staging. Confirm negative results obtained by EBUS-guided TBNA and/or EUS-guided FNA using surgical staging if clinical suspicion of mediastinal malignancy is high. Consider combined EBUS and EUS for initial staging of the mediastinum as an alternative to surgical staging. Interventional procedures NICE has produced guidance on EBUS-TBNA for mediastinal masses with normal arrangements for consent, audit and clinical governance. Page 6 of 11

7 7 Further tests before treatment with curative intent Ensure all patients potentially suitable for treatment with curative intent are offered PET-CT before treatment. Evaluate PET-CT-positive mediastinal nodes by mediastinal sampling (except when there is definite distant metastatic disease or a high probability that N2/N3 disease is metastatic [for example, if there is a chain of lymph nodes with high 18 F-deoxyglucose uptake]). Confirm isolated distant metastases/synchronous tumours by biopsy or further imaging (for example, MRI or PET-CT) in patients being considered for treatment with curative intent. Consider MRI or CT of the head in patients selected for treatment with curative intent, especially in stage III disease. EGFR-TK mutation testing The tests and test strategies listed below are recommended as options for detecting EGFR-TK mutations in the tumours of adults with previously untreated, locally advanced or metastatic non-small-cell lung cancer (NSCLC), when used in accredited laboratories participating in an external quality assurance scheme. The laboratory-developed tests should be designed to detect the mutations that can be detected by one of the CE-marked tests as a minimum. therascreen EGFR RGQ PCR Kit (CE-marked, Qiagen) cobas EGFR Mutation Test (CE-marked, Roche Molecular Systems) Sanger sequencing of samples with more than 30% tumour cells and therascreen EGFR RGQ PCR Kit for samples with lower tumour cell contents Sanger sequencing of samples with more than 30% tumour cells and cobas EGFR Mutation Test for samples with lower tumour cell contents Sanger sequencing followed by fragment length analysis and polymerase chain reaction (PCR) of negative samples. There was insufficient evidence for the Committee to make recommendations on the following methods: high-resolution melt analysis pyrosequencing combined with fragment length analysis single-strand conformation polymorphism analysis next-generation sequencing Page 7 of 11

8 therascreen EGFR Pyro Kit (CE-marked, Qiagen). These recommendations are from EGFR-TK mutation testing in adults with locally advanced or metastatic non-small-cell lung cancer (NICE diagnostics guidance 9). 8 Neck nodes Offer neck ultrasound with biopsy of visible lymph nodes to patients that have neck nodes detected by initial CT. If negative, follow with non-ultrasound-guided TBNA or EBUS-guided TBNA or EUS-guided FNA. Interventional procedures NICE has produced guidance on EBUS-TBNA for mediastinal masses with normal arrangements for consent, audit and clinical governance. 9 Advanced and metastatic disease Tests for brain and bone metastases Offer patients with features suggestive of intracranial pathology, CT of the head followed by MRI if normal, or MRI as an initial test. An X-ray should be performed in the first instance for patients with localised signs or symptoms of bone metastasis. If the results are negative or inconclusive, either a bone scan or an MRI scan should be offered. Avoid bone scintigraphy when PET-CT has not shown bone metastases. 10 Treatment and supportive and palliative care See Lung cancer / Treatment and supportive and palliative care for lung cancer Page 8 of 11

9 Glossary EEG electroencephalography BIS Bispectral Index Consistent with the finding has characteristics that could be caused by many things, including cancer EBUS endobronchial ultrasound EUS endoscopic ultrasound EGFR-TK epidermal growth factor receptor tyrosine kinase FNA fine needle aspiration MDT multidisciplinary team NSCLC non-small-cell lung cancer Page 9 of 11

10 Persistent The continuation of specified symptoms and/or signs beyond a period that would normally be associated with self-limiting problems. The precise period will vary depending on the severity of symptoms and associated features, as assessed by the healthcare professional. SCLC small-cell lung cancer TBNA transbronchial needle aspiration Unexplained symptoms or signs that have not led to a diagnosis being made by the healthcare professional in primary care after initial assessment (including history, examination and any primary care investigations) Sources Lung cancer: diagnosis and management (2011) NICE guideline CG121 EGFR TK mutation testing in adults with locally advanced or metastatic non-small-cell lung cancer (2013) NICE diagnostics guidance 9 Your responsibility The guidance in this pathway represents the view of NICE, which was arrived at after careful consideration of the evidence available. Those working in the NHS, local authorities, the wider public, voluntary and community sectors and the private sector should take it into account when carrying out their professional, managerial or voluntary duties. Implementation of this guidance is the responsibility of local commissioners and/or providers. Commissioners and providers are reminded that it is their responsibility to implement the guidance, in their local context, in light of their duties to avoid unlawful discrimination and to have regard to promoting equality of opportunity. Nothing in this guidance should be interpreted in a way which would be inconsistent with compliance with those duties. Page 10 of 11

11 Copyright Copyright National Institute for Health and Care Excellence All rights reserved. NICE copyright material can be downloaded for private research and study, and may be reproduced for educational and not-for-profit purposes. No reproduction by or for commercial organisations, or for commercial purposes, is allowed without the written permission of NICE. Contact NICE National Institute for Health and Care Excellence Level 1A, City Tower Piccadilly Plaza Manchester M1 4BT Page 11 of 11

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