Somerset, Wiltshire, Avon and Gloucestershire (SWAG) Cancer Services. Lung Cancer Network Site Specific Group. Clinical Guidelines.

Transcription

1 Somerset, Wiltshire, Avon and Gloucestershire (SWAG) Cancer Services Lung Cancer Network Site Specific Group June 2017 Revision due: April 2019 Page 1 of 15

2 VERSION CONTROL THIS IS A CONTROLLED DOCUMENT. PLEASE DESTROY ALL PREVIOUS VERSIONS ON RECEIPT OF A NEW VERSION. Please check the SWCN website for the latest version available here. VERSION DATE ISSUED SUMMARY OF CHANGE OWNER S NAME Draft 0.1 May 2015 First draft V Masani Draft th June 2015 Addition of EBUS A Medford Guidelines Draft th June 2015 Addition of SABR C Comins Guidelines Draft th June 2015 Pathology Guidelines N Bhatt Draft rd November Reduction of SABR C Comins 2015 information th December Document agreed H Dunderdale May 2017 Biennial review MDT Leads th May 2017 EBUS update A Medford 23 rd June 2017 Revision of Lung Cancer Best Practice Pathway. Addition of link to PET CT Guidelines (2013) H Steer / H Dunderdale th June 2017 Finalised H Dunderdale Page 2 of 15

3 This document was edited by: Adam Dangoor, Chair of the SWAG Lung SSG, Consultant Medical Oncologist, University Hospitals Bristol NHS Foundation Trust Vidan Masani, previous Chair of the SWAG Lung SSG, Consultant in Respiratory Medicine, Royal United Hospital Bath Andrew Medford, Consultant & Hon Senior Lecturer in Respiratory Medicine, North Bristol NHS Trust Charles Comins, Consultant Clinical Oncologist, University Hospitals Bristol NHS Foundation Trust Nidhi Bhatt, Consultant Histopathologist, University Hospitals Bristol NHS Foundation Trust Henry Steer, Consultant in Respiratory Medicine, Gloucestershire Hospitals NHS Foundation Trust Helen Dunderdale, SWAG Cancer Network SSG Support Manager These clinical guidelines have been agreed by: Name Position Trust Date agreed Sarah Foster Consultant in Taunton and June 2017 Respiratory Medicine Somerset NHS Foundation Trust Claire Parker Consultant in Yeovil Hospitals NHS June 2017 Respiratory Medicine Foundation Trust Rajiv Srivastava Consultant in Weston Area Health June 2017 Respiratory Medicine Trust Martin Plummeridge Consultant in North Bristol NHS June 2017 Vidan Masani Henry Steer Respiratory Medicine Consultant in Respiratory Medicine Consultant in Respiratory Medicine Trust Royal United Hospitals Bath NHS Foundation Trust Gloucestershire Hospitals NHS Foundation Trust June 2017 June 2017 Page 3 of 15

4 Lung NSSG Contents Contents Measures Page Section 1 Introduction 5 The NSSG Agreed Local B03/LC for the 6 Management of Lung Cancer 2.1 The Lung SSG Network Wide Patient Pathway The Tertiary Endobronchial Ultrasound Service (EBUS) (also EUS-B/narrow band 7 imaging) 2.3 Stereotactic Ablative Radiotherapy For Peripheral 8 Lung Tumours Patient selection criteria Radiotherapy Guidelines for PET Imaging Pathology Guidelines 12 3 Appendices Appendix 1: 14 Page 4 of 15

5 1. Introduction The following clinical guidelines pertain to the local management of lung, mesothelioma and other pleural cancers for the Somerset, Wiltshire, Avon and Gloucestershire (SWAG) Network Lung Cancer Site Specific Group (NSSG). The NSSG refers to the National Institute for Health and Care Excellence (NICE) Lung Cancer clinical guidelines (2012). Primary care clinicians should refer to the NICE guidelines Suspected Cancer: recognition and management of suspected cancer in children, young people and adults (2015) for the signs and symptoms relevant when referring to lung cancer services. Further details on the two week wait referral process can be found in the NSSG constitution. The guidelines should be reviewed alongside three other key documents for the SSG: the Constitution, Annual Report and the Work Programme. The Lung SSG Constitution provides an overview of how the SSG operates, outlining the general working processes of the SSG, the patient referral pathways and the guidelines to which the SSG adheres. The annual report reflects the period of activity for the SSG from the previous year. It contains a summary of the activity of the Lung SSG for this period against several key performance indicators that have been outlined in the National Cancer Peer Review Programme. The Work Programme summarises the key areas for growth, development and improvement of the SSG over the next financial year (and beyond where appropriate). All four documents should be reviewed together to give a full overview of the SSG, its performance and future plans. The NSSG is committed to offering all eligible patients entry into clinical trials where available. Consent to provide tissue for research purposes will also be sought wherever appropriate. Page 5 of 15

6 2. The NSSG Agreed Local for the Management of Lung Cancer (B03/LC ) 2.2 SWAG Lung SSG Best Practice Network Wide Patient Pathway The location for each stage of treatment must be clearly stated on the appointment card, and where appropriate, on the local information leaflets. Page 6 of 15

7 2.2 The Tertiary Endobronchial Ultrasound Service (EBUS) (also EUS-B/narrow band imaging) The EBUS service provides an alternative option for mediastinal node sampling for both diagnosis and staging for both operable and lung cancer tumours with mediastinal adenopathy. We have now completed over 900 EBUS procedures. Referrals are taken from anywhere in the SWAG but also out of area including Dorset, Oxford and Wales. Stations 2, 3a, 4, 7 are accessible as well as stations 10 and 11 if needed. EBUS is now considered a first line mediastinal sampling procedure in suspected lung cancer (as well as non-malignant disease and other cancers). Research shows a sensitivity for malignancy of at least 90% for enlarged lymph nodes (Our local sensitivity at North Bristol is 94.6% with an accuracy of 97.2% as of May 2017, for the last 861 cases, in house data, data awaited from remaining 40 cases). Real-time ultrasound allows safer and more extensive sampling of the mediastinal lymph nodes. Samples are taken with either a 19G, 21G or 22G needle depending on location, likely pathology and size (19G mainly). Molecular profiling is possible in 99% of EBUS-TBNA samples (in house data). Two EBUS-TBNA bronchoscopes and one ultrasound processor are used. Conscious sedation is used (midazolam and fentanyl) and the patient needs to be able to lie nearly flat for up to 50 minutes). Intubation is through the mouth as the scope is slightly larger; the procuedre is well tolerated (in house patient satisfaction data). Procedure time varies between 10 minutes (for a simple diagnostic EBUS) to 30 minutes (for an extensive staging EBUS). We have been referred approximately 1100 patients so far for mediastinal sampling procedures; we have performed approximately 950 procedures so far of which 900 are EBUS, the other 50 conventional TBNA, 150 were more suitable for other tests. EBUS-TBNA is as safe as bronchoscopy if not safer as real-time sampling occurs. EUS-B (via the oesophagus, see below) tends to result in less coughing and is better tolerated by those with hypoxaemia or poor lung function. MDTs across the SWAG cancer services are encouraged to consider referring patients for EBUS with evidence of mediastinal adenopathy for staging and/or diagnosis or malignant (or ruling out benign mediastinal disease). If there is high volume/bulky N2 disease or visible neck nodes on the CT, neck ultrasound +/- biopsy is suggested first before EBUS if expertise if available locally as neck USS is superior to CT in detection of neck nodes. If there is any doubt clinically, early contact with the EBUS team is encouraged to confirm the suitability of EBUS. An EBUS referral form to facilitate the referral process electronically to a shared address is in the appendix; paper referrals via conventional mail are not advised for speed of communication. It would be appreciated if patients were not referred to more than one mediastinal sampling centre simultaneously for the same procedure as this can cause confusion for the administrative team and may lead to delays for other referrals. It is not usual practice perform EBUS in patients WHO PS of 3 or where there is no plan to offer radical treatment or palliative chemotherapy. Page 7 of 15

8 NB: Dr Medford also performs EUS-B-FNA (via the oesophagus) sometimes which allows sampling of para-oesophageal lesions and narrow band (NBI) bronchoscopy for patients who need surveillance for early dysplastic lesions not seen on white light bronchoscopy (as a proxy for autofluorescence bronchoscopy (AFB) with better specificity than AFB but slightly less sensitivity than AFB). Dr Plummeridge and Jeyabalan also perform NBI. EBUS service Team: Dr Andrew Medford, Consultant & Hon Senior Lecturer in Respiratory Medicine, North Bristol NHS Trust & University of Bristol (EBUS Clinical Lead) Dr Martin Plummeridge, Consultant in Respiratory Medicine, North Bristol NHS Trust Dr Abiramy Jeyabalan, Consultant in Respiratory Medicine, North Bristol NHS Trust Booking/admin support/pt queries: Sarah Smith & Deborah Walton, Lung Cancer & Mesothelioma Nurse Specialists, North Bristol NHS Trust 2.3 Stereotactic Ablative Radiotherapy For Peripheral Lung Tumours This protocol has been adapted from the Stereotactic Ablative Radiotherapy (SABR) Consortium guidelines. Stereotactic ablative body radiotherapy (SABR) refers to the precise irradiation of an imagedefined extra-cranial lesion with the use of a high radiation dose in a small number of fractions Patient selection criteria Inclusion Criteria MDT confirmed diagnosis of NSCLC based on findings of positive histology, positive PET scan or growth on serial CT scan Clinical stages of T1 N0 M0 or T2 ( 5cm) N0 M0 or T3 ( 5cm) N0 M0 [radiologically N2 (CT or PET), patients only eligible if possible nodal disease is subsequently confirmed as histologically negative with mediastinoscopy or endoscopic bronchial or oesophageal ultra-sound biopsy] Not suitable for surgery because of medical co-morbidity, lesion is technically inoperable or patient declines surgery after surgical assessment WHO performance status 0-2 Peripheral lesions outside a 2cm radius of main airways and proximal bronchial tree. This is defined as 2cm from the bifurcation of the second order bronchus e.g. where the right upper lobe bronchus splits (figure 2.1) Age 18 years Page 8 of 15

9 Exclusion Criteria NSCLC patients with T2 or T3 primary tumours > 5cm. T3 primary NSCLC tumours involving the mediastinal structures or central T3 primary tumours. Metastatic lung tumours Any tumour that is not clinically definable on the treatment planning CT scan e.g. surrounded by consolidation or atelectasis. Tumours with respiratory motion 1cm despite using techniques to reduce tumour motion. If it is possible to achieve the suggested normal tissue and tumour planning constraints then only can mobile tumours be treated with this technique. Tumours within 2cm radius of main airways and proximal bronchial tree (figure II.1). Primary NSCLC tumours with clinical evidence of regional or distant metastasis after appropriate staging studies. Previous radiotherapy within the planned treatment volume Chemotherapy administered within 6 weeks prior to study entry or planned for < 6 weeks following SBRT. Pregnant or lactating females Inability to obtain informed consent or comply with treatment requirements Page 9 of 15

10 Figure 1 Proximal bronchial tree as defined by RTOG 0236 protocol Radiotherapy Refer to network radiotherapy protocols for detail. Acceptable dose and fractionation regimens include: 54Gy in 3 fractions 55Gy in 5 fractions (conservative) 60Gy in 8 fractions (very conservative) The conservative regimen should be used when any part of the PTV is in contact with the chest wall. The very conservative regimen is only recommended where organ at risk constraints cannot be met. Page 10 of 15

11 Treatment assessments & Follow Up Table 4 Assessments at baseline and during radiotherapy. Procedure Base-line During RT 4-6 weeks post RT Medical History Physical Examination Weight WHO PS score FBC Biochemistry profile1 Lung function test Pregnancy test2 CT scan thorax and abdomen Chest ray CT/ MRI head PET/CT Informed Consent Adverse event monitoring CTCAE v3.0 QOL (QLQ C30) optional Tables 4 and 5 detail the suggested assessments to be undertaken. Patients should be reviewed prior to delivery of each fraction to review any symptoms and toxicity. We recommend using the CTC v3.0 for assessing toxicity during and after RT. Post-SABR we suggest that the first follow up should be at 4-6 weeks post radiotherapy to assess acute toxicity. Patients should have a repeat chest x-ray at each follow up visit. Subsequent follow up visits should be of the order of 3 monthly for the 1st year, and 6 monthly for subsequent years. Page 11 of 15

12 Table 5 Assessments during follow up post-sbrt Procedure Months post RT Medical History Physical Examination Weight ECOG score Lung function test CT scan thorax and abdomen Chest ray Adverse monitoring event QOL 2.4 Guidelines for PET Imaging SWAG Lung Cancer NSSG radiologists refer to the Royal College of Radiologists Evidence based indications for the use of PET-CT in the UK, 2013 as per the Clinical Commissioning Policy Statement from July 2015: PET_CT_Guidelines_2013 The 2016 guidelines have yet to be adopted (23 rd June 2017). 2.5 Pathology Guidelines SWAG Lung Cancer NSSG pathologists refer to the Royal College of Pathologists Guidelines: Lung cancer (May 2014) Mesothelioma (Apr 2013) Thymic epithelial tumours (Feb 2013) It is recommended that the IASLC (International Association for the Study of Lung Cancer) update to the 2004 WHO classification of lung cancers be used in pathology reports. In particular, the term bronchioloalveolar cell carcinoma should no longer be used in pathology reports. Page 12 of 15

13 Guidance for molecular testing in lung cancer (see reference below 1 ) EGFR and ALK molecular testing should be performed on primary lung adenocarcinomas, non-small cell lung carcinoma, unclassifiable (NSCLC-NOS) and on combined lung carcinomas with an adenocarcinomatous component. Primary and metastatic lesions are equally suitable for testing. Due to cost implications, it is recommended that tumours should be tested for EGFR first and then for ALK if EGFR is of wild-type. EGFR and ALK testing for patients presenting with stage I-III disease is encouraged but the decision to do so should be made locally by each laboratory, in collaboration with its oncology team. Reflex testing (requesting by pathologist the time of diagnosis without requiring separate request form from a clinician order) is appropriate if agreed upon by the lung cancer care team and may help to ensure expedited and consistent routing of specimens for molecular testing. Exceptions include patients with stage IV disease who are being considered for palliative care only and patients in whom targeted TKI therapy is not clinically indicated. Good communication with oncology team is needed to ensure testing is performed for patients whose management will be impacted by the test result. Tissue/cytology material should be prioritised for EGFR and ALK testing. It is critical to retain sufficient material for molecular analysis and to be judicious in the use of sections for IHC studies, histochemical stains, or deeper levels that may not be essential to establish a histopathological diagnosis. Unstained sections between deeper levels may be retained for immunohistochemistry. Although smears can be used effectively for DNA extraction for EGFR mutation assays, expert consensus opinion recommends use of a cell over smear preparations because of the ability to correlate with malignant cell content, the preservation of the original diagnostic specimen, and the possible retention of more material for additional diagnostic studies. Molecular testing should be available between 5-10 working days of specimen receipt by molecular pathology laboratory. Pathology departments should have established processes in place to retrieve and send out materials (blocks or unstained sections) within 3 working days of receiving such requests. NICE has published comprehensive guidelines on techniques used for EGFR testing - NICE diagnostics guidance [DG9] Published date: August 2013 ALK testing Page 13 of 15

14 Laboratories should use an ALK FISH assay using dual-labeled break-apart probes for selecting patients for ALK TKI therapy. ALK immunohistochemistry, if carefully validated, may be considered as a screening methodology to select specimens for ALK FISH testing. Expert consensus opinion is that a properly validated IHC method may be used as a screening modality, and that tumours that fail to demonstrate ALK immunoreactivity with a sensitive IHC method need not be tested for ALK rearrangement by FISH. Furthermore, tumours that are positive for ALK IHC, either weakly or strongly should still be referred to FISH for confirmation of a rearrangement. At this time, there are insufficient data available to develop a specific recommendation on the use of ALK IHC as a sole determinant of ALK TKI therapy. Reference: Journal of Thoracic Oncology: July Volume 8 - Issue 7 - p Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors: Guideline from the College of American Pathologists, International Association for the Study of Lung Cancer, and Association for Molecular Pathology. 3. Appendices 3.1 Appendix 1 The EBUS Referral Form should be completed and ed to nbn-tr.ebusreferrals@nhs.net IF YOU DO NOT HEAR BACK FROM THE EBUS TEAM IN ONE WEEK, PLEASE CALL EBUS Referral Form (Endobronchial Ultrasound) Please completed forms to nbn-tr.ebusreferrals@nhs.net DATE OF REFERRAL PLEASE ENSURE THAT THE PATIENT IS AWARE OF THIS REFERRAL CONTACT / REFERRING PHYSICIAN REFERRING PHYSICIAN ADDRESS CONTACT TELEPHONE NUMBER Page 14 of 15

15 REFERRING HOSPITAL Choose one PATIENT DETAILS NAME DATE OF BIRTH NHS NUMBER TELEPHONE NUMBER GP, ADDRESS & TELEPHONE NUMBER REASON FOR REFERRAL Choose one: Comments: WHO PERFORMANCE STATUS Choose one IS THE PATIENT TAKING ANTICOAGULANTS? Choose one: For AF, PE, Heart Valve CLINICAL REQUIREMENTS INR WITHIN 2 WEEKS: DATE: RESULT: MRSA SCREEN: DATE: FEV 1 : % predicted: OYGEN SATURATION: RECENT INVESTIGATIONS CT: DATE: MAJOR CO-MORBIDITIES OR UNDERLYING DISEASE PET: DATE: RECENT BRONCHOSCOPY Y/N DATE: Y/N: Comments: PLEASE ENSURE THAT YOUR PATIENT HAS TRANSPORT ARRANGEMENTS TO GET TO BRISTOL CONTACT NUMBER FOR EBUS QUERIES AT NORTH BRISTOL TRUST END- Page 15 of 15