Meeting of the SWAG Network Haematology Site Specific Group (SSG) Wednesday 2 nd November 2016, 14.00-16.30 Engineers House Conference Centre, Clifton Down, Bristol Chair: Dr Deepak Mannari (DM) This meeting was sponsored by Janssen, Celgene and Roche Notes (To be agreed at the next meeting) Actions 1. Welcome and apologies Please see the separate list of attendees and apologies uploaded on to the South West Strategic Clinical Network website here. 2. Service development 2.1 100,000 genomes project and haematological malignancy Please see the presentation uploaded on to the SWCN website Presented by Dr Andrew Mumford (AM), Clinical Director West of England NHS Genomic Medicine Centre The West of England Genomic Medicine Centre, hosted by UH Bristol with support from Gloucestershire, North Bristol, Weston and RUH Bath, came into fruition 11 months ago, enabling access to the 100,000 genomes project for the West of England patient population. Each host hospital has a local steering group with executive representation. Patients with rare diseases can be consented to give a blood sample, and patients with certain cancer types can be consented to give a blood sample and solid tumour specimen, which are then sent for whole gene sequencing in Cambridge. The service is being rolled out in stages; the first recruit to the rare disease arm was a patient with congenital neutropenia. A breast cancer pathway has been created and the first patient recruited in North Bristol Trust. All pathway processes have to undergo a wet and dry run before approval to commence recruitment of patients can be obtained from the national team. The list of eligible cancers is as detailed in the presentation. Funding generated from the samples sent is used to maintain the GMC workforce, including provision of funding for research teams time in each speciality, and for educational programmes. The project aims to provide the opportunity to install the processes that will transform how future care is delivered. It is hoped to improve diagnostic yield by processing over 4650 samples from patients with rare diseases and their families over the next two years. The use of next generation sequencing, which involves the four steps of fragmentation, ligation, cluster generation and then sequencing, allows for the coding sequence of selected genes (gene panels), and the coding sequence of all Page 1 of 8
genes (whole exome), to be processed simultaneously. The patient s sequence is compared with a reference sequence and any differences are highlighted. Two case studies were discussed that showed how results can inform prognosis and treatment. The process for identification of breast cancer patients occurs within the MDT. If a tumour of sufficient size for extraction of DNA is found, the GMC representative will approach the patient, give them information about participation, and liaise with the surgeon, should the patient choose to consent. Participants can choose to consent to have incidental findings fed back to them and the clinical team; tests will be routinely run to check for 20 known actionable gene mutations. At the moment, the whole gene sequencing process takes between 3-6 months to report. It is hoped that this can be reduced to 3-6 weeks, in time to inform clinical decision making. Links to variant level actionability will be included in the GMC report for review by the MDT. Inclusion of haematological malignancies in the GMC project was considered highly relevant due to its prevalence, the risks of recurrence, progression, treatment related morbidity, and due to molecular diagnostics for prognostic estimates and targeting therapies already being standard care, although with variation across the country. Funding for processing 6000 samples (3000 patients) with haematological malignancies has been agreed. This will be rolled out in two stages. Stage 1 is restricted to patients with CLL, AML and Myeloma, who might best be enrolled alongside enrolment into the clinical trials FLAIR, AML 18/19 and MUK9/10, with the necessary samples gathered simultaneously. Stage 2 will include lymphoma; further details can be found within the presentation. CLL recruitment will commence in 2 weeks. AML recruitment will commence from 31 st January 2017. It was felt to be preferable for patients to process their diagnosis, consider enrolment into a clinical trial, plus consider enrolment into the GMC, in more than one sitting. After the initial two years, the whole gene sampling will no longer be free, with the expectation that it will be integrated into standard care. Individuals will be sought to lead on the GMC project in each speciality, and then visits will be made to relevant MDTs to discuss how this can be put into practice. Andrew Mumford is to contact Sophie Otton and Sally Moore. AM Information on the different components of the project, educational opportunities and launch events, are available on the website: www.wegmc.org. 3. Review of previous notes and actions/mdt membership As there were no amendments or comments following distribution of the notes from the meeting on the 12 th July 2016, the notes were accepted. Members are to email Helen Dunderdale (HD) with details of any new colleagues to add to the distribution list. Page 2 of 8
4. Clinical guidelines 4.1 Protocol update and website layout review Please see the separate table of protocols, for update, circulated with the notes. The myeloma protocols were reviewed in a recent breakout meeting and will be finalised by Sarah Murdoch following receipt of responses from attendees. A response was awaited from NHS England on the funding of Panobinostat. The possibility of altering the dosing schedule was discussed. A caveat could be added to the protocol to confirm that this was adapted according to the local clinician s discretion. The protocols developed by other regional teams will be consulted. Following review of the website layout, a request to replace abbreviations with the full regimen product names had been sent to website manager Isobel Rorison. Further suggestions included making the layout more user- friendly by organising alphabetically under headings similar to the Thames Valley website, and separating the lymphoma section into high and low risk. Deepak Mannari will send ideas for the layout to Sarah Murdoch to see if this would be feasible. The PMit CEBO protocol will be moved to the bottom of the list. Mini BEAM and Brentuximab are to be allocated to Lisa Lowry and Nelaribine to Deepak Mannari. Sophie Otton will look at the 2-CDA with Sarah Murdoch. The Velcade containing regimens will be sent to Jeremy Braybrook for authorisation. A link to the national amyloid website protocols will be put on the website. Due to the shorter cancer drug fund review process, the SSG will aim to look at the drugs due for appraisal within each meeting so that the impact can be assessed and relevant protocols developed proactively. SWCN funding for Consultant Pharmacist Sarah Murdoch s work on the protocols will cease at the end of March 2017. Further funding for the post needs to be secured so that the protocol work can continue; this will be escalated to the Cancer Operational Group and Cancer Alliance. DM/SM LL DM SO/SM HD 4.2. GP Guidelines GP guidelines have been published on the website with a disclaimer stating that separate Trusts may have individualised pathways and subtle alterations to this guidance. These will be circulated every 2 years for review along with the Clinical Guidelines. A link to the guidelines has been added to the new suspected haematological malignancy referral form. Information on the amount of times the guidelines have been viewed on the website will be brought to a future meeting once the relevant website permissions have been activated. The location of the guidance on the website can be further promoted in GP e-bulletins. Commissioner Beverly Haworth plans to make a quarterly cancer specific newsletter for circulation to GPs and would be happy to include this information. HD BH Page 3 of 8
5. Patient experience / living with and beyond cancer 5.1. Request for patient stratification criteria Cancer Network Manager, Jonathan Miller, has asked that site specific groups agree on a consistent approach for the following: The groups into which patients are risk stratified (high risk, low risk etc.) Criteria for determining risk stratification Consultant led face-to-face follow-up agreed for each group (if any) Other scheduled appointments (e.g. nurse led, non-face-to-face) Scheduled diagnostics for upgraded groups (if any) Health & Wellbeing clinics, including timing and whether generic or site specific Signs for concern (including side effects and recurrence) and method of re-access to service. North Bristol Trust has now submitted this information. The CNS in Weston will liaise with their Cancer Manager to provide assistance with the process. It has not been possible for the CNS team to meet and discuss the results of the National Cancer Patient Experience Survey prior to the SSG meeting due to time constraints. A further meeting will be arranged to include discussion on the comments from the survey. 5.2 User representative feedback Angela Absolam, a former patient from Musgrove Park, has agreed to become a user representative member of the group in addition to Victor Barley. A formal user representative feedback form has been created for use across the site specific groups. Feedback from the form will be published in the SSG Annual Reports. 6. Research 6.1 Clinical Trials Update Please see the presentation uploaded on to the SWCN website Presented by Maxine Taylor (MT) Recruitment to haematological trials was going well across the region in comparison with other networks across the country, and recruitment to lymphoma trials was currently second to last in the country. Recruitment data should be entered onto the Edge database as soon as consent has been obtained. It was increasingly important to demonstrate that the NHS can conduct effective research, by recruiting within estimated times and to target, to be eligible to open trials run by the pharmaceutical industry. A traffic light system, as seen in the Page 4 of 8
presentation, indicates whether a trial is recruiting as predicted; a black background indicates that the study has yet to recruit. Members of the group are to check the list of trials and inform MT if any information is missing, and if there are any unidentified gaps in the research portfolio that need to be addressed. All RUH Bath is experiencing significant challenges with expanding their research portfolio. AML 18 and 19 are still in set up, with eligible patients currently being sent to the Bristol team, which was not considered a sustainable option in the long term. The Phase 1/11 WT1 gene therapy trial for leukaemia, which is open in Bristol and London, is to be promoted. Research Leads, Sally Moore (SM) and Lisa Lowry plan to increase research activity by coordinating a collaborative network approach. Regular meetings will be convened to enable the following: Expand the network portfolio Review trials open elsewhere to facilitate cross referral Problem solve obstacles to recruitment Share best practice. Trials that are suitable to conduct as a network are to be identified, focusing on trials that are not available elsewhere. The trials that are not meeting recruitment targets are to be reviewed to see if the Principal Investigator would want to close and redirect the resources. Any areas where help is needed will be identified. Current challenges include financial / resource limitations, duplication of work, and competition with non-malignant trials. A network constitution on the essential requirements for conducting research, with practical advice on how this can be achieved, will be compiled and circulated. It was noted that the variety of haematological diseases made it difficult to establish research trials in comparison with other cancer sites. It would be ideal if expressions of interest in commercial studies could be made as a network group, with different studies set up in each Trust. Recruitment could then be sourced from across the region. A commercial study lead will be identified in each centre. It was the opinion of user representative Angela Absolam that patients would be willing to travel for the opportunity to be involved in research. The first research meeting will be held one hour prior to the next SSG meeting. A separate distribution list of relevant staff from the research teams across the region will be compiled. HD Page 5 of 8
7. Quality indicators, audits and data collection 7.1 Audit of Hepatitis/HIV Screening Lymphoma fellow Karan Wadehra has commenced work on a network audit on virology testing prior to R-Chemotherapy in patients with newly diagnosed diffuse large B-cell lymphoma, to determine compliance with the SWAG clinical guidelines. These state that all such patients should be screened for Hepatitis B and C. HIV screening has also been included. An audit proforma has been emailed to each team across the region, including the Swindon team. The dataset is to include all patients diagnosed from the 1 st January 2016-30 th June 2016. Completed profomas are to be submitted to KW by the 30 th November 2016. It is hoped that results will show 100% compliance. There is a comments box should any non-compliant result be found, where a reason for omission of the screening test can be included. So far, data has been submitted by UH Bristol and NBT. Results will be presented at the next meeting. The audit will be sent to Weston General Hospital and Yeovil District Hospital. KW 7.2 Audit of Two Week Wait Referral Pro-forma Version 9.3 of the South West Suspected Haematological Malignancy Referral Proforma has been published by Bristol North Somerset and South Gloucestershire CCG. A SWAG SSG nhs.net email has been set up for network audits: ubhtr.swagssgaudits@nhs.net If feasible, after processing 2WW referrals in the usual way, any incorrectly completed referral forms or details of the referring GP surgery, NHS number and the reason why the form was not completed appropriately, can be emailed to this account. Forms must be sent from another nhs.net email account to comply with Information Governance with the subject Haem referral. Feedback on the forms will then be sent to the relevant CCGs approximately every three months, who will then provide feedback to GP practices. Referral forms are processed in a variety of ways across the region. Cancer Managers will be asked if they can recommend who can provide this information. Previous versions of the referral proforma are still being received as the three other CCGs within the region have yet to publish the latest version of the proforma. This should be resolved early in the new year. It would be helpful to have information on the number of two week wait referrals that each Trust receives, the conversion rate to cancer, and whether the referrals was considered appropriate from a clinical point of view. A similar audit had been conducted for the Colorectal SSG, using data pulled from the Somerset Cancer Register. This will be investigated further. HD Page 6 of 8
8. Network issues 8.1 Cancer Alliance Update In order to implement the National 5 Year Forward Cancer Strategy, providers and commissioners have been instructed to form Cancer Alliances. For the South West area, it has been decided that there will be 2 Cancer Alliances (CA). The SWAG Cancer Alliance matches with the geography of the SWAG SSGs. For the SWAG CA, it has been agreed that the existing cancer steering groups, Bristol North Somerset, South Gloucestershire, Bath Wiltshire and Swindon, Somerset and Gloucestershire will continue to convene, working to agreed terms of reference. They will nominate 2 to 3 representatives to form the Cancer Alliance steering group, who will represent primary care, secondary care and CCG members. A Clinical and Managerial Lead have been appointed to Chair the Cancer Alliance group: Amelia Randle Macmillan GP from Somerset Deb Lee CEO of Gloucestershire Hospital. Membership will also include patient and charity representatives. Agreement is awaited on whether the SSG Support Service will provide administrative support for the alliance and ensure two way communications between the CA and SSGs. It is hoped that SSGs will be asked to participate in decision making exercises proposed by the alliance. When relevant items are on the CA agenda, SSG Chairs will be invited to contribute to these meetings. The practicalities of how the CA will function, the availability of money and resources, and the agreed standards to deliver are currently being assessed. A report is being drafted detailing the overarching priorities and site specific priorities that have been identified through the SSGs, in the hope that this will be used to inform the Cancer Alliance Work Programme. This has been circulated to the SSG Chairs for their opinions. Administrative support is needed for a chemotherapy group. A workload analysis had shown that it was not feasible for the SSG Support Service to provide this a present. This had been added to the report for the CA to consider. 9. Any other business/date of next meeting User Representative Angela Absolam (AA) is due to attend the Britain Against Cancer all party parliamentary meeting on Tuesday 6th December 2016 and will Page 7 of 8
provide relevant feedback to the group at the next meeting. Lisa Lowry will give a presentation on the updated NICE lymphoma guidelines at the next SSG meeting. AA LL Date of next meeting: Wednesday 1 st March 2017, Taunton. -END- Page 8 of 8