12 March 2018

Present

Professor Julietta Patnick (Chair) (JP)

Ms Krys Baker (KB)

Dr Isobel Barnes (IB)

Professor Dame Valerie Beral (VB)

Dr Lucy Carpenter (LC)

Professor David Hunter (DH)

Dr Hongchao Pan (HCP)

Professor Malcolm Reed (MR)

Professor Sir Mike Richards (MAR)

Mr Keith Shaw (KS)

Apologies

Mrs Claire Borrelli (CB)

Professor Kevin Fenton (KF)

Mrs Jacquie Jenkins (JJ)

Professor Iain Lyburn (IL)

Professor Sir Richard Peto (RP)

1. Welcome and Introductions

Apologies were received from Prof Kevin Fenton (KF), Mrs Claire Borrelli (CB), Professor Iain Lyburn (IL) and Mrs Jacquie Jenkins (JJ). JP welcomed Professor David Hunter and Dr Isobel Barnes to the TMG. Isobel has succeeded Kath Moser who retired in April 2017. The committee also thanked Kath for her work in setting up the trial.

2. Minutes of the last meeting (20^th Feb 2017) and matters arising

The minutes of the last meeting were accepted as an accurate record.

Matters arising:

It was noted that some DMEC Members were present at the 2017 TMG meeting. However this year the DMEC met earlier, on the 22^nd February 2018, and a note from the DMEC to the TMG was circulated in the papers for this meeting.

Action points:

The “Be Clear about Cancer” campaign run by PHE inviting over 70s to attend for breast screening is not evidence based and has had some unwanted effects on the trial, by increasing screening among the controls. PHE has agreed to consider the AgeX TMG views on suspending these campaigns. 

It has not yet been possible to commence sending the invitations to the 74-76 years olds. Some funds for this will come from the money released from the Breast Screening Units that were screening 47-49 year olds, without randomisation.

3. Mid-year update

TMG members found the mid-year newsletter useful.

4. Trial Update

VB presented a report prepared by the AgeX investigators for the meeting of the PHE Breast Screening Programme Research Advisory Committee (RAC) in January 2018 (which she had attended). VB explained that, at the meeting, PHE representatives unexpectedly suggested that some women who were randomised into AgeX when they were aged 70 should have been offered routine screening instead. The trial investigators found, however, that there were discrepancies between the definition of age used by PHE and that used for routine breast screening invitation procedures (which also applied to AgeX). PHE asked that this apparent discrepancy be reported to the DMEC and regulatory authorities. The AgeX DMEC met on 22 February 2018 and agreed that no change to the AgeX trial materials or procedures was necessary at present, and this information was conveyed to members of the TMG.

The TMG discussed if there were any steps that the trial might have taken to avoid this issue, pointing out that the method that the screening programme procedures currently use to define age was based on year of birth and that women aged 70 who were due to turn 71 by the end of the year were not eligible for routine screening. VB reported that the trial investigators continued to be in discussion with PHE about this.

VB presented the report based on other work to date:

4.1   Recruitment: 3.1 million women have been randomised up to 31/03/17; 67% of those aged <50 and 69% of those aged 71+ allocated to be invited for screening have accepted.

4.2  Numbers randomised: The study is now randomizing just over 500k women per year. The annual number of women randomised is likely to be stable from now on, as no more screening services are joining the trial. Recently the proportion of older women has increased slightly, largely because women born in the post-war baby boom are now reaching their 70s.

4.3  Randomised batches: There has been some increase in the average batch size over the last few years. The number of batches randomising women to be invited or not are similar.

4.4  Excluded records: The number of women who could not be flagged has increased in the last two years. This is due to the care.data episode which led to about 3% of people requesting that their health data not be passed on to others.

4.5  Data sources: Data on those randomised and follow-up data come from 7 different sources. The numbers randomised, screening outcomes and death data were available up to 31/3/2017, but information on tumour characteristics (COSD data) was last available in 2013 and on past cancer screening history in 2015. It is hoped that planned improvements in PHE data systems will reduce these delays and simplify data transfer. There are still relatively small numbers of women with 5 years follow-up. SMR reported asked to be kept updated about the timeliness of provision of cancer data (including COSD).

5. Report by DMEC

The report issued by the DMEC who met in 22^nd Feb 2018 had been circulated.

6. Presentations about AgeX at Scientific Meetings

JP will be presenting information about the Trial at the Symposium Mammographicum conference in July 2018. The audience is people working in breast screening, mostly radiographers. The TMG agreed that since the trial started new radiologists and radiographers have been appointed and stressed the importance of keeping them informed about the trial.

HCP and RP have been working on a meta-analysis of breast screening around the world to present at the Early Breast Cancer Trialists’ Collaborative Group meeting in April 2018.

The TMG agreed that more conference presentations and liaison with PHE were important.

7. Membership of TMG

It was agreed that all TMG members who had not attended 2 consecutive meetings would receive a letter to ask if they wished to continue as members of the TMG. If a meeting was missed for the third time, the member would generally be replaced on the committee. The TMG members agreed that it is essential to have Radiologist and Radiographer representation on the TMG. MR suggested that a second lay representative such as a patient representative was appointed and offered suggestions on where to find lay representation

It was suggested that Suzanne Wright (Head of Implementation & Training for PHE Screening) replace Margot Wheaton as a member of the TMG.

Action: KB contact MR to find and appoint a 2nd lay representative Action: JP to invite Suzanne Wright to become a member of TMG

Action: JP/KB write to TMG members who have not attended for 2 consecutive meetings to ask if they wish to continue as members of the committee.