2 July 2024
Present
Professor Julietta Patnick (Chair) (JP)
Associate Professor Isobel Barnes (IB)
Dr Jillian Boreham (JB)
Professor Robert Hills (RH)
Professor David Hunter (DH)
Associate Professor Toral Gathani (TG)
Associate Professor Hongchao Pan (HCP)
Dr Gurdeep Mannu (GM)
Professor Sir Richard Peto (RP)
Professor Malcolm Reed (MR)
Professor Gillian Reeves (GR)
Mr Keith Shaw (KS)
Dr Louise Wilkinson (LW)
Ms Krys Baker (minutes) (KB)
Apologies received
Mrs Claire Borrelli (CB)
Professor Philip Clarke (PC)
Ms Sima Goldney (SG) (resigned)
Mrs Jacquie Jenkins (JJ) (resigned)
Professor Anneke Lucassen (AL)
Professor Carolyn Taylor (CT)
Professor Sian Taylor-Phillips (STP)
Dr Suzanne Wright (SW)
1. Welcome and introductions
JP welcomed TMG members and investigators. It was noted that lay member Dr Jillian
Boreham, Professor Philip Clarke, an expert in health economics, and Professor Anneke
Lucassen, an expert in clinical genetics, have been appointed to the TMG, while Jacqui Jenkins and lay member Sima Goldney have resigned from the TMG.
2. Minutes of the last meeting (26/07/2022) and matters arising
The minutes of the last meeting were accepted as an accurate record.
3. Presentation of progress report
3.1 AgeX is currently in the second of three phases of activity. Phase 1 took place during 2009–2020 and included the pilot study and randomisation of 4.5 million women (3 million aged 47–49 and 1.5 million aged 71–73). Phase 2 involves low-cost electronic follow-up, particularly of breast cancer mortality, to 2026. Phase 3 will involve further electronic follow-up to 2031.
3.2 The Trial Co-ordinating Group at the University of Oxford has been restructured following the death of Professor Valerie Beral and the retirements of Professor Julietta Patnick and Professor Sir Richard Peto. Associate Professors Isobel Barnes and Toral Gathani have become co-chief investigators. Professor Julietta Patnick, Professor Richard Peto, Professor Gillian Reeves, Mr Keith Shaw and Ms Krys Baker continue in their respective roles as Trial Management Group chair, senior statistical consultant, senior epidemiological consultant, data manager and trial manager. Associate Professor Hongchao Pan is now lead analyst for the mortality outcomes. Professor Carolyn Taylor and Dr Gurdeep Mannu join as co-investigators bringing valuable expertise in breast cancer research and clinical management.
3.3 Smoothly functioning linkage to the databases used by AgeX for follow-up has been re-established following delays caused by the COVID pandemic and by successive changes in national data governance.
3.4 Details of the exclusions from primary analyses, which were as per the protocol, were presented. Around 2 million women aged 47–49 and 1 million women aged 71–73 remain (after exclusions) for the primary analyses. Most of the exclusions were due to prior breast disease or cancer, or due to not having accepted the previous cancer screening invitation and therefore being unlikely to comply with an invitation by AgeX. All these exclusions are unbiased as they are based on information recorded prior to randomisation.
4. Statistical Analysis
Plan A draft Statistical Analysis Plan for phases 2 and 3 of the AgeX Trial was presented to the TMG.
5. DMEC report to TMG June 2023 and April 2024
The DMEC reports were presented to the TMG congratulating the trial team on the continued successful progress of the trial. In particular, the 2024 report congratulated the trial team on the re-establishment of continued high quality and timely data linkages following delays noted in the 2023 report.
6. Membership of the TMG Membership of the
TMG moving forwards was discussed and it was agreed that, as the operational phase of randomisation is completed, and the trial is in a follow-up and analytical phase, any new members should provide analytical expertise.
7. Any other business
The TMG requested that a publication plan for the trial be prepared by the beginning of September. Three publications are planned: 1) a report in 2025/26 on breast cancer incidence and treatment, but follow-up of breast cancer incidence and treatment will continue after this date; 2) a report in 2027/28 on breast cancer deaths up to the end of 2026; and 3) a report in 2032/33 on breast cancer deaths up to the end of 2031. The trial protocol and statistical analysis plan are being updated and will be published on the trial website.
8. Date of next meeting
It was suggested that, unless there are unexpected events, the next TMG meeting should be in about one year’s time.