Hello, my name is Lynda Wyld and I’m Professor of Surgical Oncology at the University of Sheffield and I work clinically at Doncaster teaching hospitals in the UK.I’m going to talk a little bit about the age-gap study which we are presenting at the European Breast Cancer Congress later on today. So this study is a large study that we’ve been running since 2013. The aim of the study was to try and find out whether primary endocrine therapy, so omitting surgery altogether, for older women with breast cancer was safe and also what impact it has on older women in terms of their quality of life and the adverse events that they suffer from.

We’ve tried in the past to run randomised controlled trials to assess whether surgery or primary endocrine therapy are as good as each other or one is better than the other but we were unable to do this because women weren’t willing to accept randomisation. So we decided we’d run an observational study and recruited a very large number of women and then used a technique called propensity score matching to adjust for the baseline variation between women in the different treatment allocation groups.

The study started in 2013 and it finished in 2018 and in that time we recruited over 3,500 women over the age of 70. The oldest patient that we recruited was 102 and we had a very wide range of health and fitness states within the cohort which was broadly representative of the general population in terms of the age demographic, although slightly skewed towards the younger.

We compared women who had surgery and standard treatment with those who had primary endocrine therapy and when we look at all of the women included we found that surgery has a clear advantage in terms of survival rates from breast cancer. We expected this, based on some historic randomised controlled trial data and also observational data from UK cancer registries.

However, we know that the women who are treated with primary endocrine therapy tend to be less fit women and so when we look at propensity score matched cohort, so we pulled out two women for every one woman who had primary endocrine therapy, we pulled out two women with matching characteristics from the surgery group and we then ran the comparison again. When we look at this matched cohort, which were about nearly a decade older than the overall cohort, we found that the differential benefit for surgery largely disappears in terms of breast cancer specific survival, although there was still a slight persistent overall survival disadvantage to having primary endocrine therapy.

We ran some Kaplan-Meier analyses and the match between survival rates, breast cancer specific survival rates, in the matched cohort stayed very similar until around about 4½ to 5 years of follow-up, at which point we’re just starting to see some slight divergence. From this we draw the conclusion that whilst the majority of women over 70 should be encouraged to have surgery, for those women who are in poor health and probably likely to have a life expectancy of less than five years, we would suggest that primary endocrine therapy can be offered to them if they are interested.

The other thing that we looked at was the quality of life of women who had either surgery or primary endocrine therapy. We found that surgery is associated with a detriment to quality of life in these women and, in particular, women who have mastectomy rather than lumpectomy and women who have axillary clearance. You can clearly see in the quality of life data that we have when we followed these women and ran quality of life questionnaires up to two years after the treatment that these treatments, these more major types of surgery have quite a significant impact on quality of life for these women. This is something that also needs to be taken into consideration when these older, frailer women are making a choice between whether to have surgery or primary endocrine therapy.

So the next element of the age-gap project was to develop a decision support tool. So this would be something that could be used by both patients and also their doctors to help them to decide which was the best option for them. We worked with patients themselves in this age group, finding out what information they wanted and needed to help them make this decision and we developed some booklets specifically written to be age appropriate for this group of women and also an online tool, the age-gap decision tool, which is now available on the web. We wanted to test what impact using this tool would have on women and the decision making that they make, so for the latter half of recruitment to the age-gap cohort study we gave this tool to half of all the centres that were recruiting for us. So we had 56 centres in the main cohort study and I think 21 centres were given the tool to use in decision support.

We then analysed a range of different measures to see what percentage of women had each of the different treatment options, how much knowledge they had to support them in making that decision and a range of other metrics. We also looked at survival to see if using the tool had any impact on that. We found that using the tool was associated with a significant increase in levels of knowledge of women who had used the tool to support their decision. We also found that it slightly increased the percentage of women having primary endocrine therapy which we thought was slightly unexpected because we know that the tool generally gives survival advantage to surgery. But we also know from previous research that we’ve done that older women have a slightly higher priority for quality of life than they do for length of life in some cases. So we felt that this probably reflected the fact that although they could see a small survival disadvantage from having primary endocrine therapy, they felt that it would probably allow them to maintain their quality of life and independence better.

So the age-gap tool is now available online and we would encourage people to have a look at it and see if it’s something that they might want to use in their clinical practice. The booklets that we developed can be printed off and downloaded from the tool and are available for use. We would, of course, value any feedback that people want to send us. Thank you.