The epidemiological shift of cancer

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Published: 21 Mar 2019
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Dr Antonella Brunello - Istituto Oncologico Veneto, Padova, Italy

Dr Antonella Brunello speaks to ecancer at the 2019 EORTC Groups Annual Meeting (EGAM) about the misrepresentation of elderly cancer patients in clinical studies.

Dr Brunello references an ongoing trial that has been developed alongside the EORTC Breast Cancer Group, which uses a CDK4/6 inhibitor in older breast cancer patients.

She also highlights the challenges that this population are faced with when it comes to clinical research - including strict inclusion criteria, suitable endpoints and limited funding opportunities.

Dr Brunello and her group hope to conduct more clinical trials that focus on several cancer types, solely in this age population.

We are observing an epidemiological shift towards older patients and actually most cancers nowadays are diagnosed in people aged 75 years and older. So this is really an important age cohort that is normally excluded from commonly run trials and so I think that more and more attention should be paid to conducting research specifically in this age group since most of the trials not oriented to older patients are normally with strict inclusion criteria. If some patients that are aged 70 years or older are included in the commonly run trials they are usually the fit ones and the day after in the clinics you have to extrapolate results from these trials. So it’s not really a good thing to do.

What can we expect from the EGAM meeting?

Today we are going to discuss some ongoing studies and some proposals for new studies and some brainstorming about new potential areas for improving research in this age population. It will be an interesting meeting.

Are there any ongoing studies you’d like to shed light on?

Yes, there is an ongoing study that has been developed in collaboration with the breast group and is a trial which will be using a CDK4/6 inhibitor in breast cancer. This is one of the most advanced phase studies that we are going to discuss. There are some other proposals that we are going to discuss and hopefully we will find some ways to get them funded, such as the proposal by Professor Brain, who is Chair of the Breast Cancer Group, of slowly escalating the dose of drugs in older patients. This is really something that we normally do in the clinics but it is not as often now supported by strong evidence, so something that needs to be tested in clinical trials.

What are the challenges surrounding particularly the elderly patients?

As a heterogeneous population they really face a lot of challenges mostly because clinical trials that are addressed to non-elderly patients have, as I said before, strict inclusion criteria. Patients with comorbidities are normally excluded so older patients normally do not fit into the inclusion criteria for other trials. So this is a challenge; another challenge is the endpoints for such trials. For an otherwise healthy person normally improving survival is the strongest endpoint but for some older patients, in which cancer probably is one of the multi-morbid conditions, would it be still improving survival the main endpoint or probably there are some other endpoints that should be taken into account in order to run a more proper clinical trial in this age population.

So there are really some challenges and probably one of the greatest challenges in conducting trials in this age population is the difficulty in finding some resources and funding from pharma companies that normally are not so willing to invest in this age population because of the greater burden of comorbidities and the high rate of frailty in this population.

What are the main successes you’ve achieved so far?

As I stated, conducting clinical trials in older patients is really a success and earlier this year, actually last year, a clinical trial in older women with metastatic breast cancer treated with an adapted chemotherapy and targeted agents was published. So this is one of the greatest successes these past years of the group and it was a clinical trial that was run in collaboration with the Breast Cancer Group and led by Hans Wildiers. One of the keys to success in conducting research in this age population and as a task force is the strong collaboration we have with other disease oriented groups.

What are the main objectives for the next few years?

We definitely would like to have elderly task force led clinical trials, so not just in collaboration. Collaboration is vital for the task force but we would like to develop and run a clinical trial directed to older patients with several types of cancers and with a strong presence of geriatric assessment because we know that including older patients in clinical trials without having a strong geriatric assessment baseline will not be able to convey real evidence to translate it into clinical practice. So this is why we developed what we call a minimum dataset that includes a screening tool for geriatric assessment and some other items that must be collected when including older patients in clinical trials. We are hoping to develop a trial in which this minimum dataset is included and is used to evaluate the proper treatment in an era in which chemotherapy is no longer the mainstay of treatment. So we have a lot of possibilities of treatment targeted therapies, immune oncology therapies and these are heterogeneous treatment possibilities and older patients are a heterogeneous population. So it’s a challenge but we like to take challenges so we hope to be able to run this kind of trial.

Is there anything else you’d like to mention?

I think that unfortunately the feeling of being a geriatric oncologist and a geriatric oncology researcher is to be in a niche. Probably more information must be conveyed because it’s going to be a really huge issue, the problem of older patients with cancer. So probably having a high attendance also from other people involved in other cancer types or other disease oriented groups would be really well accepted.