Lisbon, Portugal: Patients living with advanced breast cancer (ABC) have many new treatment options available to them, but these new drugs are very expensive and may lead to further inequalities in access to the best care. This will happen if the existing model for developing and financing new therapies is not changed substantially, according to Professor Fatima Cardoso, President of the Advanced Breast Cancer Global Alliance (ABC Global Alliance).
In remarks made at the conclusion of the Advanced Breast Cancer Eighth International Consensus Conference (ABC8) in Lisbon [1], medical oncologist Prof. Cardoso said: “The good news is that we have many new drugs, and many new treatments, including some for triple negative disease. In many cases, these drugs extend the lives of patients significantly.
“The bad news is that they are all very expensive drugs, and they have not been compared with one another, only with the usual standard of care on different groups of patients, so there is no way, at the moment, that we can say that one of these new drugs is better than another.
“Personally, I find it very difficult to believe that any government can approve them all, as they are unlikely to be able to afford them all. How will they choose which drugs to approve? Will they approve them all, or maybe just one? It may depend on the wealth of each country, which will, inevitably, lead to patients in different countries, and even in different parts of a country, having unequal access to the best drugs and treatments.”
She issued a plea to the agencies responsible for approving the use of new drugs, such as the European Medicines Agency (EMA) and the US Food and Drugs Administration (FDA), not to approve treatments based on results from clinical trials that show only a small benefit, even if it is ‘statistically significant’.
“If they do approve such drugs, then they should issue recommendations that help national funding organisations and policymakers to prioritise which ones to cover when resources are limited,” she said.
“I have a plea that the selection should not be done based on which one is less expensive, but that there is a discussion in each country with the healthcare professionals and with the patient groups. In addition, it is important that treatment guidelines, like the ones we have agreed today at ABC8, also prioritise the most effective treatments to help the decision-makers take the best decisions. Otherwise they will just go with the ones that are the least expensive.”
At the conclusion of ABC8, a panel of international cancer experts agreed new guidelines on the treatment of ABC, which is a treatable but usually incurable disease. They based their decisions and recommendations on the level and quality of evidence available from different types of studies, ranging from good randomised clinical trials (the gold standard) through to studies without control groups, or on expert opinion.
Among the new drugs that they assessed, the experts recommended that patients with triple negative ABC, for whom immunotherapy is not an option, should be given sacituzumab-govitecan or datopotamab-deruxetan as first-line therapies. Triple negative disease is a type of breast cancer that lacks receptors for the hormones oestrogen and progesterone, and the HER2 protein. It is among the hardest types of ABC to treat as it is aggressive and does not respond to hormone and HER2-targeted therapies.
The consensus panel gave advice on the possible side-effects of these drugs, such as diarrhoea, vomiting and dry eyes, and the best way to manage them.
They also agreed new definitions for the different categories of endocrine (hormone) resistance, which is when a cancer fails to respond or becomes resistant to hormonal therapies.
Prof. Cardoso said: “These new definitions are important because our former definitions have started to be used in clinical trials and so we want them to use these updated definitions. They are based on the very newest data to come from the AURORA Molecular Screening Initiative, which is researching mechanisms of resistance to anti-cancer therapies for advanced and metastatic breast cancer.”
The consensus panel reviewed and made recommendations on several new drugs for ER+/HER2- breast cancer, such as inavolisib combined with palbociclib and fulvestrant, camizestrant, imlunestrant, vepdegestrant, giredestrant and gedatolisib.
“All these new drugs arriving at about the same time, represent an important challenge on how to incorporate them in the treatment algorithms and how to sequence them in clinical practice, since they were not compared to each other or evaluated one after the other,” said Prof. Cardoso.
For personalised or ‘precision’ medicine that targets a patient’s individual genetic mutations that drive their cancer, the experts are now recommending the use of next generation sequencing to analyse the mutations in multiple DNA fragments from tumours circulating in the blood.
“This is because we had almost no treatments that we could use depending on the results of these multi-gene panels,” said Prof. Cardoso. “But now there are several treatments that do have a target and it may become less expensive to do a multi-gene panel test and look for all the targets than to look for the targets one by one. However, we are recommending that these tests should not be performed routinely unless relevant treatments have been identified that are accessible and clinically suitable for the patient.”
The experts recommended that elinzanetant, a new drug that controls the hot flushes many patients experience as a result of their treatment can be an option as long as there are no problems with it interacting with other therapies. They agreed there were many other non-drug options as well, such as cognitive behavioural therapy. The FDA approved elinzanetant on 24 October for use in this setting, and the EMA is currently considering it.
They also included new guidance on the role that exercise can have in improving the quality of life for patients with ABC. They said this exercise should be structured, guided and tailored to the limitations of each patient.
The consensus panel endorsed the new ABC Global Charter for 2025-2035, which includes ten goals for ABC, ranging from continuing to improve survival for patients living with ABC to improving the quality and extent of data collected by cancer registries worldwide. The full papers for the Charter have been published in The Breast.
Honorary Chair of ABC8, Professor Eric P. Winer, Director of the Yale Cancer Center, USA, said: “The treatment of advanced breast cancer continues to improve, and there has been truly incredible drug development over the past 10-15 years. Individuals with ABC are living longer than ever before and living better. We are even beginning to discuss whether treatment programmes could be devised that could result in cure in a subset of patients. We always want progress as quickly as possible, but research takes time. Ultimately, both basic and clinical investigation are critical if we are going to continue to make progress.”
A paper will be submitted to the journal, The Breast, based on the new consensus guidelines from ABC8. The panel expects it to be published in 2026.
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[1] Consensus session, Auditorium 1, 08.30-13.00 hrs GMT, Saturday 8 November.
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