Personalised cancer medicine, an opportunity or a threat?
The term ‘personalised medicine’ has become hip lately, so no wonder it also appears in Europe’s Beating Cancer Plan and its accompanying Cancer Mission. But what’s it all about? And is personalised medicine really the way forward in treating cancer?
Personalised medicine, also referred to as precision medicine, contains so much more than medical care customised for an individual patient. But it seems as the definition isn’t the same for all.
That’s why caution is justified when it comes to using personalised medicine in cancer war strategies, and policymakers should be wary of the hype.
“Personalised medicine as a whole has become a buzzword in both the academic and public debate around health care. The lack of clear definition means that its use is open to interpretation, complicating discussions around the associated risks, benefits and potential limits and leading to confusion on the part of patients. Having a well-defined, globally consistent terminology would benefit patients and their health literacy.” (cited from Gill et al., 2020 ‘Access to Personalised Oncology in Europe’ London School of Economics).
One definition is that personalised medicine means your medical care is based on your genes. Researchers started digging into our genes years ago, because they noticed that a treatment worked for one person, but not for another person with the same type of cancer. Additionally a tumour might contain mutated cells that respond in a specific way to treatment. So now physicians collect information about the genes of a cancer patient but more importantly also about the tumour’s genes, before prescribing a personal therapy.
What could be the danger of this? We already flagged, earlier this year, that innovative drugs do not always imply true value for patients, meaning that patients should live longer and/or better following treatment. Unfortunately, when a new drug enters the market these essential criteria of true value for the patient, are not always fully demonstrated.
What about the outcomes?
The same concern also emerges in this: recent policy documents by the European Union, Europe’s Beating Cancer Plan and its Cancer Mission, articulate broad policies aimed at reducing cancer mortality across Europe. The focus for cancer treatment in these manifestos is personalised cancer medicine. However, the Cancer Mission suggest in its documents that the uptake of personalised cancer medicine is ‘hampered by uncertainty about its outcomes’. How so?
The European Commission is working on a new Partnership on Personalised Medicine, which will be funded under Horizon Europe. This new Partnership on Personalised Medicine will make recommendations for the roll-out of new personalised medicine approaches in medical practice. One of the initiatives is to use ‘Next generation sequencing’ (NGS) to apply therapeutic approaches based on cancer profiles. However, there are some limits in this.
Think of the complex biology of advanced cancers, for instance. The complexity, plasticity and genetic heterogeneity of advanced cancers will continue to thwart the impact of personalised cancer medicine, limiting it to specific pathologies, or rare subsets of them.
Indeed, in personalised cancer medicine with a targeted therapy guided by a validated molecular biomarker, known as pathology-driven, reviews learn that targeted treatments can cause toxicity. Moreover, clinical benefit can sometimes be marginal so proper assessment of the added value for patients is required.
In the second type of personalised cancer medicine, the pathology-agnostic use of targeted therapies in so called basket trials, the outcomes are not very encouraging either. In this, patients receive drugs that target specific genes. But it seems that few patients are able to receive a drug that truly matches and only a very few had a response. More details of the findings just mentioned, can be read in this publication.
Individuals and health systems face new challenges
Earlier findings of the European Council on personalised medicine for patients should also be taken into consideration (2015/C 421/03). The Council notes for instance that, “with the development of personalised medicine, individuals and health systems face new challenges, including balancing its risks and benefits while also considering its ethical, financial, social and legal implications, particularly regarding pricing and reimbursement, data protection and public interest in processing personal data.”
Our conclusion? Personalised medicine is an opportunity, but to reveal its potential, we strongly advice that new treatment strategies should be properly studied to provide a solid evidence base demonstrating patient’s benefit based on relevant endpoints, before full implementation in Europe’s ambitious war on cancer.