Of all women who develop metastatic breast cancer, only a fraction, 14%, are given the opportunity to enter a clinical trial.
This, at least, would be the situation in the UK, where a patient – Lesley Stephen – led a survey, presenting the results at the opening of the Advanced Breast Cancer Sixth International Consensus Conference (ABC 6), the most important scientific appointment in the field of advanced breast cancer, which is currently underway online.
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It is known that patients included in the studies tend to have better prognoses, regardless of the treatment they receive. Stephen has had the idea of conducting a survey to figure out how many metastatic women are involved since the time she was diagnosed with the disease. “I was included in a clinical trial for about 6 years and that gave me years of life that I wouldn’t have expected,” she says: “But from talking to other women, I realized that most of them never had discussed with their doctors the possibility of entering a trial. And I wanted to understand why. ”
The investigation
To do this, he asked for the collaboration of researchers and clinicians, such as Carlo Palmieri, oncologist at the Clatterbridge Cancer Center and the University of Liverpool, Janet Dunn, head of the Warwick Clinical Trials Unit, e Ellen Copson, Professor of Medical Oncology at the University of Southampton.
Together with them, Stephen has developed a survey aimed at metastatic patients across the UK. The survey was launched last May and in August over 600 patients (626 women and one man) had responded. The questionnaire is still open, but neither Stephen nor the researchers expect the data and conclusions to change.
Here’s what emerged. To date, only 90 patients of those who participated in the survey (14%, in fact) have been enrolled in a trial, and for almost all (72) it has been a positive experience. 77% of the sample (466 women), on the other hand, never received information from their doctors on any clinical studies, and 69% never asked for them on their own.
The 31% who asked were given different answers, in some cases vague and hasty, as the patients themselves testify: “I’m still waiting for an answer. Talking to my oncologist is like talking to the wall. it comes back to me is my voice “; “They told me I would be notified if there was a suitable trial for me”; “The oncologist was very little supportive. He told me that most trials fail and that these should be the last resort”; “Nobody told me I could go to another hospital to access a trial.”
In Italy
And in Italy? What’s the situation? “There is no data, but I fear that the percentage is even lower than the 14% that emerged for the UK”, he replies. Michelino De Laurentiis, director of the Senology and Thoraco-Pulmonary Department of the National Cancer Institute IRCCS Fondazione ‘G. Pascale ‘of Naples.
“The reason – he continues – is partly linked to how our health system is organized: the resources allocated to hospitals, in fact, also depend on the number of patients and this means that the centers are in some way competing with each other. There is a tendency to keep one’s own patients. It is a sort of underlying schizophrenia in a very delicate system: there is a lot of talk about oncological networks, but in fact these networks are unable to reach their full realization, precisely because they transfer a patient. in another center where a clinical trial is active it means losing resources. In my personal experience, most of the patients who are referred to me from other centers have already exhausted all standard treatments. “
This means losing chances, explains the expert, because today the phase III clinical studies, on the most promising drugs that have passed the other phases of the trial, already enroll patients for the first lines of treatment.
“Unfortunately, there is no automatic transfer mechanism even between large cancer centers”, De Laurentiis reiterates: “There are instead many conscientious oncologists who take the burden of verifying whether a suitable protocol for their patient is active in other hospitals. It will hardly be possible to change this system, so it is necessary to educate patients: explain to them that it is important not to stop at the first consultation, that asking for a second opinion in one or two large cancer centers that have many active trials is important and is perfectly normal . Again in Italy there is this concept of a fiduciary and unbalanced relationship with the doctor, as if it were wrong to ask the opinion of another clinician: it is an obsolete concept that must be overcome. At stake is the life of the patients “.
Across the Channel is no different. “Many doctors – says Stephen – are a bit like ‘gatekeepers’: they often do not mention the studies and, if they do, they tend to seek only local practices, without asking their patients if they are willing and able to travel. a lot of power in the doctor-patient relationship. We must encourage them to discuss trials as treatment options with their patients. However, they cannot do it alone: we also need the pharmaceutical industry, which funds clinical trials, to cooperate. educate patients and enable them to be proactive “.
If the studio is in another city
But if participating in a clinical trial means having to travel, are patients willing to do so? In the English survey, the answer was yes for 56% of the interviewees: 43% said they were ready to go anywhere in the world. When it comes to out-of-pocket costs, the possibilities range from 0 to over £ 100 per month. But in the face of the possibility that the costs of the move are covered by others, the share of patients willing to move rises to 61%.
pros and cons
For almost all (93%), entering a trial means having access to possible new treatments, but 90% would participate just so that other people can benefit in the future. This does not mean that they have no qualms: 63% say they fear the possible side effects of experimental therapies and 43% have doubts about the benefits.
In addition, about a third fear they do not understand the purpose of the trial and 8% have other doubts, such as fear of receiving a placebo instead of new drugs. 90% would be willing to search for a trial on their own through a database, but most would prefer to receive this information from doctors.
“There are advantages in participating in a clinical study, regardless of whether or not you will receive the experimental drug – continues De Laurentiis – and in fact it has been shown that the prognosis improves in any case. The protocols are very strict: they provide for a very careful monitoring of the disease. and the management of each side effect. Little is left to the ability of the individual oncologist and this is a guarantee for patients “.
Among the key points highlighted by the research, there is the urgent need for a patient-friendly database “for the research of active trials. In Italy a database exists, developed by the Italian Association of Medical Oncology, but it is directed mainly to doctors and only includes centers that send information on ongoing studies on their own initiative.
“All of us – clinicians, researchers, the pharmaceutical industry, academic groups and funders – must work together to reverse this situation,” he concludes. Fatima Cardoso, Director of the Breast Unit of the Champalimaud Clinical Center in Lisbon and Chair of the ABC 6 Consensus Conference: “This is not just a problem in the UK: in most countries it is difficult for patients with advanced breast cancer to participate in clinical trials, and in some it is impossible “.
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