They are called PRO, acronym for patient-reported outcomes, that is, the results reported by patients involved in clinical studies. A theme still neglected today, as he points out Massimo Di Maio, national secretary of the Italian Association of Medical Oncology and director of Medical Oncology at the Mauriziano hospital in Turin in an editorial on ESMO Daily reporter. Yes, because the PROs – he explains – are generally not published together with the efficacy and safety data of the new molecules, and it is a shame, because they provide important information, very useful for the decision-making process on the treatment.
The occasion to reflect on this issue was the presentation of the data on the quality of life of the Poseidon study (on the first-line combination of immuno and chemotherapy in patients with advanced non-small cell lung cancer) during the ESMO Congress on lung cancer that was recently held in virtual mode. “In recent years, fortunately, many studies have presented quality of life data, this is certainly not the first”, says the oncologist: “But it was nice that among the things that stood out at the congress there was the oral presentation of this type of data, even if delayed with respect to the presentation of the efficacy results, which dates back to September 2021 “.
Breast Health
Breast Cancer Interventions, How Much Women’s Perception Matters
by Tiziana Moriconi
April 22, 2022
PROs measure quality of life
PROs are the set of symptoms that measure the quality of life of patients during an experimental treatment (or even in other situations), to evaluate its impact. How exactly? By administering to enrolled patients standardized and validated questionnaires on which to report any effects. For example, in lung cancer studies, the triad of the most common symptoms are pain, cough, wheezing. But the questionnaires we are talking about allow us to obtain much more, because they not only detect the symptoms but also the functional scales, for example physical, emotional, social well-being. In short, inside the PROs there is all the quality of life, and not just in a physical sense.
Without filter
“The purpose of these questionnaires is to take stock of the balance between the disease, the way in which the treatment controls the symptoms and the side effects of the treatment,” says Di Maio. But isn’t that always the way it’s done? “In traditional oncology – continues the expert – these factors were based on the doctor’s description: it was he who described the control of instrumental disease and it was always he who reported the toxicity of the treatment. But this did not necessarily correspond to the patient’s perception. The PROs do not allow you to replace the doctor’s information, but to add the data reported directly by the patients, without any filter “.
Colon cancer, minimally invasive or classic surgery?
by Tina Simoniello
April 27, 2022
Useful data for everyone
Unfiltered data that is certainly useful for the patient community, given that if the study is successful in terms of efficacy, they will benefit from the new results. But they are also useful for the doctor who has to decide whether to propose the new treatment to his patient. “Exactly”, resumes the oncologist: Knowing that a treatment controls the disease for a certain number of months longer when they are subjected, for example, to a CT scan is fundamental information for a doctor, that’s for sure, and patients too they believe it is. But it is not the only one, because if I do not know how that benefit obtained from CT translates into the patient’s real life, I cannot give complete information to that person, who therefore cannot consciously choose. Having said that, we choose, and we have always done so, however without PRO data the communication risks being more superficial “.
Oncowellness, the first platform for the psycho-physical well-being of cancer patients
by Irma D’Aria
April 29, 2022
The effect of not publishing
A few years ago, Di Maio and his collaborators conducted an analysis of all the cancer studies published from 2012 to 2016 to discover that a substantial part of those trials did not include quality of life among the objectives to be measured. “We also saw that even when quality of life data were collected, their publication was very often delayed, even for years,” he adds. But the effect of a non-publication is important, particularly in the case of studies that confirm the initial hypothesis, namely that a new treatment actually improves life expectancy or the control of instrumental disease: given that in these cases the new treatment will become clinical practice, the oncologist should be able to judge its impact on the quality of life for his patients, reflects the national secretary of Aiom. For example, many cancer studies investigate what happens when drugs are added to treatments. Now, it being understood that it is very good that a combination prolongs life expectancy and disease control, it is also important to understand if there is and what the price per patient is. There are cases in which the two things, improvement of effectiveness and quality of life, go hand in hand, but this is not always the case. A patient with advanced disease, even if well aware that one treatment on average lengthens the life, might consider it too heavy for him, and prefer another one “.
Cancer, non-profit clinical trials decrease. The campaign to promote research in Italy is underway
by Tiziana Moriconi
April 28, 2022
Subjective data? Welcome
There is someone who still today, although less and less, believes that PROs are non-objective data. But this is an added value, because patients must be asked precisely for subjectivity. “They are the ones who have to tell us how they are, we doctors only have to make sure that they fill out the questionnaires correctly”, continues the expert: “There is also a prejudice on the quality of the data collected, on their reliability, but it is being overcome. Today even scientific societies emphasize the importance of these results. Questionnaires are standardized and validated tools for the vast majority of cancer types. This is not the problem. Then it is also plausible that some authors do not publish the data all together to keep the interest in the study high for longer times “. However, the time could be ripe to give the right space, and in the right time, to the measurement of the quality of life and not only for a change of mentality, but also for thanks to technologies: today when we publish studies we no longer have space limits, as it was when it was published on paper – concludes Di Maio. Today with electronic publications, the journals in which they are published give the possibility to add appendices, supplementary data. If you want to publish everything immediately, you can do it and it will stay online forever.