Immunotherapy represented an indisputable breakthrough for some cancers, “a novelty that has enriched the arsenal of cancer ammunition”, but “it is not the Holy Grail”. In communicating the results that it produces against some neoplasms, caution must therefore be used not to generate false hopes, and “hasty approvals” must be avoided, which risk producing more harm than good. This is the warning launched by a group of Italian oncologists, some active between the Peninsula and the United States, authors of a scientific letter published in ‘Lancet Oncology’ commenting on some studies that have tested drugs that inhibit immune checkpoints (ICI) in the treatment of refractory mesothelioma.
The analysis of the signatories – Pierpaolo Correale, Francesca Pentimalli, Valerio Nardone, Antonio Giordano, Luciano Mutti – starts from an article that reports the results of the Confirm phase 3 trial on nivolumab, continues also recalling the Promise study on pembrolizumab and concludes by explaining that , “In the second-line setting for mesothelioma, there is no data to support that nivolumab or pembrolizumab as single agents perform better than conventional (even suboptimal) chemotherapy.”
But “unfortunately the impact” of the trials examined could go well beyond what was expected “, warn the experts, saying they are” very concerned that the subsequent miscommunication of their results could confuse patients “with mesothelioma” with a significant social impact “.
“Without a doubt” that of the Confirm study “is a rather unique design – observes Mutti, president of the Italian Mesothelioma Group (Gime) and Adjunct Professor Temple University and Sbarro Health Research Organization (Shro), USA, in a Shro communication – For the arm control first, because patients on nivolumab are compared with patients given placebo. This raises a deep ethical concern, because it is clear that a group of patients have been denied any treatment. Not surprisingly, nivolumab is slightly superior to placebo – adds the oncologist – but a scientifically valid study design should have compared nivolumab with the standard second-line treatment “.
As for the other studies analyzed on ICI in refractory mesothelioma, Correale, director of the Medical Oncology Unit of the Large Metropolitan Hospital Bianchi Melacrino Morelli, Reggio Calabria, considers the results “very clear: none of the current treatments in this area is superior (in particular ICI vs chemotherapy). , because the survival of the patients to the different therapeutic regimens considered is the same. Nevertheless we are dismayed to note that the results are often distorted and misleading “in the descriptions that reach the general public. “This is disrespectful to patients and to the truth,” he points out.
He goes beyond Giordano, director of Sbarro Institute for Cancer Research and Molecular Medicine Temple University and lecturer at the University of Siena: “It is clear that the procedure for the approval of new drugs needs a review – he says – In particular the ‘fast’ approvals track ‘must be followed by robust confirmatory studies, otherwise the risk of delayed withdrawal (if it occurs) ends up harming patients exposed to unnecessary toxicity. On the other hand, hasty approvals force health systems to bear the brunt of exorbitant costs of new anticancer drugs. If we consider that sometimes hasty approvals influence guidelines and some countries (such as Italy) refer to guidelines when a doctor is called into question for negligence, it becomes easy to understand – he warns – how much It is essential to adhere to the scientific evidence of clinical trials designed with a view to responding to the needs of patients “.
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