There is no doubt that the use of recently approved drugs to “boost” the immune response to cancer cells represents a novelty that has enriched the arsenal of ammunition against human cancer
Nevertheless, even though some of these drugs (i.e. the class of drugs named Immune-checkpoint-Inhibitors, ICi) have been sometimes hailed as “wonder drugs,” the issue of a deeper insight into their real impact on patients’ survival is currently being raised by many patients and caregivers
A first response to this surging demand has been suggested by the authors of the scientific letter just published in Lancet Oncology, whose title itself “What is the real efficacy of second line immunotherapy in mesothelioma?” clearly anticipates what the authors intend demonstrating in their work
The authors offer an analysis of the most recent trials using ICi for refractory Mesothelioma starting from the recent paper published by D. Fennell et al on Lancet Oncology in October, 2021.
“No doubt it is a rather unique design. For the control arm, firstly, because patients on Nivolumab (ICi) are compared with patients treated with placebo. This raises a deep ethical concern because it is clear that a group of patients has been denied any treatment,” remarks Luciano Mutti, Adjunct Professor at the Sbarro Institute for Cancer Research and Molecular Medicine at Temple University and frequent research collaborator with fellow scientists of the Sbarro Health Research Organization (SHRO). Mutti also serves as Chairman of the Gruppo Italiano Mesotelioma.
“No surprise that nivolumab slightly tops placebo but a scientifically sound and more ethical design of the study should have compared Nivolumab vs standard second line treatment,” Mutti concludes.
From this assumption, the authors have analysed all the most recent clinical trials for patients with refractory Mesothelioma and summarised the results in a table.
“The results are very clear,” says Pier Paolo Correale, MD, Director of the Medical Oncology Unit at Grand Metropolitan Hospital ‘Bianchi Melacrino Morelli,’ Reggio Calabria, Italy. “None of the current treatments in this setting are superior – in particular ICi vs chemotherapy – because survival of the patients on the different therapeutic regimens considered is the very same.
“In spite of these facts, we are dismayed noting how the results of trials are oftentimes distorted and misleading,” Correale says. “This trial with Nivolumab has been hailed – “hyped,” I would say – on social media and on the web, as being able to “improve survival” of patients with Mesothelioma. Lo and behold, on the same web-sites the details on the comparison with placebo have been omitted or, at least, greatly downplayed. This is disrespectful toward patients and toward truth.”
“In collaboration with two international teams specialised in biomedical statistics, our group has just concluded an independent analysis of the so-called “front line therapies” for Mesothelioma and also for other tumours at higher incidence,” says Antonio Giordano, MD, PhD, Director and founder of the Sbarro Health Research Organization (SHRO), at Temple University in collaboration with the University of Siena, Italy. “It is clear the procedure for new drug approvals needs a prompt repeal. In particular, the “fast track” approvals must be followed by solid confirmatory studies. Otherwise, the risk of delayed withdrawal ends up harming patients exposed to useless toxicity. On the other hand, Health Systems are obliged to bear the brunt of the exorbitant costs of the new cancer drugs. If one considers that sometimes “hasty” approvals influence the guidelines and some countries, like Italy, refer to guidelines when a doctor is arraigned for malpractice, it becomes easy to understand, once more, how paramount it is to follow the science.”
About the Sbarro Health Research Organization
The Sbarro Health Research Organization (SHRO) is non-profit charity committed to funding excellence in basic genetic research to cure and diagnose cancer, cardiovascular diseases, diabetes and other chronic illnesses and to foster the training of young doctors in a spirit of professionalism and humanism. To learn more about the SHRO please visit www.shro.org
To see more information about our Founder & Director Dr. Antonio Giordano visit:
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