The data shows that none of the studies analyzed allow conclusions to be drawn on the real effectiveness in improving the survival of the tested combinations.
Malignant pleural mesothelioma is a tumor that originates in the mesothelium, the membrane that covers most of the internal organs of the body and which, in the case of the lungs, is called the pleura. Mesothelioma is one of the few cancers of which there is substantial etiopathogenetic certainty, as its cause of onset is almost entirely attributable to exposure to asbestos fibers.
It is no coincidence that its incidence has increased in the last century following the massive use of asbestos and is almost certainly destined to increase, both because of the constant presence of asbestos in the environment that surrounds us, and because of the long period of latency that characterizes the development of this tumor (about 40 years) between the initial exposure time and diagnosis.
To date, despite enormous scientific advances, mesothelioma remains a neoplasm with a poor prognosis. The first-line therapies available today also include combinatorial regimens and, among these, the most effective is the one that includes bevacizumab. A study conducted in collaboration between the Sbarro Health Research Organization (SHRO), the Italian Mesothelioma Group (GIMe), and the medical biotechnology department of the University of Siena was recently published in the international journal Jama Open, in which the efficacy is clarified of some treatments tested on mesothelioma patients.
The study was based on monitoring the clinical course of these patients and on data collection and subsequent analysis of survival data.
The study involved a multidisciplinary international team of scientists from different institutions (United States, United Kingdom, Ireland, Italy, and Israel) and involved multiple expertise.
Three clinical trials were well evaluated: MPS (2003), MAPS (2016), and CM743 (2021) which tested three drug combinations cisplatin / pemetrexed, cisplatin / pemetrexed / bevacizumab, and Ipilimumab / Nivolumab, respectively. The data obtained showed that none of the studies analyzed allowed conclusions to be drawn on the real effectiveness in improving the survival of the tested combinations.
Furthermore, the analysis of these studies showed that the average survival of the most recent therapy tested for mesothelioma, immunotherapy with Ipilimumab / nivolumab, overlaps perfectly with that obtained with the therapies previously used (platinum / pemetrexed / bevacizumab). And in fact, even in this case, there are no improvements in terms of quality or life span.
The important result that emerged from this study consists in the consideration that, sometimes, clinical trials are conducted in artificial conditions that do not mimic what actually happens in reality. Consequently, this study highlighted the presence of some important persistent and worrying gaps in the design of clinical studies, in particular in mesothelioma, but also in other cancers for which, on the one hand, the data show us a long way to go yet, from other offers us an incentive to improve preclinical research, but also the design of impartial clinical trials.
This article was first published in Italian on La Voce Di New York.
You can check the study on Jama Network here.