There is a growing awareness that the design of clinical trials can be misleading and provide evidence that does not end up actually benefiting patients in the clinical setting. This discrepancy includes clinical trials testing the efficacy of new anti-cancer treatments.
A recent analysis shows that in the US, despite increased expenditure for anti-cancer drugs in recent years, the effects on survival have been very modest. The study, “Abemaciclib for malignant pleural mesothelioma,” is published in Lancet Oncology.
On the other hand, other authors have provided evidence of a clear-cut tendency to test (and possibly achieve the registration) of the same compounds for different neoplasms rather than working to discover more suitable drugs for each tumor.
“That’s why our group has recently focused on the screening of clinical trials with a particular interest in Mesothelioma,” says Antonio Giordano, President, and Founder of the Sbarro Health Research Organization (SHRO) at Temple University.
“Mesothelioma is a tumor that, because of its biological complexity together with social and legal implications, has always been a paramount field of research at our Institute,” adds Luciano Mutti, M.D., co-author and Adjunct Professor, SHRO, Temple University.
This time the team has screened a recent clinical trial using Abemaciclib, a cell cycle inhibitor, for Mesothelioma in patients with refractory disease.
The study of the cancer cell cycle has always been crucial in my research,” explains Professor Antonio Giordano. “In 1989, we discovered p/60Cyclin A: a pivotal protein whose dysregulation plays a crucial role in carcinogenesis and cancer cells proliferation and tumor growth. This discovery has trailblazed the use in clinical settings of a specific class of inhibitors of the effects of Cyclin A.”
”Because of our research history on cancer cell-cycle and our full awareness of the strong impact of the therapeutic inhibition of cancer cell proliferation, we consider it paramount that our results are properly translated into clinical settings,” says Prof Antonio Giordano.
“The Cyclin-dependent cells proliferation is even more important when a gene for protein serving as a brake called p16 is lost,” adds Prof Antonio Giordano.
The authors conclude that, although the patients with Mesothelioma treated with Abamciclib were carriers of p16 loss, the presence of bias in the trial design makes the results far from convincing.
“Once more, we need more solid design of the trials,” the authors say. “Patients should be selected to resemble those usually treated in real-world practice. Nothing matters more than survival. The exorbitant cost of the new drugs should be justified by what can really be achieved for all the patients,” they conclude.
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