This is especially important because of the far-reaching complexity of every part of our immune system.....
In this study, researchers reviewed publications from 81 trials of targeted therapies and immunotherapies approved by the US Food and Drug Administration between 2000-2015 for solid malignancies in adult patients. Each publication was assessed according to a 24-point score card based on the Consolidated Standards of Reporting Trials (CONSORT) guidance.
More than 90% of trials scored poorly in their reporting of recurrent and late toxicities, and in reporting the duration of adverse events; 86% of trials did not adequately report on the time of the adverse event occurrence; and 75% of trials only reported on adverse events that occurred at a frequency above a fixed threshold.
More than half of the analysed papers showed limitations in the method for presenting adverse events, in describing the toxicities leading to therapy withdrawal, and in the follow-up interval assessment, while dose reductions due to adverse events were not reported in one-third of trials.
"Toxicities of targeted agents and immunotherapy are obviously different from the toxicities we are used to observing and treating due to chemotherapy, and there are some aspects of the toxicities of these newer agents that we are not so well informed about," Dr Bossi said.
He highlighted the issue of duration of an adverse event - the so-called 'third axis' (the other being severity and frequency) in the evaluation of toxicities - which is not regularly considered with a new drug comes to market.