Abstract
The architects of phase I radiochemotherapy development programs impose a semblance of structured radiation “intensity” and adverse event predictability upon radiation-anticancer agent interactions whose natural complexity and improper mixing would otherwise lead to dire health consequences. It is incumbent upon radiation oncology investigators to pledge radiation quality and safety to the participants of radiochemotherapy trials. Measures of radiation quality and safety may be tools to scrutinize radiation-anticancer agent dose and schedule, as well as, radiation field design among diverse radiation delivery platforms. In this article, the merits and demerits of phase I radiochemotherapy quality and safety policies are critiqued considering the current era of rapidly evolving radiation technologies.
Highlights
OPINION The traditional first-in-human radiochemotherapy study or phase I investigation often determines the dose and schedule of radiation and investigational anticancer agent combination
In an effort to maximize clinical benefit, architects of phase I radiochemotherapy development programs conduct stepwise dose-escalated trials of radiation, of anticancer agent(s), or both together. It has been held in such dose-escalated trials that one accepts an adverse event or toxicity rate of 33% or less in participants, based on the premise that the limited study subject numbers are largely representative of patient cancer groups sharing common traits
Discovery of a toxicity rate target may be done by escalating radiation or anticancer agent dose until two of six (i.e., 33%) enrollees manifest an adverse event, often a toxicity arising from a pre-determined list
Summary
OPINION The traditional first-in-human radiochemotherapy study or phase I investigation often determines the dose and schedule of radiation and investigational anticancer agent combination. We gain an illustrative safety portfolio for radiation-anticancer agent combinations that allow step study of therapeutic response in phase II or III clinical trials. In an effort to maximize clinical benefit, architects of phase I radiochemotherapy development programs conduct stepwise dose-escalated trials of radiation, of anticancer agent(s), or both together.
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