Report Argues Oncology Drug Dosing is Too High and Should Be Revised

Using outmoded dosing structures, oncologists may be giving patients unnecessarily high doses of cancer meds, which provides no added benefit to the patient and, in fact, causes unnecessary side effects. The answer? More trials in oncology.

That’s the assertion of a new report from the nonprofit cancer research think tank and advocacy organization Friends of Cancer Research. The organization convened a working group that included leaders from industry, academia, patient advocacy groups and the FDA, who hammered out details on how regulators and drugmakers can alter the way they approach dosing of cancer drugs.

Outside of oncology, said Friends of Cancer Research in the report, most drugs are evaluated in randomized dose-ranging trials that support a broader understanding of the impact of different doses on efficacy and toxicity. But in oncology, dose-finding studies are largely performed only in phase 1 clinical trials and intended to identify the maximum tolerated dose (MTD).

This paradigm, the group said, relies on the notion that an increased dose leads to increased tumor suppression, so traditionally the MTD was selected based on how much a patient could safely tolerate.