Clinical trials for non–small cell lung cancer (NSCLC) are increasingly demanding tumor samples or research biopsies, which may bar participation and delay treatment for patients, a new study finds.
The need for tumor tissue samples or repeat biopsies follows from the rise of precision medicine: many trials are now being conducted to evaluate the effectiveness of targeted therapies, or those designed specifically for certain tumor mutations. Therefore, patients increasingly are being accepted for trials on the basis of either the presence or absence of certain biomarkers.
Researchers investigated whether this new trend led to trial delays or barriers for NSCLC patient enrollees in an article published in the Journal of Thoracic Surgery. For their analysis, researchers looked at data from 55 clinical trials of systemic therapy at the Princess Margaret Cancer Centre (Toronto, Ontario) from January 2007 to March 2015. Of those trials, 38 required tumor samples for enrollment, and 6 required repeat biopsies. Trial participation was offered to 636 patients; however, results revealed that far more patients actually ended up receiving treatment when trials did not require mandatory tissue samples (83% vs 55%). Treatment also began far earlier in trials that didn’t require tissue samples (after 9 days on average) than in those that did (after 16 days on average).
The researchers also reported that the most common barriers to trial enrollment included an absence of required biomarkers (34%), withdrawal of consent (20%), deterioration of death (17%), exclusion criteria (15%), and insufficient biopsy tissue (10%).
From these results, the team concluded that NSCLC trials that require tissue samples or repeat biopsies for treatment eligibility pose significant barriers to trial enrollment and time to treatment. To manage these delays, researchers suggested using other diagnostic methods, such as peripheral blood assays for molecular markers, accelerating laboratory testing turnaround, and applying more resources for rapid biopsy.
