Black and Latino Patients Are Underrepresented in Phase 1 Cancer Trials

Black and Hispanic/Latino patients with cancer were less likely to be enrolled in phase 1 cancer trials compared with phase 2/3 trials, suggesting a need for targeted interventions, a new study indicated.

“Longstanding disparities exist in enrollment of older, female, Black, and Hispanic/Latino patients to cancer clinical trials,” the study authors wrote. “However, although most of the literature on cancer clinical trial disparities has focused on later-phase trials, few studies have examined phase 1 cancer clinical trial.”

This cross-sectional study used a sample of 3,103 patients aged ≥18 years enrolled in cancer trials from October 2011 to November 2014 at a single academic center. The 3,103 patients included 2,657 unique patients: 1,401 enrolled in a phase 1 trial and 1,256 in a phase 2/3 trial.

There was no significant difference in age, insurance status, marital status, and income between participants that enrolled in a phase 1 compared with a phase 2/3 trial. Phase 1 trials did have a higher proportion of females than phase 2/3 trials (57% vs. 44%; P<0.001). Phase 1 trials also had significantly lower proportion of Black patients (2% vs. 4%) and Hispanic patients (2% vs. 5%, P<0.001), but a greater proportion of Asian patients (6% vs. 3%; P<0.001) compared with phase 2/3 trials.

A multivariable analysis showed that Black patients were significantly less likely to be enrolled on phase 1 trials (odds ratio [OR]=0.46; 95% confidence interval [CI], 0.25-0.82) compared with White patients. The same was true for Hispanic/Latino patients (OR=0.25; 95% CI, 0.08-0.79).

“Phase 1 trials have grown increasingly important in the molecular-driven era of oncology, and thus our findings should inform future efforts to address inequities in access to the cutting-edge treatment offered in these studies,” the researchers wrote.