’Much work remains’ to ensure adequate diversity in trials of immune checkpoint inhibitors
Click Here to Manage Email Alerts
Key takeaways:
- Black and Hispanic patients continue to be underrepresented in immune checkpoint inhibitor trials.
- Almost one-third of trials analyzed did not report racial composition.
Although progress has been made, lack of diversity continues to be problematic in trials of immune checkpoint inhibitors, according to study results.
Gaps in reporting of trial participants’ racial or ethnic backgrounds also remain, results showed.
“This underrepresentation limits our understanding of how different populations respond to immune checkpoint inhibitors,” Alfredo V. Chua Jr., MD, medical oncologist and PhD student at Roswell Park Comprehensive Cancer Center, told Healio. “For equitable cancer care, trials must be more inclusive such that each racial/ethnic group is represented corresponding to the incidence of a particular cancer type for that group, and reporting should be more transparent.”
Certain racial and ethnic groups have been historically underrepresented in cancer clinical trials.
Chua and colleagues examined whether that gap had been exacerbated in trials of immune checkpoint inhibitors over the past 2 decades.
Researchers reviewed 471 English full-text trials of immune checkpoint inhibitors published from 2007 to 2022.
They sought to obtain information about trial characteristics and racial/ethnic composition of study participants.
Researchers analyzed differences in participation by ICI agent, publication year, and cancer site. They also calculated an enrollment-incidence ratio (EIR) to measure how representation of certain groups varied based on based on age-adjusted cancer incidence data for the U.S. population. A value over 1 indicated overrepresentation and a value under 1 indicated underrepresentation.
Researchers determined racial composition to be unreported in 146 trials (31%) and Hispanic ethnicity to be unreported in 278 trials (59%). They found 6% of trials reported race- or ethnicity-specific results.
An analysis of all trials showed Hispanic/Latinx patients to be 65% underrepresented (EIR = 0.35; 95% CI, 0.24-0.48) and Black/African American patients to be 34% underrepresented (EIR = 0.66; 95% CI, 0.54-0.79).
Trial representation and reporting for all racial or ethnic minority groups did trend upward over time (P .05), according to researchers.
However, the overrepresentation of white patients persisted regardless of publication year (EIR range, 1.19-1.24), immune checkpoint inhibitor class (EIR range, 1.16-1.23) and cancer site (EIR range, 1.11-1.31).
An analysis of 174 trials conducted only in the United States showed an overrepresentation of white individuals (EIR = 1.2; 95% CI, 1.17-1.22) but underrepresentation of Hispanic (EIR = 0.35; 95% CI, 0.24-0.48) and Black individuals (EIR = 0.66; 95% CI, 0.54-0.79).
“There has been some progress in recent years, as seen in the increasing trend in the representation of minoritized racial and ethnic groups,” Chua told Healio. “However, while improvements have been made, much work remains to ensure that these populations are adequately represented in clinical trials.
“Because of the continuous growth of the number of clinical trials on immune checkpoint inhibitors and other novel therapies, we need to continuously assess representation in more recent trials, including those on newly approved immune checkpoint inhibitors,” he added. “Future research should also focus on identifying barriers to the diverse representation of these groups in all cancer clinical trials — not just immune checkpoint inhibitor clinical trials — that could give insights on how to improve our sampling design and recruitment strategies. Additionally, more studies should explore race/ethnicity-specific responses to immune checkpoint inhibitors to guide personalized cancer care.”
Collapse
Chua AV, et al. JCO Oncol Pract. 2024;doi:10.1200/OP.24.00033.
Click Here to Manage Email Alerts