Racial, ethnic minorities have similar outcomes in phase 1 trials for advanced cancers
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Key takeaways:
- Comparable median OS data occurred among white patients and racial, ethnic minority groups in phase 1 trials.
- Worse prognostic factors included patients aged over 60 years and more than two metastatic sites.
Compared with non-Hispanic white individuals, patients from racial and ethnic minority groups experienced similar clinical benefits when participating in phase 1 trials for advanced cancers, data published in JAMA Network Open showed.
The findings come from a from a meta-analysis of studies conducted at an urban cancer center and indicate similar survival outcomes regardless of race or ethnicity.
“It is believed that the unfair treatment of patients from racial and ethnic minority groups by the U.S. health care system, including the infamous Tuskegee trials and genetic studies among American Indian populations, has led to a lower interest in clinical trial participation,” Sanjay Goel, MD, MS, director of phase 1/investigational therapeutics and professor of medicine in the division of medical oncology and section of solid tumor at Rutgers Robert Wood Johnson Medical School, and researchers wrote. “However, when studied in an objective manner, the results are clear: patients from racial and ethnic minority groups remain open to and interested in learning about the opportunity to partake in trials; it simply needs to be discussed with them as an option during the consultation.”
Background, methodology
Patients from racial and ethnic minority groups, such as individuals with Asian, Hispanic or non-Hispanic Black heritage, have low representation in phase 1 cancer clinical trials, according to background information provided by researchers.
Goel and colleagues used records of trial participants at Montefiore Einstein Cancer Center in Bronx, New York, from January 1999 to December 2016, to determine whether non-Hispanic white patients and racial and ethnic minority patients shared the benefit of enrollment in phase 1 cancer trials.
Data included treatment-related responses, treatment-related toxicities and deaths.
The study included 738 patients (median age, 60 years; 467 women), including 197 Hispanic patients (26.7%), 238 non-Hispanic Black patients (32.2%) and 282 non-Hispanic white patients (38.2%) across 64 phase 1 trials.
Of the trials included, 33 focused on cytotoxic effects (51.5%) and 21 focused on biologics (32.8%), with the remaining 10 being combined therapy trials (15.6%).
Primary cancer diagnoses among patients included colorectal (25.3%), ovarian (19.1%), lung (7.9%), uterine (6.6%) and breast (5.6%). Patients received a median of three therapies (range, 0-13) prior to trial enrollment.
OS, assessed using univariate and multivariate time-to-event analyses, served as the study’s primary outcome measurement.
Results, next steps
Among the 558 patients evaluated for response, researchers observed a clinical benefit rate of 49.1% and an overall response rate of 6.5%.
Grade 3 or 4 nonhematologic toxic effects occurred in 27.8% (95% CI, 24.6-31.3) of patients and grade 3 or 4 hematological toxic effects in 19.7% (95% CI, 17-22.8).
Researchers observed a treatment-related mortality rate of 0.9% (95% CI, 0.4-1.9) and a median OS of 9.6 months (95% CI, 8.2-11) among Hispanic patients, 8.3 months (95% CI, 6.7-10.4) among non-Hispanic Black patients and 9.8 months (95% CI, 8.5-11.4) among non-Hispanic white patients.
Multivariate analysis showed several factors associated with worse outcomes, including age older than 60 years, an ECOG performance status score of at least 2, more than two metastatic sites, lactate dehydrogenase grade 1 or 2, grade 2 or greater low albumin, grade 1 of greater total bilirubin and grade 2 or greater anemia.
However, leukocytosis greater than grade 1 appeared associated with better OS, according to researchers.
Study limitations acknowledged by the researchers included the single-institution scope of the analysis, its 16-year timespan that comes with the burden of heterogeneity of patients, demographics, and the limited number of immunotherapy drug trials represented in the study pool.
“In this meta-analysis, we present the largest multiracial and multiethnic study of phase 1 trials for patients with cancer to our knowledge,” researchers wrote. “We found that enrollment from racial and ethnic minority groups in such trials is feasible, and encouraged, and that the clinical benefits and outcomes are similar for all patients.”
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Goel S, et al. JAMA Netw Open. 2024; doi:10.1001/jamanetworkopen.2024.21485.
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