A RECENT study showed that racial and ethnic minority groups, particularly Asian, Hispanic, and non-Hispanic Black patients, have historically been underrepresented in clinical trials, including phase I cancer trials. These trials offer crucial treatment options for patients with advanced cancer who have exhausted standard therapies. Understanding the benefits of these trials for minority groups compared to non-Hispanic White patients is vital for equitable healthcare. The study aimed to determine if the benefits of phase I cancer trial enrolment are comparable among racial and ethnic minority patients.
Researchers reviewed patient records from January 1999 to December 2016 at a single institution. The study included all phase I trials conducted during this period. Data on treatment responses, toxic effects, and patient outcomes were independently extracted following PRISMA guidelines. Data from 738 patients was analysed (median age 60 years; 63.3% female), including 197 Hispanic (26.7%), 238 non-Hispanic Black (32.2%), and 282 non-Hispanic White patients (38.2%). Patients participated in 64 phase I trials, categorised into cytotoxic (51.5%), biologic (32.8%), and combined therapy trials (15.6%). The primary cancers included colorectal (25.3%), ovarian (19.1%), lung (7.9%), uterine (6.6%), and breast (5.6%). The patients had undergone a median of three therapies before trial enrolment.
Results showed that in 558 patients, the clinical benefit rate (stable disease plus response rates) was 49.1%, with an overall response rate of 6.5%. In terms of toxic effects, grade three or four nonhematological toxic effects were seen in 27.8% of patients, while grade three or four hematological toxic effects occurred in 19.7%. The treatment-related mortality rate was 0.9%. The median overall survival was 9.6 months for Hispanic patients, 8.3 months for non-Hispanic Black patients, and 9.8 months for non-Hispanic White patients, with no significant difference (P=0.13). Factors associated with a worse prognosis included age (over 60), poor performance status, multiple metastatic sites, and certain laboratory abnormalities. However, leukocytosis was shown to be associated with better overall survival.
Overall, this study showed that Hispanic and non-Hispanic Black patients enrolled in phase I cancer trials experienced similar benefits to non-Hispanic White patients. These findings highlight the importance of inclusive clinical trials to ensure that all patients, regardless of racial or ethnic background, have access to potentially beneficial treatments.
Aleksandra Zurowska, EMJ
Reference:
Goel S et al. Outcomes Among Racial and Ethnic Minority Patients With Advanced Cancers in Phase 1 Trials: A Meta-Analysis. JAMA Netw Open. 2024;7(7):e2421485.
