424 Health disparities in clinical trials for mycosis fungoides/Sézary syndrome: A systematic review

Abstract

Despite the growing evidence of health disparities in cancer clinical trials, there is a dearth of similar research in clinical trials for mycosis fungoides (MF)/Sézary syndrome (SS). We sought to determine whether participants in clinical trials for MF/SS would differ demographically, either by age, gender, or race, compared to the United States (US) population of MF/SS patients. Per the Surveillance, Epidemiology and End Results (SEER) database, the incidence of MF/SS in the US is highest between ages 70-79. Incidence is also higher in males, with a male: female (M:F) ratio of 1.57, and in black patients, with a black: white (B:W) ratio of 1.55. A systematic review was performed of all studies in MEDLINE via PubMed, EMBASE, Scopus, and Cochrane Controlled Register of Trials of phase II, III, and IV clinical trials for MF/SS in the US from 1984 – 2020. Two reviewers performed title/abstract review and data extraction. Forty studies met inclusion criteria, comprising 1,496 participants with a median age of 61. There were 839 (56%) males and 632 (42%) females, with a M:F of 1.32. All trials included participants' age, 39 (98%) included gender, but only 26 (63%) included race. There was no significant difference in the reporting of race between articles published before and after 2000 (p=0.07) when calculated using chi-square. In trials in which race was specified, there were 205 (21%) black and 863 (77%) white participants, with a B:W ratio of 0.23. In a sub-analysis of clinical trials that led to FDA-approved medications, eight trials qualified. The median age of participants was 61. The M:F ratio was 1.1. Of the six (75%) trials that included data on race, the B:W ratio was 0.1. In conclusion, although the gender of MF/SS patients is adequately exemplified in clinical trials, there is a discrepancy in age, with trials favoring younger patients. More prominently, there remains a great disparity in race, particularly among black patients. The limited reporting of race in clinical trials highlights the need to specify racial backgrounds to ensure equitable representation.