Abstract
BackgroundUterine fibroids are common among women at the reproductive age. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a novel and a conservative treatment for symptomatic cases. The aim of the study was to evaluate the efficacy of MRgFUS in African-American (AA) women compared with that in non-African-Americans (non-AA).MethodsA single-armed phase IV study was conducted to establish the efficacy of treatment in AA women. Comparison of patient, fibroid, and treatment characteristics from this trial was compared with that of the previously published phase III trial. Both studies were approved by the IRB of each medical center.ResultsSixty-three AA and 59 non-AA women were treated with MRgFUS. Although AA women had a different pattern of disease, outcomes were similar in both groups. AA patients had a significant higher total number of fibroids compared with non-AA (median 6.0, interquartile range (IQR) 3.0–10.0 vs. 2.0, IQR 1.0–4.0, respectively, p < 0.001), although their total fibroid volume was significantly smaller (median 196.9 cm3, IQR 112.8–415.3 cm3 vs. 394.8 cm3, IQR 189.8–674.4 cm3, respectively, p < 0.001). AA women were younger compared with non-AA (mean ± SD 43.4 ± 5.1 vs. 46.3 ± 4.1 years of age, respectively, p = 0.001) when they presented for treatment. The rate of alternative treatments as well as fibroid-associated symptoms at follow-up time points (3, 6, 12, 24, and 36 months, period following MRgFUS treatment) did not differ according to race (p ≥ 0.62).ConclusionDespite differences in the pattern of fibroid disease, MRgFUS for uterine fibroids has a similar efficacy for AA women compared with non-AA women.
Highlights
Uterine fibroids are common among women at the reproductive age
Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a Food and Drug Administration (FDA)approved therapy for uterine leiomyomas that has been demonstrated in multiple reports to result in sustained treatment efficacy [14,15,16,17,18,19,20]
A secondary goal was to compare the pattern of fibroids in AA women enrolled in this study to that in other women enrolled in a previous clinical trial of MRgFUS that had the same enrollment criteria [21]
Summary
Uterine fibroids are common among women at the reproductive age. Magnetic resonance-guided focused ultrasound surgery (MRgFUS) is a novel and a conservative treatment for symptomatic cases. The aim of the study was to evaluate the efficacy of MRgFUS in African-American (AA) women compared with that in non-African-Americans (non-AA). Genetic and biologic differences and differential growth rates may contribute to this racial disparity [9,10,11,12] Despite this disparity, most studies of fibroid treatment have not reported the racial composition of enrolled participants, and studies that do report race often have few AA women [13]. Cohorts studied with this treatment were largely non-AA In light of this reality, the primary purposes of this report were to evaluate the efficacy of MRgFUS in AA women relative to non-AA women and to determine the risk of adverse effects in the AA population. A secondary goal was to compare the pattern of fibroids in AA women enrolled in this study to that in other women enrolled in a previous clinical trial of MRgFUS that had the same enrollment criteria [21]
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