A first-in-human proof-of-concept trial of intravaginal artesunate to treat cervical intraepithelial neoplasia 2/3 (CIN2/3)
Gynecologic Oncology Feb 03, 2020
Trimble CL, Levinson K, Maldonado L, et al. - In order to determine the safety as well as the efficacy of self-administered artesunate vaginal inserts in biopsy-proven cervical intraepithelial neoplasia 2/3 (CIN2/3), researchers undertook this first-in-human Phase I dose-escalation study. At study weeks 0, 2, and 4, overall 28 patients underwent 1, 2, or 3 five-day treatment cycles, respectively, before a planned, standard-of-care resection at study week 15. Mild, and self-limited adverse events were documented. Overall 19/28 (67.9%) participants showed histologic regression in the modified intention-to-treat analysis. In 9 of the 19 (47.4%) patients whose lesions underwent histologic regression, clearance of HPV genotypes detected at baseline was reported. Findings revealed the safety as well as the good tolerability of self-administered vaginal artesunate inserts at clinically effective doses to treat CIN2/3.
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