Investigation of ototoxicity of artesunate as add-on therapy in patients with metastatic or locally advanced breast cancer: new audiological results from a prospective, open, uncontrolled, monocentric phase I study

Cancer Chemotherapy and Pharmacology
Miriam KönigSerkan Sertel

Abstract

Artesunate (ART) has been used for a long time in the treatment of Plasmodium falciparum malaria and has been considered safe. The present phase I study aimed to determine the daily dose of ART that is well tolerated as add-on therapy in patients with breast cancer for 4 weeks of therapy. Ototoxicity could be a potential safety concern in settings different from malaria. Therefore, comprehensive audiological assessment was essential. The ARTIC M33/2 study was a prospective, open, uncontrolled, monocentric phase I dose-escalation study to evaluate the safety and tolerability of ART in patients with advanced breast cancer. Patients received either 100, 150 or 200 mg oral ART daily for a test phase of 4 weeks as add-on therapy to their ongoing oncological treatment. For the investigation of the safety of ART for hearing, an audiological assessment was performed with each patient before the intake of ART and after 4 weeks of therapy. Twenty-three female patients were included in the study. During the test phase, four patients had adverse events (AEs) of the auditory system possibly related to the intake of ART. However, none of these AEs was classified as severe AE (SAE) and did not require treatment interruption. Four patients had...Continue Reading

Associated Clinical Trials

Oct 1, 2008·Cornelia von Hagens

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Sep 12, 2016·Tumour Biology : the Journal of the International Society for Oncodevelopmental Biology and Medicine·Manoj KumarD K Dhawan
Mar 3, 2018·Medical Sciences : Open Access Journal·Enrique Konstat-KorzennyRosalino Vázquez-López
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Jul 1, 2021·Drug Design, Development and Therapy·Haoyang HuangXuerong Li

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