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Prospective open uncontrolled phase I study to define a well-tolerated dose of oral artesunate as add-on therapy in patients with metastatic breast cancer (ARTIC M33/2)

PurposeThe antimalarial drug artesunate (ART) is a promising candidate for cancer treatment as it displays anticancer effects in various models. While in short-term treatment of malaria, an excellent safety profile has been found for ART, the potential long-term treatment of cancer patients demands...

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Main Authors: Hagens, Cornelia von (Author) , Walter-Sack, Ingeborg (Author) , Goeckenjan, Maren (Author) , Osburg, Julia (Author) , Storch-Hagenlocher, Brigitte (Author) , Sertel, Serkan (Author) , Elsässer, Michael (Author) , Remppis, Bjoern-Andrew (Author) , Edler, Lutz (Author) , Munzinger, Judith (Author) , Schneeweiss, Andreas (Author) , Strowitzki, Thomas (Author)
Format: Article (Journal)
Language:English
Published: 24 April 2017
In: Breast cancer research and treatment
Year: 2017, Volume: 164, Issue: 2, Pages: 359-369
ISSN:1573-7217
DOI:10.1007/s10549-017-4261-1
Online Access:Verlag, Volltext: http://dx.doi.org/10.1007/s10549-017-4261-1
Verlag, Volltext: https://link.springer.com/article/10.1007/s10549-017-4261-1
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Author Notes:Cornelia von Hagens, Ingeborg Walter-Sack, Maren Goeckenjan, Julia Osburg, Brigitte Storch-Hagenlocher, Serkan Sertel, Michael Elsässer, Bjoern Andrew Remppis, Lutz Edler, Judith Munzinger, Thomas Efferth, Andreas Schneeweiss, Thomas Strowitzki
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Summary:PurposeThe antimalarial drug artesunate (ART) is a promising candidate for cancer treatment as it displays anticancer effects in various models. While in short-term treatment of malaria, an excellent safety profile has been found for ART, the potential long-term treatment of cancer patients demands a phase I dose-finding clinical trial determining the daily ART dose which would be well tolerated as add-on therapy.MethodsPatients with metastatic breast cancer were to receive either 100 or 150 or 200 mg oral ART daily as add-on to their guideline-based oncological therapy for a study period of four weeks with frequent clinical and laboratory monitoring until 4-8 weeks thereafter. According to the statistical design, recruitment was scheduled in groups of three patients in order not to miss a more than 33% frequency of dose-limiting adverse events (DL-AE) prior to dose escalation.ResultsTwenty-three patients were recruited, and all planned dose levels were applied. During the actual trial period of 4 ± 1 weeks, three patients experienced six DL-AEs altogether (leucopenia, neutropenia, asthenia, anemia) possibly related to ART (not exceeding 33% in any dose level).ConclusionsUp to 200 mg/d (2.2-3.9 mg/kg/d) oral ART were safe and well tolerated; therefore, 200 mg/d are recommended for phase II/III trials. Safety monitoring should include reticulocytes, NTproBNP, as well as audiological and neurological exploration.
Item Description:Gesehen am 26.07.2018
Physical Description:Online Resource
ISSN:1573-7217
DOI:10.1007/s10549-017-4261-1

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