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| Verfasst von: | Hagens, Cornelia von [VerfasserIn]  |
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| | Walter-Sack, Ingeborg [VerfasserIn] |
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| | Goeckenjan, Maren [VerfasserIn] |
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| | Osburg, Julia [VerfasserIn] |
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| | Storch-Hagenlocher, Brigitte [VerfasserIn] |
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| | Sertel, Serkan [VerfasserIn] |
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| | Elsässer, Michael [VerfasserIn] |
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| | Remppis, Bjoern-Andrew [VerfasserIn] |
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| | Edler, Lutz [VerfasserIn] |
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| | Munzinger, Judith [VerfasserIn] |
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| | Schneeweiss, Andreas [VerfasserIn] |
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| | Strowitzki, Thomas [VerfasserIn] |
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| Titel: | 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) |
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| Verf.angabe: | 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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| E-Jahr: | 2017 |
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| Jahr: | 24 April 2017 |
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| Umfang: | 11 S. |
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| Illustrationen: | Illustrationen |
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| Fussnoten: | Gesehen am 26.07.2018 |
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| Titel Quelle: | Enthalten in: Breast cancer research and treatment |
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| Ort Quelle: | Dordrecht [u.a.] : Springer Science + Business Media B.V., 1981 |
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| Jahr Quelle: | 2017 |
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| Band/Heft Quelle: | 164(2017), 2, Seite 359-369 |
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| ISSN Quelle: | 1573-7217 |
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| Abstract: | 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. |
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| DOI: | doi:10.1007/s10549-017-4261-1 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
Volltext: http://dx.doi.org/10.1007/s10549-017-4261-1 |
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| | Volltext: https://link.springer.com/article/10.1007/s10549-017-4261-1 |
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| | DOI: https://doi.org/10.1007/s10549-017-4261-1 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| K10plus-PPN: | 1577960726 |
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| Verknüpfungen: | → Zeitschrift |
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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) / Hagens, Cornelia von [VerfasserIn]; 24 April 2017 (Online-Ressource)
