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000124441 0247_ $$2doi$$a10.1007/s10549-017-4261-1
000124441 0247_ $$2pmid$$apmid:28439738
000124441 0247_ $$2ISSN$$a0167-6806
000124441 0247_ $$2ISSN$$a1573-7217
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000124441 037__ $$aDKFZ-2017-01318
000124441 041__ $$aeng
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000124441 1001_ $$00000-0001-8259-4946$$avon Hagens, Cornelia$$b0
000124441 245__ $$aProspective 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).
000124441 260__ $$aDordrecht [u.a.]$$bSpringer Science + Business Media B.V.$$c2017
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000124441 520__ $$aThe 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.Patients 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.Twenty-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).Up 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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000124441 7001_ $$aWalter-Sack, Ingeborg$$b1
000124441 7001_ $$aGoeckenjan, Maren$$b2
000124441 7001_ $$aOsburg, Julia$$b3
000124441 7001_ $$aStorch-Hagenlocher, Brigitte$$b4
000124441 7001_ $$aSertel, Serkan$$b5
000124441 7001_ $$aElsässer, Michael$$b6
000124441 7001_ $$aRemppis, Bjoern Andrew$$b7
000124441 7001_ $$0P:(DE-He78)621efe295db6fdfa7f9f95011a5ea943$$aEdler, Lutz$$b8$$udkfz
000124441 7001_ $$aMunzinger, Judith$$b9
000124441 7001_ $$aEfferth, Thomas$$b10
000124441 7001_ $$aSchneeweiss, Andreas$$b11
000124441 7001_ $$aStrowitzki, Thomas$$b12
000124441 773__ $$0PERI:(DE-600)2004077-5$$a10.1007/s10549-017-4261-1$$gVol. 164, no. 2, p. 359 - 369$$n2$$p359 - 369$$tBreast cancer research and treatment$$v164$$x1573-7217$$y2017
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