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024 7 _ |a 10.1007/s10549-017-4261-1
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024 7 _ |a pmid:28439738
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024 7 _ |a 0167-6806
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024 7 _ |a 1573-7217
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037 _ _ |a DKFZ-2017-01318
041 _ _ |a eng
082 _ _ |a 610
100 1 _ |a von Hagens, Cornelia
|0 0000-0001-8259-4946
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245 _ _ |a 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).
260 _ _ |a Dordrecht [u.a.]
|c 2017
|b Springer Science + Business Media B.V.
336 7 _ |a article
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336 7 _ |a Journal Article
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336 7 _ |a ARTICLE
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520 _ _ |a The 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.
536 _ _ |a 313 - Cancer risk factors and prevention (POF3-313)
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700 1 _ |a Walter-Sack, Ingeborg
|b 1
700 1 _ |a Goeckenjan, Maren
|b 2
700 1 _ |a Osburg, Julia
|b 3
700 1 _ |a Storch-Hagenlocher, Brigitte
|b 4
700 1 _ |a Sertel, Serkan
|b 5
700 1 _ |a Elsässer, Michael
|b 6
700 1 _ |a Remppis, Bjoern Andrew
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700 1 _ |a Edler, Lutz
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700 1 _ |a Munzinger, Judith
|b 9
700 1 _ |a Efferth, Thomas
|b 10
700 1 _ |a Schneeweiss, Andreas
|b 11
700 1 _ |a Strowitzki, Thomas
|b 12
773 _ _ |a 10.1007/s10549-017-4261-1
|g Vol. 164, no. 2, p. 359 - 369
|0 PERI:(DE-600)2004077-5
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|p 359 - 369
|t Breast cancer research and treatment
|v 164
|y 2017
|x 1573-7217
909 C O |o oai:inrepo02.dkfz.de:124441
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910 1 _ |a Deutsches Krebsforschungszentrum
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914 1 _ |y 2017
915 _ _ |a Nationallizenz
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