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)

Publication type:
Journal article
Metadata:
Autoren
  • Cornelia von Hagens
  • Ingeborg Walter-Sack
  • Maren Goeckenjan
  • Julia Osburg
  • Brigitte Storch-Hagenlocher
  • Serkan Sertel
  • Michael Elsaesser
  • Bjoern Andrew Remppis
  • Lutz Edler
  • Judith Munzinger
  • Thomas Efferth
  • Andreas Schneeweiss
  • Thomas Strowitzki
Autoren-URL
https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=fis-test-1&SrcAuth=WosAPI&KeyUT=WOS:000404162400010&DestLinkType=FullRecord&DestApp=WOS_CPL
DOI
10.1007/s10549-017-4261-1
eISSN
1573-7217
Externe Identifier
  • Clarivate Analytics Document Solution ID: EY7ID
  • PubMed Identifier: 28439738
ISSN
0167-6806
Ausgabe der Veröffentlichung
2
Zeitschrift
BREAST CANCER RESEARCH AND TREATMENT
Schlüsselwörter
  • Artesunate
  • Metastatic breast cancer
  • Phase 1 clinical trial
  • Safety
  • Antimalarial
Paginierung
359 - 369
Datum der Veröffentlichung
2017
Status
Published
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)
Sub types
  • Article
Ausgabe der Zeitschrift
164

Data source: Web of Science (Lite)

Other metadata sources:
Autoren
  • 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
DOI
10.1007/s10549-017-4261-1
eISSN
1573-7217
ISSN
0167-6806
Ausgabe der Veröffentlichung
2
Zeitschrift
Breast Cancer Research and Treatment
Sprache
en
Online publication date
2017
Paginierung
359 - 369
Datum der Veröffentlichung
2017
Status
Published
Herausgeber
Springer Science and Business Media LLC
Herausgeber URL
http://dx.doi.org/10.1007/s10549-017-4261-1
Datum der Datenerfassung
2017
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)
Ausgabe der Zeitschrift
164

Data source: Crossref

Abstract
<h4>Purpose</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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).<h4>Conclusions</h4>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.
Addresses
  • Naturopathy and Integrative Medicine, Department of Gynecological Endocrinology and Reproductive Medicine, University Women's Hospital Heidelberg, Im Neuenheimer Feld 440, 69120, Heidelberg, Germany. cornelia.von.hagens@med.uni-heidelberg.de.
Autoren
  • 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
  • Thomas Efferth
  • Andreas Schneeweiss
  • Thomas Strowitzki
DOI
10.1007/s10549-017-4261-1
eISSN
1573-7217
Externe Identifier
  • PubMed Identifier: 28439738
Funding acknowledgements
  • HEIFAN (Heidelberger Förderverein der Ambulanz für Naturheilkunde) e.V., Heidelberg, Germany: Annual Allowance Grants for Staff 2008-2013
  • Dafra Pharma, Turnhout, Belgium: Study medication
  • Monika Kutzner Stiftung, Berlin, Germany: Grant from August 25th, 2009
  • H.W. &amp; J. Hector Stiftung, Weinheim, Germany: M33/2
Open access
false
ISSN
0167-6806
Ausgabe der Veröffentlichung
2
Zeitschrift
Breast cancer research and treatment
Schlüsselwörter
  • Humans
  • Breast Neoplasms
  • Neoplasm Metastasis
  • Artemisinins
  • Antineoplastic Agents, Hormonal
  • Antineoplastic Combined Chemotherapy Protocols
  • Treatment Outcome
  • Drug Administration Schedule
  • Prospective Studies
  • Maximum Tolerated Dose
  • Adult
  • Aged
  • Middle Aged
  • Female
  • Artesunate
Sprache
eng
Medium
Print-Electronic
Online publication date
2017
Paginierung
359 - 369
Datum der Veröffentlichung
2017
Status
Published
Datum der Datenerfassung
2017
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).
Sub types
  • Clinical Trial, Phase I
  • Journal Article
Ausgabe der Zeitschrift
164

Data source: Europe PubMed Central

Abstract
PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
Date of acceptance
2017
Autoren
  • 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
Autoren-URL
https://www.ncbi.nlm.nih.gov/pubmed/28439738
DOI
10.1007/s10549-017-4261-1
eISSN
1573-7217
Ausgabe der Veröffentlichung
2
Zeitschrift
Breast Cancer Res Treat
Schlüsselwörter
  • Antimalarial
  • Artesunate
  • Metastatic breast cancer
  • Phase 1 clinical trial
  • Safety
  • Adult
  • Aged
  • Antineoplastic Agents, Hormonal
  • Antineoplastic Combined Chemotherapy Protocols
  • Artemisinins
  • Artesunate
  • Breast Neoplasms
  • Drug Administration Schedule
  • Female
  • Humans
  • Maximum Tolerated Dose
  • Middle Aged
  • Neoplasm Metastasis
  • Prospective Studies
  • Treatment Outcome
Sprache
eng
Country
Netherlands
Paginierung
359 - 369
PII
10.1007/s10549-017-4261-1
Datum der Veröffentlichung
2017
Status
Published
Datum, an dem der Datensatz öffentlich gemacht wurde
2018
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).
Sub types
  • Clinical Trial, Phase I
  • Journal Article
Ausgabe der Zeitschrift
164

Data source: PubMed

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