Long-term add-on therapy (compassionate use) with oral artesunate in patients with metastatic breast cancer after participating in a phase I study (ARTIC M33/2)

Publication type:
Journal article
Metadata:
Autoren
  • Cornelia von Hagens
  • Ingeborg Walter-Sack
  • Maren Goeckenjan
  • Brigitte Storch-Hagenlocher
  • Serkan Sertel
  • Michael Elsasser
  • Bjoern A Remppis
  • Judith Munzinger
  • Lutz Edler
  • Thomas Efferth
  • Andreas Schneeweiss
  • Thomas Strowitzki
Autoren-URL
https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=fis-test-1&SrcAuth=WosAPI&KeyUT=WOS:000460119500014&DestLinkType=FullRecord&DestApp=WOS_CPL
DOI
10.1016/j.phymed.2018.09.178
Externe Identifier
  • Clarivate Analytics Document Solution ID: HN3XW
  • PubMed Identifier: 30668363
ISSN
0944-7113
Zeitschrift
PHYTOMEDICINE
Schlüsselwörter
  • Metastatic breast cancer
  • Artesunate add-on therapy
  • Long-term treatment
  • Compassionate use
  • Safety
  • Anti-malarial drug
Paginierung
140 - 148
Datum der Veröffentlichung
2019
Status
Published
Titel
Long-term add-on therapy (compassionate use) with oral artesunate in patients with metastatic breast cancer after participating in a phase I study (ARTIC M33/2)
Sub types
  • Article
Ausgabe der Zeitschrift
54

Data source: Web of Science (Lite)

Other metadata sources:
Autoren
  • Cornelia von Hagens
  • Ingeborg Walter-Sack
  • Maren Goeckenjan
  • Brigitte Storch-Hagenlocher
  • Serkan Sertel
  • Michael Elsässer
  • Bjoern A Remppis
  • Judith Munzinger
  • Lutz Edler
  • Thomas Efferth
  • Andreas Schneeweiss
  • Thomas Strowitzki
DOI
10.1016/j.phymed.2018.09.178
ISSN
0944-7113
Zeitschrift
Phytomedicine
Sprache
en
Paginierung
140 - 148
Datum der Veröffentlichung
2019
Status
Published
Herausgeber
Elsevier BV
Herausgeber URL
http://dx.doi.org/10.1016/j.phymed.2018.09.178
Datum der Datenerfassung
2019
Titel
Long-term add-on therapy (compassionate use) with oral artesunate in patients with metastatic breast cancer after participating in a phase I study (ARTIC M33/2)
Ausgabe der Zeitschrift
54

Data source: Crossref

Abstract
<h4>Background</h4>The antimalarial artesunate (ART), a semisynthetic derivative of artemisinin from the Chinese herb artemisia annua has remarkable anticancer properties in vitro and in vivo. Its excellent safety profile known from short-term therapy in malaria was confirmed in an open phase I trial (ARTIC M33/2) for dose-finding as add-on therapy for four weeks.<h4>Purpose</h4>Patients with metastatic breast cancer, who had not experienced any clinically relevant adverse events (AE) during participation in ARTIC M33/2, were offered to continue ART as compassionate use (CU). Regular monitoring was continued in order to ensure adequate individual safety and tolerability and to collect information about long-term treatment with ART. Clinically relevant AEs or second progression of disease during ART were reasons for discontinuation of the add-on therapy.<h4>Study design</h4>Compassionate use was offered open-label to participants of ARTIC M33/2.<h4>Methods</h4>Patients continued to take 100, 150 or 200 mg oral ART daily as add-on therapy to their guideline-based oncological therapy. Clinical and laboratory monitoring included audiological and neurological examination, ECG, NTproBNP and reticulocyte determination. Cumulative treatment days and cumulative ART doses encompass both the phase I study as well as the continued add-on treatment period (CU).<h4>Results</h4>Following the 4 ± 1 weeks of the phase I trial, thirteen patients continued the add-on therapy as CU, resulting in a total of 3825 treatment days. In individual patients up to 1115 cumulative treatment days (37 months) and cumulative ART doses up to 167.3 g were reached. A total of 25 AEs grade ≥ 2 at least possibly related to ART long-term add-on therapy were documented, two, six and 17 in dose groups 100, 150 and 200 mg/d ART respectively. Six of these AEs were classified as grade 3, two in patients taking 150 and four in patients on 200 mg/d, none of them being probably or certainly related to ART.<h4>Conclusions</h4>In thirteen patients with metastatic breast cancer up to 200 mg/d long-term oral ART (2.3-4.1 mg/kg BW/d) in up to 1115 cumulative treatment days (37 months) did not result in any major safety concerns.
Addresses
  • Naturopathy and Integrative Medicine, Department of Gynecological Endocrinology and Reproductive Medicine, University Women's Hospital, Heidelberg, Germany. Electronic address: cornelia.von.hagens@med.uni-heidelberg.de.
Autoren
  • Cornelia von Hagens
  • Ingeborg Walter-Sack
  • Maren Goeckenjan
  • Brigitte Storch-Hagenlocher
  • Serkan Sertel
  • Michael Elsässer
  • Bjoern A Remppis
  • Judith Munzinger
  • Lutz Edler
  • Thomas Efferth
  • Andreas Schneeweiss
  • Thomas Strowitzki
DOI
10.1016/j.phymed.2018.09.178
eISSN
1618-095X
Externe Identifier
  • PubMed Identifier: 30668363
Funding acknowledgements
  • Monika-Kutzner-Stiftung: ARTIC M 33/2
  • HEIFAN:
Open access
false
ISSN
0944-7113
Zeitschrift
Phytomedicine : international journal of phytotherapy and phytopharmacology
Schlüsselwörter
  • Liver
  • Humans
  • Breast Neoplasms
  • Creatinine
  • Natriuretic Peptide, Brain
  • Peptide Fragments
  • Treatment Outcome
  • Administration, Oral
  • Adult
  • Aged
  • Middle Aged
  • Female
  • Compassionate Use Trials
  • Artesunate
Sprache
eng
Medium
Print-Electronic
Online publication date
2018
Paginierung
140 - 148
Datum der Veröffentlichung
2019
Status
Published
Datum der Datenerfassung
2019
Titel
Long-term add-on therapy (compassionate use) with oral artesunate in patients with metastatic breast cancer after participating in a phase I study (ARTIC M33/2).
Sub types
  • Clinical Trial, Phase I
  • Journal Article
Ausgabe der Zeitschrift
54

Data source: Europe PubMed Central

Abstract
BACKGROUND: The antimalarial artesunate (ART), a semisynthetic derivative of artemisinin from the Chinese herb artemisia annua has remarkable anticancer properties in vitro and in vivo. Its excellent safety profile known from short-term therapy in malaria was confirmed in an open phase I trial (ARTIC M33/2) for dose-finding as add-on therapy for four weeks. PURPOSE: Patients with metastatic breast cancer, who had not experienced any clinically relevant adverse events (AE) during participation in ARTIC M33/2, were offered to continue ART as compassionate use (CU). Regular monitoring was continued in order to ensure adequate individual safety and tolerability and to collect information about long-term treatment with ART. Clinically relevant AEs or second progression of disease during ART were reasons for discontinuation of the add-on therapy. STUDY DESIGN: Compassionate use was offered open-label to participants of ARTIC M33/2. METHODS: Patients continued to take 100, 150 or 200 mg oral ART daily as add-on therapy to their guideline-based oncological therapy. Clinical and laboratory monitoring included audiological and neurological examination, ECG, NTproBNP and reticulocyte determination. Cumulative treatment days and cumulative ART doses encompass both the phase I study as well as the continued add-on treatment period (CU). RESULTS: Following the 4 ± 1 weeks of the phase I trial, thirteen patients continued the add-on therapy as CU, resulting in a total of 3825 treatment days. In individual patients up to 1115 cumulative treatment days (37 months) and cumulative ART doses up to 167.3 g were reached. A total of 25 AEs grade ≥ 2 at least possibly related to ART long-term add-on therapy were documented, two, six and 17 in dose groups 100, 150 and 200 mg/d ART respectively. Six of these AEs were classified as grade 3, two in patients taking 150 and four in patients on 200 mg/d, none of them being probably or certainly related to ART. CONCLUSIONS: In thirteen patients with metastatic breast cancer up to 200 mg/d long-term oral ART (2.3-4.1 mg/kg BW/d) in up to 1115 cumulative treatment days (37 months) did not result in any major safety concerns.
Date of acceptance
2018
Autoren
  • Cornelia von Hagens
  • Ingeborg Walter-Sack
  • Maren Goeckenjan
  • Brigitte Storch-Hagenlocher
  • Serkan Sertel
  • Michael Elsässer
  • Bjoern A Remppis
  • Judith Munzinger
  • Lutz Edler
  • Thomas Efferth
  • Andreas Schneeweiss
  • Thomas Strowitzki
Autoren-URL
https://www.ncbi.nlm.nih.gov/pubmed/30668363
DOI
10.1016/j.phymed.2018.09.178
eISSN
1618-095X
Zeitschrift
Phytomedicine
Schlüsselwörter
  • Anti-malarial drug
  • Artesunate add-on therapy
  • Compassionate use
  • Long-term treatment
  • Metastatic breast cancer
  • Safety
  • Administration, Oral
  • Adult
  • Aged
  • Artesunate
  • Breast Neoplasms
  • Compassionate Use Trials
  • Creatinine
  • Female
  • Humans
  • Liver
  • Middle Aged
  • Natriuretic Peptide, Brain
  • Peptide Fragments
  • Treatment Outcome
Sprache
eng
Country
Germany
Paginierung
140 - 148
PII
S0944-7113(18)30458-6
Datum der Veröffentlichung
2019
Status
Published
Datum, an dem der Datensatz öffentlich gemacht wurde
2019
Titel
Long-term add-on therapy (compassionate use) with oral artesunate in patients with metastatic breast cancer after participating in a phase I study (ARTIC M33/2).
Sub types
  • Clinical Trial, Phase I
  • Journal Article
Ausgabe der Zeitschrift
54

Data source: PubMed

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