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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer
EBioMedicine, Volume 2, No. 1, Year 2015
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Description
Background: Artesunate is an antimalarial agent with broad anti-cancer activity in in vitro and animal experiments and case reports. Artesunate has not been studied in rigorous clinical trials for anticancer effects. Aim: To determine the anticancer effect and tolerability of oral artesunate in colorectal cancer (CRC). Methods: This was a single centre, randomised, double-blind, placebo-controlled trial. Patients planned for curative resection of biopsy confirmed single primary site CRC were randomised (n. =. 23) by computer-generated code supplied in opaque envelopes to receive preoperatively either 14 daily doses of oral artesunate (200. mg; n. =. 12) or placebo (n. =. 11). The primary outcome measure was the proportion of tumour cells undergoing apoptosis (significant if >. 7% showed Tunel staining). Secondary immunohistochemical outcomes assessed these tumour markers: VEGF, EGFR, c-MYC, CD31, Ki67 and p53, and clinical responses. Findings: 20 patients (artesunate. =. 9, placebo. =. 11) completed the trial per protocol. Randomization groups were comparable clinically and for tumour characteristics. Apoptosis in >. 7% of cells was seen in 67% and 55% of patients in artesunate and placebo groups, respectively. Using Bayesian analysis, the probabilities of an artesunate treatment effect reducing Ki67 and increasing CD31 expression were 0.89 and 0.79, respectively. During a median follow up of 42. months 1 patient in the artesunate and 6 patients in the placebo group developed recurrent CRC. Interpretation: Artesunate has anti-proliferative properties in CRC and is generally well tolerated. © 2014.
Available Materials
https://efashare.b-cdn.net/share/pmc/articles/PMC4484515/bin/mmc1.docx
https://efashare.b-cdn.net/share/pmc/articles/PMC4484515/bin/mmc2.doc
Authors & Co-Authors
Krishna, Prof Sanjeev
Unknown Affiliation
Saeed, Mohamed E.M.
Germany, Mainz
Johannes Gutenberg-universität Mainz
Jansen, Herwig F.
Belgium, Turnhout
Dafra Pharma nv
Kremsner, Peter G.
Germany, Tubingen
Universitätsklinikum Und Medizinische Fakultät Tübingen
Efferth, Thomas H.
Germany, Mainz
Johannes Gutenberg-universität Mainz
Statistics
Citations: 149
Authors: 5
Affiliations: 5
Identifiers
Doi:
10.1016/j.ebiom.2014.11.010
ISSN:
23523964
Research Areas
Cancer
Disability
Health System And Policy
Study Design
Randomised Control Trial
Quasi Experimental Study