Article Publish Status: FREE
Abstract Title:

A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer.

Abstract Source:

EBioMedicine. 2015 Jan ;2(1):82-90. Epub 2014 Nov 15. PMID: 26137537

Abstract Author(s):

Sanjeev Krishna, Senthil Ganapathi, Irina Chis Ster, Mohamed E M Saeed, Matt Cowan, Caroline Finlayson, Hajnalka Kovacsevics, Herwig Jansen, Peter G Kremsner, Thomas Efferth, Devinder Kumar

Article Affiliation:

Sanjeev Krishna


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.

Study Type : Human Study

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