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A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer
Sanjeev Krishna1, Senthil Ganapathi2, Irina Chis Ster1
1Institute of Infection and Immunity, Department of Pathology, United Kingdom.
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.
Insights
Artesunate demonstrated anti-proliferative effects in colorectal cancer (CRC) patients, showing potential for reduced recurrence. This study suggests artesunate is a well-tolerated option for CRC treatment.
Area of Science:
- Oncology
- Pharmacology
Background:
- Artesunate, an antimalarial, exhibits anti-cancer properties in preclinical studies.
- Rigorous clinical trials on artesunate's anticancer effects are limited.
Purpose of the Study:
- To evaluate the anticancer efficacy and tolerability of oral artesunate in colorectal cancer (CRC) patients.
- To assess artesunate's impact on tumor cell apoptosis and key molecular markers.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 23 CRC patients undergoing curative resection.
- Patients received either oral artesunate (200 mg daily for 14 days) or placebo preoperatively.
- Primary endpoint: tumor cell apoptosis rate; secondary endpoints: tumor markers (VEGF, EGFR, c-MYC, CD31, Ki67, p53) and clinical response.
Main Results:
- Artesunate treatment showed a trend towards increased apoptosis (67% vs. 55% in placebo).
- Bayesian analysis indicated a high probability of artesunate reducing Ki67 expression (0.89) and increasing CD31 expression (0.79).
- Over 42 months median follow-up, only 1 patient in the artesunate group experienced CRC recurrence compared to 6 in the placebo group.
Conclusions:
- Artesunate exhibits anti-proliferative properties in colorectal cancer.
- The drug was generally well-tolerated in the study population.
- Artesunate shows promise in reducing CRC recurrence and warrants further investigation.
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