A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer.
A Randomised, Double Blind, Placebo-Controlled Pilot Study of Oral Artesunate Therapy for Colorectal Cancer.
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DOI：
10.1016/j.ebiom.2014.11.010
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发表时间：
2015-01
期刊：
影响因子：
11.1
通讯作者：
Kumar, Devinder
中科院分区：
文献类型：
--
作者：
Krishna, Sanjeev;Ganapathi, Senthil;Ster, Irina Chis;Saeed, Mohamed E. M.;Cowan, Matt;Finlayson, Caroline;Kovacsevics, Hajnalka;Jansen, Herwig;Kremsner, Peter G.;Efferth, Thomas;Kumar, Devinder
青蒿琥酯是一种抗疟药，在体外和动物实验及病例报告中具有广泛的抗癌活性。青蒿琥酯的抗癌效果还没有经过严格的临床试验研究。目的：探讨口服青蒿琥酯在结直肠癌（CRC）中的抗癌作用及耐受性。这是一项单中心、随机、双盲、安慰剂对照试验。计划对活检证实的单原发部位结直肠癌进行根治性切除的患者随机分组（n = 23），术前接受每日14剂量口服青蒿琥酯（200mg; n = 12）或安慰剂（n = 11）。主要结局指标是发生凋亡的肿瘤细胞的比例（如果> %显示Tunel染色，则显着）。次级免疫组化结果评估了这些肿瘤标志物：VEGF、EGFR、c-MYC、CD31、Ki67和p53，以及临床反应。20名患者（青蒿琥酯= 9，安慰剂= 11）完成了每个方案的试验。随机分组在临床和肿瘤特征方面具有可比性。在青蒿琥酯组和安慰剂组中，分别有67%和55%的患者出现bb7%的细胞凋亡。使用贝叶斯分析，青蒿琥酯治疗效果降低Ki67和增加CD31表达的概率分别为0.89和0.79。在42个月的中位随访期间，青蒿琥酯组1例患者和安慰剂组6例患者出现复发性结直肠癌。青蒿琥酯在结直肠癌中具有抗增殖特性，通常耐受性良好。青蒿琥酯是一种廉价、可口服、广泛使用的抗疟疾药物，在体外模型中具有抗癌特性。在手术切除肿瘤之前，对患者进行了青蒿琥酯对结直肠癌的影响进行了测试
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. To determine the anticancer effect and tolerability of oral artesunate in colorectal cancer (CRC). 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. 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. Artesunate has anti-proliferative properties in CRC and is generally well tolerated. Artesunate is a cheap and orally available, widely used antimalarial drug that has anticancer properties in in vitro models Tested the effects of artesunate on colorectal cancer in patients before they have had surgery to remove the tumour Results from this pilot study are promising and support further studies to explore anticancer effects of artemisinins
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影响因子：
4.7
作者：
Breuer E;Efferth T
通讯作者：
Efferth T
影响因子：
11.8
作者：
Bethell, Delia;Se, Youry;Fukuda, Mark M.
通讯作者：
Fukuda, Mark M.
影响因子：
168.9
作者：
Gomes, M. F.;Faiz, M. A.;Gyapong, J. O.;Warsame, M.;Agbenyega, T.;Babiker, A.;Baiden, F.;Yunus, E. B.;Binka, F.;Clerk, C.;Folb, P.;Hassan, R.;Hossain, M. A.;Kimbute, O.;Kitua, A.;Krishna, S.;Makasi, C.;Mensah, N.;Mrango, Z.;Olliaro, P.;Peto, R.;Peto, T. J.;Rahman, M. R.;Ribeiro, I.;Samad, R.;White, N. J.
通讯作者：
White, N. J.
影响因子：
5.8
作者：
Efferth, T;Ramirez, T;Halatsch, ME
通讯作者：
Halatsch, ME
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作者：
Bendardaf, R;Ristamäki, R;Pyrhönen, S
通讯作者：
Pyrhönen, S