ADD-ASPIRIN: A phase III, double-blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours.
ADD-ASPIRIN: A phase III, double-blind, placebo controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours.
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DOI：
10.1016/j.cct.2016.10.004
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发表时间：
2016-11
影响因子：
2.2
通讯作者：
Add-Aspirin investigators
中科院分区：
文献类型：
--
作者：
Coyle C;Cafferty FH;Rowley S;MacKenzie M;Berkman L;Gupta S;Pramesh CS;Gilbert D;Kynaston H;Cameron D;Wilson RH;Ring A;Langley RE;Add-Aspirin investigators
有相当多的临床前、流行病学和随机数据支持阿司匹林有可能成为一种有效的癌症辅助治疗的假设。ADD-Aspirin是一项第三阶段、多中心、双盲、安慰剂对照的随机试验，有四个平行队列。接受过乳腺癌(n=3100)、结直肠(n=2600)、胃食道(n=2100)或前列腺癌(n=2120)潜在治疗的患者被登记到四个肿瘤特异性队列中。所有队列都在英国招聘，乳房和胃食道队列也在印度招聘。符合条件的参与者首先进行积极的磨合期，在大约8周的时间里，每天服用100毫克阿司匹林。能够坚持和耐受阿司匹林的参与者然后接受双盲随机试验，并按1：1：1的比例被分配到每天服用100毫克阿司匹林、300毫克阿司匹林或匹配的安慰剂，至少五年。那些75岁的参与者≥只随机服用100%毫克的阿司匹林或安慰剂，因为毒性风险增加。主要结果是乳房队列的侵袭性无病生存率、结直肠队列的无病生存率、胃-食道队列的总体生存率和前列腺队列的生化无复发生存率，所有队列的总体生存率是共同的主要结果。次要结果包括依从性、毒性，包括严重出血、心血管事件和一些队列特异性措施。ADD-Aspirin试验调查了在标准治疗后定期使用阿司匹林是否可以防止复发并延长患有四种非转移性常见实体肿瘤的参与者的生存时间。
There is a considerable body of pre-clinical, epidemiological and randomised data to support the hypothesis that aspirin has the potential to be an effective adjuvant cancer therapy. Add-Aspirin is a phase III, multi-centre, double-blind, placebo-controlled randomised trial with four parallel cohorts. Patients who have undergone potentially curative treatment for breast (n = 3100), colorectal (n = 2600), gastro-oesophageal (n = 2100) or prostate cancer (n = 2120) are registered into four tumour specific cohorts. All cohorts recruit in the United Kingdom, with the breast and gastro-oesophageal cohort also recruiting in India. Eligible participants first undertake an active run-in period where 100 mg aspirin is taken daily for approximately eight weeks. Participants who are able to adhere and tolerate aspirin then undergo a double-blind randomisation and are allocated in a 1:1:1 ratio to either 100 mg aspirin, 300 mg aspirin or a matched placebo to be taken daily for at least five years. Those participants ≥ 75 years old are only randomised to 100 mg aspirin or placebo due to increased toxicity risk. The primary outcome measures are invasive disease-free survival for the breast cohort, disease-free survival for the colorectal cohort, overall survival for the gastro-oesophageal cohort, and biochemical recurrence-free survival for the prostate cohort, with a co-primary outcome of overall survival across all cohorts. Secondary outcomes include adherence, toxicity including serious haemorrhage, cardiovascular events and some cohort specific measures. The Add-Aspirin trial investigates whether regular aspirin use after standard therapy prevents recurrence and prolongs survival in participants with four non-metastatic common solid tumours.
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影响因子：
168.9
作者：
Burn, John;Gerdes, Anne-Marie;Macrae, Finlay;Mecklin, Jukka-Pekka;Moeslein, Gabriela;Olschwang, Sylviane;Eccles, Diane;Evans, D. Gareth;Maher, Eamonn R.;Bertario, Lucio;Bisgaard, Marie-Luise;Dunlop, Malcolm G.;Ho, Judy W. C.;Hodgson, Shirley V.;Lindblom, Annika;Lubinski, Jan;Morrison, Patrick J.;Murday, Victoria;Ramesar, Raj;Side, Lucy;Scott, Rodney J.;Thomas, Huw J. W.;Vasen, Hans F.;Barker, Gail;Crawford, Gillian;Elliott, Faye;Movahedi, Mohammad;Pylvanainen, Kirsi;Wijnen, Juul T.;Fodde, Riccardo;Lynch, Henry T.;Mathers, John C.;Bishop, D. Timothy
通讯作者：
Bishop, D. Timothy
影响因子：
8.8
作者：
Fraser, D. M.;Sullivan, F. M.;Thompson, A. M.;McCowan, C.
通讯作者：
McCowan, C.
影响因子：
45.3
作者：
Kelsen, David P.;Winter, Katryn A.;Willett, Christopher G.
通讯作者：
Willett, Christopher G.
影响因子：
2
作者：
LANG, JM;BURING, JE;HENNEKENS, CH
通讯作者：
HENNEKENS, CH
影响因子：
45.3
作者：
Allum, William H.;Stenning, Sally P.;Langley, Ruth E.
通讯作者：
Langley, Ruth E.