Adjuvant chemotherapy in older women (ACTION) study - what did we learn from the pilot phase?
Adjuvant chemotherapy in older women (ACTION) study - what did we learn from the pilot phase?
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DOI：
10.1038/bjc.2011.377
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发表时间：
2011-10-25
影响因子：
8.8
通讯作者：
Bliss, J. M.
中科院分区：
文献类型：
--
作者：
Leonard, R.;Ballinger, R.;Cameron, D.;Ellis, P.;Fallowfield, L.;Gosney, M.;Johnson, L.;Kilburn, L. S.;Makris, A.;Mansi, J.;Reed, M.;Ring, A.;Robinson, A.;Simmonds, P.;Thomas, G.;Bliss, J. M.
ACTION试验的启动是为了从一项随机试验中提供证据，证明化疗对70岁以上妇女的影响，而这些妇女缺乏风险和益处的证据。这是一项针对高风险、雌激素受体（ER）阴性/ER弱阳性早期乳腺癌的随机III期临床试验。该试验计划招募1000名年龄在70岁及以上的女性，随机接受4个周期的蒽环类化疗或观察。主要终点为无复发间期。该试验包括一个试验阶段，以评估征聘的可接受性和可行性。该试验在英国的43个中心开展。38个中心提供了接触患者人数的信息。在接近的43例符合条件的患者中，39例由于患者拒绝进入而未随机分组。10个月后，只有4名患者被随机分配，在与研究资助者讨论后，试验结束，资金终止。尽管在几次公开会议上得到了广泛的支持，患者群体（包括试验管理小组的代表）也提供了意见，但由于无法说服患者接受随机化，该试验未能招募到患者。因此，在当前这个时代，随机分配患者接受化疗与观察似乎不是一个可行的设计。
The ACTION trial was initiated to provide evidence from a randomised trial on the effects of chemotherapy in women aged over 70 years where evidence for risk and benefit are lacking. This was a randomised, phase III clinical trial for high risk, oestrogen receptor (ER) negative/ER weakly positive early breast cancer. The trial planned to recruit 1000 women aged 70 years and older, randomised to receive 4 cycles of anthracycline chemotherapy or observation. The primary endpoint was relapse-free interval. The trial included a pilot phase to assess the acceptability and feasibility of recruitment. The trial opened at 43 UK centres. Information on number of patients approached was available from 38 centres. Of the 43 eligible patients that were approached, 39 were not randomised due to patients declining entry. After 10 months only 4 patients had been randomised and after discussion with the research funder, the trial was closed and funding terminated. Despite widespread support at several public meetings, input from patient groups including representation on the Trial Management Group, the trial failed to recruit due to the inability to convince patients to accept randomisation. It would therefore seem that randomising the patients to receive chemotherapy vs observation is not a viable design in the current era for this patient population.
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