Adjuvant chemotherapy in older women (ACTION) study - what did we learn from the pilot phase?

Leonard, R., Ballinger, R., Cameron, D., Ellis, P., Fallowfield, L.J., Gosney, M., Johnson, L., Kilburn, L. S., Makris, A., Mansi, J., Reed, M., Ring, A., Robinson, A., Simmonds, P., Thomas, G. and Bliss, J. M. (2011) Adjuvant chemotherapy in older women (ACTION) study - what did we learn from the pilot phase? British Journal of Cancer, 105 (9). pp. 1260-1266. ISSN 0007-0920

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Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.

Item Type: Article
Keywords: chemotherapy elderly breast cancer clinical Trials
Schools and Departments: Brighton and Sussex Medical School > Sussex Health Outcomes Research & Education in Cancer (SHORE-C)
Subjects: R Medicine > R Medicine (General)
R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology Including cancer and carcinogens
R Medicine > RG Gynecology and obstetrics > RG0491 Diseases of the breast
R Medicine > RM Therapeutics. Pharmacology > RM0260 Chemotherapy
Depositing User: Tracy Woodcock
Date Deposited: 31 Oct 2011 09:53
Last Modified: 30 Nov 2012 16:55
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