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NEWS EXTRA: Debashis Singh Tamoxifen reduces risk of breast cancer in high risk patients BMJ 2003; 326: 244a [Full text]

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Labelled `patients` before their time?

Hazel Thornton   (1 February 2003)

Numbers needed to treat

James A. Thompson   (30 October 2003)

Labelled `patients` before their time? 1 February 2003
Hazel Thornton, Honorary Visiting Fellow, Department of Epidemiology and Public Health, University of Leicester. "Saionara", 31 Regent Street, Rowhedge, Colchester, UK. Send response to journal: Re: Labelled `patients` before their time?	Recent reports and research activities blur the distinction between prevention of developing breast cancer and prevention of recurrence of breast cancer. The first category involves healthy (albeit high risk) citizens; the second involves `patients`. This grouping of `citizen` and `patient` in one overview, report, or `prevention` trial, can result in inaccurate use of those terms as can be seen from the title of a BMJ News Extra item: Tamoxifen reduces risk of breast cancer in high risk patients. (http://bmj.com/cgi/content/full/326/7383/244/a) [1] It reports findings from a comprehensive overview ("study"? [1])of data from breast cancer prevention trials. [2] The overview included all five trials involving healthy high-risk women (`citizens`), one of which was the IBIS I trial. The remaining nine trials involved women (`patients`) who had had a tumour and received tamoxifen to prevent the cancer returning. The new IBIS II `prevention` trial [3] has a ductal carcinoma in situ (DCIS) stratem comparing tamoxifen with anastrozole in women with locally excised DCIS, and is seeking to recruit 4,000 post-menopausal women (`patients`) with DCIS within a total of 6,000 women (`citizens` and `patients`) for this two arm double blind, double placebo trial. Yet the interpretation within the overview report [2] of the main outcomes in breast cancer prevention trials is: "Although tamoxifen cannot yet be recommended as a preventive agent (except possibly in women at high risk with very low risk of side effects), continued follow up of the current trials is essential for identification of a subgroup of high risk women for whom the risk benefit ratio is sufficiently positive." Should we not be prioritising "identification of subgroups" [3] and clinical significance of DCIS as recommended in another recent paper [4] rather than launching IBIS II without benefit of full systematic review of DCIS trials? Hazel Thornton References: [1] Debasha Singh. Tamoxifen reduces risk of breast cancer in high risk patients. BMJ 2003; 326:244 (1 February) [2]Cuzick J, Powles T, Veronesi U, Forbes J, Edwards R, et al. Overview of the main outcomes in breast-cancer prevention trials. Lancet 2003; 361:296-300 [3] IBIS II (Prevention)Trial. NCRI Current National Trials. November 2002. [4] Virginia L. Ernster, Rachard Ballard-Barbash, William E. Barlow, Yingye Zheng, Donald L. Weaver et al. Detection of Ductal Carcinoma In Situ in Women Undergoing Screening Mammography. JNCI 2002; 944:20:1546- 1554 Competing interests:   None declared
Numbers needed to treat 30 October 2003
James A. Thompson, Senior Lecturer in Psychology Centre for Behavioural and Social Sciences in Medicine Send response to journal: Re: Numbers needed to treat	Following the illustrated example of 1000 patients, it would seem that the numbers needed to treat in order to prevent a breast cancer death over ten years are 333. Numbers needed to harm would be 111, though this harm would fall short of death. On the face of it, not a particularly appealing treatment at this stage. Competing interests: None declared