ATAC trial did not report interim results

doi:10.1136/bmj.327.7422.1050

BMJ 2003;327:1050 (1 November), doi:10.1136/bmj.327.7422.1050

Letter

ATAC trial did not report interim results

The first 150 words of the full text of this article appear below.

EDITOR—We agree with Goodare et al that it is inappropriateto publish interim analyses.¹ However, the results of the ATAC(arimidex, tamoxifen, alone or in combination) trial publishedin the Lancet were the first major analysis as fully definedin the protocol, not an interim analysis.²

The statistical power of the trial, defined in the protocol,determined that this analysis would be triggered at 1056 events.Using first event as the primary end point in breast cancertrials is widespread since it is highly likely to predict latersurvival.

Data from the first analysis of the ATAC trial indicated thepotential superiority in efficacy and overall tolerability ofanastrozole over tamoxifen as adjuvant treatment for postmenopausalwomen with early breast cancer. However, it also showed thedisappointing performance of the arm receiving combined treatment,which the independent data monitoring committee advised us toclose, to limit exposure of . . . [Full text of this article]

Michael Baum, visiting professor of medical humanities

Clinical Trials Group, Department of Surgery, University College London, London W1W 7EJ

Aman Buzdar, doctor

Department of Medical Oncology, Medical Breast Cancer Service, University of Texas, MD Anderson Cancer Center, Houston, TX 77030, USA

Anthony Howell, professor of medical oncology

Department of Medical Oncology, Cancer Research UK, University of Manchester, Manchester M20 4BX

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