Aminoglutethimide vs. Surgical Adrenalectomy in Breast Cancer

To the Editor: The paper in the September 3 issue by Santen et al.,¹ comparing surgical adrenalectomy with“medical adrenalectomy”using aminoglutethimide in the treatment of advanced breast cancer makes a strong argument for the increased use of hormonal therapy, as discussed in the accompanying editorial.² However, the comparison of the two therapies has serious methodologic errors. The authors state that they used a modification of the method of Zelen³ in designing a randomized trial wherein randomization preceded the obtaining of informed consent. Yet a key ingredient of Zelen's design is that patients who refuse the experimental treatment must.