Men and breast cancer drug trials

There has long been discussion about the exclusion of women from many clinical trials. Until recently, women of childbearing age were often ineligible to participate, and other studies were designed specifically to consider men. Times have fortunately changed, and even scientists who work with mice and rats are now encouraged to include animals of both sexes.

Thus, it seems overdue and a bit ironic that the Food and Drug Administration (FDA) has just issued a recommendation that men be routinely included in trials of breast cancer drugs. Men make up less than1% of all people diagnosed with breast cancer, but they are treated the same way as women, and no one has ever paid attention to the possibility that drugs might work differently between the two sexes. Breast cancer in men is usually diagnosed at a later stage (after all, men are not encouraged to have annual mammograms or even to think about the possibility of breast cancer), and they are more likely to be older and to have lymph node involvement.

The FDA's draft recommendation is now open for public comment and can be viewed here.

Through the years, I have worked with fewer than ten men with breast cancer, but have been impressed by the extra stress that this diagnosis brings to them. I remember one man who told me that several of his friends laughed when he told them of his diagnosis and then said something like: Come on, what do you really have? Men endure the same surgeries, same radiation, and same chemotherapy or hormonal therapies that we do. Although losing a breast may have less of a psychological impact for a man, their scars are visible, and they may be self-conscious about being shirtless in public. We may assume that a man cares less about chemo-related hair loss, but that may not be the case for any one person. Their prognoses are similar. They surely deserve to be considered in the future development of new medications.