I take issue with the underlying assumptions of the P-1 investigators. They have left out the woman's point of view. In their published results the investigators state that the diseases tamoxifen causes, such as endometrial cancer and pulmonary embolism, are not as bad as breast cancer. They cavalierly suggest, for example, that endometrial cancer is simply dispatched with a hysterectomy. Yet this is major surgery with a small rate of mortality and a large rate of complications, including sexual dysfunction, bladder and bowel incontinence.
Quality of life is an even more important issue here.
The woman with breast cancer might tolerate terrible tamoxifen-induced hot flashes, suppression of libido, and vaginal discharge. Now healthy women are being recruited for the STAR trial. Tamoxifen will be compared against raloxifene. I worry that the results will not be meaningful because there is no placebo arm in this trial. There will be no longterm followup from the P-1 trial either because when it was halted back in 1998, the participants on placebo were actively encouraged to join the STAR trial.