Estrogen–progestin replacement therapy: regulatory action needed

It is now established that the most commonly prescribed estrogen–progestin replacement therapy regimen significantly increases breast cancer risk. What are the risks associated with other regimens? Studies with breast cancer as the outcome cannot answer these questions in the right timeframe. It is incumbent on us to agree that some intermediate marker of risk must be used to show the probable effect of a regimen. We should then act as if the effect on the marker is a quantitative guide to the probable effect on breast cancer risk. Regulatory authorities need to require such studies on all current regimens.

目前已有定论：临床最常用的雌激素-孕激素替代疗法（estrogen-progestin replacement therapy）方案可显著增加乳腺癌发病风险。那么其他同类治疗方案对应的发病风险又如何呢？若以乳腺癌发病作为研究终点，相关研究无法在合理的时间窗内解答上述问题。因此我们理应达成共识：必须借助某种风险中间标志物来评估某一治疗方案的潜在效应。后续便可将该标志物所反映的效应，作为评估该方案对乳腺癌发病风险潜在影响的量化参考依据。监管机构应要求针对所有现行治疗方案开展此类研究。