美国加利福尼亚大学旧金山分校海伦迪勒家族综合癌症中心Hope S. Rugo教授

　　Hope S. Rugo教授为美国加利福尼亚大学旧金山分校肿瘤学教授，海伦迪勒家族综合癌症中心乳腺癌及临床试验培训组组长，晚期乳腺癌国际共识1（ABC1）编写专家组成员。

　　Oncology Frontier: With regard to hormone therapy in premenopausal women with early-stage breast cancer， what are your suggestions for treatment?

　　《肿瘤瞭望》：对于绝经前早期乳腺癌的激素治疗，您有什么建议？

　　Dr Rugo: There is quite recent data suggesting we should think about hormone therapy for premenopausal women a little bit differently. The combined analysis of the two arms of the SOFT trial with the TEXT trial showed that in women with early stage breast cancer， using ovarian suppression with the aromatase inhibitor， exemestane， was superior to ovarian suppression and tamoxifen. Interestingly， the side effect profiles， although different， were not substantially different. Patient-reported outcomes were relatively similar. If you look at an in-depth analysis of that data (the median follow-up is now just over five years which is still early for patients with hormone receptor-positive disease but still intriguing) you find that distant recurrence， which is our most important outcome in our treatment choices， was lower by about 1.8%， an absolute amount. But if you look at that difference in distant recurrence in patients based not so much on nodes but getting chemotherapy or not， the patients who didn’t get chemotherapy tended to have lower risk disease. They had very few recurrences and there were no differences between the two arms. But the patients who received chemotherapy with higher risk disease had more recurrences and the difference was more striking between the two arms. My take on this right now is that for patients with higher risk disease， I would consider the approach of ovarian suppression/exemestane versus ovarian suppression/tamoxifen. One big question that remains is who should get just tamoxifen alone? That is waiting for the presentation of the SOFT trial where they compared tamoxifen to tamoxifen/ovarian suppression and a third arm of ovarian suppression/exemestane. It will be interesting to see what happens. I think that we have to deal with the issue of ovarian suppression very cautiously with young women. We want the best outcome but we also want to maintain quality of life and that is a critical issue.

　　Two issues to keep in mind when treating premenopausal women with early stage hormone receptor positive breast cancer is that firstly， if you use ovarian suppression and an aromatase inhibitor， you might have recovery of ovarian function so you should monitor estradiol carefully. The second issue to consider is the duration of hormone therapy. Some people have said that that might change their approach to the use of ovarian suppression and aromatase inhibitors. It is important to remember that the median follow-up was over five years. At that time， you haven’t yet seen the added benefit of the longer duration. You are preventing relapses in the first five years and obviously extending hormone therapy can’t prevent relapses in 0-5 years because you have already had those relapses. Those are important points to keep in mind when we think about whether or not we should employ more aggressive hormone therapy or not.

　　Rugo教授：就在最近，一些研究资料表明，对于绝经前乳腺癌患者的激素治疗，我们的看法要有一些改变。综合了SOFT试验与TEXT试验的联合分析显示，在早期乳腺癌的治疗中，芳香化酶抑制剂依西美坦联合应用卵巢抑制的效果要优于他莫昔芬联合应用卵巢抑制。有趣的是，两种方案的副作用虽然有所不同，但并没有本质差异。患者报告的结果也大体相似。

　　如果你深入分析数据（虽然对于激素受体阳性乳腺癌患者来说，现在5年的中期随访时间还太短，不过结果还是能激起大家的兴趣），你会发现在治疗结局中最重要的远处复发率降低1.8%，这是一个相当好的指标。但是如果你不考虑淋巴结情况，只是根据是否接受化疗来比较患者远处复发情况的差异，你会发现未接受化疗的患者往往为低危患者，几乎没有复发，而且两组无明显差异。但是接受化疗的高危患者中，复发比例更高，而且两组结果差异更加显著。对此，我的观点是对于高危乳腺癌患者，相比于卵巢抑制联合他莫昔芬，我会更倾向于给予卵巢抑制联合依西美坦。

　　剩下的一个大问题是哪些患者可以只用他莫昔芬治疗？那要等待SOFT试验的结果，试验中比较了单用他莫昔芬、他莫昔芬联合卵巢抑制以及卵巢抑制联合依西美坦治疗的差异。我们在处理年轻女性接受卵巢抑制治疗时得非常谨慎。我们既想要最好的治疗结果，也想要保持患者的生活质量，这是很关键的。

　　在治疗绝经前、激素受体阳性的乳腺癌患者时，需要铭记两个问题：①如果使用了卵巢抑制和芳香酶抑制剂，有可能出现卵巢功能恢复，因此要严密监测雌二醇；②激素治疗的持续时间。有学者认为这可能会改变他们使用卵巢抑制和芳香化酶抑制剂的方式。需要记住的是现在的中期随访只有5年多，此时，更长疗程的额外获益还未表现出来。在最初5年你一直在阻止复发，而且很明显，既然已经发生了复发，那么延长激素治疗在0~5年无法阻止复发。在我们考虑是否要给予更强的激素治疗时，以上方面都是需要记住并仔细考虑的。