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Dr. Swain:
This is CME on ReachMD and I'm Dr. Sandra Swain.
Dr. Kaklamani:
And I'm Dr. Virginia Kaklamani.
Dr. Swain:
Virginia, how long should we maintain ovarian function suppression in premenopausal patients with hormone receptor-positive early breast cancer?
Dr. Kaklamani:
So, the data here comes really from three trials. We have the TEXT, SOFT, and the ASTRRA trials. So, let’s go over the first two trials because we always refer them together as the TEXT and SOFT. So, the SOFT trial was a trial looking at three arms, one arm was tamoxifen, then tamoxifen and ovarian suppression, and then aromatase inhibitor with exemestane and ovarian suppression. And the TEXT, very similar trial, but only had two arms; ovarian suppression plus tamoxifen or ovarian suppression plus exemestane. In those trials the OFS and the endocrine therapy were given for 5 years.
In the ASTRRA trial, the OFS was given for 2 years with tamoxifen, and then there was a tamoxifen only arm. All three of these trials showed a significant benefit with ovarian suppression added to endocrine therapy, and so we really can give it for either 2 or 5 years. I personally give it for 5 years of therapy or I give it for as long as I'm going to give endocrine therapy for. We now have extended endocrine therapy, so sometimes we're going to give patients another 5 years of endocrine therapy, and so in that case, I will discuss with them continuing ovarian suppression for longer than 5 years.
So, Sandy, what are the current guidelines as far as what the recommendations are for ovarian suppression? What does NCCN, what does ASCO have to tell us about that?
Dr. Swain:
Well, I think you summarized the data really well and that's what the guidelines are based on in this situation is mainly the TEXT and the SOFT data where the 5 years were used. So, the NCCN guidelines do say that 5 years are optimal according to the SOFT and TEXT trials. There's really no data to support prolonging ovarian suppression. I did find that there’s one trial, I think it was in China, that's looking at another 5 years of ovarian suppression in patients but we have zero data on that. So, 5 years would be optimal. And definitely, a minimum of 2 years is encouraged, and that's based on the ASTRRA data showing a benefit at 2 years. So, if you can at least get the patient to do 2 years, that would be really important. And then the ASCO guideline panel also supports ovarian suppression for 5 years.
Now, one of the issues is, we haven't been doing this for a long time, only since the SOFT trial and TEXT trial data has come out, that is giving it for 5 years, so we really don't know the long term effects of ovarian suppression that we’re going to maybe see 10, 20, 30 years down the road in these very young patients.
That is, regarding cardiovascular effects, bone effects, and even cognitive effects. So, we really need to be doing studies in that area since we're giving patients this kind of treatment. We know that the short term effects of ovarian suppression are hot flashes and different things like that. If you use the aromatase inhibitors, you have the musculoskeletal effects. But again, the long term effects are really unknown.
Dr. Kaklamani:
I think that's an extremely important point, Sandy, and some of our data really comes from the cardiovascular literature in patients that are going through premature menopause. So, not really OFS, but premature menopause, which is probably very similar. And the data does suggest that not only do we have bone and cardiovascular issues, do we actually have lung comorbidities that end up popping up, and as you mentioned, cognitive issues as well? So, when you’re talking about a 35-year-old patient that you will subject to ovarian suppression for 5 years, that becomes an issue when they're 55 or 60 and that's something that we have to consider.
Now, one question that I always have, because a lot of these women will need extended endocrine therapy, if you're giving 5 years of the OFS and then you do a genomic assay or, based on the patient's risk, you're planning on giving another 5 years, do you then switch them to tamoxifen if you think they're still premenopausal? Or do you try to extend the ovarian suppression for another 5 years?
Dr. Swain:
Because there's no data as I mentioned, I would switch them to tamoxifen at that point because I think having another 5 years of ovarian suppression could even have more long-term effects that we don't know about and until we had some data, I would switch them to tamoxifen.
Well, this has been a brief but a really great discussion. I hope we gave you something to think about and thanks for tuning in.
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