Jason Mouabbi, MD: I’m Jason Mouabbi. I’m a breast medical oncologist at the University of Texas MD Anderson Cancer Center.
Kate Yandell, Interviewer: Great. Thanks for joining us. What data presented at SABCS should change practice in the community today?
Dr. Mouabbi: Thank you for having me. That’s an amazing question. So two abstract come to mind that can change the practice of all practicing oncologists right away. The first one is called the POSITIVE trial, and this one looked at the pregnancy outcome and safety of a short-term interruption of endocrine therapy for those patient who are taking it in the adjuvant setting, and they found that interrupting the endocrine therapy for up to two years did not negatively impact the disease outcome, so those were short-term outcomes. We don’t know yet the long-term outcomes, but the study author said that those are up and coming and are currently pending, but at least it’s comforting to know short-term interruption for our females to get pregnant is safe.
The second abstract that come to mind is the RIGHT Choice study, and this one looked at changing the current understanding of using chemotherapy in patient with aggressive diseases. Aggressive hormone receptor-positive, HER2-negative metastatic breast cancer is considered... those are the patients who present with cancer in visceral organs that’s leading to a visceral crisis, or leading to an impending organ damage, so those patients historically, we felt like we need to give them chemotherapy and that’s how currently we’ve been treating them, so the study wanted to challenge that by comparing chemotherapy, doublet to endocrine therapy plus CDK4/6 inhibitor. In this case, they chose ribociclib, and they found that actually doing endocrine therapy plus CDK4/6 inhibitor not only is better, but also the response rate is also a little bit better, so that’s excellent, that’s reassuring, and that’s how we should treat all our patients regardless whether they have aggressive or non-aggressive metastatic breast cancer.
Yandell: Wonderful. Can you highlight abstracts that will change practice in maybe the next year or so?
Dr. Mouabbi: Yes. There was some very exciting abstracts presented at this San Antonio that might impact the near future, two of them in particular. The first one is the abstract that presented the results of the CAPItello-291 trial, and this one looked at the addition of an AKT inhibitor called capivasertib to endocrine therapy, in this case fulvestrant, and compared it to a placebo plus fulvestrant. We were happy to see that the addition of capivasertib to fulvestrant doubled the progression-free survival in the intention to treat populations for all comers and in the population that have an AKT alter pathway. This is very comforting to know because, at this point in time, patient in the second-line setting after progressing from first-line CDK4/6 inhibitor plus endocrine therapy have two options. One option, if they have a PI3-kinase, a mutation, is to go on a PIK3CA inhibitor, which in this case is alpelisib plus fulvestrant, or go on fulvestrant alone. Sometime they might combine fulvestrant with something else, but now we know that those patients that do not have that mutation, or even if they have that mutation, you can give them something extra that can really improve their outcomes.
The second abstract that also might change the landscape in the near future was the SERENA-2 trial. Here they looked at one of those novel oral SERDs called camizestrant, and again, when they compared it again to fulvestrant, which is an injectable SERD that we had since the ’90s, it found that it doubled the progression-free survival and especially in the area of the highest unmet need in that population, which is a patient with ESR1 mutation, so this is excellent. This is something we need today, and I’m glad that this study is positive and hopefully soon we’ll have it in our clinic.
Yandell: Did we get any updates on things that are already being done in the clinic?
Dr. Mouabbi: Yes. We got multiple updates. Two of them are of particular interest. The first one was the four-year update on the monarchE trial. In this update, it showed that after four years of follow-up, they showed there is continued increasing benefit of the addition of two year of abemaciclib, which is an oral CDK4/6 inhibitor, in combination with endocrine therapy in patient with early-stage hormone receptor-positive breast cancer. This is very reassuring because at four years all of the patients have already completed the two year of abemaciclib, and yet we still see continued separation of the curve, continued benefit, even after they stop the medication. This was excellent to hear, excellent to see, and it definitely is reassuring to all our patient that we are giving this therapy today.
The other abstract that was presented that is reassuring as well is the Babytam study, so this is a study that looked at low-dose tamoxifen in patient with DCIS, LCIS, atypical ductal hyperplasia, or atypical lobular hyperplasia. So here they looked at a low-dose tamoxifen five milligram for three years, and they found that patient who received that low dose had 50%, around 50% reduction in the risk of developing invasive cancer. Now, one caveat about this, we don’t have the five milligram in the U.S., but the author did state that an alternative to that is to use the 10 milligram, which is available in the U.S., every other day, so that’s very reassuring that with the patient with no invasive breast cancer, we can use a very low dose of a medication that’s already available.