This podcast episode is made possible in part by a grant from Lilly.
Welcome to The Breastcancer.org Podcast, the podcast that brings you the latest information on breast cancer research, treatments, side effects, and survivorship issues through expert interviews, as well as personal stories from people affected by breast cancer. Here's your host, Breastcancer.org Senior Editor, Jamie DePolo.
Jamie DePolo: Hi, I’m Jamie DePolo, senior editor at Breastcancer.org. I’m podcasting live from the 2023 San Antonio Breast Cancer Symposium. My guest is Dr. Hatem Azim, a medical oncologist and adjunct professor at the School of Medicine and Breast Cancer Center at the Tecnológico de Monterrey in Mexico.
He presented a new analysis of the POSITIVE trial, which looked at whether women diagnosed with hormone receptor-positive breast cancer could safely stop taking hormonal therapy to become pregnant, and those results were positive. For women who had a baby, recurrence rates were not higher and the babies were healthy.
Dr. Azim’s new analysis looked at whether the women could use fertility preservation and assisted reproductive technologies without increasing the risk of recurrence. He is going to discuss the results with us.
Dr. Azim, welcome to the podcast.
Dr. Hatem Azim: Thank you very much for having me.
Jamie DePolo: So, to start, could you tell us what types of fertility preservation and assisted reproductive techniques were used in the study?
Dr. Hatem Azim: So, as for fertility preservation, the three main techniques were captured in these studies. First is the use of GnRH analogues along with chemotherapy, adjuvant chemotherapy, before enrollment to POSITIVE; or ovarian stimulation for embryo or oocyte cryopreservation; or ovarian tissue cryopreservation.
So, these are the three fertility preservation options that were captured in the study and were used in the study.
As for assisted reproductive techniques, several assisted reproductive techniques were used at the discretion of the treating physician and the patient, obviously. And this included the transfer of the cryopreserved embryos or oocytes that was done in the past as a part of fertility preservation; or ovarian stimulation for in vitro fertilization, IVF; or clomiphene used; or intrauterine insemination or egg donation.
Jamie DePolo: Perfect. Thank you and how many women in the POSITIVE study used one of those techniques?
Dr. Hatem Azim: So, as for fertility preservation, almost 50% of women -- 53% exactly -- of women underwent some form of fertility preservation technique before entering into POSITIVE.
As for assisted reproduction, nearly 43% of patients underwent some form of assisted reproduction as well.
Jamie DePolo: Okay. So, nearly half of the women did that.
Dr. Hatem Azim: Almost half, maybe the vast…I mean, among the patients who underwent fertility preservation, the most common use technique was oocyte or embryo cryopreservation, which was almost in 36% of the entire population of the study.
As for assisted reproduction, the two most common techniques that were used were either the transfer of the cryopreserved embryos or ovarian stimulation for in vitro fertilization.
Jamie DePolo: Okay. Great. And how many women became pregnant and was one technique more successful than the other in these women?
Dr. Hatem Azim: In general, if we take the entire population of the trial, 75% of patients became pregnant on trial. So, when we start to break it down according to the use or not to certain assisted reproductive techniques, we found that the transfer of the cryopreserved embryos was the technique associated with the higher odds of becoming pregnant.
So, we did this model in which we compared, or we inserted the different model, the different techniques that were used on the study, the different assisted reproductive techniques, and we found that the higher odds were observed with the transfer of the cryopreserved embryos.
Jamie DePolo: Okay. Now, what everyone wants to know: the results of the study. Were recurrence rates affected?
Dr. Hatem Azim: So, we looked into different…recurrence in so many ways.
So, first we….the main concern on the use of these different techniques that often it requires what we call ovarian stimulation, which induces high hormonal levels, and obviously in patients with hormone-sensitive disease this could be of concern.
So, we looked into those women who underwent ovarian stimulation for embryo or oocyte cryopreservation before enrollment to POSITIVE, and we looked into their outcome at three years, and we found that the rate of recurrence was highly comparable, so almost identical between those women who underwent embryo or oocyte cryopreservation, which were almost one-third the patients, compared to the other two-thirds who did not undergo this procedure.
We also looked into the use of ovarian stimulation post-enrollment to POSITIVE, so on study. So, these women did not undergo any form of fertility preservation before, but they wanted to have an ovarian stimulation to increase the chance…with the aim to increase the chance of getting pregnant, and this is what called ovarian stimulation for IVF, for in vitro fertilization, and again we did not find a detrimental impact on outcome, although the absolute number of breast cancer events in this analysis was relatively low, and long-term follow-up is indeed required to confirm this observation.
Jamie DePolo: That was my…that’s my last question. How long are you going to be able to follow these women because we do know that hormone receptor-positive disease can come back 10, 15, 20 years later? So, do you have plans to follow them that long? Or how long are you going to follow them?
Dr. Hatem Azim: Absolutely. So, I mean, the main analysis and all the secondary analysis will be subjected to further follow-up, and this is planned towards 2028 or 2029 in order to have a second look and see how the evolution of the disease over time.
We were relatively prudent in communicating the conclusions of this trial, underscoring indeed that we are having now a look, an early look at almost three and a half years of follow-up, so around 41 months exactly, which is as you rightly mentioned is a short duration for disease like hormone receptor-positive breast cancer in which events could occur later. So, indeed this is…this is indeed foreseen in the trials.
Jamie DePolo: Great. Dr. Azim, thank you so much.
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