Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: I’d love to hear from each one of you, and Heather, we’ll start with you, walk me through some unmet needs in this patient population. And then, I’d love to hear from everyone if you have any different identifiable unmet needs that you see.

Heather McArthur, MD: I’ll start by saying that it is an incredibly exciting time actually to be treating breast cancer because we have had an unprecedented number of FDA approvals of novel drugs in recent years that have really dramatically changed clinical outcomes for patients, improved cure rates in the adjuvant curative intensity setting, and improved survival in the metastatic setting. It really is an incredibly exciting time and there are a number of exciting drugs that are in the pipeline that I think will further improve that benchmark. We haven’t though cured all breast cancer, and so that’s always the goal. We’ve had some tremendous improvements, but there’s still more work to be done. We need to minimize the toxicity with our curative intent strategies at the moment. A lot of the toxicity comes from some of the drugs that we’ve already talked about, the chemotherapeutics, hormone therapy, and ovarian suppression for our younger patients. It’s a lot of treatment, so we desperately need better biomarkers that not just predict, for example, who derives benefit from chemotherapy versus not, but what’s the right chemotherapy for specific patients. Does everyone require an anthracycline in a taxane, for example? And then we need better biomarkers to address racial disparities. There were some interesting presentations at the last San Antonio [San Antonio Breast Cancer Symposium] meeting. One study looked at differences in black versus white patients after neoadjuvant chemotherapy, clearly different tumor microenvironments. And there was an interesting presentation from the ARC [apoptosis repressor with caspase recruitment domain] responder study showing that the outcomes based on the cutoffs that were established largely from white patients may not be ideal for black patients, and that Asian patients actually might even do better than white patients. So we need a lot more nuanced data to address these racial disparities, and a lot of that can only come from broader inclusion in prospective clinical trials.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: I love that you brought that point up. Sam, is there anything on your end from unmet needs in this population?

Samyukta Mullangi, MD, MBA: I would say that when folks get diagnosed with breast cancer, with really any type of cancer, there is a significant hardship that I think patients face in navigating from the point of detection to the point of diagnosis, where somebody says, “Here’s a positive screening—you may have cancer, to you do have cancer, and let’s get started on your treatment journey.” Of course, I think the patient’s anxiety and fear don’t necessarily end with that first appointment, but there’s just a particularly fraught sense of feeling unmoored in those early days. I think the way our health care system is set up right now; oftentimes we find that patients will navigate from that point of detection to diagnosis kind of on their own. For example, I’m practicing right now at an academic health system where we don’t see patients until and unless they have a positive pathological diagnosis. So we need that tissue sample before they can even get in through the door for their first appointment. Which means that either the primary care physician or the radiology suite or wherever it is that they had that early detection, is then sending these patients on their own to figure out what are the next steps in workup, where patients are trying to educate themselves. “Can I be seen locally in the community setting? Do I really need to go to a tertiary care system? Do I need a clinical trial? Do I need a second opinion? How do I work out the mechanics and logistics of my insurance approvals for all of these things?” I think the fact of the matter is that cancer treatment right now, the cancer journey in general, is just a series of phases. Detection, diagnosis, treatment, survivorship, end-of-life care, and all of these phases lead to these care silos and there’s not one person overseeing that whole journey. I think to some extent the way our health system is set up a little bit does a disservice to folks with a brand-new diagnosis of cancer and certainly early breast cancer.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: I love how you called out that detection to diagnosis. I mean, that’s where a lot of Dr Google is happening. A lot of uncertainty and unpredictability for that patient, and you can imagine the amount of stress. Anything from you, Sarah, or Jay, anything you guys want to add to unmet needs?

Sarah Sammons, MD: Yeah. I think, particularly in high-risk hormone receptor-positive HER2-negative breast cancer, we really treat it right now based on genomic and pathologic features. But it’s really probably multiple diseases, and we’ve done a great job with drug development and we have approvals of abemaciclib [Verzenio] and ovarian suppression, and we have some genomic assays that help us determine who may and may not benefit from chemotherapy. But I do think that we can do a better job with biomarker selection, and who really does benefit from adjuvant CDK4/6 inhibitors, and who really benefits from ovarian suppression, which has incredible implications on quality of life. And in the premenopausal setting, probably the topic of half of our tumor boards [is] which premenopausal women really do need chemotherapy, [and] which don’t. We still don’t have the answers to a lot of those simple questions. And I think a lot of that will come from biomarkers.

Heather McArthur, MD: I’m excited to see actually circulating tumor cells. Although, because a lot of studies are incorporating circulating tumor cells and it makes rational sense to me that if you can detect cancer cells in the blood and liquid biopsies, you might identify people who are at higher risk or earlier at recurrence and be able to intervene earlier. So it’ll be exciting. Of course, we don’t know yet how to apply those strategies, when to do it, how often to do it, which is the best technique to do it. But I think that’ll be coming in short order to a clinic routine practice.

Sarah Sammons, MD: I agree.

Kirollos S. Hanna, PharmD, BCPS, BCOP, FACCC: Anything for you, Jay?

Jay Andersen, MD: I’ll just add I agree with all the comments. But I think as much as we’re talking about, in this case, a higher-risk patient population adding something to their therapy, the concept of de-escalation is also becoming more popular. Meaning maybe patients who can forego certain elements of routine care and have equal outcomes, how can we identify those patients? So de-escalation and, again, to the notions that were already referenced, better tailoring individual therapy based upon biomarker and genomic markers that become really personalized.

Transcript edited for clarity.