ER+, HER2- Breast Cancer Pathways at University of Chicago Hospital and OHSU Knight Cancer Institute

In this series, we speak with cancer care practitioners about how pathways are being used in their practices, how they are being applied in a particular disease state, and what challenges remain for treatment decision-making.

For this installment, we spoke with Michael A Savin, MD, assistant professor of medicine at the OHSU Knight Cancer Institute (Portland, OR), and Olwen Hahn, MD, associate professor of medicine at University of Chicago Medicine (Chicago, IL), about the revision and practical use of Via Pathways for ER+, HER2- breast cancer in their respective institutions. 

Please described the updating process of the Via Pathways used at the University of Chicago Hospital and at the Knight Cancer Institute.

Dr Hahn: Dr Savin and I joined the Via committee when it already had a good skeleton of pathways, so our primary charge has been incorporating new data and information into the pathways. We stay alert to new studies and data coming out of the literature and the meetings. We have quarterly committee calls where we have robust participation and discussion in order to incorporate that data appropriately and then continue to reevaluate and revise the pathways based on data, expert input, and experience to reflect best standards of practice for our members. 

Speaking for University of Chicago, our relationship with Via started as we were entering into insurance contracts and looking for the best options for demonstrating that we provide value-based care; we became a Via member as part of that. Within the breast group, we were fortunate; all of us that treat patients with breast cancer we able to sit down with the initial Via Pathways and reviewed them. We have a model at University of Chicago where we have some ability to customize the pathways to best reflect our local practices. We spent several hours making sure that the pathways reflect the best choices for our patients.

Each quarter we have faculty members submitting questions or comments to Via for consideration. When the pathways come out, we are provided another opportunity to reevaluate the pathways and to make sure that they reflect our best practice. Each faculty member is expected to “navigate” them on Via while we see patients in clinic. It is incorporated into our electronic medical record, so right on the patient’s chart we can select the appropriate pathway for our patients.  

Dr Savin: We have a similar situation at OHSU. At about the time I arrived at OHSU, they were just starting to use the Via pathways, so there was some groundwork on the pathways that had already been done beforehand. I’ve basically ended up as the oversight person for our Via oncology pathways for the whole Knight Cancer Institute, not just for breast.

The updating process is similar to what Dr Hahn described. Updating is all done with the support of PharmDs who are with Via oncology, who help us gather data together that we then review prior to the quarterly meetings. The quarterly committee meetings include us and representatives from both academic practices and community practices and provide input from members of their practices to help guide us in making the appropriate selections that align with best practices including clinical efficacy, safety, and, where appropriate, cost. Obviously, efficacy and safety are our primary concerns. 

Each quarter, we review the pathways; while we cannot look at the entire pathways every quarter, we select areas where there may be new things coming out or areas where issues have arisen that need addressed. We get input from all the committee members, academic and nonacademic, before the meetings, and they actively participate. They can be pretty energetic meetings and conferences.

Like the University of Chicago, we also have the option of doing a certain degree of customization. That is a stand-out feature of the Via process. Some of that is related to insurance issues. For example, we run into situations where there may be something that would be more expensive here or not covered by insurance here that would be covered at other sites. We need to make adjustments in the pathways for that.

As we roll them out, we ask all of our clinicians to navigate the pathways and make appropriate decisions on or off-pathway as appropriate for their patients. We have a general expectation that roughly 80% of decisions will be on-pathway and that there will be valid reasons for going off pathway; there can be a variety of reasons for being off-pathway because no pathway can cover every clinical circumstance.

Please describe each of your institution’s clinical pathway for ER-positive HER2-negative breast cancer. What is your approach to stratifying patients with this disease to guide therapeutic decision making?

Dr Hahn: The driving factors for an ER+ HER2- patient are, what line of therapy are we looking at, ie, is this a newly-diagnosed, first-line, second-line therapy? Is the patient still getting endocrine therapy? Later on down the line, consideration of when they’re getting chemotherapy. When you’re looking at the endocrine therapy options, the decision should be reflective of what the patient may or may not have received; whether they are pre-menopausal or post-menopausal; and what they have received in the adjuvant setting, as well as the interval therapy from adjuvant setting to being diagnosed at the metastatic setting.

I think the Via oncology pathway does a nice job in breaking out those various scenarios and also allowing patient-specific factors to come into play in making a therapeutic decision.

Dr Savin: I think this is, by nature, a complex process. It sounds simple, hormone-receptor-positive disease, but there are really a lot of nuances, from the simple things like menopausal status to much more complex things such as prior therapies and aggressiveness of disease. As a rule of thumb, even with metastatic disease, we try to use endocrine therapy options as much as possible. Historically, we used to go with chemotherapy, or, as we had very few options for endocrine therapy, we would give tamoxifen and then go on with chemotherapy. But now we try to explore the endocrine options as much as we can and hold chemotherapy for visceral crisis or when we no longer have an effective endocrine option available. I think this works to patients’ benefit because we tend to gain a lot of reasonable quality time without that degree of toxicity. We have far more endocrine options than we did even just a few years ago and that has helped greatly, although some of them have their own issues and toxicities.

What are the benefits of neoadjuvant therapy with endocrine therapies for this disease population, and what is the role of this approach within your pathways?

Dr Hahn: For us, like many of the members of the academic pathway, we are fortunate to not only have Via incorporate the best evidence for standard-of-care therapies, but it also allows institutions to enroll patients on clinical trials, and I think neoadjuvant therapy is an area of robust clinical trial activity. At University of Chicago, we are fortunate to be a member of the I-SPY Research Consortium, and so our ER-positive patients that we are thinking about putting on chemotherapy, we consider for enrollment in that clinical trial. Then, they would have a research biopsy for genomic analysis and, if high-risk by the MammaPrint test using I-SPY, they are randomized onto one of the appropriate I-SPY treatment arms. 

Dr Hahn: If a patient does not want to go on a study or is not qualified for a study, one really needs to consider: do you think that this patient is going to be chemotherapy-sensitive to get neoadjuvant chemotherapy up front, or is this maybe a better neoadjuvant endocrine therapy patient, and would you want to consider the alternate study that is being conducted by the Alliance?

Dr Savin: We are also in the I-SPY trial, but outside of that trial we have several ongoing studies as well. We do not have a neoadjuvant endocrine study right now. But we do provide a lot of neoadjuvant endocrine therapy, and the decision tends to be based on the certain circumstances where we know we actually do better with endocrine therapy than we do with chemotherapy. Low grade receptor-positive lobular carcinomas respond very poorly to chemotherapy, but they will often respond to endocrine therapy. Those are often advanced or difficult to evaluate preoperatively, and I think many patients end up able to avoid a mastectomy because they are also frequently quite extensive through the course of neoadjuvant endocrine therapy, which tends to be a long course—we’re typically talking about 6 to 12 months of therapy before surgery to have a response. 

Dr Hahn: In our institution, we present all of our patients to our multidisciplinary tumor board, and we put a great amount of thought into whether we think a patient is going to be most responsive to endocrine therapy, ie, is this a luminal A-type, ER-positive breast cancer, or do they have some high-risk features that we think would be more appropriate for neoadjuvant chemotherapy on our I-SPY study. And, of course, those patients will also need to have the appropriate high-risk genomic signature.  

Dr Savin: OHSU is similar to University of Chicago, as we have a very robust and active multidisciplinary tumor board that involves everybody from genetics to surgery to imaging and so on. We meet every week and discuss patients. It really helps us get input from a variety of perspectives as we make recommendations about how to proceed with particular patients.

Dr Hahn: I agree, because although it is a systemic therapy question, I think the surgical inputs, the surgical imaging, even plastic surgery input, is key in thinking about what type of surgery they are going to have, and what their surgical options are, thus what kind of response are you wanting for your systemic therapy? 

Do the discussions at these tumor boards in any way factor into the pathways?

Dr Hahn: I think in general, multidisciplinary care is delivered in many different models. For us, we have a set multidisciplinary tumor board that meets once a week, and we typically review at least 20 patients on a weekly basis. I know some centers will have multidisciplinary clinics where all of the providers are there seeing the same patients. At University of Chicago, our Via pathways are primarily chemo therapy, systemic therapy in the medical oncology domain. The appropriate choices that are on the pathway are discussed by the medical oncologists that attend the tumor board, but each patient is what drives the decision. While we do not have the pathways displayed in the tumor board driving the decisions, it is very much one and the same, if that makes sense.   

Dr Savin: One of the nice things about our situation is we also have a multidisciplinary tumor board, and we have it on the day that we have a breast cancer clinic all day (but we see breast cancer patients other days as well). So we go from the multidisciplinary meeting in the morning to the clinic where we have surgical oncology, genetics, plastic surgery, radiation oncology, and medical oncology all in the clinic at the same time, and with new patients the same day, which makes a busy day for the patient. But a lot of our patients come from a long distance, so we try to get a lot done. We are in a large state with a small population, and we are in one corner of it.

In your respective institutions, how do you balance the need for standardization of treatment decisions on pathway with the need to optimize care for individual patients?

Dr Savin: I do not think there is a conflict there. I think the multidisciplinary meetings help us provide more person-centered care because these issues get addressed at the meeting: the issues of cost of care, impact of treatment/symptoms on patients’ ability to maintain their income, and the issue of traveling for many of our patients, etc. Just having a place where you can address these concerns is helpful. Every patient that is presented has an interview, typically for a better part of an hour, with a nurse navigator prior to that conference wherein this personal, financial, work situation information, etc, is gathered. So all of this becomes a part of the discussion. 

Finally, what are some of the challenges to optimizing therapeutic decision-making that you continue to see in your practice today, and how do you anticipate these challenges might be overcome? 

Dr Savin: One of the things that is a little unusual about the situation in Portland is we are in Oregon, and Oregon is an alternative therapy site. We have a naturopathic college that is just down the road from the medical school, so one of the challenges we run into is getting patients engaged in treatment that has an opportunity to be effective for them. I know that is a problem everywhere, but I think we certainly run into it more here than, for example, when I was in Texas, although it was sometimes an issue there as well. 

Dr Hahn: I would say one of the challenges is keeping up with novel therapies that are being developed. With the Via meetings convened quarterly, I think that is a good frequency to incorporate new FDA approvals or new trial information that has come out at meetings or in the literature. This way, the Via pathways pretty quickly reflect the best current practice.

Something we have struggled with as a committee, specifically in ER-positive, HER2-negative disease, is we have three CDK4/6 inhibitors that have received quick approval within a couple years of each other. So when you have multiple drugs approved in similar settings, how do you best incorporate those options on the pathway with the tenets of efficacy, toxicity, and cost effectiveness? In breast cancer, this is something that has been a topic of robust discussion in our committee meetings, but I also think that this is probably seen in other diseases with all the PD-1 immunotherapies too.