Denalee O'Malley, PhD, LSW, Instructor, Department of Family Medicine and Community Health, Research Division, Rutgers Robert Wood Johnson Medical School, New Brunswick, New Jersey
How can primary care doctors and oncologists collaborate to ensure that premenopausal patients with breast cancer have the necessary support to address the unique concerns of relationships, work, parenting, and other caregiving issues in a younger generation?
It’s important for the primary care physicians to get a report from the primary oncology team with both the treatments that patients have received and the anticipated late and long-term effects, as well as a surveillance plan. That’s currently called a cancer survivorship plan, and so as a part of that plan, [it designates] who’s going to be responsible for the different aspects of a patient’s care. For younger [survivors of] breast cancer, in particular, if there are anticipated changes in menopausal status, that would be helpful for primary care physicians to know. Also, who is going to be...the point person for symptoms management—so if something comes up, does the patient know who to call and how to get their needs met? [That] is important for the navigational experience for the patient.
In your research, have you discovered trends that indicate which patients fare better after active cancer treatment has been completed?
In my own research, what I focus on often is the experience of [patients with] cancer [who] have comorbid conditions. Also, I’ve done some work with longer-term survivors, and with longer-term survivors, [those] patients who have perceived to have had to make a financial sacrifice during the acute treatment experience can have longer-term experiences of distress, psychological distress. So I think the impact [on] finances at the acute phase can have a really enduring effect on someone’s experience over the long term. What gaps do caregivers and patients face when trying to access and understand health information during treatment and post treatment? How can oncologists and primary care physicians ensure that health literacy issues are resolved so that patients are informed about their options?
This is a really tricky issue because [as] treatments become more and more complicated, it…can be very time consuming and complex to communicate treatment options but also risk in a way that people understand that. I think it’s really important to assess what a patient understands about their illness. Also, what they understand about the goals of their treatment: Is everyone on the same page [regarding] the actual goal of the treatment? And what are the practicalities: Do they understand what they need in that environment to manage that? Do they have the practical issues covered financially to be able to get the resources they need to manage the day-to-day issues getting to and from treatment? I think that not only do we need to asses it from a health literacy perspective, but [we] also [need to help] patients make sense of what this means to them in their world. Do they accommodate it without help, and do they need help, and are there people on the healthcare team who can assist them so that they can have the optimal treatment outcome?
Are payers doing enough to ensure that survivors of cancer receive appropriate follow-up care, and, if not, what needs to change?
I think that currently the evidence in survivorship is evolving as the population of [survivors of] cancer is growing. I think that as more information is developed about risk stratifications, which patients have the most complex long-term sequelae. Payers can really incentivize providers coordinating that care and providing that care in a way that’s efficient but also effective. I think that is improving the information evidence over time, and I think payers can incentivize putting that evidence into practice.How has care for the sexual health needs of patients changed over the years?
The care for sexual health needs for patients unfortunately has not changed that much over the years. Part of it is [because] I don’t think oncologists are necessarily trained or comfortable discussing sexual health with their patients. There is a movement now in select centers where sexual health services specific to patients with cancer have started to gain footing. Certainly, in my own experience, I have started several sexual health programs in my own institutions. More recently, I’ve started working on what I call the oncology sexual health first responders clinic at the Lifespan Cancer Institute.
But what it takes is really some passionate provider to take up this area and say, “I will be the person to help my patients.” Without it, it’s hard to develop these services nationwide. But to meet these needs of patients no matter where they are, there are some very good resources—both in written form as well as online—that patients can access independent of their oncologist visits or independent, I should say, of the lack of discussion within their cancer centers. I do still believe that these are essential issues that need to be discussed to help improve survivorship, whether it’s a patient who’s living without any evidence of cancer or for patients still living with active disease. You should not have to give up your sexual health because of cancer. My hope is that going forward, these issues will be more readily available and addressed by cancer centers.
Are there services that payers are not covering that could improve quality of life for women after breast cancer? If so, what are they?
There are certainly some services that are not typically covered today by insurance, particularly for that group of women who had breast cancer. If you look at that group, those women who are premenopausal, because our therapies, probably now more than in the last 5 years, are geared toward estrogen deprivation, [PS1] women actively menstruating at the time of breast cancer are being put into treatment-induced ovarian failure and accelerated menopause. [Some] of these consequences are significant changes in vaginal health and the experience of sexual function as well as intimacy. Things insurance companies can do a better job of [providing] are consultative services, particularly for survivorship needs in a sexual health program.
There are certainly some emerging modalities that are available but are not covered services, such as vaginal laser therapies, which have been shown to be effective for postmenopausal patients, as well as some medications. The ones I’m thinking of that do have use in very selective situations might be things like PDE-5 [phosphodiesterase-5] inhibitors, for those women who are experiencing sexual dysfunction after cancer but are also on an antidepressant, for example. So yes, there are some medications, some procedures, and some techniques that could be covered more broadly as well as sexual health visits—and I’m hoping we’re going to see more covered than not-covered services in the future.How do you decide when a patient should receive next-generation sequencing testing?That’s not as straightforward of a question as you might think, and I think that’s a question for which the answer is evolving. At Memorial Sloan Kettering, we’ve had a longstanding interest in this approach. We have an in-house assay that we’ve been leveraging both to try and help individual patients as well as to understand the biology of tumors. So, perhaps our practice is somewhat different than what can be expected to be out there in general practice.
Now that there is at least 1 assay commercially available that’s FDA approved, and a number [that are] FDA authorized, I think we’re going to see an increased use of the technology, and our challenge is going to be to figure out when and how. I would argue that we don’t really know how to use it for early-stage disease, and I don’t think that’s the right place to do it.
I think that at the initiation of treatment for metastatic disease would be the most value-added time to think about using next-generation sequencing to try and understand what our options are. It’s important to take a look at what’s covered because not only does the assay itself cost money, but the results of the assay are going to cost money.
Right now, as I read the approval, it’s covered as kind of a 1-shot deal. It’s not a sequential process. So, I think getting that information early on in the strategizing of how you’re going to approach the patient with metastatic disease makes the most sense.
If a patient is tested and there is no available targeted therapy for them to be matched with, can the patient still benefit from the test?
Of course, the easiest thing is if we find a mutational profile that tells us there’s a high probability of benefit from a current commercially available drug. That’s perhaps the best-case scenario. The next would be if we see something that suggests an investigational approach if there is availability of that investigational approach. Now that would require that there be a clinical trial, that the clinical trial have openings, and that the patient be well enough to be treated on that trial.
One of the things I worry about is patients are imbuing this concept of precision oncology with almost magical ability, and there’s a bit of magical thinking going on in terms of what it might offer. Everybody wants to believe that they’ll have seen 4 or 5 doctors [who] tell them there really isn’t more to be done, that hospice care is appropriate, and that the next one is going to do some precision medicine and cure them.
That’s not going to happen in the overwhelming majority of people, and the question of whether it happens at all is really suspect. It depends on how sick the individual is. Once a person gets to the point where they’re too sick for clinical trials, they’re often too sick to tolerate or benefit from therapies, and that’s something that we have to bear in mind.
What role does next-generation sequencing (NGS) currently play in advancing precision medicine?
Precision medicine is a term that we’re still working on defining, and to some degree, these next-generation sequencing assays are what most people have in mind when we talk about precision medicine. One of the points I tried to make in the session we had this afternoon is that we’re not talking about the precision use of accepted targets. We’re talking about trying to use NGS to open a new therapeutic option for a patient [who] otherwise might not have it.
What we’re finding, and what the data I went through this afternoon show, is that, unfortunately, that happens in a very small minority of patients. So, as we work to move this field forward, we have to keep a certain balance between optimism and realism and help patients understand that this is not going to help everyone. In fact, it’s not going to help a very substantial percentage of patients. Arguably, the substantial majority. There’s a limited number of people for whom it’s going to be helpful, and that’s going to be very useful.
I think it’s also going to become more important as we start to see some therapies become available that are highly effective with a very rare target, and it’s not going to be practical, I don’t believe, to go searching for multiple targets separately when we’re looking for the needle-in-the-haystack kind of patient.
But if we can assemble an NGS assay that looks for a lot of different rare possibilities, that may be a more practical way to bring those therapies to patients.
Do you plan to prescribe Mylan’s biosimilar trastuzumab to patients? Would you switch patients from the reference product to the biosimilar, or just begin new patients on the biosimilar, and will payer coverage decisions affect provider and patient choices?
There’s always a big question about whether or not you would—okay, now the biosimilar is available, are you going to use it in your patients? In everybody? Are you going to switch patients who are on the originator to a biosimilar?
I think that there are a number of issues that we need to understand. In the [United States], that’s very much driven by insurers and what insurers are going to mandate. For example, with biosimilars for the filgrastim, the insurers, very quickly, many of them said, “you have to use the biosimilar because it’s cheaper.” And then what happens is, the institution—I work at an academic institution—changes over wholesale to say, “Okay, that’s what we’re going to give people,” so [that] you don’t have to worry about what the insurance said beforehand.
So that’s one thing that I think often happens, and with the trastuzumab—and we also switch people because, you know, supportive care it comes and goes, right? With the trastuzumab biosimilars, I think it’s going to depend on the price points and what the insurers and institutions say about if there is a real cost savings, and then they will want us to switch over to the biosimilars, which I am very happy to do.
I think these are agents which are biosimilar, so I don’t have a problem switching over. And I don’t have a problem switching a patient either, I just took a patient off trastuzumab who has been on it for 17 years and has no evidence of disease. We had a big conversation about stopping the trastuzumab and I said, “I really would’ve stopped you at 10 years, but you said no,” and she’s moving away now. But that’s a patient where you may have a patient on it for so many years; if you could have a drug that’s 20% or 30% less, that’s a huge savings over time, so it’s possible that those people who are on forever-maintenance trastuzumab in the metastatic setting, that that will be a situation where patients are switching or switched.
I don’t think that I would switch anybody that was in the neo-adjuvant or adjuvant setting on short-term exposure to the drug. It’s going to be an interesting time to see what happens.