Well, good morning, everyone. Nice to see you all. My name is Eric Wasatsky from MedStar Health, Georgetown University. My first disclosure today is I'm suffering from a medical condition called New Orleans voice. It is a side effect of merriment involving venues with very loud music. So I will battle through that today. So thank you for coming to our talk today that's based on our project that was funded by the Foundation for PM&R, which we'll definitely thank them quite a bit today. So first of all, I wanted to introduce my co-investigator on this study who has worked with me very closely on this project, Dr. Ami Chitalia. She is a medical oncologist specializing in breast care at the MedStar Washington Hospital Center and Georgetown University. Dr. Chitalia went to medical school at Tufts University, did her residency in internal medicine at Georgetown, a fellowship in hospice and palliative medicine at Mount Sinai, and then came back to Georgetown for her Hemonc fellowship. I was very honored to have the opportunity to meet her as a fellow. She started to gain an interest in breast cancer care at that time and actually took it upon herself to do a rotation in cancer rehabilitation with our team as a Hemonc fellow. So I've had the honor to know her since that time and then see her career grow as a medical oncologist. So she's been really integral with this project. As a medical oncologist really came to me. We kind of worked together on coming up with the idea for this study, has been really integral in our proposal and making this project happen along the way. So I feel very indebted to her for working with me as a colleague and I think is a great example of how we as physiatrists can work closely with our oncology colleagues to do fun things. So without further ado, I'd like to welcome Dr. Chitalia. Thank you, Eric, for the very kind introduction. It's a pleasure to be here. And you know, thank you for the opportunity for Dr. Wazowski and I to be able to present our work on the acceptability and feasibility of early cancer physiatry consultation to decrease AIMS in early stage breast cancer. It was a pleasure to work alongside Dr. Wazowski and the rest of the cancer rehab team. I'll start off by giving a background on breast cancer and the use of aromatase inhibitor therapy as well as the characteristics and common treatment strategies for AIMS. I'll then present our study concept and design and then Dr. Wazowski will present the study's results, conclusions and future AIMS. So breast cancer is the most common female cancer in the Western world. An estimated 297,000 new breast cancers will be diagnosed in 2023. One in eight women diagnosed with breast cancer in their lifetime between ages 18 to 90. So it's about 12.5% incidence. Though the incidence of early stage breast cancer is on the rise, mortality rates are improving through the use of improved screening with easier access to care and more sophisticated techniques for imaging screening, improvements in our adjuvant therapies and a decline in the use of hormone replacement therapies. Breast cancer happens in a series of steps. For hormone receptor positive breast cancer, this happens due to estrogen stimulation. So you can see here a duct lined with usual or normal epithelial cells. The next step is that these cells become bigger or hyperplastic. They then become atypical with irregular borders. This is called atypical ductal hyperplasia or ADH. The next step is that these atypical hyperplastic cells become cancerous, but they have not yet broken out of the duct. This is known as ductal carcinoma in situ or DCIS. The next step is invasive breast cancer where the cancerous cells escape the duct and then spread to the breast tissue. Finally, if those cancer cells spread outside of the breast tissue or the axillary lymph nodes, that is metastatic breast cancer. There are three major breast cancer subtypes. Hormone receptor positive breast cancers are the most common and comprise 70 to 75 percent of all breast cancers. Triple negative breast cancers are less common, about 10 to 15 percent. And then third are HER2 overexpressed or HER2 positive breast cancers, which comprise 15 to 20 percent of all breast cancers. The majority of breast cancer patients, as you can see, will require endocrine therapy as most will have hormone receptor positive breast cancers. The standard of care for adjuvant therapy for early stage hormone receptor positive breast cancer is endocrine therapy for 5 to 10 years. There are two types of endocrine therapy. First is tamoxifen, which is a CIRM, or selective estrogen receptor modulator, which sits at the level of the hormone receptor and blocks the action of estrogen. The second is aromatase inhibitors, which block the conversion of testosterone to estradiol so that it can no longer stimulate the breast tissue and cause cancerous changes. Compared with tamoxifen, aromatase inhibitors, or AIs, are superior in the treatment of hormone receptor positive breast cancer in postmenopausal women. Five years of AI has shown to reduce 10-year breast cancer recurrence by about 40 percent compared with no endocrine therapy. There are three major adverse effects of aromatase inhibitors, vasomotor symptoms and loss of bone density, and then AI-associated musculoskeletal symptoms, or AIMS. These can present in the form of joint pain, stiffness, or cramping pain, usually within the first three months of therapy. It can happen in any of the joints, but most commonly occurs in those listed. It can also present more focally in the form of carpal tunnel or trigger finger. Previous studies have demonstrated that up to 50 percent of patients will develop symptoms and 30 percent will rate their symptoms as severe. Symptoms resulted in these studies in 20 to 30 percent of patients discontinuing AI therapy, and it was found to correlate with a decreased 10-year survival from 80.7 percent for adherent patients to 73.6 percent for patients who discontinued therapy. So we can see here how important this phase of treatment is for breast cancer, for early stage hormone receptor positive breast cancer. The risk factors for AIMS have been reported to include previous hormone replacement therapy use, hormone receptor positivity, previous chemotherapy, and obesity. All of these risk factors may be potentially related to a greater decrease in estrogen concentrations when AI is initiated. Both pharmacologic and non-pharmacologic treatment strategies have been studied for AIMS. Pharmacologic treatments include acetaminophen and NSAIDs, opioids, supplements such as glucosamine and chondroitin, omega-3 fish oils, and vitamin D, for which there are mixed results in phase 2 and 3 studies, as well as duloxetine. And there is a randomized controlled trial using duloxetine against placebo, which reduced BPI scores, but with an increase in side effects in the duloxetine arm. Pharmacologic treatments include acupuncture and exercise, both of which were studied in randomized controlled trials and demonstrated a reduction in BPI scores. Though treatment options for AIMS exist, there is no data on the use of cancer rehabilitation consultation. Therefore, we pose the following clinical question. Is cancer rehabilitation consultation a feasible and acceptable therapeutic and or preventative intervention for AIMS? There were two primary aims for our study. Aim one was to assess the feasibility and acceptability of early cancer physiatry consultation to reduce AIMS symptoms in early stage hormone receptor positive breast cancer using a quantitative approach. Our first hypothesis was that early physiatry referral would be feasible, as demonstrated by greater than or equal to 70% show rate to physiatry clinic appointments. Our second hypothesis was that early physiatry referral would be acceptable to patients, as demonstrated by a TAP score of greater than or equal to 2.5 on the treatment acceptability and preferences or TAP questionnaire for greater than or equal to 70% of patients enrolled in this study. Our second aim was to explore the trajectory of pain and function among breast cancer patients on aromatase inhibitors receiving early consultation with physiatry. These were our inclusion and exclusion criteria. Our inclusion criteria were all patients who had ER and or PR positive early stage breast cancer, stages one, two, and three, or DCIS, stage zero. They had to have a good performance status. They could be pre or post-menopausal. If they were pre-menopausal, they were given ovarian suppression in order to receive their aromatase inhibitor therapy, so they did have to be a candidate for that treatment. They were all females greater than 18. They had to be able to sign a consent, and they had to be able to read and speak English. Our exclusion criteria were patients with stage four or metastatic breast cancer, patients who had other previous invasive malignancies within the past five years. Prior AI therapy was not allowed. Prior tamoxifen was allowed. If patients had any serious or unstable conditions that would prevent compliance, they were excluded. If they were currently pregnant or breastfeeding, they were excluded. And also, patients who had existing diffuse musculoskeletal symptoms or secondary conditions requiring ongoing monitoring or medication use with pain scale greater than five at baseline were also excluded. So 25 newly diagnosed early stage hormone receptor positive breast cancer patients who are candidates for AI therapy were identified and recruited at their medical oncology visit prior to AI initiation. Enrolled participants were referred for cancer physiatry consultation at the time of initiation of AI therapy, as well as visits at six-week, three-month, and six-month intervals, and more if required. A typical cancer physiatry consultation included a visit with a focused history and physical exam on the musculoskeletal system. Diagnostic tests, therapies, and other referrals may be part of the visit as follows. If patients were to present with diffuse symptoms, a typical protocol could include home exercise, PT, medications, and alternative treatments, such as supplements or acupuncture. Where patients presented with focal symptoms, the typical protocol could include diagnostic testing, such as x-ray or ultrasound, PT or OT, bracing, anti-inflammatory medications, or injections. Patients completed validated questionnaires during each of their physiatry visits, including the BPI short form, the WOMAC, and the QuickDash. Of note for our purposes, we did define AIMS as any new or worsening joint pain. Each patient was also given a small stipend for participation at study completion. I'm sure that many of you have seen or used the BPI short form pictured here. It asks questions about pain level and interference with daily activities, and higher scores indicate more pain. The WOMAC asks about pain, stiffness, and physical function, with higher scores again indicating worse symptoms. And here is the QuickDash, which is the disabilities for arm, shoulder, and hand. And again, higher scores indicate more upper extremity disability. In terms of the assessment of feasibility and acceptability, feasibility was assessed by percentage of the four physiatry visits each patient attended, and feasibility would be demonstrated if patients showed up to more than 70% of their physiatry visits. Acceptability was assessed by the validated TAPS questionnaire, which assesses perceived interventions, one, appropriateness, two, suitability for lifestyle, three, effectiveness, and four, convenience. Items are then rated on a five-point Likert scale from zero to four, with a total score computed as a mean of the four items. Acceptability was demonstrated by a mean TAPS score greater than or equal to 2.5 for greater than or equal to 70% of participants, as was determined to be an acceptable score in previous studies that used this questionnaire. All data extracted from MedStar EHR and collected from questionnaires was entered into a Red Caps database. I will then have Eric present the results and conclusion. All right, thanks Dr. Chitalio. So first of all, it's important to note that we have not collected all of our data yet. We have enrolled all of the 25 patients we intended to enroll in the study, but we have completed data on 19 of them and six more who are rolling through for kind of their final visits through our protocol. So please keep that in mind. The other thing to mention is that as we're not complete with the study yet, we're really just kind of starting to look at the data. We really got our first statistical analysis literally just a few days ago. So we're kind of sorting through this and we'll present to you what we have kind of looked at preliminarily. And I'm also really hoping that with the wonderful brains in the room today, as we present this, if you have any suggestions for us on ways that we can look at the data and kind of present this as we move towards publication and other presentations, we'd love to hear that from you as well. So yeah, so we have 19 who have gone through this. So first of all, patient demographics, our mean age is 66.1, mean BMI 30.6. In terms of cancer stage, you can see the majority 1A. So certainly not as many higher stage. I do wanna point out with our patients, 14 of the 19 we have data for now are African-American patients. And we have found that a lot of the publications, certainly from our oncology group in our DC area, do garner a lot of interest because of our high proportion of African-American population in our region, as opposed to a lot of oncologic studies that tend to have a higher Caucasian population. So I think this adds a different perspective to our data. So kind of looking at what we've analyzed for treatments that have been provided at these visits for our patients who have gone through our protocol. So first of all, in terms of rehabilitation, the recommendations, we've had eight of our 19 that were specifically referred to physical therapy, no specific occupational therapy referrals as of yet. In terms of medications, so you can see here, we have, in terms of topical medication, we've actually had 12 of the 19 in which topical medications have been recommended or used. Over-the-counter medications were actually only used in three of the 19 patients there as well. And let me just see, we're good. You can see my pointer there, that's helpful. And then in terms of prescription medications, there were only two prescriptions that were provided, medication prescriptions for our patients, and actually both of those were meloxicam for kind of short courses for these patients. Other treatments, acupuncture was recommended for two. Yeah, two of our patients there. In terms of bracing was recommended for two, and that was specifically thumb spica splints for wrist-related symptoms. And only one injection was performed, that was an intra-articular hip injection that was performed for a patient. So that's kind of the main treatment results that we are gonna present today, and there will be more data forthcoming as we complete going through all of our results. So the purpose of this study, again, was a feasibility, acceptability study, so really getting at our primary measures. So in terms of feasibility, all visits were attended. We did have three patients that had one virtual visit, which, to be honest, at least in our protocol at the beginning, that was not something that we explicitly discussed, whether or not we'd have virtual visits, but a lot of the patients we take care of, obviously they have a lot of doctor's visits, a lot of our patients have significant transportation concerns and things that have come up, so we did have some flexibility there to allow at least a few virtual visits there as well, I just wanted to bring that up as a potential confounder, as obviously, with our assessments, can't do as much of a physical exam, so certainly wanna note that as well. So in terms of the acceptability, Dr. Jatalia kind of talked about this questionnaire that we used. So again, kind of looking at this question by question, and first of all, you can see that the mean here, down this column. So we basically said before, a score of 2.5 or higher is considered acceptable as per the published data on this questionnaire. So as you kind of go through this, effectiveness, I think I'll use this, it's easier. So yeah, the question the patients are asked is how effective do you think this treatment will be in improving your blank condition? So in this, we call this aromatase inhibitor-induced musculoskeletal symptoms. Next one, how acceptable or logical does this treatment seem to you? How suitable or appropriate does this treatment seem to you? And how willing are you to comply with the treatment? So those were the questions they were asked, and as you can see here, we were above 2.5 for all of those categories, 2.6 or above for those. So again, we do have some more data to review, but certainly at this point, certainly looking acceptable by what we've collected so far. So in terms of the functional and pain measures, as Dr. Chitalia mentioned, we looked at a few of these. I think I definitely wanna say that that was kind of our secondary measures. We did wanna collect some of this to kind of look at it, but without a control group, it is difficult to make a lot of firm conclusions based on this. I'll kind of show you what you have so far, what we have so far and kind of what we're thinking about how we can potentially look at this, but would love to hear your thoughts as well. And it's really different. We talked about maybe looking at some historical controls. A lot of the studies out there were on patients who actually had AIMS kind of at baseline, not patients like ours that we were seeing kind of preventatively right at the beginning. So it's certainly difficult to compare our brief pain inventory to patients in another study of patients of all of which who had AIMS. So definitely not an apples to apples comparison there, but there may be some other ways to look at it. So our graphs so far in terms of the brief pain inventory with on the left being the mean pain severity scores and on the right the interference. How much does their pain interfere with their functional activities? And this is going across from baseline to six weeks, three months, six months, et cetera. So again, difficult to statistically come to really strong conclusions here. I mean, I think one of the things that we wanna try to explore is, what does this curve look like? And one of the things I was gonna mention at the conclusion, I'll mention it now, is that it may be interesting to kind of look at how this compares to kind of the incident studies. So we're really looking at incidents kind of following them over time. And is it possible that our curves may be a little bit flatter than the AIMS incident studies potentially due to physiatry getting involved earlier? Because as we mentioned before, the higher scores are worse for all the measures we looked at here. And it's a little bit interesting here to see that it was kind of peaked up at three months and came back down. And were there any interventions that were provided during this period, maybe when symptoms were starting, that maybe made things come back down? And you can see a little bump here and coming back down. I'm certainly not gonna say to you today that this is something statistically significant, but these are some of the things that are on our mind as we continue to explore this work and potential future projects. WOMAC. So yeah, similarly, you can kind of see there's a little uptick, but relatively flat, not a big change over time there as well. Remembering that a higher score is worse with WOMAC. And same with QuickDash. A higher score is worse in terms of upper extremity function here. And a little uptick, but relatively flat. But perhaps, what if we lived in a world in which patients, without a physiatry consultation, this is really kind of, this bar's really moving up and their function is worsening. And if we were to do a controlled study in the future, could we show a difference there? I think that's something exciting to potentially think about. So a few conclusions here, just based on the data we were able to review. So first of all, a number of our patients were referred to physical therapy. So that's certainly something that would be a common intervention for our patients. Very few, at least that we saw, based on our assessments, required prescription medications, but a lot of them used topical medications. It seems to be very feasible. So again, that was our primary measure, feasibility and acceptability. So our patients made all their appointments just with three virtual. So certainly seemed quite feasible for our population. And also seems to be demonstrating acceptability, but we do need to kind of finish our data review. What else? Oncologists and physiatrists can work together as an interdisciplinary team for projects like this in clinical care. As part of these visits, if we're seeing these patients prospectively, we can prescribe education and counseling. Our oncologists certainly do this as well and do an amazing job of it. But I think having another layer, maybe looking at from more of the functional perspective of talking to our patients about symptoms that they could potentially have and kind of getting ahead of the game. All of these visits, we would talk to our patients about exercise and hopefully that would be another layer of inspiration for our patients to be active while they're going through these treatments. And the third point here, which I certainly wanna bring up is, I think this type of work, I think what gets me excited about this, I don't think we have more work ahead, more to be done, but this line of thinking, all of us at this conference here, we're all thinking, there's a lot of value-based lectures here, what is the value of physiatry? Where do we fit in? How do we make a difference? And I think what gets me excited about this line of thinking is, this is really something that's very specifically looking at not just rehab, not just an injection or a medication, it's looking at physiatry, it's looking at us. And what is our role? How can us being involved in that team make a difference for our patients? And Dr. Chitalia and I were talking earlier about this today, is there's these great palliative care studies that are really just looking at what kind of difference does it make having a palliative care physician or team take care of patients, and amazing studies looking at oncologic outcomes. And there's a great PM&R paper looking at using that as a blueprint for things that we could do to really try to demonstrate how we can make a difference, not just with function, we all know we do that, but actually potentially oncologic outcomes, as you can imagine here, as Dr. Chitalia mentioned, adherence to these medications affect oncologic outcomes, and what if we can demonstrate that we can make a difference there? That's exciting to me. And yeah, we'd love to hear ideas on how we can further look at this data. We have some references for you here. This is uploaded. It should be on the app, so you can access all these references. And definitely wanna have a couple of shout outs today. Certainly the foundation for funding this. Dr. Cat Power is here today, who's also saw a lot of these patients and has been part of our protocol, big part of our protocol. Stacey Malloy is our research coordinator who does all the amazing legwork of hustling these patients over to our clinic to do the outcome measures and making sure patients come and can come across the street from our cancer center to our rehab center to make sure things happen. Our patients need that navigation. Odeh is a Hemock fellow who's done a lot of work, especially with the statistics on our study. Mishetu is our statistician who's been helping us. And really all of our last and current cancer rehabilitation fellows have been helping out and participating in this. Some just at the ground level and some as we've been actually seeing and taking care of these patients. So our contact info is here. And we would absolutely love to hear your questions, comments, thoughts, ideas. All right, and this is on the Zoom. So for anyone who has a question, please come to the mic so anyone logging in virtually can hear. Thank you. It's definitely an excellent display of your initiative to tackle this idea in regards to where physiatrists fit in the grand scheme of medicine and working cross-functionally with other groups, such as oncologists. I do have a few questions. I did notice your patient population is diverse, which I really don't see that often, to be honest with you. I think that that is promising. However, I did notice, as you mentioned, that there are no controls. So it's difficult to not draw conclusions in terms of the significance, but as the data is coming in, do you have any plans to have a control group later so that further analysis regarding the significance can take place? Yeah, sure. Yeah, thanks for the question. So when we looked in the literature, when we were sort of brainstorming this concept and this protocol, there was nothing like this out there. I'm using physiatry consultation as an intervention. There are studies on aims with exercise, with acupuncture, with Cymbalta, duloxetine, but not the actual consultation. So the first thing we wanted to do was to demonstrate whether or not this type of intervention would be feasible to do. Would patients actually show up? And then also, was it acceptable to them? So it is exciting because I think even though we don't have all of our data, so far we have seemed to meet those two endpoints. So I think a next future step would be to do, as you said, a more randomized, larger controlled study looking to see if the intervention actually pushes the needle on adherence to aromatase inhibitor therapy. Thank you so much. Hi, Dr. Bargo. Hi. I have a few questions. So if anyone else has questions, come behind me so I won't stay too long. So time zero for you guys was the start of aromatase inhibitor treatment. So were some of these patients, like they must have already been having symptoms like post-mastectomy and maybe even formal therapy already? Or were they all totally new to the MNR? Yes. There was one patient that we've seen so far that had seen us for one visit prior to the AIMS protocol for lymphedema prospective surveillance. But other than that, they were all new, healthy, doing well patients that had already seen our oncologists. Dr. Jatalia, as well as some of her other colleagues, had been given their prescription for their aromatase inhibitor, and basically said, go to your rehab consultation, and then right after that visit, you can start your medication. So then, as far as what you're treating, did you separate, like, does this seem like an AIMS phenomenon versus maybe some more local, regional post-mastectomy, or this is any, you know, treatments? Yeah, I mean, I think, at least as per what we're talking about today, I mean, I think the symptoms that we're kind of including in this are not what we would traditionally call post-mastectomy symptoms. You know, chest wall issues, we're really talking about the more traditional, you know, joint and tendon-related pains, and new symptoms that have started, you know, after they started the AI. And then, with, say, a physical therapy recommendation, I see a lot where it's recommended, but the patient might not necessarily follow up, and were you tracking that, or do you think that might have played into some of the results? I love that question. We did not, but it would be very easy for us to look at that, and that's a great, I have my computer here, because I want to take notes. That's a great suggestion that we can definitely look at. Okay, I'm gonna give someone else a chance. Yeah, I'm sorry to interrupt. Yeah, that's a great idea. So, when I was in residency, I did kind of a survey, or a retrospective study of what we were doing at Megan Nelson's clinic, and kind of the idea behind it, and this is kind of what it seems like you're doing as well, is laying foundational research, because you have to kind of see what you're doing, and kind of laying, like, hey, is this feasible? Are patients gonna come? Is this type of a program gonna be viable? Do you need to have individual appointments, like a more traditional referral-type base, or do you need to have a multidisciplinary clinic, kind of like a ALS-type clinic, where you have the oncologist, the therapist, and everything rotating in the room? So, I think this is really important work, just to figure out, how do you intersect physiatry into this program that's feasible? And I think one of the things that would be interesting down the road is to partner with a place that's not in the middle of the city, that's more remote, and see, like, hey, what are the challenges for those patients that have to come in from, for instance, the middle of Kentucky to get to Louisville, because that's where their oncologist is, whereas, when you're in Georgetown, you got Bethesda, Silver Spring, DC, everyone's right there, right? And so, it's like traveling patients. But I did miss the very beginning, and I kind of wanted to just clarify in my head, so maybe I could ask more pertinent questions. Is the 30,000-foot view for this research to determine how you can prevent AIMS? So you're trying to get a physiatrist involved before any of the interventions happen. So then, the problem is, okay, well, now we have all of these patients that are coming to you, but now a portion of them may not have actually ever needed your services, so now you're increasing cost in patients coming to you, versus looking at the reactionary model of, okay, now we are just getting patients who need this, but we're missing some over here that never made it to us. Is that kind of the idea behind all of this? Yeah, so that's a great question, too. So I think your point is well taken about looking at other places outside it, because we're across the street, so it's very easy to do something like this, I agree. I think for our patient population, just kind of trying to look at their risk factors for AIMS. Like, they come from urban D.C. In terms of socioeconomic status, it's a predominantly African American population. A lot of patients come from the neediest wards of D.C. They don't have a lot of access to care. So I think looking at them from the beginning, I think it's both prevention and treatment, right? So I think if we don't identify that patients are having AIMS from the beginning, it's then hard to then think about whether, they'll be non-inherent and we wouldn't even know. So I think, again, this study we were just looking at, is it feasible, is it acceptable? And to be honest, with the patient population we work with, the fact that we had 100% feasibility was really amazing to us. They showed up, that's great. Yes, they did. And we had a great team to help support that in terms of our research team. But they showed up, so we did demonstrate that. But I think doing it from a baseline, so that we don't, in a future study, so that we don't miss patients who are not going to be inherent, I think would be important. And then I guess my last follow-up point slash question would be, I see a lot of GBMs and stuff coming over from the acute side. And the big question a lot of those patients have are, okay, now I'm in inpatient rehab. I'm delaying the initiation of my chemotherapy and treatment, what's gonna happen there? There's a lot of stress and anxiety about this. You're kind of catching those breast cancer patients once they're transitioning to their kind of surveillance and preventative stuff. So as you're designing the protocol, what would be interesting to see is, okay, are you just doing the initial consultation, providing education support, and then saying, hey, I'm here for you if you need it? Or would there be value in delaying the onset of that aromatase inhibitor by like a month? So you can get them in a very condensed physical therapy protocol to build a foundation of strength and mobility and things like that to reduce the onset of AIMS. Is there gonna be a benefit to that? So you're just delaying treatment a little bit. Is it gonna cause an oncologic problem? Maybe, but could you intervene more aggressively in this window to prevent things from going on further? It's just like, how involved are you gonna be? And so I just thought that might be an interesting point to look at. Yeah, so you're getting at a prehab study for AIMS, which this is not, but that's certainly something. You're just going to see, okay, how can we intervene and what can we do? Right, yeah, so we don't know a lot about prevention, and that would be one potential way to look at that. But yeah, like Dr. Jatalia said, I think as we look forward to other potential studies, I think we could be looking at prevention of AIMS. We could be looking at adherence to medication. I think all of those outcomes could be very meaningful. Hi, my name's Evelyn. I'm a cancer rehab fellow at Memorial Sloan Kettering currently. I just wanted to get a little information. You had said in the background slides that the AIMS symptoms appear at three months, and it looks like you're following them six months, and then you said maybe more if needed. What is the timeline in which patients, if they want to, they're having a lot of AIMS symptoms, and decide to switch off? When in the period since they started do they usually transition? Is it usually at the three months since they started and they switch because the symptoms are most severe, or is it more than six months later? Should you be following patients even more further along in their course of treatment, like a year, two years? When they typically end up switching their AIMS. Yeah, so what I find during their med-onc follow-ups for toxicity checks for on the medication is there are maybe a couple patients that will develop symptoms later, but the majority, I would say, develop them within six to eight weeks. And typically what we do, so there are, I didn't get into this in the background, but there are three different types of aromatase inhibitors. Two of them chemically are a non-steroidal ring. One of them is a steroidal ring. So typically I, and I think most med-oncs in practice, will try to switch from one to the other. Sometimes it's just about finding the right fit. So sometimes when we switch to another one, the AIMS symptoms do tend to be better, not always. But I do find, and then there's always tamoxifen to go to if, you know, in certain situations, if we find that that's safe for the patient in terms of its different adverse effect profile. So we follow them fairly closely in that first six months. And I think, you know, our med-onc appointments were in the same, you know, six week, three month, six month interval, yeah. So then at that point, do you decide to go, maybe we do some more rehab type of interventions with your study if they're starting to develop symptoms or are you also deciding, are we switching to a different aromatase inhibitor? Yeah, so all the patients, along with the four visits for physiatry, they also got their routine medical oncology visits too. So we were still doing everything we normally do. So we weren't doing anything differently. Is that, I don't know if that's your question. I think so, I was just wondering if that might change what some of the findings you're seeing is like, are they improving because you switched them to a different drug or it's because of the rehab interventions? Yeah, so we actually, that's a good question. I don't know if we know how many of them switched. That would be good data to collect just to see if that, you know, what that adds to the results. That's a good question, yeah. Thank you. Yeah, we would love to look at that. I think that would be super helpful. And, you know, I mean, to your point about, you know, should we be following them longer? I mean, maybe, you know, studies have shown it's quite atypical for new AI-related symptoms to occur after about a year. So, you know, maybe you could make an argument that, you know, following them even longer could be beneficial. But really this was getting me thinking about what Steven had said before is like, you know, it's not necessarily preventative because we don't necessarily know what will prevent it. It's more of like the concept of like, can we catch it early so it's less morbid, we can intervene before symptoms get more severe. Yeah. Hi, Jim Atchison, Mayo Clinic, Florida. And I apologize, I missed the very first part. But so you're referring everybody to PT after the initial consultation? No, all of the patients are seeing a PM&R physician specializing in cancer rehab. But we did present, you know, a large number of the patients the physiatrists saw did end up getting PT referrals. And so my question is, those all go to a specific PT that works in your center with your program, not going out into the periphery and getting unknown therapy as we all know, PT in one place is not always the same as PT in the other places. And I was just gonna suggest that might be a variable when you start looking at PT, you may wanna look at how they came to the person that you would think has the expertise versus some may have gone elsewhere and we know they may not get the same protocols. And then please, when you publish, if you could put in what the therapist did. I hate reading our articles in our journals with they went to PT. Great, okay, but it doesn't tell us what we should be prescribing for them when they do that. So I would suggest when you do publish, if you would put in what you feel is the best protocol so that I can extrapolate that and helping my therapist do the same thing. Thank you. Yeah, that's a great point. Yeah, and we have not specifically looked at that, but it would be easy to look at where they went for therapy. My guess would be the majority of them went to see our in-house therapist, but there may have been some that went outside. And really to your point, I think the tricky part of looking at the benefits of a particular medical specialties consultation is that obviously the recommendations are gonna be extremely heterogeneous. But I mean, the palliative care studies, they did that very well. They were really, the things that palliative care might recommend could be a wide variety of things, but they were really looking at what were the outcomes of that consultation at least, even though the recommendations could vary. Hi, anecdotally, I can say that I saw a couple of these patients and if they had post-mastectomy pain, I did address that and it was kind of like in a separate kind of thing. And none of the ones I saw switched AIs to my knowledge, so I can kind of go, but I can't speak to all yours. But I was just curious, you mentioned for the risk factors for this, and I was kind of thinking in terms of next steps and selecting patient populations that might benefit from this and looking at more closely. You mentioned hormone positive, which obviously these patients have to be because, so is it the percentage that they are ER and PR positive has been correlated to a higher degree of AIMS symptoms? Yeah, so I don't know that there's specific studies on that but I know that there are a couple of studies, I think we just briefly discussed in the presentation, that potentially the level of pain symptoms could correlate to the decrease in estrogen concentration. So probably, again, I don't know that that's been explored or looked at, but I would assume that just looking at it physiologically, that the higher ER, PR they have, the more symptoms they may have, because it's more estrogen deprivation. Yeah, I don't think I've seen that, that's why when you said something, I was like, ooh, I don't know that, that seems like something that would be an interesting article or research project to work on. It is, yes. Because, yeah, if you can kind of establish that, then you know, kind of like prospective surveillance for lymphedema, you could be like, ooh, we need to get those people in for us sooner. Yeah, so, yeah. Yes. Yeah, and just building on that risk factor question, I mean, they were not generally incredibly high pain levels and they're not incredibly high number of patients, though still a great start, but just looking at other things like correlations with stage of disease or age or maybe socioeconomic variables. I mean, it gets to be a lot of variables, but it is kind of an exploratory study, so I don't know if you're doing any of that with the data. And another question, so the outcome measures, it's a lot of, you know, patient reported outcomes, which is great, but sometimes I feel like there can be almost like a moving goalpost with that as the patient comes in the clinic and they start to realize, oh, somebody's paying attention to these issues that maybe it would have been less reported at the beginning, but as they get dawns on them that they might be helped, there might be, they might not really be worse, but there's more reporting possibly. So I'm wondering if there's any like objective measures to, you know, companionize that. Yeah, that's a great suggestion. I mean, we did not include that in this, but that would be really, really helpful for future work, I agree. Yeah, and I think for this study, since it was just a small feasibility study, we did have patients who didn't have a lot of risk factors like, you know, pain score of less than five, no previous, you know, symptoms, but I think if we were to approach a bigger study, we'd probably have all comers. You know, yeah, so. Hey. Thank you for the talk. My name's Sammy. I'm one of the PGY-4 residents at New York Presbyterian. I was just curious, along the same lines of how there's variability in physical therapy referrals and what patients may get out of that, acupuncture as well. As a resident, I'm not routinely referring to acupuncture. I'm just curious how your relationships are with acupuncturists, and how do you kind of, I guess, figure out which patients you're going to send out to for AIMS symptoms specifically? And what does that kind of treatment course look like for that? I would say, at least where we are, access to acupuncture services can be challenging. But most specifically, that's one of the interventions we really look at for more diffuse musculoskeletal symptoms, because it's really going to have whole body effects. And I think sometimes I'll chit-chat with my oncology colleagues who may have seen some of that research, like, oh, acupuncture may help. I mean, if they're coming to me with wrist pain, I'm going to treat that with a rehabilitation approach, not acupuncture. I'll use the acupuncture for more diffuse symptoms. But yeah, the access to that care can be challenging. I don't know if you have any specific people you use, or? Yeah, we used to have someone specifically that, pre-COVID, was actually housed at Georgetown, at the Cancer Institute. And so we'd refer to that person. It's been a challenge as of the last few years. So I think it's something we could probably work on trying to get a relationship with an acupuncturist. Thank you. And this is just for my curiosity. I noticed that you excluded individuals with stage 4 breast cancer. What was the thought process behind that exclusion? Yeah, so that's a great question. So typically now, the standard of care for first line, for metastatic hormone receptor positive breast cancer patients, is a combination of aromatase inhibitor therapy with another therapy called CDK4-6 inhibitor therapy, which sometimes can have its own side effects. And then, of course, metastatic cancer itself, it's hard to, you know, I think it would be hard to tease out what symptoms would come from the AI versus what would come from cancer. If patients, you know, typically cancer, metastatic breast cancer goes to the bones, lymph nodes. So I think it would have been just a little bit more challenging to follow those patients. Yeah. That made me think of a question. For a possible control for you guys, because I mean, how many of these patients you're, because one of the ways you define aims is if they start developing like pain in the joint. What if that's just run of the mill arthritis? It has nothing to do with aromatase inhibitors. So I guess my question is for ERPR negative patients. Obviously, you're not going to be treating them. Is there any data behind their generalized pain profiles? Because that could be a population that you use as a control to monitor, OK, what the intervention there would be the aromatase inhibitor. And now we have all these new pains. So in the population that's breast cancer positive, they have breast cancer. Yes, it's a different genotype. How many of those, given the same age and demographics go on to develop just run of the mill things that we could attribute to musculoskeletal issues like just arthritis or whatever? And then what can we attribute more towards the aromatase inhibitor? Is it more of an additive effect? Like, hey, it just makes you more pronounced to feel these MS cases? I don't know. I don't know how feasible or how good of a control that would be, but something to consider as a control in ruling out just the normal progression of musculoskeletal disease versus the AI. Yeah, I mean, AIMS is always defined as new or worsening musculoskeletal symptoms, not necessarily. It has to be something. Yeah, absolutely. So yeah, these patients, sometimes when we image, they have joint abnormalities, and sometimes they don't. But it's really more about the new symptoms. In terms of that idea as a control group, I have no idea. We'd have to think about that. So I think, obviously, well, we couldn't use ERP or negative because they wouldn't be getting aromatase inhibitor therapy. So. Yeah. I think it's tough, too, because a lot of these patients, it's very heterogeneous what treatments they're getting beforehand, too. Some patients are getting chemotherapy. Particularly, we use a lot of taxol chemotherapy, which is known to cause arthralgias. So that actually might be a good thing to look at as a subset patients who got previous taxol versus who didn't. I think that was one of the risk factors noted was previous chemotherapy. So in a larger study, that would be something definitely to look at as a subset. Yeah. How in the LSDK world would you have patients before they have breast cancer, have arthritis, and how much knee injections and nodes would accelerate arthritis to actually set them up for worse conditions? Yeah. We don't know. I mean, we were trying to account for that by excluding patients with significant pain prior to the initiation of the AI. I just had a question. Would the control group just be patients on the medications that just were not referred to us? Right. Yeah. I think that that's where I was confused with. Yeah. So they'd still be taking it, but they just wouldn't have us. Right. Because the intervention is you guys. Yeah. Exactly. Yeah. Thank you, Dr. Bauer. We really appreciate your great questions and suggestions, and we'll keep you all posted on how this all develops. Thank you so much. Thank you.

feasibility study

acceptability

early cancer physiatry consultation

AI-associated musculoskeletal symptoms

AIMS

hormone receptor positive breast cancer

physiatry referral

pain and function

aromatase inhibitors