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Answers straight from the experts on the latest news and topics in oncology

Tuesday, February 4, 2020

With Katherine E. Reeder-Hayes, MD, MBA, MSc, Assistant Professor of Medicine at University of North Carolina School of Medicine

By Sarah DiGiulio

One of the factors that may be behind some of the disparities between health outcomes for black women with breast cancer compared with those for white women with breast cancer may be delays in how long it takes from the point of diagnosis for women to start treatment and how long the treatment takes once started. That’s according to research published in the journal Cancer (2019;125:3985-3992).
An analysis of 1,328 black women with breast cancer and 1,331 white women with breast cancer showed that the black women tended to start treatment for their cancers later than white women (even when receiving similar treatments), and similar therapies took longer to administer the full course to black women compared with white women. The black women were 1.73 times more likely to wait 60 days or longer from being diagnosed with breast cancer until they started treatment. The black women were also more likely to be in the highest quartile of treatment duration (when factors like other demographics, tumor type, and treatment type were controlled for).
And finally, the data found that women whose treatment took longer and those who had longer delays in starting treatment tended to have worse outcomes (though that trend was not statistically significant).
The data doesn’t necessarily explain why on an individual level the delays are taking place, says the study’s first author, Katherine E. Reeder-Hayes, MD, Assistant Professor of Medicine at University of North Carolina School of Medicine. “For instance, we don’t know whether a woman chose to put off an appointment, whether the oncology providers serving her community don’t have enough resources to see all patients quickly, or whether another health problem, lack of transportation, or lack of money to pay for care might have been the reason for the delay.”
But the data do point to some significant realities that bear on racial disparities in cancer outcomes. Here’s what Reeder-Hayes told Oncology Times about her group’s work.

1. What are the key findings from your new research and how do they differ from what we already know about these kinds of disparities?

“We found that, after taking the characteristics of a person’s cancer and the types of treatment they received into consideration, black women compared to white women were more likely to have lengthy waits between diagnosis and starting any cancer treatment, and also took longer to finish similar treatments. We know from other work that
timely treatment—whether that is defined as getting started quickly or proceeding through treatment at the ideal pace—is connected to better cancer outcomes. So this is very concerning.
“This study is a type of disparities research that tries to understand what is different about the treatment experiences of one group of people (in this case, black women with breast cancer) that may explain worse cancer outcomes that have already been observed. This type of research is an important step along the way to actually intervening to
improve disparity because a pattern of worse cancer survival can be observed without much understanding of why that pattern occurs, and it takes understanding the ‘why’ to design and test good interventions.”

2. What types of interventions might eliminate these types of disparities in the way breast cancer treatment is delivered and, ultimately, outcomes?

“One intervention with a lot of potential is the use of oncology navigators. These individuals do not have to be medical providers, but should be familiar with the community they work in and the cancer care resources in that community—and they should have good teamwork with cancer care providers. The health system is very complex and fragmented. The idea of navigation is that the patients at highest risk of getting lost in that system, such as those with lower health literacy, less support from family or friends, less financial resources, or other barriers, would get extra help from a knowledgeable person to figure out their way through the system to the care they need.
“While we can’t fix everything that’s broken about the cancer care delivery system, I believe we can think creatively about ways to work with patients: Do I really need that next test before we begin treatment, or can we get it later? Did I ask my patient if she will be able to afford the medicines we just prescribed? Does my patient have the information needed to let me know quickly if they get sick during treatment?
“We can also think about how we allocate limited resources, like new patient appointments. Are we using a system that schedules the most urgent patients first, or just takes the next person in line, or accommodates a more privileged patient first? These simple practices all add up to more or less timely treatment, and our patients need us to be their advocates in this area.”

3. So what’s the next step to help make some of these changes happen?

“Many of the things that could make the health system more patientfriendly, like proactive telephone calls to check on symptoms or a navigator to intensively guide a patient, are fairly expensive and are not paid for by insurance companies. This makes it challenging to convince health systems to provide adequate numbers of staff in these areas. We hope that, as cancer care reimbursement begins to be better linked to quality metrics, systems will appreciate how these team members could improve their patients’ outcomes.
“We are planning lots of exciting next steps, including reaching out to patients during some parts of breast cancer treatment using telephone counselors rather than requiring them to come in to clinic and creating maps of cancer care resources across the state that help us understand the gaps in what’s available and how those gaps connect to
the ultimate outcomes such as cancer survival.”

Tuesday, February 4, 2020

With Gabrielle Rocque, MD, of University of Alabama at Birmingham

By Sarah DiGiulio

How do you, as a clinician, decide how to treat a patient with cancer when the patient sitting in front of you does
not look anything like the patients in the clinical trials that have established the efficacy of the known treatments
for that cancer? Research shows that two of every three new cancers occur in older adults, yet these older
adults only account for 30 percent of clinical trial enrollment, Gabrielle Rocque, MD, Assistant Professor of Medicine in the Division of Hematology & Oncology at the University of Alabama at Birmingham (UAB), and Grant Williams, MD, Assistant Professor at The Institute for Cancer Outcomes and Survivorship at UAB, noted in an editorial (J Clin Oncol 2019; doi: 10.1200/JCO.19.02588).
In the editorial, the coauthors argue that clinicians need more evidence when it comes to making decisions about how to treat older adults with cancer. More evidence from clinical trials, they note, would be ideal; but in the absence of those studies, other steps can be taken to learn from cancer databases and to better understand patients’ unique preferences about treatment that could impact treatment decisions.
“Right now we are in a data-free zone. And in many cases, we don’t have any data on frail older adults. That’s a particular population that is vulnerable and may in fact not be appropriate to give the most intense chemotherapy regimens,” Rocque told Oncology Times. “But we don’t know because those studies haven’t been done to say how should frailty impact decision-making.”
The data-free zone means these patients are at risk of both being undertreated and of being overtreated, she said.
The editorial accompanies a report by a group of FDA researchers that evaluated the efficacy of a group of targeted therapies in older women for the treatment of metastatic breast cancer (J Clin Oncol 2019; doi: 10.1200/JCO.18.02217). Here’s what else Rocque says about the editorial.

1. Your editorial refers to a study that looked at the efficacy of novel targeted agents in treating older women with breast cancer compared with younger women. Why was this study so significant to the points you make in the editorial?

“For this editorial, we started by reviewing the manuscript and saw that the researchers had done an excellent job of really thinking about how older adults are doing with this particular class of drugs [CDK4/6n inhibitors and aromatase inhibitors].
“They highlighted the efficacy benefits that were seen in older adults. At the same time, there was definitely a decline in the patients’ functional status. The message of my editorial is that we should look, not only at efficacy outcomes, but also other patient outcomes, like functional status, which are really important factors that older adults, and frankly all patients, consider when making decisions.
“We have a real need to fill in this evidence gap because we care for a lot of older adults and we don’t have great data, not only on efficacy, but also on how treatments are impacting things that are important to them.
“I, as a clinician, work with metastatic breast cancer patients and have done a fair amount of research in terms of preferences in decisions.
We’ve seen that individual patients’ preferences often include many different facets of life beyond what we typically think about as physicians, which is how effective is this drug in controlling the growth of the cancer, what are the potential toxicities, and what are the costs.
“Patients are also considering [things like] the impact on their functional status, how is this going to impact their families, are they going to be a burden on their families, and what are the implications for their emotional state.
“So this to me provided a great opportunity to highlight that we don’t enroll older adults in clinical trial as much as we should, which leads to an evidence gap. Without good data, people will often do things that aren’t evidence-based in terms of reducing the intensity of treatment without having the evidence to back that up."

2. What needs to change and what are the next steps to initiating these shifts?

“An optimal approach is doing more studies that are specifically looking at older adults—and really including all of these measures, like frailty and geriatric assessment.
“A second level is making sure that we are promoting enrollment of older adults into our regular clinical trials. And I think that is something that is very actionable that we really need to work on.
“And I think the third level is conducting analyses in populationlevel, real-world data, such as using some of the newer electronic databases like ASCO’s CancerLinQ and Flatiron. These types of analyses can be done to understand what are the practice patterns and outcomes for populations that are not well-represented in clinical trials.
“One approach is relaxing some of the eligibility criteria [for clinical trials]—so actually including patients with comorbidities because that is what we see in a general practice.
“I also think there needs to be more support infrastructure for educating both the patients and the clinicians about the importance of including older adults in clinical trials. Additional work needs to be done to understand what
are the barriers [that] prevent older adults from participating.”

3. What is the bottom-line takeaway message?

“Number one, we need to evaluate outcomes for older adults with cancer, and as practicing clinicians really have an understanding when you are applying clinical trial results to populations that aren’t well-represented who were included in the trial and how that might differ from the patients sitting in clinic. And to that end, having clinicians referring older adults to trials is really important.
“And finally, I think it is incredibly important to ask patients what’s important to them. And for clinicians in an area where we don’t have perfect evidence, I think it’s incredibly important to understand what is the patient hoping for out of their treatment and what are the aspects of their life that are particularly important to their quality of life—and really think about how the treatments we’re delivering align with those prefere

Tuesday, January 7, 2020

With Holly Fernandez Lynch, JD, of the Perelman School of Medicine at University of Pennsylvania

By Sarah DiGiulio

For some patients with life-threatening conditions for which all approved therapies and treatments have failed, investigational drugs might be sought out. If those patients cannot access that drug through a clinical trial, two pathways exist that can make those medications available: Expanded Access and Right to Try.

The former is a process that has been around for decades that involves both the FDA and the company who makes the drug weighing in on the decision about whether or not the drug will be made available to the patient. The latter is the result of a new 2018 federal law that takes the FDA out of the equation.

In a recent commentary article, Holly Fernandez Lynch, JD, MBE, and her coauthors argue the case for why the Expanded Access pathway is preferable (J Clin Oncol 2019; doi: 10.1200/JCO.19.01741). Fernandez Lynch is the John Russell Dickson, MD Presidential Assistant Professor of Medical Ethics and Assistant Faculty Director of Online Education, both in the Department of Medical Ethics and Health Policy at the Perelman School of Medicine at University of Pennsylvania.

"I want oncologists to be aware of the different pathways—and that Right to Try isn't the only pathway," she told Oncology Times. "There was a really effective pathway that was already in existence [when Right to Try was legalized]."

1. What is important to know about "Right to Try" versus "Expanded Access" pathways?

"Expanded Access is a long-standing pathway. It's been around for several decades. And its key feature is that you have to get FDA sign-off to get the investigational product. A doctor and patient decide together that an investigational product might be beneficial. If the patient is unable to enroll in a clinical trial, then they go to the drug company and say, 'we'd like to access this product outside of your trial. Are you willing to provide it?'

"The company can say yes or no. And they might have lots of good reasons for saying no. They might not have the resources to provide the drug outside a trial; they might not want to distract from their clinical development pathway, because getting the product approved is the best way to help the most patients; or they might just think the patient is not a good candidate for the product.

"But if the company says yes, the next step under Expanded Access is to ask the FDA for permission to use the investigational product outside of a trial. FDA is then looking at various eligibility criteria. Does the patient have a serious or life-threatening condition? Are the risks and benefits reasonable? Has the patient exhausted approved alternatives? Will Expanded Access interfere with ongoing clinical trials?

"The big difference with Right to Try is that you don't have to go to the FDA at all. With [this] you go to the company, and if they say yes, you're good to go. The product has to be past phase I for Right to Try, which is different from Expanded Access. And it has to still be in active clinical development. But there's not an independent entity standing in to say you can only have this product if the risk and benefits are reasonable for you, that's not one of the legal requirements. FDA isn't making that judgment, and IRB approval isn't required either. That's another difference from Expanded Access.

"The most important thing to note is that Right to Try cuts FDA out of the process. Proponents of the law say that's a good thing; 'FDA is standing in the way.' But it turns out that FDA says yes to almost 100 percent of Expanded Access requests. So, they're really not a barrier.

"Also, in about 10 percent of the cases in which FDA authorizes Expanded Access, they offer additional information to minimize risk. For example, they might say—'yes, you can use this product, but you should make sure the patient is aware of this safety concern or you should change the dose.' They might have information the physician and even the company don't have. So cutting FDA out when they weren't the barrier and when they were offering helpful information is really problematic. And that's exactly what Right to Try does."

2. Does FDA's involvement in the Expanded Access pathway delay getting patients drug access?

"No, it really doesn't. There was a period of time where the FDA process was more burdensome; but over the past decade, FDA has really streamlined things. For example, the form physicians need to fill out is now supposed to take only 45 minutes. [And FDA] can turn emergency requests around in 24 hours and most other requests are handled in just a few days.

"There's also a new pilot program specific to oncology, called Project Facilitate, where physicians are assigned a liaison from FDA who walks you through the process, helps you contact the company, and really tries to make it easy.

3. As a next step, what would you like to see happen?

"The purpose of our article was to help physicians and oncologists understand their options. If a patient comes in and says I'm interested in Right to Try, we think the first response should be 'Let me tell you about Expanded Access.' It will likely still help you access the drug you're interested in, but it's more protective of you as the patient and it's more protective of patients in general.

"One of the concerns around Right to Try is safety reporting. Under Expanded Access, you have similar reporting requirements to what you would have for a clinical trial. But for Right to Try, companies just have to make an annual safety report to FDA of aggregated data: how many doses they provided, for what indications, and any adverse events that they know about. So it doesn't have to be nearly as robust. That's bad for the patients who are taking the product—and it's also bad for future patients because there might be bad things that are happening that we're not getting data about.

"So while I think Expanded Access is the preferable pathway, in the rare instance that there's a company that says we'll only provide the product through Right to Try, then the physician can still add protections back in that resemble Expanded Access. They can commit to doing intensive safety follow-up even though it's not a requirement of the Right to Try law. They can reach out to FDA to make sure they have all the information they need to use the product as safely as possible, again even though that's not a requirement of the law. They can ask their IRB to weigh in. They can do all of these things voluntarily as a matter of their professional duties in the care of patients."

Wednesday, December 18, 2019

With Julia Seay, PhD, Research Assistant Professor at Sylvester Comprehensive Cancer Center at University of Miami Health System

By Sarah DiGiulio

Patients who identify as lesbian, gay, bisexual, or transgender (LGBT) experience health disparities, including poorer overall health and less satisfaction with cancer care compared with individuals who identify as heterosexual or cisgender. Julia Seay, PhD, Research Assistant Professor at Sylvester Comprehensive Cancer Center at the University of Miami Health System—who researches health disparities in cancer care—suspects one of the factors contributing to these disparities is a lack of understanding on the part of health care providers about the unique health care needs of LGBT patients.

"Many LGBT cancer survivors encounter clinic environments that are not inclusive or welcoming, and [they] may be more likely to have negative experiences with the health care system during cancer care. These experiences can contribute to poorer patient-provider communication, as well as poorer health outcomes among LGBT cancer survivors," Seay told Oncology Times.

Seay and her colleagues have developed an LGBT cultural competency training program, the Curriculum for Oncologists on LGBT populations to Optimize Relevance and Skills (COLORS), to try to increase that understanding in cancer care providers.

And a new study published online ahead of print in the journal Cancer that evaluated the feasibility of using such a program was promising (2019; Thirty three of the 44 oncologists who participated in the study completed the program. Those who completed the program showed gains in LGBT-related knowledge, attitudes, and clinical practice after completing the program. And 82 percent of the physicians rated the training as high-quality and 97 percent reported they would recommend the training to a colleague.

Here's what else Seay told Oncology Times about the program and LGBT cultural competency training for oncologists and cancer care providers.

1. Can you explain what the key findings were from this study about the COLORS program?

"We have conducted a pilot study of the COLORS training among oncologists, and we do not yet know whether providing this training will lead to substantial improvement in LGBT patient outcomes. The pilot results are promising, however, and we are in the process of planning larger trials to examine whether this training will effectively address LGBT cancer disparities.

"The COLORS training is an interactive, web-based LGBT cultural competency training designed specifically for oncologists. It is comprised of four, 30-minute modules: 1) LGBT Basics; 2) Inclusive Environments; 3) Initiating Oncology Care with LGBT Patients; and 4) Issues in Cancer Survivorship among LGBT Patients.

"Each of these modules focuses on the development of effective communication strategies, which ideally may improve the patient-provider relationship, and ultimately clinical outcomes."

2. What are some of the barriers to implementing training programs like this one for practicing oncologists, as well as new medical students?

"A key barrier is that many medical schools do not yet have institutional support and policies regarding the provision of training in the unique care needs of LGBT patients. Thus, the onus is often on the individual physician and/or student to engage in LGBT cultural competency training. Additionally, oncologists and medical students often have extremely busy schedules, which can impede their ability to complete these types of trainings.

"We designed COLORS specifically with this barrier in mind, such that trainees can complete the training on their own time and at their own pace (all of the modules do not have to be completed at once)."

3. What is the takeaway message about your work and LGBT cultural competency training?

"Currently, many health care systems do not include sexual orientation and gender identity questions as part of the standard intake, and thus the disclosure of patient sexual orientation and gender identity within cancer care is limited. However, this information is important to understand, as LGBT cancer survivors face not only the stress of living with cancer, but often also the limitation of not being able to fully share who they are or details about their lives with their health care providers due to the fear of stigmatization.

"LGBT cancer survivors experience a myriad of health disparities, including poorer mental health and lower satisfaction with their cancer care than their cisgender and heterosexual counterparts. Lack of LGBT cultural competency among oncology care providers can lead to poor communication with LGBT patients and weaken the patient-provider relationship, contributing to the development of these disparities. Thus, LGBT cultural competency trainings may improve LGBT-related knowledge, attitudes, and clinical practices among providers, which ultimately may lead to improvements in care provision and patient outcomes.

"LGBT cultural competency training, such as the COLORS training, sheds light on these issues and encourages the development of effective communication skills among health care providers, ultimately aiming to address health disparities among LGBT cancer survivors. The COLORS training is a promising new intervention aimed at improving LGBT cultural competency among oncologists, and its effectiveness in improving patient outcomes will be examined in the future."

Monday, November 25, 2019

With Joseph Shirk, MD, of the David Geffen School of Medicine and the Jonsson Comprehensive Cancer Center at UCLA

By Sarah DiGiulio

Virtual reality technology has for a while been touted as holding all sorts of benefit for medical outcomes. Now new research shows that, when used to help cancer surgeons prepare for kidney tumor surgeries, the technology not only works, but also leads to superior outcomes compared with using the current standard CT and MRI scans.

The study published in JAMA Network Open analyzed outcomes of 92 people with kidney tumors who had surgeries to remove those tumors at six different hospitals (all were large teaching hospitals) (2019; doi: 10.1001/jamanetworkopen.2019.11598). Of the group, 48 individuals had surgeries for which surgeons prepared by using conventional methods, and 44 had surgeries for which surgeons prepared by reviewing both conventional CT and MRI scans, as well as 3D virtual reality models (which could be viewed with mobile phones or with a virtual reality headset). The patients in the latter groups had better postoperative outcomes, including shorter operating times, less blood lost during surgery, and shorter postoperative hospital stays.

"Visualizing the patient's anatomy in a multicolor 3D format, and particularly in virtual reality, gives the surgeon a much better understanding of key structures and their relationships to each other," noted the study's lead author Joseph Shirk, MD, a clinical instructor in urology at the David Geffen School of Medicine at UCLA and at the UCLA Jonsson Comprehensive Cancer Center. "This study was for kidney cancer, but the benefits of using 3D models for surgical planning will translate to many other types of cancer operations, such as prostate, lung, liver, and pancreas."

Importantly, this research shows that, not only do 3D virtual reality models help surgeons better prepare for surgery and better understand their patients' specific anatomies, but the technology actually improves patient outcomes, too.

"Actually seeing evidence of this magnitude, generated by very experienced surgeons from leading medical centers, is an entirely different matter. This tells us that using 3D digital models for cancer surgeries is no longer something we should be considering for the future—it's something we should be doing now," he stated. In an interview with Oncology Times, Shirk shared his thoughts about the new findings.

1. What were the key findings from the study?

"We conducted a multi-institution, randomized, controlled trial comparing surgeries performed for the removal of a kidney tumor using the current standard of care [reviewing CT or MRI images only] versus surgeries performed using CT and MRI [images], plus the virtual reality model. We looked at the outcomes that define a successful surgery: operating time, blood loss, clamp time (a measure of how long this kidney is deprived of oxygen), and length of hospital stay.

"The use of these 3D virtual reality models reduced operative time, blood loss, and clamp time—and shortened length of hospital stay. This means that using the models for this type of surgery led to better surgeries being performed.

"We achieved the sample size that we had calculated prior to initiating the trial, so the number of cases is sufficient to ensure the results are highly accurate."

2. Can you explain how the models work: how did the physicians view the 3D models and is it feasible that this type of technology can be scaled up to be used more widely by all hospitals?

"The models were made from the CT or MRI scan. The physicians were able to view the models on the screen of a smartphone or iPad, or using an off-the-shelf virtual reality headset for the full virtual reality experience. The entire model was in virtual reality.

"Yes, I do [think it's feasible to use this type of technology more widely in different sized hospitals across the country]. And the reason is that the only hardware required is a smartphone and an off-the-shelf virtual reality headset. The technology is now commercially available and should be easy to adopt at all kinds of hospitals."

3. So what do these findings mean for the future of using 3D virtual reality models in cancer surgery prep?

"The study shows that 3D virtual reality models used for kidney cancer surgeries improved patient outcomes. This should certainly change clinical practice and quickly become the new gold standard for surgical planning. Surgeons are very motivated to improve outcomes, and patients will likely ask for their surgeon to use the technology once they are aware it is the new state of the art.

"The next step is to examine the impact of the models on other types of cancer surgeries. Any surgery performed on a solid organ to remove a tumor should benefit from using this technology.

"Advanced visualization of patient anatomy in the operating room is the future of surgery. Based on the results of this study, this type of technology can help surgeons provide better care to cancer patients."