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Wednesday, June 22, 2016

With PAUL SABBATINI, MD, Deputy Physician-in-Chief for Clinical Research at MSKCC[NC1] 

By Sarah DiGiulio

The medical and research community knows that clinical trial patient enrollment is low, Deputy Physician-in-Chief for Clinical Research at Memorial Sloan Kettering Cancer Center (MSKCC), Paul Sabbatini, MD, explained. For adult cancer patients, the enrollment rate is just three percent, according to the Institute of Medicine's 2010 "Transforming Clinical Research in the United States."

That's a problem, Sabbatini said. "Every advance in the way we approach cancer treatment today has come from a past clinical trial--and tomorrow's advances will be generated by today's clinical trials."

To better understand some of the dynamics behind those low clinical trial enrollment rates, MSKCC commissioned a national survey of consumers, as well as of practicing physicians late last year. The survey data included 1,511 consumers 18 to 69 and 694 practicing physicians who had previously discussed clinical trials with patients across the specialties of oncology/hematology, obstetrics/gynecology, urology, ear/nose/throat medicine, neurology, pulmonology, or dermatology. MaPS/Millward Brown Analytics conducted the survey; Sabbatini and his colleagues have submitted an abstract with the data for publication.

Sabbatini walked through the key findings from those data (available online: www.mskcc.org) and the implications for oncology in an interview with Oncology Times.


1. What would you say were the key findings from this survey and were they surprising?

"One of the most significant things we learned through the survey was that only 40 percent of American consumers have a positive overall impression of clinical trials, and only 35 percent are likely to enroll. This was extremely alarming to us.

            "Yet after reading a brief statement that helped them to better understand clinical trials, positive impressions among consumers increased to 60 percent. Their likelihood to enroll increased to 44 percent. This points to a desire for education, which is both an opportunity and a challenge that we must embrace.  

            "Additionally, when we asked about top barriers for clinical trial participation, we found that consumers and physicians share similar concerns. When asked about their main deterrents when considering participating in a clinical trial for cancer treatment, consumers surveyed pointed to side effects/safety (55%), potential costs (50%), location of treatment (48%), and worries over getting a placebo (46%). When physicians were asked what they believe are their patients' biggest concerns when considering participation in a clinical trial for cancer treatment, they cited side effects/safety (63%) and concern about getting a placebo (63%).

            "Finally, of the almost 600 physicians polled, more than half (56%) of physicians said they considered clinical trials late in treatment, with 28 percent noting them 'as a treatment of last resort.' Only one-third (32%) said they discuss the topic with their patients at the beginning of treatment. However, it is important to evaluate clinical trial enrollment every time a change in treatment is considered."


2. How do these results inform how to actually increase clinical trial participation?

"The survey findings signal to us that we must do a better job educating people on what clinical trials are and what they are not--this includes consumers and physicians.

            "We also need to be communicating about the importance of clinical trials of all kinds, but especially with cancer. Thanks to the many advances in precision medicine, researchers are now able to sequence more and more genes and to do it at a faster rate. But we must start by having the necessary volume, and that comes from patients feeling they are armed with the information they need to opt in to a clinical trial."


3. What would you say is the bottom line that practicing oncologists everywhere--whether they are involved in clinical trials research or not--need to know about these findings?

"Education is our biggest barrier to enrollment. We were pleased to see that when we shared some basic information about what trials are, the overall positive impression of consumers jumped from 40 percent to 60 percent. Physicians also reviewed the statement and the majority responded in a positive way, noting that this type of statement could be helpful/useful--68 percent said they would be likely to use the statement with patients and 69 percent felt it would be effective in educating patients.

"We need to commit to starting a national dialogue on the importance of clinical trials--one that involves oncologists and institutions around the country. Speaking with a collective, collaborative voice is the best way to ensure that the message is being heard."


Sarah DiGiulio is a contributing writer.

Tuesday, June 14, 2016

With Arti Hurria, MD, of City of Hope Comprehensive Cancer Center

By Sarah DiGiulio

Last year, the American Society of Clinical Oncology published recommendations to improve the evidence base for treating older adults with cancer (JCO 2015;33:3826-3833). And as part of the response to those recommendations, the U.S. Food and Drug Administration launched its Snapshot database (OT 2/25/2016 issue). Within that database the FDA has published information for every new molecular entity approved as of Jan. 1, 2015, on who participated in the clinical trials that supported the FDA approval of that drug, as well as any differences in the benefits and side effects based on sex, race, and age groups for that drug (www.fda.gov/drugtrialssnapshot).

It's a good start, but more efforts are still needed to improve the care of geriatric patients with cancer, experts have said. Arti Hurria, MD, Professor and Director of the Cancer and Aging Research Program and Co-Leader of the Cancer Control and Population Sciences Program all at City of Hope Comprehensive Cancer Center, and several colleagues penned a letter published in the Journal of Clinical Oncology praising the Snapshot efforts, but calling for expanded steps from the FDA (2016;34:1708-1709).

The FDA should have the authority to require that studies be performed in populations most likely to have the disease for which a drug being considered for approval is intended to treat, Hurria said. "It's about the need for further research in geriatric oncology."

Hurria elaborated on how these additional actions would ultimately help improve patient care in a phone interview with Oncology Times.

1. What was the key message of this letter about the Snapshot database and the FDA's efforts to improve the evidence base for treating older adults with cancer?

'We're quite happy that they have given us information for [patients] age 65 and over [via Snapshot] so that we can take a closer look at data with regard to the representation and tolerance of therapy in older adults. But there is a further opportunity to really focus on even older patients. In clinical practice we are often really struggling with patients who are 75 and older, or even 80 and over, because that's where the evidence is limited.

"So [FDA's] work needs to expand in those areas to look at those extremes of age—and break down that data for the person who is treating those patients."

2. How would having that data for older adults as part of a database like Snapshot change your experience as an oncologist treating those patients—and change the experiences of the patients themselves?

"Older adults in general have been underrepresented on clinical trials to-date, and hence there is limited data about the risks and benefits of therapy within those older adults. Really having a chance to understand among the pivotal trials that led to FDA approval [for a drug]—how many older adults were included in those studies, as well as the average events by age strata—would at least be some level of evidence for delivering that drug in an older patient population.

"So when we're sitting in clinic where the vast majority of patients are older adults, we can at least say okay, our best quality data to date treated 'x' number of patients within your age group and these were the specific adverse events to date. I think that would be helpful. I think that would help inform that discussion with the patient.

"Also if there isn't data or very limited data it would inform that discussion with the patient, so we could be transparent that this new drug was approved, but there was limited data within your age group in particular—or there was limited data in patients that have the same co-morbid conditions that you have. Anything along those lines, I think, would be very helpful in the patient and physician interaction together."

3. In the JCO letter, you and your co-authors call for the FDA to have expanded authority to "incentivize and require research in older adults, particularly if they represent the majority of those with the disease." Could you elaborate?

"The FDA has been an advocate to do exactly what they're doing—which is trying to increase the transparency of clinical trial data with regard to patient characteristics and outcomes. But the FDA has limited authority right now in terms of being able to require that there's this data in older adults.

"Our goal is to actually have them have the authority that's needed to be able to stimulate research or require research or incentivize research in a group when there's not enough data.

"And there is a precedent (which we explain in the editorial) in pediatrics. There's been legislation to allow for additional information about drugs in children. There's something called the Best Pharmaceuticals for Children Act and the Pediatric [Research] Equity Act, and we would love to do the same for geriatrics."

Friday, June 10, 2016

With DANIEL MULROONEY, MD, MS, of St. Jude Children's Research Hospital

By Sarah DiGiulio​

Advances in cancer research, treatments, and care have simultaneously improved five-year survival rates and created a population of patients with health surveillance and screening needs drastically different than their peers, coauthors Malek J. Baassiri, MD, a fellow in Cancer Survivorship at St. Jude Children's Research Hospital, and Daniel A. Mulrooney, MD, MS, of St. Jude, explain in a recent editorial in the Journal of Clinical Oncology (2016;34:1570-1572).

They are referring to cancer survivors who not only because of the biology of their tumors, but also because of side- and late-effects of their cancer treatment and radiation have different health care needs than others without cancer. And in this editorial, Baassiri and Mulrooney more specifically address the needs of survivors of childhood cancers, whose survivorship period can be a lifetime, and even more specifically how their risks of cardiovascular disease differ from their peers without a history of cancer.

The editorial is a response to a study by Chao, et al, that analyzed the medical records of 5,673 adolescents and young adults with a history of cancer (diagnosed between ages 15 and 39), matching them with 57,617 patients with no history of cancer as a control group (JCO 2016;34:1626-1633). The data showed the rate of cardiovascular disease in cancer survivors was 2.37 times the rate in the healthy population.

This finding has big implications for an entire population of cancer survivors across their lifetimes, Baassiri and Mulrooney explain. The editorial state: "Screening and treatment of these risk factors, well known to modify health outcomes in adults, may be overlooked in a younger population yet potentially be of even greater importance for those exposed to cancer therapies."

In an email interview, Mulrooney, Assistant Member of the St. Jude Faculty, elaborated on the implications of these findings and why there is still a lot to understand about cancer survivorship.


1. What is new about these findings from Chao, et al, compared with other survivorship research?

"Investigators were able to use a series of large, comprehensive datasets to describe the risk of and mortality from cardiovascular disease in a young population of cancer survivors (the mean age was 33.4 years).  Other studies frequently only include adolescent and young adult cancer survivors as a subset of the broader study population. [Chao and his colleagues] were able to focus their study uniquely on this population.  

"Not only did the investigators identify an increased risk for cardiovascular disease, but [they] also described the added risk of other known cardiovascular risk factors (diabetes rates were 3.18 times higher among cancer survivors; hypertension rates were 3.67 times higher; and dyslipidemia rates were 1.79 times higher).

"These [risks] are important for primary care providers caring for this population to be aware of because these are modifiable risk factors that can be treated with lifestyle modifications and/or medication."


2. The editorial mentions it is noteworthy that the patients in this study all came from a single insurance database. How does that inform the implications of these findings from Chao, et al?

"The study used individuals in the Kaiser Permanente Southern California Health Plan databases, thus individuals who were insured and received care through this organization. Cancer survivors who are not insured, or who may have had difficulty obtaining insurance, are not included. 

"Therefore, the findings of the study may actually underestimate the incidence and risks of cardiovascular disease in this population."


3. What should all practicing oncologists and cancer care providers know about these findings?

"The importance of screening for and treating modifiable cardiovascular risk factors in survivors of adolescent and young adult cancers.

"Future studies need to investigate if the risk of cardiovascular disease can be reduced by early identification and treatment of associated risk factors." 

Monday, May 9, 2016

With DONGHAO LU, MD, of Karolinska Institutet 

By Sarah DiGiulio 


Several previous studies have shown that patients with cancer are more likely to be at increased risk of psychiatric symptoms and disorders, but a new, large study has revealed that patients are more specifically at an especially increased risk of several stress-related mental disorders both immediately before and after being diagnosed with cancer. The new paper was published online ahead of print in JAMA Oncology (doi:10.1001/jamaoncol.2016.0483).

"To the best of our knowledge, our study represents the first and largest study to date estimating the burden (and its temporal pattern of) mental disorders potentially related to psychological stress, among adult cancer patients during the pre-diagnostic to post-diagnostic periods," the study's lead author Donghao Lu, MD, a PhD candidate in the Department of Medical Epidemiology & Biostatistics at Karolinska Institutet in Stockholm, said in an email.

The researchers cross-referenced data from the 1990 Swedish Population and Housing Census to identify all individuals born and living in Sweden at the time (7,792,012 individuals) with data from the Swedish Cancer Registry, Patient Register, Prescribed Drug Register, Cause of Death Register, and Migration Register to identify a cohort of individuals who were diagnosed with a first cancer between 2001 and 2009 – and to also identify if and when those individuals were diagnosed with a mental disorder. They designated a prediagnostic period as the time frame two years prior to the diagnosis of each individual with cancer and the postdiagnostic period as the time period from cancer diagnosis onward.

The researchers also randomly selected 10 individuals from the census data per each patient with cancer who had not been diagnosed with cancer or a mental disorder to serve as a control group (3,041,174 individuals).

The data showed the patients with cancer were at a heightened risk of developing a stress-related mental disorder—stress reaction/adjustment disorder, depression, anxiety, substance abuse, and somatoform/conversion disorder—in the two-year prediagnostic period, as well as in the10 years after being diagnosed with cancer. And the risk was highest in the year preceding and year following the diagnosis.

Lu elaborated on the implications of those findings are for practicing oncology care providers and in terms of rethinking about current guidelines on the role of psychosocial care in cancer care.


1. Other studies have shown that cancer patients are at increased risk of psychiatric disorders—what was new about these findings?

"The vast majority of clinical and research efforts have been given to the post-diagnostic period of cancer, focusing on the survivorship, the end-of-life stage, and increasingly also the immediate periods after diagnosis and primary cancer treatment. Whether or not the diagnostic workup leading to a cancer diagnosis increases the risk of mental disorders was however largely unknown.

"We found that among cancer patients, the risks for several common and potentially stress-related mental disorders, including depression, anxiety, substance abuse, somatoform/conversion disorder and stress reaction/adjustment disorder started to increase from ten months before cancer diagnosis and peaked during the first week after diagnosis, compared with cancer-free individuals in Sweden.

"We also found that—in addition to depression—anxiety, stress reaction and adjustment disorders were also common among cancer patients."


2. Psychosocial care and mental health screening are already a part of cancer care (OT 11/25/13 issue) and cancer survivorship care guidelines (OT 5/25/14 issue). What implications do these new findings have on the existing guidelines and how oncologists should use those guidelines in the clinical setting?

"Our findings support the existing guidelines of integrating psychological management into cancer care. And we specifically call for the extended vigilance for multiple mental disorders, instead of focusing on depression or anxiety alone, and we stress the importance of such interventions already [be in place] during the time of cancer diagnostic workup."


3. What did your research reveal about how mental health disorders in patients diagnosed with cancer are different than those diagnosed in others without cancer? And what are the next steps to your research?

"More research is needed to better understand this question. Although our findings highlight the importance of a timely psychological intervention throughout cancer diagnosis, whether or not such intervention should be specifically tailored for cancer patients as compared to individuals without such life-threatening condition remains to be explored.

"We are currently examining in more details the temporal pattern of stress experience as well as its related health outcomes (including mental disorders) within the time period of cancer diagnostic workup and by patient characteristics. We aim to identify specific time windows or high risk groups for potential clinical intervention."

Friday, April 15, 2016

With LAURIE MARGOLIES, MD, FACR, Director of Breast Imaging at Dubin Breast Center of Mount Sinai Hospital

By Sarah DiGiulio 

Laurie Margolies.jpg 

Screening mammography has been a topic of debate in breast cancer diagnostics due to a shifting consensus (or lack thereof) over the age women benefit most from having the test (OT 3/10/14 issue). But new findings from a group of breast imaging experts, cardiologists, and internists, bring a whole new variable to the equation.

The researchers found that breast arterial calcification, as assessed by digital mammography, is a strong predictor of coronary artery calcification—and is a superior predictor of women at high risk of cardiovascular disease compared with other standard risk factors, according to their study presented at the American College of Cardiology Annual Scientific Session last month and recently published in the Journal of the American College of Cardiology Cardiovascular Imaging (2016;9:350-360).

"Mammograms can serve a dual function," the study's lead author Laurie Margolies, MD, FACR, Associate Professor of Radiology at Icahn School of Medicine and Director of Breast Imaging at Dubin Breast Center at Mount Sinai Hospital, explained in an email.

"The same mammogram exam can screen for breast cancer and look for evidence of cardiovascular disease. This dual function can be accomplished without additional radiation to the patient; the patient's mammogram would not take any longer; and it would add only seconds to the interpretation and reporting time for the breast radiologist," she said.

For the study, Margolies and her colleagues screened 292 women using both digital mammography and nongated computed tomography, and then compared how closely the breast artery calcification scores were related to the coronary artery calcification score. The data showed a sensitivity of 63 percent, a specificity of 76 percent, a positive predictive value of 70 percent, a negative predictive value of 69 percent, and an accuracy of 70 percent.

While additional confirmatory data would be necessary to make recommendations on cardiac risk assessment, the authors note in the study, "The opportunity to significantly improve the identification of high-risk women by further simple analysis of a broadly used screening tool should be intensively evaluated in larger patient cohorts."

Here's what Margolies said cancer care providers should know about the research.

1. Could you elaborate on why these findings suggest mammograms might also be useful in identifying women at risk for cardiovascular disease?
"A key finding in this study is that breast arterial calcification is a very strong independent risk factor for the presence of coronary artery calcification—more significant than age or hypertension. And there is actually a strong quantitative correlation between breast and coronary artery calcification.

"When the information about breast arteries is added to traditional risk evaluation, its significance is even greater. The positive predictive value of about 70 percent is as good as Framingham Risk Scores or the 2013 Cholesterol Guidelines Pooled Cohort Equations for identification of women at high risk of cardiovascular disease."

2. Is this the first evidence that mammography might play a role in predicting heart health? Is the evidence sufficient to suggest mammograms can or should be used for more than just diagnosing breast cancer?
"Breast arterial calcification has been the subject of previous research, and most studies have shown a correlation of breast arterial calcification with myocardial infarction, stroke, and other cardiovascular diseases. As Drs. Nasir and McEvoy note in their editorial accompanying this research (J Am Coll Cardiol Img 2016;9:361-363), the reporting of breast arterial calcification has not though been incorporated into reporting guidelines and health care delivery protocols.

3. What should practicing oncologists know about the findings from this research?
"Cancer care providers should know that there is a strong correlation between breast arterial calcification and cardiovascular disease. This suggests that women who have breast arterial calcification might benefit from further testing such as gated formal cardiac calcification scoring and/or preventative treatments such as diet modification, exercise, smoking cessation, medication, or other strategies. Practicing oncologists can and should incorporate breast arterial calcification data into their patients' overall treatment plans.

"Primary care physicians and others receiving mammography reports do, however, need education about the linkage of breast and systemic arterial calcification. And this study will hopefully add momentum to the increasing awareness and discussion of women's cardiac health."

About this Blog

Sarah DiGiulio

SARAH DIGIULIO, Associate Editor of Oncology Times, asks oncology’s thought leaders for their perspectives and takes on the field’s current news and controversies.

Want to get answers to your questions? Add a comment or email OT@LWWNY.com to suggest a topic for a future column.

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