publication date: Mar. 22, 2019
Trials & Tribulations
SWOG’s 1501 study takes aim at the silo wall between cardiology and oncology
Heartland NCORP, Cancer Care Specialists of Illinois (Swansea, IL)
Many have written and spoken about the goal of eliminating the effect of developing and delivering medical care in “silos.”
Silos can simply be defined as medical or scientific environments functioning in parallel. They are independent and not often visible by those working in another silo.
Silos often exist unintentionally, but have been a real part of medicine historically. Common silos include, but are not limited to, government agencies, industry, academic medical centers, community practices, research groups, medical specialties, etc.
Cancer research possesses the ability to reduce the silo effect—on multiple levels. An example is S1501, an active NCI-funded trial evaluating the efficacy of carvedilol in reducing cardiac dysfunction in metastatic HER-2 overexpressing breast cancer patients.
Because cancer is often a disease of aging, many patients come with co-morbid conditions.
On average, breast, prostate, colorectal, and gynecologic cancer patients have five co-morbid conditions and develop at least two more during their survivorship period (1).
Premature cardiovascular disease is especially common, regardless of the regimen used for cancer treatment, with poorer survival in cancer survivors with cardiovascular disease, in comparison with non-cancer patients with the same cardiovascular conditions.
For example, the Ontario Health Insurance Plan Registry documented that breast cancer patients have higher cardiovascular mortality than patients without prior breast cancer (2).
This is especially true for women with cardiovascular risk factors. Abnormalities related to cardiac function may offset the substantive gains made in breast cancer-specific mortality.
Understanding the etiology of breast cancer-related cardiovascular disease may help to improve quality of life and overall survival.
Unfortunately and unintentionally, patients most often receive care for their heart disease and cancer in separate cardiology and oncology silos. Recognition of this care model being less than optimal has prompted cardio-oncology to emerge as a multi-disciplinary field aimed at better studying and treating these patients.
NCI has recognized this and facilitated the development and implementation of the Community Cardio-oncology Task Force comprised of cardiologists and oncologists with an interest in addressing these issues.
S1501 was vetted and designed, across cardiology and oncology silos, in part through this task force, facilitating ultimate trial approval and activation.
Academic/community based medical practices
Academic and community-based physicians experience and participate in research and clinical care in different environments, each with unique strengths and limitations.
S1501 is led by both an academic cardiologist and a community based oncologist, resulting in a granular understanding of differences potentially affecting S1501 implementation in these environments.
Understanding this has been critical in developing a work flow and identifying potential barriers to accrual that differ across academic and community sites.
Having academic and community sites represented at the principal investigator level is another example of S1501 promoting collaboration across silos.
Cancer research is continually being designed and conducted through multiple silos, including industry, NCI, its National Clinical Trials Network, academic institutions, and NCI Community Oncology Research Program sites.
Each of these entities faces challenges and has perspectives unique to their mission and purpose.
As these entities participate with trial development and implementation, progress is made as challenges are identified and addressed, further refining shared best practices.
This has definitely been the case, as the S1501 trial design was vetted within the Heartland NCORP, SWOG Cancer Research Network, the University of Michigan, and NCI.
Currently, S1501 is being implemented through the NCTN at LAP and NCORP sites throughout the country.
S1501 continues to demand collaboration across silos, including recruitment of patients who are co-registered on other clinical trials—other potential silos.
With an ambitious accrual goal of 817 patients, S1501 is actively accruing patients and performance sites. Please see the graphic below illustrating our progress thus far. For NCORPs and academic centers that are interested in learning more about and potentially offering S1501, have questions regarding the trial, or are looking for suggestions to facilitate accrual, contact us at S1501question@swog.org.
Leach CR, et al. The complex health profile of long term cancer-survivors: prevalence and predictors of comorbid conditions. J Cancer Surviv 2015, 2015;9(2):239-251
Abdel-Qadir, et al. A population-based study of cardiovascular mortality following early-stage breast cancer. JAMA Cardiol. 2017;2(1):88-93