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National initiative establishes research priorities for VTE in cancer
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An estimated 900,000 cases of venous thromboembolism are diagnosed each year in the United States, according to CDC statistics.
Approximately 100,000 to 300,000 of these cases are fatal.
Nigel S. Key
The risk for VTE is elevated among individuals with cancer — particularly those who undergo chemotherapy — and it also portends poorer survival in this group, according to Nigel S. Key, MD, chief of the section of hematology and director of the UNC Hemophilia and Thrombosis Center at University of North Carolina at Chapel Hill.
“However, many fundamental questions about cancer-associated VTE ... remain unanswered,” Key and colleagues wrote in an advisory opinion on research priorities to address VTE in patients with cancer.
In their paper, Key — a HemOnc Today Editorial Board member — and colleagues highlighted the main research priorities that oncologists and hematologists identified during a strategic workshop convened in 2014 by NCI and the National Heart, Lung, and Blood Institute (NHLBI).
These experts addressed basic science, clinical, epidemiologic and translational issues in cancer-associated VTE, and they identified several unmet needs in the field of cancer-related VTE.
They included: the role of clotting proteins in cancer-associated thrombosis; platelet and white blood cell contributions to VTE in patients with cancer; inflammation as a trigger for prothrombotic changes; the impact cancer therapies have on thrombotic pathways and blood cells; and efforts to evaluate specific malignancies as determinants of thrombosis.
HemOnc Today spoke with Key about these research priorities, the need for increased funding and the potential role of new oral anticoagulants.
Question: How did the NCI and NHLBI workshop come about?
Answer: The workshop was an effort between the blood division of the NHLBI and members of NCI who decided to come together and host a joint workshop. The point of a workshop like this is to identify key research questions and then potentially send out requests for funding applications to move the field forward.
Q: What did you and your colleagues identify as key research priorities ?
A: Based on the state of the science presented at the meeting, the working group found a need for mechanistic studies of thrombosis and thrombocytosis in cancer; identification and validation of improved, actionable biomarkers and risk factors for VTE in patients with cancer; as well as the need for prospective cohort studies and intervention trials.
Q: Why is there a need for more study in this area?
A: There is a gap in the knowledge base in terms of research. One of the real issues is, how does VTE come about? How does cancer cause VTE? This question is definitely a “black box.” Another major category in this area is to identify and validate biomarkers and risk factors for VTE. There is a need to identify and validate — based on blood tests — which patients are at risk for VTE. Finally, there is a great need to develop clinical studies, to understand how to use biomarkers to identify the highest-risk patients, and then to prevent VTE in these patients.
Q: It has been suggested that VTE has long been managed poorly in pati ents with cancer. Do you agree?
A: I am not sure that VTE has been managed poorly, as the scope of the problem is quite broad. The standard of care is generally thought to be injectable low–molecular-weight heparin (LMWH), at least during the first few months of treatment. If it has been managed poorly, it is not necessarily because of physicians, but rather because of copays and the costs of these drugs for outpatients. Also, patients are generally reluctant to use an injectable rather than pills. This standard of care is not, therefore, necessarily patient-friendly.
Q: Why are certain cancers more conducive to promoting thrombosis?
A: This is the $64,000 question. We do not know why. One point to be made is that not all cancers have the same risk for VTE. There is a wide spectrum of risks depending upon the cancer type and stage. There also are patient factors at play. Still, without a doubt, there are certain cancers that place patients at higher risk. These include pancreas, ovarian and brain cancers. It must be presumably related to the biology of the tumor and how the tumor itself initiates coagulation systems or, alternatively, speaks to the patient’s biologic systems to turn on coagulation. Still, I do not think we have a good handle yet on why certain cancers are more prone to cause thrombosis.
Q: What needs to be done to increase funding for research in this area?
A: My hope is that this workshop ultimately results in the call for more research and stimulates the field by offering NIH funding to promote research in this area. This workshop was unusual in that it involved two NIH Institutes with the focus of cancer-associated thrombosis. If there is one thing that could be pointed to in the past, it is that perhaps this is an area that has fallen between the cracks of the institutes — the NHLBI and NCI — that deal with cancer-associated VTE. Because the problem involves both, maybe there has been a relative lack of ownership of the area.
Q: What newer oral anticoagulants are on the horizon , and what is your perspective on the ir safety and effectiveness as demonstrated in clinical trials?
A: There are a lot of studies now that include much newer, more convenient anticoagulant agents that are orally administered. However, the amount of data concerning specifically cancer-associated VTE are limited. From what we know so far, the data from these trials look promising. It is very likely that these newer anticoagulants are going to produce results that are reassuringly similar to LMWH, thereby potentially eliminating the need for self-injection of LMWH. I think it is very likely that these newer agents will fill that gap.
Q: Until new data emerge and newer anticoagulants are available, what do you recommend as the optimal prevention and treatment for VTE in patients with cancer?
A: There are many guidelines out there, including ASCO’s guidelines on the prevention and treatment of VTE in patients with cancer. I think these guidelines will eventually change until newer data become available. I still use LMWH when possible. However, we are all eagerly anticipating the results of the clinical trials. – by Jennifer Southall
For more information:
Nigel S. Key, MD, can be reached at University of North Carolina at Chapel Hill, 1079 Genetic Medicine Building, CB #7035, Chapel Hill, NC 27599; email: nigel_key@med.unc.edu.
Reference s :
Key NS, et al. Cancer Res. 2016;doi:10.1158/0008-5472.CAN-15-3100.
Lyman GH, et al. J Clin Oncol. 2016; doi:10.1200/JCO.2014.59.7351.
Disclosure: Key reports no relevant financial disclosures.