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For clinical oncology providers, understanding the potential and the limitations of DNA sequencing (next-generation sequencing) will be crucial for providing genomically driven care in this era of precision medicine.
I don’t think its hyperbole to say that next-generation sequencing is the future of multiple myeloma. Or maybe I should say that next-generation sequencing is the future of multiple myeloma diagnostics. Yes, this is a tall statement. Let me try to make my case based on the articles linked and excerpted below.
Multiple myeloma is a very heterogeneous cancer. This means that there is a great deal of genetic variability among MM patients. This is the main reason why multiple myeloma diagnostics are so important to the newly diagnosed MM patient.
One of the most common phrases written in online MM forums is “everybody’s different.” One person can fly through induction therapy reaching complete remission in two or three cycles of chemotherapy while the next person, undergoing the exact same therapy regimen barely responds.
The three most significant events in an MMer’s life are:
diagnosis,
therapy plan and
MDR (multi-drug resistance)
Life as an multiple myeloma patient can be made or broken at any of these three points in time. According to the bottom article linked below, next-generation sequencing can address all three of these challenges improving oncologic decision-making at every juncture. After all, an oncologist is only as good as the diagnostic information he or she receives. Next-generation sequencing provides the MM patient’s individual genetic results meaning, this sequencing provides the patient with the correct multiple myeloma diagnostic information.
From ’12-’17 or so, conventional oncology made great strides learning about the genetic make-up of MM. And a great deal more work needs to be done. MM diagnostic needs to continue to improve.
One way to slow or inhibit understanding of next-generation sequencing would be to restrict how oncologists use genetic-sequencing technology. According to the top article below, the FDA is considering limiting the options of oncologists regarding next-generation sequencing. Certainly, it is too early to tell what will happen to this fast-changing technology. We will have to watch and wait for now.
“Abstract- As a result of multiple technological and practical advances, high-throughput sequencing, known more commonly as “next-generation” sequencing (NGS), can now be incorporated into standard clinical practice. Whereas early protocols relied on samples that were harvested outside of typical clinical pathology workflows, standard formalin-fixed, paraffin-embedded specimens can more regularly be used as starting materials for NGS…
For clinical oncology providers, understanding the potential and the limitations of DNA sequencing will be crucial for providing genomically driven care in this era of precision medicine…
NGS utility-There are three general ways that NGS can aid a clinician.
The first is with diagnosis; tumor subtypes that only a few years ago were defined by morphologic criteria are now defined by genetic mutations, either inclusively or exclusively…
The second is finding an appropriate “targeted therapy”, as an increasing number of therapies have indications based on DNA sequencing results- Patients who lack the mutation targeted by a drug will not only fail to benefit but can actually be harmed by inappropriately targeted therapies [51].
The third point at which clinicians stand to benefit from NGS is when a patient stops responding to a targeted therapy with known resistance mutation...
“It seems to be that we also get a fine-tuned as well as important gene regulation machinery that can be influenced by our environment and individual lifestyle”
Multiple myeloma is a disease characterized by uncontrolled plasma cell growth and proliferation. For cancer to develop, genes regulating cell growth and differentiation must be altered; these mutations are then maintained through subsequent cell divisions and are thus present in all cancerous cells. Multiple myeloma treatment is a function of stoping this uncontrolled cell growth.
In order to treat a person’s cancer:
Surgery cuts out cancer cells.
Toxic therapies such as chemo and radiation kills cancer cells.
The question of relapse, cancer stem cells (CSC), chemo, radiation causing inflammation remains.
Consider a different type of therapy. What if cancer patients could change how their genes express themselves? What if cancer patients could stop a relapse of their cancer by changing how their genes work?
According to the article linked and excerpted below, genetic expression can be altered by what we eat, drink, how we live, etc. The evidenced-based, non-toxic therapies that I follow daily in order to maintain my complete remission from my cancer, multiple myeloma, changes how may genes express themselves.
Could this be how I have remained in complete remission from my “incurable” cancer all these years?
“We are more than the sum of our genes. Epigenetic mechanisms modulated by environmental cues such as diet, disease or our lifestyle take a major role in regulating the DNA by switching genes on and off…
Moreover, contrary to the fixed sequence of ‘letters’ in our DNA, epigenetic marks can also change throughout our life and in response to our environment or lifestyle. For example, smoking changes the epigenetic makeup of lung cells, eventually leading to cancer. Other influences of external stimuli like stress, disease or diet are also supposed to be stored in the epigenetic memory of cells…
It seems to be that we also get a fine-tuned as well as important gene regulation machinery that can be influenced by our environment and individual lifestyle.
Further, since the disruption of epigenetic mechanisms may cause diseases such as cancer, diabetes and autoimmune disorders, these new findings could have implications for human health.”
A New Regulatory Threat to Cancer Patients
Washington may impose needless limits on genetic testing.
Wall Street Journal 2/26/18
“The federal government is threatening to limit treatment options for doctors fighting cancer. A regulatory decision due Wednesday from the Centers for Medicare and Medicaid Services could undermine the care delivered to the more than 1.6 million Americans who are diagnosed with cancer each year.
At issue is whether reimbursements will be available to most physicians, hospitals, and patients with a diagnostic technology known as next-generation sequencing. A cornerstone of the emerging field of precision medicine, next-generation sequencing (NGS) tests analyze molecular changes that occur in cancerous tumors and show up in biopsies.
To fight tumors, DNA-sequencing-based tests can determine how genes and mutations differ from one patient to the next. Next-generation sequencing tests enable oncologists to prescribe and administer customized, highly targeted drug therapies. The technology limits patients’ exposure to unnecessary toxic drugs and helps doctors make vital treatment decisions. Hundreds of thousands of cancer patients have already received NGS testing.
The proposed new CMS policy would abruptly change the way NGS testing is regulated and administered. It would drastically limit insurance coverage by requiring that tests be approved by the Food and Drug Administration. Current NGS tests are conducted at accredited clinical laboratories and premier academic medical centers under strict regulation. They are as accurate and reliable as FDA-approved testing. There is no evidence that restricting reimbursement to FDA-approved tests would improve care.
Under the proposed policy, only one of the hundreds of laboratories that currently offer NGS testing would meet all the new reimbursement requirements. The policy would in effect force clinicians and institutions to send all NGS testing to a single vendor, Foundation Medicine.
This is unfair to cancer patients. The proposal would result in a monopoly, allowing price manipulations, decreasing quality, and potentially contributing to market failure. It would turn the entire genomic-testing industry upside-down. The FDA is already unable to keep up with advances in precision medicine. Restricting access to cutting-edge molecular testing would stifle growth in precision medicine at approved testing sites nationwide. The limits could prevent desperately needed innovation, setting back progress in genomic testing and oncology by at least a decade…”
