Deductive reasoning can kickstart productive discussions; some of the greatest thinkers used them for the foundation of their studies.
- Each person is unique.
- Each cancerous tumor-type is unique.
- Therefore, each person diagnosed with a unique tumor-type provides a unique environment in which to host the cancer.
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In health, and in life, we are each an experiment of 1, an n of 1.
Every day of our lives we go out into the world emotionally and chemically interacting as exactly one individual.
Unfortunately, those individuals living with advanced, intractable malignancies still rely on ‘population level medicine’ (averages) to dictate treatment regimens for third, fourth, and subsequent lines of treatment.
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Those living with advanced refractory cancer deserve a treatment program which recognizes the unique tumor challenge and host environment that comprises their uniquely human n of 1 status.
Here’s some good news: we’re getting there.
‘Population level medicine’ is the result of the prevailing process of large, placebo-controlled randomized clinical trials. (Not to be confused with ‘population health’, which is a branch of research conducted by epidemiologists.)
Population medicine investigations endeavor to discover specific anticancer drugs or other interventions which offer a statistical difference of effectiveness (as compared to the current standard of care) for the largest common denominator of cancer patients.
Success is typically measured in mere weeks or a few months of progression-free survival or overall survival—these are the primary endpoints measured in the study of drug effectiveness.
But for those faced with relapsed cancer after undergoing multiple lines of therapy for an advanced, metastatic disease, NCCN standard of care—FDA-approved regimens—are largely ineffective at curing disease, let alone providing long-term disease control.
That is why I am a Cancer-Treatment Agnostic.
Not the word ‘agnostic’ in a faith-based context. No, I am referring to the definition of ‘agnostic’ that closely resembles its meaning in technological agnosticism.
Technological agnosticism is the recognition that there is no one single solution-system that will satisfy every technological challenge, therefore technological challenges which appear similar are handled effectively with solutions customized to each unique situation.
As a cancer-treatment agnostic, I posit that there is often not “one true cancer care approach” that is repeatedly effective for those living with advanced cancer, where multiple lines of NCCN-guided treatments have failed.
And to be clear, this is a debate about probabilities. On average, is an evidence-based protocol, informed by large randomized controlled trials, going to provide better treatment guidance than an ‘alternative’ but personalized medicine approach?
… About That Agnosticism
I’ve written about being of no party or clique, and I’ve personally (and professionally) been all-in with lifestyle factors, and the core tenets of integrative oncology—long before these were recognized, organized practices.
I may follow the early investigations of mistletoe therapy for cancer, and delve into obscure articles, mainstream studies, and peer-reviewed papers that share the efficacy of exercise and diet, but this does not mean I ever stop paying attention to the evolution of synthetic novel drug development, targeted therapies, surgical procedures, radiation, novel functional testing, imaging, and other remarkable scientific and clinical innovations.
But whether a cancer treatment is comprised of one-hundred percent natural approaches or cutting-edge novel targeted synthetic agents, I am open to reviewing the data on anything and everything that may be suitable for each unique individual hosting cancer. From broccoli extracts and high intensity interval training to CAR-T therapy, and everything in between, all reasonable agents, devices, and therapies deserve investigating. If a therapy is proven safe and effective, or meet the goals and interests of an individual, I want to review and study that therapy… as a cancer-treatment agnostic.
Host and Tumor
Conventional oncologists still tend to focus solely on tumors, with scant attention focused on the host… the person sitting in front of them who is living with cancer. The host environment should be supported by all possible means—physical and emotional—so it becomes a horrible host to cancer.
Personalized Medicine and Integrative Oncology Are Not Mutually Exclusive
The future portends a personalized approach for each unique tumor and each person hosting such tumor. Personalized therapeutic regimens will essentially become a custom-made protocol for each person diagnosed with cancer.
It will include individualized drug regimens, prescriptive diets, exercise, and stress reduction programs tailored for the individual’s overall health, recognition of comorbidities, stage of life, and one’s capacity to adhere to such protocols. Each patient’s treatment experiences will be seen as a series of experiments, and we will learn from each of the experiments and then scale what works.
[Related content: Beyond Standard Cancer Care: Intelligent Considerations.]
We will move away from the current ‘population medicine paradigm’ whereby large randomized clinical trials dictate a one-size-fits-all approach to cancer treatment. That way of delivering medicine—comprised of FDA-approved, NCCN Guideline-driven anticancer agents for general populations of cancer—will eventually become obsolete.
This future I speak of is not that far away… read on.
Integrative Oncology Defined
Integrative oncology is a patient-centered, evidence-informed field of cancer care that utilizes mind and body practices, natural products, and/or lifestyle modifications from different traditions alongside conventional cancer treatments. Integrative oncology aims to optimize health, quality of life, and clinical outcomes across the cancer care continuum and to empower people to prevent cancer and become active participants before, during, and beyond cancer treatment. ~Society for Integrative Oncology.
Agreed, but this definition of integrative oncology lacks the clinical and patient-empowered and patient-centered pursuit of optimizing the health of those living with cancer—and that also includes a core focus to strengthen immune function, resiliency, and increase quality of life.
Outcomes include the reduction of the often-deleterious side effects of conventional therapies (therefore improving efficacy by allowing patients to stay on their prescribed regimens). Ultimately, lifestyle approaches to prevent cancer can also help ensure long-term survivorship post-diagnosis.
Precision Medicine Defined
A form of medicine that uses information about a person’s own genes or proteins to prevent, diagnose, or treat disease. In cancer, precision medicine uses specific information about a person’s tumor to help make a diagnosis, plan treatment, find out how well treatment is working, or make a prognosis. Examples of precision medicine include using targeted therapies to treat certain types of cancer cells, such as HER2-positive breast cancer cells, or using tumor marker testing to help diagnose cancer. Also called personalized medicine. ~National Cancer Institute
The definition above from the National Cancer Institute only hints at what’s truly happening in this space. NCI’s own definition does not seem to accurately define precision medicine, because at the end it conflates the term with personalized medicine. ASCO also conflates the terms here.
When integrative oncology has a core focus to strengthen immune function, resiliency—and increase quality of life—and is informed by a deep set of testing, and is delivered comprehensively… then that is personalized medicine.
The problem is, the nomenclature around this fast-evolving field can be confusing.
Since I cannot seem to find an accurate definition of personalized medicine in the context of cancer treatment, I will offer my own…
Personalized Medicine Defined
Personalized medicine is a process to deeply understand a patient’s unique tumor and environment. It includes tailoring various tests to help inform the most effective treatment solutions for that individual. Identified therapies may or may not include FDA-approved drugs for the specific disease indication that a patient is hosting; it may include off-label anticancer agents. Personalized medicine is an n of 1 approach to care, where each person hosting cancer becomes their own personalized medical experiment comprising one subject.
Personalized medicine is not precision medicine, which focuses on the development of novel, targeted therapeutics based on the disease profile itself, at the population level.
My Immersion into Personalized Medicine
As a cancer coach, I work with many folks—sadly, too many—living with advanced cancer. Over the years, several of my clients have run out of standard treatment options as captured in the NCCN Guidelines.
NCCN by and large dictates to oncologists a set of approved therapeutic approaches for any given population of disease at different stages, depending on various factors such as tumor type, tumor grade, mutational status, any prior treatment (called ‘lines’ of treatment), comorbidities, and age.
But oncologists do have the latitude to prescribe off-label drugs. If they feel a certain drug or combination may be appropriate for their patient, but is not FDA approved for their specific cancer type, they can prescribe ‘off label’.
Over 30% of FDA-approved anticancer drugs are prescribed off label, more so than for any other condition. In large part, this is because after a drug company spends upwards of a billion dollars to bring a new anticancer drug to market for a specific indication—a specific cancer type—it is often too expensive to get additional FDA-approval for additional indications. Unfortunately, the incentives are not always there.
Coverage through private insurance or Medicare is most possible when oncologists advocate on a patient’s behalf, especially if a drug or combination of drugs are initially denied.
Despite many available tests covered by private insurance and Medicare, they are not (yet) ordered as frequently as they should be. These include whole exome sequencing, whole genome sequencing (DNA and RNA), liquid biopsies, proteomics, and FISH (fluorescence in situ hybridization).
Multi-omics
Certain branches of science are recognized with the suffix omics (example: genomics, and phenomics). Multi-omics is a new approach combining the data sets of various ‘omic’ groups. Studying the combinations provides the potential to discover more about disease—for example: understanding molecular change and cell response. Ultimately, the more scientists learn, the more connections will be made, and the more information will be available to influence treatment.
The fast-emerging field of multi-omics—a core facet of personalized medicine—provides unprecedented opportunities to further classify cancers into subtypes. Multi-omics improves the survival prediction and therapeutic outcome of these subtypes.
The framework that integrates multiple omics datasets generated from the same individual provides a view to understand the molecular and clinical features of the cancer the individual is hosting. This is a serious step forward whereby specific methods are applied to various datasets including gene expression, somatic mutations, methylation, and proteomics. These provide insight into the biological pathways driving the growth and spread of a specific cancer.
The more information that patients can gather about their disease, the more it will help guide them to more personalized and effective treatment.
We need more oncologists applying a rigorous level of inquiry, curiosity, and tenaciousness to go the extra mile on behalf of their advanced cancer patients, by pursuing the additional omics testing that would allow personalization of their treatment.
The above only scratches the surface of the innovation afoot in personalized medicine. The conflation of industry terms makes it a bit wonky to consume and a challenge to fully understand. Those interested in a basic framework for navigating and determining one’s next best cancer treatment, check out this piece.
Creating n of 1 Exceptional Responders … By All Means Necessary
The significant correlation of remarkable outcomes and those patients who are super-engaged, well-informed, and proactive, in that order, is remarkable.
I am cancer treatment agnostic, because I am most interested in supporting the creation of more exceptional responders: outliers who were given long odds of survival, but managed to be an aberration in the process of living their best lives.
In an n of 1, personalized medicine world, we must learn from each patient’s experience by capturing the data within a learning health system—to ensure that each ‘experiment’ brings advances in the care for those who follow.
The promise of personalized medicine and integrative oncology as one—personalized focus on the tumor and the host—will pave the way.
Whether by natural products, the kitchen, and the gym, a metabolic approach using fasting, keto, and repurposed drugs—or off-patent or novel synthetic anticancer agents … I don’t much care. Whatever is effective, with a 100% steadfast focus on tumors and host to improve the human condition. One n of 1 at a time.
Integrative Oncology. Check.
Personalized n of 1 Medicine for all. Check.
Meanwhile, as treatment development moves along, I will continue to advocate for, and sadly wonder aloud about, the most effective and largely ignored cancer cure ever known: comprehensive prevention.
Note from Glenn Sabin:
I would like to thank Brad Power from CancerHacker Lab for his substantive input into the development of this piece. Brad will be contributing a guest post in the near future.
Join my private Facebook Group Anticancer Thrivers—a community forum for achieving your best life while living with cancer.
Photo credit: bigstockphoto.com_inimal_Graphic
