Category: News

” Active” Active Surveillance in Prostate Cancer

Dr. Charles Meakin
Dr. Charles Meakin

As Chief Medical Officer of Care Oncology, I have witnessed many prostate cancer patients (in the above scenarios) find their way to our metabolic protocol to engage a truly “Active” Active Surveillance strategy.

One of the therapeutic options upon diagnosis of prostate cancer is the prospect of deferring commencement of traditional therapies while one monitors the PSA level. (https://www.nccn.org/patients/guidelines/content/PDF/prostate-patient.pdf).

In line with this, at Care Oncology we have many men who have chosen to start the COC Protocol and ultimately been able to enjoy long periods away from traditional therapy and its side effects and cost. It is possible the protocol is having a favorable impact on proliferation drivers that foster the cancer cell growth reflected in a rising PSA, and we are tracking our cohort over time to analyze this further.

The strategy may be a sensible one since many patients are diagnosed with indolent cancers and at an age where they are likely to have comorbidities. Hence the statement that many men with prostate cancer “die with it, but not from it.”  The first step is identifying the risk category of the prostate cancer (PSA level, Gleason Score, degree of spread etc) versus the anticipated life expectancy of the patient. Once these two characteristics have been evaluated, one can consider which threat is the greatest – the prostate cancer versus the other advancing potential causes of death as men age. The traditional Active Surveillance strategy incorporates frequent PSA  or tumor marker checks as measured in an annual biopsy procedure, which can become very challenging for patients (https://pubmed.ncbi.nlm.nih.gov/28512731/). Generally, about 50% of the patients will transition to some treatment over a ten-year period without any loss of treatment success as compared to immediate treatment with surgery or radiation.

The difficulty with active surveillance is going to bed every night, knowing there may be cancer growing in your body. Some men handle this dilemma better than others, and I have noticed that after one to two years, many say, “Hey Doc, can we go ahead and treat it!”.

In my big cancer center oncology role, during this watchful waiting window, I would frequently put patients on some nutrition and supplements strategies associated with anti-proliferation. In many instances, I would see the PSA reduce or even flatline, resulting in emotional satisfaction for the patients, many of whom reported feeling able to exert some element of direct control over their disease for the first time. Personally, I found management of these patients very rewarding too, as I believe there is a strong likelihood the “active” strategies we deployed also had a positive impact on other existing chronic health conditions  or chronic disease risk factors prevalent in men of a certain age.

The other situation that frequently would come up with similar options and implications is the very common occurrence of PSA failure after attempted curative surgery or radiation (External Beam or Implant). At this unfortunate juncture, men often continue to feel fine. Still, they are tortured by the knowledge that the cancer is growing back and may be a problem at some time in the future, and some new therapies may be necessary despite the initial treatment. This dilemma can be complicated by consideration of therapies such as androgen blockade that can accelerate other chronic comorbidities and impact the quality of life in order to treat an asymptomatic lab value like the rising PSA.

We’re very excited about the encouraging preliminary results we are seeing, so in addition to continuing to audit the outcomes of our own patients at Care Oncology, we have now also begun  approaching large urology  groups to explore initiating the COC metabolic protocol as a  formal study, given the ease of implementation, fundamental affordability of the program and most importantly how empowering it has the potential to be for patients.

Stay strong and curious,

Charles Meakin MD

 

The tumor microenvironment, immune response and the COC Protocol

The body’s own anti-tumor immune response can be a powerful weapon against cancer. Once mobilized it can target and destroy cancer cells very efficiently. New and developing immunotherapies seek to harness this ability. But tumors are also very good at recruiting the immune system for their own protection. Scientists are looking for ways to help improve the body’s immune system respond to cancer and help facilitate immunotherapy treatment activity.

Tumor Associated Macrophages (TAMs) are key immune cells which help to modulate the body’s own anti-tumor immune response. TAMs circulate in the region immediately around the tumor, called the tumor microenvironment. Once recruited by the tumor, TAMs can help to promote growth and spread of tumor cells. They can also help to stimulate the formation of new blood vessels (angiogenesis) to feed the tumor.

TAMs are generally thought to ‘polarize’ into anti-tumor M1-type or pro-tumor M2-type cells, depending on outside signals they receive. This is a growing field of research, and scientists are still working to understand just how and when TAMs can polarize to promote or inhibit cancer growth. However, there is emerging evidence that polarization of TAMs may in part be influenced by the metabolic state (i.e. nutrient availability) of the tumor microenvironment. In this way, TAMs and cancer cells may also be able to directly influence each other, depending on their own metabolic activity (Vitale et al, 2019).

In line with this, emerging evidence also suggests that the COC Protocol medications (which can help to influence cell metabolic activity), may help to beneficially modulate the anti-tumor activity of TAMs and other immune cells.

For example, a 2018 lab study found that metformin can ‘skew’ TAM polarization in the tumor microenvironment from pro-tumor M2 to anti-tumor M1. Metformin inhibited both tumor growth and angiogenesis in this study (Wang et al. 2018). Other studies suggest metformin may also boost other immune cell functions, potentially helping to increase abundance of (anti-cancer) tumor infiltrating lymphocytes, and enhancing the cancer cell-killing ability of  T-cells (Pereira et al 2018).

Mebendazole has also been shown to help initiate the TAM mediated anti-tumor immune response. In one study, gene expression profiling in mebendazole-treated breast cancer and leukemia cells showed that mebendazole strongly upregulated several genes related to activation of the anti-tumor M1 monocyte/macrophage (i.e. TAMs). A further lab study in colon cancer cells also showed that mebendazole’s tumor suppressive effect is intrinsically linked to monocyte/macrophage immune cell response (both studies reviewed in Guerini et al 2019).

Further reports suggest that statins and doxycycline can also have antitumor effects on TAM polarization and other immune cell functions. For example, in a study which analyzed samples from patients with lung cancer, statin use was associated with reduced levels of pro-tumor TAMs, and reduced tumor invasiveness (Dujaily et al. 2020). And in a mouse model of breast cancer, statin helped to improve anti-tumor T cell infiltration into tumors, and decrease the number of M2-type TAMs. Initiation of new cancerous lesions in these mice was also decreased (Mira et al. 2013). In a different study using a mouse model of breast cancer, doxycycline slowed tumor growth, and this effect was associated with changes in levels of cytokines and TAMs (Tang et al. 2017).

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Important Notice

Purpose of this article

This article is an overview of some of the scientific and medical published literature concerning the medications which comprise the patented Care Oncology protocol. Care has been taken to select relevant articles supporting the off-label use of these medicines in a clinical setting for the adjunct treatment of cancer. This article does not purport to be a comprehensive review of all the evidence, nor does it capture all the potential side-effects of such treatment.

This article is for information purposes only and it does NOT constitute medical advice. The medicines discussed herein are available on prescription-only and should not be taken without consultation with your doctor or other professional healthcare provider. Care Oncology doctors will discuss the suitability of these medicines with you and will liaise with your doctor or oncologist to discuss their suitability for you.

You must NOT rely on the information in this article as an alternative to medical advice from your doctor or other professional healthcare provider. If you have any specific questions about any medical matter you should consult your doctor or other professional healthcare provider. If you think you may be suffering from any medical condition you should seek immediate medical attention. You should never delay seeking medical advice, disregard medical advice, or discontinue medical treatment because of information contained in this article.

Copyright

The copyright in this article is owned by Health Clinics USA Corp and its licensors.

Patent

The Care Oncology (“COC”) Protocol is protected by United States patent US9622982B2 and by various additional international patents.

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References

Dujaily, Esraa Al, Juvenal Baena, Madhumita Das, Marco Sereno, Claire Smith, Tamihiro Kamata, Leah Officer, Catrin Pritchard, and John Le Quesne. 2020. “Reduced Pro-Tumourigenic Tumour-Associated Macrophages with Statin Use in Premalignant Human Lung Adenocarcinoma.” JNCI Cancer Spectrum. https://doi.org/10.1093/jncics/pkz101.

Guerini, Andrea Emanuele, Luca Triggiani, Marta Maddalo, Marco Lorenzo Bonù, Francesco Frassine, Anna Baiguini, Alessandro Alghisi, et al. 2019. “Mebendazole as a Candidate for Drug Repurposing in Oncology: An Extensive Review of Current Literature.” Cancers 11 (9). https://doi.org/10.3390/cancers11091284.

Jeong, Hoibin, Sehui Kim, Beom-Ju Hong, Chan-Ju Lee, Young-Eun Kim, Seoyeon Bok, Jung-Min Oh, et al. 2019. “Tumor-Associated Macrophages Enhance Tumor Hypoxia and Aerobic Glycolysis.” Cancer Research 79 (4): 795–806. https://doi.org/10.1158/0008-5472.CAN-18-2545.

Mira, Emilia, Lorena Carmona-Rodríguez, Manuel Tardáguila, Iñigo Azcoitia, Alicia González-Martín, Luis Almonacid, Josefina Casas, Gemma Fabriás, and Santos Mañes. 2013. “A Lovastatin-Elicited Genetic Program Inhibits M2 Macrophage Polarization and Enhances T Cell Infiltration into Spontaneous Mouse Mammary Tumors.” Oncotarget 4 (12): 2288–2301.

Pereira, Melo, Low, de Castro, Braga, Almeida, Batista de Lima, Hiyane, Correa-Costa, Andrade-Oliveira, Origassa, Pereira, Kaech, Rodrigues, Olsen, Camara, 2018.  Metformin exerts antitumor activity via induction of multiple death pathways in tumor cells and activation of a protective immune response.” https://doi.org/10.18632/oncotarget.25380

Tang, Xiaoyun, Xianyan Wang, Yuan Y. Zhao, Jonathan M. Curtis, and David N. Brindley. 2017. “Doxycycline Attenuates Breast Cancer Related Inflammation by Decreasing Plasma Lysophosphatidate Concentrations and Inhibiting NF-ΚB Activation.” Molecular Cancer 16 (February). https://doi.org/10.1186/s12943-017-0607-x.

Vitale, Ilio, Manic, Gwenola, Coussens, Lisa M, Kroemer, Guido, Galluzzi, Lorenzo. “Macrophages and Metabolism in the Tumor Microenvironment.” Cell Metab. 2019;30(1):36-50. https://doi:10.1016/j.cmet.2019.06.001.

Repurposed medicines and COVID-19

The coronavirus pandemic has put drug repurposing in the spotlight in a way that has never happened before. If shown to be effective in COVID-19, existing medicines with known safety profiles can be brought to clinical use quickly and will likely offer a more rapid hope of tackling the virus than a vaccine. In nearly all cases, use of existing drugs will also offer a highly affordable solution.

Many Artificial Intelligence and bioinformatics studies are cross-referencing vast numbers of different medicines with new information about the biology of SARS CoV-2 (the virus which causes COVID-19) and dynamic clinical trials are taking place all over the world. These trials have secured regulatory approval far more quickly than would normally be the case and many have been designed to allow for rapid review of information so that the most promising agents can be prioritised.

More research is required before various medicines can be widely prescribed as COVID-19 prophylaxis or treatment, but the direction of travel is encouraging.

As this data develops, it is interesting to note that various druggable targets associated with the COC Protocol medications in cancer (e.g. glycolysis, lipid accumulation, inhibition of pro-inflammatory cytokines) also appear to be relevant in COVID-19.

Please see below for further reading.

The SARS-CoV-2 Transcriptional Metabolic Signature in Lung Epithelium

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3650499

 

Metformin Treatment Was Associated with Decreased Mortality in COVID-19 Patients with Diabetes in a Retrospective Analysis

https://www.ajtmh.org/content/journals/10.4269/ajtmh.20-0375

 

Metformin in COVID-19: A possible role beyond diabetes

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7190487/

 

Modulation of Cytokine and Cytokine Receptor/Antagonist by Treatment with Doxycycline and Tetracycline in Patients with Dengue Fever

https://www.hindawi.com/journals/jir/2011/370872/

 

Further aspects of doxycycline therapy in COVID‐19

https://onlinelibrary.wiley.com/doi/full/10.1111/dth.13810

 

A Combination of Ivermectin and Doxycycline Possibly Blocks the Viral Entry and Modulates the Innate Immune Response in COVID-19 Patients

https://chemrxiv.org/articles/preprint/A_Combination_of_Ivermectin_and_Doxycycline_Possibly_Blocks_the_Viral_Entry_and_Modulate_the_Innate_Immune_Response_in_COVID-19_Patients/12630539

 

In-hospital use of statins is associated with a reduced risk of mortality among individuals with COVID-19

https://www.cell.com/cell-metabolism/fulltext/S1550-4131(20)30316-8

There are many reasons Care Oncology has decided to utilize Mebendazole

There are many reasons Care Oncology has decided to utilize Mebendazole as part of the complete COC Protocol. The article below is an extensive review of the current literature.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6769799/

In addition:

We have selected Mebendazole in the COC Protocol because:

1. It has a human license
2. It is already demonstrated as safe in humans
3. It is already demonstrated as safe in humans with cancer
4. Has the right anticancer mechanisms of action
5. Has a significant amount of clinical data in cancer
6. Has cancer data that is covered by the existing dosage schedule
7. Can be prescribed and monitored by clinicians
8. Has the largest amount of scientific and medical data on its use in cancer

The other Benzimidazole drugs may have utility in cancer but it is only Mebendazole that satisfies all our criteria about both efficacy data patient safety and history of use.

Dr Ndabezinhle Mazibuko MBBS talks about the COC Protocol and its clinical study.

Validating the Outcomes of the COC Protocol

Validation Institute LogoWe brought Care Oncology to the United States almost four years ago. Since then, and because of COVID-19 now, the value offered by drug repurposing has captivated the public’s attention, as highlighted by this recent article in the New York Times.  As one of the first companies to offer a combination of repurposed drugs as an adjuvant cancer therapy, we promised to do two things: Maintain a consistent formulation that is able to be safely administrated, and second, maintain a consistent formulation so the outcome can be measured and validated. Unlike some clinics that offer repurposed drugs for cancer, at Care Oncology we have embarked on wide-ranging, real-world clinical trial so patients and oncologists can see our outcomes for themselves. Last year, we published our first outcome data on glioblastoma.

No one disputes the fact that health care in the United States is in a state of crisis. We spend far more than any other industrialized nation on healthcare (20% of GDP versus 11% of GDP) and get less. However, we remain optimistic that this is changing. The market place is responding to the crisis. Innovative, value-based companies are being created like never before. Companies that offer proven value for the money paid.

Moreover, recognizing the need for responsible third-party validation of these newly formed health care companies has become critically important. The Validation Institute has become the trusted name to lead this critical mission. Their mission is to thoroughly vet health care companies so the general public and payers know if they offer recognized and proven value for their patients or not.

Today, we are incredibly proud to announce that we have passed the Validation Institute’s extremely rigorous validation process of data analysis, outcome claims, and value calculation. We have worked hard to get to this point. Early on, we recognized the tremendous value a responsibly delivered program of repurposed drugs offered to cancer patients, yet, it was not being offered at scale. Four years ago, we set out to change this knowing it was a marathon, not a sprint.

Today is a milestone. Tomorrow, we have even bigger aspirations. We have a clarity of mission like never before, and an unbridled energy to keep changing oncology for the better.

View Care Oncology at the Validation Institute

The COC Protocol during the COVID-19 outbreak

We hope you and your family are well and keeping safe. 

We are pleased to report that all our staff are currently in good health and we continue to run normally with all appointments taking place.

The COC Protocol during the COVID-19 outbreak

With this note, we felt it would be helpful to address a question which our doctors have been asked by a number of patients recently: is it useful to continue with the COC Protocol in a scenario where standard of care treatments such as surgery, chemotherapy and immunotherapy are being paused or postponed?

The short answer is that yes, we believe it is. The COC Protocol down-regulates cancer cell metabolism (or in other words, it “starves” cancer cells) and therefore may be beneficial to you during a time where there is a wait for your standard of care to start or to resume.

While it is always our preference for the COC Protocol to run alongside standard of care wherever possible, the research literature and our own analysis of our Glioblastoma brain tumor cohort shows there is the potential for it to play a supportive role when administered as standalone therapy too – click here to read: Frontiers: A case study in Glioblastoma.

We would also like to further reassure you that none of the COC medications cause immunosuppression, and where it is safe and appropriate, our physicians will actively consider upward dose adjustments, particularly in a situation where systemic treatment has been interrupted. 

Interval blood tests and other concerns

We understand that it may currently be difficult to arrange your usual follow up blood tests at your hospital or GP surgery and if this is the case, please contact us to discuss your situation. In line with our usual advice, we also ask that you contact us if you think you may be experiencing any adverse effects, symptoms of an infection/other symptoms of concern or have any general questions regarding your COC treatment at this time. 

COVID-19 driving forward research into existing drugs

One silver lining of the current virus outbreak is that the spotlight is being shone on repurposing of medicines in a way that has never happened before. Different groups of researchers are busy evaluating how existing licensed medications could be usefully deployed in COVID-19 infection. For example, the following article from a well-respected French bioinformatics organisation examines possible druggable targets in COVID-19 and it is interesting to note that both metformin and atorvastatin are mentioned as two of the possible 97 agents that require further study in this context – click here to read: Repositioning common approved drugs against COVID-19

This underscores that well-conducted, robust research into repurposed medicines is a logical and important therapeutic strategy in cancer and many other disease processes.

General Advice

CDC Guidelines: CDC guidelines

Cancer Research UK: CRUK – COVID-19

Finally, should you need to book a review or have any questions you’d like to discuss with our team, please get in touch with us at 1-800-392-1352, casemanager@careoncology.com.

A note from our Medical Director, Dr. Charles Meakin, Regarding the COVID-19 Virus

Amid the growing uncertainty related to the Coronavirus COVID-19 outbreak, Care Oncology would like to assure you that we are here for you during this challenging time.

All cancer patients, including our existing Care Oncology patients, may be concerned about best practices during this unprecedented time. For some patients, the risks associated with exposure to the virus and even moderate immune dysfunction may possibly present a more significant threat than a delay to your standard cancer therapy. You and your oncologist will need to decide if you can continue to receive your treatment given the strain that hospitals are under with treating people with the Coronavirus, or whether you should suspend your standard treatment for a while. Every individual situation is different, and these are personal decisions unique to your cancer aggressiveness, the local viral risk, available treatment resources, and you and your family’s wishes.

We are writing to confirm to you that the Care Oncology protocol should not cause immunosuppression nor should it change your risk to the COVID 19 virus. The Care Oncology protocol down-regulates the cancer cell metabolism (or starve the cancer cells) and may be beneficial to you during this time while you wait for your standard of care to start or to resume. The protocol should not impact your ability to fight off typical infections or this COVID 19 virus and may be helpful.

Through our online telemedicine platform, new or existing patients are evaluated via video conferencing without the need to travel to our clinics and to be exposed to the risks from the virus. Our medications are sent to your home in 2-4 days after the oncology consult to start therapy immediately. Our oncology nurses are on standby to promptly answer your questions, online or by telephone, for all our patients.

If you do become sick from the virus, and you find that you cannot take the Care Oncology medications, it is fine to stop them until you feel well enough to begin taking them again.

Throughout the world, every day, we are witnessing human kindness at its very best as people pull together and make sacrifices for the good of everyone else. At Care Oncology we recognize the unique challenges of today’s environment and have a team of Oncology doctors and nurses ready to serve your needs with coverage throughout the United States and most of Canada.

Sincerely,
Charles Meakin MD, MHA,
Care Oncology Chief Medical Officer
CareOncology.com

Interview with Travis Christofferson (Tripping Over The Truth)

Travis Christofferson Tripping Over the TruthTravis Christofferson , author of “Tripping Over The Truth,” sits down with Phil Mikan on their shared experiences with cancer treatment. Travis discusses his insights on doctor’s attitudes toward developing treatment methodology such as Care Oncology’s COC Protocol. Recorded: January 28, 2020 For more information, visit www.careoncology.com

Tripping over the Truth: How the Metabolic Theory of Cancer Is Overturning One of Medicine’s Most Entrenched Paradigms 1st Edition Available at Amazon

Curable: How an Unlikely Group of Radical Innovators is Trying to Transform our Health Care System Available at Amazon