Updated Oct 2017
SEF CHEMO IS NO LONGER AVAILABLE IN CANADA. WE ARE UNABLE TO PROVIDE THIS THERAPY DUE TO THE COLLEGE OF PHYSICIANS AND SURGEONS RESTRICTIONS. CANCER PATIENTS RECEIVING THIS LIFE-SAVING THERAPY MUST TRAVEL TO CALIFORNIA OR SEEK OTHER TREATMENT. READ THE PRESS RELEASE
OVERVIEW
Medicor Cancer Centres is privileged to be the third center in the world to receive authorization to administer a unique therapy called “Side Effect-Free” or SEF chemo (pronounced “safe” chemo)SM. This treatment was developed by Dr. Ken Matsumura and his team of researchers at the Berkeley Institute in California. Dr. Matsumura is a physician and the inventor of the world’s first artificial liver, artificial pancreas and wristwatch heart alarm. Dr. Matsumura also created the ALIN Foundation to help fund medical research and innovative therapies.
Many researchers around the world are trying to develop drugs which target cancer cells while sparing healthy cells in the body from injury. This has largely been a failure. Dr. Matsumura selected the opposite approach: use a powerful chemotherapy drug that aggressively kills cancer cells but also damages some healthy cells, combined with an antidote to protect the healthy cells in the body. It took over 30 years of research to develop this new therapy, and we have received permission to use it since mid-2013, with the ongoing guidance of the Berkeley Institute’s SEF chemo team.
SAFETY
Although it is called “side effect free”, there is no such thing as any drug therapy with zero side effects. In reality, many patients experience so few side effects that they would not feel like they are receiving chemotherapy at all. For example, typically there is no hair loss or vomiting, and the most common side effects are mild to moderate fatigue and mild nausea for 3 or 4 days after treatment, despite minimal anti-nausea drugs use (no steroid). Most patients experience stable or mildly reduced blood cell counts, without immune suppression. It is also common to have pain in the areas of tumours, due to inflammation that occurs as the cancer cells are being attacked by the immune system.
DRUGS USED
The standard drugs used for SEF chemotherapy are carboplatin with mesna as an antidote. Both of these drugs are generic and legally can be used for cancer therapy in Canada. Since they are only approved for a small number of cancer types in Canada, in most cases they are being prescribed “off label”, in other words, not for their “approved” purpose. Off-label drug therapy is legal in Canada and is permitted by the College of Physicians and Surgeons of Ontario.
Occasionally a second gentler chemo drug may be added to enhance the carboplatin (if the cancer responds slowly to carboplatin alone). This may consist of gemcitabine or capecitabine. We prefer to avoid adding a second chemo, since this chemo drug is not being used with an antidote. More often we are combining intravenous sodium phenylbutyrate or metformin with SEF chemo since our lab research and patient data indicate these drugs can be powerful chemosensitizers. That means these drugs can allow the chemo to work much better, but without creating immune suppression or other serious side effects.
EFFICACY
Dr. Matsumura has reported approximately 90% response rate for patients with stage 3 and early stage 4 cancers, and in the first small clinical trial of 6 patients, 4 achieved a long-term complete remission of cancer (no detectable cancer in the body for years after therapy).
For our first 20 patients (almost all stage 4 cancers, various types including rare tumours and those that typically respond poorly to chemo), our overall response rate was over 80% using modified RECIST definitions. After some adjustments to the therapy to account for the unique patient population we serve, our response rate has increased to over 90%. This type of response rate is 2 to 5 times higher than conventional approved chemotherapy in these types of patients. Since the data is preliminary (small patient numbers), direct comparison to published chemo response rates, as determined by large clinical trials, is not entirely fair. However, the SEF chemo responses indicate the therapy is very promising.
Complete remission is possible, especially for patients with low disease bulk (even if they are stage 4). For example, one of our early SEF patients with stage 4 cervical cancer spread to the abdomen and lungs achieved complete remission as determined by clear scans, normal tumour markers, circulating tumour cell count of 0, and repeat circulating tumour cell count of 0, performed 3 months after therapy completion. She received no conventional cancer therapy along with SEF chemo.
Near-remission is possible for patients with larger amount of disease. This can increase the chance of response to non-toxic drugs after completion of SEF chemo, which allows us to achieve long-term cancer stability and prolonged survival.
Despite the initial promising results, SEF chemo is not accepted by Cancer Care Ontario, the College of Physicians and Surgeons of Ontario, or large cancer hospitals. SEF chemo is considered to be a complementary/alternative cancer therapy.
SKEPTICISM
We often hear comments from patients or oncologists asking how such good responses are possible, when standard chemo responses seem to be relatively poor. The key to the improving response to chemo is protection of the bone marrow from damage by the chemo. If the bone marrow is protected, the white cells are not compromised, and they participate in the killing of cancer cells. In other words, this is not just “chemotherapy”, rather it is “chemo-immunotherapy”, with the patient’s own immune system contributing a large percentage of cancer cell kill.
Most oncologists have never used any therapy that is similar to SEF chemo, and therefore are not in a good position to make adverse judgments against this therapy. If your oncologist expresses concern, we recommend you ask them if they are familiar with the concept of using antidotes which prevent chemo side effects, but do not interfere with chemo effectiveness. An example is the use of folinic acid to prevent side effects of methotrexate chemo. If they are familiar with this concept, they should at least recognize the possibility that SEF chemo is based on sound science and may work as claimed.
Your oncologist may feel that the lack of published data on SEF chemo means it cannot be real. They would be partly correct – the data remains unpublished. However, publication does not determine if a therapy is real or not. Dr. Matsumura has made the decision to withhold publication of his clinical trial, for a number of reasons which are too long to discuss here. The United States FDA gave approval to begin his first clinical trial after a record review time of just 4 days. We were given permission to review Dr. Matsumura’s internal patient data, and we were satisfied that the therapy was real. In addition, after using it for over 3 years, we can state clearly that it works as intended. It is not a simple therapy, but when it is done correctly in the right patients, it can work quickly and safely and give excellent results.
In order to address the limitation of lack of published patient data, we are in the process of computerizing our data collection for all of the SEF chemo patients treated at Medicor. This data is being complied and published online in a completely transparent manner, with no “cherry picking” of best cases or omission of non-responders. Presentation of the complete data set will allow informed opinions, and should silence critics who believe SEF chemo can’t be real. In addition, several detailed case reports are presented. These are not simply atypical “best” results, but real-world examples of what patients might expect with this therapy.
CANCER TYPES
We are seeing strong responses with non-small cell lung cancer, small cell lung cancer, breast cancer (including triple negative/chemo-resistant), melanoma, pancreatic cancer, non-Hodgkin’s lymphoma, ovarian cancer, cervical cancer, liposarcoma, and prostate cancer. Since carboplatin is a “broad-spectrum” chemo drug, and SEF chemo creates an immune response against the cancer, it is possible that any cancer type will respond well, including rare tumours and unknown primary tumours.
Dr. Matsumura has reported cures of leukemia with a small number cycles of SEF chemo. We have not yet had the opportunity to treat leukemia with this therapy, but we are excited to offer it to interested leukemia patients who meet certain criteria.
For the first time in the world, SEF chemo has been used successfully with glioblastoma. Previously, SEF was not used at all with brain tumours due to the risk of sudden life-threatening brain swelling. Based on our experience in Toronto, we have received permission from Dr. Matsumura to continue to use SEF chemo in selected patients with glioblastoma, who have minimal disease volume (small tumours, or no visible tumour after surgery).
TREATMENT SCHEDULE – STANDARD 2 WEEK CYCLE
The standard treatment schedule consists of 4 days of intravenous treatment, given on a 2 week cycle:
On day #1, a mesna infusion will be given.
On day #2, a mesna infusion is given followed by an infusion of carboplatin chemo after about 3 hours.
On day #3, a mesna infusion is given.
On day #4, a final mesna infusion is given.
For further details, please see SEF Chemo Patient Instructions
After 3 cycles of therapy, patients are assessed to determine if they are responding well. If so, then the therapy is continued until the cancer is in remission, or until there is therapy failure, or until there are side effects or other reasons that cause the patient to stop. We estimate that a remission of stage 3 or early stage 4 cancers will require 10-15 cycles of “safe” chemo, depending on the speed of response. If therapy continues to work but the cancer is not in remission by 12-15 cycles, we generally recommend switching to another therapy.
In Toronto, the carboplatin dose for the standard SEF protocol is about 80% of what is given in hospitals, but it is given about 1.5 – 2 times as often. This means patients receive more chemo than standard hospital protocols, yet they experience far fewer side effects.
TREATMENT SCHEDULE – LOW DOSE WEEKLY CYCLE
In 2016 we have started using a new SEF chemo regimen developed by Dr. Matsumura to help patients with compromised bone marrow and low cell counts (mainly due to prior toxic chemo use). This regimen is also gentler and is thus useful for advanced cases where very rapid killing of the cancer cells would cause complications. It consists of a low chemo dose, with 3 days of intravenous treatment, given on a 1 week cycle:
On day #1, a mesna infusion is given.
On day #2, a mesna infusion is given followed by an infusion of carboplatin chemo after about 3 hours.
On day #3, a mesna infusion is given.
For further details, please see SEF Chemo Patient Instructions
After 6 cycles of low dose weekly therapy, patients are assessed to determine if they are responding well.
The carboplatin dose for the low dose SEF protocol is about 30% of what is given in hospitals, but it is given about 3 – 4 times as often. This means patients receive about the same total chemo per month as in standard hospital protocols, yet they experience far fewer side effects.
MONITORING
Routine weekly blood tests will be performed. Routine urine tests are performed only as needed. Tumour markers may be tested every 1-2 months (these do not apply to all patients). Tumour markers may show sudden increases with SEF chemo, even with the therapy is effective. Routine imaging tests will be performed to monitor the cancer (such as x-rays, ultrasounds with Doppler to measure a tumour’s blood flow, MRI, CT and PET/CT scans). The exact imaging required will depend on the patient’s unique situation. Maintrac live cell circulating tumour cell testing will be performed in most cases (blood samples are sent to a specialized lab in Germany). This test can be used to monitor patients who have no tumours visible on any scan, but are not cancer-free. Maintrac cannot be used for leukemia or lymphoma.
For SEF chemotherapy, CT or PET scans can falsely suggest tumour growth if done at the wrong time. This is related to inflammation and swelling in the tumours caused by the immune system attacking the cancer rapidly. We are aware of this issue, and will order the most appropriate scans with the correct timing, and will help interpret the results for you. We do not rely on any one test alone to interpret the response to treatment. Please note that a CT scan is NOT the “gold standard” to assess the cancer’s response to therapy when a patient is treated with SEF chemo.
SEF CHEMO WITH NATURAL THERAPY
Most of our patients have received natural medicines at some point as part of their cancer therapy. While we understand that interactions between natural medicines and carboplatin chemo may be favourable (like mistletoe or IV vitamin C), we do not have adequate data for interaction of natural medicines with carboplatin + mesna. We have already witnessed a few negative interactions which resulted in treatment failure. Since Dr. Matsumura has achieved remarkable results of SEF chemo without the use of supplements, we ask all SEF chemo patients to hold their supplements beginning 1 week prior to the therapy start. Natural therapies may resume after SEF chemo completion. For patients who find it difficult to avoid supplements, please keep in mind that mesna is like a “mega supplement” because it provides a high degree of protection against the chemo toxicity.
Natural medicines that are not absorbed into the bloodstream are permitted (e.g. oral probiotic or some skin creams). Essential oils are NOT permitted (oral and topical). Natural medicines which enhance blood cell counts are NOT permitted (like mistletoe). Enemas with natural medicines or coffee are NOT permitted. Vitamin D is permitted and encouraged since we have tried combining high dose vitamin D with SEF chemo, and not seen any issues. Please check with Dr. Khan for further advice. After completion of SEF chemo, it is important to return to your naturopathic doctor for ongoing cancer prevention advice.
CHEMOTHERAPY REGULATIONS
Some physicians have expressed concern about our administration of chemotherapy drugs outside of a hospital setting. This is currently permitted, although the guidelines and safety standards that must be followed are very strict. Medicor has obtained and reviewed many chemotherapy guidelines from Ontario, B.C., Québec, and USA. Best practices have been taken from these guidelines to create a comprehensive set of standards that is most suitable for our SEF chemo program. These standards can be found in the Medicor Safe Chemo Policy and Procedure Manual. If desired, the manual is available for viewing in person in the office, by making a written request to the Medicor C.E.O. In addition we have been subjected to a surprise audit of the entire SEF chemo program by the provincial physician regulatory body, with no adverse findings to date. We are also constantly working to improve our standards of care delivery from year to year. It is our hope to always meet or exceed all applicable safety standards of chemo administration.
COSTS
Medicor does not sell SEF chemo, we only infuse it. We do not set the price, this is determined by the Berkeley Institute. Payment for SEF chemo must be made directly to the Berkeley Institute with a credit card. Payment is made with each cycle of therapy, 1 day before therapy begins (pre-payment for multiple cycles is not required). The cost of SEF chemo (including carboplatin + mesna) is roughly $4200 US per cycle, regardless of chemo dose. There is an additional one-time consultation fee of approximately $650 for the Berkeley Team at the start of therapy. There will be additional charges if a second chemo drug (gemcitabine) is needed, although we don’t often use this drug in Toronto. Patients should budget for 3 cycles of biweekly therapy (or 6 cycles of low dose weekly therapy) to determine how their cancer responds. If there is a favourable response, patients should budget for an additional 6 – 9 biweekly cycles (or 12 to 18 low dose weekly cycles). If this is not within your budget, a different therapy should be considered.
Please note that the number of cycles required depends on each person’s individual speed of response to therapy, and to the amount of cancer present in the body. Minimal cancer that responds rapidly will give the best results in the least number of cycles.
Québec patients must pay physician fees in addition, and can request reimbursement from le Ministère de la Santé (because there is no agreement between Québec and Ontario for government payment of physician fees). Most blood and imaging tests are covered by government insurance since this is a medically necessary off-label therapy using Health Canada-approved medications.
Canadian patients with a valid Health Card receive most imaging and blood tests and doctor visits at no charge. Patients with no Canadian healthcare coverage must pay physician fees and blood/imaging test fees.
Circulating tumour cell counts are not covered by government insurance (less than $600 per test). PET/CT is about $2300 per test, and is usually not required. There are additional charges for chemosensitizing drugs (if needed). Patients who have been treated previously with several chemos may have carboplatin resistance, requiring the addition of one of these drugs. See below under CHEMOSENSITIZING DRUGS.
Private medical insurance may not cover SEF chemo in Canada. Please check with your insurance company. The Berkeley Institute does not accept direct payment from insurance. Our experience is that off-label chemo may not be covered by Canadian private insurance plans, unless prescribed by a Canadian oncologist. Therapy for our SEF chemo patients is prescribed by the Berkeley Institute team. Critical Illness Insurance and Health Spending Accounts should cover SEF chemo. Life insurance may allow advance payment of a lump sum for patients diagnosed with a life-threatening illness like cancer. Finally, you may contact a medical financing company such as Medicard or CreditMedical for quick financing with a monthly repayment plan. Medicor is registered with both companies.
CHEMOSENSITIZING DRUGS
Certain patients who have chemo-resist cancer cells from the use of multiple prior chemo drugs, or due to an inherently resistant tumour type, may need to use a chemo-sensitizing drug to get a favourable response to therapy. We offer iv sodium phenylbutyrate (PB), iv metformin and iv dichloroacetate (DCA) to enhance the cancer cell kill, if needed. All of these medications have been researched and shown to overcome chemo-resistance by different mechanisms. Interference with SEF chemo is uncommon. PB causes a temporary drunken feeling and can rarely lower blood cell counts with the protocol that we are using. DCA can rarely reduce the effectiveness of chemo, but is much more likely to enhance chemo. DCA can also cause neuropathy, which may be worse when combining with carboplatin. Metformin can lower blood pressure, but should not cause low blood glucose. Cost of each infusion is usually between $200 and $300. Please check in advance if this is financially feasible in case it may be required to boost your therapy.
CHEMOSENSITIVITY TESTING
Chemosensitivity / chemoresistance (CS/CR) testing is available to determine who will respond well to SEF chemo, to save the cost of trying it. Since the response rate to SEF chemo (without testing) is quite high, such testing is not necessarily required. CS/CR testing can help give you optimal results. CS/CR testing can give you an idea if you are likely to respond very quickly, and can suggest if a second drug should be combined with carboplatin from the beginning for the best response.
If you are having cancer surgery soon, you may request a small piece of live tumour (e.g. 1cm diameter) taken during surgery to be shipped fresh to a lab in USA such as AccuTheranostics (for ChemoFit test), Weisenthal Cancer Group (for Personalized Chemo test), or other high quality lab that does live cell chemosensitivity testing. These labs can test most solid tumours. The ideal time to do this type of CS/CR testing is at the time of cancer surgery. Needle biopsies likely will not obtain enough cancer cells to run tests at these labs. Open biopsies of cancers close to the skin surface, or superficial lymph nodes involved with cancer, are minimally invasive, and should yield enough cells for successful testing.
If you are not having surgery, and there is no easily accessible tumour for biopsy, we generally do not recommend an invasive biopsy just for CS/CR testing. However, it may be possible to perform a CS/CR test on live tumour cells collected from a blood sample. This is called the Maintrac CS/CR Test and is conducted through Pachmann Labs in Germany. The Maintrac chemosensitivity test is designed to work for carcinomas, but it does also work for sarcomas and other solid tumours based on our experience. Myeloma, lymphoma and leukemia cannot be tested at this lab.
The cost of CS/CR testing ranges from about $2,600US to $10,000US depending on the lab and the number of drugs tested. AccuTheranostics charges about $2600 for testing a panel of several drugs or combinations. Maintrac CS/CR testing is about $4000 for a typical set of SEF chemo drugs, although the cost can be reduced if fewer drug combinations are tested.
Standard drug combinations that we test for SEF chemo are:
carboplatin alone
carboplatin + sodium phenylbutyrate (we find the most success with this combination)
carboplatin + metformin
carboplatin + sodium dichloroacetate
carboplatin + gemcitabine
Please note that the actual cancer cell kill in the body is significantly higher than what a CS/CR assay predicts. The reason is that SEF chemo is a chemo-immunotherapy, but CS/CR assays don’t measure cell kill due to anti-cancer immunity. They only measure the direct kill from the drug or drug combination.
HYPERTHERMIA AND SEF CHEMO
In addition to medications like metformin or DCA, another powerful chemo-sensitizing therapy is Loco-Regional Hyperthermia (LRHT). This therapy uses radio waves (precisely controlled by a computer) to internally heat up tumours to a temperature beyond a high fever. This makes the cancer more susceptible to chemo drugs. Hyperthermia is approved in Canada for treatment of sarcoma in combination with standard chemotherapy, but is rarely offered by oncologists. Our experience with this therapy in combination with SEF chemo has been extremely positive. It is available at 2 clinic in Ontario, Dr. Eric Marsden’s Health Centre (in Maple, ~15 min drive from the Medicor Office) and Dr. Michael Reid’s Health Centre (for patients in the Kitchener-Waterloo area). Pricing is in the $300 to $500 range depending on the number of regions treated. Please check in advance if this is financially feasible in case it may be required to boost your therapy.
MEDICOR SEF CHEMO PATIENT DATA
At Medicor, we have administered over 600 cycles of SEF chemo as of April 2017. We have collected response data and safety data for every single patient treated.
CASE REPORTS
We have treated the following cancer types so far: anal (squamous cell), bladder (transitional cell), brain (glioblastoma), breast (ductal adenocarcinoma), cervix, colon (adenocarcinoma), esophageal (adenocarcinoma), Fallopian tube (adenocarcinoma), lung (non-small cell), lung (small cell), lymphoma (non-Hodgkin’s), melanoma, oropharyngeal (squamous cell), ovarian (adneocarcinoma), pancreas (adenocarcioma), prostate (adenocarcinoma), sarcoma (clear cell), sarcoma (lipo), small bowel (adenocarinoma), thyroid (papillary). Cancer reduction has been successfully achieved in all of these tumour types.
ELIGIBILITY
To see if you are eligible to receive SEF chemo, please visit the eligibility page and review with your healthcare practitioner.
ADDITIONAL QUESTIONS?
For details about the treatment schedule including drug timings, please see SEF Chemo Patient Instructions
Call Medicor at 416-227-0037
Email Dr. Khan: akhan@medicorcancer.com
Email the SEF chemo team: medical@cancer-institute.com