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
MEDICOR SEF CHEMO PATIENT RESPONSE DATA
We have just compiled the SEF chemo patient data for over 100 patients and over 600 cycles of therapy during a period of over 4 years! Almost all patients were stage 4 incurable cases, many with extensive disease, and many had failed to respond to conventional chemotherapy. Despite the challenges, the data is very exciting and positive!
Out of 102 patients treated, 76 could be evaluated for response. Of the 76 patients, 62 had a partial response, 4 had a complete response and 1 had stable disease (with prior growth). The 26 patients that could not be evaluated either did not take enough therapy to make a proper analysis of response, didn’t get all the necessary testing done, had mixed results that were impossible to interpret or had just recently started therapy.
COMPLETE RESPONSES
| Age | Diagnosis | Sex | Prior Chemo | Best Response 1 | Comments | Best Response 2 | Comments | Best Response 3 | Comments |
| 60 | breast cancer | F | N | reduction by serial photography | reduction on imaging | absence of perfusion on Doppler | |||
| 62 | breast cancer | F | Y | reduction on imaging | reduction of CTC count | 650->0 | |||
| 51 | cervical cancer | F | N | reduction of blood markers | reduction on imaging | reduction of CTC count | 1050->0 | ||
| 77 | Fallopian tube cancer | F | Y | stability on imaging | MRI (no changes despite CA125 normalization) | reduction of blood markers | 3784 -> 20 (normalized) |
STABLE DISEASE
| Age | Diagnosis | Sex | Prior Chemo | Best Response 1 | Comments | Best Response 2 | Comments | Best Response 3 | Comments |
| 57 | breast cancer | F | Y | stability by direct measurement | stability by serial photography |
PARTIAL RESPONSES
| Age | Diagnosis | Sex | Prior Chemo | Best Response 1 | Comments | Best Response 2 | Comments | Best Response 3 | Comments |
| 48 | anal cancer | F | N | reduction of CTC count | 1050->200 | ||||
| 69 | appendiceal cancer | M | N | reduction of CTC count | 1550->650 | stability on imaging | CT scan | ||
| 68 | bladder cancer | M | Y | reduction on imaging | pancreas mass 2.7->1.2cm on CT | ||||
| 65 | bladder cancer | M | N | reduction on imaging | US | stability of CTC count | |||
| 53 | bladder cancer | F | Y | reduction on imaging | US | ||||
| 57 | brain cancer (glioblastoma) | M | Y | reduction of CTC count | 1050->50 | stability on imaging | MRI | ||
| 40 | breast cancer | F | N | reduction of CTC count | 400->0 | ||||
| 60 | breast cancer | F | N | reduction on imaging | reduction of CTC count | 50 -> 0 | reduction of perfusion on Doppler | ||
| 37 | breast cancer | F | N | reduction on imaging | reduction of symptoms | pleural fluid accumulation stopped (cath removed) | reduction by direct measurement | examination of axially nodes: signif reduction | |
| 52 | breast cancer | F | Y | reduction of CTC count | 1800->50 | reduction of symptoms | reduction on imaging | US | |
| 63 | breast cancer | F | N | reduction of CTC count | 450->50 | stability on imaging | CT | ||
| 55 | breast cancer | F | Y | reduction of CTC count | 500 -> 100 | reduction of blood markers | CEA 0.9 -> 0.5 | progression of blood markers | CA15-3 7 -> 13 |
| 51 | breast cancer | F | N | reduction on imaging | CT | ||||
| 44 | breast cancer | F | Y | reduction on imaging | decr meningeal mets on MRI | stability of CTC count | 50>350>50 | ||
| 52 | breast cancer | F | Y | reduction of CTC count | 1000->50 | ||||
| 69 | breast cancer | F | Y | reduction by serial photography | visual reduction of skin metastases | ||||
| 68 | breast cancer | F | Y | reduction of CTC count | 500->150 | ||||
| 55 | breast cancer | F | Y | reduction on imaging | CT, MRI | reduction of symptoms | headaches | ||
| 49 | breast cancer | F | N | reduction of CTC count | 950->150 | ||||
| 63 | breast cancer | F | N | reduction on imaging | necrosis on CT | reduction by direct measurement | visual reduction of left parotid mass | ||
| 84 | breast cancer | F | Y | reduction on imaging | other | improvement of renal function (node compr ureter) | |||
| 70 | breast cancer | F | N | reduction on imaging | CXR effusion resolved | reduction of symptoms | reduction by direct measurement | fungating R breast mass | |
| 46 | colon cancer | M | Y | reduction of CTC count | 550->50 | reduction of perfusion on Doppler | |||
| 54 | colon cancer | M | N | reduction of CTC count | 8900->50 | ||||
| 41 | colon cancer | M | Y | reduction of CTC count | 150->0 | ||||
| 36 | colon cancer | M | Y | reduction of CTC count | 750->300 | reduction on imaging | US | reduction of perfusion on Doppler | |
| 64 | esophageal cancer | M | Y | reduction on imaging | ultrasound | absence of perfusion on Doppler | |||
| 59 | esophageal cancer | M | Y | reduction on imaging | CT scan | reduction of blood markers | CA19-9 from 8855 to 35 | ||
| 67 | lung cancer | M | Y | reduction of CTC count | 10350->100 | progression on imaging | reduction of symptoms | ||
| 74 | lung cancer | F | Y | reduction of symptoms | energy incr, appetite incr, SOB decr | reduction on imaging | L pl eff resolved, R eff. decr drainage (pleur-X) | ||
| 55 | lung cancer | F | Y | reduction on imaging | CXR | ||||
| 66 | lung cancer (small cell) | M | Y | reduction of CTC count | 1350->250 | stability on imaging | CXR – no tumours | ||
| 74 | lung cancer | F | Y | reduction of CTC count | 100->50 | reduction of symptoms | |||
| 64 | lung cancer | M | N | reduction of CTC count | 100->50 | reduction of symptoms | |||
| 67 | lung cancer | M | N | reduction of CTC count | 14250->0 | reduction of symptoms | cough | reduction on imaging | PET-CT -node resolution / reduced SUV of main mass |
| 57 | lung cancer | F | N | reduction on imaging | ultrasound | reduction of symptoms | rapid reduction of SOB after chemo | ||
| 68 | lymphoma | F | Y | reduction on imaging | CT | ||||
| 55 | lymphoma | F | Y | reduction of symptoms | other | bilat renal lym infiltr, decr creat after ea chemo | reduction by direct measurement | visual reduction of thyroid mets | |
| 52 | ovarian cancer | F | Y | reduction on imaging | U/S reduction of liver mets | ||||
| 52 | ovarian cancer | F | Y | reduction of blood markers | CA125 | symptomatic improvement | reduced cancer-related skin rash | ||
| 62 | ovarian cancer | F | Y | reduction of blood markers | CA125 | ||||
| 47 | ovarian cancer | F | Y | reduction of CTC count | 1550 -> 250 | reduction of symptoms | partial bowel obstruction resolved | reduction of blood markers | slight reduction of CA125 |
| 71 | ovarian cancer | F | N | reduction of perfusion on Doppler | reduction of symptoms | other | hypercalcemia resolved | ||
| 58 | pancreatic cancer | M | N | reduction on imaging | pre CT 6.4 x 3.4cm mass, post U/S 3.1 x 3.6cm | ||||
| 68 | pancreatic cancer | F | Y | reduction of perfusion on Doppler | 4.5/5 liver mets no perfusion after 4 cycles | ||||
| 60 | pancreatic cancer | F | Y | reduction of CTC count | 900->0 | other | necrosis of liver met on PET scan | ||
| 62 | pancreatic cancer | F | Y | reduction of CTC count | 900->50 | reduction of blood markers | 743->322 | reduction on imaging | resolution of liver mets |
| 58 | pancreatic cancer | F | N | reduction on imaging | US disappearance of 1 mass, reduction of 2nd mass | ||||
| 66 | pancreatic cancer | F | N | reduction on imaging | ultrsaound | reduction of CTC count | 600->50 | ||
| 67 | pancreatic cancer | F | Y | reduction of CTC count | 1100->0 | stability on imaging | US | reduction of perfusion on Doppler | |
| 71 | prostate cancer | M | N | reduction on imaging | US hydronephrosis improved | reduction of CTC count | 400->0 | reduction of blood markers | PSA 0.61 -> 0.2 |
| 52 | prostate cancer | M | N | reduction of blood markers | PSA 368->345 | reduction of CTC count | 400->300 | ||
| 63 | prostate cancer | M | N | reduction on imaging | necrotic brain met on MRI | reduction of symptoms | |||
| 62 | sarcoma (lipo) | M | Y | reduction of CTC count | 4250->50 | stability on imaging | no mets on CT | ||
| 70 | sarcoma (lipo) | M | N | reduction of perfusion on Doppler | absence of perfusion on angiogram | ||||
| 27 | skin cancer (melanoma) | F | N | reduction on imaging | mri spectroscopy – necrosis | reduction of CTC count | |||
| 38 | skin cancer (melanoma) | M | N | reduction of perfusion on Doppler | 1 of 2 masses: loss of vascularity | reduction of CTC count | 50->0 | reduction on imaging | US |
| 58 | small bowel cancer | F | N | reduction on imaging | CT scan | ||||
| 54 | thyroid cancer (papillary) | M | N | reduction of CTC count | 300->0 | stability on imaging | CT | ||
| 65 | tonsillar cancer (SCC) | F | N | reduction on imaging | neck ultrasound | reduction of symptoms | pain, dysphagia | ||
| 22 | tracheal cancer (sarcoma) | F | Y | reduction of CTC count | 250->0 | ||||
| 68 | uterine cancer | F | N | reduction of CTC count | 750->150 | reduction on imaging | ultrasound |
NO RESPONSE
| Age | Diagnosis | Sex | Prior Chemo | Best Response 1 | Comments | Best Response 2 | Comments | Best Response 3 | Comments |
| 56 | bladder cancer | M | N | progression on imaging | ultrasound | ||||
| 58 | breast cancer | F | Y | progression on imaging | progression of symptoms | ||||
| 73 | colon cancer | F | Y | progression on imaging | progression of symptoms | ||||
| 49 | colon cancer | F | Y | progression of blood markers | |||||
| 77 | esophageal cancer | M | Y | progression of symptoms | new pain | progression of CTC count | 0->50 | ||
| 79 | lymphoma | M | Y | progression on imaging | |||||
| 78 | pancreatic cancer | M | N | progression of blood markers | progression on imaging | stability of symptoms | |||
| 46 | sarcoma (osteo) | M | Y | progression on imaging | MRI | progression of symptoms | |||
| 54 | uterine cancer (carcinosarcoma) | F | Y | reduction of CTC count | 300->150 | progression on imaging | US |
CT = computerized tomography
CTC = circulating tumour cell count (# of cancer cells floating in the bloodstream)
US = ultrasound
PR – Partial Response = 62 / 76 (82%)
CR – Complete Response = 4 / 76 (5%)
SD – Stable Disease = 1 / 76 (1%)
NR – No Response = 9 / 76 (12%)
Total Response Rate = 88%
UNDERSTANDING THE DATA
Analysis and further specifics of the data will be available shortly.
One of the first comments is for pancreatic cancer. With SEF chemo, 6 out of 7 (86%) stage 4 pancreatic cancer patients responded to therapy. With the best standard chemo (e.g. FOLFIRINOX), the response is only 30-40%. Patients often comment to us that they don’t want the chemo as a result of the severe side effects.
MEDICOR SEF CHEMO PRELIMINARY PATIENT RESPONSE DATA
We collected preliminary data for the first 17 patients treated. This was at the start of the SEF chemo program in Toronto when the therapy was new to us, and we began treating the most difficult cases on a compassionate basis. Most were hopeless cases that either failed to respond to standard therapy or had a very poor prognosis. Despite the difficulties the initial data is quite remarkable.
DATA FROM CONSECUTIVE INITIAL SEF CHEMO PATIENTS, 2013 – 2014
| Age | Cancer Type | Stage | Prev Chemo? | Response |
| 50 | Lung (non-small cell) | 4 | Y | Partial response (rapid visible improvement on chest x-ray) |
| 62 | Lung (non-small cell) | 4 | N | Partial response (clinical, CTC from 14250 to 0, PET/CT) |
| 61 | Lung (small cell) | 4 | Y | Partial response (CTC reduction, no visible tumours) |
| 52 | Lung (non-small cell) | 4 | Y | Partial response (rapid breathing improvement, ultrasound) |
| 53 | Breast | 4 | Y | Progression (imaging, clinical) |
| 63 | Pancreatic | 4 | Y | Partial response (Doppler – 4 of 5 liver mets dead after 4 cycles) |
| 53 | Pancreatic | 4 | N | Partial Response pre: 6.4 x 3.4 x 4cm by CT, post 3.1 x 3.6cm by US |
| 46 | Cervical | 4 | Y | Complete Response (imaging, blood markers, CTC) |
| 69 | Colon | 4 | Y | Progression (imaging, clinical) |
| 59 | Gastric | 4 | Y (MTX for RA) | Partial Response (loss of vascularity and decr size on ultrasound) |
| 41 | Sarcoma | 3 | Y | Progression (imaging, clinical) |
| 63 | Bladder & Pancreas (neuroendocrine) | 4 | Y | Partial Response (pancreatic mass decr from 2.7cm to 1.2cm on CT) |
| 23 | Melanoma | 4 | N | Partial Response (CTC reduction) |
| 43 | Colon | 4 | Y | Not evaluable |
| 58 | Liposarcoma | 4 | Y | Partial Response (CTC 4250 to 500) |
| 67 | Prostate | 4 | N | Partial Response (PSA 0.61 to 0.2, decr CTC) |
| 65 | Breast | 3 | Y | Partial Response (visual – skin mets clear reduction) |
CT = computerized tomography
CTC = circulating tumour cell count (# of cancer cells floating in the bloodstream)
MTX = methotrexate
RA = rheumatoid arthritis
US = ultrasound
PR – Partial Response = 12 / 16 (75%)
CR – Complete Response = 1 / 16 (6%)
NR – No Response = 3 / 16 (19%)
Total Response Rate (PR+CR) = 81%
UNDERSTANDING THE DATA
To put this data into perspective, it may be compared against published phase 1 trial data of plain carboplatin administration without the protection of mesna. We have collected observational data of actual patients, outside of a clinical trial. However, since the data is from consecutive patients, in our opinion it can be reasonably compared against an open label phase 1 trial.
Comparison limitations:
1. One of the limitations in comparing the data is that patients were permitted to take concurrent natural medicines. Natural medicines could potentially enhance outcomes, but could just as easily interfere with SEF chemo and produce worse outcomes.
2. Another confounding factor is that patients are not accepted into a clinical trial if they don’t fit into specific parameters (e.g. certain blood tests must be normal or close to normal). We accept patients outside of such limits on a compassionate basis, so our patients may actually be more ill than those entering a trial. Accepting sicker patients tends to bias results against SEF chemo, making any favourable outcomes even more meaningful.
3. Another difference between the trial and our data is the chemo infusion speed. In the trial, carboplatin was given as a 24 hr infusion, whereas we administer it as a 30 minute infusion. It is possible the long infusion time caused greater toxicity.
When carboplatin was first used in humans, the dosing was calculated in mg per m2 of body surface area. Now dosing is calculated by the area under the carboplatin blood concentration/time curve (AUC). In the phase 1 trial a dose of 320mg/m2 given every 4 weeks was found to have dose-limiting toxicity. For our patients listed above, standard dosing was AUC4 – AUC5 every 2 weeks. Dose reduction to AUC3 was occasionally required. This corresponds to similar dosing as the clinical trial, with many of our patients actually receiving more chemo than the trial dosing of 320mg/m2 every 4 weeks.
In the clinical trial only 5 of 14 (35%) of patients treated were able to tolerate multiple cycles, with a mean number of cycles being just 5.2. In our data, all the patients were able to tolerate multiple cycles and the mean number of cycles was 11.5 (corrected for 1 patient who received 37 cycles that included 7 low dose cycles). Thus with the addition of mesna we were able to administer, on average, more than double the number of chemo cycles, without having to stop therapy.
The main dose-limiting toxicity of carboplatin is a lowering of the platelet count. In the phase 1 trial, the rate of severe thrombocytopenia (platelet count < 20,000) was 6 out of 14 patients, or 43%. With our SEF chemo patients, the rate of severe thrombocytopenia was 1 out of 17 patients, or 6%. Thus carboplatin + mesna resulted in one seventh the number of cases of severe thrombocytopenia of carboplatin alone, despite (on average) double the number of chemo cycles being administered. Therefore, one may say that SEF chemo is 14 times safer than plain carboplatin in terms of major platelet toxicity!
Carboplatin is a “broad spectrum” chemotherapy drug that works on many different cancer types. In the phase 1 trial, carboplatin was used to treat a variety of cancer types. In our data, a variety of cancer types were also treated, including some which typically do not respond well to chemo (e.g. melanoma or sarcoma). In the trial, response to therapy was seen in only 5 of 34 patients (15%). In our patients, responses were seen in 13 of 16 patients (81%). Our data shows a 5 fold improvement in response over the clinical trial of plain carboplatin. Although this is a reasonable comparison, it should be noted that some of our patients had responses measured by circulating tumour cell counts, whereas the trial only looked at visible tumour reduction. The reason we often utilize CTC counts to confirm response is that immunotherapies like SEF chemo frequently cause “pseudoprogression” on imaging (increase in tumour size which does not represent cancer growth). CTC counts help us determine the true response despite the limitations of scans when assessing immunotherapies.
MEDICOR SEF CHEMO SAFETY DATA
At Medicor, we have administered over 600 cycles of SEF chemo as of April 2017. Standard SEF carboplatin dosing is AUC4 every 2 weeks. This is more chemo than the typical dosing given in a hospital setting. For example for ovarian cancer, typical carboplatin dosing is AUC5 every 3 weeks (equivalent to AUC3.3 every 2 weeks). Patient data has been carefully recorded. Our findings are extremely favourable, confirming the high safety level of this therapy. When looking at serious infection risk (the most common serious side effect of traditional chemo), our data shows that SEF chemo is infinitely safer. Out of 600 cycles, the following rates of serious complications attributed directly to the therapy have been noted:
MI (heart attack): 0%
CVA (stroke): 0.16%
DVT / PE (life-threatening blood clot): 0.3%
febrile neutropenia (fever with low white cell count, requiring hospital admission for intravenous antibiotics): 0%*
tumour lysis syndrome: 0% (we have only treated a small # of cases of lymphoma and leukemia)
vomiting requiring hospital admission: 0.5%**
carboplatin allergy (life-threatening): 0.16%
carboplatin allergy (non life-threatening): 0.16%
death: 0%
*includes treatment of patients with active infections such as abscess, pneumonia and rectovesical fistula, which is not possible with regular chemotherapy
**not a chemo drug side effect, but caused by bowel blockage due to tumour inflammation after chemo, where there was an existing tumour pressing on the bowel
WITH routine use of ondansetron for all patients (some stop it on their own with no complications)
NO routine use of steroid, like dexamethasone (only for a small number of patients where there is tumour swelling causing bowel blockage or pressure in the brain)
NO routine use of aprepitant (only for a small number of patients who have a sensitive stomach)