SEF Chemo Patient Safety and Response Data

Updated Sep 11, 2017

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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)