Results
There can be nothing
more gratifying to us than to see our patients beating the odds. While we cannot help every patient, so far we have
been able to see the great majority of our patients do significantly better than with previously available treatments.
If that ever changes we will close our doors.
It is important for patients evaluating these results
to note several things. First, these are from a relatively small number of patients so far and because of that they
are not "statistically significant," that is, they do not come from a large enough group of patients to confidently
predict future outcomes. We're still very new and we're steadily building toward larger numbers. Second, these
data are not from controlled clinical trials. Currently this is simply an off-label treatment offered in our independent
medical practice. So while we are very thankful for these results and pleased to be able to share them, they do
not constitute controlled clinical data and we do not represent them as such. Having said those things, we're happy
to share exactly how we're doing.
Please note several definitions and parameters. First, these outcomes
also include our patients with stage 4 and late stage 3 cancers, which most trials won't include because of their much lower
chance for successful treatment. Second, we have defined successful responses as either complete response (no evidence
of remaining cancer), partial response (significant reduction in size or volume of tumors), or stable disease (no significant
increase or decrease in tumor mass, and no new metastases) using the standardized criteria of the World Health Organization.
Patients with an initial ECOG performance status of 0, 1, or 2 are included. We do not include patients who do not follow
the treatment program for at least eight full weeks or who do not return for at least an initial follow-up visit. In
summary, these results include all patients who meet criteria typical for clinical trials, although for the sake of honesty
we also include unsuccessful outcomes from patients who did not return for follow-up but whom we know followed the treatment
program and had clear radiologic evidence of disease progression.
As of early January 2012, our successful response rates
have been as follows.
Malignant melanoma
All patients, 86% (12 of 14) / Patients with stage 4 or 3c
disease, 83% (10 of 12)
Pancreatic adenocarcinoma 78% (7 of 9) (all patients stage 4 or extensive
stage 3)
Colon & rectal cancer All
patients, 70% (7 of 10) / Patients with stage 3 or 4
disease, 67% (6 of 9)
All
diagnoses combined 80% (39 of 49)
Two patients have experienced progression of pancreatic cancer while in
the first few months of treatment. In one the large primary tumor was significantly reduced at two months and gone
at four months, but pulmonary metastases continued to grow slowly. In the second individual there was continued slow
progression of liver metastases but no new metastatic disease.
Successful responses have also been
achieved in all patients evaluated so far with renal (kidney) carcinoma (1 patient), malignant fibrous histiocytoma (2 patients),
desmoplastic small round cell tumor (1 patient), mesothelioma (1 patient), prostate cancer (2 patients), squamous cell carcinoma
(2 patients, head & neck region), non-Hodgkin's lymphoma (1 patient), pancreatic neuroendocrine (islet cell) cancer, and
non-small-cell lung cancer (1 patient).
Many additional patients are currently in treatment, and these results will be updated periodically
as information becomes available.
Two trends are becoming very clear even in this early experience. First, there has been a dramatically
lower incidence of new distant metastases in patients using this treatment program (not a statistically significant finding
at present), suggesting that it may have potential to prevent or inhibit seeding of new metastases. Thus the treatment
may have its greatest benefit if instituted before too much time has passed and cancer has spread to distant sites.
Second, patients whose overall health has been extensively debilitated by either cancer progression or cytotoxic treatments
have far less chance of a successful outcome. Therefore, patients for whom our treatment program is a viable option
may have better chances if it begins earlier while overall health is still good. These observations are not statistically
significant and do not constitute outcome data from controlled clinical trials.
We hope that this honest information, even though preliminary, can be helpful
to you.