We don't take credit for our cancer results. We give thanks
Here are just a few of our most recent outcomes:
> Major partial response and long-term disease control (five years and counting
of overall survival, last 3.5 years disease-free survival) in a patient with aggressive and widely metastatic stage 4 melanoma
> 7.5 years of stability with functional improvement in a patient
with fronto-temporal dementia (one of our non-cancer patients)
> Seven years of disease-free survival in a patient with resected stage 3 colon cancer
> Continuing stable disease and improvement in function, now
six months and counting progression-free survival, in a patient with unresectable glioblastoma
> Complete response and continuing disease-free survival in a patient with
locally advanced breast cancer
of ascites and continuing stable disease in a patient with advanced follicular B-cell lymphoma, after failing treatment at
a major national cancer center
stable disease in a patient with residual pancreatic cancer after surgical resection and chemothrapy at a major national cancer
center, 33 months survival and counting
regaining of muscle strength in a patient with advanced Multiple System Atrophy (a rare disease very similar to Amyotrophic
Lateral Sclerosis / ALS / "Lou Gehrig's Disease")
Cumulative results and a special
note on mesothelioma and pancreatic cancer
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 yet from controlled clinical
trials, the next essential phase of this work. Currently this is simply an off-label treatment offered in our independent
medical practice which is very similar to a phase II clinical trial but accepts patients who wouldn't be able to qualify for
most formal trials. 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 many trials won't include because of their much lower
chance for successful treatment. Second, we have defined successful outcomes 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
and RECIST. This method and definition is also equivalent to the terms "disease control rate" and "clinical
benefit ratio" which you may see in many cancer publications. Patients with an initial ECOG performance status
of 0, 1, or 2 are eligible for inclusion. 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 believe followed the treatment program and had apparent
disease progression by radiologic evidence.
As of mid June 2017, our successful outcome rates have been as
Malignant melanoma All
patients, 83.3% (15 of 18) / Patients with stage 4 or 3c
disease, 81.3% (13 of 16)
Pancreatic adenocarcinoma and cholangiocarcinoma 84.6% (11 of 13) (all patients stage 4
or extensive stage 3)
Colon & rectal cancer also including
All patients, 76.5% (13 of 17) / Patients with stage 3 or 4 disease, 75% (12 of 16)
all types combined 66.7% (8 of 12)
(these and others) combined 82.8% (72 of 87)
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. There were no new sites of metastatic disease.
In the second individual there was continued slow progression of liver metastases but no new metastatic disease. Three
melanoma patients reported as failure of treatment above had limited progression which still represented a substantially better
outcome than what was expected and had been experienced on previous treatment.
responses have also been achieved in all patients evaluated so far with breast cancer (6 patients, including triple receptor
negative and widely metastatic stage 4), renal (kidney) carcinoma (1 patient), ovarian cancer (3 patients), rhabdomyosarcoma
(2 patients), malignant fibrous histiocytoma (2 patients), desmoplastic small round cell tumor (1 patient), mesothelioma (2
patients; see additional note below), prostate cancer (2 patients), hepatocellular carcinoma (1 patient, also with hepatitis
C), carcinoid syndrome (1 patient), squamous cell carcinoma (3 patients, head & neck region), non-Hodgkin's lymphoma (2
patients), pancreatic neuroendocrine (islet cell) cancer (1 patient), non-small-cell lung cancer (1 patient), vulvar cancer
(1 patient, squamous cell type), adenoid cystic carcinoma (1 patient), and several others. Some of these patients were
not even in sufficient health at the beginning of treatment to meet the criteria for inclusion in the reportable statistics
above but had excellent response to treatment anyway.
Many additional patients are currently in treatment, and these results will be updated periodically
as information becomes available.
Four 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, some of
which could be more resistant to treatment. Second, it appears that this treatment has a significant capacity to enlist
the immune system to hold malignancies in check even when not actively regressing. Because of this, many of our patients
who achieve only stable disease in fact have such remarkable stability that they become eligible for surgical resection of
nicely contained tumors and go on to very prolonged active and healthy survival, often with no further evidence of disease.
Third, the rate of progression of disease has been significantly reduced even in most patients for whom disease control
could not be achieved. This is also translating into longer overall survival, and since side effects of this treatment
regimen tend to be very tolerable, this could mean more enjoyable quality time with family and loved ones. Finally,
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 from a large enough
group of patients to be statistically significant and do not constitute outcome data from controlled clinical trials.
Occasionally we encounter physicians or
patients who wonder if this kind of success could even be real. It's real, and our steadily growing group of long term
survivors attest to that. We hope that this honest information, even though preliminary, can be helpful to you.
Mesothelioma and pancreatic adenocarcinoma
We are experiencing a trend in mesothelioma
treatment which, though far too preliminary for any conclusions, may be extremely useful to patients and families dealing
with this universally progressive and fatal diagnosis. Our first two patients with pleural mesothelioma who have undergone
treatment with this technique and Alimta (pemetrexed) concurrently have both experienced dramatic tumor regression and improvement
in clinical status and performance. We do not yet know whether similar results could have been achieved without pemetrexed.
No statistically valid conclusions can be drawn from these results because of the small numbers, but given the unprecedented
success of treatment in these patients and the tolerability of the regimen, mesothelioma patients may wish to give consideration
to this possibility. Benefit to the patient can usually be evaluated within two months from start of combined treatment.
Individuals considering this treatment should understand that we do not recommend forgoing other appropriate treatments, and
we strongly recommend surgical resection of cancer whenever feasible and to the greatest extent possible.
A similar phenomenon is emerging in pancreatic
adenocarcinoma. Our first few patients demonstrated a mix of remarkable responses and impressive early stability of
disease. Several did develop some treatment resistance after long periods of healthy stability, though progression of
disease was still generally at a much slower pace than with typical indicated therapy. Therefore outcomes tended to
be better with this regimen in several meaningful ways. However more recently we have been able to achieve even better
outcomes with a carefully monitored and tailored combination of this regimen with cytotoxic agents (specifically gemcitabine
and capecitabine above others). The outcomes for all these patients are grouped together on this page since numbers
are still small, but this latter approach is producing more impressive outcomes and is now our preferred approach pending
proper confirmatory trials. We emphasize once again that these results are not from controlled clinical trials and are
not statistically significant.