We don't take credit for our cancer results. We give thanks
Here are just a few of our most recent outcomes:
> Ongoing partial response leading to complete response in
a patient with mucinous adenocarcinoma, now 29 months and counting of progression-free survival, in excellent health and working
disease-free survival (now 27 months and counting) in a patient with metastatic ovarian cancer, healthy and active
> Complete response and continuing disease-free
survival, now 16 months and counting, in a patient with locally advanced breast cancer
> 7.5 years and counting of disease-free survival in a patient
with resected stage 3 colon cancer, in excellent health and working full time
> 6.5 years and counting of disease-free survival in a patient with
both renal cell cancer and a highly aggressive multiply recurring lung cancer, in excellent health and working full time
> Complete response and ongoing disease-free
survival in a patient with widely metastatic stage 4 follicular B-cell lymphoma, in excellent health and working full time
> Three years and counting of disease-free
survival in a patient with previously aggressive and multiply recurring stage 3 melanoma, in excellent health and working
> Continuing partial response in a patient with
advanced follicular B-cell lymphoma, after failing treatment at a major national cancer center, now fourteen months and counting
of progression-free survival
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.
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 late December 2018, our successful outcome rates have been
Malignant melanoma All
patients, 85.0% (17 of 20) / Patients with stage 4 or 3c
disease, 82.4% (14 of 17)
Pancreatic adenocarcinoma and cholangiocarcinoma 86.7% (13 of 15) (all patients stage 4
or extensive stage 3)
Colon & rectal cancer also including
All patients, 77.8% (14 of 18) / Patients with stage 3 or 4 disease, 76.5% (13 of 17)
all types combined 66.7% (8 of 12)
(these and others) combined 84.3% (86 of 102)
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 the majority of patients evaluated so far with breast cancer (6 of 7 patients, including
triple receptor negative and widely metastatic stage 4) and all our patients with 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 (4 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.
Excellent responses are accruing for our patients with
lymphoma as well, especially in the last eighteen months. Many additional patients with varied diagnoses 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
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.