Results and a special note on mesothelioma
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 many 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 mid April 2013, our successful response rates
have been as follows.
All patients, 81% (13 of 16) / Patients with stage 4 or 3c
disease, 79% (11 of 14)
Pancreatic adenocarcinoma 78% (7 of 9) (all patients stage 4 or extensive
Colon & rectal cancer All
patients, 75% (9 of 12) / Patients with stage 3 or 4
disease, 73% (8 of 11)
All diagnoses combined 83% (48 of 58)
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.
Successful responses have also been achieved in all patients evaluated so far with breast cancer (3 patients), renal
(kidney) carcinoma (1 patient), rhabdomyosarcoma (1 patient), 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), squamous cell carcinoma (3 patients, head & neck region), non-Hodgkin's lymphoma (1 patient), pancreatic
neuroendocrine (islet cell) cancer (1 patient), and non-small-cell lung cancer (1 patient). 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.
Three 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, the rate of progression of disease has been significantly reduced
even in most patients for whom disease control could not be achieved. This may translate into longer 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 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.
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, 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.