Updated on July, 2009
Medicor Cancer Centre’s Observational DCA Treatment Data
This is the third in our series of DCA data analysis updates.
When we presented our first DCA observational data analysis in December 2007, our intent was to share our knowledge of treating patients with DCA and to show the potential of DCA as a viable cancer treatment option outside the laboratory in the real world for the first time. With our second data update in March 2008, we showed that our DCA treatments results were consistent with our earlier analysis and further solidified our views of using DCA in cancer treatment. For our next update, since our overall DCA treatment data showed similar results as before, we decided to present DCA case reports instead of a complete data update. Since then we have received numerous requests and enquiries about another data update and are happy to present our most recent findings here.
It has taken us longer than we anticipated compiling this report. We were hoping to provide an update in May 2009, but our regular clinic work (treating cancer patients) took precedence over data analysis and updates. Since we are not conducting a clinical trial and our main focus is patient care and providing novel care options, the pure data collection and analysis aspect of our work sometimes has to wait. Realizing this challenge of balancing our day to day patient care with requests for data, we have decided to add a “Live DCA Update” which will provide a real time update of our number of patients treated and type of tumour. In the coming weeks we will continue to refine and expand this page, adding more variables like responses, side effects etc. As always we welcome input from our patients to better serve your needs.Just like our previous updates, the data presented below is not from a clinical trial. It is based on our observations of the patients we have treated so far and does not meet the rigorous criteria employed in clinical research. It may not be generalizable and should be interpreted with caution. We are sharing this to further patient care and improve medical understanding and knowledge regarding DCA as a cancer treatment.
At Medicor Cancer Centres, as of April 2009, we have treated 347 patients with DCA. Most of these patients have exhausted conventional treatment options. The proportion of males and females treated was 48% males to 52% females.Patients treated range in age from 2 years to 90 years. The majority of patients (96 patients, or 29%) are 50- 59 years old, followed by patients who fall in the 60-69 year age group (79 patients, or 24%).
The site of primary cancer in the 347 patients is presented below.
Site of Primary Cancer in Patients Treated with DCA
Our treatment regimen generally consists of DCA in a 2 week on / 1 week off cycle which is modified based on side effects (e.g. ranges from 1 week to 3 weeks of DCA followed by a rest period). In children we sometimes offer continuous DCA treatment. Typical doses are in the range of 20-25mg/kg/day for adults and 25-50mg/kg/day for children. For elderly patients or those with complicating factors, we may use less than 20mg/kg/day. The reason that we favour cyclic DCA treatment is that it allows us to use higher doses and minimize side effects at the same time by having a period of time where DCA can be cleared from the body. We believe a dose-response relationship exists with DCA (higher doses = better response), therefore cyclic treatment may provide a higher response rate while preventing the drug from being discontinued due to adverse events. It also allows us to clearly determine which side effects are from DCA and which are due to other causes (like the cancer itself). This can be invaluable in determining if DCA should be stopped, or may be safely continued.
We are treating more patients with combination therapy (DCA + 1 or 2 other drugs) and feel more confident now that DCA works better in combination with other agents than by itself over a prolonged time period.
All of our patients understand that a positive to DCA treatment is not a guarantee and just like most chemotherapies, the individual response varies. We encourage discussion of treatment options, known side effects, monitoring protocol, and the uncertainty and paucity of knowledge of the long term effects of DCA in cancer treatment.
We continue to use our criteria of evaluating patient responses after a minimum of 4 weeks from start of treatment for the following analyses.Based on this criterion, as of April 2009, we were able to evaluate 179 (52%) of our total (347) patients treated. The reasons for not evaluating the 168 patients are as follows:
Patient Evaluation Status 4 Weeks after start of DCA Treatment
Based on our evaluation criteria, we have evaluated 179 patients who took DCA for at least 4 weeks. We have chosen the 4 week mark for our analyses to allow time for DCA to work, and to eliminate the placebo effect (which can typically last for 1-2 weeks). Please be advised that this is not a standard criterion and other people may choose to use different criteria in their research. In fact, the 4 week cutoff likely underestimates true DCA response. We have seen patients improve only after 8 weeks of DCA treatment in some cases.In these 179 patients we have observed the following responses to DCA:
To complete the picture, the following data shows only the best response of each of the 106 patients who had a positive response. We have chosen to define the responses in decreasing level from category 1 to 5 with category 1 (reduction in tumour size) being the best response and category 5 (disease stabilization) being the lowest level of positive response to DCA. The data is categorized as above but here the categories are mutually exclusive with a total of 106 responses. This is unlike the data we have presented previously and therefore is not comparable to our earlier analyses.
Patient Responses to DCA Treatment
Type of Positive Response to DCA Treatment
The site of primary cancer in the 179 patients who were evaluated after at least 4 weeks from start of DCA is as follows:
Brain Cancer: The 38 patients were subdivided into gliomas (37) and other cancers (1).
The duration of treatment was from 4 to 68 weeks.
Lung Cancer: Of the 37 lung cancer patients, 19 had non- small cell carcinoma, 4 had mesothelioma, 3 had non-small cell carcinoma and in 11 patients the type of cancer was unknown. It is most likely that the 11 patients with unknown type of cancer had a non small cell carcinoma but it is not confirmed.
The results for the 19 non small cell carcinoma patients have been reported previously (10 (52%) showed a positive response, 3 (16%) were indeterminate and 6 (32%) had no response to DCA treatment). The other numbers are too small for meaningful interpretation. The maximum duration of treatment was 24 weeks.
Colon Cancer: Of the 22 colon cancer patients treated, 17 (77%) showed a positive response, 4 (18%) did not respond and the response in 1 patient (5%) was indeterminate. The duration of treatment ranged from 4 – 36 weeks.
Breast Cancer: Twelve (75%) of the 16 patients responded positively to treatment while 4 (25%) did not respond. The maximum duration of treatment was 44 weeks.
Ovarian Cancer: Out of the 10 patient treated, 7 (70%) responded to treatment while 3 (30%) did not respond. The treatment was continued for up to 40 weeks.
Other cancers: While the numbers are too small for any meaningful interpretation, we have seen results similar to the above. Since these numbers are not meaningful, they will not be listed.
The duration of treatment in the 179 evaluable patients ranged from, 4 weeks to 68 weeks.
Duration of DCA Treatment in Patients Who Were Evaluated After at Least 4 Weeks
As of April 2009, 159 (89%) patients had stopped treatment with DCA while 20 (11%) were continuing treatment. This is not a static number and you can get an idea of the current numbers from the Live Update page.The reasons for stopping treatment in the 159 patients are presented below.
Reasons for Stopping DCA Treatment
We continue to hold the view that DCA is a relatively safe cancer treatment (especially compared to toxic treatment like chemotherapy) and that use of supplements such as alpha lipoic acid and benfotiamine (vitamin B1) are helpful in managing the neurological side effects. In some patients side effects are apparent quite soon while others seem to do quite well from several months to nearly 2 years of treatment. While most side effects seem reversible, we do not know what the long term effects will be (> 2 years). There is no medication which is known to completely prevent DCA-related neurological side effects such as neuropathy.Out of the 179 patients who were evaluable for response, the frequency of reported side effects is as follows:
Comments and Opinions
Our observational DCA data continues to show consistent rates of response and mild side effects confirming that DCA has the potential to be a useful part of a cancer treatment plan. We are receiving comments from many physicians indicating increased levels of interest in DCA and increased willingness to support their patients who wish to use DCA. We are also receiving positive feedback from physicians around the world who have used DCA and noted positive results.
Proof of Treatment EffectivenessThere are many ways to establish whether a disease treatment is effective or not. All these methods have their limitations. The only method that constitutes 100% proof that a treatment is effective is to treat a patient with a drug and observe the response, then go back in time, withdraw the drug and observe the response (and change nothing else). Clearly this is impossible, so we must rely on methods that are practical and possible.
The most common methods are listed in order of decreasing strength of evidence:
Based on our observational data we believe that:
The above points have been discussed in our March 2008 update.
We have noted that DCA by itself does not appear to be as effective (or curative) compared to combination therapy. When we initially started DCA therapy, most patients took DCA by itself. We observed that in patients who showed a positive response initially, DCA had to be stopped either due to side effects or because it started to lose its effectiveness. By adding supplements like alpha liopic acid, adjusting the dose and having a non-continuous DCA regimen we have managed to reduce the side effects to a more tolerable level. While patients started experiencing more tolerable and reversible side effects, the loss of effectiveness of DCA was troubling. Change in dose was not able to reverse this effect for long leading us to discontinue DCA treatment. However, when we started combining DCA with other treatments like TM therapy, we found that treatment could be continued for much longer and was more effective.
We have now started using DCA more in combination with other treatments (e.g. chemotherapy, TM, ribavirin, radiation therapy etc.) and have observed more favorable responses. For combination with chemotherapy we strongly recommend a ChemoFit test to determine effectiveness. While there are no general criteria to predict if patients will respond to DCA or a combination therapy with chemo, a ChemoFit test can provide very sensitive and specific response information for the individual patient.
Our two cases of complete remission both took combination therapy. More information about these cases are available on the Case Reports pages.
A potential limitation of our data is the combination of DCA with other drugs. Our data asnd analyses does not account for this confounding factor. Many of our newer patients take combination treatments. Confounding is always a consideration in any clinical trial and different methods are used to minimize it. In our case, we acknowledge that our responses may not be purely DCA because of this confounding factor of combination therapy. We aim to treat patients with the best possible treatment options and unlike pure research, we do not stop other treatments which may confound our results. When we started our data collection, we did not anticipate this extent of analysis.
In spite of this potential confounding, our earlier data analyses (which were done before most combination therapies) have shown similar results. This gives us confidence in the accuracy of our results. In our previous analyses, our duration of treatment did not last long due to loss of DCA effectiveness whereas now we can continue longer with combination therapies. Nevertheless this potential limitation of our data should be kept in mind while viewing our results which are not from a clinical trial.We have not previously acknowledged the psychological aspects of DCA treatment or quality of life enhancements. Subjective responses are always hard to report and categorize and we have based all our evaluations on objective and measurable criteria. Our review of the subjective aspects of DCA treatment indicate that there is a very small number of patients who are unhappy about trying DCA, mainly because they experience significant side effects (such as neuropathy with burning pain). However, a majority of patients and their families are highly satisfied and uplifted by DCA treatment. The main reason for this is likely the fact that DCA substantially changes the outlook of patients who are deemed “end stage palliative”. Since DCA is a gentle cancer treatment with scientific merit, patients’ hope for survival or life extension is restored without fear of severe side effects (such as vomiting, diarrhea, hair loss, immune suppression/infection or other loss of quality of life that accompanies treatments like chemo). Even compared to approved “targeted” non-chemo treatments, DCA has fewer side effects, and does not appear to results in severe side effects like internal hemorrhage.
This subjective aspect of DCA treatment is invaluable and cannot be discounted.These statements are the opinions of Medicor physicians. They are based on existing research and our experience and observations in over 400 cancer patients treated with DCA. They should not be used as a guide to self medicate and the results may not be generalizable. We hope this information is helpful to physicians around the world who are interested in using DCA to treat their cancer patients.
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