The Di Bella Method Increases by the 30% the survival rate for Pancreas tumors and for this reason should be proposed as first line therapy for this type of cancer
The Di Bella Method Increases by the 30% the survival rate for Pancreas tumors and for this reason should be proposed as first line therapy for this type of cancer.
Abstract
Starting from the data of the "Istituto Superiore di Sanità" (ISS - "The Higher Health Institute") report on the experimentation results of the Di Bella Method (DBM) the data referring to the survival percentage have been worked out and compared with survival percentage known and published in literature. The comparison seems to be in favout of the Di Bella Therapy (DBM).
In Istisan report 99/12, the Istituto Superiore di Sanità (the Higher Health Institute) are shown the results of the observational study on the Di Bella Method (DBM). This report can be found on the ISS (Istituto superiore di Sanità) website and can be easily consulted by Internet. This study involved 769 patients divided into 9 different types of cancer (Protocol 2, originally planned, was not performed). The types of cancer under study were the same previously tested, the results of which were made known in late 1998;
- Which were the results? Here is what the Institute says: "There is no evidence that Di Bella Therapy (DBM) has some anticancer activity of clinical interest [1]". Therefore, according to the ISS, the Di Bella Therapy (DBM) has no efficacy in cancers!
- Which was the purpose of the observational study? "The main purpose of the observational study was to evaluate the survival of patients treated with the Di Bella Method (DBM)" (see image "Purpose study", red box). If survival increases the result is positive, while if survival does not increase, the result is negative.
- How do you evaluate the effectiveness of an anticancer therapy, by taking survival as standard? We must start by saying that for each kind of cancer, at a certain stage, in literature there are survival rates depending on how the situation is managed:
- The patient doesn't follow any treatment (natural evolution of the disease);
- The patient follows the well-known treatments.
The aim of any new treatment (in our case the Di Bella Therapy) is to increase survival compared to the natural evolution of the disease (no therapy) and compared to known treatments.
If the new therapy proves to increase survival compared to the already known methods and if its toxicity is acceptable, it should become the treatment of choice for this kind of cancer!
- What is the level of increase in survival beyond which you can begin to talk about effectiveness of the new method compared to previous ones? It should be noted that cancer is a potentially mortal disease and that, like all experts agree upon, advance in cancer therapy is got step by step: so, even a survival increase of 5-10% is a good result. Survival is usually appreciated after six months, one year, two years or more.
- How was therefore, the survival of patients treated with the Di Bella Therapy (DBM) in this observational study? Let’s take a real example, the exocrine pancreatic carcinoma, protocol #7 (see below - Italian Language only).
- What is the ISS opinion on the Di Bella Therapy (DBM) in this case? "The results observed in this study, can be considered as comparable to the expected evolution based on the natural history of the disease in the absence of any intervention" (see image "ISSResults", red box), i.e. survival in patients treated with the Di Bella Method was the same as the one of those patients who do not follow any therapy: the Di Bella Method did not do anything! Damn!
- But, what is the survival rate of patients with exocrine pancreatic carcinoma who do not follow any therapy or follow conventional therapies? Two prestigious sources relate the following:
- "Pancreas cancer is difficult to diagnose and its therapy is not satisfactory: most patients die within six months after diagnosis, and within one year almost all patients are dead! [2]";
- "Only a few percentage points of all patients with pancreas cancer survive more than 1 year! [3]".
So, both the article in the British Medical Journal and the guidelines for physicians of the National Cancer Institute, agree the following: "With conventional methods, 95-96 % of patients die within a year, without therapy, almost 100% of patients die!". The National Cancer Institute makes an exception: "The survival rate is slightly higher, if cancer is really limited only to the pancreas.", but this was not the case for patients who followed the Di Bella Therapy because patients had to have metastases to be included in the study (page 36, table 15, point 2 - see image "Table 15"): we are therefore dealing with patients with a particularly serious type of pancreas cancer, which is, in turn, one of the worst!
- What was the survival in patients who followed the Di Bella method, in such a serious situation? According to the ISS, as the Di Bella Therapy has not changed the natural evolution of the disease we can expect that, within a year (or even before, because of metastases) all patients under study will be dead!
- What was the survival recorded in the study? "In this study, 14 patients were tested from 9 April to 27 June 1998" (see image "ISSResults": Italian Language "Nello studio sono stati arruolati 14 pazienti dal 9 aprile al 27 giugno 1998") . "The control was performed on 15 May 1999 approximately one year after the beginning of the observational studies, ..." (see image "Survival Recorded", red box).
So, the DI Bella Therapy has been applied for one year [4]. What was the survival after one year? The answer can be found in the survival table on page 39 (see image "Figure 10"): according to the chart, we can clearly find out that, after one year (360 days) the survival rate was equal to 36-37%! Hence, the Di Bella Therapy has produced, after one year, a survival increase of more than 1/3 compared both to the natural evolution of the disease and to traditional methods. As the purpose of the study was to evaluate the increase in survival, the Di Bella Method has proved highly effective! We can finally highlight that even in the experimental protocol, there has been an increase in survival, although slightly lower: the survival rate was 30% after one year (see image "Figure 10"). Since both the observational study and the experimentation data match, this confirms the validity of the Di Bella Method in exocrine pancreatic cancer!
- How come does the ISS reach an opposite conclusion? This doesn't come out of the text! We are only limiting ourselves to highlight:
- That the survival rates in exocrine pancreatic cancer derive from important international sources and are consistent...;
- ...and that the survival rates with the Di Bella Therapy are issued directly from the ISS study!
- How was the toxicity of the Di Bella Method in this type of cancer? Chart N.23 (see image "Table 23") shows that 3 out of 14 patients (21 %) had "serious adverse effects": fundamentally this is a limited toxicity, especially if you consider the toxicity of conventional methods and the severity of the cancer!
DEBATE
Since any scientific conclusion must start from the data, according to the ISS data, the only conclusion that can be drawn is that the Di Bella Therapy has led to a significant increase in survival in patients under treatment, both in the experimental study and in the observational study!
You can argue that the total number of patients under treatment is not sufficient to draw therapeutic conclusions; this observation, however, is contradicted by the fact that, according to the ISS, the total number of patients tested in the two studies (experimental and observational) who had cancer of the pancreas is sufficient to draw conclusions about the effectiveness or not of the Di Bella Method. Then, both studies are significant and can have therapeutic effects!
In addition, it is necessary to note the value of survival from a scientific point of view. Recently, the National Cancer Institute has drafted a classification of levels of scientific evidence of studies in Oncology [5].
The two parameters, which combined, give the level of evidence, are:
- Scientific evidence of the study;
- Scientific evidence of objectives (end-point).
This classification shows that survival is the end-point that has more scientific validity, because "this result is obviously the most important for patients and is also the easiest to define and less subject to be influenced by the experimenters". So, survival is the main parameter in Oncology (cancer mass parameter is classified by the NCI as the lower one, as level of scientific evidence, since it is "subject to the interpretation of the researchers). More importantly, this parameter (i.e., cancer mass reduction) does not represent automatically a benefit for the patient, like survival or quality of life".
Therefore, since both in the experimental and observational study survival has increased in a significant way, these data have a considerable scientific value.
Moreover, it should be noted that the current treatment of pancreatic cancer is completely unsatisfactory [2 - 3]: in these situations, the normal procedure is to use a new effective treatment, even if the new treatment is based on limited data. According to these data, the Di Bella Method should be proposed as a therapy of choice in exocrine pancreatic carcinoma!
CONCLUSION
According to the information about effectiveness (increase in survival of more than 30% after a year) and toxicity (limited) the Di Bella Method should be proposed as a therapy of choice in exocrine pancreatic cancer. On the strength of previous data, the need for further clinical trials (phase III) is highlighted to compare the results of The Di Bella Method in exocrine pancreatic cancer with conventional methods on a larger scale.
Translated by: Rita Frustaci
Bilbliography
[1] Summary of the observational study Di Bella Method;
[2] Greenway BA. - Effect of flutamide on survival in patients with pancreatic cancer: results of a prospective, randomised, double blind, placebo controlled trial. BMJ. 1998 Jun 27;316(7149):1935-8 (see below):
[3] PDQ (Physician Data Query) treatment health professional - National Cancer Institute - Pancreatic cancer: Stage IV Pancreatic Cancer Treatment, Treatment Options for Stage IV Pancreatic Cancer. See also Incidence and Mortality paragraph.
[4] Actually, many patients followed the Di Bella Method for a lower time, because when there was an evolution in their disease, the therapy was stopped: "The treatment was stopped because of an evolution in the disease, toxicity or patient's voluntary withdrawal", note in chart 3 page 9 of Istisan report 99/12 (see Image "Table3");
[5] National Cancer Institute - Levels of Evidence for Adult and Pediatric Cancer Treatment Studies (PDQ) - Strength of Endpoints:
- A - Total mortality (or overall survival from a defined time): "This outcome is arguably the most important one to patients and is also the most easily defined and least subject to investigator bias";
- D - Indirect surrogates: "These endpoints may be subject to investigator interpretation. More importantly, they may, but do not automatically, translate into direct patient benefit such as survival or quality of life.".