What is therapy?
The therapy is cause neutrophilia (neutrophil count elevation) in the vicinity of the patient's tumors ...
Neutrophils are immune cells that, unlike other body cells, supporting the acidic environment generated by the tumor environment. According to the work of A. Bru, these cells are capable of exerting pressure on the tumor. Tumor cells pressurized first enter a quiescent state, which do not divide, and then die by necrosis. To cause neutrophilia is injected the patient Neupogen ®.
What is Neupogen ®?
Neupogen ® is a product that is used for patients receiving chemotherapy regain a normal level of leukocytes. Although it is a medicine that is available in all Spanish hospitals with oncology unit, its use is authorized only the former, without exception.
What other names can refer to Neupogen?
G-CSF, Neupogen ® and Filgrastim. G-CSF is the name of the protein (active) Filgrastim is the generic name (available in various commercial forms) and Neupogen Filgrastim version is manufactured by Amgen.
Is it an alternative therapy?
In an experimental therapy with limited clinical experience but is based on previous theoretical work. The objective is to conduct clinical trials to verify their therapeutic potential. The principle on which it is based (mechanical pressure necrosis of the tumor) has been described only in the work of A. Bru. (Although there are some other references of different groups in which advocates a potential antitumor capacity of neutrophils, the concepts on which they are based are quite different from A. Bru).
How are the 2 patients initially treated for A. Bru?
The latest news (about a year and a half) is that their cancers were in remission. After these treatments, there is formal and informal evidence from other cases that have been tested, either compassionate or outside of health coverage. Of these treatments, there is no other which has been observed remission. In addition, only one case has been published.
What% response is therapy?
That question can only be answered by clinical trials.
For what type of tumor therapy is given?
According to the authors, except for solid tumors, for now, those in the brain. They must be sick for which there is no alternative treatment. It is very important to make a preliminary assessment of the patient to know that you can support causes inflammation therapy. There are multiple circumstances that may make therapy is contraindicated in a patient, and side effects that could occur in a case not be important alternative.
In any case, the only cancers for which health authorities have granted permits generally are those of the initial 2 patients: hepatocellular carcinoma and melanoma.
What are the problems for use in the brain?
The brain is very sensitive, damage occurs in a small part of most serious consequences of damage to the same size in another organ like the lung or liver. In addition to being inside the skull when the brain swells has no room to expand.
Can I use steroid therapy?
In principle, the immunomodulatory and anti-inflammatories can not be used while therapy. However, there may be many circumstances under which doctors would have to change the treatment protocol, or simply stop. You should always prioritized the patient's life so if the use of NSAIDS or corticosteroids is necessary to stop treatment is essential to apply the anti-inflammatory drugs or steroids and once resolved to reassess whether the patient can continue with therapy.
Would it work with metastases or with only primary tumors?
According to the theory of A. Bru, both metastases and primary tumors grow at the same dynamic can then inhibit the same mechanism. Therapy should also work in primary tumors or metastases.
Would it work with semi-solid tumors?
In principle it should work in solid and semisolid. But since there is no well-established boundary, it is wise to say that depends on the case.
Would it work better if you get higher levels of neutrophils?
No. It would be dangerous and would not benefit. In fact, the protocol called for treatment foresees the suspension of the above total leukocytes per milliliter 60-70000.
Would it work if they get lower levels of neutrophils?
As refencia value indicated some 40,000 patients total leukocytes per milliliter. Lower values is foreseen an increase in dose, without the latter exceeds 20 micrograms per kilogram of body weight per day.
Is it compatible with other therapies?
The therapy may be used only if the patient has no other choice and if their clinical condition permits. The vast majority of currently approved therapies seek to destroy cancer cells divide, whereas this therapy produces a large number of neutrophils. Standard chemotherapy or radio would prevent the occurrence of neutrophilia in the tumor environment then you should not mix.
Can you use if you have previously used chemo, radio or surgery?
If clinical conditions are met and once you have missed a timely fashion.
What are the risks?
The main risk is that the inflammation has damaged any of the organs and structures surrounding the tumor, eg the brain. If not controlled the level of neutrophils and is titrated continuously can produce serious side effects such as internal bleeding.
Some of the diseases that are potentially incompatible are: presence of ascites, hepatic or renal insufficiencies, enfermendad any hematological or spinal cord inflammation commitment bloodstream, respiratory failure ... and possibly many more.
What side effects?
Side effects have been reported so far in patients who have commented on their treatment are:
· Dolores in areas of tumors. Be associated with inflammation. The pain has gone from mild discomfort to intense pain
· Discomfort due to bone marrow activity
· Fever Light
· Fatigue
Changes in analytical · blood.
How do you know if the therapy is working?
For some tumors in which there are specific tumor markers should see a decrease in blood markers. The images can be misleading during therapy and the end of it. You must wait a while for pictures to be reliable.
The improvement in the quality of life of patients is a qualitative indicator that can start due to many factors, but says nothing about a possible anti-tumor response. This therapy has been proposed as a potentially curative, not palliative.
Neupogen Am I can manage without medical supervision?
NO. You need regular and frequent checks of blood levels and that a physician assess any changes (fever, aches, ..) that occurs in the patient. Potential problems are serious enough to require close monitoring and comprehensive malaria.
Can I buy Neupogen ® in pharmacy?
In Spain Neupogen can be achieved only through hospital pharmacies. Not sold in pharmacies "normal." Therefore, it is only possible to obtain after your prescription by a hospital specialist and with the approval of the treatment by the authorities.
Can I buy Neupogen ® abroad and sent to Spain?
In Spain it is legal to import drugs from other countries. It would probably be delayed at customs.
Can you prescribe Neupogen ® any doctor?
Neupogen it must prescribe a hospital doctor, not necessarily an oncologist. In Spain, where to go for an antitumor therapy, also requires permits from the hospital and the Ministry of Health.
What should the doctor for therapy?
To follow the regulation through the physician should ask the hospital where you are allowed a "compassionate use" of Neupogen ®. The hospital must decide whether prosecuting the petition to the Spanish Agency of Medicines and Health Products (Competent Authority). If authorized by the hospital is sent to the Medical Products Agency to decide whether to authorize. When you have received all permits the physician may lawfully begin therapy. We must remember that, today, these authorizations have been obtained only for treatment of hepatocellular carcinoma and melanoma.
Can a doctor refuse to ask for compassionate use?
Yes According to the law is the doctor who requested the compassionate use, not the patient. Not being an approved therapy, is entitled to consider that there is insufficient evidence to apply the therapy. Ethically addition, the Declaration of Helsinki of the World Medical Association, which regulates human experiments, said one of its points:
"Doctors shall not engage in research projects involving human subjects unless they are confident that the risks have been adequately assessed and can cope successfully. Should cease if they see the risks are more important than the potential benefits or if there is no conclusive evidence of positive and beneficial results. "
Can the hospital refuse the compassionate use?
Yes, but you must issue a report with his reasons for denial. The patient must request a copy of the documentation that is denied.
Can the drug agency refused compassionate use?
Yes, you must issue a report with its reasoning for denial. The patient must request a copy of the documentation that is denied.
What maintains the Agency to deny compassionate use?
That there was insufficient evidence that the therapy works.
If you wish to receive therapy, does it make sense to insist my doctor to ask for compassionate use if AGEMED going to refuse?
Yes If no request will be impossible to have legal access to therapy. The criterion AGEMED can change at any time and begin licensing applications in new types of tumors. It is important to place on record that the patient wants to access to therapy and is AGEMED you are denying it. In any event, it should get the highest possible technical information to reason the application.
How can I get that permit compassionate use for other tumors?
That depends mainly on the development of research. Arguably, the conduct of clinical trials with satisfactory results would consider extending its application. But whether one day be made that these trials.
What situation are rehearsals?
Proposed a test for liver cancer (cancer that originates in the liver, no metastases in the liver) in the Ramón y Cajal de Madrid, promoted and financed by the Universidad Complutense de Madrid. Ultimately unsuccessful (the reasons depend on the source consulted, the announcement by A. Bru can be seen in http://www.mat.ucm.es/ ~ abruespi /).
The team of A. Bru has recently commented that they would continue trying while making the rest of their investigations.
Is it easier to get therapy in a private hospital?
It is probably easier to get to the doctor and ask for compassionate use authorized by the hospital but the authorizations have to go through the agency of the drug.
How has therapy in patients who have tried (apart from the 2 initials)?
No official data are not reliable. Unofficially, there have been no major disease remissions and in the two initial cases. This may be due in equal parts by a clinical condition deteriorated in some patients who have been treated as a failure of therapy.
Why GM-CSF was used with mice and no G-CSF to humans?
It was a preliminary animal study. Have worked, according to the authors, also with G-CSF
Is it being used outside of Spain therapy?
Yes. Some patients with tumors other than melanoma and hepatocarcinoma are following therapy. Specific types of tumors, except one case of renal carcinoma are not known but there are several.
Can you have advance access to the articles of melanoma and brain?
None of these works has been published today.
Contacting Antonio Bru: bru@mat.ucm.es
For historical research: http://ayudacancer.wordpress.com/2006/09/17/el-tratamiento-de-neutrofilos-de-antonio-bru/
This information has been adapted from the forum FAQ http://www.terapia-cancer.org/foro/index.php, and is intended as a rough guide to some of the questions we ask when we hear of the proposal A. Bru.
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In our opinion, we should remember that:
* This is a job that is interesting from a theoretical point of view, has little clinical experience. That is novel is not at all an objective criterion for considering its use. Although theoretically all sound very nice, with real experience seems to yield a fairly negative.
* The chances of access to treatment in minimum security conditions are poor, unless permission is obtained for compassionate use (hepatocellular carcinoma and melanoma)
* The fact is indicated only for patients who have no other possibility does not justify, by its poor positive nor its potential danger, which seeks to apply outside of those safety conditions.
