The immunotherapy - answers to the Frequently Asked Questions (FAQs)
The additional drugs which can be combined with RESAN to increase the effects of immunotherapy
1) Better results are obtained from the immunotherapy RESAN if combined with recombinant γ-interferon.
The gamma-interferon increases the number of HLA-I class molecules on the surface of the tumor cells. The more the molecules of these kind on the cell membrane of the tumor cells, the more the cells become recognizable for the T-killers and, thus, more the tumor cells are captured and destroyed by T-killers. Besides, the γ-interferon decreases the angiogenesis.
Synonyms of medicinal forms of γ-interferon: Imukin, Actimmune, Ingaron...
Scheme & Doses:
The gamma-interferon is started to administer from the 7-14 day after the vaccine injections. In adults it is prescribed as 500 000-1 000 000 IU (million international units) γ-interferon, i.m., once in every 12 hours for 20 days or more (the continuance of injections depends on the clinical condition of the patient and his laboratory data).
The possible side effects:
As a whole, in about 10.7% of the patients in which the drug is administered at the given dose can be expected side effects. In such cases it is necessary to determine what exact forms and kinds of threat these side effects possibly represent in each particular patient.
The side effects appearing similar to the "symptoms of cold" do not necessitate the withdrawal of the preparat. If the cold symptoms are tolerated poorly by the patients then it is advisable to change the scheme or doses of the drug administration. In certain patients the cold like symptoms may arise even during an administration of minimum doses of IFN-γ.
Other side effects which may appear during the γ-interferon therapy: fever, myalgia, algor, headache, allergic reactions in the forms of skin rashes, neutropenia, anemia (it is not recommended to administer γ-interferon in the patients with haemoglobin < 100 g/l), thrombocytopenia, transitional rise of liver transaminases in blood serum and rarely – proteinuria.
The side effects during which the drug should be immediately withdrawn: anaphylactic shock, oedema lungs, allergic reaction in the form of skin rashes.
The side effects during which it is necessary to change the scheme or doses of the drug administration: mild anemia, neutropenia, headache.
If a patient tolerates poorly the i.m. injections (1 MIU of γ-interferon) then it is advisable to change the injecting form into subcutaneous at the dose of 0.5 MIU, once a day. If such scheme is still intolerable for the patient then the dose may be reduced down to 0.3 MIU.
One should be very careful when prescribing the gamma interferon in the patients with ischemic heart, congested heart failure, arrhythmia, epilepsy. Following the single shot of 1 MIU IFN-γ, its concentration starts to rise in blood serum after 3 hours and reaches maximum in 6 hours which can be detected for 24 hours.
More about γ-interferon...
2) Chemotherapy with 5-Ftoruracil can be combined with RESAN to increase the overall results of the cancer treatment. 5-Ftoruracil, in additional to its main function, increases the number of HLA-I class molecules on the surface of the tumor cells which again becomes better recognizable for cytotoxic T-lymphocytes. The combined therapy of RESAN with adriamycin(doxorubicin) also supposed to get good results, as the given antitumor antibiotic does not decrease but increases the formation of cytotoxic T-lymphocytes.
Scheme for 5-ftoruracil (5-FU):
- surgical resection of the primary tumor.
- treatment by 5-ftoruracil, 10 mg/kg or 400 mg/m2, intra-venous, daily, for 8 days.
- after one month the vaccine RESAN is injected.
- 1 month after the injection of RESAN, again start to treat with 8 mg/kg or 320 mg/m2 of 5-FU, intra-venous slowly within 2-3 minutes on the 1, 2 and 3 days, then 5 mg/kg or 200 mg/m2on the 6, 7 and 9 days.
Scheme for adriamycin (doxarubicin):
- administration of RESAN 7-12 days before the operation.
- surgical resection of the primary tumor.
- intravenous injection ofadriamycin 60-75 mg/m2 once every 4 weeks, altogether 3 courses.
3) Xeloda® (capecitabine) is changed in the body to the substance 5-fluorouracil. In some patients with colon, rectum or breast cancer, this substance stops cancer cells from growing and decreases the size of the tumor. Xeloda is used to treat:
cancer of the colon or rectum that has spread to other parts of the body (metastatic colorectal cancer) when fluoropyrimidine therapy alone is preferred. Patients and physicians should note that combination chemotherapy has shown a survival benefit compared to 5-fluorouracil (5-FU)/ oral leucovorin (LV) alone. A survival benefit over 5-FU/LV has not been demonstrated with Xeloda monotherapy.
breast cancer that has spread to other parts of the body and has not responded to treatment with certain other medicines. These medicines include paclitaxel (Taxol) and anthracycline-containing therapy such as Adriamycin and doxorubicin.
The recommended dose of XELODA is 2500 mg/m2 administered orally daily with food for 2 weeks followed by a 1-week rest period given as 3 week cycles. The XELODA daily dose is given orally in two divided doses (approximately 12 hours apart) at the end of a meal. XELODA tablets should be swallowed with water. The RESAN vaccination is done 7-12 days before the beginning of XELODA treatment.
4) May be very effective the simultaneous of RESAN vaccination and SEHYDRIN® administration. It is a good combination of antitumor products for palliative help to cancer patients. Usually these drugs together are used in case of advanced stages of disease, relapses and metastases and in patients with the practically exhausted possibilities of the standard cancer treatment.
Alongside with antitumor and tumor growth stabilising effect of such therapy produces symptomatic action that leads to decrease or full discontinuation of pain through cancellation of narcotic anaesthetics, reduction of fever, sometimes normalisation of temperature, decrease or disappearance of blood coughing, respiratory insufficiency and oedemas, normalisation of laboratory parameters, return of appetite and reduction of intensive loss of weight, considerable improvement of general state of health, increase of motor performance, improvement of the mood. As a result RESAN and SEHYDRIN® combination allows to improve the quality of life of cancer patients and to prolong the life.
The action of SEHYDRIN® is connected with its influence on a number of biochemical processes: SEHYDRIN® suppresses monoaminooxydase, inhibits gluconeogenesis, reduces permeability of cell membranes, affects exchange of B6 vitamin.
SEHYDRIN® is administered at the dose of 1 tablet 3 times a day during 30-40 days. The recommended time for SEHYDRIN® administration is the next day after the RESAN vaccination. Quantity of SEHYDRIN® cycles is not limited, the interval between cycles is at least 2 weeks.
It is possible to prescribe RESAN after a course of chemo- and radiotherapy
The chemotherapeutical drugs destroy the cells, which under go fast cell division in an organism. The irony is that the tumor cells as well as the immunocompetent cells referred to such group of cells. Thus the required conditions to get successful results by RESAN after the chemical therapy are:
1) The absolute absence of the drugs of chemotherapy in the organism (except XELODA, 5-ftoruracil, SEHYDRIN and adriamycin).
2) Good and stable condition of the immune system of the organisms for not less than a month: in the weekly blood analysis (in empty stomach), the leucocytes in the peripheral blood should be not less than 4.5·109/l, where as the lymphocytes should be not less than 18%. Otherwise effective immune answer can not be obtained.
Radiotherapy is even more destructive for the immune system than the chemical therapy – the matured immunocompetent cells as well as the young immature cells of the bone marrow get killed. After the radiotherapy the required conditions to get successful results are similar to that of chemotherapy.
In fact very often the immunotherapy has to be conducted after the courses of chemo – and radiotherapy when the immune system is weakened. In such cases we can stimulate the immune system with the help of preparats so called immunostimulators.
It is possible to prescribe a course of chemo- and radiotherapy after the drug administration of RESAN
Yes, it is possible, but the anticancer activities of the immune-system built by RESAN will be liquidated (the anticancer-immune system turns off or reduces drastically for a long period).
The exceptions are chemotherapy drugs, which are not influent toxically on immunity system, and radiotherapy in dosages, which are not provoke the development of leukopenia.
Not all the cancer patients may be benefited by RESAN...
RESAN is effective in all the histological types of cancers listed here.
Cancers located in spinal cord and brain can not be treated by RESAN because the immunocompetent cells normally do not penetrate through so called the blood-brain barrier.
Similarly the blood cancers can not be treated by RESAN because in these types of cancers the stem cells or the immune cells are affected. For the similar reasons - that the stem cells are involved in one way or other, RESAN has low effects in case of prostate cancers with metastatic growths into bones.
In case of virus induced tumors it is compulsory to carry out a preliminary effective antiviral therapy in order to have a successful anticancer vaccinotherapy.
The other important factor we need to consider is the sizes of the tumors. The more the volume of cancers or metastases, the less the probability to get an absolute cure by the vaccine RESAN. This is for the simple reason- when the immune system has to detect and fight a smaller number of cancerous cells, it is more likely to be successful. In contrast, when the immune system is matched against a very large number of tumor cells, it is more likely to be overwhelmed and ineffective - an outnumbered army.
The time required for RESAN to response against cancers
The length of time required before seeing results varies greatly from one patient to another. Such factors as the type of cancer, the cancer stage, the immune state and the patient's general health (other than the cancer ) can all play a role in determining the speed with which RESAN responses against the targeted cancer.
Although the anticancer immune system switches on with in 3 days after the vaccination, usually the convincible clinical results (decrease in tumor markers, halt or shrinkage of tumor sizes, reliefs of clinical complaints etc.) you would start to notice after 1-1.5 months.
Having said all this, it is imperative to keep one thought firmly in mind! RESAN takes time to work! As noted above, 1-1.5 months is typical and in some cases take up to 3 months or more to see positive responses. If a patient has only a few weeks to live, RESAN may not have time to be effective. In such cases, the objective is to prolong the life expectancy i. e. palliative therapy.
The derivation of the correct volume of the cancer in the patient
The volume of the cancer is derived by using the following formula: (A x B x C x 3.14):6 where A,B,C – are the length, breadth and height of the cancer in cm (which are perpendicular to each other) – and we get the volume in cm3. In case of metastasis - the volumes of each metastatic tumors are derived and added all together.
Note: in most of the cases the actual volume of the cancer is far more than the derivated - as the intra-tissue growth of the cancer or some of the metastases are not included in the calculations.
