The law is against common sense
NMIC Oncology has created an effective vaccine against kidney cancer and melanoma
Experimental treatment of patients with melanoma and stage III-IV kidney cancer with a vaccine from their own tumor cells made it possible for 25.1% of them to live for 5 years or more. The effectiveness is higher than that of new immunopreparations. About the study and why such treatment is not included in clinical practice, "Dr. Peter" was told at the NMIC of Oncology. Petrova.
A vaccine based on the patient's own (autologous) tumor cells modified with the tag7/PGRP-S gene was created by the N.N. Petrov National Research Center of Oncology and the Institute of Gene Biology of the Russian Academy of Sciences. Work on the project was carried out within the framework of a grant from the Moscow government in 2001-2009. At that time, modern immuno-oncological drugs, which today have turned the idea of cancer treatment, did not yet exist. Oncologists did not believe that it was possible to "wake up" the antitumor immunity, help it detect and destroy cancer cells.
Patients with melanoma and kidney cancer could then be offered only surgical treatment, they did not receive systemic drug treatment in an adjuvant (postoperative, supportive) mode - standard chemotherapy is ineffective. That is, these diagnoses sounded like a verdict.
A group of researchers from the Institute of Gene Biology of the Russian Academy of Sciences, led by Academician Georgy Georgiev, discovered the tag7 gene during experimental studies on mice. With the transfer of genetic information carried by this gene into the tumor, the cells of the immune system were activated, thereby slowing down the growth of cancer cells. Scientists have suggested that the Tag7 protein participates in the transmission of a signal to special cells that "show" a target for destruction to T-lymphocytes – killer cells.
When they discovered an analogue of the tag7 gene in human immune system cells, they suggested that it could be used in antitumor therapy. The research of the Institute of Gene Biology of the Russian Academy of Sciences became the scientific basis for creating a vaccine based on autologous tumor cells modified with the tag7/PGRP-S gene.
The following study was conducted from 2001 to 2014 on the basis of the Scientific Department of Oncoimmunology of the N.N. Petrov NMIC of Oncology, 80 patients participated in it: 68 with skin melanoma and 12 with kidney cancer. In 26 (33%) patients, stage III was established, in 54 (67%) – stage IV of the disease.
The vaccine is made from tumor cells, which are taken from the surgical material of the patients themselves. Their samples were modified with the tag7 gene, and then the ability of tumor cells to multiply was destroyed by radiation. Modified tumor cells can live in the patient's body for about two months without giving deadly offspring, but they synthesize the Tag7 protein at this time, which attracts and activates cells of the immune system.
The resulting vaccine (i.e. modified cells) was administered subcutaneously to patients every three weeks before the disease progressed or for two years from the start of treatment. In the first case, 19 people received it: 17 with melanoma, 2 with kidney cancer – after complete removal of the tumor. In the second - after incomplete removal of the tumor and after the detection of metastases – 61 patients: 51 with skin melanoma, 10 with kidney cancer. None of them were treated with other immunotherapeutic drugs and methods – they simply did not exist then.
Experimental treatment was completed by 2014 and patient monitoring began until 2018. An analysis of its long-term results, which are primarily determined by overall survival, is published in the Oncologist journal.
Overall survival is the percentage of patients with a certain type and stage of cancer who did not die from any cause within a certain period of time after diagnosis.
Thus, the 5-year overall survival rate in the joint group of patients with both melanoma and kidney cancer was 25.1%. There were no differences in overall survival between them. The 10-year overall survival rate was 22% for patients with skin melanoma, 42% for patients with skin melanoma with a favorable prognosis. For comparison: according to the data described in the medical literature, the 10-year overall survival of patients with skin melanoma treated with ipilimumab (an immuno-oncological drug registered in Russia in 2016) was 17%.
The median overall survival (the time experienced by 50% of the study participants) is 6.6 years in the favorable prognosis group and 4.6 months in the unfavorable prognosis group. For patients with stage III-IV skin melanoma, for half of the study participants with a favorable prognosis, the survival rate was 2.3 years, while 31% of them lived for more than 10 years. In the unfavorable prognosis group, the median overall survival was only about 5 months.
The researchers concluded that a genomodified autologous vaccine is an additional opportunity to prolong the life of thousands of patients with skin melanoma and kidney cancer, because so far none of the drugs currently used has become a panacea, none of them has 100 percent effectiveness. The vaccine will be able to give a chance for remission to those for whom the possibilities of standard treatment have been exhausted. The only question is when he can.
Work on a genomodified vaccine has been suspended: at the beginning of 2017, Federal Law No. 180-FZ "On Biomedical Cell Products" came into force, according to which a vaccine based on autologous tumor cells modified with the tag7/PGRP-S gene should again undergo the entire cycle of preclinical and clinical studies. This requires new funding and time, because scientists will have to go back to where they started 20 years ago: with research on laboratory animals. This means that it will take at least 10-15 years before the vaccine is used in clinical practice, even within the framework of an experimental study.
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