Method for treatment of malignant neoplasms

FIELD: medicine, oncology.

SUBSTANCE: method involves carrying out chemotherapy. Firstly, dose of nicotinic acid is administrated that is sufficient to initiate hyperemia of skin integuments and in appearance of first symptoms of hyperemia cytostatics are administrated by parenteral route. Method provides increasing duration of contact of cytostatics with tumor cells and micrometastasis due to inclusion of blood volumes depots in the parent state in vascular skin networks to volume of circulating blood. Invention can be used in treatment of malignant neoplasms with cutaneous and subcutaneous localization.

EFFECT: improved treatment method.

2 ex

 

The invention relates to medicine, namely to Oncology, and can be used for the treatment of malignant neoplasms of the skin and subcutaneous localization.

Understanding analogues of the proposed technical solution can give the results of studies demonstrating the possibility of reducing the resistance of tumor cells and their ability to repair chemoradiation damage by changing microcirculation in the area of the tumor (Ressel, A., Weiss C., Feyerabend, Etc Tumor oxygenation after radiotherapy, chemotherapy, and/or hyperthermia predicts tumor free survival. -International Journal of Radiation Oncology, Biology, Physics. - V 49. - #4. - P 1119-1125. -2001). For example, during a combined use of local hyperthermia and chemoradiation treatment (Falk M.H., R.D. Issels Hyperthermia in oncology. - International Journal of Hyperthermia. - V 17. No. 1. - P 1-18) locally advanced head and neck cancer (Hoshina H., Takagi R., Tsurumaki, H., Nagashima K., et al. Clinical result of thermochemoradiotherapy for advanced head and neck cancer. - Japanese Journal of Cancer and Chemotherapy. - V 28. - N 3. - P 331-336. - 2001).

The prototype of the proposed technical solutions elected "Method of treatment of malignant tumors" (patent for invention №2211714 with priority dated 12.11.2001,; publ. Bull. No. 25 dated 10.09.2003,). The technical solution chosen by the prototype is activated before each session of local hyperthermia peritumoral blood flow by injection into the soft tissue surrounding the tumor, vasoactive the neuropeptide oxytocin.

The choice of the prototype is the binding of the proposed technical solution to the state of blood flow in the zone of contact with the tumor, which affects not only the induction of apoptosis in lipooxygenase, i.e. adapted to the condition of acidosis areas of the tumor (T. Ohtsubo, H. Igawa, T. Saito, H. Matsumoto et al. Acidic environment modifies heat - or radiation-induced apoptosis in human maxillary cancer cells. - International Journal of Radiation Oncology, Biology, Physics. - V 49. - N 5. - P 1391-1398. - 2001), (i) but also the availability in principle of induction medications, (ii) the likelihood of exposure of tumor cells to immune cells, (iii), respectively, the prospect of subsequent lymphoplasmacytic infiltration of the tumor, (iv) and, of course, its zone of lymphoplasmocytic infiltration, oxygen regime, which determines, ultimately, the cytotoxic potential of immune cells.

Here are the main disadvantages of the chosen prototype.

As vasoactive neuropeptide oxytocin is introduced peritumoral, so far for the implementation of the prototype need to be clear about the boundaries of the tumor.

For the implementation of peritumoral injection of oxytocin, even under the control of ULTRASONIC imaging, the tumor (i) must be of an acceptable size and (ii) be located within reach of the injection method of administration.

Accordingly, after radical surgical interventions as a tool for adjuvant is therapy the usefulness of the chosen prototype technical solutions is simply dubious.

The aim of the invention is to improve the immediate and remote results of anticancer therapy.

This objective is achieved in that at first a dose of nicotinic acid, sufficient to initiate flushing of the skin, and when the first manifestations of cutaneous hyperemia start parenteral introduction of drugs.

The invention is new, as for the specialist oncologist claimed technical solution is not obvious from the level of development of medicine and Oncology related areas of knowledge.

The novelty of the claimed technical solution is:

In recognition of the direct dependence of the antitumor effect from timed to coincide with the introduction of cytostatics activation peritumoral blood flow (the synchronization effect).

In recognition of the tumor cells, tumor metastases localized in the structures responsible for the depositing of blood (liver, spleen, Podmoskovye sosudistye plexus of the skin), the special properties of resistance to anticancer treatment.

In selecting a dose of nicotinic acid, is sufficient to trigger marked hyperemia of the skin, and therefore, dose, providing connection to the volume of circulating blood volume of blood in the initial state deposited (in particular, in Podmoskovya with distich plexus of the skin).

- The effect of "sequestration" of drugs at the level of structures, depositing the blood upon termination of nicotinic acid and increasing the duration of contact of drugs with tumor cells, metastases.

The invention involves an inventive step, since the claimed technical solution is not obvious from the present knowledge in the field of Oncology.

The inventive method is not obvious, is not known in the medical literature and clinical practice, neither in Russia, nor in the CIS or abroad.

Comparative analysis with the chosen prototype allows to conclude that the set of features of the proposed technical solution has significant differences in the approach to achieving the goal of improving the immediate and remote results of chemotherapy of malignant neoplasms:

In contrast to (i) injection, (ii) peritumoral injection (iii) vasoactive neuropeptide oxytocin in response to the introduction of resolving dose (iv) nicotinic acid is achieved (v) generaliza-EN, (vi) are well expressed at the level of the microcirculatory bed of the skin activating blood flow, (vii) providing access of the cytostatic agent in the vast space of the structures responsible for the depositing of blood.

In contrast to the prototype after the termination of the activities of the Oia nicotinic acid has the effect of "sequestration" of the cytostatic agent in the vast expanses of the structures, responsible for the depositing of blood.

- Unlike the prototype of the inventive method can be used as a tool for prevention of skin lesions with metastases in the process of conducting standard courses of adjuvant chemotherapy, for example, breast cancer.

The invention is industrially applicable as it can be used in health: the research Institute of Oncology, oncologic dispensaries.

The proposed solution can be used to treat tumors of the skin and subcutaneous localization, including, for example, skin lesions in breast cancer.

The claimed technical solution may be with a special effect used to treat the skin of the head and neck, because the effect of resolving doses of nicotinic acid in the area of the skin of the head and neck is most pronounced.

"The method of treatment of malignant tumors" as follows.

0.2 g of nicotinic acid appoint inside on an empty stomach or intravenously based two-fold excess dose (Medmaravis. Medicinal product. - Moscow: "Medicine". - 1985. - T. II. - S-15). Waiting for the first signs of skin redness. And only after that start parenteral introduction of drugs.

Examples of specific application "method of treatment locates the public neoplasms"

Patients who have undergone a full course of complex treatment of breast cancer, local and regional recurrences remain a serious problem. Skin lesion substantially complicates the forecast. Even less chance of leaving the state of the generalization breast cancer.

Valentina Balueva - one of these patients. Being a doctor, she has agreed not only to test for yourself the inventive method of treatment, but also to share personal observations of the effect of two injections thio-Tepa (20 mg + 20 mg) according salemaa technical solution.

Patient Balueva VI.. born in 1951.. IB No. 5805/L.

Status localis for admission to RNII (15.05.2000): in the left breast on the upper quadrants of the tumor irregular shapes 6.0*5.5 cm with fuzzy boundaries, with some (?!) the interest of the skin over the tumor. In the axillary region, many enlarged lymph nodes located chain, soldered between them, sedentary, size 2.5*3.0 cm, the minimum - 1.0 cm in diameter.

With 22.05.00, 26.05.00 was held course magnicient autogame-chemotherapy: vincristine - 2.0 mg; methotrexate - 50.0 mg; 5FU - 2500 mg; cyclophosphamide 1000 mg; doxorubicin - 150,0 mg Effect a clearer delimitation of the upper border of the tumor, the tendency to separation of the lymph nodes, the tumor decreased to 4.5*4.0 cm, lymph nodes to 0.7-2.5 cm in diameter. DS: Cancer of the left breast W is Lesa the nodular form with metastases in axillary lymph nodes, T3N2MO, St III, gr. II. Condition after the 1st course of neoadjuvant magnicient autohemotherapy.

With 19.06.2000, 14.07.2000, course preoperative DHT on the tumor of the left breast and the left axillary region (SOD - 40,0 G). 31.07 2000 radical mastectomy on Pati left. DS: breast Cancer, nodular form, pT1N2MO condition after the treatment, St. Ill, gr. 3.

Historiarum: on the site of the tumor fibrosis, tumor is not defined in the subclavian cellulose - 2, in axillary tissue - 3, - dense nodules 0.5 see HA No. 575165-72 from 2.08.2000,: infiltrating ductal cancer, stromal sclerosis, 3 axillary lymph nodes with metastasis.

With 9.08.2000, 1.09.2000, - post-operative course of DHT on the remaining path of lymphatic drainage (SOD - 40,0 G).

By April 2001 the patient was held on 4 courses of adjuvant chemotherapy, each of which included: vincristine -2,0 mg methotrexate - 50.0 mg; 5FU - 1000,0 mg; cyclophosphamide 800,0 mg; doxorubicin - 60,0 mg

In April 2002, the patient on the left hand appeared lymphostasis, in June 2002 - hyperemia of the postoperative scar, pain, temperature rise up to 37.5°S. over the next three months the patient on family circumstances refrain from engaging in anti-tumor therapy.

Status localis for admission to RNII (9.102002): left breast cancer postoperative scar with severe hyperemia, infiltration of the soft tissues, the expansion of the subcutaneous vessels, extending to the lower edge of the clavicle, the front side surface of the chest, on his back. Supraclavicular lymph nodes are not clearly palpable, on the left hand expressed lymphostasis. R-skopicki in the lungs 2-sided lymphangitic, multiple metastatic foci. DS: Generalisation of cancer of the left breast, a metastasis in soft tissue, in both lungs.

With 15.10.2002, 25.10.2002, held the 1st course of chemotherapy: methotrexate - 60,0 mg; 5FU - 1000,0 mg, thio-hpef to 120.0 mg, doxorubicin - 140,0 mg Effect - reduction of hyperemia, infiltration of soft tissues. With 11.11.2002, 27.11.2002, held the 2nd course of polychemotherapy methotrexate 60,0 mg; 5FU - 1000,0 mg, thio-hpef 100.0 mg, doxorubicin - 120,0 mg Effect further reduction of hyperemia, infiltration of the soft tissue swelling of the hands. With 11.12.2002, 26.12.2002 was held the 3rd cycle of chemotherapy: methotrexate - 60,0 mg; 5FU - 1000,0 mg, thio-hpef 100.0 mg, doxorubicin to 90.0 mg Effect - reduction of hyperemia, infiltration, edema of the hands. With 16.01.2003, 24.01.2003 was held the 4th course of chemotherapy: methotrexate - 60,0 mg; 5FU - 500.0 mg, thio-hpef 60,0 mg, doxorubicin to 90.0 mg Effects - swelling of the hands less but the course is interrupted because of SARS. With 14.02.2003, 27.02.2003, held the 5th cycle of chemotherapy: methotrexate - 50.0 mg; 5FU - 1000,0 mg, thio-hpef to 120.0 mg, doxorubicin - 120,0 mg. Aromasin 1 ton per day. The effect remiss who I am. With 18.04.2003, 28.04.2003, held the 6th cycle of chemotherapy: methotrexate - 50.0 mg; 5FU - 1000,0 mg, thio-hpef to 120.0 mg, doxorubicin - 40,0 mg Aromasin 1 ton per day. The effect of remission.

Given the state of remission, the next hospitalization is moved on 9.09.2003 year. This time when entering occurrence of cutaneous metastases with a diameter of 0.4 cm at the edge of the scar. With 11.09.2003, 22.09.2003 was held the 7th course of chemotherapy: methotrexate - 50.0 mg; 5FU - 1000,0 mg, thio-hpef 100.0 mg, doxorubicin - 60,0 mg Aromasin - t per day. The effect of partial resorption of metastasis in the skin.

Two of the remaining introductions thio-Tepa recommended to spend at the place of residence. These two doing Weebalow carried out in accordance with the proposed technical solution.

"I Balueva VI 22.09.2003 was ingested 0.2 g of nicotinic acid. When I felt a slight burning of the skin and have noticed a moderate hyperemia open areas of the body, I was given intramuscularly 20 mg thio-Tepa. Health remained good, with no significant changes. Over the next hour, slowly, I returned home on rough terrain. Redness of the skin and feeling the heat became more and more pronounced, until pronounced. In the rest of health remained good. Flushing of the skin, caused by nicotinic acid is, lasted almost 2 hours. Those areas of the skin, which adjoined his underwear, including area postoperative scar metastases continued to keep its color and contrasted with areas of GI-paraminophenol skin. Gradually the effect of nicotinic acid has ended, the General feeling has not changed.

The following introduction was 24.09.2003, As with the first introduction, I took 4 tablets (0.2 g) nicotinic acid. And when I felt a slight burning face and saw a slight flushing of the open areas of the body, was asked to enter intramuscularly 20 mg Thio-Tepa.

Overall health was good. After the injection I stayed in his office and cleared the area of postoperative scar, removing his underwear. Reaction to nicotinic acid was at this time less pronounced and shorter (50-60 min), but the skin in the area of the scar visibly flushed. In the coming days, changes in feeling I had not noticed. After 5-7 days, periodically, I began to notice intermittent vague sensation in the left axillary region and in the postoperative scar. Sometimes were pulling sensations in the axillary region, sometimes short-term acute pain in postoperative scar in the place where they were most pronounced changes in the skin caused by relapse in with what ntable 2002. 3-4 times I was worried about moderate pain in the right breast. Approximately 1.5-2.0 weeks I started to "travel" skin in the area of the scar. After 2 days, the production was completed.

By the end of October, i.e. approximately one month after the first injection Thio-Tepa on the background of the action of nicotinic acid I completely disappeared metastatic lesions in the axillary region (in the form of numerous subcutaneous seal the size of a millet grain and a little more) and in postoperative scar (in the form of a flat seal 0.5×0.5 cm). In addition, in mid-October I intensively hair began to fall. However, after a few days the process has slowed, though continued for another two weeks. Ultimately, your hair is extremely thinned, but not out completely.

In the first days after administration of Thio-Tepa on the background of the action of nicotinic acid I was sometimes said light podtashnivaet. Otherwise, she was feeling good. Every day I went walking to work and back from work (one hour there and the same back), was raised without much effort on the 5th floor. The first few days after returning from RNII I went slower due to shortness of breath, and on the 5th floor was raised with 3-4 stops. By late October, the walking became easier, decreased dyspnea, on the 5th floor I began to rise from 1-2 stop the kami, and sometimes without stopping. Throughout this period of time, the mood was always cheerful and optimistic.

Balueva Valentina Ivanovna. 8.11.2003 the year".

2. Patient ATA 1952.. r.p.. IB No. 11249/R.

In October 1996 underwent a right radical mastectomy: T1N0M0, St 1, .ll. In February 2003 after the SARS long-continued pyrexia, cough, shortness of breath, pain in the left half of the thorax.

A month later in MLDC, Rostov-on-don with ultrasound examination was revealed right-sided pleural effusion. It was also noted increased erythrocyte sedimentation rate, anemia. In April 2003 drew attention to the emergence of numerous nodules in the skin of the anterior chest wall (where she has for many years been atheroma), as well as on the back of the neck, on both sides of the occipital region. R-gram lung 24.04.2003 - metastasis in 1 rib on the right, encysted midlevel pleurisy on the right. If osteointegration 15.5.2003 revealed foci of intense fixation of the radionuclide in the front part of the skull, in particular in the projection of the right orbital cavity, which were interpreted as metastases of breast cancer.

DS: Generalisation of cancer of the right breast: bone metastases (I rib on the right, the front part of the skull, pelvic bones, soft tissue, the pleura on the right.

With 11.07.2003 on 23.07.2003 entered on autoplast is: methotrexate 40,0 mg, 5FU - 2500 mg, doxorubicin - 100.0 mg alkeran - 50,0 mg the Effect of reducing pain, normalization of temperature, flattening of skin metastases. Similar courses with 13.08.2003, - 20.08.2003,; 11.09.2003,-19.09.2003,

The difference of the 4th course of chemotherapy was potentiation of the action of the injected drugs according to the claimed technical solution. The effect is further resorption of skin metastases, the disappearance of almost all of the complaints, normalization of laboratory parameters. It is necessary to mention the almost complete absence of this patient side effects. Apparently, last but not least this is due to the inherent autolackiererei features.

Technical and economic efficiency "method of treatment of malignant tumors".

Technical and economic efficiency "method of treatment of malignant tumors" is:

- increased life expectancy of patients with usually resistant to chemotherapy of malignant neoplasms;

- to increase the effectiveness of "traditional" drugs available to the General population.

The method of treatment of malignant neoplasms of the skin and subcutaneous localization, including chemotherapy, characterized in that initially a dose of nicotinic acid, sufficient to initiate flushing of the skin, and when the first choice of the manifestations of skin hyperemia start parenteral introduction of drugs.



 

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