Therapy of bone metastases in breast cancer

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to oncology, and can be used in therapy of breast cancer with bone metastasis. Substance of the invention consists in puncture with a needle between III and IV lumbar vertebras in subarachnoid spinal marrow space. Cerebrospinal fluid in amount 2 ml is poured in a sterile bottle and added with Epitalamine 10 mg. The bottle is incubated in a thermostat at temperature 37°C within 20 minutes. Then the prepared mixed liquor and Epitalamine are introduced back into subarachnoid space that is combined with introduction of hydrocortisone 125 mg. The therapeutic course includes 4 lumbal punctures with introduction of preparations once a week.

EFFECT: application of the invention provides regress of bone metastases, reduced toxic collateral reactions of hormonotherapy, immune correction ensured by combined endoliquor introduction of said agents.

2 ex

 

The invention relates to medicine, namely to Oncology, and can be used in common form of breast cancer IV stage with metastasis to the bone.

Known "Method of treatment of generalized prostate cancer" by endolyumbalno introduction 2%oil solution sinestrola consistently in doses of 10,20, 30, 40 and 50 mg every 5-6 days after each dose. The method reduces the side effects, increases the life expectancy of the patient. However, the application of the method is limited to one location, does not apply to other generalized cancer.

Known "Method of treatment of breast cancer" (patent No. 2158588, publ. Bull. No. 31 dated November 10, 2000), namely, that before the operation of the cellular part of autoplasma patient connect with epithalamin, the supernatant autoplaza mixed with chemotherapy, incubated for 30 min at t=36,5-37°C and injected sick for 2 weeks 3 times per week to 1.5 course doses consisting of: vincristine 1.5 mg, methotrexate 50 mg, doxorubicin 30 mg, cyclophosphamide 200 mg, epithalamin 10 mg 3, 5, 10, 12 days intravenous drip, other days 2, 4, 6, 7, 9, 11, 13, 14 enter epithalamin 10 mg, diluted extempore intramuscularly. The clinical efficacy of the method is regression of primary tumor, reducing toxic side effects, correcting them is onogo status. However, application of the method does not affect the decrease in the distribution process, the bone metastases.

Known "Method of treatment of generalized breast cancer" (see Aiguaviva. Hormone therapy generalized breast cancer (abstract. Kida. the honey. Sciences. Moscow, 1983, p.20), selected as a prototype by injection of hydrocortisone into the subarachnoid space. A known method can reduce the side effects from hormonal therapy to reduce pain, increase life expectancy.

However, the method has drawbacks: neoplastic process is accompanied by the development of immunosuppression. In addition, endocrine imbalance in breast cancer involved all parts of the endocrine system, including hypothalamus-pituitary system, which is reflected in the condition of patients with generalized breast cancer.

The aim of the invention is the effect on the metastatic lesion of bones, decreased toxicity.

This objective is achieved in that sterile needle for spinal punctures produce puncture between the third and fourth lumbar vertebrae into the subarachnoid space of the spinal cord, take the cerebrospinal fluid in the amount of 0.5 ml in a test tube and determine the content of protein and lymphocytosis in the cerebrospinal fluid, and then 2 ml of cerebrospinal liquid the spine is placed in a sterile vial and injected 10 mg of epithalamin, put the bottle in a thermostat and the temperature is 37°C, incubated with exposure time of 20 minutes, return the mixture of liquor and epithalamin in the subarachnoid space and is still administered 125 mg hydrocortisone company "Gedeon Richter", diluted in 2 ml of physiological saline, the course of treatment 4 provides lumbar puncture with injection of drugs 1 time a week.

The invention of "a Method of treatment of bone metastases in breast cancer" is new, because it is unknown the level of medicine in the field of Oncology in the treatment of patients with generalized tumor process with the presence of bone metastases, which were previously considered incurable.

The novelty of the invention lies in the fact that in generalized breast cancer with bone damage andliving hormone therapy is performed in conjunction with epithalamin. Epithalamin - drug epiphysis class of citomedines, which is used in inoperable forms of breast cancer with chemotherapy, radiation therapy. However, epithalamin never used for introduction into the subarachnoid space, never used for dissolving autricor-combined environment. This introduction of epithalamin allows to strengthen its hormonomodulizing and immunomodulatory effect on the organism as a whole. It is impossible to exclude and antitumor d the op perate epithalamin as extract epiphysis indirectly through the endocrine system, as for the successful therapy of hormone-dependent tumors to be affected by endocrine and immune systems. In addition, the main mechanism of antitumor action andlivorno hormone connected with the Central inhibitory effect of hydrocortisone through the hypothalamic-pituitary system in the adrenal cortex, which results in a more pronounced and more persistent anti-estrogenic effect, contributing to the restoration metastatically modified bone.

The invention of "a Method of treatment of bone metastases in breast cancer" is industrially applicable, as may be used in health care, hospitals with cancer, oncologic dispensaries and cancer research institutes.

"A method of treatment of bone metastases in breast cancer" is as follows.

In patients with generalized breast cancer with a primary lesion of the bone needle for spinal puncture into the subarachnoid space of the spinal cord produce puncture between the third and fourth lumbar vertebrae in sterile conditions. Release dropwise cerebrospinal fluid, control of pressure, trying to 0.5 ml of cerebrospinal fluid in the tube. The swab is sent to a clinical laboratory for measuring the population in the CSF protein content, the lymphocytosis, another 2 ml of cerebrospinal fluid collect in a sterile vial, close the needle with mandrin and injected into the vial contains 10 mg of epithalamin, incubate the contents of the vial in the incubator at 37°C for 20 minutes. After incubation liquor with epithalamin return through the puncture into the subarachnoid space and even impose 125 mg hydrocortisone (company "Gedeon Richter"), diluted with 2 ml of saline. Treatment involves 4 lumbar puncture 1 time a week.

The specific examples of the application of the Method of treatment of bone metastases in breast cancer" on the patient.

Clinical observation No. 1.

Patient Nikitenko M.P., born in 1943, IB. No. 11169/n, is observed in Rostov cancer research Institute since 2001, when it was exposed to a complex radical treatment for cancer of the right breast stage III T2N2M0. Histological examination remote operation tumors found infiltrating ductal cancer with metastases in axillary and infraclavicular lymph nodes (histogenesis No. 614935-941 from 10.08.2001 year). Postoperative treatment included remote gamma-therapy is recommended in the path of lymphatic drainage and 3 courses of adjuvant chemotherapy.

Bone pain was bothering the woman already in the period of the comprehensive treatment and was localized mainly in the lumbar-BAP is tzovas region, hip joint range of motion decreased gradually, the patient began to take analgesics.

On re-produced x-ray signs of bone destruction were not found.

13 October 2003 produced by computed tomography revealed multiple metastases of breast cancer in nijaguna and lumbar vertebrae, the head of the left femur, iliac bones.

Signs of tumor lesions of other organs and systems of organism conducted clinical and instrumental examination is not found.

4 and 11 November 2003 in the Department of chemotherapy produced for therapeutic purposes 2 introduction hydrocortisone 125 mg in cerebrospinal fluid, 250 mg of the drug in total. Given the lack of positive clinical dynamics, decided treatment to complement endolyumbalno the introduction of epithalamin on Autostore. Treatment continued 18 and 25 November 2003, two lumbar-puncture with injection of 10 mg of epithalamin, diluted with 2 ml of cerebrospinal fluid obtained by puncture, and 125 mg of hydrocortisone (250 mg).

The immediate effect of treatment was expressed as a reduction in the intensity of pain, increase range of motion, reducing demand, and then the rejection of analgesics. Headaches, which appeared in the period of treatment, were mild, completely regressed within the next month the.

Examination of the patient one year after treatment has allowed to treat her condition as clinical and radiological remission - pain in the bones are absent, the motion of a free, painless, in full.

Clinical observation # 2.

Patient Solovyov TI, born in 1953, IB. No. 5770/I, observed in Rostov cancer research Institute since 1991, when she was diagnosed with cancer of the left breast with metastasis in the left axillary lymph nodes, stage III, T4N1M0. After preoperative chemoradiation therapy with marked clinical effect on August 23, 1991 produced simultaneously radical left mastectomy and bilateral ovariectomy. Histogenesis No. 310825-832 "infiltrating ductal cancer in the axillary lymph nodes, subscapularis and subclavian fiber metastatic tumors of the above-described structure". After the surgery took 6 courses of adjuvant chemotherapy, took prednisolone 10 mg per day for 2 years.

In March 2002 addressed again with complaints of pain in the legs, lower back. Generated x-ray signs of multiple bone metastases foci of osteolysis in the area of the right iliosacral joint, the body of the right iliac bone, the upper third of the left femur. Started hormone therapy by Omnadren 250 mg intramuscularly 1 time in 4 weeks. After 4 injections, the patient refused treatment specified drug. When appearing in Rostov cancer research Institute in October 2002, the pain in the bones remain. On osteointegration signs of metastatic lesions of the left iliac bone, sacrum, head of the right femur. Lesions tumors of other organs and systems not found. Obtained the consent of the patient on indolinone the medications.

24 October, 31 October and 4 November 2002 endolyumbalno were administered 10 mg of epithalamin on Autostore and 100 mg of hydrocortisone intrathecal. Bone pain regressed completely, but there was a strong headaches at normal body temperature, normal blood pressure, no meningeal signs. Therapy is discontinued. Within 2 weeks my headaches were completely gone.

Done 6 months x-ray examination of the affected bone found expressed reparative, osteolytic changes in them. Clinical and radiological remission, the patient continued for more than 3 years.

Technical and economic efficiency "method of treatment of bone metastases" is that the method provides regression of bone metastases, reduction of toxic side reactions, hormonal therapy, immunotherapy, which then helps to improve the quality and increase the life expectancy of patients.

A method of treatment of bone metastases in breast cancer, including andliving hormone therapy, characterized in that the conduct of the puncture needle between the third and fourth lumbar vertebrae into the subarachnoid space of the spinal cord, 2 ml of spinal fluid is placed in a sterile vial and injected 10 mg of epithalamin, put the bottle in thermostat and when temperature 37°C, incubated with exposure time of 20 min, return the mixture of liquor and epithalamin in the subarachnoid space and enter another 125 mg hydrocortisone, diluted in 2 ml of physiological saline, the course of treatment 4 provides lumbar puncture with injection of drugs 1 once per week.



 

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