A method of treating breast cancer

 

(57) Abstract:

The invention relates to medicine, namely to Oncology, and can be used for the treatment of locally advanced and disseminated breast cancer (stage III-IV) cytostatic agents. Offered in inoperable patients first stage of treatment to produce 4-7 introductions peritumoral and soft tissue in the path of lymphatic drainage from the breast cancer drugs: 10 ml of 0.5% solution of rihanana, 5-10 mg of methotrexate, 3 ml of diclofenac on one introduction separately, through the day, then without a break in treatment carry out the introduction of anticancer drugs in the standard course doses autologous blood in combination with 50 mg of rihanana on autologous blood 3 times a week, separately, sequentially in two weeks, next courses autohemotherapy in combination with the introduction of rihanana repeat after a two-week break without prior administration of drugs peritumoral and soft tissue in the path of lymphatic drainage from the breast. The method allows to increase the effectiveness of breast cancer treatment, to improve the interoperability of patients, has immunomodulatory effect, improves the tolerability of chemotherapy due to SL.

The invention relates to medicine, namely to Oncology, and can be used for the treatment of locally advanced and disseminated breast cancer cytotoxic agents.

There is a method of treating breast cancer by a combination of anticancer drugs by the scheme CMFVP, including cyclophosphamide 2 mg/kg orally or/m 1-28 days, vincristine at 0.025 mg/kg methotrexate 0.75 mg/kg 5-fluorouracil in 12 mg/kg, the latter three drugs in/in 1,8,15,22 day, prednisolone 0.75-0.25 mg/kg orally 3 weeks, then 10 mg for 1 week. The course lasts for 4 weeks, the interval between courses of 4 weeks (see Anticancer therapy. Edited Perevozchikova N. I. , M. , 1996, page 70).

The disadvantages of this method of breast cancer treatment is the need for a significant reduction in the standard one-time and course doses of chemotherapy and interruptions in therapy due to the emergence hematotoxicity, diarrhoea and other side effects that are not able to comply with the strategic principle of the maximum possible radicalism chemotherapeutic effects. In addition prednisolone included in the scheme, has an immunosuppressive action, wspolna the gastrointestinal tract, hyperglycemia, hypertension, obesity, osteoporosis, violations of water-salt metabolism and other - cause a wide range of contraindications to treatment (gastric ulcer and duodenal ulcer, hypertension, diabetes and other common pathological conditions in patients with breast cancer). Meanwhile, created on the basis of the scheme other combinations of chemotherapy drugs, not including corticosteroids (CMF, CMFV, and others ), including schemes with the use of anthracycline antibiotics row, widespread at the present time for the treatment of breast cancer, also do not allow for chemotherapy in the recommended doses and observe the modes of introduction due to toxic side effects that adversely affect the immune system, which ultimately affects antitumor efficacy.

Known "Method of treatment of cancer" (see author's certificate 940379 from 15.05.1980, And 61 K 35/14, authors: Y. Sidorenko S. , Katzman M. C. ), chosen as a prototype, providing intravenous vincristine, methotrexate, 5-fluorouracil and characterized in that 1/4 part of the common course doses of the drug are dissolved in 50 ml firestat patient - how autohemotherapy (AGHT).

This method improves the portability of the common course doses of drugs, overcoming toxic barrier inherent systemic polychemotherapy, but also has its disadvantages. His own limit toxicity limits the amount of doses of chemotherapy and lengthens the intervals between injections, and in some percentage of cases General toxic manifestations are forced to interrupt the course of conducting IGHT. In addition, this method does not provide for correction of immune status.

Breast cancer, especially in advanced stages, like other cancers, is accompanied by the development of immunosuppression and impaired regulation of immunopath. The maximum effect of the treatment of this disease is possible with the use of chemotherapy, providing antitumor activity without suppressing the body's defenses. This raises the need for correction of the immune system in the treatment of breast cancer.

The aim of the invention is to increase the efficiency of treatment of locally advanced and disseminated breast cancer, improving operability of patients, correction of them is giving the quality of life in unresectable patients.

This objective is achieved in that the first stage of treatment produce 4-7 introductions peritumoral and soft tissue in the path of lymphatic drainage from the breast cancer drugs: 10 ml of 0.5% solution of rihanana, 5-10 mg of methotrexate, 3 ml of diclofenac on one introduction, separately, through the day, then, without a break in treatment, carry out the introduction of anticancer drugs in the standard course doses autologous blood in combination with 50 mg of rihanana on autologous blood 3 times a week, separately, sequentially, within two weeks, next courses autohemotherapy in combination with the introduction of rihanana repeat after a two-week break without prior administration of drugs peritumoral and soft tissue in the path of lymphatic drainage from the breast.

The invention of "a Method for the treatment of breast cancer" is new, because it is not known from the level of medicine in the field of Oncology in the treatment of breast cancer cytotoxic agents.

The novelty of the invention lies in the fact that medicinal treatment of breast cancer unconventional topically and systemically used in the preparation of rihlokain as immunocorrector and modifier chemotherapy; exercise 4-7 introductions paratungstate anti - inflammatory drugs - NSAIDs (diclofenac), after which patients are 2-3 courses of polychemotherapy according to the scheme CAMFV standard course-dose chemotherapy for autologous blood with the parallel introduction of rihanana on autologous blood separately consistently for 2 weeks: vincristine and methotrexate to the dose rate of 1 per week, 5-fluorouracil and cyclophosphamide to course doses 3 times a week, doxorubicin 1-3 times per week (mode, and the dose is adjusted individually), rihlokain 3 times a week.

The Method of treatment of breast cancer involves a combination of autohomeomorphisms, autohemotherapy effects and, in addition, local-regional therapeutic effect on the tumor and metastatically modified lymph nodes. Used in our Method for the treatment of breast cancer" NSAIDs (diclofenac) as blocker of prostaglandin, which is one of the factors of metastasis, and rihanana synthesized as a drug for local anesthesia, not having antitumor activity, but in combination with chemotherapy enhances its therapeutic effect and contributing to correction of the immune status of the organism, improves the effectiveness of the treatment.

Rihlokain (resources N 250 from 31.08.1995, registration certificate N 95/250/8).

Experimental rationale for the use of rihanana in the proposed "cure breast cancer".

In the experiment on animals with tumor-45, subcutaneously transplantable, it was found that rihlokain has a modifying effect of chemotherapy cyclophosphamide (Y. N. Borduchkov with co-authors, Proc. of Autolymphocyte and other issues of Oncology, M. , 1997 , pp. 278-282).

In our preliminary experiments, it was discovered the stimulating effect of rihanana on the cytotoxic activity of natural killer cells, which is the most important factor antitumor protection by incubation in vitro with lymphocytes of cancer patients. We found that this effect is provided by two concentrations of rihanana and depends on background values. The initial high values of cytotoxic index after action rihanana remain at the same level, and the original low - statistically significant increase (table. 1).

The invention involves an inventive step, as for a specialist oncologist-medical physicist is not obvious from the level of medicine in the treatment of breast cancer.

Offer "With the second area of Oncology - treatment of locally advanced and disseminated breast cancer - either in CIS or in Russia or abroad.

The invention is industrially applicable as it can be used in health care during chemotherapy for breast cancer in various medical institutions, especially cancer, Oncology, oncologic dispensaries.

Specific perform a method of treatment of breast cancer".

10 ml of 0.5% solution of rihanana, 5-10 mg diluted in 5 ml saline methotrexate and 3 ml of diclofenac should be typed in a separate disposable syringes and sequentially injected the patient with breast cancer through one needle peritumoral and soft tissue in the path of lymphatic drainage from the breast. Such introductions are made through the day a total of 4-7 depending on therapeutic effect. Then, without a break in treatment, patients are 1st rate OUGHT scheme CAMFV with the parallel introduction of rihanana. The patient from the cubital vein taken 200 ml of blood, 100 ml 2 vial geoconservation "gleyzer". In a bottle N1 with Autocraft injected 50 mg rihanana (10 ml 0.5% solution, 5 ml of 1% solution, 2.5 ml of 2% solution). In vial 2 Autocraft injected drugs, PRRI temperature 37.5-38oC for 25-30 min and consistently (bottle N1, N2 bottle) enter through one system/drip 3 times a week. The combination of chemotherapy and rihanana last 2 weeks. The introduction is as follows: vincristine 1 mg, methotrexate 25 mg 1.8 days, 5-fluorouracil 500 mg, cyclophosphamide 200 mg in 1,3,5,8,10,12 days, doxorubicin 30 mg 1, (3,5), 8, (10,12) days (frequency of administration is determined individually depending on the state of the cardiovascular system of the patient), rihanana 50 mg in 1,3,5,8,10,12 days. Subsequent courses IGHT repeat after a two-week break without prior administration of drugs peritumoral and soft tissue in the path of lymphatic drainage from the breast.

After introductions observe the General condition of patients, perform laboratory monitoring: complete blood count 2 times a week, biochemical blood analysis, urinalysis 1 time per week, electrocardiogram, immunological, ultrasound of the breast and lymph nodes before and after treatment.

Clinical and immunologic results of the application of the Method for the treatment of breast cancer".

The proposed treatment Method of breast cancer treatment has undergone 20 primary the patients aged from 34 to 70 years (mean age 53.9 years). In 8 of them the menstrual function was retained, 12 were in menopause. According to the degree of tumor patients were characterized as follows. Locally common process without going beyond breast cancer without distant metastases (signs of locally advanced process and primary inoperable breast cancer have been established with regard to the Colombian clinical classification Haagensen, C. D. , 1978, Donegal W. J. , 1979) was detected in 7 patients (T3-4 N1 MO - two, with T4 N2 MO - five). The generalized form (T4, N1-2 M1) was diagnosed in 13 patients: tumor spread beyond the breast with the transition to the soft tissue of the chest wall - three, defeat supraclavicular lymph nodes on the same side in two, bilateral involvement in the metastatic process of the cervical-supraclavicular and axillary lymph nodes in three cases, and the combination of distant metastases in lymph nodes, skin, soft tissue and visceral organs - five patients (bone - 2, -1 light, bones and lungs - 1, liver - 1). The nodular form met one patient, the other - node with secondary edema or edematous-infiltrative.

To assess the effectiveness of the treatment for breast cancer" the tion, the prevalence of process groups were comparable. Patients of the control group were subjected to IGHT the same drugs in the same doses and regimen, and patients of the main group, but without rihanana.

Compared immediate clinical effect separately after one and two courses of chemotherapy. Carried out laboratory monitoring: complete blood count 2 times a week, biochemical blood analysis, urinalysis 1 time per week, electrocardiogram, immunological before and after treatment. For objectifying change the size of the tumor and lymph nodes in the treatment process was used primarily sonographic method.

After 4-7 introductions drugs peritumoral and soft tissue in the path of lymphatic drainage (before IGHT) we observed a positive trend in condition: improvement of health, the disappearance of pain in the area of the breast, which occurred in 11 women, a significant decrease in edema of the mammary gland in all patients with nodular with secondary edema and edematous-infiltrative forms of the disease, reducing infiltration of the soft tissues of the chest wall outside the gland observed in 6 cases, reducing the height and brightness of Exo who offered gland and IGHT without rihanana presented in table. 2 and 3.

After the first course OUGHT objective response to treatment, valued as regression of a tumor by 50% or more in the group of patients receiving rihlokain, met 2 times more often (65%) than in the control (31.6%). In contrast to the control, there was no case of disease progression.

Two courses IGHT was subjected to 16 patients in both groups. After 2 courses of objective response to treatment in the study group we observed also significantly more often (87.5%) than in the control (65%). Cases of disease progression during treatment in the main group was not, in the control group, 3 patients in new metastases in soft tissue and lymph nodes.

20 initially unresectable patients, in whom was applied the Method for the treatment of breast cancer", 13 patients were successfully operated, the other because of the prevalence of the process surgical treatment was not appropriate.

For comparative evaluation of the toxicity of the two methods were analyzed side effects 38 courses standard IGHT and 40 courses modified IGHT with relocaion (see tab. 4). Assessment of severity of side effects was performed according to who recommendations and meidt significant differences in the incidence of radiation when compared methods of treatment, from table. 4 shows that there is a tendency to preserve the normal number of leukocytes and lesser intensity of radiation in a modified IGHT in contrast to the standard. Reducing the number of leukocytes in the peripheral blood include treatment of rihanana came later, it was shorter and did not require special treatment and statistically significantly less often resulted in interruption of chemotherapy (5% vs. 21%). Most patients initially had moderate anemia (I-II), significant changes in indicators of red blood on the background of treatment were observed. Cases of thrombocytopenia was not.

As for the toxic side effects of chemotherapy side effects: gastro-intestinal tract, while the modified OUGHT stomatitis met significantly less than the standard, were less pronounced, was primarily the deferred nature and did not require special treatment. At the same time, 5 of the 38 courses standard IGHT were interrupted by the development of stomatitis. Diarrhea when AGHT with relocaion rarer. Nausea and vomiting, occurring with equal frequency in both treatments, were transient in nature, quickly stoped untie the EB.

Other side effects of chemotherapy, such as cardiotoxicity, skin reactions, have been infrequent (up to 5%), significant differences between the methods were not found.

The study of the immune status of patients in the dynamics showed that the inclusion of rihanana in the complex therapy of breast cancer leads to improved performance compared to IGHT without rihanana.

After 2 courses modified OUGHT statistically significant increase in the number of T-lymphocytes, normalization of immunoregulatory index(CD4+/CD8+), increase of the functional activity of T - and NK-cells, which is manifested in increased mitogenic response to PHA and con, and to enhance the cytotoxic index of cytotoxic test with target cells To 562 in comparison with IGHT without rihanana (see tab. 5).

Thus, the drug rihlokain has immunomodulatory properties discovered in experiments in vitro and in his inclusion in the comprehensive treatment of patients with breast cancer, what we believe, and determined the best clinical effect compared to standard IGHT. With this, in our opinion, the related lower the frequency and severity of adverse reactions in patients, who aetsa the most important component of the proposed "cure breast cancer".

Examples of specific application "method of breast cancer treatment

Observation 1.

Patient M 50 years (IB N 12074/W), menstrual function is stored. He enrolled in the Department of chemohormonal RNII in January 1999 complained of weakness, pain in the breast, the presence of tumors and ulcers in the breast. About 1 year ago noticed a tumor in the breast in the form of ectopia on the border of the upper quadrants, where 9 months formed the plague.

In the initial examination (see Fig. 1): right breast was pulled upwards, smaller than healthy left, has the shape of a hemisphere with a diameter of 15 cm, very dense, fully occupied by the tumor, relative to the chest wall perfectly still. Infiltration of the soft tissues outside of the gland extends up to the clavicle, lateral to the posterior axillary line. In the upper outer quadrant of the breast with the transition to verhnovodjane on the border of the chest wall - crateriform purulent ulcer size 7.5x5 cm, depth 4 cm, with dense rigid walls and bottom, easily bleeding upon contact, the edges of crimson infiltrative shaft height up to 1 cm In place of the areola - superficial ulcer 5x5 see a shift, determines the positive symptom "lemon peel" and multiple cutaneous metastases up to 0.5 cm in diameter. Skin sensitivity over the gland is absent, needle biopsy is extremely painful. In the axillary region to the right is palpated sedentary single lymph node with a diameter of 1.5 see supraclavicular areas on the right and left, in the axillary region on the left - dense lymph nodes up to 1 cm in diameter.

C/N 12149: "atypical cell carcinoma". From other organs and systems of pathological changes it is not revealed.

Diagnosis: Cancer of the right breast, ulcerative form with the spread on the soft tissue of chest wall metastases in skin cancer (satellites), axillary and supraclavicular lymph nodes with 2 sides, T4N2M1, stage IV.

The treatment begins with an introduction peritumoral (under hardware) and in the soft tissue on the path of lymphatic drainage from the breast of rihanana, methotrexate and diclofenac in accordance with the above method. After 3 injections subjectively the patient's condition has improved, pain in the breast disappeared, infiltration of the soft tissues outside the gland decreased: top - up to the third rib, lateral to the middle axillary line, appeared mobility gland refers courses OUGHT scheme CAMFV with relocaion by the proposed method with a two-week break. Each course was designed for 2 weeks. The total dose for 3 year amounted to: vincristine - 6 mg methotrexate - 190 mg, 5-fluorouracil - 8000 mg of cyclophosphamide - 3600 mg of doxorubicin of 300 mg, rihanana - 750 mg.

After 3 courses IGHT (see Fig. 2) infiltration of the soft tissues outside the cancer completely disappeared, cleared of soft tissue and skin on the periphery of the gland, making it become movable relative to the chest wall. In the Central part of the gland even royalty tumor h see Festering ulcer on the upper quadrants of the fully cleansed, significantly decreased after 3 courses was superficial ulcer 4x2 cm, with soft edges and bottom, pure pink epitelizirutmi surface. Metastases in the skin glands and lymph nodes completely regressed. Remained superficial ulcer on the place of the areola. Recovered skin sensitivity over the surface of the gland.

Of complications, the patient was deferred stomatitis II degree after the 2nd course, leukopenia, grade II (up to 2.8) after 2-year and 1 degree - after the 3rd, nausea, alopecia.

The study of the immune status of the patient in the dynamics showed improvement during treatment (see table. 6) make the>/P>After 3 courses IGHT with relocaion the patient was able to perform simple mastectomy on the right, g and 534464-71: "infiltrating ductal cancer with invasion into the dermis, the stromal sclerosis, healing by primary intention. Subsequently, the patient underwent a remote gemmoterapii on the path of lymphatic drainage and areas of metastasis and mnogochasovoj polychemotherapy.

Observation 2.

Patient D. , 43 years (IB N 23 K), menstrual function is stored. He enrolled in the Department of chemohormonal RNII in February 1999, the Tumor in the right breast noticed 3 years ago, the last 6 months - rapid growth.

During the inspection (see Fig. 3): right breast was swollen, enlarged, much more left, mobility relative to the chest wall is limited. The skin over the gland pale, edematous, in the form of "lemon peel". Areola infiltrated and pale. Nipple retracted, not shown. In the gland palpable 3 tumor site. Most (tumor N1)- h cm (with ultrasound -5.6x4.3 cm, see Fig. 5A), occupies the lower quadrants and the Central part of the gland grows the skin (ectopic bluish-red color 5x5 cm, height up to 1 cm in the Central part of a small ulcer - 2x0.7 cm, covered with a dry crust). The second largest node (on the external quadrants the size of 3x2 cm (with ultrasound - 1.9x1.8 cm, see Fig. 56), captures and draws the skin. In the axillary region is inactive, dense, lumpy conglomerate lymph node size 8x5 cm (with ultrasound lymph node 3.H.5 cm, see Fig. 5B), in the upper part span with the skin. Soft tissue axillary region swollen. Other lymph nodes are not palpable.

C and # 46-49: "carcinoma". From other organs and systems of pathological changes it is not revealed.

Diagnosis: Cancer of the right breast, the nodular form with multicentric growth, invasion and ulceration of the skin, secondary phenomena of swelling, metastases in axillary lymph nodes, TMMO, stage IIIB, grade group II.

The treatment begins with an introduction peritumoral and soft tissue in the path of lymphatic drainage from the breast of rihanana, methotrexate and diclofenac. After 7 injections gland swelling decreased significantly (Breasts about the same size), the symptom of "lemon peel" is less pronounced, the size of the tumor nodules in the breast palpation and ultrasonography decreased: the tumor N1 - 4.5x4 cm (US - 3.5x2.6 cm), ectopic - 4x3 cm, tumor N2 - 3.5x3 cm (US - 2.2x1.6 cm), tumor N3 - 1.5x1.5 cm (US - 1.2x0.7 cm).

Then the patient underwent a 2-m courses OUGHT scheme CAMFV with the dosage of drugs on 2nd year amounted to: vincristine - 4 mg methotrexate - 135 mg, 5-fluorouracil - 4500 mg of cyclophosphamide - 1500 mg of doxorubicin - 130 mg, rihanana - 850 mg.

After 2 courses of treatment (see Fig. 4) swelling of the gland completely disappeared, the symptom of "lemon peel" is not defined, retracted nipple, areola intact, on the border of the lower quadrants of the tumor 4x2.5 cm (US 3.H.0 cm, see Fig. 6), ectopia - "Playground" 3x3 cm, other tumors in the mammary gland is not palpable and not lazerous. In the axillary region chain dense lymph nodes with a diameter of 1 cm to 4 cm, mobile, when ultrasound is not lazerous.

Of the complications noted severe nausea and coming vomiting, kupirovalsa antiemetic drugs, transient leukopenia (up to 3.3) at the end of the 2nd course.

Immunological studies in the dynamics revealed an improvement in the immune status during treatment (see table. 7), consisting in the increase in the absolute number of T-lymphocytes, their functional activity, immunoregulatory and cytotoxic indices.

The patient made a radical mastectomy on Pati right, g and N 534575-82: "infiltrating ductal cancer, focal fibrosis, in ptkr. the tissue - focal fibrosis, subclavian tissue - cancer metastasis".

Nab is jagoroner RNII in October 1999 Complaints about the tumor in the right breast, enlargement of axillary lymph nodes, severe pain in the region of the tumor, weakness, temperature rises in the evening to 37.5oC. the Tumor in the right breast noticed 2 years ago, last 2 months of rapid growth.

During the inspection (see Fig. 7a, b): the patient asthenic physique drastically reduced power. Mammary glands are small, flabby, about the same size. The skin over the gland pale, reduced turgor. In the lower quadrants - swelling of the skin-type "lemon peel". Areola infiltrated. Nipple retiremen and tuck up. High on the upper quadrants and the chest wall fixed, dense, very painful to palpation of the tumor 5.HH cm (US 5.1x3.4 cm, see Fig. 9) with a bright red brilliant ectopia 4x3.5 cm with ulceration in the center. Due to the small intensity of subcutaneous fat in the localization of the tumor, the latter actually "lies" on the chest wall. In the axillary region is inactive, dense, rough conglomeration of lymph nodes the size of 4x3 cm (with ultrasound lymph nodes 3.5 and 1.1 cm in diameter). Other lymph nodes are not palpable.

C and N18967-68: moderately differentiated carcinoma". From other agencies and sisomicin growth, ulceration of the skin, secondary phenomena of swelling, metastases in axillary lymph nodes, T4N2MO, stage IIIB, grade group II.

The treatment begins with an introduction peritumoral of rihanana, methotrexate and diclofenac. After 5 injections, the patient's General condition improved, the temperature returned to normal, the pain disappeared. Locally there was some mobility of the tumor relative to the chest wall, decreased height of the tumor to 3.5 cm, ectopic pale, axillary lymph node became more mobile.

Then the patient underwent a 2-m courses OUGHT scheme CAMFV with relocaion by the proposed method with a two-week break. Each course was designed for 2 weeks. The total dose for 2 year amounted to: vincristine - 4 mg methotrexate - 125 mg, 5-fluorouracil - 2000 mg of cyclophosphamide - 2400 mg of doxorubicin of 300 mg, rihanana - 650 mg.

After 2 courses of treatment (see Fig. 8A, b) swelling of the gland completely disappeared, the symptom of "lemon peel" is not defined, areola intact tumor 3.5x2.5 cm (US 3.2x2.0 cm, see Fig. 10), movable relative to the chest wall. In the axillary region of the lymph node with a diameter of 1 cm, when ultrasound is not lazerette. From complications of the disease 1 degree at the end of the 2nd course.

The study of the immune is icenii the absolute number of T-lymphocytes, their functional activity, immuno-regulatory index.

The patient made a radical mastectomy on Pati right, g/and N 572134-38: "infiltrating ductal cancer, fibrosis and hyalinosis stroma, healing by primary intention. Subject postoperative remote gemmoterapii.

Technical and economic efficiency "method of treatment of breast cancer" is that consistent local and systemic non-traditional drug use of rihanana in combination with exposure to antineoplastic drugs in the standard course doses, administered at the autologous blood, increases the effectiveness of breast cancer treatment, increases the interoperability of patients, has immunomodulatory effect, improves the tolerability of chemotherapy by reducing toxic reactions of the organism, improves the quality of life of patients in inoperable cases.

A method of treating breast cancer, including autohemotherapy with intravenous drip of anticancer chemotherapy, characterized in that the first stage of treatment produce 4-7 introductions peritumoral and soft tissue in the path of lymphatic drainage from the breast cancer drugs: 10 ml of 0.5% RA is without interruption of treatment carry out the introduction of anticancer drugs in the standard course doses autologous blood in combination with 50 mg of rihanana on autologous blood 3 times a week separately, consistently for two weeks, then courses autohemotherapy in combination with the introduction of rihanana repeat after a two-week break without prior administration of drugs peritumoral and soft tissue in the path of lymphatic drainage from the breast.

 

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