Method of treating patients with operable mammary gland cancer

FIELD: oncology.

SUBSTANCE: treatment consists in performing 2-4 courses of preoperative chemotherapy with 2-weak intervals between courses, each course comprising intravenous administration of methotrexate in dose 40 mg/m2 on first or eighth day and intramuscular cyclophosphanin dose 100 mg/m2 during 14 days, while introducing additionally oral Xeloda in dose 1000 mg/m2 twice a day on the first to fourteenth days.

EFFECT: achieved complete regression of tumor focus owing to high selectivity of Xeloda preparation diminishing toxic effect of chemotherapy.

3 ex

 

The invention relates to medicine, specifically to Oncology, and relates to methods of treatment of resectable breast cancer.

There is a method of treating breast cancer by assigning chemotherapy in the preoperative period: methotrexate at a dose of 40 mg/m at 1 and 8 days, 5-florouracil 1 to 5 days in the form of a continuous 120-hour infusion at a daily dose of 1000 mg/m and cyclophosphamide intravenous, bolus, 1 and 8 days of chemotherapy in a daily dose of 600 mg/m - similar (1).

However, despite a fairly high efficiency, this method has several disadvantages.

Continuous infusion of 5-fluorouracil established by the Central venous catheter, which limits the movement of the patient within the chamber and makes it mandatory hospital stay. In addition, you need special equipment for protection of 5-fluorouracil from exposure to sunlight. Administration of high doses of 5-ftorurazila, the total dose exceeds 4-5 times the standard dose, causes pronounced toxic reactions, because the drug has only a relative selectivity. This was manifested: 3-4 leukopenia degree in 20.9% of cases, without reactions registered in 94.2% of observations. Some patients reported clinical phenomenon of drug cystitis. Also during the por is maintenance infusion of 5-fluorouracil, in 37.2% of cases were noted hyperthermic reactions. Several patients registered complications associated with catheterization of the subclavian vein (acute phlebitis, suppuration designated standing catheter) (2).

Closest to the developed scheme of chemotherapy on the essential characteristics is a method of treatment of resectable breast cancer by assigning chemotherapy according to the classical scheme CMF, which is to assign drugs: methotrexate 40 mg/m21 and 8 days intravenous; 5-fluorouracil 600 mg/m21 and 8 days intravenous; cyclophosphamide 100 mg/m2intramuscularly daily from 1 to 14 day interval between courses 14 days - the prototype.

However, at a moderate toxicity schemes CMF its effectiveness remains unsatisfactory because of low total course dose of drugs, in particular 5-fluorouracil. This place intravenous 5-fluorouracil, which, in turn, increases the invasiveness of the technique.

The task of the invention is to increase efficiency, reduce toxicity, improve the portability and convenience of chemotherapy.

The problem is solved by a method for the treatment of resectable breast cancer by appointment in the preoperative period of 2-4 cycles of chemotherapy according to the following scheme:

xeloda 1000 mg/m2 2 times a day per os 1 to 14 days;

methotrexate 40 mg/m2intravenously at 1 and 8 days;

cyclophosphamide 100 mg/m2intramuscularly daily from 1 to 14 days.

The duration of each course is 14 days, with breaks between courses of two weeks.

What's new is that prescribed the drug xeloda, which is derived ftorpirimidinu carbamate, turning it into an active form, 5-fluorouracil, directly into the tumor tissue.

In the analyzed literature not found in a given set of distinctive features that lead to the achievement of new technical challenges. They explicitly do not follow from the prior art for a specialist. This solution has passed clinical trials in Oncology research Institute in Tomsk. Thus, this solution meets the criteria of the invention of "novelty", "inventive step", "industrially applicable".

The method is as follows:

The patient in the preoperative period prescribed 2-4 chemotherapy according to the following scheme: xeloda 1000 mg/m22 times a day per os 1 to 14 days; methotrexate 40 mg/m2intravenously at 1 and 8 days; cyclophosphamide 200 mg/m2intramuscularly daily from 1 to 14 days. The duration of each treatment was 14 days, with breaks between courses of two weeks. The calculation of the individual is the dosage of chemotherapeutic agents spend relatively square body surface area (Dubois formula). The daily dose of xeloda is divided into two sessions - morning and evening. The drug is taken after a meal with 1/2 Cup water. During the entire course of chemotherapy conduct monitoring of peripheral blood, for the correction of side effects of drugs prescribed standard drugs taken in General Oncology practice (antiemetics, stimulants leucopoiesis). The immediate effectiveness of the treatment is evaluated according to who criteria after conducting 2 courses of chemotherapy. When reaching the partial regression - reduced tumor volume by more than 50% spend another 1-2 cycles of chemotherapy under the above scheme with an interval of 2 weeks. In other cases, when the stabilization process or achieving full clinical effect of the treatment, the patient performed a radical mastectomy. At the end of each course to evaluate the immediate effectiveness, toxicity and tolerability conducted drug treatment. Specific examples of the complete method:

1. Patient M., aged 65, IB No. 128313.

Diagnosis: breast cancer T2N2M0.

Menstrual function: menopause 5 years.

Cytologic conclusion No. 9466 from 14.10.03 moderately-differentiated carcinoma.

Initial inspection: in the upper inner quadrant of the left breast the drive has detected a tumor with a diameter up to 35 mm, limited mobile symptom "site" is positive. In the axillary area is palpated conglomeration of lymph nodes up to 30 mm in diameter.

During ultrasonographic examination of the size of the primary lesion was 33x29x26 mm, axillary lymph nodes - 23 mm

The treatment begins with preoperative chemotherapy according to the developed method.

Calculation of drug doses were held, respectively, anthropometric data of the patient and amounted to:

xeloda - 1500 mg 2 times a day per os 1 to 14 days;

methotrexate 60 mg intravenously at 1 and 8 days;

cyclophosphamide 150 mg intramuscularly daily, from 1 to 14 days;

Received 2 courses of chemotherapy duration of 14 days each, with intervals between courses of two weeks.

During treatment was observed following complications: nausea 3 degrees, vomiting 2 degrees, which were controlled prescription of symptomatic drugs. After two courses of chemotherapy during the clinical examination the tumor in the breast palpation was not determined. According to the ultrasound in the tissue of the gland was determined by the area of fibrosis to 0.6 mm in diameter. Axillary lymph nodes up to 0.8 mm, the Effectiveness of preoperative chemotherapy was 100% reduction in tumor volume and valued as full regression. Taking into account the effectiveness l the treatment of the patient, the next step has been performed a radical mastectomy.

2. Patient O., 56, IB No. 128847.

Diagnosis: cancer of the right breast T2N1M0.

Menstrual function, menopause 3 years.

Cytologic conclusion No. 1492 from 9.02.04 moderately-differentiated carcinoma.

Initial inspection: in the lower-inner quadrant of the right breast is determined by the tumor up to 40 mm in diameter, partially mobile, a symptom of "platform" is positive. In the axillary region even royalty enlarged lymph node up to 30 mm in diameter, partially mobile, painless.

During ultrasonographic examination of the size of the primary lesion was 21x20x20 mm, axillary lymph node 22 mm

The patient had received a total of 3 courses of chemotherapy according to the developed program with intervals between courses 2 weeks.

Calculation of drug doses were held, respectively, anthropometric data of the patient and amounted to:

xeloda 1700 mg 2 times a day per os 1 to 14 days;

methotrexate 70 mg intravenously at 1 and 8 days;

cyclophosphamide 200 mg intramuscularly, daily from 1 to 14 days.

After conducting 2 courses of chemotherapy immediate effectiveness assessed as partial regression - 70% reduction in tumor volume, and therefore was assigned to another course in the programme. During the treatment AutoClickExtreme toxic effects: leukopenia 1-2 degrees nausea 2 degrees. After 3 courses of chemotherapy, the tumor in the breast was not determined neither clinically nor according to ultrasonographic study. The effectiveness of therapy was 100%, which is regarded as complete regression of the primary lesion. The next stage of complex treatment of the patient was performed a radical mastectomy.

3. Patient T., 48 years old, IB No. 128105

Diagnosis: breast cancer T2N0M0.

Menstrual function, menopause 6 years.

Cytologic conclusion No. 8313 from 5.09.03 data for cancer.

Initial inspection: on the border of the upper quadrants of the left breast was determined by the tumor to 35 mm in diameter, partially mobile, a symptom of "platform" is positive. In the axillary region even royalty enlarged lymph node up to 15 mm in diameter, partially mobile, painless.

During ultrasonographic examination of the size of the primary lesion was 31x24 mm, axillary lymph node 26x9 mm

The patient had received a total of 4 cycles of chemotherapy under the programme, with an interval between courses of two weeks of days.

Calculation of drug doses were held, respectively, anthropometric data of the patient and amounted to:

xeloda - 1800 mg 2 times a day per os 1 to 14 days;

methotrexate 70 mg intravenously at 1 and 8 days;

cyclophosphamide 200 mg intramuscularly, daily from 1 to 14 days.

After conducting 2 courses of chemotherapy immediate effectiveness assessed as partial regression - 60% reduction in tumor volume, and therefore was assigned to conduct another 2 courses of treatment according to the developed method. During chemotherapy was observed following toxic reactions: nausea 1 degree, toxic hepatitis 1 degree, which were controlled prescription of symptomatic drugs. According to clinical examination, ultrasonography and mammography after 4 courses of chemotherapy, the tumor site was not determined. The effectiveness of therapy was 100%, which is regarded as complete regression of the primary lesion. This was confirmed by the results of morphological studies after performing radical mastectomy patient.

A positive effect was achieved thanks to the new distinctive characteristics that led to achieve a new result, namely:

1. Increase the effectiveness of the treatment, which was achieved through the use of the drug xeloda, which ensured a high concentration of 5-fluorouracil in the tumor.

2. Reducing the toxicity of chemotherapy due to reduce the toxic effects of cytostatic agents on the surrounding healthy tissue in SV is due to the high selectivity of the drug xeloda.

3. Improved tolerance of chemotherapy as a result of reducing the toxic effects of the drug.

4. Ease of chemotherapy, which is associated with the dosage form of the drug xeloda (tablets).

Thus, the proposed method has several advantages: first, the use of the drug xeloda allows you to increase the concentration of 5-fluorouracil in the tumor, which increases the effectiveness of treatment, and secondly, because the drug has a selective action and is activated directly in the tumor tissue, its use can reduce the toxic effects of cytostatic agents on the surrounding tissue and improve subjective tolerability of chemotherapy patients, and third, its dosage form - pill - reduces the invasiveness of the technique. All these advantages make the proposed method is more preferable in comparison with the use of preoperative chemotherapy regimen according to the scheme CMF both standard and high doses.

Literature:

1. P. No. 2134111 from 10.08.99 "Method of treatment of patients with nodular forms of breast cancer" authors: Slonimsky E.M., Karasev V.V., Kolesnikov S.V.

2. Abstract of Diss. on competition of a scientific degree of candidate of medical Sciences "High-dose 5-fluorouracil in the treatment of patients with breast cancer" Kolesnikov S.V., the Omsk. 1998

A method for the treatment of resectable breast cancer, which consists in conducting 2-4 courses of preoperative chemotherapy with breaks between courses of two weeks, methotrexate intravenously at a dose of 40 mg/m2in the 1st and 8th day and cyclophosphamide intramuscularly in a dose of 100 mg/m2within 14 days, characterized in that it further introduce xeloda oral dose of 1000 mg/m22 times a day from the 1st to the 14th day.



 

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5 cl, 1 dwg

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