RU2393879C1 - Method of treating advanced and recurrent skin cancer - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely to oncology, and can be used in treating the patients with advanced and recurrent skin cancer. Substance of the method consists that the patient is exposed to the discrete gravity plasmapheresis; blood 400 ml is drawn once; prepared autoplasma is divided on two portions, each 150 ml whereto 30 ml of erythromass and 10 portions, each 10 ml. All the portions are collected in sterile containers and frozen at t =-24°C. Then wide excision of a tumour nidus follows. Next day, erythrocyte-enriched autoplasma is incubated with cisplatin - 100 mg, methotrexate - 50 mg, bleomycine - 15 mg in a thermostat for 30 min at t=37°C and introduced drop-by-drop intravenously. It is combined with intradermal paratumour immunotherapy with Lifeferon pre-incubated from one of the portions of the defrosted plasma 10 ml within 10 days.

EFFECT: use of the invention allows reducing risk of recurrent tumour following surgical excision of a primary tumour due to enabled direct immunomodulator delivery to the tumour nidus and its prolonged local action.

1 ex

Description

The invention relates to medicine, namely to oncology, and can be used to treat patients with advanced skin cancer, whose surgical treatment is limited.

Despite the external localization of skin cancer and the availability of the tumor for research, to date, there are often common, advanced forms of the disease, the treatment of which is complex and does not always lead to satisfactory results due to the recurrence of the process. Despite the successes achieved in the treatment of cancer patients, locally advanced and recurrent skin cancer is still considered an almost incurable disease.

Radiation treatment remains the most commonly used type of therapy for common forms of skin cancer (I.N. Pustynsky, V.V.Shental, A.I. Paches, V.D. Ermilova, T.T. Kondratyeva, Tabolinovskaya T.D. Kliniko morphological features of common forms of skin cancer // In the book: Materials of the VI Russian Oncological Conference November 26 - 28, 2002, Moscow). 37 patients received repeated courses of radiation treatment for the primary spread tumor and its relapses, moreover, 17 patients received two courses of radiation, 3 patients received 12 courses, 4 patients received 5 courses and 5 patients received 5 courses.

However, out of 37 patients in this group, 20 had a primary and repeated recurrence of the disease. Moreover, in all cases, the tumor acquired infiltrative growth with fuzzy borders. Subsequently, despite the subsequent treatment, which included extensive excision of the tumor, 12 of 29 patients who received 2 and 3 courses of radiation, and all 8 patients who underwent 4 and 5 courses of radiation therapy, died of disease progression. The authors concluded that irradiating the tumor without taking into account its properties and individual characteristics of the patient does not contribute to optimal results. Radiation treatment is not justified in cases of a recurrent tumor, and the authors do not recommend repeated courses of radiation therapy in this case.

It is known that for the treatment of all forms of common skin cancer, platinum-containing chemotherapy regimens are used ("Antitumor chemotherapy" edited by N. N. Perevodchikova, M., "Medicine", 1993, p. 174). However, the effectiveness of using this drug in this disease does not exceed 70%, and, as a rule, it is generally not possible to achieve complete regression. Remission at the same time lasts an average of 4-6 months.

The aim of the present invention is to improve the results of conservative treatment of patients with common and recurrent forms of skin cancer.

This goal was achieved by the fact that on an empty stomach in the morning they performed the procedure of discrete gravitational plasmapheresis with the MCS + Hemonetics device using the LPC protocol (obtaining plasma depleted in leukocytes) with a blood separation rate of 4600 rpm. Once taken 400 ml of blood, the resulting autoplasma was divided into two 150 ml portions, to which 30 ml of erythromass and 10 portions of 10 ml were added. All portions were collected in sterile containers and subjected to freezing at t = -24 ° C. The first stage of treatment was a wide excision of the tumor focus. Then, the next day, autoplasma enriched with red blood cells was incubated with cisplatin 100 mg, methotrexate 50 mg, bleomycin 15 mg in an incubator for 30 min at t = 37 ° C and was administered intravenously to the patient. In parallel, for 10 days the patient was given intracutaneous paratumoral immunotherapy with lyferon preincubated from one of the portions (10 ml) of thawed plasma; the total dose of the immunomodulator was 30 million ME.

The invention is new, as it is unknown from the level of medicine in the field of oncology in the treatment of common and recurrent forms of skin cancer with chemotherapeutic agents in combination with local immunotherapy. The novelty of the invention lies in the fact that in the treatment of common and recurrent forms of skin cancer, chemotherapeutic agents and immunomodulators are administered on the formed elements of the patient's blood and plasma enriched in lymphocytes, respectively. The invention has an inventive step, since it is unknown to an oncologist in this field and does not explicitly follow from the level of clinical oncology.

In accessible sources of information from Russia, the CIS countries and abroad, no indications of a similar method for improving the treatment results of common and recurrent forms of skin cancer were found.

The invention is industrially applicable, as it can be repeatedly reproduced and applied in healthcare, in medical institutions of a specialized profile. The method is as follows. On an empty stomach in the morning, a discrete gravitational plasmapheresis procedure is performed using the MCS + Hemonetics device using the LPC protocol (obtaining plasma depleted in leukocytes) with a blood separation rate of 4600 rpm. Once 400 ml of blood is taken, the resulting autoplasma is divided into two 150 ml portions, to which 30 ml of erythromass and 10 portions of 10 ml are added. All portions are collected in sterile containers and subjected to freezing at t = -24 ° C. The first stage of treatment is a wide excision of the tumor focus. Then, the next day, an autoplasma enriched with red blood cells is incubated with cisplatin 100 mg, methotrexate 50 mg, bleomycin 15 mg in an incubator for 30 min at t = 37 ° C and is administered to the patient intravenously. In parallel, for 10 days, the patient is given intracutaneous paratumoral immunotherapy with lyferon preincubated from one of the portions (10 ml) of thawed plasma.

An example of the clinical application of the method.

Patient O., born in 1958, medical history No. s-12091 / h, was admitted to the department. Reconstructive plastic surgery RNII on 08.19.2006 with complaints of the presence of skin formation of the left calcaneal region. 6 months ago, surgical treatment at the place of residence for cancer. St.localis: on the skin of the left calcaneal region, the formation of pink color, the size of 4.5 cm in diameter, multicyclic form, smooth, in the center with ulceration is determined.

Comprehensive treatment was as follows: 08/20/2006 in Dep. reconstructive plastic surgery, an operation was performed - a wide excision of a skin tumor of the left calcaneal region with plastic surgery with a free skin flap. The postoperative period was uneventful, without features. Seams and a pressure gauze roller were removed on the 10th day. Histological analysis of 5.09.2006, No. 54979-80 - relapse of squamous cell carcinoma with keratinization, with underlying tissue.

On August 20, 06, a patient in the morning on an empty stomach underwent a procedure of discrete gravitational plasmapheresis with the MCS + Hemonetics device using the LPC protocol (obtaining plasma depleted in leukocytes) with a blood separation rate of 4600 rpm. Once they took 400 ml of blood, the resulting autoplasma was divided into two 150 ml portions, to which 30 ml of erythromass and 10 portions of 10 ml were added. All portions were collected in sterile containers and subjected to freezing at t = -24 ° C. On 21.08.06, an autoplasm enriched with red blood cells was incubated with cisplatin 100 mg, methotrexate 50 mg, bleomycin 15 mg in an incubator for 30 min at t = 37 ° C and was administered to the patient intravenously. In parallel, for 10 days, the patient was given intradermal paratumoral immunotherapy with lyferon preincubated from one of the portions (10 ml) of thawed plasma; the total dose of the immunomodulator was 30 million ME.

The patient is under observation for two years with no signs of relapse.

In this way, 12 patients with advanced and recurrent skin cancer were treated. There were no signs of relapse of the disease in any case.

The technical and economic effect of using the method of treating advanced and recurrent skin cancer is the ability to improve the results and quality of life of patients; reducing the risk of recurrence of the disease after surgical excision of the primary tumor; the possibility of direct supply of immunomodulators to the tumor site, the creation of conditions for their continued local exposure, and the reduction of pathological side effects of antitumor therapy.

Claims (1)

A method for the treatment of advanced and recurrent skin cancer, including surgery, the introduction of chemotherapeutic agents incubated with autologous blood cells and immunomodulators incubated with autoplasma, characterized in that patients undergo discrete gravitational plasmapheresis, 400 ml of blood are taken once, and the autoplasma obtained is divided into two portions 150 ml, to which 30 ml of erythromass and 10 servings of 10 ml are added, all servings are collected in sterile containers and frozen at t = -24 ° C, then a wide excision of the tumor site, the next day the autoplasma enriched with red blood cells is incubated with cisplatin 100 mg, methotrexate 50 mg, bleomycin 15 mg in an thermostat for 30 min at t = 37 ° C and is administered to the patient intravenously, in parallel with 10 days intracutaneous paratumoral immunotherapy with lyferon preincubated with one of the servings of 10 ml of thawed plasma.