Method of treating locally advanced vaginal cancer

IPC classes for russian patent Method of treating locally advanced vaginal cancer (RU 2493846):

A61N5/00 - Radiation therapy (devices or apparatus applicable to both therapy and diagnosis A61B0006000000; applying radioactive material to the body A61M0036000000)

A61K31/704 -

A61K31/282 -

A61H7/00 - Devices for suction-kneading massage; Devices for massaging the skin by rubbing or brushing not otherwise provided for (electro-medical massage devices applying electric current by contact A61N0001180000)

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FIELD: medicine.

SUBSTANCE: invention refers to medicine, namely oncology and concerns treating locally advanced vaginal cancer. For this purpose, the therapy is staged. The first stage involves the chemotherapeutic course that provides administering cisplatin 100 mg/m and doxorubicine 30 mg/m² intravenously drop-by-drop; the gamma-ray teletherapy covering a primary centre in a dose of 20 Gy is followed by two fractions 2.5 Gy of the intracavitary Co⁶⁰ therapy every 5 hours twice a week; in the middle of the 5-hour period, platidiam 5 mg dissolved in saline solution 1.0 ml is introduced into surface layers of the tumour which is exposed to ultrasound of frequency 880 kHz and intensity 0.4 Wt/cm² through the licensed dimexide gel tissue for 5 minutes; the therapy requires the gamma-ray teletherapy covering the lymphatic nodes alternated with 10-11 sessions of the intracavitary Co⁶⁰ therapy in total to reach a total dose of the primary centre exposure of 70-75 Gy, of the lymphatic nodes exposure of 40 Gy.

EFFECT: specified integrated therapy provides the effective treatment and prevention of the recurrences also ensured by using the chemotherapy combined with the ultrasonic exposure that promotes the deeper chemopreparation penetration into tumour tissues.

1 ex

The invention relates to medicine, namely to Oncology, and can be used for treating patients with locally advanced cancer of the vagina.

There is a method of treatment of patients with common forms of cancer of the vagina (A.M. Granov, Volvieron "Radiation therapy in gynecology and oncourology", S.-Petersburg, 2002. - S-169), based on the use of combined intracavitary and remote exposure and chosen as a prototype. In stage III of the process total intracavitary irradiation of all the vaginal walls is to doses of the order of 55-56 G, the optimal mode of fractionation is the exposure twice a week for 5-6 Gr on the mucous membrane. In the presence of residual tumor by the end of the irradiation effect continues localized to a total dose of 70 to 80 Gy. If the tumor is located in the upper parts of the body remote external irradiation are groups of the pelvic lymph nodes. Single doses are usually about 2 Gy total - 40-50 Gy. When the tumors located in the lower third of the vagina, remote radiation exposed group inguinal-femoral lymph nodes. Normalization dose when this is carried out to a depth of 4-5 see Remote irradiation is carried out two front fields, a single dose of 2-3 Grams total - 40-45 Gr. When solicitorgeneral lymph nodes total dose can be increased to 55-60 Gr. At stage IV cancer of the vagina, the authors propose to conduct palliative radiation therapy, consisting of a uniform irradiation of the pelvis with opposite open fields to a total dose of 45-50 Gy, and intracavitary irradiation to implement on an individual plan.

However, five-year survival after radiotherapy in stage III cancer of the vagina is 25-37%, while stage IV is 0-3%.

There is a method of suppressing tumor growth (RF patent 2188054, A61N 7/00, A61K 31/40, 1999), we selected as a prototype. This method includes the introduction in the tumor taratala (octacarbonyldicobalt cobalt and ascorbic acid and additional impact on tumor tissue by ultrasonic irradiation with a frequency of 0.5-3 MHz and an intensity of 0.5-5 W/cm². The ratio of the concentration of the complex reducing agent is from 1:5 to 1:50, and a single dose of taratala 30-40 mg/kg optimal use of the way the indicator of antitumor activity - inhibition of tumor growth is 65-68%.

However, the antitumor activity of the drugs used remains unsatisfactory and cannot be increased due to the toxicity of the way when higher doses of the drugs used. Unknown time before progression of the tumor. And this method was not applied in the treatment of cancer patients is legalese.

The aim of the present invention is to improve results of treatment of patients with locally advanced cancer of the vagina. This goal was achieved by the fact that patients with cancer of the vagina treatment begins with an introduction to day 1 cisplatin 100 mg/m²and doxorubicin 30 mg/m²intravenous drip. 7-10 days begin remote gamma-therapy is recommended opposite open fields in a single focal dose of 2 Gy up to a total focal dose of 20 Gy. Then connect intracavitary radiation therapy 2 times a week depending on the localization process calpastatin source along the axis of the vagina. Intracavitary Co⁶⁰therapy is carried out on the AGAT-B3 using fractionation ROD 5 Gr. However, the planned dose down for 2 fractions of 2.5 Gy with an interval of 5 hours. In the middle of the 5-hour interval in the surface layers of the tumor injected with 5 mg platydema dissolved in 1.0 ml of saline and immediately affect the tumor by ultrasound with a frequency of 880 kHz and an intensity of 0.4 W/cm²through a licensed napkin Dimexidum-gel for 5 min (total 10-11 sessions).

Topometric training includes the determination of the geometry of the sources (imitators entered in endostatin) using elektrorentgenograficheskogo consoles ERG-MP.

Sessions intracavitary radiation therapy is the rhythm of the exposure 2 times a week alternating with remote gamma-therapy, which is carried out with 2 other fields with the Central screening unit. Total primary focus down 70-75 Gy, lymph nodes - 40 Gr.

The invention is new, because it is unknown the level of medicine in the field of Oncology in the treatment of locally advanced cancer of the vagina by the combination of gamma-therapy, supplemented by local application of radiomodifying as chemotherapeutic agents and ultrasound.

The novelty of the invention lies in the fact that when treating patients with locally advanced cancer of the vagina between sessions intracavitary irradiation chemotherapy injected into the superficial layers of the tumor and act on it by ultrasound through tissue dimexide-gel.

The invention involves an inventive step, since it is unknown for a specialist oncologist in this area and is not obvious from the level of clinical Oncology.

The use of ultrasound and chemotherapy, which radiomodifying, causes, first, the combination of their specific antitumor action, and secondly, enhances this action, because the chemo makes consensualization, and ultrasound, in turn, promotes deeper penetration of the chemical into the thickness of the tumor, which generally increases the efficiency of the beam t is rapie common cancer of the vagina.

In the available sources of information Russia, CIS and abroad indications in such a way to improve the results of treatment of patients with advanced cancer of the vagina is not found.

The invention is industrially applicable, as may be repeatedly reproduced and used in health care, in hospitals specialized profile.

The method is as follows: 1 day intravenous drip of cisplatin 100 mg/m²(mode overhydration and forced diuresis) and doxorubicin 30 mg/m²

After 10 days held remote irradiation of the pelvic organs with 2 opposite diamond fields 15-16×15-16 cm (lower limit-level field borders the entrance to the vagina), RICK 75 see GENUS 2 Gy daily, 5 fractions per week to 20 Gy (WDF 33 ed).

Then there was intracavitary Co⁶⁰therapy AGATE-B3 using colostate. Uses the traditional mode of fractionation ROD 5 Gy, which, in our proposed method, is fed by two separate fractions of 2.5 Gy with an interval of 5 hours.

In the middle of the 5-hour interval in the surface layers of the tumor was injected 5 mg platydema dissolved in 1.0 ml of physiological solution, on the surface of the tumor caused a napkin dimexide-gel (registration certificate SDF 200/05407 THE 9393-009-58223785-2005) and using external planar localizer attached to the apparatus, such as-3. (Unit UST-E, certificate of compliance No. of ROOMS RU.MM 18.B01660, passport TAS PS), was carried out for 5 minutes session ultrasonic impact frequency of 880 kHz and an intensity of 0.4 W/cm²

Just held 11 sessions intracavitary Co⁶⁰therapy with rhythm 2 times a week to SOD 55 sogr (WDF 93 ed). In the days free from intracavitary Co⁶⁰therapy continues remote gamma-therapy is recommended with 2 standard diluted (6 cm at the level of point a) of sloping fields on regional lymph collectors pelvis.

Thus, on average, the total dose to the primary tumor site is 75 Grams, lymphatic and 44±2 Gr. The total dose of cytostatics, on average, 150 mg of cisplatin and doxorubicin 50 mg, administered intravenously and 55 mg of platydema connected locally, using ultrasonic treatment.

In the future, shall be held not less than 3 courses of chemotherapy with platinum source derived drugs.

For proof, here is the excerpt from the history of the disease, confirming the clinical effect of the treatment approach.

Patient P. 1964 born in (East. bol. No. 2561/h), is under the supervision of RNII with 14.01.09 diagnosed with cancer of the vagina T₃NxM₀. Cllr. 2.

Complaints at admission for bleeding the smell of vaginal discharge, mild pain when urinating. Considers herself a patient in the course of 6-7 months.

14.01.09. Local status with the finger study: the lumen of the vagina is narrowed, the study of disease. On the left side panel with the transition to the rear and the front wall of the vagina on the border of the middle and lower thirds of its extent is determined by the dense hilly education. Dimensions 4×6×3 see edematous Mucosa, dense, not shifting. Infiltration of tissues distributed to the entrance of the vagina on the lower third of the vagina. Blood on the examined finger. The mucosa of the rectum smoothed. Infiltration of the parametrium, almost reaching the pelvic wall to the right.

GAA No. 75290 from 14.01.09 - moderately differentiated squamous cell carcinoma.

14.01.09. Ultrasound hyperplasia iliac lymph nodes on the left. Moderate hepatosplenomegaly. Diffuse changes of a liver. Chronic cholecysto-pancreatitis.

15.01.09. FLO EXHAUST gas TO # 46 - heart and Lungs - age-related changes.

The Council of RNII process recognized irresectable, the patient enrolled in the radiology Department for a course chemoradiation treatment.

Blood from 16.01. 09. HB - 104 g/l, er. and 3.4×10¹²/l, ESR - 35 mm/hour; L - 13,2×10⁹/l, PAL. - 25%, segm. - 62%, EOS. - 1%, mon. - 2%, lim. - 10%.

Biochemical parameters of blood from 16.01.09, Urea - 6.3 mmol/l; creatinine - 112,3 µmol.

19.01.09 held polychemotherapy, in trevenna introduced 150 mg of cisplatin and 45 mg of doxorubicin. Standard mode gipergidrataciei, antiemetics and forced diuresis.

Blood from 23.01. 09. HB - 104 g/L. er. and 3.4×10¹²/l, ESR - 24 mm/hour; L - 8,,2×10⁹/l, PAL. - 17%, segm. - 52%, EOS. - 1%, mon. - 2%, lim. - 28%.

With 26.01.09 on 06.02.09. was in the area of primary tumor and lymph held DHT on the device "AGATE", with 2 opposite diamond open fields 16×16 cm, RICK - 75 cm, GENUS 2 Gr. 20 Gy (WDF 33 ed).

After topometric training with the determination of the geometry of the sources in colostate 09.02.09 started With intracavitary⁶⁰therapy AGATE-B3. Announced first fraction focal dose of 2.5 Gy.

2.5 hours (in the mirror) under the superficial layers of the tumor, type 5 mg platydema dissolved in 1.0 ml of saline. On the surface of the tumor caused napkin Dimexidum-gel, has a planar remote ultrasonic detector and held for 5 minutes a session, such as with a frequency of 880 kHz and an intensity of 0.4 W/cm².

After 2.5 hours, summed up the second part of the focal intracavitary dose With⁶⁰therapy 2,5 Gr.

Sessions intracavitary Co⁶⁰therapy conducted 09.02.09, 12.02.09, 16.02.09, 19.02.09, 24.02.09, 27.02.09, 03.03.09, 06.03.09, 10.03.09, 13.03.09.

Blood from 06.02.09. HB - 114 g/L. er. is 3.3×10¹²/l, ESR 25 mm/hour; L to 6.8×10⁹/l, PAL. - 15%, segm. - 55%, EOS. - 3%, mon. - 5%, lim. - 22%.

Blood from 03.03.09. HB - 109 g/l, er. - 3.3×10 12/l, ESR - 15 mm/hour; L - 5,6×10⁹/l, PAL. - 7%, segm. - 52%, EOS. - 0%, mon. - 6%, lim. - 35%.

With 10.02.09 on 04.03.09 continue alternating sessions intracavitary Co⁶⁰treatment with DHT in static mode on the path of lymphatic drainage, 4 (2 iliac and 2 sacral) diluted sloping field size of 6×18 cm, RICK - 75 cm, GENUS 2 Gr. to SOD 40 Gr. The total dose to the primary tumor site was 76 Gy.

Blood from 13.03.09. HB - 114 g/l, er. of 3.1×10¹²/l, ESR - 5 mm/hour; L - 4,2×10⁹/l, PAL. - 7%, segm. - 64%, EOS. - 3%, mon. - 8%, lim. - 18%.

16.03.09, Local status: the lumen of the vagina is free. The study painless. On the left side there is an area damaged velvety appearance of the mucosa with eroded surface to 0.5, see parametric freely.

Cytological study No. 55472 from 16.03.09, the blood cells of chronic inflammation.

16.03.09, ultrasound pelvic lymph nodes are not enlarged. Moderate hepatosplenomegaly. Diffuse changes of a liver. Chronic cholecysto-pancreatitis.

At discharge clinical diagnosis of cancer of the vagina T₃NxM₀. CL gr. 3 Condition after chemoradiation treatment.

With a turnout of 15.06.09 (3 months) no complaints.

At the place of residence with an interval of 3-4 weeks spent 3 courses of chemotherapy cisplatin 150 mg, doxorubicin 40 mg and 600 mg of cyclophosphamide.

22.11.11. Local status: the lumen of the sheath is free. Fabric soft, clean. Vaginal mucosa is easily taken into the folds. On the left lateral wall of the vagina is part of the whitish atrophic tissue. Scar tictacti parametrium, more to the left.

22.11.11. Ultrasound - moderate hepatosplenomegaly. Diffuse changes of a liver. Chronic cholecysto-pancreatitis.

With clinical diagnosis of cancer of the vagina T₃N_xM₀. CL group 3. Condition after chemoradiation treatment. The patient is observed for 3 years with no signs of recurrence and metastasis.

Technical and economic effect from the use of "treatment common cancer of the vagina" is the ability to increase the length and improve the quality of life of patients with cancer localization by modifying ongoing radiation treatment combination of systemic and local application of cytostatics and local effects of ultrasound.

The method of treatment of locally advanced cancer of the vagina, including chemotherapy, remote gamma-therapy is recommended, With intracavitary⁶⁰therapy, characterized in that the first step in conducting a course of chemotherapy with intravenous injection of 100 mg/m²cisplatin and doxorubicin 30 mg/m²then after remote gemmoterapii on primary tumor site total dose of 20 Gy, carried out with the rhythm 2 times a week vnutri is complete With ⁶⁰therapy two fractions of 2.5 Gy with an interval of 5 h, and in the middle of the 5-hour interval in the surface layers of the tumor injected with 5 mg platydema dissolved in 1.0 ml of physiological solution, and treat tumors by ultrasound with a frequency of 880 kHz and an intensity of 0.4 W/cm²through a licensed napkin Dimexidum-gel for 5 minutes, just in alternation with remote gamma-therapy is recommended in regional lymph nodes hold 10-11 sessions With intracavitary⁶⁰therapy to a total dose to the primary tumor site 70-75 Gy, lymph nodes 40 Gr.