Method for thermo-radio-therapy of malignant tumors

FIELD: medicine, in particular, oncology.

SUBSTANCE: in accordance to method, thermo-radio-therapy of malignant tumors is performed in form of split course in mode of enlarged dynamic fractioning of dose in 6 fractions of 4 Gy and 8 fractions of 2 Gy in first course, and 6 fractions of 4 Gy and 3 fractions of 2 Gy in second course in conjunction with hyper-thermal effect in the same day when radio-therapy is performed.

EFFECT: increased apparent counter-tumor local effect.

2 ex

 

The invention relates to medicine, in particular to the treatment of superficial malignant tumors, and tumors of the internal organs by combined radiation and hyperthermia exposure.

The well-known series of works whose authors have successfully used the hyperthermia as a modifier of radiation therapy. In particular, it is known the use of hyperthermia as radiomodifying radiation therapy in breast cancer (Trofimova OP "Thermoradiotherapy in the complex treatment of breast cancer", dissertation, p.30, M., 2002). According to known technique courses of radiation therapy was performed by classical fractionation, dose GENUS 2 Gy over 5 treatment days per week, split the course up to SOD 66 Gr. Modification of hyperthermia was used in the second week of treatment, to achieve SOD 10 Gr. The disadvantage of this method is that when using it missed opportunity of hyperthermia as radiosensibility in the first week of treatment. As a result, when SOD 30 Gy in most patients experiencing local radiation reaction, which are an obstacle to the continuation of the course of radiation therapy and require interruption of treatment until they subsided.

Closest to the claimed invention by way of the same purpose is a method of treatment of Slokas the public tumors, including radiation therapy, which in the border of the tumor healthy tissue injected solution mezatona, and the subsequent hyperthermia (RF patent No. 2048, publ. 27.11.95, bull. No. 33) - the prototype. The use of this method leads to the enhancement of hyperthermic effect of radiation therapy due to vasoconstrictor effect, which reduces the blood flow in tumor vessels. However, the use of known techniques is limited to the treatment of superficial malignant neoplasms locally localized processes. On the other hand, the introduction into the tissues mezatona injection method proposed in this work is an additional risk factor for the development of complications (eg, abscess, allergic reactions and so on).

The claimed invention is directed to solving the problem of increasing the Express local antitumor effect.

Use in clinical practice, the proposed method allows to achieve several technical (medical) and economic performance:

- reducing the risk of metastasis of the tumor during treatment;

- the possibility of increasing SOD;

- providing surgical removal of the tumor;

- reduction in the incidence of radiation reactions;

- reduced the duration of treatment.

These therapeutic results by carrying out the invention to tigalda by much as in the known method of treatment of malignant tumors is carried out by radiation and subsequent hyperthermic effect on the tumor in the day session of radiotherapy. A feature of the invention lies in the fact that radiation exposure exercise split rate mode enlarged dynamic fractionation dose of 6 fractions of 4 Gy and 8 fractions of 2 Gy in the first course, 6 fractions of 4 Gy and 3 fractions of 2 Gy in the second course, and the sessions of hyperthermia spend 30 minutes after radiation treatments with a time interval between sessions of hyperthermia 72 hours.

The invention consists in the selection of the optimal mode of combined radiation and local thermal effects on the tumor to achieve maximum antitumor effect without lethal cell damage normal tissue. The specified optimal mode, according to the authors of the claimed invention is enlarged dynamic fractionation of the dose of radiation at which this energy is produced for the shortest possible time due to the rapid escalation of SOD (16 Grams for the first week) using the aggregate fractions in combination with hyperthermic effect.

The advantage of the aggregate fractions of ionizing radiation is before the classical fractionation is a quantitative increase and damage accumulation of tumor cells by increasing the degree of lipid peroxidation.

In the first four days of tumor cells exposed to the dose required for maximum destruction and death (4×4 Gy), and sessions of hyperthermia spend 30 minutes after radiation treatments in the 1-St and 4-th day of treatment. The specified dose of radiation exposure is the maximum allowable for the vitality of the surrounding normal tissues. The result is the sum of the aggregate fractions is the damage of tumor cells of various degrees is lethal and sublethal. When this destructive radiation exposure are the most active tumor cells capable of metastasis. At the same time, less-active tumor cells are transferred in sub - and potentially lethal condition. Thermal effect on the tumor in the first and fourth day of the sum of the aggregate fractions causes blocking of the recovery sub - and potentially lethal damage in the tumor, which ultimately leads to increased radiation tumor destruction. Subsequent use of fractions of 2 Gy along with increasing SOD and further accumulation of damage in tumor cells leads to the consolidation of the antitumor effect obtained when exposed aggregate fractions in combination with hyperthermia.

Hyperthermia along with damaging effect is characterized by the significance of the additional radio-sensitizing effect due to temporary disruption of the repair processes, that leads to increased cellular radiosensitivity. After heating of the tumor is observed period induced thermotolerance, which increases in 1-2 days. The cause of tolerance is the accumulation in the cell heat shock proteins, so the session hyperthermia should not be done more than 2-3 times a week. Different temperature level causes in different tumor effect. When heating the tissue more 43-45°With the coagulation of proteins and mainly mechanical damage to the cells, and the temperature is below 41°may contribute to activation of tumor growth. Based on the data of the inverse relationship of the duration of the interval of tolerance and temperature level (i.e. with increasing temperature, decreasing the interval of tolerance), as radiomodification selected optimal level of tissue heating 42-43°With intervals between sessions of hyperthermia 72 hours, i.e. the period of maximal tolerance. Throughout the course of treatment to no more than 4-6 sessions of hyperthermia, because in connection with the development of thermotolerance tissues inappropriate conduct more than 2 sessions of hyperthermia in a week. Between sessions of hyperthermia in the second and third day of treatment, it is advisable to expose the tumor cells that are in thermoresistance condition, only radiation impacts the view enlarged fractions of 4 Gy, causing further damage. A two-week break in treatment is necessary in this scheme to restore normal tissue.

Thus, in the proposed method uses two complementary radiomodifying - hyperthermia and aggregated dose fractionation radiation exposure.

The inventive method is successfully tested for the treatment of patients with locally extensive tumor process. Namely, the superficial and deep soft tissue tumors, particularly tumors of the neck, as well as tumors of the pelvic organs: bladder, rectum, cervix, prostate. Restrictions for the treatment of locally advanced tumours caused only by instrumental effects and control of tissue temperature using the apparatus of hyperthermia.

The total duration of the two courses of treatment is five weeks versus seven weeks standard course of radiation therapy.

The method is as follows. Treatment begins on Monday. 1-St, 2-nd, 3-th and 4-th day of the fraction of radiation therapy are ROD 4 G; 5-th, 6-th and 7-th day - break in treatment, 8-day RACE 4 G, 9th and 10th days of GENUS 2 G, 11-day RACE 4 G, the 12th day of GENUS 2 G, 13-th and 14 th days break in treatment; 16th, 17th, 18th th, 19 th and 20 th days GENUS 2 Gr. Sessions of hyperthermia carried out after 30 minutes with the ANSA radiation therapy in the 1st, 4-th, 8-th and 11-th day of treatment. The time interval between sessions of hyperthermia is 72 hours. The number of fractions for the first half of the course is 14, SOD 40 Gr.

Prior to the second half of the course of treatment in accordance with the inventive method to control clinical diagnostic studies of the patient to clarify the dynamics of the tumor process.

Radiation exposure in the amount of SOD 40 Gy in combination with hyperthermia in accordance with the inventive technique can be used in clinical practice as a preoperative component of combined treatment, including hyperthermia with radiation therapy and surgical treatment. When initially insensitive or unresectable malignant processes using this method allows you to:

- to create conditions for surgery, due to the resorption of swelling, release of adjacent vital structures such as major neurovascular bundles;

to prevent or reduce metastasis of a tumor during surgery, to reduce the likelihood of generalization of the tumor due to the elimination of the most malignant cells;

- to reduce the volume of the tumor, facilitating the conduct of subsequent conserving surgery.

When radiation therapy radical programme of the donkey two-week break in treatment is the 2nd half of the course of radiation therapy: in the 1st, 2-nd, 3-th and 4-th day fraction radiotherapy is a GENUS of 4 G, 5 th, 6 th and 7 th days - a break in treatment, 8-day RACE is 4 G, 9-th and 10-th day - GENUS 2 G, 11-day - RACE 4 G, 12-day - RACE 2 Gr. Sessions of hyperthermia are conducted after a 30 minute session of radiotherapy in the 1st, 4th, 8th and 11th day of treatment. The time interval between sessions of hyperthermia is 72 hours. The number of fractions in the second half of the course is 9, SOD 30 Gr. The total dose per course of treatment 70 Gr.

Sessions of hyperthermia is performed on the device YACHT-4 with a working generator frequency 433.92 MHz. Radiation therapy - any radiotherapy technique presented in hardware Park radiological departments, for example, high energy accelerator Microtron-M devices with cobalt source - Rocus-AM.

Clinical example 1

Patient S., 19 years, clinical diagnosis: soft tissue sarcoma of the right tibia Ia stage T1dN0M0G1. If the comprehensive examination in the soft tissues of the medial third of the right tibia on the lateral surfaces of the identified tumor 3,0×2.0 cm, length - 3.5 cm, depth from the surface of the skin 1 cm, with distinct irregular contours, moving, painful to palpation, swelling motoblaze covered fibula that was a contraindication to perform limb-sparing surgery. Combined modality treatment plan myrabolans given the young age of the patient, prospects of its further rehabilitation and socialization, as well as with regard to cancer prognosis. Given the morphological structure of the tumor and low radiocontaminated, it was decided to hold the first stage of preoperative radiation therapy on the background of hyperthermia: the 1st, 2nd, 3rd and 4th day fraction radiotherapy was RACE 4 G; 5-th, 6-th and 7-th day - break in treatment, 8-day RACE 4 G, 9th and 10th days of GENUS 2 G, 11-day RACE 4 G, the 12th day of GENUS 2 G, 13-th and 14 th days break in treatment; 16th, 17th, 18th, 19th and 20th days of GENUS 2 Gr. Sessions of hyperthermia was performed after 30 minutes of sessions of radiation therapy in the 1st, 4th, 8th and 11th day of treatment. The time interval between sessions of hyperthermia was 72 hours. The number of fractions for the first half of the course is 14, SOD 40 Gr. On the 10th day after the end of the 1st course held control tests, which revealed a linear decrease of tumor size in 2 times and the appearance in it of necrosis. In the second stage of treatment in accordance with the results of the examination performed surgical treatment in the amount of removal of tumors of the soft tissues of the right tibia with resection of the fibula, autodermoplastiki. Histological examination of postoperative material M-55 - angioleiomyoma with extensive foci of necrosis beam pathomorphosis of the 3rd degree, which corresponds to a significant extent the damage is the origin of the tumor process under the action of radiation therapy and hyperthermia.

The observation period of 1 year, with no signs of recurrence and distant metastasis.

Clinical example 2.

Patient C., 65. Clinical diagnosis: prostate cancer stage II T2N0M0. In February 2000, held Rasputina prostatectomy, the Institute identified morphologically and biochemically recurrence of the tumor: in the bed of the remote prostate tumor formation in sizes 3,4×3.2 cm, with a rough, bumpy contours adjacent to the rear wall of the bladder.

Patients received radiotherapy with hyperthermia radical programme by the claimed method: 1-St, 2-nd, 3-th and 4-th day of the fraction of radiation therapy are ROD 4 G; 5-th, 6-th and 7-th day - break in treatment, 8-day RACE 4 G, 9th and 10th days of GENUS 2 G, 11-day RACE 4 G, the 12th day of GENUS 2 G, 13-th and 14 th days break in treatment; 16th, 17th, 18th, 19th and 20th days of GENUS 2 Gr. Sessions of hyperthermia conducted after a 30 minute session of radiotherapy in the 1st, 4th, 8th and 11th day of treatment. The time interval between sessions of hyperthermia was 72 hours. The number of fractions for the first half of the course is 14, SOD 40 Gy, field sizes 5×8 cm, SOD 40 Gr. On the background of the aggregate fractions held 4 sessions of hyperthermia apparatus YACHT-4 at a temperature of 42°, session duration 60 minutes, the first half of the course was without complications, radiation reactions not detected.

After a two-week p is rarawa treatment held the 2nd half of the course of radiation therapy: in the 1st, 2-nd, 3-th and 4-th day of the fraction of radiation therapy are ROD 4 G, 5 th, 6 th and 7 th days - a break in treatment, 8-day RACE is 4 G, 9-th and 10-th day - GENUS 2 G, 11-day - RACE 4 G, 12-day - RACE 2 Gr. Sessions of hyperthermia conducted after a 30 minute session of radiotherapy in the 1st, 4th, 8th and 11th day of treatment. The time interval between sessions of hyperthermia is 72 hours. The number of fractions in the second half of the course is 9, SOD 30 Gr. The total dose per course of treatment was 70 Gy. On the background of the aggregate fractions sessions of hyperthermia. Manifestations of ranjita and cystitis in early pollution period is not observed. The observation period a year with no signs of biochemical recurrence, regional and distant metastasis.

Thus, the inventive method has considerable advantages over known methods of the same purpose and meets the criteria of patentability.

How thermoradiotherapy malignant tumors, including radiation and subsequent hyperthermic effect on the tumor in the day session of radiotherapy, characterized in that the radiation exposure exercise split rate mode enlarged dynamic fractionation dose of 6 fractions of 4 Gy and 8 fractions of 2 Gy in the first course, 6 fractions of 4 Gy and 3 fractions of 2 Gy in the second course in combination with hypertension.stimulation the day of the session of radiation therapy.



 

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where Dn/o - value of relative dose in %, Io - original intensiveness of radiation at the moment of injection of radionuclide, In - average intensiveness of radiation from focuses at day or hour of measurement of n, B0 and Bn - background values of radiation intensiveness at the moment of injection of radionuclide and at the day of measurement, respectively, k - coefficient of daily or hourly decomposition of radionuclide, n - number of days or hours having passed since the moment of injection of radionuclide.

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1 ex

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2 tbl, 3 dwg, 3 ex

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EFFECT: higher efficiency of therapy.

1 ex

FIELD: medicine, oncology.

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EFFECT: higher efficiency of therapy.

1 cl, 4 ex

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