RU2398608C1 - Method of treating rectal cancer - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: invention refers to medicine, oncology, and can be used for treating rectal cancer. That is ensured by daily 5-fluorouracil chemotherapy for 5 days combined with the following introduction of a platinum preparation. It is followed with gamma therapy according to the dynamic dose fractionation with the amplified fractions of 4 Gy for the first 3 days. Further, said ray therapy is ensured by small fractions in the superfractionation mode, twice a day, every 4-5 hours, of 1.25 Gy to total basic dose of 47.0 Gy. In addition, every night at bedtime, Derinat gel is introduced in microenemas of 5-10 ml for the first 5 days of treatment, of 10-20 ml in amplified fraction radiation, of 30-35 ml in small fraction radiation, of 25-30 ml after the termination of the radiation course for 2 weeks.

EFFECT: method provides increasing TBD to 47,0 Gy that is an equivalent of 50 Gy of conventional radiation dose fractionation, as normal tissues allow delivering the specified dose without the evident ray-induced reactions.

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Description

The invention relates to medicine, namely to oncology, and can be used in the treatment of colorectal cancer by combined radiation and chemotherapeutic effects.

A known method of treatment of generalized tumor processes (RF Patent for the invention No. 2200008, IPC A61K 31/522, publ. 2003), including chemotherapy with 5-fluorouracil in combination with a leukostimulator, which can be used as Derinat.

The disadvantage of this method is that when used in the treatment of colorectal cancer, derinat acts systemically, and its directed local effect is extremely limited. The absence of radiation exposure in colorectal cancer does not allow for pronounced tumor regression.

There is a method of increasing the efficiency of radiation therapy of tumors of various localization (RF Patent for the invention No. 2088247, IPC A61K 36/752, publ. 1997), including conducting radiation therapy and applying to the tissue in the irradiation zone of the drug - "Vitaon", weakening radiation tissue damage.

The disadvantage of this method is the inefficiency of its use rectally, since only aqueous solutions are actively adsorbed in the rectum and this does not allow the penetration of drugs into the tissues.

The closest is a method of treating colorectal cancer (V.I. Chissov et al. “Alternative approaches to the treatment of patients with locally advanced rectal cancer,” Russian Journal of Oncology, No. 2, 2000, pp. 10-12), including chemotherapy with 5-fluorouracil for 5 days daily, followed by the simultaneous administration of a platinum-containing drug and gamma-therapy according to the dynamic dose fractionation scheme with enlarged fractions of 4 Gy for the first 3 days, and then radiation therapy with small fractions to be continued superfractionation 2 times a day for 1 Gy 4-5 hours apart.

The disadvantage of this method of this method is that the radiation reactions that occur lead to unplanned interruptions in treatment, which negatively affects its effectiveness.

The claimed invention is directed to solving the problem of increasing the effectiveness of treatment.

Using in clinical practice the proposed method allows to achieve several technical (therapeutic) results:

- protection of normal tissues from radiation exposure,

- providing a tread effect from ionizing radiation,

- the possibility of increasing SOD to 47.0 Gy, which is equivalent to 50 Gy with the classical fractionation of the dose of ionizing radiation.

These therapeutic results in the implementation of the invention are achieved due to the fact that, as in the known method for the treatment of colorectal cancer, chemotherapy with 5-fluorouracil is carried out for 5 days daily, followed by the simultaneous administration of a platinum-containing drug and gamma-therapy according to the dynamic dose fractionation scheme with aggregated fractions of 4 Gy for the first 3 days, and then radiation therapy with small fractions is continued in the superfraction mode 2 times a day with an interval of 4-5 hours.

A feature of the proposed method is that irradiation with small fractions is carried out at 1, 25 Gy to a total focal dose of 47.0 Gy. In addition, derinat gel is introduced in the form of microclysters at night for the first 5 days of treatment of 5-10 ml, when irradiated with large fractions of 10-20 ml, when irradiated with small fractions of 30-35 ml, and after the end of the irradiation course, 25 -30 ml for 2 weeks.

The invention consists in the following.

Irradiation according to the proposed scheme provides an increase in SOD to 47.0 Gy, which is equivalent to 50 Gy with the classical fractionation of the dose of ionizing radiation, since normal tissues exposed to derinat gel allow you to bring the specified dose without pronounced radiation reactions.

Derinat gel (a hydrogel preparation based on sodium alginate with sodium deoxyribonucleinate) belongs to universal metabolic modulators and is a unique polymer molecule with a multifaceted positive effect on human hemostasis in the absence of toxicity and contraindications. It has a non-specific general biological stimulating effect on all organs and tissues, normalizes the immune status, stabilizes hematopoiesis, and enhances tissue regeneration. Its introduction during the entire course of treatment and after the end of the course of radiation therapy ensures the restoration of oxidative-antioxidant processes and a decrease in the concentration of free radicals in normal tissues included in the volume of radiation. The indicated therapeutic effect is provided by the proposed scheme of fractional administration of derinate throughout the course of treatment. In hydrogel material, sodium alginate, a natural biopolymer obtained from brown algae rich in trace elements, is used as a depot for derinate. The water-soluble base of the polymer causes the absence of a film that inhibits cellular respiration.

The implementation of the method shown in specific clinical examples.

Example 1

Patient P., 50 years old (and / b TA-3649, 2008). Received with a diagnosis of Colorectal cancer of the third century, T3N × M0. During the examination, a locally distributed tumor of the lower and middle ampullar regions of the rectum was revealed.

In the study, parenchymal organs of the abdominal cavity without pathological changes, in the lower and middle ampullar sections of the rectum for 7.5 cm, a tumor is identified mainly on the front wall, growing through the entire thickness of the wall, with the presence of thin spicules in the mesorectal tissue, along the back wall in the form exophytic formation, sprouting muscle layer in the area up to 3.8 cm, in the mesorectal tissue 2 small l / y up to 0.5 cm. Conclusion: MP-picture of cancer of the lower-middle ampulla of the rectum with signs of exit process beyond the wall. Enlarged mesorectal lymph nodes. CT scans of the abdominal cavity and retroperitoneal space of additional formations and altered lymph nodes are not determined.

Radiation therapy was carried out according to the proposed method: 5-FU at 500 mg (based on 350 mg / m ² ) for 5 consecutive days of intravenous DM - 2500 mg, then cisplatin 30 mg followed by delivery of ROD 4 Gy for 3 consecutive days, then 1 , 25 Gy 2 times a day to SOD - 47.0 Gy. The treatment was carried out against the background of daily administration of derinate in the form of microclysters at night for the first 5 days of treatment, 10 ml each, when irradiated with large fractions 15 ml each, when irradiated with small fractions 30 ml each, and after the course of irradiation, 25 ml each for 2 weeks. The volume of microclysters was determined by the clinical condition of the patient's irradiation zone.

The treatment was carried out without interruption, at the end of treatment, a radiation reaction of the first degree of severity from the rectal mucosa was noted.

The patient was discharged under supervision at the place of residence. After 4 weeks, organ-sparing surgery was successfully performed (low anterior resection of the rectum, aorto-iliac lymphadenectomy). The postoperative period was uneventful.

During the follow-up examination after 6 months - without signs of relapse, metastases and late radiation changes.

Example 2

Patient P., 68 years old (and / b RA-4751, 2006). He was admitted with a diagnosis of Colorectal cancer of the third stage T3N1M0. An examination revealed a locally advanced rectal tumor.

According to the proposed method, chemoradiation treatment was carried out.

The patient received 5-FU at 600 mg (based on 350 mg / m ² ) for 5 consecutive days of intravenous DM - 3,000 mg, then cisplatin 30 mg followed by delivery of ROD 4 Gy for three consecutive days, then 1.25 Gy twice per day before SOD - 47.0 Gy.

The treatment was carried out against the background of daily administration of derinate in the form of microclysters at night for the first 5 days of treatment, 15 ml each, when irradiated with large fractions 20 ml each, when irradiated with small fractions 30 ml each, and after the end of the irradiation course 30 ml each over 2 weeks. The volume of microclysters was determined by the clinical condition of the patient's irradiation zone.

The treatment was carried out without interruption. Against the background of treatment, blood flow from the rectum stopped, the feeling of a foreign body and incomplete bowel movement disappeared. At the end of treatment, a radiation reaction of the first degree of severity from the rectal mucosa was noted.

The patient was operated on after 6 weeks in the amount of sphincter-saving surgery. The postoperative period was uneventful. Transversostom unloading closed after 6 months.

During follow-up examination after 12 months - without signs of relapse, metastases and late radiation changes.

The proposed method allows to increase the number of organ-saving operations and thereby improve the quality of life of patients, reduce disability.

Claims (1)

A method for the treatment of colorectal cancer, including chemotherapy with 5-fluorouracil for 5 days daily, followed by the simultaneous administration of a platinum-containing drug and gamma-therapy according to a dynamic dose fractionation scheme with enlarged fractions of 4 Gy for the first 3 days, and then continued radiation therapy with small fractions in superfraction mode 2 times a day with an interval of 4-5 hours, characterized in that the irradiation with small fractions is carried out at 1.25 Gy to a total focal dose of 47.0 Gy, enter derinat gel in the form of microclysters at night for the first 5 days of treatment of 5-10 ml, when irradiated with large fractions of 10-20 ml, when irradiated with small fractions of 30-35 ml, and after the end of the course of irradiation, 25-30 ml in within 2 weeks.