RU2524309C1 - Method for selecting therapeutic approach to locally advanced prostate cancer - Google Patents

Abstract

FIELD: medicine.

SUBSTANCE: blood prostate specific antigen is measured. Radiation therapy is carried out, and Zoladex 3.6 mg is administered every 28 days before, during and after radiation. If the blood PSA is lower than 1 ng/ml three months after the beginning of the Zoladex therapy, administering the preparation is continued for the following 6 months. Radiation therapy involves a split course in the regimen of the common radiation dose fractionation to the total radiation dose 64 Gy. If the blood PSA is found to be below 1 ng/ml only six months after the beginning of the Zoladex therapy, administering the preparation is continued for the following 9 months. Radiation therapy involves the split course in the regimen of the common radiation dose fractionation to the total radiation dose 70 Gy. If the blood PSA is above 1 ng/ml six months later, Zoladex is administered in a combination with Casodex 50 mg administered daily for the following 12 months. Radiation therapy involves the split course in the regimen of the common radiation dose hypofractionation to the total radiation dose 70 Gy.

EFFECT: higher effectiveness and optimisation of treatment, substantial reduction of a number of complications on the part of a wide range of a patient's body systems, and prolonged remission.

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Description

The invention relates to medicine, namely to oncourology, and can be used in the treatment of patients with prostate cancer.

Prostate cancer is one of the most common forms of cancer in middle-aged and older men. If cancer is detected in the early stages, a surgical cure is used - prostatectomy, which causes cure in more than 90 percent of patients. However, most patients turn to the oncologist when the tumor becomes locally spread, spreading to the capsule of the gland or seminal vesicles. Such a tumor cannot be resected, and radiation or hormonal antiandrogen therapy is used to treat it.

A known method of treating prostate cancer (RF Patent No. 2258503, IPC A61K 31/282, publ. 2005), including enucleation of testicles, the introduction of antitumor chemotherapy drugs and radiation therapy. Moreover, on the day of the start of radiation therapy, 25 mg of Cisplatin is introduced, incubated with 10 ml of the patient's plasma in both lobes of the prostate gland and paraprostatic tissue on the right and left. Upon reaching a focal dose of 20 Gy, the administration of a chemotherapy drug in a similar dose is repeated, and radiation therapy is continued until the total focal dose (SOD) of 40 Gy.

The disadvantage of this method is that the authors apply a total dose insufficient for significant damage to the cells forming a tumor of the prostate during irradiation. It should also be noted that the chemotherapeutic drug cisplatin used with this method is not an effective treatment for prostate cancer, and its introduction into paraprostatic fiber is associated with a high risk of life-threatening complications to the patient.

There is a method of combined treatment of patients with locally advanced prostate cancer, involving the appointment of a long, several years, course of zoladex followed by radiation therapy in the classical fractionation mode to SOD 65 - 69 Gy. Such combined treatment in patients with locally advanced prostate cancer leads to an increase in 7-year survival of up to 77% (Warde P., Mason M, Ding K., et al. Lancet. - 2011. - V.378, No. 9809 - P.2104-2111, prototype).

The disadvantages of the method are: firstly, the occurrence in response to the long-term administration of zoladex of severe complications from the cardiovascular, nervous, musculoskeletal systems that significantly reduce the comfort of life of patients, and sometimes leading to their death; secondly, in some cases, the patient cannot afford long-term treatment with zoladex because of the high cost of the latter; thirdly, the group of locally advanced prostate cancer includes patients in whom prostate tumors differ in size, PSA level of blood and the degree of morphological differentiation, and radiation therapy is prescribed to everyone in the same mode, without considering that each of the above indicators can have a significant role in its sensitivity to radiation.

The task of the invention is to remedy these disadvantages, increase the efficiency and optimize the treatment of prostate cancer by individualizing the treatment regimen, including irradiation and the use of androgen deprivation. Creating a method that will avoid the introduction of an unreasonably high dose of radiation in the case when this can be avoided will reduce the risk of side effects with prolonged use of hormonal treatment, the occurrence of which reduces the comfort of life of patients, and in some cases leads to their death, to achieve an increase of 5 summer survival of patients with locally advanced prostate cancer.

To do this, in the method of choosing tactics for the treatment of locally advanced prostate cancer, including a study to determine the level of the prostatic specific antigen PSA blood, radiation therapy, the introduction of zoladex before, during and after irradiation at a dose of 3.6 mg with an interval of 28 days , it was suggested that when detecting a PSA level below 1 ng / ml three months after the start of zoladex administration, it should be continued for the next 6 months. In this case, radiation therapy should be carried out in a split-dose regimen in the mode of classical fractionation of the radiation dose to SOD 64 Gy, if PSA levels below 1 ng / ml are detected, only six months after the start of zoladex administration, zoladex should be administered over the next 9 months, and radiation therapy should be given in a split-dose regimen. in the mode of classical fractionation of the radiation dose to SOD 70 Gy. If the PSA level is detected six months later than 1 ng / ml, administer zoladex and daily intake of casodex at a dose of 50 mg for the next 12 months, while radiation therapy should be administered in a split-dose regimen in the form of hypofractionation of the radiation dose to SOD 70 Gy.

The proposed method of treatment, based on an objective criterion for assessing the patient’s condition, makes it possible to individually approach the appointment of treatment procedures for patients with severe tumor pathology, which will inevitably lead to an increase in five-year survival in patients with locally advanced prostate cancer and will avoid unreasonable use of surgical intervention, very often ending with disability of the patient. As you know, it is the patients with this stage of cancer (T2-T3) that make up the majority of prostate tumors detected annually, and the results of their treatment are very often unsatisfactory.

The implementation of the method shown in specific clinical examples.

Example 1

Patient S., 56 years old, is referred for treatment for a prostate cancer detected in him. A patient underwent a biopsy of a prostate tumor at the place of residence. A histological examination revealed that he has prostate adenocarcinoma (8 points according to Gleason). His blood PSA was at the level of 25 ng / ml. During scintigraphy of the bones of the skeleton, accumulation of radiopharmaceuticals was not detected, which could indicate the presence of metastases in the bone. Ultrasound and MRI of the prostate showed no tumor spreading to the seminal vesicles or capsule sprouting. The patient was diagnosed with locally advanced prostate cancer 2 tbsp TH0Mo.

The patient was prescribed treatment according to the proposed method: subcutaneous administration of zoladex in a dose of 3.6 mg for 3 months, after which a control measurement of PSA blood level was performed, its value was 0.06 ng / ml.

After that, a split course of radiation therapy was prescribed in the regime of classical fractionation of the radiation dose to a total focal dose of 64 Gy. At the same time, subcutaneous administration of zoladex was continued according to the same scheme for 6 months until the total number of injections No. 9.

The patient is under observation for five years after the end of treatment. During the entire observation period, the PSA level was below 4 ng / ml, indicating biochemical remission. Analysis of the patient's complaints also indicated the presence of persistent remission of prostate cancer.

Example 2

Patient K., 66 years old. The examination found that the patient has prostate adenocarcinoma (7 points according to Gleason), the growth of which was accompanied by an increase in blood PSA level to 56 ng / ml. Ultrasound of the prostate is diagnosed with the germination of the capsule of the prostate. No foci of distant bone metastasis were found. Diagnosed with prostate cancer T3NoMo.

The patient was prescribed zoladex according to the scheme of 3.6 mg subcutaneously 1 time in 28 days for 3 months. Measurement of the PSA level of blood after 3 zoladex administration revealed that its level decreased significantly and amounted to 16 ng / ml. They continued treatment with zoladex over the next 3 months. When examining the level of blood PSA 6 months after the onset of androgen deprivation, its level was 0.9 ng / ml. Treatment with zoladex was continued as described above for the next 9 months until the total number of injections No. 15. A split-dose course of radiation therapy was prescribed in the classical dose fractionation mode (ROD-2.5Gy) to a SOD of 70 Gy, but its onset had to be postponed for 2 months due to the exacerbation of the chronic concomitant pathology present in this patient.

Within 3 years after completion of treatment, the patient underwent regular monitoring - a stable biochemical remission was diagnosed - the PSA level did not rise above 4 ng / ml.

Example 3

Patient S., 62 years old. After the examination, it was found that he has prostate adenocarcinoma (7 points according to Gleason). The tumor spread to the seminal vesicles, there was a single node enlarged to 14 cm in the iliac region. The PSA level was 70 ng / ml. The patient was prescribed zoladex 3.6 mg subcutaneously 1 time in 28 days.

After 3 and 6 months, a decrease in blood PSA was noted, respectively, to 51 ng / ml and 30 ng / ml. The patient continued with androgen deprivation of zoladex according to the same scheme for the next 12 months, but already in combination with casodex 50 mg daily by mouth. 6 months after the start of treatment with zoladex, a split course of radiation therapy was prescribed for the area of the prostate gland and seminal vesicles in the hypofraction mode (ROD = 2.5 Gy) to a SOD of 70 Gy.

The patient is observed for 3 years - PSA blood is stably fixed below 4 ng / ml, which indicates a biochemical remission.

This method of treatment was used in 17 patients with locally advanced prostate cancer. An individual approach to the appointment of zoladex significantly reduced the number of complications from a number of patient systems. In no case have we recorded the development of cardiovascular pathology, which is the most serious, life-threatening patient, complication of the use of zoladex. During a three-year observation period for patients who received treatment as described above, only two were diagnosed with biochemical relapse. In no case, distant metastases in the skeleton bone were found. The period of remission has increased.

An important positive feature of the method is the fact that in most patients, after treatment with this method is completed, erectile function is restored, which distinguishes this treatment method from all others and significantly increases the patient’s life comfort.

Claims (1)

A method for selecting treatment tactics for locally advanced prostate cancer, including studies to determine the level of the prostatic specific antigen PSA blood, radiation therapy, the introduction of zoladex before, during and after irradiation at a dose of 3.6 mg with an interval of 28 days, characterized in that when the PSA level is detected below 1 ng / ml three months after the start of zoladex administration, it should be continued for the next 6 months, while radiation therapy is carried out in a split-dose course in the mode of classical fractionation of the radiation dose to SOD 64 Gy, if the PSA level is found to be lower than 1 ng / ml six months after the start of zoladex administration, zoladex is prescribed for the next 9 months, and radiation therapy is carried out in a split-rate mode in the classical fractionation of the radiation dose to SOD 70 Gy, if PSA levels are detected six months later than 1 ng / ml, zoladex and a daily dose of 50 mg casodex are prescribed for the next 12 months, with radiation therapy split rsom in gipofraktsionirovaniya mode radiation dose up to 70 Gy.