Method for photodynamic therapy of patients with metastatic tumoural pleuritis

FIELD: medicine.

SUBSTANCE: photosensitiser Photosense is administered. The patient is irradiated with using an optical fibre with a lens on a distal end in contact with a chest wall along intercostal spaces in 8-10 random positions for 1 therapeutic session. A light dose of one position of the laser radiation is 100 J, and an output power is 200-250 mWt,.

EFFECT: method provides regression of the tumoural process, obliteration of the pleural cavity without the aggressive intrapleural intervention, and eliminates potential infections.

2 ex

 

The present invention relates to medicine, namely to Oncology, and can be used as a method of treatment of patients with metastatic cancer pleurisy.

Pleural effusion - accumulation of fluid in the pleural cavity, as a complication of some diseases. The cause of pleural effusion in cancer patients is tumor of the pleura, the lung. It can be as primary malignant tumors of the pleural - mesothelioma and metastatic tumors.

The tumor of the pleura causes local inflammation, increased capillary permeability, violation of the integrity of the lymphatic vessels. Cancer cells induce angiogenesis, stimulating growth of new capillaries and neovascularization of the pleura, which increases the permeability of fabrics and expressed the exudate (selçuk V.Y. and other "Tumor serosity". Practical medicine. Moscow. 2011, p.27-28).

Tumor metastatic pleural effusion is one of the most frequent complications of malignant neoplasms. About half of patients with common forms of cancer the disease is complicated by the development of neoplastic pleural effusion. In particular, the incidence of neoplastic pleural effusion in lung cancer is 20-25%, breast cancer - up to 48%, lymphomas and leukemia, to 26%, ovarian cancer up to 10%. Exudate in the pleural cavity results is it in the compression of the lung, shift of the mediastinum and, as a consequence, the presence of severe shortness of breath, and disorders of the respiratory and cardiac activity. Often pleurisy is the only manifestation of the tumor process and may cause death of the patient. Without treatment, the median life expectancy of a patient with tumor pleurisy is 4 months (selçuk V.Y. and other "Tumor serosity". Practical medicine. Moscow. 2011, P. 55). The treatment of these patients, aimed at relief of pleurisy, significantly increases the life expectancy of patients.

Maintaining a good quality of life of cancer patients is the primary goal of therapy in disseminated cancer of any location and can be achieved by reducing the symptoms of the disease (ESMO-2010).

Treatment of patients with metastatic neoplastic pleural effusion is difficult and requires a strong individual approach. A single treatment algorithm of patients with this pathology no. In the treatment of patients with neoplastic pleural effusion use therapeutic thoracocentesis, systemic drug therapy, intrapleural therapy, long-term drainage of the pleural cavity.

Thoracocentesis - puncture of the pleural cavity with the evacuation procedure is an extremely symptomatic therapy and 98-100% of patients Ceres month marks the re-accumulation of exudate. Systemic chemotherapy is not effective enough. In particular, in breast cancer, ovarian cancer, small cell lung cancer, lymphoma can lead to the elimination of pleural effusion in 30-60% of patients. Possible intrapleural chemotherapy using cytotoxic drugs, and the use of sclerosing funds, resulting in obliteration of the pleural cavity (pleurodesis) and is symptomatic treatment. However, such aggressive intrapleural impact has a number of complications and more than 30% of patients, potentially considered as candidates to run pleurocentesis have contraindications to its implementation. Complications are manifested in the form of intoxication and, as a consequence, renal, hepatic, cardiac and pulmonary failure (selçuk V.Y. and other "Tumor serosity". Practical medicine. Moscow. 2011, P.65-78).

Invasive intrapleurally therapy has a number of disadvantages:

- intrapleurally therapy is aggressive intervention with the introduction into the pleural cavity toxic agents for the obliteration of the cavity,

introduction preparations for the obliteration of the pleural cavity causes of intoxication and significant deterioration of the sick,

- intrapleurally effect is accompanied by a pronounced inflammatory processes in the pleural the cavity,

- pleurodesis with the introduction of drugs into the pleural cavity for its obliteration is purely symptomatically treatment

- there is a high risk of complications in patients with severe concomitant diseases of the heart, lungs, liver, kidneys.

There is a way intrapleural photodynamic therapy with Photosens in patients with primary and metastatic pleural complicated with malignant pleural effusion (Varsol D., the dissertation on competition of a scientific degree of candidate of medical Sciences, Moscow, 2009, prototype), namely, that after the intravenous administration of a photosensitizer photosense in the pleural cavity by thoracocentesis injected from 2 to 5 diffusers, then hold intrapleurally exposure pleural cavity daily for 5-7 sessions. During the treatment by the proposed method, the results of the study, the obliteration of the pleural cavity - the pleurodesis was achieved in 93% of cases.

During PDT was achieved not only the effect of obliteration of the pleural cavity, as palliative treatment, and partial regression of malignant tumors of the pleura.

Disadvantages invasive intrapleurally photodynamic therapy:

- intrapleural therapy is an invasive procedure that involves the introduction by thoracocentesis pleural cavity 2-5 diffusers and drainage for up to 6-8 days,

- intrapleural effects with long-term availability of percutaneous drainage and diffusers can lead to infection of the pleural cavity and purulent process,

- introduction of fibers into the cavity of the diffuser for everyday laser irradiation may be accompanied by a perforation channel of the diffuser (mechanical or thermal), which can cause additional infection of the pleural cavity,

- the patient within 6-8 days is on bed rest when installed drains and diffusers,

- treatment of patients by this method is carried out only in a hospital environment.

The present invention was to provide such a method of treatment, which would exclude aggressive intrapleural intervention would be organoboranes, would be no complications, and also created the possibility of treating patients in the outpatient setting, even in the presence of severe concomitant pulmonary and cardiac pathology.

The problem is solved in the following way: after intravenous injection of the photosensitizer photosense irradiation is carried out through the optical fiber with a lens at the distal end in contact with the chest wall along the intercostal space in 8-10 arbitrary positions on the entire chest wall for 1 session, with a light dose of a single irradiation position 10 j, the capacity of 200-250 mW at the fiber output.

The proposed method is as follows. At the first stage before carrying out the treatment of a patient spend pleural puncture with the evacuation of exudate. Preferably the conducting x-ray examinations to clarify the localization of the pathological process. If necessary, pleural puncture repeat during the course of treatment in case of accumulation of exudate (usually 7-8 days after the beginning PDT). 1-2 days after pleural puncture injected photosensitizer photosense. Preparation before the introduction diluted with 0.9% sodium chloride in a ratio of 1:4. The solution Photosense administered once intravenously through a 30-minute infusion at a dose of 0.3-0.4 mg/kg 24 hours after the introduction of Photosense conduct a session contact PDT (RF patent No. 2275945, A61N 5/067, 2004). Exposure pleural cavity is conducted through the optical fiber with a lens diameter of 1 cm at the distal end in contact with the chest wall along the intercostal space, 8-10 arbitrary positions on the entire chest wall after 1 session of treatment. A light dose of one position laser irradiation 100 j, the output power of the fiber 200-250 mW. The number of sessions (days of treatment) - 9-10.

The proposed method is illustrated by the following examples.

Example 1.

Patient P. 76 years. Diagnosis: cancer of the right breast T2, N1, M0, comp is exee treatment in 1997, metastases to the pleura, right exudative pleurisy. Before PDT evacuated 1000.0 ml of pleural exudate. 2 days after pleural puncture entered the photosensitizer photosense at a dose of 0.4 mg/kg 24 hours after the introduction of Photosense held a session contact PDT. Exposure pleural cavity was performed through the optical fiber with a lens diameter of 1 cm at the distal end in contact with the chest wall along the intercostal space, 8-10 arbitrary positions on the entire chest wall after 1 session of treatment. A light dose of one position laser irradiation 100 j, the output power of the fiber 200-250 mW. Held 9 sessions of treatment. The result achieved by the stabilization process. After 2 months in the control of pleural puncture evacuated 500 ml of residual liquid. Radiological control within 1.5 years of follow-up revealed a strong stabilization process. There are no complications.

Example 2.

Patient B. 71. Diagnosis: cancer of the left breast T2, N0, M0, comprehensive treatment in 2000, metastases to the pleura, left exudative pleurisy. Before PDT evacuated 1500.0 ml of pleural exudate. A day after pleural puncture entered the photosensitizer photosense at a dose of 0.3 mg/kg 24 hours after the introduction of Photosense held a session contact PDT. Exposure pleural cavity was carried out by the of vetoed with a lens diameter of 1 cm at the distal end, in contact with the chest wall along the intercostal space, 8-10 arbitrary positions on the entire chest wall after 1 session of treatment. A light dose of one position laser irradiation 100 j, the output power of the fiber 200-250 mW. Held 9 sessions of treatment. The result achieved by the stabilization process. After 1 month in the control of pleural puncture evacuated 250 ml residual liquid. X-ray control after 1 year of observation revealed the stabilization process, the obliteration of the pleural cavity, fibrosis. There are no complications.

Using Photosens and laser irradiation on the proposed method were treated 14 patients with oncological pathology of the pleura and the presence nekapasyanago pleurisy. As a result, in 9 (64%) cases registered stabilization process is the partial regression of tumors and obliteration of the pleural cavity. Complications associated with PDT.

Thus, the proposed method of treatment allows to exclude aggressive intrapleurally intervention is organochromium ensures the absence of complications, creates the possibility of treating patients in the outpatient setting, even in the presence of severe concomitant pulmonary and cardiac disorders, improves the quality of life of patients.

The method of photodynamic therapy of patients with metastatic swollen the left pleurisy, includes intravenous administration of a photosensitizer photosense, followed by irradiation with a laser, wherein the irradiation is carried out through the optical fiber with a lens at the distal end in contact with the chest wall along the intercostal space in 8-10 positions on the entire chest wall during one session, with a light dose of one position of irradiation with 100 j, the output power of the fiber 200-250 mW.



 

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1 ex

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2 ex

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