Method of predicting efficiency of treating patients with nasopharyngeal cancer

FIELD: medicine.

SUBSTANCE: method of predicting efficiency of complex treatment of patients with nasopharyngeal cancer, which includes carrying out two-step course of radial therapy at the background of automyelochemical therapy, lies in the following: before treatment individual activity of enzyme kallikrein is determined in patient's blood plasma, and then on the 1-2 day after the end of the 1 step of complex treatment activity of enzyme kallikrein is determined in patient's blood plasma, and in case of its 2 and more fold reduction with respect to initial individual activity, efficiency of treatment is predicted, and in case if it reduces by less than 2 times, absence of clinical effect is predicted.

EFFECT: method ensures possibility of objective assessment of individual response to complex treatment and, in case of necessity, timely change of therapeutic mode.

3 ex

 

The invention relates to medicine, namely to Oncology, and can be used to predict the impact of radiotherapy on the background of automalaxoare patients with cancer of the nasopharynx.

There is a method of assessing the efficacy of chemoradiation therapy in patients with cancer of the mucous membranes of the oral cavity and the oropharynx (the Effectiveness of chemoradiation therapy for regional metastases in patients with cancer of the mucous membranes of the mouth and oropharynx. Aydarbekova A.A., Lubaev V.L., Tkachev, S., Aliev, S. B., Brzezowski WE Vestnik Ross. on Oncology. the scientific. center Russian Academy of medical Sciences, 2006, 17, No. 1). When conducting chemoradiation treatment of regional metastases the best results are achieved when the mobile tumors of the tongue, anterior floor of the mouth and of all departments of the oropharynx, as well as when shifting regional metastases with index N1. Evaluation of results was carried out by considering the 2 - and 5-year survival of patients with complete clinical regression of the tumor, which was exophytic and ulcerative forms of growth 60,0% 35,0%, respectively.

However, this method requires a long observation time and have not been applied in malignant tumors of the nasopharynx.

There is a method of evaluating the effectiveness of radiation and chemotherapy by examining the response of blood cells to treatment (Response of peripheral blood cells from the pain what's with laryngeal cancer to radiotherapy and chemoradiation therapy on the background of radiological. Petrov V.N., Andreev V.G., Petrov V.A., Budagov R.S., Bojkova M.E. Ter-Minassian, Pankratov, VA, sapina E.V. Ross. on Oncology. zhurn., 1999, No. 3), which was chosen as a prototype. The authors studied changes Lomonosovskiy chemiluminescent activity of blood cells in 77 patients with tumors of the upper respiratory tract. Mononuclear cells (lymphocytes and monocytes) and granulocytes (segmento and stab neutrophils) were separated from peripheral blood by density gradient. Analyses were performed at the time of admission to the clinic after summing up the dose of radiation exposure to 10-12 G on the background of polychemotherapy, magnetic or laser therapy, and after summing up the dose of radiation exposure to 30-40 Gy. It is established that the original values of chemiluminescence were significantly higher than the level of biocontrol (donors) in 45% of patients with tumors of the upper respiratory tract. The remaining patients are below or at the level of biocontrol. This was considered an indicator of different initial functional status of blood cells of cancer patients. Combination therapy resulted in a significant increase in the activity of blood cells, which was clear evidence of the involvement of mononuclear cells in the restoration of homeostasis in the body of patients with tumors of the upper respiratory tract. The authors believe this method is promising for the evaluation of complex therapy of cancer pain is different.

However, this method has not been applied to assess the effectiveness of therapy in patients with cancer of the nasopharynx and, despite the apparent information content, requires a long observation time. In addition, it is quite time consuming, which is associated with the separation of blood cells and determination of their activity.

The aim of the invention is to evaluate individual response to radiation therapy on the background of automalaxoare patients with cancer of the nasopharynx.

This objective is achieved in that before treatment in the blood plasma of the patient determine the individual activity of the enzyme kallikrein and then in 1-2 day after the end of phase 1 of a comprehensive treatment in the blood plasma of the patient determine the enzyme activity of kallikrein and its decline in 2 or more times in relation to the original individual activity predict the effectiveness of treatment, and when reduction is less than 2 times predict the absence of clinical effect.

The invention of "a Method for predicting the effectiveness of treatment of patients with cancer of the nasopharynx is new, because it is unknown the level of achievements of medicine in the field of predicting the effectiveness of radiotherapy in combination with chemotherapy.

The novelty of the invention lies in the fact that before treatment and after 1 treatment stage in the blood plasma of the patient determine individualno the activity of the enzyme kallikrein, when it is reduced in 2 times or more and according to normal values predict the effectiveness of therapy. This method of forecasting is new and provides opportunities for early individual assessment of the effectiveness of radiation treatment on the background of automalaxoare, as well as timely and adequate measures for correction of the treatment.

In open sources information of Russia, CIS and abroad indications for a similar method for predicting the effectiveness of chemotherapy drugs us not detected.

The invention is industrially applicable as it can be reproduced and re-reproduced in any clinical laboratory medical health care institutions.

The method is as follows.

Before the start of treatment (1-3 days) the patient is taking blood in a test tube with a 3.8% sodium citrate in a ratio of 9:1 for citrate plasma. Citrate blood was centrifuged, got citrate plasma and used it for the determination of kallikrein in the same day. Immediately upon completion of phase 1 of radiotherapy on the background of automalaxoare (1-2 day) the procedure was repeated. The determination was performed by the unified method Pashino FORCE and Krinsky AV (Pashina T., Krinsky AV Simplified method for the determination of kallikrein and kallickrein the serum (plasma) blood in norm and in certain pathological conditions. Questions of medical chemistry, 1974, t.20, 6) by obtaining readsorbing on DEAE Sephadex brand-50 plasma fractions containing kallickrein, and subsequent spectrophotometric measurement of the rate of cleavage by kallicrein low molecular weight synthetic substrate N-benzoyl-L-arginine ethyl ester at a wavelength of 253 nm within 15 minutes vs. control for the reagents. The results were calculated according to the formula specified in the method, and expressed in arbitrary units "honey/ml: meliadine 1 ml of blood plasma for 1 minute in the SI system. The results were compared with data obtained in the study of citrate plasma of healthy blood donors in similar conditions. In healthy donors activity of kallikrein was determined in the range from 12,61 honey/ml to 47,79 honey/ml (average 30,21±4.6 Miu/ml). For the analysis required 2 hours and General laboratory equipment.

An example of the application method can serve as a statement of case histories.

1. Patient M., 1949 born., AMB. card, case history No. 24767/h, C-16161/h

Diagnosis: cancer of the nasopharynx extending into the apex hole metastases in the lymph nodes of the neck to the left, T4N2M0, st. IV, the state after chemoradiation treatment, class gr. 2.

Conclusion histological analysis: No. 72684-686/08 - undifferentiated nasopharyngeal cancer.

Endoscopic examination dated 28.1.2008 - The left half of the nasopharynx infiltrated and wounded. Infiltration extends to the left pipe roller, which is almost not differentiated. The nasal passages are not passable due to infiltration.

SRCT brain and neck from 28.11.2008, the Tumor of the nasopharynx with the spread on both the bow stroke, 6,8×5.5 cm, the destruction of the posterior Coulter, a slope, the top of the pyramid of the left temporal bone, the main bone. Metastases in the lymph nodes of the neck to the left to 7 see

Treatment:

1 stage of comprehensive treatment: 01.12.2008, is held the 1st of automalaxoare: after tremenously right Ilium received 110 ml of automatozoni, after incubation which at 37°C for 30 minutes with 100 mg of cisplatin was introduced in/drip. Mode overhydration standard. Physiological solution introduced 1000 mg of 5-fluorouracil.

with 03.12.2008, 16.12.2008, - conducted phase I of course DHT on the AGAT-R for the area of primary focus with three fields: 2 opposite cheek-cheek size 7×8 cm and one anterior nasal field of size 5×8 see Irradiation was carried out twice a day with an interval between fractions 5 hours (1.5 G + 1.5 Gy). The total focal dose equal 32,0 from Gr (WDF=52 Units) made a scheduled break. On the lymph nodes of the neck direct field block larynx radiation treatment was carried out by 2.4 Gy per fraction, to SOD=26 from Gr (WDF=44 Ed)

with 17.12.2008, 23.12.2008 - break in treatment 1 week after the end of phase 1 of the comprehensive treatment.

stage 2 complex treatment

24.12.2008, - repeated automalaxoare with the introduction of 200 mg of cisplatin on the background of the water load and forced diuresis. Conducted infusion of 5-fluorouracil 1000 mg and 60 mg bleomycin

with 25.12.2008, 31.01.2008, break 1 week after 2 courses of automalaxoare.

since 01.01.2009 to, 14.01.2009 - II stage of the course of DHT on the primary lesion twice a day for a 1.3 Gy with an interval between sessions of 5 hours (GENUS=2,4 Gr) to SOD=64 from Gr (WDF=106 IU). On the lymph nodes of the neck direct field block larynx radiation treatment was carried out by 2.4 Gy per fraction, to SOD=52 from Gr (WDF=88 Ed). Then continue on the remaining lymph nodes in the neck after topometric training locally to reforming fields to SOD=60 from Gr (WFM=101 Ed).

1 day before treatment (30.11.08) the patient has taken the blood, the plasma, the determination of the activity of kallikrein showed the result is 145,4 honey/ml, which is 4.8 times higher than normal. With 1.12.08 on 16.12.08 conducted stage 1 complex therapy. 1 day after the end of the 1st stage of complex treatment (17.12.08) the patient has taken blood derived plasma and determined the activity of kallikrein, the result is 32,72 honey/ml (decreased 4.4 times - within normal limits).

The status of the tumor after the first stage of treatment:

1) CRKT head and neck from 23.12.2008 - about whole nasopharynx 1×1.5 cm, submandibular lymph nodes on the left to see 0,7

After completion of phase 1 of treatment was observed clinical signs of tumor regression.

2) Endoscopic examination of 23.12.2008 - Expressed positive dynamics. Residual tumor 1.5 cm on the left back wall.

The status of the tumor through 1 month after treatment:

1) CRKT head and neck from 16.02.2009 - Tumor in the nasopharynx is not rendered. The bones of the skull base without lesions destruction and defeat. Lymph nodes in the neck are not increased.

2) Endoscopic examination from 16.02.2009 - signs of tumor recurrence is not defined. Pronounced positive dynamics after chemoradiation therapy. Determined by hyperemia and edema of the mucosa, signs of islet epithelitis in the area of the nasopharynx.

Dynamically observed in RNII without signs of recurrence and metastasis, the last turnout 19.03.2010,

2. Patient R., 1985 born., AMB. card, case history No. 25482/h

Diagnosis: cancer of the nasopharynx, with invasion of the bones of the skull base metastases in the lymph nodes of the neck to the right, T4N1M0st. IV, the state after chemoradiation treatment, class gr. 2.

Conclusion histological analysis: No. 98409/08 - small fragments of undifferentiated nasopharyngeal cancer.

The status of the tumor before treatment:

a) SRCT head and neck from 17.11.2008, CT signs of tumor in the nasopharynx of 6.5×5,7×6,2 the m A tumor growing in the bones of the skull base, basal areas medium cranial fossa. The lymph nodes in the neck right up to 2.0, see

Endoscopic examination from 17.11.2008, - the Rear wall of the right half of the nasopharynx busy submucosal education. In the apex of the host mucosa infiltrated. Tumor of the nasopharynx.

Treatment:

1 stage of comprehensive treatment: 15.12.2008, spent 1 year of automalaxoare: after tremenously right Ilium received 100 ml of automatozoni, after incubation which at 37°C for 30 minutes with 100 mg of cisplatin was introduced in/drip, overhydration standard. Physiological solution introduced 1000 mg of 5-fluorouracil.

With 17.12.2008, 31.12.2008, - conducted phase I of course DHT on the AGAT-R for the area of primary focus with three fields: 2 opposite cheek-cheek the size of 7×10 cm and one anterior nasal field size of 5×10 cm, Irradiation was carried out twice a day with an interval between fractions 5 hours (1.5 G + 1.5 Gy). The total focal dose equal 32,0 from Gr (WDF=52 Units) made a scheduled break. On the lymph nodes of the neck direct field block larynx radiation treatment was carried out by 2.4 Gy per fraction, to SOD=26 from Gr (WDF=44 Ed).

Since 01.01.2009 on 07.01.2009, break in the treatment in 1 week.

stage 2 complex treatment

08.01.2009, - repeated course automarken is terapii with the introduction of 100 mg of cisplatin on the background of the water load and forced diuresis. Conducted infusion of 5-fluorouracil 1000 mg and 60 mg bleomycin

with 09.01.2009, 15.01.2009, break in treatment 1 week after 2 courses of automalaxoare,

with 16.01.2009, 29.01.2009, - II stage of the course of DHT on the primary lesion twice a day for a 1.3 Gy with an interval between sessions of 5 hours (GENUS=2,4 Gr) to SOD=64 from Gr (WDF=106 IU). On the lymph nodes of the neck direct field block larynx radiation treatment was carried out by 2.4 Gy per fraction, to SOD=52 from Gr (WDF=88 Ed).

3 days before the start of treatment (12.12.08) the patient has taken the blood, the plasma, the determination of the activity of kallikrein showed the result is 72,72 honey/ml, which is 2.4 times higher than normal. With 15.12.08 on 31.12.08 conducted stage 1 complex therapy. For 2 days after completion of the 1st stage of complex treatment (2.01.09) the patient has taken blood derived plasma and determined the activity of kallikrein, the result is 30,30 honey/ml (decreased 2.4 times corresponds to the norm).

The status of the tumor after the first stage of treatment:

1) CRKT head and neck from 07.01.2009, residual tumor in the nasopharynx of 2.4×3×1,8 see improved from 17.11.2008, Destructive changes of the bones of the skull base. The neck lymph nodes are not enlarged.

2) Endoscopic examination from 07.01.2009, On the right wall of the mucosa of the nasopharynx with the transition to the set of residual tumor to 2.5 see Condition after chemoradiation treatment. Positive dynamics.

The status of the tumor after 1 month p is after the end of treatment:

1) CRKT head and neck from 02.03.2009, the Bones of the skull base without lesions destruction and defeat. Tumor of the nasopharynx is not rendered. The neck lymph nodes are not enlarged.

2) Endoscopic examination from 02.03.2009, - Mucous nasopharynx hyperemic. Tumor tissue is not defined. Condition after chemoradiation treatment.

Dynamically observed in RNII without signs of recurrence and metastasis, the last turnout 12.02.2010,

3. Patient A., 1962 born., AMB. card, case history No. 16419/h, C-14851/h, s-775/Y.

Diagnosis: cancer of the nasopharynx, metastases in the lymph nodes of the neck on both sides, T3N3M0st. IV, the state after chemoradiation treatment, class gr.

Conclusion histological analysis: G.A. No. 57831-4/08 - small complexes undifferentiated cancer.

The status of the tumor before treatment:

a) SRCT head and neck from 19.09.2008, Cervical lymph nodes on both sides until 4 see, cancer of the right half of the nasopharynx 5×4,7×7 cm, with a heterogeneous structure, the internal carotid artery is not differentiated; the lymph nodes of the neck on both sides up to 4.5 cm in diameter.

b) an endoscopic examination from 19.09.08 - mucous ½ right nasopharynx infiltrated, infiltration overlaps the mouth right Evstafieva pipe, passes on the left ½ of the nasopharynx to the tubular roller, acts in the lumen of the right joany and right and rear walls reaches soft the CSOs sky, infiltration hilly, with a shade of gray. Tumor of the nasopharynx.

Treatment:

1 stage of complex treatment

29.09.2008, - conducted 1st automalaxoare: after tremenously right Ilium received 110 ml of automatozoni, after incubation which at 37°C for 30 minutes with 100 mg of cisplatin was introduced in/drip. Mode overhydration standard. Physiological solution introduced 1000 mg of 5-fluorouracil.

With 1.10.2008, 14.10.2008, - conducted phase I of course DHT on the AGAT-R for the area of primary focus with three fields: 2 opposite cheek-cheek size 7×8 cm and one anterior nasal field of size 5×8 see Irradiation was carried out twice a day with an interval between fractions 5 hours (1.5 G + 1.5 Gy). The total focal dose equal 32,0 from Gr (WDF=52 Units) made a scheduled break. On the lymph nodes of the neck direct field block larynx radiation treatment was carried out by 2.4 Gy per fraction, to SOD=26 from Gr (WDF=44 Ed).

With 15.10.2008, 21.10.2008, break in treatment 1 week after the end of phase 1 of the comprehensive treatment.

stage 2 complex treatment

22.10.2008, - repeated automalaxoare with the introduction of 100 mg on a background of water load and forced diuresis. Conducted infusion of 5-fluorouracil 1000 mg and 60 mg bleomycin

with 23.10.2008, 2.11.2008, break in the treatment after 2 automail the chemotherapy.

with 3.11.2008, 14.11.2008, - II stage of the course of DHT on the primary lesion twice a day for a 1.3 Gy with an interval between sessions of 5 hours (GENUS=2,4 Gr) to SOD=64 from Gr (WDF=106 IU). On the lymph nodes of the neck direct field block larynx radiation treatment was carried out by 2.4 Gy per fraction, to SOD=52 from Gr (WDF=88 Ed). Then continue on the remaining lymph nodes in the neck after topometric training locally to reforming fields to SOD=60 from Gr (WFM=101 Ed).

3 days before the start of treatment (26.09.08) the patient has taken the blood, the plasma, the determination of the activity of kallikrein showed the result is 72,72 honey/ml, which is 2.4 times higher than normal. With 29.09.08 on 14.10.08 conducted stage 1 complex therapy. 1 day after the end of the 1st stage of complex treatment (15.10.08) the patient has taken blood derived plasma and determined the activity of kallikrein, the result is 52,98 honey/ml (decreased 1.4 times does not correspond to the norm).

The status of the tumor after the first stage of treatment:

a) SRCT head and neck from 21.10.2008, cancer of the nasopharynx to the right, the dimensions of 3.5×3×1.8 cm, with heterogeneous structure, distributed in apex hole, metastases in the lymph nodes of the neck right up to 1 cm

b) an Endoscopic examination from 21.10.08 - state after chemoradiation treatment, tumor tissue is not specified, the positive dynamics expressed postradiation filmy epithelitis.

The status of the tumor through 1 month after treatment:

a) SRCT Olavi and neck from 21.11.2008, - The right path nasopharynx (mucous) infiltrated, tumor tissue is not rendered. Right exudative sinusitis, frontal sinusitis. Ethmoiditis, steroidic. The lymph nodes of the neck to 0.8 cm

b) an Endoscopic examination on 21/11/2008, - Mucous covered with purulent-fibrinous films, tumor tissue is not defined. Condition after chemoradiation treatment.

Dynamically observed in RNII without signs of recurrence and metastasis, the last turnout 18.12.10.

The patient was on regular inspection in RNII 18.12.10, with complaints of nasal congestion, difficulty swallowing and enlarged lymph nodes in the neck from both sides. Upon further examination on CRCT brain - education nasopharynx of 5.4×6,0×4.5 cm with a spread in the oropharynx, the lymph nodes of the neck on both sides from 3.5 to 7 cm in diameter. Conclusion: Recurrent cancer of the nasopharynx. Endoscopic examination from 18.12.2010, the whole volume of the nasopharynx busy tumor tissue, down to the soft palate. Conclusion: Recurrent cancer of the nasopharynx. Recommended: repeated courses of chemotherapy.

Were examined 46 patients with cancer of the nasopharynx, were treated in the Department of radiology, FSU RNII Ministry of health of Russia. To assess the dynamics associated with exposure treatment, the activity of kallikrein was determined before treatment and after the end of stage 1, the received digits compared with the norm. Norm thought the amount of activity of kallikrein in plasma of healthy donors. Donors activity of kallikrein plasma ranged from 12,61 honey/ml to 47,79 honey/ml (average 30,21±4.6 Miu/ml). In all patients before treatment the activity of kallikrein plasma ranged from 65,45 honey/ml to 163,6 honey/ml (average to 113.4±5.9 Miu/ml). After stage 1 of automalaxoare in combination with radiation therapy found that in 37 patients with a favorable clinical effect activity of kallikrein was decreased from 2 to 4.5 times and ranged from 21,82 honey/ml to 36,36 Miu/ml (normal range)on average 30,30±1.6 Miu/ml, which corresponded to the norm. 9 patients had no effect after application of phase 1 of the treatment, the decreased activity of kallikrein was less than 2 times and this activity ranged from 52,98 honey/ml to 120,0 honey/ml, on average 86,49±3.7 Miu/ml (not a norm).

Technical and economic efficiency of the method is its high specificity, the possibility of objective evaluation of an individual's response to comprehensive treatment, analysis on the day of blood collection that allows for timely therapeutic change mode, speed, substitute or withdraw treatment.

The specificity of the method for predicting a good effect of integrated treatment is 96%for forecasting the lack of treatment effect the KTA 84%.

A method for predicting the efficiency of complex treatment of patients with cancer of the nasopharynx, including two-step course of radiation therapy on the background of automalaxoare, characterized in that before the treatment in the blood plasma of the patient determine the individual activity of the enzyme kallikrein and then in 1-2 day after the end of phase 1 of a comprehensive treatment in the blood plasma of the patient determine the enzyme activity of kallikrein and its decline in 2 or more times in relation to the original individual activity predict the effectiveness of treatment, and when reduction is less than 2 times predict the absence of clinical effect.



 

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41 cl, 4 dwg, 17 ex

FIELD: production methods.

SUBSTANCE: method is based on the capability of defibrotide to increase the fermentation activity of plasmin and foresee the stages: a) making the contact in reactional area defibrotide, plasmin and substrate specific for plasmin which, because of reaction, provides the defined product b) the definition of the amount of obtained product in temporary points.

EFFECT: invention allows to define the biological activity of defibrotide in comparison with standard etalon with height accuracy and big repeatability.

9 cl, 6 dwg, 4 tbl, 1 ex

FIELD: medicine, oncology, molecular pharmacology.

SUBSTANCE: invention relates to a method and set for identifying the individual subjected to risk for arising in it the vascular and cancer disease. Method involves stages for the quantitative determination of the analyte concentration, i. e. pepsinogen I (PGI), in serum sample taken in the personal individual; comparison of the analyte concentration determined by the proposed method with a method-specific boundary value for this analyte; determination of the homocysteine concentration in a serum sample taken in this individual. The set comprises the combination of separate components that are necessary for the quantitative determination of the PGI concentration. Method provides the early detection of the possibility for arising the vascular and cancer disease in the patient.

EFFECT: improved method for assay.

4 cl

The invention relates to medicine, in particular to the creation of a new pharmaceutical compositions containing collagenase microbial origin

The invention relates to biotechnology, medical Microbiology, concerns the detection hydrolytically active enzyme, in particular aspartic protease in a sample or preparation

The invention relates to biotechnology and can be used for the development of anti-NPC therapeutic agents

FIELD: medicine, oncology, molecular pharmacology.

SUBSTANCE: invention relates to a method and set for identifying the individual subjected to risk for arising in it the vascular and cancer disease. Method involves stages for the quantitative determination of the analyte concentration, i. e. pepsinogen I (PGI), in serum sample taken in the personal individual; comparison of the analyte concentration determined by the proposed method with a method-specific boundary value for this analyte; determination of the homocysteine concentration in a serum sample taken in this individual. The set comprises the combination of separate components that are necessary for the quantitative determination of the PGI concentration. Method provides the early detection of the possibility for arising the vascular and cancer disease in the patient.

EFFECT: improved method for assay.

4 cl

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