power of science implemented in life quality improvement of the effectiveness of radiation therapy...

power of science implemented in life quality

Improvement of the effectiveness of radiation

therapy with radiomodification by Polyplatillen

and Fluoropyrimidine

Yu.V.Dumansky 1, N. G. Semikoz 1, G.S. Efimova2, I.N. Grishina3

1 Donetsk National Medical University named after M. Gorky,2 Kharkovsky Regional Clinical Oncology Center3 Cherkassy Regional Oncology Center

PolyplatillenPolyplatillen®®platinum on DNA carrierplatinum on DNA carrier

POLIPLATILLEN POLIPLATILLEN ®®

- Does not cause :

•hemotoxicity

•nephrotoxicity

•ototoxicity

•neurotoxicity

- does not hit hematopoietic stem cells from bone marrow

- does not develop resistance

- reduces the damage to the peripheral blood and organs during radiation

injuries


Open randomized multicentre trial

807 patients

The main group The control group

Quantity of patients

406 401

Treatment

Polyplatillen

Tegafur

Reosorbilakt

Radiation Therapy according to the

order of Ministry of Health of

Ukraine № 554, 645, 247

Tegafur

Reosorbilakt

Radiation Therapy according to the

order of Ministry of Health of Ukraine

№ 554, 645, 247


Localization of the tumor process The main group

The control group

Tumors of the maxillofacial area and neck stage III - IV with metastases on one or two sides

158 148

Tumors of the reproductive system of women stage I B - III 116 120

Tumors of the rectum stage II - III B 69 65

Breast tumors stage II B - III B with metastases in lymphatic nodes as a result of disease progression on the background of chemotherapy

41 50

Esophageal tumors stage III - IV 18 16

Brain tumor: anaplastic astrocytoma, anaplastic (malignant) meningioma

4 2

Distribution according to the localization of the tumor process


The scheme of the treatment of the main group

week assignment total radiation dose

1st week Radiation, chemotherapy, detoxification therapy: Polyplatillen intravenously weekly 200mg/m2

Tegafur daily oralReosorbilakt intravenously weekly on the 2nd - 3rd day of exposure, 200-400mlRadiotherapy single radiation dose 2 Gray, 5 times a week

Up to the total radiation dose 40-45 Gray

2nd week

3rd week

4th week

5th week

The interval between courses of treatment6th week

7th week

8th week

9th weekRadiation, chemotherapy, detoxification therapy

Up to the total radiation dose 64-70 Gray

10th week




Results of treatment

complete regression

partial regression

stabilization progress

The main group

The control group

The main group

The control group

The main group

The control group

The main group

The control group

Patients, % 18 858

more than 60-70 %

45not more than 50%

24 42 5

Tumors of the reproductive system of women

31% of patients of the main group managed to hold radical surgery




complete regression

partial regression


The main group

The control group

The main group

The control group

The main group

The control group

The main group

The control group

Patients, % 8 1 76 50 16 36 13

Tumors of the maxillofacial area and neck




partial regression stabilization

The main group The control group The main group

The control group

Patients, % 100 up to 80% tumor

10up to 50% tumor

90

Tumors of the esophagus




Tumors of the rectum

-- subjective improvement of the the general condition in 70% of

patients

-- reduction of pain

-- reducing the overall weakness

-- reducing the amount of blood and mucus secretions

-- according to a sigmoidoscopy - reducing the size of the tumor and

bleeding

-- with digital examination - the appearance of the tumor mobility

-- In patients with a main clinical group with localization of the oncological

process in the lowerampullary and anal part of the rectum, after the course

of treatment was almost 100% of tumor regression




complete regression

partial regression


The main group

The control group

The main group

The control group

The main group

The control group

The main group

The control group

Patients, % 20 12 54 48 22 22 4 18

Breast tumor



Summarized results of the treatment for all localizations

scheme is effective scheme is ineffective

The main group The control group The main group The control group

n=336

82,7%

n=228

56,8%

n=70

17,3%

n=173

43,2%

3rd grade toxicity in the main group - 5.8% and 4.4% in the control group



Conclusions

Carrying chemotherapy with low toxic platinum drug Polyplatillen and oral

fluoropyrimidine Tegafur with simultaneous use of radiation therapy:

● enhances subjective and objective effectiveness of the treatment from 56.8% to

82.7%

● allows for enhanced cytotoxic effect on the tumor due to synergies effects of

drugs with different mechanisms of action and toxicity profile



Conclusions

● allowed to increase by 25.9% positive responses of primary tumors, namely the

cases of partial and complete regression

● did not enhance the toxicity of treatment. Comparison of the data analysis of the

frequency of negative phenomena III degree 5.8% and 4.4% in both groups

indicates the same toxicity profile for both regimens of treatment



www.polyplatillen.com.ua


http://www.polyplatillen.com.ua/

power of science implemented in life quality improvement of the effectiveness of radiation therapy...

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