Method of neoadjuvant chemoradiotherapy in patients suffering from thoracic esophagus cancer

FIELD: medicine.

SUBSTANCE: invention refers to medicine, oncology and to be used for neoadjuvant chemoradiotherapy in the patients suffering from thoracic oesophagus cancer. Said therapy is ensured by introduction of cisplatin and leucovorin, and continuous intravenous infusions of fluorouracil dosed 300 mg/m2. Cisplatin solution is introduced intravenously drop-by-drop and dosed 6 mg/m2 daily once a day within 1 hour. Leucovorin is injected intravenously jet-like and dosed 30 mg/m2. Radiotherapy involves daily fractions 3 Gy to total basic dose 30 Gy. The course dose of fluorouracil is 3600 mg/m2, of cisplatin is 72 mg/m2, of leucovorin 360 mg/m2. Chemotherapy and radiotherapy are to be started the same day.

EFFECT: disclosed method allows for considerably reduced toxicity of treatment to be continuous, treatment of the patients originally of bad performance status, for doubly reduced time of neoadjuvant treatment with maintaining high clinical effectiveness.

2 ex

 

The invention relates to medicine, namely to the combined use of chemotherapy and radiotherapy, and is intended to enhance the antitumor effects of radiation therapy in the neoadjuvant regimen in patients with cancer of the thoracic esophagus.

Increasing the resectability in patients with cancer of the thoracic esophagus and attempt to improve long-term outcomes contribute to the emergence of new antitumor combinations, including through a combination of radiation therapy and chemotherapy.

The basis for selection of chemotherapy in combination with radiation therapy was two works from Japan [1, 2], which were given high immediate results of treatment with low toxicity due to prolonged administration of cytostatics. The authors have introduced neoadjuvant the drug 5-fluorouracil as a continuous infusion at a dose of 250 mg/m2, cisplatin 5 mg/m21 hour before radiotherapy, leucovorin (30 mg/m2. Then radiotherapy was performed on the region of the esophagus 2 Gy per day to a total dose of 40 Gy.

However, this method of chemoradiation treatment has a number of disadvantages. First, the radiation therapy in the traditional mode of fractionation at a dose of 40 Gy in 4 weeks followed by a break in treatment for 2-3 weeks needed for ku is investing radiation reactions, is long enough (about 6-7 weeks), which requires additional costs for hospitalization and delays the timing of surgical treatment. Secondly, the prolonged introduction of drugs during this period is poorly tolerated by patients, which significantly reduces the quality of life.

The aim of the invention is the reduction of toxicity, as a consequence, the possibility of treatment for patients in poor General status (Karnofsky index = 70%); the reduction of treatment time; the length of hospitalization, while maintaining the high efficiency of treatment.

This goal is achieved by the introduction of mode fractionation radiotherapy at a total dose of 30 Gy at 3 Gy per fraction, 5 times a week for 2 weeks and by reducing the duration of treatment up to 3 weeks, increasing doses of cytostatics, enter daily: cisplatin 6 mg/m2, fluorouracil at a dose of 300 mg/m2, leucovorin (30 mg/m2.

The mentioned combination and sequence of distinctive actions are not known and are not derived explicitly from the current level of science and technology, therefore, the inventive method corresponds to inventive step.

The method is as follows.

After the examination to clarify the stage of the disease and obtain morphological confirmed what I cancer of the thoracic esophagus before treatment all patients perform catheterization of the subclavian vein by the Seldinger. Begin ongoing (hour), long-term (throughout the course of radiation therapy) intravenous fluorouracil at a dose of 300 mg/m2a day via infusion pump. Heading dose of 3600 mg/m2. In parallel with the introduction of fluorouracil, once a day, daily, intravenously, within 1 hour injected cisplatin 6 mg/m2400 ml of 0.9% saline solution. Heading dose of 72 mg/m2. Once a day (before radiation therapy, intravenous, jet within 3-5 min, administered leucovorin (30 mg/m2. Heading dose of 360 mg/m2. Chemotherapy and external beam irradiation start in one day. Within 30-60 min after injection drugs all patients receive external beam irradiation for breast esophagus, paraesophageal tissue and lymph nodes of the mediastinum with a single focal dose of 3 Gy, 5 times a week up to a total focal dose of 30 Gy. 7-10 days after the end of treatment check-up examination and perform surgical treatment in the amount Subtotal resection of the esophagus. The General term neoadjuvant treatment is 21-24 days.

Said treatment conducted in 27 patients with cancer of the thoracic esophagus, which in neoadjuvant mode conducted simultaneous production of the radiation treatment by the proposed method, thanks to all the patients received treatment in full, without interruption, toxic reactions of III degree was not observed. Reduction of toxicity has made possible the treatment of some patients with Karnofsky index = 70%. Reduced treatment time from 6-7 weeks to 3 weeks. The immediate effectiveness of the treatment was 70.4%, taking into account the stabilization of the tumor process - 100%.

Here are clinical examples of the use of the method.

Example 1. Patient P., aged 63, clinical diagnosis: Cancer of the middle third of the thoracic esophagus T3N0M0 IIA Art. Dysphagia III Art. the Histological conclusion squamous cell carcinoma moderate degree of differentiation. According to the survey, the length of the tumor in the esophagus was 3 cm, soft tissue component by x-ray 2,5 see as neoadjuvant chemoradiation treatment of the patient was performed radiation therapy in total ML 30 G, were carried out in parallel infusion of cytotoxic drugs: cisplatin 6 mg/m2, leucovorin (30 mg/m2bolus, fluorouracil at a dose of 300 mg/m2in a continuous infusion throughout the duration of radiation therapy (12 days). Complication - nausea II. Through 7 days after the end of chemoradiation therapy performed x-ray and endoscopic examination, which did not reveal the presence of a tumor in the esophagus. E is e after 3 days the patient was performed Subtotal resection of the esophagus with simultaneous formation of the esophago-gastric anastomosis in the neck. The histological conclusion therapeutic pathomorphosis of the fourth degree. The patient was discharged in satisfactory condition.

Example 2. Patient W., 52 years, clinical diagnosis: Cancer of the middle and lower third of the thoracic esophagus T3N0M0 IIA Art. Dysphagia II Art. the Histological conclusion squamous cell carcinoma moderate degree of differentiation. According to the survey, the length of the tumor in the esophagus was 5 cm, soft tissue component by x-ray 3 see as neoadjuvant chemoradiation treatment of the patient was performed radiation therapy in total ML 30 G, were carried out in parallel infusion of cytotoxic drugs: cisplatin 6 mg/m2, leucovorin (30 mg/m2bolus, fluorouracil at a dose of 300 mg/m2in a continuous infusion throughout the duration of radiation therapy (12 days). Complications nausea I degree. Through 7 days after the end of chemoradiation therapy performed control tests, which revealed a tumor resorption 80%. After 3 days the patient was performed Subtotal resection of the esophagus with simultaneous formation of the esophago-gastric anastomosis in the neck. The histological conclusion therapeutic pathomorphosis of the fourth degree. The patient was discharged in satisfactory condition home.

Thus, the inventive method can significantly reduce the toxicity of treatment and to complete all clients who am the planned treatment without interruption, allows for the treatment of patients in the original bad General status (Karnofsky index = 70%); leads to a twofold reduction of the time neoadjuvant treatment while maintaining high immediate effectiveness of therapy.

Literature

1. Shimoyama S, Aoki F, Kojima J, Kaminishi M. A case of complete response to esophageal cancer by a novel concurrent chemoradiation therapy. Hepatogastroenterology. 1999 Jul-Aug; 46(28): 2409-13.

2. Itoh Y, Fuwa N, Matsumoto A, et al. Concurrent chemoradiotherapy using a protracted infusion of low-dose CDDP and 5-FU and radiotherapy for esophageal cancer. Nippon-Igaku-Hoshasen-Gakkai-Zasshi. 1999 Jul; 59(8): 395-401.

The way neoadjuvant chemoradiation therapy in patients with cancer of the thoracic esophagus, including the introduction of cisplatin and fluorouracil, characterized in that it further administered leucovorin, the solution of fluorouracil injected hour infusion at a dose of 300 mg/m2solution of cisplatin is administered at a dose of 6 mg/m2daily once a day by intravenous drip for 1 h, and leucovorin is administered at a dose of 30 mg/m2intravenous bolus, radiation therapy performed by fractions of 3 Gy daily until the total focal dose of 30 Gy, and the dose rate of fluorouracil is 3600 mg/m2, cisplatin 72 mg/m2, leucovorin 360 mg/m2, chemotherapy and radiation therapy is started in one day.



 

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1 ex

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2 ex, 2 tbl

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2 ex

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2 ex

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2 ex, 14 tbl, 3 dwg

FIELD: medicine.

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1 ex

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3 tbl, 2 ex

FIELD: medicine.

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3 cl, 4 tbl

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