Integrated therapy of stomach cancer

FIELD: medicine.

SUBSTANCE: invention concerns medicine, namely oncology, and can be used for integrated therapy of stomach cancer. The therapy involves surgical procedure and pharmacotherapy. For 3-7th postoperative day, removal of drainages is immediately followed with endolymphatic infusion with single-stage introduction of 5-fluorouracil 750 mg, etoposide 100 mg and ceftriaxon 3.0 g in total amount up to 20 ml. The procedure is performed every 7 days.

EFFECT: application of the invention provides prevention of local recurrence of stomach cancer in the early postoperative period ensured by action on subclinical micrometastases in lymphatic channels, reduces risk of postoperative pancreatitis due to inhibitory action of 5-fluorouracil on pancreatic secretion and rate of postoperative intra-abdominal inflammatory processes owing to ensured great concentration of antibacterial preparations in abdominal cavity.

2 ex

 

The present invention relates to medicine, namely to drug therapy, and can be used in Oncology for the combined treatment of gastric cancer.

Gastric cancer remains a critical problem in modern Oncology, occupying a leading position in terms of morbidity and mortality both in Russia and around the world (Davydov M.I., Axel E.M. Statistics of malignant neoplasms in Russia and the CIS in 2005, Bulletin of the Russian oncological scientific center named. Non Russian Academy of medical Sciences, 2007, № 2, volume 2). Surgery is the primary, and in most cases, and the only method of treatment of malignant tumors of the stomach (Utkin KG, ALEXANDER Vazhenin Epidemiology of esophageal cancer, stomach (literature review). Academic journal of Western Siberia, Oncology, 2006, No. 5, 21-23). However, despite the advances in surgical techniques and the expansion of operations long-term results of treatment for forms of the disease, which is not early (T1NanyMO), not always can be considered satisfactory (Adachi y, Kamakura T., Mori M., Maechara Y. - Role of lymph node dissection and splenectomy in node-positive gastric carcinoma. Surgery 1994, 116(50): P.837-841). Indicators 5-year survival rate is already at stage II disease should not exceed 65%, and domestic data are 46-48% (Merabishvili V.M. gastric Cancer: epidemiology, prevention, assessment effective is STI treatment at the population level. Practical Oncology. 2001. № 3(7), p.3-8). One of the main reasons for poor long-term results of surgical treatment is intra-abdominal relapse: relapse in the Loco-regional area and peritoneal dissemination. According to J.J.Boneukamp 1999 the incidence of Loco-regional recurrence after surgery with LAE D2 is 27% (Bonenkamp J.J., Hermans j, Sasako m, van de Velde, C. J. H., for the Dutch Gastric Cancer Group.Extend lymph node dissection for gastric cancer. // N. Eng. J. Med. - 1999. - Vol.340. No. .12. - P.908-914), according to Vigesaa 2000 to 15.9% (State of cancer care to the population in Russia in 1999. Edited Weissova, Tel. Moscow, 2000). Katai N, examining the structure of recurrence after surgical treatment of gastric cancer, reports about 23% local recurrence and 44% of peritoneal dissemination (Katai N, Maruyama K., Sasako M, et al. Mode of recurrence after gastric cancer surgery. Dig. Surg., 1994, 11, 99-103). The extension of lymphadenectomy up to the volume of D3 did not show convincing improvements in 5-year survival compared to D2 (Pakhomov S.R. Use involving capecitabine as radiomodifying in the combined treatment of gastric cancer. Diss. Kida. the honey. Sciences. Nigga, 2005, 156 S.).

In connection with this important is the creation of new methods of treatment of tumors of the stomach, aimed at strengthening the Loco-regional control.

As the prototype is set to the known method of combined treatment of gastric cancer, including surgery the medical treatment (see Sidorenko US Endolymphatic polychemotherapy in the clinic. - Rostov-on-don: Publishing house of the Rostov state pedagogical University, 1998. 288 C.).

The known method is that a week before the surgery, chemo, lymphatic vessels of the foot injected antimetabolites: 5-fluorouracil at a dose of 2000 mg and methotrexate at a dose of 60 mg. dose rate drugs injected in two stages with an interval between infusions in 6 days. Then a week after chemotherapy perform the operation.

However, the known method has such disadvantages as increased time of preoperative period at 14 days, the surgical treatment in the period of maximum of toxic effects of chemotherapy drugs, effects of drugs on a large mass of the tumor, which reduces their effectiveness.

The task of the invention is the provision of opportunities for prevention of local recurrence of gastric cancer in the early postoperative period, inflammatory complications and reducing the risk of postoperative pancreatitis.

The problem is solved in that in the known method of combined treatment of gastric cancer, including surgical and medical treatment, for 3-7 days after surgery, immediately after removal of drains, conduct endolymphatic infusion, this one is the elemental administered 750 mg of 5-fluorouracil, 100 mg of etoposide and 3.0 g of Ceftriaxone total volume to 20 ml, the procedure is repeated every 7 days.

The present invention meets the criterion of "novelty" and the criterion of "inventive step", as held patent information research did not reveal sources of scientific, technical and patent information that would discredit the novelty of the proposed method, as well as technical solutions with the essential features of the invention.

Known application of the above-mentioned drugs during chemotherapy. The medications for the endolymphatic chemotherapy is selected in accordance with one of the most popular modes of chemotherapy in cancer of the stomach ELF: etoposide, leucovorin, 5-fluorouracil (guidelines for chemotherapy of neoplastic diseases. Edited Nieremontowany. M: Practical medicine. 2005). In the scheme of the ELF leucovorin administered to prolong the action of 5-fluorouracil. Given the long-term deposition of 5-fluorouracil with endolymphatic introduction, introduction leucovorin not appropriate.

In the proposed method, the authors first propose to use endolymphatic polychemotherapy in the early postoperative period immediately after removal of drains, i.e. for 3-7 days after surgery, to prevent Loco-regional recurrence of cancer geluk is, inflammatory complications and reduce the risk of postoperative pancreatitis.

The total volume of injected medicines for one introduction should not exceed 20 ml, as exceeding the specified volume is accompanied by an increase toxic effects of chemotherapy in connection with a hit of drugs in total venous bed through the lymph-venous angle (Endolymphatic polychemotherapy in the clinic. Edited by Sidorenko US Rostov-on-don: Publishing house of the Rostov state pedagogical University, 1998. 288 C.). In addition, the introduction of large volumes accompanied by an increase in the frequency of ruptured blood vessels and pain when the procedure is executed in connection with the overflow lymphatic vascular bed and regional lymph nodes. The procedure is repeated twice in different vessels of the extremities (right and left) with an interval of a week. Interval procedure due to the pharmacokinetics of drugs in the endolymphatic introduction: labeled radioactive label, a drug introduced in the lymphatic vessels of the foot, is defined in the lymph nodes and the urine within 5-7 days (Sidorenko US, Rozenko L.Y. New approaches to endolymphatic therapy on the model of locally advanced process of cervical cancer. Rostov n/D: Lapo, 2004; S. 20). Course dose is 1500 mg of 5-fluorouracil, 200 mg etoposide is, 6.0 g of Ceftriaxone.

The proposed method allows to obtain the following benefits :

Carrying out manipulations in the early stages after surgery provides the effect of drugs on the most open in the postoperative period lymphatic collectors for the long-term effects on metastases in InfoPath and peritoneal fluid, prevention of inflammatory complications (Ceftriaxone) and reduce the risk of postoperative pancreatitis (5-fluorouracil). This allows you to increase the time of relapse-free survival, reduce the number of Loco-regional recurrence and peritoneal dissemination, to reduce the number of cases of postoperative pancreatitis and inflammatory complications that will improve long-term results of treatment of gastric cancer, the quality of life of patients operated on tumors of the stomach.

To confirm positive results 22 procedures endolymphatic chemotherapy (APT) in the early postoperative period in patients diagnosed with stomach cancer. All the patients underwent extended combined gastroplasty with LAE D2, in 6 cases, the Subtotal resection of the pancreas, due to the ingrowth of tumor in 2 cases, the resection of the left adrenal gland, in 1 case done is to resection of the splenic angle of the colon. In the studied group there were 12 women and 10 men, mean age 64.4 years (the lowest in 38 years, the biggest 71). According to histology in all patients confirmed the diagnosis of gastric cancer. The distribution of patients by stage: Art. IV - 14 cases (63,6%), III In Art. - 4 (18,2%), III And Art. - 1 (4,5%), Art. II - 2 (9,1%) and Art. I - 1 (4,5%). In most patients, the tumor had the structure of poorly differentiated or undifferentiated adenocarcinoma (73,3%), 20% are diagnosed with moderately differentiated adenocarcinoma and in 1 patient (6,7%) - well-differentiated adenocarcinoma. The first course APT was conducted on average 6.5 days: minimum 2 days, maximum of 13 days. The increase in the period until the chemotherapy is associated with a high percentage of combined operations with resection of the pancreas, which culminated in the installation of the DPS. In these cases APT was conducted on the day of replacement DPS ointment on the pad. In one case, to hold endolymphatic administration of drugs failed due to the individual characteristics of the structure of lymphatic vessels (net type structure of the vessels without the formation of trunks), this patient was not included in the study.

Registered 6 cases (27.3 per cent) of lymphangitis with slight edema of the limbs on the side of the procedure, which was easily stopped by the local application of heparin ointment and purpose of nikolaeku the popular heparins. Other local complications were noted. No cases of nausea and vomiting, changes in blood and urine and other complications specific for PCT.

Clinically significant postoperative pancreatitis registered in 1 patient (4.5%), while after gastroplasty with Subtotal pancreatectomy and resection of the left adrenal gland, from the same patient were formed subphrenic abscess reactive with left-sided pleurisy. Transient increase of amylase in blood and urine registered in 9 patients (40.9 percent). Inflammatory complications in the abdominal cavity other patients not registered.

The proposed method combined treatment of gastric cancer can reduce toxicity and improve the tolerability of the drugs, which allows to approximate chemotherapy to surgery to increase its effectiveness. Also for the first time have a positive effect EPT on the proposed scheme to the frequency of intra-abdominal inflammatory processes and postoperative pancreatitis.

This invention provides:

- As soon as possible to have a chemotherapeutic effect on subclinical metastases in the lymph paths and abdominal cavity, which prevents the occurrence of Loco-regional recurrence and improves survival.

With the new maximum concentration of chemicals in the lymph nodes, lymphatic collectors and the free abdominal cavity.

To ensure prolonged effects of chemotherapy, overlapping in time with every phase of dividing tumor cells.

To reduce the frequency and severity of postoperative pancreatitis due to the inhibitory action of 5-fluorouracil on the secretion of the pancreas.

- Reduce the frequency of postoperative intra-abdominal inflammatory processes through the creation of large concentrations of antibacterial drugs in the abdominal cavity.

Analysis of the results shows good endurance APT in the early postoperative period and its availability. Not marked by severe local and systemic complications during EPT, achieved good indicators of postoperative intra-abdominal inflammatory complications and postoperative pancreatitis despite the large volume of surgery (resection of the pancreas in 42% of cases, LAHE D2 with splenectomy 100%).

The proposed method is as follows.

Endolymphatic infusion performed immediately after the removal of drainage from the abdominal cavity for 3-7 days in order to avoid the loss of drug from discharge to drains. In the first and second interdigital spaces of the foot injected 1.5-2.0 ml of 1% solution of methylene blue or 0.4% solution of Indigo Carmine. Under m/a 0.25% races is the thief of novocaine perform a skin incision on the back surface of the foot size of 2.0 to 3.0, see Stupid by mosquitoes and eye tweezers allocate stained lymphatic vessel, after which produce a puncture and simultaneously injected 750 mg 5-fu, 100 mg of etoposide, and 3.0 g of Ceftriaxone total volume of about 20 ml. The stitches on the wound. Aseptic bandage.

The main features of the endolymphatic injection of medications:

1. the drug is injected directly into the lymphatic system and it reaches the tumor and areas of lymphogenous metastasis, bypassing the small and big circles of blood circulation and organs that its inactivation.

2. the maximum concentration of the drug in the lesion (abdominal cavity) and the minimum in the target organs of its toxic action.

3. is the deposition of drug in the lymphatic system of the affected area, which ensures its long contact with cancer cells that overlap in time more phases of the cell cycle (more likely to "catch" the cage at the most sensitive to chemotherapy phase of the cycle).

4. is the absorption of the drug proteins (albumin) and shaped elements lymph, biomodification their properties, leading to an increase of tumorotropic and reduced toxicity.

5. washing the lymph manifold pressure causes mechanical "washout" biological clots, Thu which eliminates the blockage of the lymph nodes and thereby stimulates lymphopoiesis.

6. the absorption of the drug on lymphocytes leads to activation of the latter, they migrate into the tumor tissue and dissolved with evolution of a large number of enzymes, biologically active substances, the active factors of oxygen. Tumor cells are damaged and become more active for chemotherapy.

7. introduction aggressive drugs in the lymphatic system is for her stress factors, which leads to severe immune.

8. the lymphatic system has extensive receptor relationships, irritation which activates the hypothalamic-pituitary-nadpochechnikovaya system, which leads to normalization of neurohumoral background of the organism.

Example 1

Patient A., 53 years old (case history No. 5018) was treated in state of NOT for cancer of the antrum pT2N1M0, II stage. 07.12.06, laparotomy found infiltrative-ulcerous tumor of the distal 2/3 of the stomach, not the germinating serosa, about what made gastroplasty with D2 lymph node dissection. The postoperative period is smooth. Histological study No. 25835/50 identified persinality cancer growth within the muscle layer in the lymph nodes in small and large curvature metastatic tumors of similar structure. In the postoperative period on the 4th and 10th days endolymphatic introduction of Himyar the preparations according to the scheme: 750 mg of 5-fluorouracil, 100 mg of etoposide, and 3.0 g of Ceftriaxone total volume of about 20 ml. Satisfactorily. Complications were noted. On the 14th day the patient was discharged from hospital. At the control examination of the patient in November 2007 any complaints does not show signs of disease progression no.

Example # 2

Patient U., 66 years old (case history No. 5231), was treated at the SMT of NOT for cancer of the antrum pT3N2M0, II stage. 20.10.06, laparotomy found infiltrative-ulcerous tumor of the middle third of the body of the stomach, germinating serosa, about what made gastroplasty with D2 lymph node dissection. The postoperative period is smooth. Histological study No. 26481/95 revealed poorly differentiated adenocarcinoma, growth through all layers of the gastric wall, the lymph nodes in small and large curvature, in the region of the celiac trunk and the common hepatic artery metastatic tumors of similar structure. In the postoperative period on the 5th and 12th days endolymphatic introduction of chemotherapy according to the scheme: 750 mg 5-fu, 100 mg of etoposide, and 3.0 g of Ceftriaxone total volume of about 20 ml. After the procedure was observed lymphangitis, which were stopped after the introduction of low-molecular-weight heparins and local application troxivasini ointment. At the control examination the patient in January 2008 any doubt who no complaints, during FGDs, and 3-D ultrasound abdominal signs of progression of the disease there.

The method of combined treatment of gastric cancer, including surgical and medical treatment, characterized in that at 3-7 days after surgery, immediately after removal of the drains spend endolymphatic infusion, while simultaneously injected 750 mg 5-fu, 100 mg of etoposide and 3.0 g of Ceftriaxone total volume to 20 ml, the procedure is repeated with an interval of 7 days.



 

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FIELD: chemistry.

SUBSTANCE: claimed invention relates to novel derivatives of 2,6-dihydro-7H- pyrazolo[3,4-d]pyradazin-7-one, 1,4-dihydropyrazolo[3,4-b]thiazin-5(6H)-one; N-acylated 4-imidazo[1,2-a]pyridin-2-yl- and 4-imidazo[1,2-a]pyrimidin-2-yl- anilines; amides of [(4H-thieno[3,2-b]pyrrol-5-yl)carbonyl]pyperidin-4-carboxylic acid; amides of 2-(4-carbamoylpyperidin-1-yl)isonicotinic acid; amides of N-sulfonyl-1,2,3,4-tetrahydrochinolin-6-carboxylic acid; as well as to N-acylated 3-azolyl derivatives of 2-amino-4,5,6,7-tetrahydtithieno[2,3-c]pyridine possessing properties of Hh-signal cascade inhibitors.

EFFECT: compounds can be applied for use in pharmaceutical compositions and medications for treating diseases induced by abberant activity of Hedgehog (Hh) signal system, in particular, oncological diseases, for instance, for pancreatic carcinoma treatment.

23 cl, 13 dwg, 11 tbl, 26 ex

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