The method of treatment of malignant tumors of the pancreas


(57) Abstract:

The invention relates to medicine, namely to Oncology, and can be used for the treatment of malignant tumors of the pancreas. It is suggested to fat oily chemo-embolization of the pancreas on the background of the application of sandostatin, using 1/5-1/3 of the dose of chemical at its introduction into the artery supplying the tumor, with the reduction of their blood flow distal to the introduction of chemotherapy drugs. The method allows to reduce the overall toxic effect of chemical and improve the quality of life of patients. 2 C.p. f-crystals.

The invention relates to medicine, more specifically to Oncology, and can find application in the treatment of malignant tumors.

Pancreatic cancer (PC) is a disease with extremely poor prognosis. At the time of diagnosis 75-85% of patients with PC have irresectable tumors. Five-year survival rate is 0.4 - 3.0% and is observed only in patients, tumor diameter not exceeding 2 see the life Expectancy of radically operated patients is in the range from 6 to 23 months. Patients with locally common, irresectable tumor live 6 - 8 months, PQS rule, accompanied by growing pains with the localization of the tumor in the pancreatic head (PJ) - duodenal and biliary obstruction.

Low efficacy of surgical treatment but in most cases its inability motivates us to search for new ways to extend the life of these patients and improve their quality.

Known methods of systemic chemotherapy FPW. However, the sensitivity of most chemotherapy remains quite high that it is not possible to achieve with this introduction therapeutic drug concentrations in the tumor tissue.

Most often for the treatment of cancer of the pancreas is used chemoradiotherapy. - Conducted randomized studies have shown significant differences between combination therapy and isolated administration of each component. So, chemoradiotherapy in combination, 60 G 5 - fluorouracil is the most effective scheme and allows the average survival rate from 4.8 to 10.5 months. [1]. However, chemoradiotherapy does not reduce the likelihood of metastatic lesions of the liver.

Closest to the present invention is a method of treatment FPW by selective bodenheimeri at PC is used since 1983 [2]. However, the results are comparable with chemoradiation therapy, and are sometimes even worse [1], this can be explained by the fact that, first, the blood supply to the pancreas is from multiple sources, namely, from the branches from the common hepatic, gastroduodenal, upper mesenteric and splenic arteries, which are widely anastomose with each other. Secondly, a tumor of the pancreas is characterized by a relatively poor blood supply : blood flow in normal tissue is 87 ml/min/100 g, whereas in its tumor - 45 ml/min/100 g [3]. As a result of these features of the chemical rapidly leaves the region of the tumor. The increase of the duration of the session of chemotherapy by infusion is limited to 5 days is the maximum allowable period of stay in blood stream of the patient introduced percutaneous arterial catheter. The prolonged exposure to high concentrations of the drugs due to frequent sessions regional chemotherapy inevitably leads to an increase in total dose chemotherapy and General toxic effect and, as a consequence, the quality of life.

The technical result of the present invention is to reduce the overall toxic dehornoy chemotherapy, at which, according to the invention, the chemotherapeutic drug is administered in the radiopaque oil in the amount of 1/5 - 1/3 of its dose in the arteries supplying the tumor, pre-reducing the blood flow in them is distal to the introduction of chemotherapy drugs directly before the introduction of it in the same artery is injected at 0.05 - 0.1 mg sandostatin, within 3-4 days after injection of chemotherapy drugs continue introduction of sandostatin subcutaneously 2-3 times a day in amounts of 0.05 mg / introduction, with such chemotherapy perform repeatedly with an interval of at least 1 month.

It is advisable as chemotherapy using doxorubicin or Gemzar, and as a radio-opaque oil - lipiodol in the amount of 3-10 ml

Know the use of gimigiano embolization in the treatment of malignant liver tumors [4] by sequential introduction of chemotherapy in the radiopaque oil initially in reduced blood flow of the artery with subsequent overlapping the latter, and then in reduced blood flow of the portal vein. This creates conditions for prolonged contact of the chemical with the tumor due to limited its removal from the liver due to a sharp reduction in the blood supply. As a result of this chemical is Crozat. Using this type of chemotherapy in the treatment of malignant liver tumors is justified by the fact that the liver has a dual blood supply from the hepatic artery and portal vein. Dosed, by creating a fat embolism, a blood flow disorder is well tolerated hepatic tissue. However, for the pancreas such conditions chemotherapy unacceptable. She eats only due to arterial blood flow and overlap it is associated with the risk of acute pancreatitis. Any damaging tissue mud factors (mechanical trauma, toxic exposure, ischemia etc) can cause the progression of it and cause severe complications and even death of the patient. In our opinion, the possibility of such consequences deters clinicians from the use of chemoembolization mud.

Doing professionally for many years the treatment of acute pancreatitis, we know that the autolysis mud occurs in the intraorganic activation of proteolytic enzymes cytokinesis released during cell death of cancer. Blocking the synthesis of inactive forms of enzymes with synthetic somatostatin currently used in the treatment and profilaktika derived natural somatostatin, immediately before the chemical embolizarea mud to block the production of an inactive form of the enzyme mud and prevent autolysis under the action of the input then chemotherapy. Because tumor vessels do not have the muscle membrane, regional intraarterial chemotherapy is often carried out on the background of the introduction of the synthetic analogue of the hormone angiotensin II with the aim of strengthening regional action of chemotherapy on the tumor. However, a significant drawback of this combination is pronounced systemic vazopressornye effect of angiotensin-II, which limits, as we believe, the possibility of its application in the implementation of chemotherapy, especially in the elderly because of the high risk of cardiovascular complications. Unlike angiotensin, vazopressornye effect of somatostatin is limited only by the arteries of the abdominal cavity. Hence, intra-arterial injection of chemotherapy drugs along with sandostatin, in our opinion, should contribute to electoral redistribution chemoembolization between healthy and tumor tissue mud. Moreover, as evidenced by clinical data, sandostatin well tolerated by all categories of patients.

With a student who was in a cancer patient mud stage IV to prevent the development of severe forms of acute pancreatitis with the introduction of doxorubicin in contrast oil. After performing chemoembolization introduction of sandostatin continued for several days.

The success of the treatment has allowed us to continue running chemoembolization mud in developed conditions with positive results, which date back to this time 6 cases.

Introduction chemotherapy is having a devastating effect on tumor cells, while damaging healthy cells mud. However, the introduction of sandostatin avoids destructive forms of pancreatitis. However, chemotherapy drugs, disrupting cellular metabolism, reduce the exocrine function of the mud, which further leads to the reduction of the risk of acute pancreatitis. Arising in postembolization period the fibrosis tissue mud increases its resistance to ischemia, which makes it more secure repeat courses of chemotherapy.

The introduction of chemotherapy in the form of oil solution or suspension provides a more long-term presence in the area of the tumor compared to aqueous infusion, which greatly increases the effectiveness of the treatment. Moreover, the use of soft x-ray contrast substances allows control of the arterial branches, which are widely anastomosis in glandular tissue, reduction of blood flows distal to the introduction of chemotherapy helps, first, to reduce its revenues to the General blood flow, which significantly reduces the overall toxicity, secondly, makes possible local reduction in blood flow without fatal consequences and, thirdly, can create the necessary concentration of the chemical in the tumor at a lower dose of it - as we have shown, a positive therapeutic effect is achieved when using 1/5 - 1/3 of its single dose.

All the above indicates a relatively mild conditions of implementation of the proposed chemoembolization, which is well tolerated and allows repeated it again with the aim of maintaining a constant concentration of chemical in the tumor. In addition, the use 1/5-1/3 of a single dose of chemotherapy allows for repeated his introduction every month to maintain the proper concentration in the tumor without the risk of serious complications. The life expectancy treated in this way patients with III-IV stage FPW is to date from 9 to 16 months, with satisfactory quality of life.

Cosmostigma them. Acad. I. P. Pavlova 8.04.97,, history N 4608. Diagnosis: cancer of the head of the pancreas stage IV, T 4 N 1 MO. Cholecystectomy, the imposition of hepaticoenterostomy 31.10.96, the Histological conclusion adenocarcinoma. Upon receipt complained of constant aching pain in the right hypochondrium, increased pain after eating. Lost 14 kg General condition is relatively satisfactory. Skin and visible mucous few pale, white sclera. The liver is not enlarged, no ascites. Ultrasonography in pancreatic head hypoechoic with rough contours education dimensions 45 x 36 mm According to fluoroscopy of the stomach - subcompensated stenosis postbulbar Department of the duodenum due to compression from the outside. 18.04.97 was done arteriography of the pancreas. Discovered that a tumor of the pancreatic head krovosnabzhayutsya mainly of short branches of the gastroduodenal artery. Selectively in the vessels feeding the tumor, added: sandostatin 0.1 mg in 5 ml saline, doxorubicin 10 mg/m2(the recommended dose is 30-60 mg/m2), substance, 4 ml for five days, there has been increased polylactic pancreatitis during the first three days were injected with 0.05 mg sandostatin x 3 R/day. Increase of amylase in blood and urine were observed. Within 7-10 days postembolization period of observed phenomena decompensation stenosis postbulbar Department of the duodenum and subsequent restoration of patency. In a satisfactory condition and was discharged for outpatient treatment. Later from the hospital to the clinic for follow-up examination was refused. Gained weight, phenomena disorders of the passage of food through the duodenum was not observed, abdominal pain wore moderate stoped tablets analgesics. Felt good until the end of June 1998, when the newly increased abdominal pain became progressively lose weight. In June pathological fracture of the right shoulder. The radiological examination diagnosed metastatic tumors in bone. August 21, 1998 the patient died after 16 months after execution gimigiano embolization of malignant tumors of the pancreatic head.

Example 2. Patient D. 48 years, history N 1465, was admitted to the hospital 17.04.99 year , 11 months from the onset of the disease, diagnosis: cancer of the head of the pancreas stage IV. Upon receipt complained of persistent intense the l 11 months ago in the last 4 months, began a sharp deterioration of the General condition, has been a notable weight loss. Itself has defined intra-abdominal tumor, because of increasing weakness and pain was forced to leave work. Surveyed by place of residence, clinically established stage IV disease. MRI 29.03 99, the size of the tumors in the pancreatic head 77 x 93 mm Last month the effect of non-narcotic analgesics became ineffective. Upon admission to the clinic is a state of moderate severity. The skin and sclera normal color. Ascites no. Palpation of the abdomen is determined by fixed hilly tumor filling the subhepatic space. MRI and ultrasound, tumor diameter is 110 mm, metastatic lesions of the liver, and increased regional lymph nodes is not defined. Ultrasonic doplerometriya indicates the hypervascular nature of the neoplasm. The study material of fine-needle biopsy of the tumor is poorly differentiated adenocarcinoma of the pancreas, chronic pancreatitis.

7.05.99, the patient was about the Noah gland was determined rounded hypervascular education, containing tumor vessels. Carried out the reduction of the distal part of the gastroduodenal artery fragments of metal spiral, then made her oily chemo-embolization of the proximal branches that supply most of the tumor, 10 mg doxorubicin in 3 ml of lipiodol. Postembolization period proceeded with minor pain intensity. Prevention of acute pancreatitis in the course of three days was conducted infusion therapy: sandostatin 0.05 mg 2 R/d. During the observation level of amylase in blood and urine remained within normal values. When the control gastroduodenoscopy changes from the mucous membrane of the stomach and duodenum was not found. On the 7th day marked decrease in pain compared with diabolization period. On the 9th day the patient was discharged from hospital. Felt good, the pain was not renewed. Given the clinical benefit and tolerability of therapy, 6.06.99, the procedure was performed again. Control angiograms tumor size was somewhat reduced vascularization it fell. Distal branches previously Ambrosiano gastroduodenal artery participation in the blood supply of the tumor was not accepted. The main power source astmh/m2doxorubicin in 5 ml lipiodol. Postembolization period proceeded without signs of pancreatitis, increased pain was transient in nature. On day 7, the patient was discharged to outpatient treatment. Felt good, abdominal pain, disturbed only when violations of the diet, gained weight 4 kg, significantly decreased weakness, with 26.06.99, went back to work.

6.09.99 was hospitalized for the third time with the aim of monitoring and further treatment. The patient's health is good, pain in the abdomen anecdotal. By ultrasound dimensions of education 137 x 95 x 66 mm, contours equal, precise, portal vein is passable. The common bile duct is not expanded.

16.09.99, angiography of the superior mesenteric, celiac, common hepatic, and pancreatic arteries. Marked stabilization of the tumor process. On angiograms compared with previous studies, the size of the tumor in the pancreatic head slightly decreased, significantly decreased vascularization, is determined by the improvement of blood flow in the portal vein. Made chemioterapia embolization: 200 mg/m2the Gemzar (recommended dose of 1000 mg/m2) in 5 ml of lipiodol after jet injection of 0.05 mg sa the pancreatitis was conducted according to the standard scheme, increase amylase urine was not observed. In a satisfactory condition the patient was discharged to outpatient treatment.

Example 3. Patient P., 43 years old, was admitted to the clinic in cnerry 22.06.99,, history N 1887. Diagnosis: cancer of the head of the pancreas stage IV, T4 MO Nx. The histological conclusion: adenocarcinoma of the average degree of differentiation. Upon receipt complained of almost constant pain in the epigastrium and podrebarac with irradiation in the back. Noticeable weight loss in the last three months. Considers herself a patient 27.02.99, when first appeared and remained expressed epigastric pain with radiation to the back. Ultrasound in the clinic at the place of residence 9.03.99 g found education in the area of the isthmus of the pancreas dimensions 39 x 33 mm When viewed overall condition is relatively satisfactory. The skin is a normal color, white sclera. The abdomen is soft, painless. The liver is not enlarged. Ascites no. Ultrasound - education of the head with the transition to the isthmus of the pancreas, size 66 x 53 x 43 mm, heterogeneous, with individual large vessels and increased blood flow. The bile duct is not slated to be actually extended to obrazovce - the bulb of the duodenum deformed due to compression from the outside. In sanluqueno Department, on the medial wall of germination mucosal ulcer on the area of 25 x 15 mm

6.07.99, with angiography in the projection head of the pancreas is determined hypervascular education oval in shape, size 20 x 50 mm, with signs of malignancy, turning on the gate region of the liver. The main source of blood supply to tumors are the proximal branches of the gastroduodenal artery, which in the projection of the tumor narrowed and sourirajan. There are also lots of usuali hepatic artery, branches of which are also involved in the blood supply of the tumor. Defines a constriction in the connections pane of the portal and splenic veins, in place of the discharge of the left portal vein from the main stem, the flow hepatopathology. Angiographic pattern corresponds to a malignant tumor in the pancreatic head with signs of presentability. Performed distal embolization of the gastroduodenal artery multiple pieces of metal spiral jet in 5 ml of 0.9% NaCi entered 0.05 mg sandostatin, then made the oily chemo-embolization of the proximal branches gastroduodenoscopy the period was characterized by increased pain. During the first day was observed nausea, double - vomiting. There was an increase amylase urine returned to normal level on the third day, respectively: 5365 - 1953 - 485 (normal up to 700 u/L). Prevention was performed destructive pancreatitis introduction of sandostatin 0.05 mg x 3 times subcutaneously, detoxification infusion therapy in a volume of 2000 ml per day. On the second day of clinical signs of pancreatitis regressed the observed decrease pain. If fibrobronchoscopy 13.07.99 noted the presence of edema and ulcerations in the field of germinating the wall of the intestine tumors, changes from the rest of the mucous membrane of the stomach and duodenum were observed. On the 8th day after the procedure was discharged for outpatient treatment.

Was admitted to the hospital again, two months after chemoembolization. Pain in the upper abdomen is moderate, removable preformed analgesics. The General condition is satisfactory. The skin and sclera normal color. Loss of body weight no. Clinical analysis of a blood: a Hemoglobin - 103 g/l, erythrocytes-3.5 1012the platelet - 184 109leukocyte - 6.5 109. Ultrasound 7.09.99, the liver is homogeneous, no ascites. In the head the COP bile in the stomach. The bulb of the duodenum deformed, is permeable, the size of ulceration of the mucous membrane on the bottom wall decreased to 8 mm

14.09.99, with angiography of the superior mesenteric, celiac, common hepatic artery compared with the previous study, the size of the tumor of the pancreas has increased. In the field of head cancer, subjected chemoembolization, vascularization significantly reduced tumor growth almost none. Growth is projected gland, blood flow to this area has evolved from small branches byeeeee artery. By the proposed method performed their chemioterapia embolization. The procedure satisfactorily, continues to occur.

The proposed method is compared with the known has a number of advantages:

1. The method can reduce the General toxic effect of an administered drugs by depositing them directly into the pancreas and reduce their dose, while the known methods of regional infusion therapy are accompanied by high General toxicity.

2. The result of the use of this minimally invasive method for inoperable patients achieved on the duration Islamova drug to 1/5-1/5 the recommended dose, that reduces the overall toxicity of its validity.

The method developed in the Department of endovascular and operative surgery of the Central research radiology Institute, staff cnrri and Department of surgical Hepatology, St. Petersburg state University. Acad. I. P. Pavlov and was clinically tested in 6 patients with a positive result.


1. Lionetto R , Pugliese V. et al. No standard treatment is available for advanced pancreatic cancer // Eur.J. Cancer. - 1995 V. 31A, N. 6. - P. 882-887.

2. Muchmore G. H., Preslan J. I., Gorge W. J. Regional chemotherapy for pancreatic carcinoma. // Cancer. - 1996. - V. 78, - N 3, Suppl. 1. - P. 664-673.

3. Fiorentini G. , et al. Intra-arterial chemotherapy for stage 3-4 pancreatic cancer. // Digestive Surgery. - 1997. - V. 14, N 2. - P. 113-118

4. The granov A. M. "a Method for the treatment of malignant liver tumors" Patent N 1420696, MKI 17/00 A 61.

1. The method of treatment of malignant tumors of the pancreas by regional chemotherapy, wherein the chemotherapeutic drug is administered in the radiopaque oil in the amount of 1/5 - 1/3 of its dose in the artery supplying blood to a tumor, pre-reducing the blood flow in them is distal to the place of its introduction, just before the introduction of chemotherapy drugs eccii of subcutaneous sandostatin 2 - 3 times a day, 0.05 mg, and this dose chemotherapy perform repeatedly with an interval of not less than 1 month.

2. The method according to p. 1, characterized in that as chemotherapy using doxorubicin 10 mg/m2or Gemzar 200 mg/m2.

3. The method according to PP.1 and 2, characterized in that the radiopaque oil used substance, in a quantity of 3 to 10 ml.


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