Clinical Trial Of Endostar Combined With Cisplatin Hyperthermic Intraperitoneal Perfusion Chemotherapy For Malignant Ascites

BackgroundThe incidence and mortality of cancer present an increasing tendency these years in China.A variety of malignant tumors in the middle and late period can cause malignant ascites,the quality of life and survival time of patients with malignant ascites will be seriously reduced,which is a serious burden on the society.At present,there are many kinds of treatment methods for malignant ascites,but no one therapy can control the disease progression of patients with malignant ascites absolutely,so it is urgent to find a standard and effective method to treat malignant ascites.The precision medicine plan,which Obama proposed in 2015,has received strong support from both doctors and patients,government departments and the public.The precision treatment model for tumor has been recognized by the medical community and the society in particular.New targeted drug Endostar(Recombinant human vascular endostar injection)combined with classical chemotherapy drug Cisplatin for hyperthermic intraperitoneal perfusion chemotherapy was adopted in our hospital to precisely attack the tumor lesions in the abdominal cavity,thus control malignant ascites effectively.To explore the effectiveness and safety of this technology can make it reach a large-scale clinical application as soon as possible,promote the new model of precision treatment of tumors and traditional medical model combine perfectly,reduce the social burden of malignant ascites.ObjectiveTo found a safe and reliable method to control malignant ascites by comparing Endostar combined with cisplatin hyperthermic intraperitoneal perfusion chemotherapy and traditional single drug cisplatin hyperthermic intraperitoneal perfusion chemotherapy.MethodsSelect 94 patients with malignant ascites(peritoneal effusion who was diagnosed as malignant tumor by pathology)admitted to the Department of Oncology of Nanyang Central Hospital from December 2016 to May 2018 were selected and divided into the Endostar combined with cisplatin hyperthermic intraperitoneal perfusion chemotherapy group(observation group)and the single drug Cisplatin hyperthermic intraperitoneal perfusion chemotherapy group(control group).There were 46 cases in observation group,21 cases in male and 25 cases in female,48 cases in control group,22 cases in male and 26cases in female.The observation group was given 30mg Endostar+60mg Cisplatin for hyperthermic intraperitoneal perfusion chemotherapy,while the control group was given60mg single drug cisplatin for hyperthermic intraperitoneal perfusion chemotherapy.Each treatment course was applied on the 1st,4th and 7th days in both groups.After one course of treatment,compare the clinical efficacy,quality of life changes,serum VEGF value,adverse reactions between the two groups and analyse ascites progressionless time.According to the treatment plan,physical examination,b-ultrasound examination and laboratory examination were conducted on time,and recorded date.Collect data to consummate the database,using SPSS 20.0 to analyze the data,t Test was used for measurement data,andχ~2 Test was used for counting data.Results1.The efficacy was evaluated 3 weeks after a course of treatment.The data showed that 13 cases(28.3%)of patients with complete remission in Endostar group,25 cases(54.3%)of patients with partial remission,and 82.6%of ORR.In the cisplatin group,9cases(18.8%)had complete response,20 cases(41.7%)had partial response,ORR60.4%.It can be seen that the ORR comparison between the two groups was statistically significant,P<0.05.2.After treatment,anorexia,abdominal pain,abdominal distension,oliguria,dyspnea,activity restriction and other symptoms were improved in both groups.The results showed that the improvement rate of QOL(quality of life)was 84.8%in the observation group and66.7%in the control group,and the difference in QOL improvement rate between the two groups was statistically significant,P<0.05.3.The value of VEGF decreased,especially in the observation group.The difference of VEGF values between the two groups was statistically significant,P<0.05.4.All subjects who participated in the study did not experience severe IV°chemotherapy side effects and deaths.Some side effects can be controlled by symptomatic treatment.The data showed that there was no statistically significant difference in the incidence of various toxic and side effects and complications in both groups,P>0.05.5.Follow-up Results:The longest ascites in the endostar group was 179 days and the patient’s condition improved significantly.The longest ascites in the in the cisplatin group was 157 days and the quality of life was also significantly improved.There were 14patients with no recurrence of ascites in the endostar group for 3 months,accounting for30.4%;6 patients with no recurrence of ascites in the cisplatin group for more than 3months,accounting for 12.5%.The difference of the rate of recurrence of ascites more than3 months between the two groups was statistically significant,χ~2=4.511,P=0.034.ConclusionEndostar combined with cisplatin hyperthermic intraperitoneal perfusion chemotherapy for the treatment of malignant ascites has a good short-term clinical effect and no obvious increase of toxicity,and can improve the quality of life of patients effectively,reduce the level of VEGF.