Efficacy And Safety Of Thalidomide Combined With IRIS In The Treatment Of Advanced Gastric Cancer

BackgroundGastric cancer is one of the most common malignancies in the world.The annual incidence is about 900,000 people and the death toll is about 700,000.The incidence of all malignant tumors in the world is forth,only behind lung cancer,breast cancer and colorectal cancer,and in the cancer death ranking,gastric cancer mortality rate ranked third,which not only seriously endangers human’s life and health,but also influenced the society,the family,and caused a serious impact.Although the global incidence of gastric cancer is declining,But East Asia is still a high incidence of gastric cancer,followed by Europe,the eastern and the United States in the south.According to statistics,in China,the number of gastric cancer incidence is about 400,000,accounting for 40% of the global incidence of new cases,has seriously affected the lives and health ofpeople.The treatment of early gastric cancer is mainly surgical treatment,gastric cancer radical surgery is the only treatment which can cure gastric cancer,but the simple survival rate of surgery alone is only 20% to 40%.However,the incidence of gastric cancer early symptoms are not typical,may only be acid reflux,heartbroken,dyspepsia or stomach pain and other atypical symptoms,so often found late,the detection rate of early gastric cancer was less than 10%,advanced gastric cancer detection rate of 37% to 39%.Advanced gastric cancer is often distant metastasis,the prognosis is poor,there is no standardized treatment,the main treatment is comprehensive treatmentbased on chemotherapy,radiotherapy and surgery after neoadjuvant chemotherapy,and new auxiliary Chemotherapy has been more and more people’s attention.For patients with advanced unresectable,early treatment mainly used fluorouracil combined with doxorubicin two drugs joint program,and later due to the platinum type of in depth study,gradually formed with platinum as the main program,and gradually replace the original fluorouracil combined with doxorubicin program in chemotherapy,both esophagus and gastric cancer in the scales or adenocarcinoma,there was no significant difference in efficacy and survival time,so in the middle of the 1990 s,the stomach esophagus and gastroesophageal junction associated were not strictly limited into the histological features.And most of the research included a part of the patients with squamous cell carcinoma.However,with the study of targeting(trastuzumab and ramucirumab)and the the differences treatment between squamous cell carcinoma and adenocarcinoma appeared.since the latter is only applicable to adenocarcinoma.The topical pathways of drug research include human epidermal growth factor receptor(HER)family signaling pathway,vascular endothelial growth factor(VEGF)signaling pathway,PI3 K / mTOR signaling pathway and NF-κB signaling pathway,etc.For different treatment regimens,The evaluation of curative effect is also different,but the study of the curative effect of gastric cancer treatment is significant.Therefore,this prospective study conclude 86 patients with advanced gastric cancer in the Department of Oncology of First Affiliated Hospital of Zhengzhou University from January 2014 to January 2016,which receive irinotecan plus S-1 program combined with or without thalidomide as a second line program.The main observation object of the study is the recent efficacy,progression-free survival,improvement of quality of life and tolerance to adverse drug reactions,so as to provide a theoretical basis for the second-line treatment of advanced gastric cancer.ObjectivesTo evaluate the efficacy and side effects of thalidomide combined with IRIS regimen and IRIS alone in the second-line treatment of advanced gastric adenocarcinoma.Methods88 patients with advanced gastric adenocarcinoma,which has relapsed after first-line treatment,according to different drugs,88 casesbe divided into two groups,44 cases combined with thalidomide group,from the day before chemotherapy,petients startd to take thalidomide tablets(oral 50 mg,once a night before going to bed),Irinotecan 200 mg / m2,intravenous infusion,the first day and the eighth days;S-1 80 mg / m2,divided into morning and night oral,1-14 days,21 days for a cycle;the control group of 44 cases,Irinotecan 200 mg / m2,intravenous infusion,the first days and the eighth days;S-1 80 mg / m2,divided into morning and night oral,1-14 days,21 days for a cycle;84 cases completed 2 to 6 cycles,evaluate the effectevery 2 cycles.The tropisetron were used during the two chemotherapy group,omeprazole protecting stomach,glutathione for liver,delayed diarrhea or severe diarrhea,should timely use Mongolia to stop diarrhea;if the-IV III myelosuppression happened,timely use the recombinant human granulocyte colony-stimulating factor,interleukin-11 and other symptomatic treatment.The main observed indicators were disease control rate,progression-free survival time,improvement of quality of life and adverse reactions.ResultsThe control rates of the combined thalidomide group and the control group were 71.4% and 66.7% respectively.There was no significant difference between the two groups(P> 0.05).The median PFS of the two groups was 4.7 weeks and 4.6 weeks,The difference was not statistically significant(P = 0.277 P> 0.05).The improvement rate of quality of life in the two groups was 80.9% in the combined group and 75% in the control group,although there was no significant difference between the two groups,but thequality of life has improved very well.In terms of safety,the hematologic toxicity of the combination group and the control group was 6.8% and 9.1%,the difference was not statistically significant(P = 0.694),the anaemia toxicity of the combination group and the control group was 18.2% and 20.5%,the difference was not statistically significant(P = 0.787),grade 3 to 4 non-hematologic toxicity(2.2% and 18.2%),vomiting(2.2 vs.20.5%),diarrhea(2.2% and 20.5%,respectively),the differences were statistically significant(P <0.05),and the remaining toxicities,such as bone marrow suppression,fatigue,elevated transaminases,constipation,rash and peripheral neuritis,the differences were not statistically significant(P> 0.05).Conclusion1.The advanced gastric adenocarcinoma patients which have relapsed after first-line treatment,IRIS program as a second-line method,the recent effect is better;2.IRIS program combined with thalidomide can significantly reduce chemotherapy-induced gastrointestinal side effects and improve the quality of life of patients;3.Thalidomide so-called anti-angiogenic drugs,the price can be accepted by the majority of patients,and oral administration,the convenience is easy to accept.