| Objective: To explore the effectiveness and safety of Xiaoyan Decoction combined with Apatinib in the Treatment of Patients with advanced gastric cancer failed by radiotherapy and chemotherapy by retrospective research.Methods: Retrospective analysis of 128 patients with chemoradiotherapy-refractory for advanced gastric cancer who were treated in the First Affiliated Hospital of Tianjin University of Chinese Medicine and Tianjin Cancer Hospital from January 1,2015,to June 30,2021.The patients were divided into observation group(Xiaoyan Decoction combined with Apatinib treatment group)118 cases and control group(Apatinib monotherapy group)116 cases.Collect and sort out the clinical case data and survival data of patients,analyze and compare the survival prognosis,quality of life and safety of the two groups.The main outcome measures were progression free survival(PFS),and the secondary outcome measures were overall survival(OS),objective response rate(ORR),disease control rate(DCR),Karnofsky(KPS)score,quality of life(EORTC QLQ-C30)score,TCM symptom score of gastric cancer and adverse event evaluation;For the observation group,Kaplan Meier univariate analysis was used to explore the relationship between gender,age,primary location,pathological type,operation and metastasis and the prognosis of patients.Cox risk ratio model was used to analyze the risk and protective factors affecting the prognosis.Results: In this study,234 patients with advanced gastric cancer who failed radiotherapy and chemotherapy were included,including 118 patients in the observation group and 116 patients in the control group.The baseline characteristics of the two groups were balanced,with no statistical difference(P > 0.05),indicating comparability.Main outcome measures: Median progression-free survival: Compared with patients treated with apatinib alone,patients treated with Xiaoyan Decoction combined with Apatinib could prolong the median progression free survival,6.31 months and 4.03 months respectively,all of which were statistically significant(P < 0.05).Secondary outcome measures:(1)Median overall survival: Compared with patients treated with apatinib alone,patients treated with Xiaoyan Decoction combined with Apatinib could prolong the median overall survival,7.98 months and 5.98 months,respectively,with statistically significant differences(P < 0.05).(2)Objective evaluation of tumor curative effect: objective remission rate was 50.8% in the observation group and 50.0% in the control group,the difference was not statistically significant(P > 0.05);The disease control rate was 81.4% in the observation group and 69.0%in the control group,with statistical significance(P < 0.05).(3)KPS score: THE KPS score of the observation group was higher than that of the control group after treatment,and the difference was statistically significant(P < 0.05),while there was no statistical difference in the KPS score of the control group before and after treatment(P > 0.05).Comparison between groups: the KPS score of the observation group was higher than that of the control group after treatment,and the difference was statistically significant(P < 0.05).(4)EORTC QLQ-C30 Quality of Life Questionnaire: After treatment,the observation group was significantly improved in the areas of physical function,role function,emotional function and overall health status compared with the control group,with statistical significance(P < 0.05),but there was no statistical significance in the improvement of cognitive function and social function(P > 0.05).(5)TCM symptoms score of gastric cance : Two groups of patients with gastric cancer of traditional Chinese medicine symptom integral,in observing group,there are eight symptoms improvement is better than that of control group: shortness of breath,fatigue,nausea and vomiting,acid regurgitation,coprostasis food less stay,loose stools,diarrhea,whose difference has statistical significance(P < 0.05),while there was no significant difference in the improvement of symptoms of abdominal pain,abdominal distension and weight loss(P > 0.05).(6)Adverse event evaluation: During the treatment,the common adverse reactions of the two groups were WBC reduction,HGB reduction,PLT reduction,abnormal liver function,hypertension,proteinuria,han-foot skin reaction,bleeding and decreased appetite,mostly grade 1 and 2 adverse reactions.Grade 3 and above treatment-related adverse reactions occurred in the observation group,including 1 case of HGB reduction(0.8%),4 cases of abnormal liver function(3.3%)and 1 case of decreased appetite(0.8%),In the control group,treatment-related adverse reactions of grade 3 and above included HGB reduction in 3 cases(2.6%),abnormal liver function in 7 cases(6.0%),hypertension in 7 cases(6.0%),hand-foot skin reaction in 1 case(0.6%),bleeding in 3 cases(2.6%)and loss of appetite in 2 cases(1.7%).The incidence of adverse reactions in proteinuria,hand-foot skin reaction and bleeding in the observation group was significantly lower than that in the control group,of which the difference was statistically significant(P < 0.05).(7)Observation group prognostic factor analysis: Kaplan Meier univariate survival analysis of the observation group found that people with tumor sites in gastric body and antrum,highly / moderately differentiated cancer,no liver metastasis and peritoneal metastasis may benefit from the addition and subtraction of Xiaoyan Decoction combined with Apatinib;Multivariate Cox regression analysis was performed on the observation group.The results showed that the primary location of the tumor was in the cardia and gastric bottom,low / undifferentiated cancer,liver metastasis and peritoneal metastasis were independent risk factors for poor prognosis of patients with advanced gastric cancer who failed radiotherapy and chemotherapy treated with Xiaoyan Decoction combined with Apatinib.Conclusion: Xiaoyan Decoction combined with Apatinib can prolong PFS and OS in patients with advanced gastric cancer who failed radiotherapy and chemotherapy,and has the advantages of alleviating clinical symptoms and improving quality of life;Reduce the incidence of adverse reactions such as proteinuria,hand-foot skin reaction and bleeding caused by Apatinib;Among them,the primary sites of tumors are in the gastric body and antrum,highly / moderately differentiated cancer,no liver metastasis and no peritoneal metastasis. |
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