| Objective:To evaluate the efficacy and safety of FOLFIRI with/without Apatinib mesylate in first-line treatment of advanced metastatic colorectal cancer based on propensity score matching.Methods:According to the inclusion criteria,20 patients with advanced metastatic colorectal cancer who received FOLFIRI regimen(irinotecan,calcium leucovorin,5-fluorouracil)combined with Apatinib mesylate in Shanxi Cancer Hospital from March 2017 to March 2019 were selected as the experimental group.And 49 patients with advanced metastatic colorectal cancer who received FOLFIRI alone in the same unit during the same period were the control group.Baseline data(age,sex,ECOG status,initial tumor location,number of metastatic sites,degree of tumor differentiation,percentage of tumor volume reduction,progression-free survival,overall survival,follow-up time,and survival)and some commonly used clinical indicators(neutrophil-lymphocyte ratio,carcinoembryonic antigen,carbohydrate antigen 199)were collected for both groups,respectively.The caliper matching method with propensity score was adopted,and the caliper value was set as 0.2.The test group and control group were matched 1:2.Age,sex,physical status score(ECOG),initial tumor location,degree of tumor differentiation,number of tumor metastasis sites,neutrophil to lymphocyte ratio(NLR),carcinoembryonic antigen(CEA),carbohydrate antigen-199(CA199)of the two groups were included in the matching model as treatment variables,and propensity score matching was performed.After matching,16 patients in the experimental group and 32 patients in the control group were obtained,which effectively balanced the influence of the distribution of confounding factors,improved the comparability between the groups,and made the groups more balanced.Survival curves were plotted by Kaplan-Meier method.The difference in distribution of Progress Free Survival(PFS)and Overall Survival(OS)curves between the two groups before and after caliper matching was compared by log-Rank test.The inverse probability weighting method(IPTW)was used to analyze the sensitivity of propensity score.Results:1.Before propensity matching,there were 20 cases in the experimental group and 49 cases in the control group.There were no statistical differences between the two groups in age,gender,ECOG,initial tumor location,tumor differentiation degree,number of tumor metastasis sites,CEA and CA199(P>0.05),while there were statistical differences in NLR(P<0.05).The median follow-up time was 36.23(7.73-129.87)months.Death occurred in 15(75%)patients in the experimental group and 35(71.43%)patients in the control group.The results of survival analysis showed that the median PFS of the experimental group and control group were 6.00 months and 2.37 months(χ~2=5.177,P=0.02),and the median OS of the experimental group and control group were 16.14 months and 20.17 months(χ~2=1.292,P=0.26),respectively.The most common grade 3-4 adverse events in the experimental group were hypertension,leukopenia and neutropenia.2.After propensity matching by caliper method,there were 16 cases in the experimental group and 32 cases in the control group,and no statistical Difference was found in all baseline data between the two groups(P>0.05).The Standard Mean Difference(SMD)of baseline data between the two groups showed that age,ECOG,initial tumor location,degree of tumor differentiation,number of tumor metastasis sites,and CEA were all less than 0.1,sex(SMD=0.126),NLR(SMD=0.151),CA199(SMD=0.105),After inverse probability weighting,the SMD of each baseline covariate of the two groups is less than 0.1,indicating a good balance.The median follow-up time was 33.20(7.73-124.73)months.Death occurred in 10(83.33%)patients in the experimental group and 18(75%)patients in the control group.The results of survival analysis after propensity matching showed that the median PFS of the experimental group and the control group were 6.15 months and 2.15 months(χ~2=5.705,P=0.02),and the median OS of the experimental group and the control group were 17.3 months and 19.15 months(χ~2=0.4357,P=0.51).The inverse probability weighted adjusted survival curve showed that there were statistical differences in OS(P<0.01)and PFS(P=0.036)between the two groups.Conclusions:A retrospective study comparing the efficacy of FOLFIRI combined with Apatinib mesylate versus FOLFIRI alone in the first-line treatment of advanced metastatic colorectal cancer has found that FOLFIRI combined with Apatinib mesylate improves progression-free survival in patients with advanced metastatic colorectal cancer without increasing risk and has an acceptable safety rating. |
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