| Objective: This study observed the near and long-term effect, toxicity and the factors affecting drug efficacy by comparing recombinant human endostatin(Endostar) micro pump continuous administration and traditional administration combined with chemotherapy compared with bevacizumab combined with chemotherapy treatment advanced malignant tumor of digestive tract. Thus it can provide better options for clinical treatment of advanced malignant tumor of digestive tract.Methods:1 This research has selected 78 hospitalized patients with locally advanced or recurrent metastatic tumors of the digestive tract diagnosed by histopathology and / or cytology. It included 3 cases of esophageal cancer, 18 cases of gastric cancer, 31 cases of colon cancer, 26 cases of rectal cancer. The patients were separated into four groups: group A(Endostar trace pump continuous to medicine + chemotherapy group), group B(Endostar intravenous infusion + chemotherapy group), group C(bevacizumab + chemotherapy group), group D(simple chemotherapy group). The efficiency was evaluated according to RECIST1.1 evaluation criteria after two to three cycles. Objective response rate(ORR:CR+PR), disease control rate(DCR:CR+PR+SD), progression free survival(PFS) and overall survival(OS) were compared in four groups and each two groups. To get to know the influence factor of drug efficiency, we analyzed the data in and between groups by gender, age, Eastern Cooperative Oncology Group(ECOG) performance status(PS) score, body mass index(BMI), primary site, treatment history(surgical history of primary disease, radiotherapy history and chemotherapy history), with and without chronic diseases such as hypertension, coronary artery disease, number of metastatic organs, line of treatment. The adverse reactions were evaluated by WHO chemotherapy adverse reaction classification standard. We compared the difference of adverse reactions among the four groups.2 We made follow-up by telephone and collecting hospitalized reexamination charts. Patients were followed up from first days after entering the group to January 15, 2016. At the end of the follow-up period, 78 of the 51 patients died, 2 were lost to follow-up, and the follow-up rate was 97.4%. The starting point of this study was the start time of treatment. The end point was set at the last time we made follow-up, lost to follow-up, or the time patients died. Analyze the PFS and OS to get to know the influence on prognosis of different drug.3 The data were organized and processed with SPSS21.0 statistical software. χ2 test or Fisher’s exact test was used in comparing the difference of the distribution of affected factors, the effect and adverse reaction of different chemotherapy regimens, and analyzing factors which influenced the effect of drugs. Kaplan-Meier method was used in survival analysis. The Log-Rank test compared PFS and OS between the four group. Data obtained with P values<0.05 were considered statistically significant.Results:1 Patients general characteristics: There was statistically significant in the line of treatment among four groups(P=0.004). There was not statistically significant in sex, age, ECOG PS score, BMI, primary site, treatment history, with and without chronic diseases, number of metastatic organs(P>0.05);2 Drug effect: ORR of the group A, B, C, D were 20.0%, 20.0%, 17.9%, 5.0% respectively, DCR were 90.0%, 60.0%, 92.9%, 65.0% respectively. ORR had no statistically significant between every two groups(P>0.05). DCR of the group C was significantly higher than that of the group B(P=0.031) and DCR of the group C was significantly higher than that of the group D(P=0.024). There were no significant differences in each of the other two groups(P>0.05).3 Influence factors of efficiency: Between the four groups of DCR hierarchical analysis showed that the factors of female, ECOG PS score of 0 points, primary colorectal cancer, surgical history of primary disease, second-line and second-line above treatment with statistical differences(P<0.05). The following factors would not affect DCR of four groups. They were age, BMI, radiotherapy history, chemotherapy history, hypertension, coronary artery disease, number of metastatic organs(P > 0.05). There were no significant differences in the above mentioned factors between the four groups of ORR and four groups of DCR(P>0.05). According to the amount of Endostar per cycle, group A was divided into three subgroups:(60-119 mg, 120-149 mg, 150-210mg). ORR and DCR were no significant differences between every two subgroups(P> 0.05);4 Adverse events: The mainly adverse events of the four group were white blood cell reduction, anemia, platelet reduction, nausea/vomiting, aminotransferase increase, Cardiac toxicity, almost were Ⅰ- Ⅱ degree. Endostar durative transfusion group had higher incidence of platelet reduction than the other three groups(P=0.004). Bevacizumab group had higher incidence of hypertension than the other three groups(P=0.024). The other adverse events of the four groups had no significant difference(P>0.05);5 Survival analysis: The median PFS of group A, B, C, D were 8, 7, 8, 8 months respectively and The median OS of group A, B, C, D were 14, 9, 18, 9 months respectively. The median PFS was no significant differences between every two groups(P>0.05). The median OS had statistically significant between group A and group D(P=0.043). The median OS had no statistically significant in each of the other two groups(P>0.05).Conclusions: The short-term and long-term survival of Endostar trace pump continuous to medicine + chemotherapy group and bevacizumab + chemotherapy group show advantages than those of Endostar intravenous infusion + chemotherapy group and simple chemotherapy group in treatment of advanced malignant tumor of digestive tract, do not increase the adverse reactions associated with chemotherapy, and has good safety. Only in recent efficiency, Endostar intravenous infusion + chemotherapy group compared to simple chemotherapy group has certain advantages. This study analyzes influence factors of drug efficacy, but not find influence factors which have clear guidance. Clinicians can prefer to Endostar trace pump continuous to medicine + chemotherapy or bevacizumab + chemotherapy regimen in treatment of advanced malignant tumor of digestive tract. |
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