| Purpose: This study compared the efficacy and safety of recombinant human endostatin(rh-endostatin)combined with standard chemotherapy regimens versus chemotherapy alone as first-line treatment of patients with advanced gastric cancer,analyzed the prognostic factors of PFS in patients with advanced gastric cancer.Methods: Patients with advanced gastric cancer who were admitted to Yantai Yuhuangding Hospital of Qingdao University from January 2018 to January 2020 were recruited.Patients were randomly assigned 1:1 to the observation group or control group.The control group was treated with SOX(Oxaliplatin + S-1)or XEOLX(Oxaliplatin +capecitabine).Observation group was treated with rh-endostatin(15mg/m2/d,continuous intravenous pumping,continuous use for 7 days and stop for 14 days)plus chemotherapy.Take 21 days as 1 treatment cycle and the efficacy was evaluated every two cycles.These patients were treated for 2-6 cycles.The curative effect was evaluated according to the RECIST1.1 and the adverse events(AEs)during treatment were evaluated using the fifth edition of the adverse drug reaction evaluation system developed by the US NCI(CTCAE-V5.0).The primary endpoint were objective response rate(ORR),disease control rate(DCR).And the secondary endpoints were progression-free survival(PFS)and 1-year survival rate.The prognostic factors of PFS were explored by sub-group analysis and adverse events(AEs)was observed during treatment.Result: This study enrolled 123 patients(61,chemotherapy alone;62,chemotherapy+rh-endostatin).The ORR of the observation group(55.00%)was significantly higher than that of the control group(43.33%),and the difference was statistically significant(p=0.028).The DCR of the observation group(78.33%)was significantly higher than the control group(60.00%),the difference was statistically significant(p =0.03).Median PFS of the observation group(7.50 m,95% CI7.59-8.41m)was significantly higher than the control group(6.80 m,95% CI 4.66-6.54m),the difference between the groups was statistically significant(p=0.03).There was no difference in 1-year survival rate between groups(43.3% vs 31.7%,p=0.062).Univariate analysis showed that median PFS was significant different between age(p=0.049),ECOG score(p=0.036),number of metastases(p=0.036),liver metastasis(p=0.001),and degree of differentiation(p=0.001).Multivariate Cox regression analysis was used to verify the relevant factors,and liver metastasis(p=0.031),differentiation(p=0.001)were independent factors affecting PFS in patients with advanced gastric cancer.The main AEs were neutropenia,thrombocytopenia,anemia,nausea/vomiting,diarrhea,abnormal liver function,fatigue,peripheral neurotoxicity,and palpitations during treatment.Most of the AEs in the two groups were grade 1 to 2.There was no statistical difference in the adverse events between the two groups,and there was no rh-endostatin-specific adverse events.Those adverse events were alleviated after symptomatic treatment or reduction of drug dosage.There was no discontinuation or death occurred due to AEs.Conclusion:1)The application of micro-pump continuous pumping rh-endostatin combined with chemotherapy significantly improved ORR and DCR,prolonged median PFS of patients with advanced gastric cancer in the first-line treatment,and did not increase the risk of adverse events,providing a new option for the first-line treatment of advanced gastric cancer;2)Liver metastasis and differentiation were independent factors affecting the progression-free survival of patients with advanced gastric cancer.Patients without liver metastasis and moderately well differentiated patients have obvious longer median PFS. |
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