Efficacy And Safety Of Bevacizumab Combined With Chemotherapy In The Treatment Of Recurrent Ovarian Cancer

Ovarian Cancer(OC)is the third most common gynecological tumor worldwide and one of the most deadly gynecological malignancy.As early clinical symptoms are not noticeable and screening is complicated,75% of patients are treated with advanced ovarian cancer,which is easy to relapse.Chemotherapy is the main choice of ROC,but eventually will develop into drug resistance,with a mortality rate of more than 90%.Therefore,a different treatment was urgently needed,and in 2014.Belarusian was approved by the FDA for platinum-resistant ROC.In 2016,platinum-sensitive ROC was approved.NCCN guidelines also recommend vivaciously in combination with chemotherapy for patients with platinum-sensitive/platinum-resistant relapsed ovarian cancer,however,it was not permitted by the China National Medical Products Administration for the treatment of ovarian cancer until November 2021.Our hospital began to gradually use vivaciously in ovarian cancer patients in 2020.The addition of BEV to chemotherapy increases medical costs and limits the use of vivaciously.Because randomized clinical trials have strict inclusion and exclusion criteria,they often do not match actual clinical practice and outcomes.Given that real-world patient settings are different from clinical trials,the aspect of valid research evidence in clinical practice settings is increasingly important.Objective This study analyzed the efficacy and safety of bevacizumab combined with chemotherapy versus chemotherapy alone for platinum-sensitive/platinum-resistant recurrent ovarian cancer.The primary endpoint was progression-free survival(PFS),while secondary endpoint included objective response rate(ORR),disease control rate(DCR),and adverse reactions.In order to provide scientific and reliable evidence-based medical evidence for the application of bevacizumab in recurrent ovarian cancer.Methods A case-control study was utilized.A total of 85 patients with recurrent ovarian cancer diagnosed in the Department of Obstetrics,Gynecology and Oncology of our hospital from January 2020 to February 2023 were gathered.There were 55 platinum-sensitive patients(experimental group 26 cases,control group 29 cases),and 30 platinum-resistant patients(experimental group 15 cases,control group 15 cases).Platinum-sensitive patients in the experimental group received 6 cycles of chemotherapy with bevacizumab combined with albumin paclitaxel plus carboplatin, and the control group received 6 cycles of chemotherapy with albumin paclitaxel plus carboplatin.Platinum-resistant patients in the experimental group received 6 cycles of bevacizumab combined with albumin-paclitaxel chemotherapy,while the control group received 6 cycles of albumin-paclitaxel monotherapy.The clinical efficacy(including objective response rate(ORR),disease control rate(DCR),complete response rate(CR),partial response rate(PR),stable SD and progressive PD)and adverse reactions were compared between the experimental group and the control group.Two independent samples T test,Chi-square test or Fisher exact probability method,Kaplan-Meier survival analysis,log-rank and COX regression models were used for statistical analysis.Results 一、Among 55 platinum-sensitive patients,there were 29 cases in the control group and 26 cases in the experimental group.There was no statistical difference in the basic data between the two groups(P > 0.05): 1.Progression-free survival: The median PFS of the experimental group was 10.5[8.9 ~ 12.10] months,the median PFS of the control group was 7.5[5.75 ~ 9.25] months,the average PFS of the experimental group was 13.07[10.49 ~ 15.66] months,and the average PFS of the control group was 9.04[7.26 ~ 10.84] months.PFS in the experimental group were better than those in the control group(hazard ratio [HR],0.468;95% confidence interval,0.240 to 0.913;Logarithmic rank P<0.05).The difference was statistically significant.2.Curative effect:In the experimental group,there were 1 CR,14 PR,6 SD and 5 PD.In the control group,there were 1 CR,8 PR,7 SD and13 PD.Objective response rate ORR(57.69% VS 31.03%;P <0.05)and DCR(80.77% VS 55.17%,P <0.05)were much improved.3.Adverse event : There were no significant differences in blood system,albuminuria,sepsis,liver function,kidney function,venous thrombosis,hypertension,gastrointestinal reactions,incomplete ileus,sensory nerve abnormalities,nasal bleeding and other adverse reactions between the experimental group and the control group(P > 0.05).The most common grade 3 or higher toxicities in the experimental group compared with the control group were abdominal pain(2[7.69%]vs0),leukopenia(9[34.62%]vs6[20.69%]),small intestinal obstruction(1[3.85%]vs0),hypertension(2[7.69%]vs0),and albuminuria(1[3.85%]vs0).No new safety issues have been identified and there have been no treatment-related death.二、Among the 30 platinum-resistant patients,there were 15 cases in the experimental group and 15 cases in the control group,and there was no significant difference in the basic data between the two groups(P > 0.05): 1.Progression-free survival: The median PFS of the experimental group was 8.0[6.55 to 9.45] months,the median PFS of the control group was 5.0[4.56 to 5.44] months,the average PFS of the experimental group was 9.24[6.83 to 11.65] months,and the average PFS of the control group was 6.43[4.36 to 8.49] months,respectively.PFS in the experimental group were better than those in the control group(hazard ratio [HR],0.441;95% confidence interval,0.194 to 0.948;Logarithmic rank P<0.05),the difference was statistically significant.2.Curative effect:In the experimental group,0 cases of CR,7 cases of PR,1 case of SD,7 cases of PD7.In the control group,there were 0 cases of CR,1 case of PR,1 case of SD and 13 cases of PD.The ORR of the two groups was 46.67% VS 6.67%(P=0.018 < 0.05),and the DCR of the two groups was 53.33% VS 27.59%(P=0.02 < 0.05).3.Adverse event : There were no significant differences in blood system,albuminuria,liver function,kidney function,venous thrombosis,hypertension,gastrointestinal reactions,sensory abnormalities,coagulation function,febrile neutropenia and other adverse reactions between the experimental group and the control group(P > 0.05).The most common toxicities of grade 3 or above in the experimental group compared with the control group were leukopenia(3[20.00%]vs(2[13.33%]),thrombocytopenia(3[20.00%]vs(2[13.33%]),hypertensio n(1[6.67%]vs0),albuminuria(2[13.33%]vs0).Conclusion Bevaccizumab combined with chemotherapy is effective in platinum-sensitive and platinum-resistant recurrent ovarian cancer,and can significantly improve PFS,ORR and DCR.There is no significant difference in the incidence of toxic and side effects between the two groups,but the incidence of grade 3 or above toxicity in the experimental group is higher: Abdominal pain,leukopenia,intestinal obstruction,hypertension,albuminuria.For patients with recurrent ovarian cancer(ROC),the effect of bevacizumab is very important and deserves further clinical application.