Clinical trial of olaparib maintenance therapy combined with GP chemotherapy regimen and thermal therapy in the treatment of patients with advanced ovarian cancer
Objective To observe the clinical efficacy of olaparib maintenance therapy combined with gemcitabine+cisplatin(GP)chemotherapy regimen and thermal therapy in the treatment of advanced ovarian cancer and analyze the prognosis.Methods Patients with advanced ovarian cancer were divided into control group and treatment group according to the random number table method.The control group was treated with GP chemotherapy regimen and thermal therapy,and given intravenous infusion of 1 250 mg·in-2 of gemcitabine on the 1st day and 8th day and 40 mg·m-2of cisplatin on the 1st day and 3rd day,and given 60 min of local deep thermal therapy(qod)with temperature at 42 ℃ on the 1st day of chemotherapy,and the patients were treated for 4 courses with 21 days as a course.The treatment group was additionally given olaparib maintenance therapy on the basis of the control group,and given continuously oral administration of olaparib 200 mg(bid)during chemotherapy,and the patients were treated for 4 courses with 21 days as a course of treatment.The clinical efficacy,peritoneal carcinomatosis index(PCI),peripheral blood lymphocyte subsets,serum tumor markers[carcinoembryonic antigen(CEA),carbohydrate antigen 125(CA125),carbohydrate antigen 72-4(CA72-4),human epididymal protein 4(HE4)],progressive-free survival time(PFS),overall survival(OS)and occurrence of adverse drug reactions were compared between both groups of patients.Results There were 37 cases in treatment group and 36 cases in control group.After treatment,the total effective rates in treatment group and control group were 54.05％(20 cases/37 cases)and 30.56％(11 cases/36 cases);the PCI scores were(10.79±2.56)and(12.54±3.17)scores,with significant difference(all P＜0.05).After treatment,the proportions of peripheral blood CD4+cell in treatment group and control group were(33.63±3.17)％and(30.06±3.24)％;the ratios of CD4+/CD8+were 0.78±0.16 and 0.67±0.13;serum CEA levels were(33.17±6.82)and(39.35±7.51)ng·mL-1;CA125 levels were(47.64±8.56)and(55.84±10.02)U·mL-1;CA72-4 levels were(6.35±1.27)and(8.59±1.64)U·mL-1;HE4 levels were(124.62±20.14)and(141.62±21.43)pmol·mL-1,all with significant difference(all P＜0.05).PFS values in treatment group and control group were 9.00 months(95％CI:7.79-10.21)and 8.00 months(95％CI:7.20-8.80),and OS values were 13.00 months(95％CI:12.35-13.65)and 11.00 months(95％CI:10.46-11.54),all with significant difference(all P＜0.05).The adverse drug reactions in treatment group mainly included nausea and vomiting,hypertension and constipation,the adverse drug reactions in control group mainly included nausea and vomiting and stomatitis.The total incidence rates of adverse drug reactions in treatment group and control group were 32.43％and 22.22％,with no significant difference(P＞0.05).Conclusion Olaparib maintenance therapy combined with GP chemotherapy regimen and thermal therapy has a significant effect in the treatment of patients with advanced ovarian cancer,and it can prolong the survival time of patients without increasing adverse drug reactions.
olaparibgemcitabinecisplatinthermal therapyadvanced ovarian cancer
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