Real-World Study Of PARP Inhibitors For Maintenance Therapy Of Ovarian Cancer

Objective:This study visually reflects the efficacy and safety of PARP inhibitors in maintenance therapy for ovarian cancer(including fallopian tube cancer and primary peritoneal cancer)through retrospective analysis and real-world data,and explores relevant prognostic factors.Methods:Include all patients who received PARP inhibitor maintenance treatment in the Department of Gynecology of Shanxi Provincial Cancer Hospital from August 2018 to December 31,2022 due to ovarian cancer(including fallopian tube cancer and primary peritoneal cancer),and collect clinical and follow-up data of the patients as much as possible;According to the indications for the use of PARP inhibitors,patients were divided into the first line treatment group,the second line treatment group,and the back line treatment group.Baseline characteristics of real-world data in each group were analyzed,and factors related to the prognosis of the first line treatment group and the second line treatment group were explored,and the safety of PARP inhibitors was evaluated.Results:(1)A total of 103 patients were included in this real-world study,of whom 1 was lost,and the remaining 102 patients were followed up for 3.6-48 months,with a median follow-up time of 16.15 months.Among them,there are 76 cases in the first-line treatment group(44 cases of olaparoli and 32 cases of nilapali),22 cases in the secondline treatment group(19 cases of olaparoli and 3 cases of nilapali),and 5 cases in the posterior line treatment group,all of whom are oral olaparoli patients,with 1 case lost in follow-up;(2)As of the end of follow-up,there were 16 cases(23.2%)of disease progression,1 case(1.4%)of death,and the median PFS was 37 months(95% CI,29.5-44.4 months).Among them,the median PFS was 38.7 months in patients with olaparoli,and 13.9 months in patients with Nilapari.The median OS did not yield results.Univariate analysis showed that surgical efficacy,chemotherapy efficacy,and FIGO stage were significantly correlated with PFS in the first-line treatment group(P<0.05).Multivariate analysis showed that surgical efficacy of R0,chemotherapy efficacy of CR,and FIGO stage were independent factors affecting PFS in the first-line treatment group(P<0.05);(3)In the second line treatment group,a total of 11 cases(50%)experienced disease progression,2 cases(9.1%)died,and the median PFS was 13.9 months(95%CI,12.1-15.7 months).Among them,the median PFS was 12.8 months in patients with olaparoli,6.1 months in patients with nilaparli,and 43.8 months in patients with OS(22.1-79.5);(4)In the posterior treatment group,there were 3 cases with recurrence,with an ORR of 75%,a DCR of 100%,and a median remission time of 12.5 months;(5)Very few patients discontinue treatment due to adverse reactions.There was no statistically significant difference in the incidence of hematological AEs,gastrointestinal AEs,insomnia,and fatigue between elderly and young patients.Conclusion:The results of real-world clinical practice in this study showed that surgical efficacy of R0,chemotherapy efficacy of CR,and FIGO staging were independent factors affecting PFS in first-line maintenance therapy patients(P<0.05);Maintenance therapy with PARP inhibitors after second or multiple line chemotherapy can improve the prognosis to a certain extent.In terms of second line maintenance therapy and posterior line maintenance therapy,the real world data of this study are basically consistent with most phase III RCT research data at home and abroad,but the relevant factors affecting the prognosis of patients with recurrent ovarian cancer need to be further explored;The use of PARP inhibitors in real-world patients differs from the recommended indications in the guidelines,and the application of PARP inhibitors is more widespread in clinical work;PARP inhibitors,as a drug that requires long-term oral administration,have excellent safety and efficacy,both for young and elderly patients.Some newly discovered adverse reaction symptoms in this study include abdominal distension,dry mouth and tongue,stomach discomfort and bloating,dry skin,rash,ankle swelling,systemic edema,muscle soreness,and oral ulcers,but their manifestations are mild.