| Objective: This study aims to examine the efficacy and safety of Olaparib administration to advanced Epithelial Ovarian Cancer(EOC)patients and compare the results of different treatment groups to those recently published in the literature.Methods: This is a retrospective study,using data of 50 patients who have been pretreated in 11 different hospitals of Fujian to evaluate and compare within different patients’ groups the response to Olaparib treatment,according to RECIST1.1 Criteria of patients enrolled between September 2018 and february2020.The Chi square test is used for different groups comparison and the Kaplan-Meier method is used to estimate PFS,while the safety profile is described in term of Tolerability,defined by the number and amount of dose changing and the incidence of treatment-related adverse events,graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0.Results: A total of 50 patients with median age of 57.50 all diagnosed with High Grade Serous Ovarian Cancer(HGSOC)underwent Olaparib treatment for a median follow-up time of 12 months.Patients were divided into 3 groups according to their treatment time and response to first line platinum-based chemotherapy(PBC): 1.primary treatment group including patients who started Olaparib treatment after first line PBC:13patients(26%,2.platinum-sensitive recurrent(PSR)group: 27patients(54%),3.platinum-resistant recurrent(PRR)group: 10patient(20%).Olaparib treatment efficacy study revealed that the greater number of patients: 21patients(42%)had a stable disease(SD).The ORR among total 50 patients was: 34% and the DCR was 76% while the remaining12 patients(24%)had a progressive disease within the course of treatment.Overall,median PFS was 15 months(95% CI 13.16-16.84);while PFS was found to be 17 months(95% CI 12.972-21.028),15 months(95% CI12.985-17.015)and 8months(95% CI 2.835-13.165)respectively in primary treatment group,PSR group and PRR group.19 patients were positive for BRCA1/2 mutation(BRCA+),16(32%)were negative for BRCA mutation test(BRCA-)while 15 patients(30%)didn’t undergo the median PFS within BRCA+ patients was 16 months slightly longer than the median PFS among BRCA-patients:(15months 95% CI 11.041-18.959).17 patients(34%)stopped the treatment during the course of study: 5 because of death,12 because of progressive disease.Adverse events were mostly mild or moderate and included: fatigue(in all 50 patients),nausea(50 patients),dysgeusia(in 49patients),anemia(in 43 patients),leukopenia(in 39 patients),Vomiting(in 32patients)and thrombocytopenia(in 25patients).Severe adverse events of grade3 have been recorded: Anemia and,Thrombocytopenia both in 6 patients,Leukopenia and vomiting both in 5 patients,fatigue in 3 patients,Vomiting and dysgeusia each 1 patient.A grade 4 adverse event was recorded only in one patient and that was anemia.Finally,all patients had at list experienced a mild adverse event that was mostly manageable with observation for grade1 and 2AEs(Adverse Events)and treatment discontinuation dose adjustment,addition of drug for SAEs(grade 3 or 4).Conclusion: In the present study,Olaparib used as maintenance therapy in patient with advanced EOC tend to show good efficacy and safety.Of all treatments sets,the best results were recorded in the primary treatment group including patients who started Olaparib treatment,right after the first line platinum-based chemotherapy.In recurrent disease sets,the PSR group had better results than the PRR group.However,studies with longer follow-up period and wider population are required for better assessment and long-term efficacy of the drug with a lighter benefice among BRCA positive patients. |
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