First Real-world Experience Of PARP Inhibitors In The Therapy Of Ovarian Cancer From China

Part One: First Real-world Experience of Olaparib in the Therapy of Ovarian Cancer from ChinaPurpose: The emergence of PARP inhibitors has changed the traditional treatment strategies of ovarian cancer.There has not yet been a real-world study of Olaparib in the therapy of ovarian cancer patients from China.This is the first study to evaluate the real-world efficacy and safety of olaparib in Chinese patients with ovarian cancer.Materials and Methods: Twenty-eight patients with ovarian cancer who started treatment with Olaparib from September 2018 to July 2019 in the Affiliated Cancer Hospital of Nanjing Medical University were enrolled.According to RECIST 1.1(Response Evaluation in Solid Tumors version 1.1)and NCI CTCAE 4.0(National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0),the efficacy and safety was analyzed.Results: Among the enrolled patients,26(92.9%)of them were ovarian cancer patients and 2(7.1%)were fallopian tube cancer patients.Patients with germline BRCA mutation accounted for 39.3%.The treatment categories included 2 cases(7.1%)with first-line maintenance treatment,10 cases(35.7%)with second-line maintenance treatment,6 cases(21.4%)with multi-line treatment,and 10 cases(35.7%)with exploratory treatment.Newly discovered adverse events included abdominal distension,decreased appetite,hypotension,increased body hair,dry mouth,burning sensation in the stomach,and leg swelling.Severe adverse events were mainly managed through dose reduction and dose interruption rather than drug discontinuation.Among all enrolled cases,8 cases received dose reduction treatment,4 cases underwent dose interruption,and 3 cases were discontinued due to adverse events.In the multi-line treatment group,1 case was assessed as SD,and 2 cases reached SD after combining with anti-angiogenic drugs due to progression with Olaparib monotherapy.In the exploratory treatment group,2 patients achieved CR,and 3 patients were assessed as SD.Conclusions: This study reported the real-world experience of Olaparib in the therapy of ovarian cancer patients from China for the first time.The efficacy was obvious,and the adverse events were manageable.Some newly observed adverse events included abdominal distension,hypotension,increased body hair,dry mouth,burning sensation in the stomach and leg swelling were also reported in our study.The efficacy of Olaparib in the exploratory treatment group also provides direction for clinical trials in future.Part Two: First Real-world Experience of Niraparib in the Therapy of Ovarian Cancer from ChinaPurpose: Currently,PARP inhibitors available in China mainly include Olaparib and Niraparib.Previously,we reported the first real-world study of Olaparib in ovarian cancer patients from China.Here,we report the first real-world study of the efficacy and safety of Niraparib in ovarian cancer patients from China.Materials and Methods: Twenty-two patients started treatment with Niraparib from June 2019 to July 2020 in the Affiliated Cancer Hospital of Nanjing Medical University were enrolled in our study,fourteen of whom were also underwent HRD test.Initial doses of patients were individually depended on basal body weight and baseline platelet count.According to RECIST 1.1 and NCI CTCAE 5.0(National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0),the efficacy and adverse events were analyzed.Results: Among patients with high-grade ovarian cancer enrolled in our study,50%of them were HRD-positive.All patient enrolled were treated with 200mg/d as initial dose.Patients were divided into first-line maintenance therapy group and exploratory therapy group,with 6 and 16 patients in each group.The exploratory group were divided into frontline therapy subgroup,second-line maintenance therapy subgroup and multi-line therapy subgroup,with 6,1 and 9 patients in each subgroup,respectively.Patients with multi-line therapy subgroup included 6 with monotherapy and 3 with combined therapy.In the subgroup of multi-line monotherapy,ORR and DCR was 33.3%(95% CI 0.060-0.759)and 50%(95%CI 0.140-0.861),respectively.The most common adverse events(any grade)were nausea,thrombocytopenia,and anemia.Serous(grade 3-4)adverse events were mainly managed through dose reduction and dose interruption.Swelling was a new adverse event we discovered.Conclusion: This study reported the real-world experience of niraparib in the therapy of ovarian cancer patients from China for the first time.The initial dose of200mg/d was feasible for patients from China with manageable adverse events and obvious efficacy.