Abstract
PurposePoly (ADP-ribose) polymerase (PARP) inhibitor, is a milestone in treatment of ovarian cancer. However, there is no real world study from China regarding the clinical outcome of the taking PARP inhibitor (PARPi), Olaparib(Lynparza™). The goal of this research is to evaluate the side effects and short-term efficacy in advanced ovarian cancer patients who administered Olaparib.MethodsPatients with ovarian cancer, fallopian tube cancer and peritoneal cancer that treated with Olaparib in The Affiliated Cancer Hospital of Nanjing Medical University between September 2018 and June 2019 were recruited. The drug associated Adverse Events (AEs) were collected and short-term efficacy were analyzed by modified Response Evaluation Criteria in Solid Tumors (mRECIST) .ResultsOf all 28 enrolled patients, 92.9% were ovarian cancer, 7.1% were fallopian tube cancer, and 39.3% cases harbored germline BRCA-mutation. There were 6(21.4%) patients received Olaparib after multi-line chemotherapy, and 10 patients (35.7%) as second-line maintenance therapy and 2 patients (7.1%) as first-line maintenance therapy. There were still other 10 cases (35.7%) received Olaparib as exploratory therapy. Abdominal distention, decreased blood pressure, increased body hair, thirsty, burning sensation of stomach and leg swelling were newly reported AEs. Serious Adverse Events(SAEs) were usually managed by dose interruption or dose reduction, rather than discontinuation. 3 patients discontinued treatment, 8 patients received reduced dose of Olaparib, and 4 patients stopped therapy after the alleviation of AEs. Of all 28 enrolled cases, in monotherapy group, 1 of 6 patients achieved stable disease(SD) and also 2 patients achieved stable disease(SD) combined with anti-angiogenic drugs when disease progressed. 2 patients achieved complete remission(CR) and 3 patients were stable with exploratory therapy.ConclusionsThe AEs of Olaparib were all manageable. For the first time, we also identified several AEs such as abdominal distention, decreased blood pressure, increased body hair, thirsty, burning sensation of stomach and leg swelling during the follow-up which have not been reported. The short-term efficacy was observed in some exploratory cases that provided new potential indication to PARPi-related clinical trials.
Highlights
Ovarian cancer accounts for about 4% of cancer deaths among women worldwide, and is the most lethal gynecological malignancy [1]
We recorded the basic characteristics of these patients, including the age, Eastern Cooperative Oncology Group performance status (ECOG PS) before the start of the treatment, histological type of the primary lesion, history, clinical stage on the basis of Federation International of Gynecology and Obstetrics (FIGO), BRCA mutation, history of therapy before and after the using of Olaparib and the follow-up
Known as FIGO III or IV, affected 19 (67.9%) and 3 (10.7%) of patients, respectively. 25 patients suffered from high-grade serous adenocarcinoma, and the remaining 3 cases were endometrioid carcinoma, mixed serous and endometrioid carcinoma and mixed serous and mucious carcinoma. 39.3% patients harbored BRCA 1/2 mutation, 39.3% patients had BRCA wild type
Summary
Ovarian cancer accounts for about 4% of cancer deaths among women worldwide, and is the most lethal gynecological malignancy [1]. In 2019, it is estimated that there will be approximately 22,530 cases of new identified ovarian cancer, and more than 13, 980 women will die from it in the United States [2]. The number of new cases of ovarian cancer in China reached 52,100 in 2015, of which about 22,500 died [3]. The vast majority (> 90%) of ovarian malignancies are epithelial ovarian cancer (EOC), and most patients are diagnosed as FIGO III/IV. The 5-year survival rate of ovarian cancer is about 30%. The standard treatment for advanced epithelial ovarian cancer is maximal cytoreductive surgery and platinum-based chemotherapy [4]
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