scholarly journals Real-World Data on Treatment Management and Outcomes of Patients with Newly Diagnosed Advanced Epithelial Ovarian Cancer in Greece (The EpOCa Study)

2021 ◽  
Vol 28 (6) ◽  
pp. 5266-5277
Author(s):  
Michalis Liontos ◽  
Eleni Timotheadou ◽  
Emmanuel I. Papadopoulos ◽  
Zafeiris Zafeiriou ◽  
Dimitra Ioanna Lampropoulou ◽  
...  

New treatment modalities have been recently introduced in the management of ovarian cancer (OC). Herein, we sought to investigate their implementation in routine clinical practice and examine the real-world management of OC in Greece. EpOCa was a non-interventional, multicenter, retrospective study in patients with advanced epithelial OC. The primary outcome was to estimate the proportions of the different treatment regimens used per line of therapy, while progression-free survival (PFS) and overall survival (OS) were the key secondary endpoints. A total of 154 patients were enrolled in the study, among whom, 40% were tested for BRCA mutations and 30% were found to be positive. Nearly 90% of patients underwent debulking surgery at diagnosis, with few operations being also recorded upon relapse. Platinum-based chemotherapy (CT) was predominantly used in the first line with half of patients also receiving angiogenesis inhibitor (AI), while non-platinum-based CT was preferred in later lines. The median PFS was 18.2 and 8.8 months in the first- and second-line setting, respectively, whereas the median OS was approximately 50 months. Our study adds to the available, but limited, real world data on the management of ovarian cancer providing evidence regarding the applied treatment strategies and outcomes of patients in Greece.

2020 ◽  
Vol 146 (5) ◽  
pp. 1335-1341
Author(s):  
Mayumi Kobayashi Kato ◽  
Mayu Yunokawa ◽  
Seiko Bun ◽  
Tatsunori Shimoi ◽  
Kan Yonemori ◽  
...  

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5547-5547 ◽  
Author(s):  
Melinda Louie-Gao ◽  
Ebru Aydin ◽  
Premal H. Thaker

5547 Background: Development of platinum resistance is a major clinical challenge in ovarian cancer (OC) treatment. In the phase 3 ENGOT-OV16/NOVA trial of the poly(ADP-ribose) polymerase inhibitor (PARPi) niraparib, 55% of BRCA wild-type ( BRCAwt) patients (pts) receiving placebo developed platinum resistance after their last platinum-based therapy (ie, progressive disease within 6 months of their last chemotherapy [CT] dose). Niraparib, a PARPi approved for the maintenance treatment of adult pts with recurrent OC following platinum-based CT, significantly prolongs progression-free survival (PFS). This real-world data analysis investigated the risk of platinum eligibility loss for BRCAwt pts who did not receive maintenance therapy after platinum treatment. Methods: This retrospective study identified 5,535 pts with OC from January 2011–October 2018 using data from Flatiron, a longitudinal, demographically and geographically diverse database derived from records of > 265 cancer clinics and > 2 million US cancer pts. BRCAwt pts who had received ≥2 lines of platinum-based CT, had disease progression ≥6 months after their previous line of therapy, and had no maintenance therapy (PARPi, bevacizumab, or CT agents) after their current treatment were included. Kaplan-Meier analysis was used to estimate the probability of pts initiating next treatment or death, whichever occurred first, within 6 months. Results: Of 5,535 pts diagnosed with OC, 147 BRCAwt pts met the inclusion/exclusion criteria of this analysis (similar to ENGOT-OV16/NOVA placebo arm). An estimated 56% of pts received the next treatment or died within 6 months after their last platinum-based therapy. Median time to next therapy or death was 5.1 months (95% confidence interval, 3.1–7.2). Conclusions: Our real-world data analysis shows that 56% of BRCAwt pts who received platinum-based treatment without maintenance therapy had recurrent OC within 6 months, classifying them as platinum resistant. Use of maintenance treatment options, such as niraparib, has been shown to significantly prolong PFS after platinum-based CT and may be beneficial in extending the platinum-free interval, enabling pts to remain eligible for further platinum therapy.


2020 ◽  
Author(s):  
Douglas Cartwright ◽  
Patricia Roxburgh ◽  
Barbara Stanley ◽  
Jennifer Brown ◽  
Alistair Mclaren ◽  
...  

2019 ◽  
Vol 84 (5) ◽  
pp. 1051-1058
Author(s):  
Mayu Yunokawa ◽  
Shinsuke Sasada ◽  
Yae Takehara ◽  
Kenta Takahashi ◽  
Tatsunori Shimoi ◽  
...  

2018 ◽  
Vol 29 ◽  
pp. viii338 ◽  
Author(s):  
E. Ratner ◽  
M. Bala ◽  
M. Louie-Gao ◽  
S. Hazard ◽  
P. Brastianos

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e18042-e18042
Author(s):  
Haley Moss ◽  
Angeles Alvarez Secord ◽  
Jessica Perhanidis ◽  
Carol Hawkes

e18042 Background: The clinical utility of maintenance therapy (MT) for patients with platinum-sensitive recurrent ovarian cancer (PSROC) has been validated in several clinical trials. We assessed real world treatment patterns using a US nationwide electronic health record database. Methods: A retrospective study of patients with PSROC between March 2017 and July 2019 was conducted using the Flatiron Health database. This longitudinal, demographically and geographically diverse de-identified database covers > 2.2 million oncology patients in > 280 cancer clinics. Patients were excluded if second or third line (2L or 3L) platinum-based chemotherapy (PBT) regimens included less than four or more than eight cycles of platinum. Information regarding somatic or germline BRCA mutations and homologous recombination deficiency (HRD) were obtained. Results: 2292 patients with PSROC were identified (had 2L or 3L treatment); 1214 of these received PBT at recurrence; 610 completed the PBT for recurrence on or after March 2017; 351 received 4–8 cycles of PBT; 225 patients had ≥2 months of active surveillance or were receiving MT of PARPi or bevacizumab (B) and were included in this analysis. 183 patients (80%) had BRCA testing and 14 patients (6%) had HRD testing. 46 (20%) had a germline or somatic BRCA mutations (t BRCA), 134 (59%) had a wildtype wt BRCA gene, and 48 (21%) were unknown. Of patients with tBRCA, 63% received a PARP inhibitor (PARPi), 17% received B, 20% received active surveillance. Of patients with wt BRCA, 40% received a PARPi, 24% received B, and 37% received active surveillance. Olaparib was the most commonly used PARPi among tBRCA patients (26%), while niraparib was most commonly used among wt BRCA patients (21%). MT was more common in younger patients, those with a better performance status and with a BRCA mutation. MT use trend increased by 21% during the study period. As PARPi use increased, the use of active surveillance as a post-platinum regimen decreased during the later time periods (Table). Conclusions: In this real world population, the majority of patients with PSROC are receiving maintenance therapy. While genetic testing is improving, universal testing of all patients with ovarian cancer remains the goal. The results provide insight into the shifting treatment patterns for patients with ovarian cancer. [Table: see text]


2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Jing Ni ◽  
Xianzhong Cheng ◽  
Qian Zhao ◽  
Zhiqin Dai ◽  
Xia Xu ◽  
...  

Abstract Background Niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, is approved for first/second-line maintenance treatment of ovarian cancer patients with complete or partial response to platinum-based chemotherapy, and multi-line monotherapy in BRCAmt patients or platinum-sensitive recurrence patients with homologous recombination deficiency (HRD). We present real-world experience from a single center of China. Methods Patients treated with niraparib in Jiangsu Cancer Hospital between June 2019 to July 2020 were recruited. The initial dose was given according to individualization. Response and adverse events (AEs) were analyzed by Response Evaluation Criteria in Solid Tumors v1.1. and National Cancer Institute Common Terminology Criteria for Adverse Events v5.0, respectively. HRD testing (AmoyDx®) was detected in most patients. Treatment was given until unequivocal progression or intolerable toxicity. Results Twenty-two patients all received niraparib at a bolus of 200 mg/d. Fifty percent of patients with high-grade serous ovarian cancer are HRD-positive. Six patients underwent first-line maintenance therapy. Sixteen patients received exploratory therapy. Ultimately image evaluation revealed that two patients achieved partial response (PR) and one patient achieved stable disease (SD), yielding objective response rate (ORR) of 33.3% (95%CI = 0.060–0.759) and disease control rate (DCR) of 50% (95%CI = 0.140–0.861) in the exploratory multi-line monotherapy group. The most common AEs were nausea, thrombocytopenia, and anemia. Grade 3–4 thrombocytopenia were managed by dose reduction and interruption. Leg swelling was observed as a new adverse event. Conclusion It is feasible that patients receiving a bolus of 200 mg/d in patients from Chinese population can acquire promising efficacy and tolerance. This is the first real-world data about niraparib in ovarian cancer patients with available HRD status from China.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5579-5579 ◽  
Author(s):  
David Garofalo ◽  
Ebru Aydin ◽  
Monica Labrador ◽  
Jennifer Webster ◽  
Greg Brown ◽  
...  

5579 Background: Approximately 1% of US women will be diagnosed with epithelial OC during their lifetime. OC patients who achieve a response to platinum-based chemotherapy may benefit from maintenance therapy, with the goal of inducing a lasting remission or extending the time interval before progression without any deleterious impact on quality of life1. This analysis, based on real world data sourced from US community oncology practices, was designed to assess the current utilization of maintenance therapy among maintenance eligible patients. Methods: This analysis utilized the Integra Data Exchange (DTX) database, a deidentified data source from community oncology practice systems (EMR, practice management, paid claims). This retrospective study included 3,629 OC patients with at least two visits between 7/16/16 and 4/16/18. 398 patients who completed 2nd line or later platinum-based chemotherapy for 4-9 cycles and/or had a complete/partial response between 1/1/17 and 7/31/18 were included. Potential maintenance therapy options were monotherapy of PARP inhibitors, bevacizumab, and non-platinum-chemotherapy agents. Rate of maintenance therapy after platinum-based treatment was assessed. Results: Our real-world analysis found that 49% of 398 maintenance eligible patients received maintenance therapy at least once following response to 2nd line or later platinum chemotherapy. Among those that received maintenance, 46% received PARPi, 28% bevacizumab, and 26% non-platinum chemotherapy. Further, 56% of women with BRCA mutations received maintenance treatment, compared with 49% of women without BRCA mutations. Conclusions: Though there are several options available, 51% of OC women studied who could potentially benefit from maintenance treatment did not receive maintenance. Only 56% of BRCA mutation carriers were targeted for maintenance in the real world. Among patients that receive maintenance therapy following 2nd line or later platinum chemotherapy 46% received a PARPi based regimen. 1) Quality of life in patients with recurrent ovarian cancer treated with niraparib versus placebo (ENGOT-OV16/NOVA): results from a double-blind, phase 3, randomized controlled trial. Lancet Oncol. 2018 Aug;19(8).


Sign in / Sign up

Export Citation Format

Share Document