Recurrence of ovarian cancer in BRCAwt patients without maintenance therapy: Real-world evidence.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5547-5547 ◽  
Author(s):  
Melinda Louie-Gao ◽  
Ebru Aydin ◽  
Premal H. Thaker
Keyword(s):  
Ovarian Cancer ◽  
Data Analysis ◽  
Maintenance Therapy ◽  
Real World ◽  
Maintenance Treatment ◽  
Treatment Options ◽  
Progression Free Survival ◽  
Platinum Resistance ◽  
Real World Data ◽  
World Data

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.

Olaparib as maintenance therapy in patients with BRCA 1–2 mutated recurrent platinum sensitive ovarian cancer: Real world data and post progression outcome

2020 ◽  
Vol 156 (1) ◽  
pp. 38-44 ◽  
Author(s):  
Sabrina Chiara Cecere ◽  
Gaia Giannone ◽  
Vanda Salutari ◽  
Laura Arenare ◽  
Domenica Lorusso ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Maintenance Therapy ◽  
Real World ◽  
Real World Data ◽  
World Data ◽  
Platinum Sensitive ◽  
Brca 1

Real-world progression-free survival among patients with newly diagnosed advanced ovarian cancer: Does maintenance therapy work?

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18707-e18707
Author(s):  
Jinan Liu ◽  
John Chan ◽  
Janvi Sah ◽  
Eric M. Maiese ◽  
Oscar Bee ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Maintenance Therapy ◽  
Real World ◽  
Maintenance Treatment ◽  
Index Date ◽  
Progression Free Survival ◽  
Tumor Biomarker ◽  
Newly Diagnosed ◽  
Debulking Surgery ◽  
Free Survival

e18707 Background: Options for first-line (1L) maintenance therapy in ovarian cancer (OC) have evolved in the US in recent years, particularly with FDA approvals of poly(adenosine diphosphate [ADP]-ribose) polymerase inhibitors (PARPi). Olaparib was approved in 2018 for 1L maintenance treatment of patients (pts) with advanced OC with BRCA mutation and in 2020 as combination therapy with bevacizumab for 1L maintenance treatment of pts with homologous recombination deficient (HRd)–positive tumors. Additionally, the FDA approved niraparib in 2020 for maintenance treatment of pts with advanced OC regardless of tumor biomarker status. This study aimed to describe use and outcomes of 1L maintenance vs. active surveillance (AS) among PARPi-eligible pts with OC in a real-world setting prior to the most recent 2020 FDA approvals. Methods: This retrospective cohort study included pts with newly diagnosed stage III/IV OC who received 6–9 cycles of 1L platinum-based chemotherapy (PBC) and either primary debulking surgery or interval debulking surgery following neoadjuvant chemotherapy between January 1, 2016, and February 29, 2020, regardless of biomarker status, from the Flatiron Health database, a longitudinal electronic health record-derived database consisting of de-identified patient-level data that are curated via technology-enabled abstraction. The end of the last cycle of 1L PBC was defined as the index date. Pts who started second-line (2L) treatment within 2 months of the index date were excluded. Primary endpoint was time to initiation of 2L systemic therapy (as a surrogate for progression) or death. Inverse probability of treatment weighting and Cox proportional hazard model were used to adjust for baseline differences among pts on maintenance therapy and pts on AS. Results: A total of 463 pts were included in the study, 87.7% from community practices and 12.3% from academic institutions. Of the pts included, 21.0% received maintenance therapy, while 79.0% did not. Of those who received maintenance therapy, 48.5% received bevacizumab, 40.2% received PARPi (olaparib, rucaparib), and 11.3% received paclitaxel. Median progression-free survival (PFS) for pts who received 1L maintenance therapy was 16.1 months, compared with 12.2 months in pts who did not receive 1L maintenance therapy. After adjusting for baseline differences in characteristics and demographics, including age, race, stage of cancer, and BRCA status, pts on maintenance therapy had a statistically significant, 29% lower risk of progression or death than those receiving AS (hazard ratio: 0.71; 95% CI, 0.52–0.99; P= 0.04). Conclusions: In this real-world analysis, the majority of pts did not receive maintenance therapy; however, a PFS benefit was found in those receiving maintenance therapy. Further studies are needed to understand how biomarker status drives practice patterns.

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 ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Real World ◽  
Treatment Strategies ◽  
Angiogenesis Inhibitor ◽  
Progression Free Survival ◽  
Treatment Modalities ◽  
Real World Data ◽  
Brca Mutations ◽  
World Data ◽  
Platinum Based Chemotherapy

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.

scholarly journals Pain Pharmacotherapy in a Large Cohort of Patients with Osteoarthritis: A Real-World Data Analysis

2021 ◽  
Author(s):  
Noga Fallach ◽  
Gabriel Chodick ◽  
Matanya Tirosh ◽  
Elon Eisenberg ◽  
Omri Lubovsky
Keyword(s):  
Data Analysis ◽  
Real World ◽  
Large Cohort ◽  
Real World Data ◽  
World Data
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