Real-world patterns and predictors of first-line maintenance use among patients with newly diagnosed advanced ovarian cancer: Is there an opportunity for change?

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18710-e18710
Author(s):  
Jinan Liu ◽  
Premal H. Thaker ◽  
Janvi Sah ◽  
Eric M. Maiese ◽  
Oscar Bee ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Maintenance Therapy ◽  
Real World ◽  
Index Date ◽  
Advanced Ovarian Cancer ◽  
Newly Diagnosed ◽  
First Line ◽  
Receive Maintenance Therapy ◽  
Platinum Based Chemotherapy ◽  
To Receive

e18710 Background: With the advent of poly(ADP-ribose) polymerase inhibitors (PARPi), options for first-line (1L) maintenance therapy in ovarian cancer (OC) have evolved in the US. This study described the use of 1L maintenance and assessed predictors of 1L maintenance use among PARPi-eligible patients (pts) with OC in a real-world setting. Methods: This retrospective cohort study included pts with newly diagnosed stage III/IV epithelial OC who received 6–9 cycles of 1L platinum-based chemotherapy (PBC) and primary or interval debulking surgery following neoadjuvant chemotherapy between Jan 1, 2016, and Feb 29, 2020, from the nationwide Flatiron Health electronic health record–derived deidentified database. The end of the last cycle of 1L PBC was defined as the index date. Those pts who started second-line chemotherapy within 2 months of the index date were excluded. Logistic regression was used to analyze variables with regard to 1L maintenance use. Results: In total, 463 pts were included; 21% received maintenance therapy, 79% received active surveillance. Baseline characteristics are shown in the table. Overall maintenance therapy use increased over the study period, from 7.7% to 37.7%. Pts with BRCA wild type were significantly less likely to receive maintenance therapy (odds ratio [OR]: 0.30; 95% CI, 0.16–0.59) than pts with BRCA mutation. Pts treated in 2018 (OR: 2.73; 95% CI, 1.25–5.98) and 2019 (OR: 8.78; 95% CI, 4.15–18.55) were significantly more likely to receive maintenance therapy than pts treated in 2017. Age, race, practice type, ECOG score, and residual disease status were not significant predictors of 1L maintenance use. Conclusions: Nearly 40% of pts with advanced stage OC received upfront maintenance therapy with an increasing trend over time, particularly in those with biomarker guidance. Research is warranted toward addressing barriers to the appropriate use of maintenance therapy.[Table: see text]

Real-world patterns and predictors of first-line maintenance use among patients with newly diagnosed advanced ovarian cancer: Is there an opportunity for change?

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 294-294
Author(s):  
Jinan Liu ◽  
Premal H. Thaker ◽  
Janvi Sah ◽  
Eric M Maiese ◽  
Oscar Bee ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Maintenance Therapy ◽  
Real World ◽  
Index Date ◽  
Advanced Ovarian Cancer ◽  
Newly Diagnosed ◽  
First Line ◽  
Receive Maintenance Therapy ◽  
Platinum Based Chemotherapy ◽  
To Receive

294 Background: With the advent of poly(ADP-ribose) polymerase inhibitors (PARPi), options for first-line (1L) maintenance therapy in ovarian cancer (OC) have evolved in the US. This study described the use of 1L maintenance and assessed predictors of 1L maintenance use among PARPi-eligible patients (pts) with OC in a real-world setting. Methods: This retrospective cohort study included pts with newly diagnosed stage III/IV epithelial OC who received 6–9 cycles of 1L platinum-based chemotherapy (PBC) and primary or interval debulking surgery following neoadjuvant chemotherapy between Jan 1, 2016, and Feb 29, 2020, from the nationwide Flatiron Health electronic health record–derived deidentified database. The end of the last cycle of 1L PBC was defined as the index date. Those pts who started second-line chemotherapy within 2 months of the index date were excluded. Logistic regression was used to analyze variables with regard to 1L maintenance use. Results: In total, 463 pts were included; 21% received maintenance therapy, 79% received active surveillance. Baseline characteristics are shown in the table. Overall maintenance therapy use increased over the study period, from 7.7% to 37.7%. Pts with BRCA wild type were significantly less likely to receive maintenance therapy (odds ratio [OR]: 0.30; 95% CI, 0.16–0.59) than pts with BRCA mutation. Pts treated in 2018 (OR: 2.73; 95% CI, 1.25–5.98) and 2019 (OR: 8.78; 95% CI, 4.15–18.55) were significantly more likely to receive maintenance therapy than pts treated in 2017. Age, race, practice type, ECOG score, and residual disease status were not significant predictors of 1L maintenance use. Conclusions: Nearly 40% of pts with advanced stage OC received upfront maintenance therapy with an increasing trend over time, particularly in those with biomarker guidance. Research is warranted toward addressing barriers to the appropriate use of maintenance therapy.[Table: see text]

scholarly journals Risk factors for progression or death after first-line platinum-based chemotherapy in real-world patients in the USA with ovarian cancer from 2011 to 2018

2021 ◽  
Author(s):  
Shannon N Westin ◽  
Melinda Louie-Gao ◽  
Divya Gupta ◽  
Premal H Thaker
Keyword(s):  
Risk Factors ◽  
Ovarian Cancer ◽  
Real World ◽  
Advanced Ovarian Cancer ◽  
Stage Iii ◽  
First Line ◽  
Debulking Surgery ◽  
Platinum Based Chemotherapy ◽  
Interval Debulking Surgery ◽  
The Usa

Aim: Patient chart data from the USA during the period of January 2011 through October 2018 were used to assess risk factors for progression in advanced ovarian cancer after response to first-line platinum-based chemotherapy. Patients & methods: Patients with stage III/IV ovarian cancer who completed first-line platinum-based chemotherapy after primary or interval debulking surgery were identified from the Flatiron Health database. Cox proportional hazards modeling was used to assess associations between baseline factors and time to next treatment (TTNT) or overall survival (OS). Results: Patients at stage IV or who received interval debulking surgery had shorter TTNT and OS than patients at stage III or who received primary debulking surgery, respectively. OS was worse in patients with residual disease and in BRCA wild-type. Conclusion: Multiple factors were associated with shorter TTNT or OS in this retrospective real-world analysis.

PAOLA-1: An ENGOT/GCIG phase III trial of olaparib versus placebo combined with bevacizumab as maintenance treatment in patients with advanced ovarian cancer following first-line platinum-based chemotherapy plus bevacizumab.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS5605-TPS5605 ◽  
Author(s):  
Isabelle Laure Ray-Coquard ◽  
Philipp Harter ◽  
Antonio Gonzalez Martin ◽  
Claire Cropet ◽  
Sandro Pignata ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Maintenance Therapy ◽  
Maintenance Treatment ◽  
Advanced Ovarian Cancer ◽  
Chemotherapeutic Agents ◽  
Phase Iii ◽  
Brca Testing ◽  
First Line ◽  
Platinum Based Chemotherapy ◽  
The Eu

TPS5605 Background: Olaparib (Lynparza) is an oral PARP inhibitor indicated in the EU for the maintenance treatment of patients (pts) with platinum-sensitive relapsed BRCA-mutated high grade serous ovarian cancer (HGSOC). Bevacizumab is an anti-VEGF monoclonal antibody indicated in the EU in first line or relapse for the treatment of OC in combination with specific chemotherapeutic agents. Bevacizumab treatment is associated with increasing hypoxia-induced homologous recombination repair deficiencies in tumor cells, and is hypothesized to increase ovarian tumor sensitivity to olaparib. Methods: PAOLA-1 (ENGOT-ov25) is a randomized, placebo-controlled trial evaluating the efficacy and safety of olaparib (tablet formulation) in pts with advanced HGSOC receiving bevacizumab maintenance therapy. Eligible pts are those in complete or partial response following first-line platinum chemotherapy plus bevacizumab, and for whom bevacizumab maintenance therapy is planned. Approximately 762 European and 24 Japanese pts will be randomized 2:1 to olaparib 300 mg twice daily or placebo for up to 24 months. All pts will receive standard maintenance care of bevacizumab (15 mg/kg every three weeks) for up to 15 months. Primary objective: PFS1 according to RECIST 1.1 Secondary objectives: PFS2, OS, Safety, PRO/QoL, TFST, TSST All pts will undergo tumor BRCA testing prior to randomization. Central BRCA testing (tumor) will be performed in five screening platforms in France. Tumor BRCA test results have to be available within two months of sample provision. PFS will be evaluated using a log-rank test stratified by response to first-line treatment and BRCA mutation status. Treatment effect hazard ratio of 0.7 is expected and final PFS1 analysis will be performed after 372 events. The first pt from eight ENGOT groups plus Japan (10 participating countries) was randomized in July 2015. As of 31 January 2017, 549 pts have been randomized. The median period between the provision of a tumor sample and returned BRCA test result is 40 days. Accrual is expected to be complete before July 2017. Clinical trial information: NCT02477644.

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.

Reasons for first-line maintenance therapy discontinuation among patients with newly diagnosed advanced ovarian cancer treated in real-world settings.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 290-290
Author(s):  
Jinan Liu ◽  
Premal H. Thaker ◽  
Janvi Sah ◽  
Eric M Maiese ◽  
Linda Kalilani ◽  
...  
Keyword(s):  
Ovarian Cancer ◽  
Maintenance Therapy ◽  
Disease Progression ◽  
Real World ◽  
Systemic Therapy ◽  
Common Reason ◽  
Newly Diagnosed ◽  
First Line ◽  
Debulking Surgery ◽  
Therapy Discontinuation

290 Background: PARP inhibitor (PARPi) and bevacizumab have been integrated into the first-line (1L) maintenance therapy for patients (pts) with ovarian cancer (OC). However, due to adverse events, the rate of PARPi maintenance discontinuation was 12% in the SOLO1 clinical trial. We aimed to better understand the rate and cause of maintenance therapy discontinuation in real-world practice. Methods: This retrospective cohort study was conducted using de-identified electronic health record (EHR)–derived data from the nationwide Flatiron Health electronic health database. From January 1, 2016, to February 29, 2020, data were obtained for pts with newly diagnosed stage III/IV epithelial OC who received primary debulking surgery followed by 6–9 cycles of 1L platinum-based chemo or neoadjuvant chemo followed by interval debulking surgery. Index date was the end of 1L systemic therapy. Results: Of 675 pts with stage III/IV OC who underwent primary systemic therapy, 144 (21.3%) received 1L maintenance therapy and were included in the analysis. Mean age was 65.0 y. Most pts were treated in community practice (93.1%), had ECOG score of 0–1 at diagnosis (81.3%), and were shown to be BRCA wild type (66.7%). Bevacizumab was the most common 1L maintenance therapy (n = 69, 47.9%), followed by olaparib (n = 46, 31.9%), paclitaxel (n = 18, 12.5%), rucaparib (n = 10, 6.9%), and gemcitabine (n = 1, 0.7%). Overall, 34 (23.6%) pts discontinued 1L maintenance therapy. The most common reason for discontinuation was disease progression (n = 19, 13.2%), followed by treatment-related toxicity (n = 13, 9.0%; Table). Of 56 pts who received PARPi (olaparib or rucaparib) 1L maintenance therapy, 21 (37.5%) pts discontinued treatment: 11 (19.6%) because of disease progression, 9 (16.0%) treatment-related toxicity, and 1 for other reasons. Conclusions: In pts with advanced OC who received 1L maintenance therapy in clinical practice, disease progression was the most common reason for maintenance therapy discontinuation. The rates of toxicity-related discontinuations were comparable with those reported in clinical trials.[Table: see text]

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