Real-world treatment patterns in patients with advanced (stage III–IV) ovarian cancer in the USA and Europe

2020 ◽  
Vol 16 (15) ◽  
pp. 1013-1030
Author(s):  
Jennifer P Hall ◽  
Jane Chang ◽  
Rebecca Moon ◽  
Olivia Higson ◽  
Katherine Byrne ◽  
...  

Aim: To analyze real-world data relating to treatment decision-making in stage III–IV ovarian cancer (OC). Materials & methods: Real world data were collected from a survey of physicians and their patients (n = 2413) across Europe and the USA in 2017–2018. Results: 49% had stage IVb disease. 39, 54 and 7% of patients received first-line (1L), second-line, or 7% third-line or later treatment. In the 1L (ongoing or completed), 93% received platinum-containing regimens, 26% bevacizumab-containing regimens and 1% a PARP inhibitor-containing regimen. In 1L maintenance treatment, 81% received bevacizumab, 17% platinum-containing treatments and 6% a PARP inhibitor. Conclusion: The most common 1L treatment for advanced ovarian cancer was platinum-containing chemotherapy. Of those receiving 1L maintenance therapy, 70–99% (across countries) received targeted therapy.

2021 ◽  
Author(s):  
Shannon N Westin ◽  
Melinda Louie-Gao ◽  
Divya Gupta ◽  
Premal H Thaker

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.


2017 ◽  
Vol 35 (4_suppl) ◽  
pp. 705-705
Author(s):  
Dimas Yusuf ◽  
Maria Yi Ho ◽  
Hagen F. Kennecke ◽  
Winson Y. Cheung

705 Background: Clinical decision support tools (CDSTs) can help physicians make complex treatment decisions and inform care. For colon cancer, CDSTs such as Adjuvant! Online and Numeracy were widely used to estimate the effects of adjuvant treatment and guide conversations with patients. Existing CDSTs, however, do not consider more contemporary predictive and prognostic factors, such as microsatellite instability (MSI), BRAF mutational status, or the presence of additional high risk clinical or pathological features (HRFs), in their assessment of outcomes. Current CDSTs are also not optimized for handheld devices. Methods: We developed ONCOPRE, which is an adjuvant chemotherapy benefit calculator for colon cancer that addresses the limitations of current CDSTs. Based on a comprehensive review of epidemiological data and results of landmark trials, ONCOPRE was devised to predict 5-year colon cancer recurrence and death. To validate ONCOPRE, we compared its predictions with those generated by existing CDSTs as well as real-world data from 7 tertiary cancer centers across Canada. Results: ONCOPRE is able to predict 5-year DFS and OS of patients with colon cancer based on age, sex, TNM status, and contemporary risk factors such as MSI status, BRAF mutations, and other HRFs. ONCOPRE’s predictions compare favorably with real-world data and predictions from other CDSTs. ONCOPRE’s predictions are typically more optimistic than historical outcomes, and this likely reflects the fact that current day colon cancer patients experience better prognosis with the use of modern therapy and improved supportive care. These attributes make ONCOPRE a potentially new benchmark among CDSTs that can reliably predict colon cancer outcomes. Conclusions: ONCOPRE ( http://www.oncopre.com/beta/ ) represents a new CDST that can assist in adjuvant treatment decision-making and patient counseling. We make the case that the next generation of CDSTs in oncology must take into account more contemporary clinical, biochemical, and genetic risk factors since these elements significantly affect outcomes. The ONCOPRE platform serves as a potential model on which to develop prediction tools for other forms of cancers.


2020 ◽  
Author(s):  
Jing Ni ◽  
Xianzhong Cheng ◽  
Qian Zhao ◽  
Zhiqin Dai ◽  
Xia Xu ◽  
...  

Abstract BackgroundNiraparib, 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) positive. We present real-world experience from China. MethodsPatients 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. ResultsTwenty-two patients all received niraparib at an bolus of 200mg/d. 50% 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 DCR of 50% (95%CI=0.140-0.861) in the exploratory multi-line monotherapy group. Commonly 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. ConclusionIt is feasible for patients received a bolus of 200mg/d in Chinese population with promising efficacy and well tolerated. This is first real world data about niraparib in ovarian cancer patients with HRD status from China.


2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5548-5548
Author(s):  
Shannon Neville Westin ◽  
Melinda Louie-Gao ◽  
Enkhe Badamgarav ◽  
Mohan V. Bala ◽  
Premal H. Thaker

5548 Background: Limited real-world information is available in ovarian cancer (OC) regarding prognostic factors for disease progression or death after initial treatment. Here, we assessed potential prognostic risk factors in OC patients (pts) who completed first-line (1L) platinum-based chemotherapy (CT) using real-world data. Methods: This retrospective study identified 5535 pts diagnosed with OC from January 2011–October 2018 from the Flatiron database, a longitudinal, demographically and geographically diverse database derived from health records from > 265 cancer clinics and > 2 million US cancer pts. Stage III/IV OC pts who completed 1L platinum-based CT after primary debulking or interval debulking surgery were included. Pts who received a poly(ADP-ribose) polymerase inhibitor (PARPi) in 1L treatment or as maintenance therapy after 1L treatment were excluded. Cox proportional hazards model was used to assess the association between baseline factors (neoadjuvant CT, disease stage, residual disease, BRCA status, ECOG, age, platelet count, hemoglobin, and neutrophil count) and time to next treatment (TTNT; a proxy for progression-free survival) or overall survival (OS) in these pts. Results: 1064 of 5535 pts were eligible per our inclusion/exclusion criteria. Neoadjuvant treatment, stage of disease, residual disease after surgery, and BRCA mutation ( BRCAmut) status were significant prognostic factors for either TTNT or OS. Neoadjuvant chemotherapy pts had a shorter TTNT (hazard ration [HR] = 1.37; P= .001) and OS (HR = 1.64; P= .0002) than pts who underwent primary surgery after adjusting for other covariates. Stage IV pts had a shorter TTNT (HR = 1.26; P= .01) and OS (HR = 1.24; P= .09) than stage III pts. OS was also worse in pts with vs without residual disease (HR = 1.27; P= .04) and worse in BRCAwt than BRCAmut pts (HR = 1.37; P= .10). Conclusions: In this retrospective analysis of a real-world data set, BRCAwt status was associated with higher risk of death. Receipt of neoadjuvant CT, higher stage of disease at diagnosis, or presence of residual disease after surgery were also associated with a shorter TTNT or higher risk of death. These real-world data confirm previously identified prognostic factors.


2017 ◽  
Vol 35 (8_suppl) ◽  
pp. 126-126
Author(s):  
Dimas Yusuf ◽  
Maria Yi Ho ◽  
Winson Y. Cheung

126 Background: Clinical decision support tools (CDSTs) can help physicians make complex treatment decisions and inform care. For colon cancer, CDSTs such as Adjuvant! Online and Numeracy were widely used to estimate the effects of adjuvant treatment and guide conversations with patients. Existing CDSTs, however, do not consider more contemporary predictive and prognostic factors, such as microsatellite instability (MSI), BRAF mutational status, or the presence of additional high risk clinical or pathological features (HRFs), in their assessment of outcomes. Current CDSTs are also not optimized for handheld devices. Methods: We developed ONCOPRE, which is an adjuvant chemotherapy benefit calculator for colon cancer that addresses the limitations of current CDSTs. Based on a comprehensive review of epidemiological data and results of landmark trials, ONCOPRE was devised to predict 5 year colon cancer recurrence and death. To validate ONCOPRE, we compared its predictions with those generated by existing CDSTs as well as real-world data from 7 tertiary cancer centers across Canada. Results: ONCOPRE is able to predict 5-year DFS and OS of patients with colon cancer based on age, sex, TNM status, and contemporary risk factors such as MSI status, BRAF mutations, and other HRFs. ONCOPRE’s predictions compare favorably with real-world data and predictions from other CDSTs. ONCOPRE’s predictions are typically more optimistic than historical outcomes, and this likely reflects the fact that current day colon cancer patients experience better prognosis with the use of modern therapy and improved supportive care. These attributes make ONCOPRE a potentially new benchmark among CDSTs that can reliably predict colon cancer outcomes. Conclusions: ONCOPRE ( http://www.oncopre.com/ ) represents a new CDST that can assist in adjuvant treatment decision-making and patient counseling. We make the case that the next generation of CDSTs in oncology must take into account more contemporary clinical, biochemical, and genetic risk factors since these elements significantly affect outcomes. The ONCOPRE platform serves as a potential model on which to develop prediction tools for other forms of cancers.


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

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

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.


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