A real-world study on characteristics, treatments and outcomes in US patients with advanced stage ovarian cancer

Abstract

Background Detailed epidemiologic descriptions of large populations of advanced stage ovarian cancer patients have been lacking to date. This study aimed to describe the patient characteristics, treatment patterns, survival, and incidence rates of health outcomes of interest (HOI) in a large cohort of advanced stage ovarian cancer patients in the United States (US). Methods This cohort study identified incident advanced stage (III/IV) ovarian cancer patients in the US diagnosed from 2010 to 2018 in the HealthCore Integrated Research Database (HIRD) using a validated predictive model algorithm. Descriptive characteristics were presented overall and by treatment line. The incidence rates and 95% confidence intervals for pre-specified HOIs were evaluated after advanced stage diagnosis. Overall survival, time to treatment discontinuation or death (TTD), and time to next treatment or death (TTNT) were defined using treatment information in claims and linkage with the National Death Index. Results We identified 12,659 patients with incident advanced stage ovarian cancer during the study period. Most patients undergoing treatment received platinum agents (75%) and/or taxanes (70%). The most common HOIs (> 24 per 100 person-years) included abdominal pain, nausea and vomiting, anemia, and serious infections. The median overall survival from diagnosis was 4.5 years, while approximately half of the treated cohort had a first-line time to treatment discontinuation or death (TTD) within the first 4 months, and a time to next treatment or death (TTNT) from first to second-line of about 6 months. Conclusions This study describes commercially insured US patients with advanced stage ovarian cancer from 2010 to 2018, and observed diverse treatment patterns, incidence of numerous HOIs, and limited survival in this population.

Real-world Outcomes Associated With Poly(ADP-ribose) Polymerase Inhibitor Monotherapy Maintenance in Patients With Primary Advanced Ovarian Cancer

“…Because of the potential differences between the clinical trial populations and the real-world AOC populations, including but not limited to the possibility of differences in age, race, comorbidities, and clinical practice locations, it is important to examine real-world evidence of PARPi monotherapy maintenance treatment outcomes. [14][15][16][17][18] Although in some cases there may be differences between the conclusions drawn from real-world data and clinical study findings, the results found in this study align with those seen in both the PRIMA trial and the PRIME trial, in which PFS benefit was shown with PARPi monotherapy in the overall intentionto-treat trial population. 7,19 In PRIMA, the overall median duration of PFS was 13.8 months with niraparib and 8.2 months with placebo (HR, 0.62; 95% CI: 0.50-0.76; P < 0.001), whereas, in the PRIME trial, the overall median duration of PFS was 24.8 months with niraparib and 8.3 months with placebo (HR, 0.45; 95% CI: 0.34-0.60; P < 0.001).…”

“…7,8 However, clinical trials often contain narrowly defined populations not reflective of real-world cancer patient populations. [14][15][16][17] In the AOC population, a lack of real-world studies has been identified, particularly in the areas of population uptake and survival outcomes. 14,18 Although PARPi monotherapy maintenance treatments have been introduced into the clinical landscape of AOC, there is little insight into their real-world uptake and the associated outcomes.…”

“…[14][15][16][17] In the AOC population, a lack of real-world studies has been identified, particularly in the areas of population uptake and survival outcomes. 14,18 Although PARPi monotherapy maintenance treatments have been introduced into the clinical landscape of AOC, there is little insight into their real-world uptake and the associated outcomes. Because of the potential differences between the clinical trial populations and the real-world AOC populations, including but not limited to the possibility of differences in age, race, comorbidities, and clinical practice locations, it is important to examine real-world evidence of PARPi monotherapy maintenance treatment outcomes.…”

Maintenance therapy for newly diagnosed epithelial ovarian cancer– a review

“…Treatment discontinuation is frequently observed with increased lines of therapy in patients with advanced OC [ 79 ]. A real-world study reported that approximately half of the treated cohort having a treatment discontinuation or death within the first 4 month or transfer to second-line or later therapies within a few months of initiation of the first-line therapy [ 80 ]. A majority (75%) of the patients received standard chemotherapy for advanced disease [ 80 ].…”

PAUF as a Target for Treatment of High PAUF-Expressing Ovarian Cancer

“…Attempts of targeting the trending tumor associated antigens PD-1 and PD-L1, have achieved great success in certain cancers, but made limited progress in other cancer settings including ovarian (Zhu et al, 2021) and pancreatic (Feng et al, 2017). Other new targeted treatments including VEGF inhibitors and PARP inhibitors received regulatory approvals, but surgery and platinum-based chemotherapies are still the current standard of care for ovarian cancer (Beachler et al, 2020). Achieving early diagnosis as well as improving the efficacy and reducing the resistance of the chemotherapies have remained clinically relevant but challenging in ovarian cancer treatment.…”