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Researchers found low rates of patient involvement in first-line ovarian cancer treatment decisions in Europe and the US from 2017 to 2020 despite the increasing use of targeted therapies, like poly (ADP-ribose) polymerase inhibitors.
Rates of physician-reported patient involvement in first-line treatment decisions for ovarian cancer were low in both Europe and the US between 2017 and 2020, according to a study published in the International Journal of Gynecological Cancer.1
There has been increasing interest in evaluating the impact of approvals on the ovarian cancer treatment landscape to generate hypotheses for prospective trials and identify gaps for improved clinical management. For example, poly (ADP-ribose) polymerase (PARP) inhibitors were approved by both the FDA and the European Medicines Agency (EMA) in 2018, continuing the evolution of the first-line maintenance treatment landscape.2
However, real-world data examining the influence of these approvals on ovarian cancer treatment choices are lacking.1 Therefore, the researchers conducted an analysis to describe treatment patterns for European and American patients with advanced ovarian cancer, with a focus on first-line maintenance. Other objectives studied included patient characteristics, drivers of treatment choices, and biomarker testing rates.
Consequently, they retrospectively analyzed electronic health records (EHRs) of patients with ovarian cancer in France, Italy, Germany, Spain, the United Kingdom (UK), and the US. Those eligible were diagnosed with epithelial ovarian, fallopian tube, or primary peritoneal cancer, regardless of the disease stage, between June 1, 2017, and May 31, 2020; they also needed to be 18 years or older at diagnosis.
The researchers collected patient data via a survey completed by treating physicians. Physicians from between 40 and 70 centers in Europe and between 50 and 100 centers in the US were randomly invited to participate. Eligible physicians were actively practicing oncologists, were younger than 62, and were the primary decision-makers for their patients’ pharmacological treatments. They also had a minimum of 3 years of experience, treated a minimum of 10 patients with ovarian cancer annually, and retrieved the EHRs for 10 to 20 of their patients.
The chosen physicians completed standardized patient record forms using patients' EHR data. The forms contained multiple-choice questions on various topics, including patient demographics, treatment patterns in the first-line treatment setting, and the amount of patient involvement in their treatment plan.
The researchers stratified patients by country and diagnosis date to better understand treatment patterns at different points. Therefore, they separated patients into 1 of 3 cohorts. Cohort 1 included those diagnosed between June 1, 2017, and May 31, 2018; cohort 2 included patients diagnosed between June 1, 2018, and May 31, 2019; and cohort 3 included patients diagnosed between June 1, 2019, and May 31, 2020.
The study population consisted of 7072 patients from 416 physicians, with a mean age at diagnosis of 61.9 years. Of the study population, 23.8% (n = 1686) patients had stage I/II ovarian cancer, and 76.2% (n = 5386) had stage III/IV ovarian cancer. Also, 97.5% of patients received primary treatment. More specifically, 62.4% (n = 4303) underwent debulking surgery (primary debulking, 72.3%; interval debulking, 27.6%) and 75.8% (n = 5224) received first-line adjuvant therapy. Conversely, optimal cytoreduction rates were low across all countries.
The researchers found that the most reported factor impacting treatment selection in the first-line adjuvant and maintenance settings overall was national and/or international guidelines. However, patient preference was documented as a factor impacting treatment selection in 15% (n = 754) of those in the first-line adjuvant setting and 16% (n = 521) of those in the first-line maintenance setting.
Of the 754 patients receiving first-line adjuvant treatment, 48% received chemotherapy, 47% received chemotherapy in combination with a vascular endothelial growth factor (VEGF) inhibitor, and 5% received a different treatment. Also, among the 521 patients receiving first-line maintenance treatment, 53% received VEGF inhibitor monotherapy, 33% received PARP inhibitor monotherapy, 7% received a VEGF inhibitor in combination with a PARP inhibitor, 5% received chemotherapy, and 2% received another first-line maintenance treatment.
Additionally, 93.7% (n = 5047) of the 5386 patients with stage III/IV ovarian cancer completed primary treatment, followed by either first-line maintenance (n = 3016) or active surveillance (n = 2031). The amount of patients receiving first-line maintenance treatment increased between cohorts 1 (53.0%; 879/1660), 2 (60.5%; 1051/1737), and 3 (65.8%; 1086/1650). Conversely, the proportion monitored by active surveillance decreased across cohorts 1 (47.0%; 781/1660), 2 (39.5%; 686/1737), and 3 (34.2%; 564/1650). Both trends were present in all countries except Germany, where the use of first-line maintenance treatment decreased.
Also, 3016 patients with stage III/IV ovarian cancer received first-line maintenance treatment. More specifically, 69.8% (n = 2106) received anti-angiogenic agent monotherapy, 23.4% (n = 705) received PARP inhibitor monotherapy, 3.5% (n = 106) received a PARP inhibitor in combination with an anti-angiogenic agent, 2.0% (n = 59) received chemotherapy, and 1.3% (n = 40) received other agents. Overall, the number of patients receiving PARP inhibitors subsequently increased across cohorts 1, 2, and 3, but the use of anti-angiogenic agents decreased.
As for biomarker testing, 26.5% (1427/5386) of those with stage III/IV ovarian cancer tested positive for a germline or somatic BRCA1/2 mutation, and 55.7% were BRCA wild-type. However, 17.8% were not tested for their BRCA mutation status.
The researchers acknowledged their limitations, including the potential for recording, coding, and interpreting errors among the EHRs. Also, clinical data may be limited or missing and often cannot be retrieved retroactively. Despite their limitations, the researchers expressed confidence in their findings.
“Dissemination of these data may help to contextualize and increase awareness regarding how the advanced ovarian cancer treatment paradigm has progressed with the approval of targeted therapies in the era of maintenance therapy,” the authors concluded.
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