Abstract
Introduction: Bevacizumab-containing therapy is considered a standard-of-care front-line option for stage IIIB–IV ovarian cancer based on results of randomized phase 3 trials. The multicenter non-interventional ENCOURAGE prospective cohort study assessed treatment administration and outcomes in the French real-world setting.Patients and Methods: Eligible patients were aged ≥ 18 years with planned bevacizumab-containing therapy for newly diagnosed ovarian cancer. The primary objective was to assess the safety profile of front-line bevacizumab in routine clinical practice; secondary objectives were to describe patient characteristics, indications/contraindications for bevacizumab, treatment regimens and co-medications, follow-up and monitoring, progression-free survival, and treatment at recurrence. In this non-interventional study, treatment was administered as chosen by the investigator and participation in the trial had no influence on the management of the disease.Results: Of 1,290 patients screened between April 2013 and February 2015, 468 were eligible. Most patients (86%) received bevacizumab 15 mg/kg every 3 weeks or equivalent, typically with carboplatin (99%) and paclitaxel (98%). The median duration of bevacizumab was 12.2 (range 0–28, interquartile range 6.9–14.9) months; 8% of patients discontinued bevacizumab because of toxicity. The most common adverse events were hypertension (38% of patients), fatigue (35%), and bleeding (32%). There were no treatment-related deaths. Most physicians (90%) reported blood pressure measurement immediately before each bevacizumab infusion and almost all (97%) reported monitoring for proteinuria before each bevacizumab infusion. Median progression-free survival was 17.4 (95% CI, 16.4–19.1) months. The 3-year overall survival rate was 62% (95% CI, 58–67%). The most commonly administered chemotherapies at recurrence were carboplatin and pegylated liposomal doxorubicin.Discussion: Clinical outcomes and tolerability with bevacizumab in this real-life setting are consistent with randomized trial results, notwithstanding differences in the treated patient population and treatment schedule.Clinical Trial Registration:ClinicalTrials.gov, Identifier NCT01832415.
Highlights
Bevacizumab-containing therapy is considered a standard-of-care frontline option for stage IIIB–IV ovarian cancer based on results of randomized phase 3 trials
Median progression-free survival was 17.4 months
Clinical outcomes and tolerability with bevacizumab in this real-life setting are consistent with randomized trial results, notwithstanding differences in the treated patient population and treatment schedule
Summary
Bevacizumab-containing therapy is considered a standard-of-care frontline option for stage IIIB–IV ovarian cancer based on results of randomized phase 3 trials. In two randomized phase 3 trials (GOG-0218 and ICON7), combining bevacizumab with a carboplatin–paclitaxel doublet for newly diagnosed ovarian cancer significantly improved progression-free survival (Burger et al, 2011; Perren et al, 2011), leading to European Medicine’s Agency (EMA) regulatory approval for stage IIIB, IIIC, and IV ovarian cancer. Bevacizumab-containing therapy was approved by the US Food and Drug Administration for stage III or IV ovarian cancer following initial surgical resection (Avastin Prescribing Information, 2020). In the GOG-0218 trial, bevacizumab was associated with a significant increase in grade ≥2 hypertension versus chemotherapy alone (Burger et al, 2011). Similar patterns were seen in the ICON7 trial using a lower dose and shorter treatment duration of bevacizumab (Perren et al, 2011)
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