Clinical outcomes according to age and comorbidities in the OSCAR UK observational study of front-line bevacizumab (BEV)-containing therapy for advanced ovarian cancer (aOC)

Abstract

Background: The efficacy and safety of front‐line BEV with carboplatin and paclitaxel (CP) for aOC were demonstrated in two randomised phase III trials (GOG‐0218 and ICON7). OSCAR (NCT01863693; funded by Roche Products Ltd) evaluated front‐line BEV‐containing therapy in routine oncology practice in 29 UK centres. Methods: Eligible patients received BEV (7.5 or 15 mg/kg q3w, typically for up to 12 months, per UK clinical practice) during and after front‐line chemotherapy (physician's choice) for high‐risk stage IIIB‐IV ovarian cancer. Co‐primary endpoints were progression‐free survival (PFS) and safety (NCI CTCAE v4.0). Patients were evaluated according to standard practice/physician's discretion during BEV treatment, with an end‐of‐study assessment 12 months after the last BEV dose. We report post hoc subgroup analyses in populations defined by age and comorbidities. Results: Of 299 patients starting treatment between May 2013 and Mar 2015, 80 were aged≥70 years, of whom 9 were ≥80 years. Almost all patients (91%) had comorbidities (pre‐existing medical condition at BEV initiation), most commonly hypertension/ essential hypertension (27%), constipation (22%) or fatigue (22%). Most (93%) received BEV 7.5 mg/kg with CP; 22% had primary debulking surgery, 40% interval debulking surgery and 38% no surgery. Patient characteristics, treatment exposure PFS and safety are summarised below. In multivariable Cox regression analysis, neither age nor number of comorbidities was prognostic for PFS. Conclusions: Older patients were more likely to receive single‐agent chemotherapy, have ongoing comorbidities and have worse surgical outcome than their younger counterparts. However, median BEV exposure, incidence of grade 3/4 AEs and median PFS were similar in younger and older patients. Grade ≥3 AEs were more common in patients with ≥3 than <3 comorbidities but PFS was similar.