Patterns of use and outcomes of adjuvant bevacizumab therapy prior to regulatory approval in women with newly diagnosed ovarian cancer

Abstract

We used real-world claims data to assess the utility of the relatively novel therapeutic bevacizumab in patients with newly diagnosed ovarian cancer in the United States after release of clinical data but prior to FDA approval. We used the IQVIA Pharmetrics Plus commercial claims database to identify women with a new diagnosis of ovarian cancer who underwent primary surgery or neoadjuvant chemotherapy followed by interval surgery from 2006 to 2018. We calculated the rate of use of bevacizumab, and the relative frequency of hospital and emergency department (ED) admissions. Treatment-related toxicities, and time to second line chemotherapy were calculated. Among 8923 women who met study parameters, 533 (6.0%) received bevacizumab. The rate of use increased over time from 1.5% in 2006 to 7.0% in 2017 (P < 0.001), with a peak of 8.6% in 2011. The use was lowest in those ≥ 70years old (2.8%), and in the West (4.5%), and was unaffected by number of comorbidities. Over one third (35.1%) received bevacizumab for less than 3 months, and 15.9% remained on it for greater than 13months. Bevacizumab use was not associated with hospitalization or ED admission. Toxicities included hypertension (15.0%), kidney damage (6.8%), bleeding (3.8%), venous thrombo-embolism (2.3%) and fistula (1.1%). Time from initiation of first line chemotherapy to initiation of second line therapy was 19.9months without bevacizumab and 22.6months with bevacizumab use. Real-world patterns of upfront bevacizumab use prior to FDA approval in 2018 differed significantly from trial data.