Charlotte R Gamble1,2, Ling Chen1,3, Elizabeth Szamreta4, Matthew Monberg4, Dawn Hershman1,3,5, Jason Wright6,7,8. 1. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, 161 Fort Washington Ave, Suite 456, New York, NY, 10032, USA. 2. New York Presbyterian Hospital, New York, NY, USA. 3. Joseph L. Mailman School of Public Health, Columbia University, New York, NY, USA. 4. Center for Observational and Real-World Evidence, Oncology Product Line, Merck & Co, Kenilworth, NJ, USA. 5. Herbert Irving Comprehensive Cancer Center, New York, NY, USA. 6. Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Columbia University College of Physicians and Surgeons, 161 Fort Washington Ave, Suite 456, New York, NY, 10032, USA. jw2459@columbia.edu. 7. Joseph L. Mailman School of Public Health, Columbia University, New York, NY, USA. jw2459@columbia.edu. 8. Herbert Irving Comprehensive Cancer Center, New York, NY, USA. jw2459@columbia.edu.
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: 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 ≥ 70 years 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 13 months. 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 19.9 months without bevacizumab and 22.6 months with bevacizumab use. CONCLUSIONS: Real-world patterns of upfront bevacizumab use prior to FDA approval in 2018 differed significantly from trial data.
PURPOSE: 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. METHODS: 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. RESULTS: 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 ≥ 70 years 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 13 months. 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 19.9 months without bevacizumab and 22.6 months with bevacizumab use. CONCLUSIONS: Real-world patterns of upfront bevacizumab use prior to FDA approval in 2018 differed significantly from trial data.
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