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.
New York Presbyterian Hospital, New York, NY, USA.
Arch Gynecol Obstet. 2022 Jun;305(6):1647-1654. doi: 10.1007/s00404-021-06282-6. Epub 2022 Jan 7.
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 ≥ 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.
Real-world patterns of upfront bevacizumab use prior to FDA approval in 2018 differed significantly from trial data.
我们利用真实世界的理赔数据，评估贝伐珠单抗在临床数据发布但尚未获得 FDA 批准后，用于美国新诊断卵巢癌患者的效用。
我们使用 IQVIA Pharmetrics Plus 商业理赔数据库，确定了在 2006 年至 2018 年间接受过初始手术或新辅助化疗后间隔手术的新诊断卵巢癌女性患者。我们计算了贝伐珠单抗的使用率，以及住院和急诊（ED）就诊的相对频率。还计算了治疗相关的毒性作用以及二线化疗的时间。
在符合研究参数的 8923 名女性中，有 533 名（6.0%）接受了贝伐珠单抗治疗。使用率随时间推移而增加，从 2006 年的 1.5%增加到 2017 年的 7.0%（P<0.001），2011 年达到峰值 8.6%。≥70 岁（2.8%）和西部地区（4.5%）使用率最低，且不受合并症数量的影响。超过三分之一（35.1%）的患者使用贝伐珠单抗的时间不足 3 个月，15.9%的患者使用时间超过 13 个月。贝伐珠单抗的使用与住院或 ED 就诊无关。毒性作用包括高血压（15.0%）、肾脏损伤（6.8%）、出血（3.8%）、静脉血栓栓塞（2.3%）和瘘管（1.1%）。未使用贝伐珠单抗时，从一线化疗开始到二线化疗开始的时间为 19.9 个月，而使用贝伐珠单抗时为 22.6 个月。
在 2018 年 FDA 批准前，真实世界中贝伐珠单抗的使用模式与临床试验数据有显著差异。
