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贝伐珠单抗作为一线治疗药物在美国用于卵巢癌的早期使用特征。

Characterization of the Early Years of Bevacizumab Use for First-Line Treatment of Ovarian Cancer in the United States.

机构信息

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.

Department of Epidemiology, University of Washington, Seattle, WA.

出版信息

JCO Oncol Pract. 2021 Nov;17(11):e1698-e1710. doi: 10.1200/OP.20.00918. Epub 2021 Apr 12.

DOI:10.1200/OP.20.00918
PMID:33844592
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9810132/
Abstract

PURPOSE

To quantify early dissemination patterns, factors influencing use, and costs of bevacizumab (BEV) for the treatment of newly diagnosed ovarian cancer (OC) in the United States before its regulatory approval for this indication (off-label use).

METHODS

We identified women 18-65 years of age with newly diagnosed OC treated with surgery and platinum-based chemotherapy from 2008 to 2016 through the MarketScan database (N = 8,109). The proportion of women receiving BEV over time was calculated, multivariate logistic regression used to determine factors associated with BEV use, and total costs per cycle of chemotherapy with and without BEV abstracted.

RESULTS

BEV utilization rose 1.8-fold during the study period, from 4.1% (2008) to 7.4 % (2016). BEV was used with non-platinum/taxane regimens over a third of the time (37.2%). Physician specialty (medical oncology gyn oncology) and geography (southeast region) were significantly associated with higher rates of use. Clinical factors associated with BEV use were metastatic disease and presence of ascites. The median cost of one cycle of platinum/taxane chemotherapy plus BEV was $10,897 in US dollars (USD) (interquartile range $7,573-$18,133 USD), compared with $1,629 USD (interquartile range, $683.0-$4,461 USD) for platinum/taxane alone.

CONCLUSION

Off-label use of BEV for newly diagnosed OC was rare (< 10%), but doubled following presentation of phase II and III data at international meetings. Both clinical (ascites, metastatic disease, and age) and nonclinical (specialty and region) factors were associated with BEV use, and its use was accompanied by a six-fold increase in the cost of one cycle of treatment.

摘要

目的

在贝伐珠单抗(bevacizumab,BEV)获得该适应证(超适应证使用)监管批准之前,量化其在美国用于治疗新诊断卵巢癌(ovarian cancer,OC)的早期传播模式、影响其使用的因素和成本。

方法

我们通过 MarketScan 数据库(N = 8109),确定了 2008 年至 2016 年期间接受手术和铂类化疗治疗的新诊断 OC 且年龄在 18-65 岁的女性。我们计算了随时间推移接受 BEV 治疗的女性比例,使用多变量逻辑回归确定与 BEV 使用相关的因素,并提取有无 BEV 的每周期化疗的总费用。

结果

在研究期间,BEV 的使用率增加了 1.8 倍,从 2008 年的 4.1%(4.1%)增加到 2016 年的 7.4%(7.4%)。BEV 与非铂类/紫杉烷方案联合应用的时间超过三分之一(37.2%)。医生专业(肿瘤内科、妇科肿瘤学)和地理位置(东南部地区)与更高的使用率显著相关。与 BEV 使用相关的临床因素是转移性疾病和腹水的存在。铂类/紫杉烷联合 BEV 化疗一个周期的中位费用为 10897 美元(USD)(四分位距 7573-18133 USD),而仅使用铂类/紫杉烷的费用为 1629 USD(四分位距 683.0-4461 USD)。

结论

新诊断 OC 的 BEV 超适应证使用(<10%)很少见,但在国际会议上报告了 II 期和 III 期数据后,其使用增加了一倍。临床因素(腹水、转移性疾病和年龄)和非临床因素(专业和地区)均与 BEV 的使用相关,其使用使一个周期的治疗费用增加了六倍。