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贝伐珠单抗在转移性乳腺癌女性中的应用:一项关于临床实践和当前争议的调查。

The use of bevacizumab among women with metastatic breast cancer: a survey on clinical practice and the ongoing controversy.

机构信息

Department of Medical Oncology, Dubai Hospital, Dubai, United Arab Emirates.

出版信息

Cancer. 2012 Jun 1;118(11):2780-6. doi: 10.1002/cncr.26579. Epub 2011 Oct 5.

Abstract

BACKGROUND

The US Food and Drug Administration's (FDA's) recent decision to remove the indication of bevacizumab for metastatic breast cancer (MBC) has fueled a debate in the breast cancer community. We conducted a survey to assess the perception of health care workers involved in the management of women with MBC on the FDA's decision to ascertain how it will affect practice and to determine how bevacizumab is commonly used in the community for MBC.

METHODS

E-mails were sent out between September and November 2010 using a database of 3000 addresses maintained by the United Arab Emirates Cancer Congress. Individuals working for Roche or Genentech were excluded. The survey consisted of 22 questions that were divided into 3 parts addressing each participant's demographic profile, their opinion of the FDA's decision, and the typical use of bevacizumab in the community in the setting of MBC.

RESULTS

A total of 564 participants were included in the final analysis, contributing to an 18.8% response rate. Of these participants, 14.6% were from the United States, 7.8% were from Canada, 31.1% were from Europe, 2.0% were from the United Arab Emirates, 11.1% were from Asia, and 33.3% were from other countries. The majority of participants believed progression-free survival to be a surrogate for overall survival, that cost played a role in the FDA's decision, and that the decision would adversely affect the future of newer drugs currently being investigated for MBC. The majority of participants indicated that they would use bevacizumab for triple receptor-negative MBC (46.5%), would use it in a first-line setting (44.7%), and would use it in combination with paclitaxel (51.9%).

CONCLUSION

Our survey results highlight the discord between the opinion of community oncologists and the FDA's recent decision to withdraw the indication of bevacizumab for MBC.

摘要

背景

美国食品和药物管理局(FDA)最近决定取消贝伐单抗治疗转移性乳腺癌(MBC)的适应证,这在乳腺癌领域引发了一场争论。我们进行了一项调查,以评估参与管理 MBC 女性的医护人员对 FDA 决定的看法,以了解该决定将如何影响实践,并确定社区中贝伐单抗在 MBC 中的常用情况。

方法

2010 年 9 月至 11 月期间,使用由阿拉伯联合酋长国癌症大会维护的 3000 个地址数据库,通过电子邮件向个人发送调查。排除罗氏或基因泰克公司的员工。该调查由 22 个问题组成,分为 3 部分,分别涉及每位参与者的人口统计学特征、他们对 FDA 决定的看法以及在 MBC 背景下社区中贝伐单抗的典型使用情况。

结果

共有 564 名参与者被纳入最终分析,应答率为 18.8%。其中,14.6%来自美国,7.8%来自加拿大,31.1%来自欧洲,2.0%来自阿拉伯联合酋长国,11.1%来自亚洲,33.3%来自其他国家。大多数参与者认为无进展生存期是总生存期的替代指标,认为成本在 FDA 的决定中发挥了作用,并且该决定将对目前正在研究用于 MBC 的新药的未来产生不利影响。大多数参与者表示,他们将在三阴性乳腺癌(46.5%)中使用贝伐单抗,将在一线治疗中使用(44.7%),并将其与紫杉醇联合使用(51.9%)。

结论

我们的调查结果突出了社区肿瘤学家的意见与 FDA 最近决定撤销贝伐单抗治疗 MBC 适应证之间的分歧。

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