期刊
JOURNAL OF THE AMERICAN ACADEMY OF DERMATOLOGY
卷 72, 期 6, 页码 1021-+出版社
MOSBY-ELSEVIER
DOI: 10.1016/j.jaad.2015.03.021
关键词
advanced basal cell carcinoma; ERIVANCE BCC study; Hedgehog pathway inhibitor; locally advanced basal cell carcinoma; metastatic basal cell carcinoma; vismodegib
类别
资金
- F. Hoffmann-La Roche
- Genentech
- Novartis
- Lilly
Background: Primary analysis from the pivotal ERIVANCE BCC study resulted in approval of vismodegib, a Hedgehog pathway inhibitor indicated for treatment of adults with metastatic or locally advanced basal cell carcinoma (BCC) that has recurred after surgery or for patients who are not candidates for surgery or radiation. Objective: An efficacy and safety analysis was conducted 12 months after primary analysis. Methods: This was a multinational, multicenter, nonrandomized, 2-cohort study in patients with measurable and histologically confirmed locally advanced or metastatic BCC taking oral vismodegib (150 mg/d). Primary outcome measure was objective response rate (complete and partial responses) assessed by independent review facility. Results: After 12 months of additional follow-up, median duration of exposure to vismodegib was 12.9 months. Objective response rate increased from 30.3% to 33.3% in patients with metastatic disease, and from 42.9% to 47.6% in patients with the locally advanced form. Median duration of response in patients with locally advanced BCC increased from 7.6 to 9.5 months. No new safety signals emerged with extended treatment duration. Limitations: Limitations include low prevalence of advanced BCC and challenges of designing a study with heterogenous manifestations. Conclusion: The 12-month update of the study confirms the efficacy and safety of vismodegib in management of advanced BCC.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据