作者
Ghassan K Abou-Alfa, Donna Niedzwieski, Jennifer J Knox, Andreas Kaubisch, James Posey, Benjamin R Tan, Petr Kavan, Rakesh Goel, Philip Edward Lammers, Tanios S Bekaii-Saab, Vincent Channing Tam, Lakshmi Rajdev, Robin Kate Kelley, Abby B Siegel, Jennifer Balletti, James J Harding, Lawrence HOWARD Schwartz, Richard M Goldberg, Monica M Bertagnolli, Alan P Venook
发表日期
2016/5/20
来源
Journal of Clinical Oncology
卷号
34
期号
15_suppl
页码范围
4003-4003
出版商
American Society of Clinical Oncology
简介
4003
Background: An exploratory analysis of a randomized phase II study in HCC comparing doxorubicin (D) alone to doxorubicin plus sorafenib (D+S) showed a significant improvement in overall survival favoring D+S (JAMA, 2011). The results appeared promising compared to the historic outcomes seen in the pivotal sorafenib (S) trials. CALGB 80802 was designed to determine if D+S improved survival compared to S alone. Methods: Patients with histologically proven advanced HCC, no prior systemic therapy and Child-Pugh A were randomized to receive D 60 mg/m2 every 21 days plus S 400 mg PO twice daily (D+S) or S alone. For bilirubin ≥ 1.3x normal, D and S doses were halved. D was maxed out at 360 mg/m2. The study was stratified by extent of disease (locally advanced; metastatic), the primary endpoint was overall survival (OS); and secondary endpoint progression-free survival (PFS). The final …
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GK Abou-Alfa, D Niedzwieski, JJ Knox, A Kaubisch… - 2016