【medical-news】索拉非尼联合化疗延长乳腺癌患者的无进展生存期
发布于 2009-07-27 · 浏览 1627 · IP 广西广西
这个帖子发布于 15 年零 289 天前，其中的信息可能已发生改变或有所发展。
Sorafenib Combined With Chemotherapy Lengthens PFS in Breast Cancer
索拉非尼联合化疗延长乳腺癌患者的无进展生存期
OncologySTAT Editorial Team. 2009 Jul 23, E Powers
Berlin – The first cooperative group–sponsored, randomized, phase II trial of sorafenib (Nexavar) in advanced metastatic breast cancer achieved its primary endpoint of progression-free survival (PFS), according to an announcement issued by Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. The study, which compared the combination of oral sorafenib and oral capecitabine in patients with locally advanced or metastatic HER2-negative breast cancer, found a statistically significant (P = . 0006) prolongation of median PFS in patients treated with sorafenib plus capecitabine compared with those receiving capecitabine plus placebo.
Safety and tolerability profiles of the combination regimen were as expected, with no new or unexpected toxicities observed. A complete analysis of the trial’s results will be reported at an upcoming scientific meeting.
“Based on these encouraging data, Bayer and Onyx are evaluating various strategies for Nexavar in breast cancer. Nexavar is already benefiting patients worldwide with liver cancer and kidney cancer,” said Kemal Malik, a member Bayer’s HealthCare Executive Committee and the company’s Chief Medical Officer. “Despite significant treatment advances, breast cancer continues to be the leading cause of cancer death in women. We hope to establish Nexavar as an important new treatment option for patients with this devastating disease.”
“This outcome represents a positive signal of the benefit of this combination for patients with advanced breast cancer and is the first statistical demonstration of efficacy for a multi-tyrosine kinase inhibitor in this disease,” said Jose Baselga, MD, Chairman and Professor of Medicine at Vall d'Hebron Institute of Oncology in Barcelona and the trial’s principal investigator. “One goal of this study was to evaluate the success of an all oral regimen, which may represent a unique treatment option for patients with breast cancer.”
The 229 patients with locally advanced or metastatic HER-negative breast cancer who participated in this double-blind, phase II study were randomized to receive either 400 mg of oral sorafenib or matching placebo twice daily plus 1000 mg/m2 of capecitabine twice daily for 14 days, followed by a 7-day, capecitabine-free interval. Study participants had received no more than 1 prior round of chemotherapy in this setting. In addition to its primary endpoint of PFS, the study also assessed such secondary endpoints as overall survival, time to progression, and safety.
Investigators and cooperative groups are currently evaluating sorafenib in various breast cancer treatment settings, according to Bayer. Ongoing trials include 3 randomized phase II studies. One phase II trial is assessing sorafenib plus paclitaxel in the first-line setting, the second trial is studying the oral multiple kinase inhibitor plus gemcitabine or capecitabine in the first- or second-line setting following progression on bevacizumab, and the third trial is evaluating the drugs plus docetaxel and/or letrozole in the first-line setting.
http://www.oncologystat.com
索拉非尼联合化疗延长乳腺癌患者的无进展生存期
OncologySTAT Editorial Team. 2009 Jul 23, E Powers
Berlin – The first cooperative group–sponsored, randomized, phase II trial of sorafenib (Nexavar) in advanced metastatic breast cancer achieved its primary endpoint of progression-free survival (PFS), according to an announcement issued by Bayer HealthCare AG and Onyx Pharmaceuticals, Inc. The study, which compared the combination of oral sorafenib and oral capecitabine in patients with locally advanced or metastatic HER2-negative breast cancer, found a statistically significant (P = . 0006) prolongation of median PFS in patients treated with sorafenib plus capecitabine compared with those receiving capecitabine plus placebo.
Safety and tolerability profiles of the combination regimen were as expected, with no new or unexpected toxicities observed. A complete analysis of the trial’s results will be reported at an upcoming scientific meeting.
“Based on these encouraging data, Bayer and Onyx are evaluating various strategies for Nexavar in breast cancer. Nexavar is already benefiting patients worldwide with liver cancer and kidney cancer,” said Kemal Malik, a member Bayer’s HealthCare Executive Committee and the company’s Chief Medical Officer. “Despite significant treatment advances, breast cancer continues to be the leading cause of cancer death in women. We hope to establish Nexavar as an important new treatment option for patients with this devastating disease.”
“This outcome represents a positive signal of the benefit of this combination for patients with advanced breast cancer and is the first statistical demonstration of efficacy for a multi-tyrosine kinase inhibitor in this disease,” said Jose Baselga, MD, Chairman and Professor of Medicine at Vall d'Hebron Institute of Oncology in Barcelona and the trial’s principal investigator. “One goal of this study was to evaluate the success of an all oral regimen, which may represent a unique treatment option for patients with breast cancer.”
The 229 patients with locally advanced or metastatic HER-negative breast cancer who participated in this double-blind, phase II study were randomized to receive either 400 mg of oral sorafenib or matching placebo twice daily plus 1000 mg/m2 of capecitabine twice daily for 14 days, followed by a 7-day, capecitabine-free interval. Study participants had received no more than 1 prior round of chemotherapy in this setting. In addition to its primary endpoint of PFS, the study also assessed such secondary endpoints as overall survival, time to progression, and safety.
Investigators and cooperative groups are currently evaluating sorafenib in various breast cancer treatment settings, according to Bayer. Ongoing trials include 3 randomized phase II studies. One phase II trial is assessing sorafenib plus paclitaxel in the first-line setting, the second trial is studying the oral multiple kinase inhibitor plus gemcitabine or capecitabine in the first- or second-line setting following progression on bevacizumab, and the third trial is evaluating the drugs plus docetaxel and/or letrozole in the first-line setting.
http://www.oncologystat.com
最后编辑于 2022-10-09 · 浏览 1627
3 1 点赞
