|
一項(xiàng)新研究結(jié)果表明，一種名為多吉美的藥物可顯著延長(zhǎng)晚期肝癌患者總生存期。有關(guān)專家說(shuō)，這種藥物為肝癌治療提供了一種新的選擇。 來(lái)自多個(gè)國(guó)家的研究人員在新一期美國(guó)《新英格蘭醫(yī)學(xué)雜志》（NEJM）上發(fā)表報(bào)告說(shuō)，他們?cè)诿绹?guó)、歐洲和澳大利亞等國(guó)家和地區(qū)選取602名晚期肝癌患者進(jìn)行了研究。這些患者都未接受過(guò)系統(tǒng)治療。研究結(jié)果發(fā)現(xiàn)，與服用安慰劑相比，服用多吉美可使晚期肝癌或原發(fā)肝癌患者的總生存期延長(zhǎng)約44%。 多吉美由德國(guó)拜耳醫(yī)藥保健公司生產(chǎn)，可同時(shí)作用于腫瘤細(xì)胞和腫瘤血管。有關(guān)研究人員今年6月曾在美國(guó)臨床腫瘤學(xué)會(huì)年會(huì)上介紹說(shuō)，他們?cè)趤喬貐^(qū)選取晚期肝癌患者進(jìn)行了研究，結(jié)果發(fā)現(xiàn)多吉美可使這些患者的生存期延長(zhǎng)約47%。 這種藥物分別于去年在美國(guó)和歐洲被批準(zhǔn)用于治療肝癌。拜耳醫(yī)藥保健公司近日發(fā)布新聞公報(bào)說(shuō)，多吉美已獲得中國(guó)國(guó)家食品藥品監(jiān)督管理局批準(zhǔn)，用于不能手術(shù)的晚期肝癌患者治療。（生物谷Bioon.com） 生物谷推薦原始出處： NEJM，359:378-390，Josep M. Llovet，Jordi Bruix Sorafenib in Advanced Hepatocellular Carcinoma ABSTRACT Background No effective systemic therapy exists for patients with advanced hepatocellular carcinoma. A preliminary study suggested that sorafenib, an oral multikinase inhibitor of the vascular endothelial growth factor receptor, the platelet-derived growth factor receptor, and Raf may be effective in hepatocellular carcinoma. Methods In this multicenter, phase 3, double-blind, placebo-controlled trial, we randomly assigned 602 patients with advanced hepatocellular carcinoma who had not received previous systemic treatment to receive either sorafenib (at a dose of 400 mg twice daily) or placebo. Primary outcomes were overall survival and the time to symptomatic progression. Secondary outcomes included the time to radiologic progression and safety. Results At the second planned interim analysis, 321 deaths had occurred, and the study was stopped. Median overall survival was 10.7 months in the sorafenib group and 7.9 months in the placebo group (hazard ratio in the sorafenib group, 0.69; 95% confidence interval, 0.55 to 0.87; P<0.001). There was no significant difference between the two groups in the median time to symptomatic progression (4.1 months vs. 4.9 months, respectively, P=0.77). The median time to radiologic progression was 5.5 months in the sorafenib group and 2.8 months in the placebo group (P<0.001). Seven patients in the sorafenib group (2%) and two patients in the placebo group (1%) had a partial response; no patients had a complete response. Diarrhea, weight loss, hand–foot skin reaction, and hypophosphatemia were more frequent in the sorafenib group. Conclusions In patients with advanced hepatocellular carcinoma, median survival and the time to radiologic progression were nearly 3 months longer for patients treated with sorafenib than for those given placebo. (ClinicalTrials.gov number, NCT00105443 [ClinicalTrials.gov] .)
|
|
|
