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8楼
发表于 2008-10-24 16:44
原帖由 张医生 于 2008-10-24 16:23 发表 
1、多吉美（索拉非尼）主要用于治疗晚期肝癌肾癌，并非用于治疗乙肝，这里是乙肝咨询版，在这里讨论多吉美不太合适，故将此帖移到肝癌、肝移植版。
2、多吉美（索拉非尼）在国内上市不久，价格非常昂贵，而且并无疗程概念，只要有效，需要 ...
正好手头有篇索拉非尼治疗晚期肝癌的III期临床试验的文献。
III期临床试验，应该是FDA还没有批准索拉非尼用于肝癌吧？？
N Engl J Med. 2008 Jul 24;359(4):378-90.Related Articles, Links
Comment in:
N Engl J Med. 2008 Jul 24;359(4):420-2.
Sorafenib in advanced hepatocellular carcinoma.
Llovet JM, Ricci S, Mazzaferro V, Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A, Raoul JL, Forner A, Schwartz M, Porta C, Zeuzem S, Bolondi L, Greten TF, Galle PR, Seitz JF, Borbath I, Häussinger D, Giannaris T, Shan M, Moscovici M, Voliotis D, Bruix J; SHARP Investigators Study Group.
Collaborators (112)
Pallota MG, Zarba JJ, Boyer M, Riordan S, Strickland A, Tebbutt N, Thomson B, Borbath I, De Greve J, Van Laethem JL, Van Steenbergen W, Van Vlierberghe H, Barrios C, Cosme de Oliveira A, Kotzev I, Takov D, Tchernev K, Burak K, Ma M, Metrakos P, Olweny C, Sherman M, Gamargo Garate C, Martinez-Castillo J, Beaugrand M, Bennouna J, Blanc JF, Bronowicki JP, Degos F, Dominguez S, Grange JD, Hillon P, Raoul JL, Seitz JF, Blum H, Buggisch P, Caspary W, Dollinger M, Galle PR, Gerken G, Göke B, Gregor M, Greten T, Häussinger D, Scherübl J, Scheulen M, Schmid R, Spengler U, Wiest R, Zeuzem S, Arvanitakis C, Germanidis G, Katsos I, Figer A, Stemmer S, Amadori D, Bolondi L, Cognetti F, Craxi A, Farinati F, Gridelli C, Martoni A, Mazzaferro V, Porta C, Ricci S, Sangiovanni A, Santoro A, Trevisani F, Cisnero Garza LE, Gane E, O'Donnell A, Leon J, Lozano A, Jassem J, Rydzewska G, Szawlowski A, Tomczak P, Badulescu F, Miron L, Kubyshkin V, Bruix J, Forner A, Bustamante Schneider J, Diago M, Montero Alvarez JL, Pascual S, Ruíz del Arbol L, Sangro B, Solá R, Tabernero J, Muellhaupt B, Roth A, Jeffry Evans TR, Falk S, Meyer T, Reeves H, Ross P, Befeler A, Boyer T, Britten C, Byrne T, Garcia-Tsao G, Gold P, Goldenberg A, Heuman D, Kennedy P, Koch A, Llovet JM, Marrero J, Schilsky M, Schwartz J, Schwartz M.
Barcelona Clinic Liver Cancer Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Centro de Investigaciones en Red de Enfermedades Hepáticas y Digestivas Hospital Clínic Barcelona, Barcelona. [email protected]
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.) 2008 Massachusetts Medical Society
（延长中位生存时间2.8个月。）
Publication Types:
Clinical Trial, Phase III
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't |
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晕,刷一下屏啦.
