Gemcitabine plus sorafenib in patients with advanced pancreatic cancer: a phase II trial of the University of Chicago Phase II Consortium.
Gemcitabine plus sorafenib in patients with advanced pancreatic cancer: a phase II trial of the University of Chicago Phase II Consortium.
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DOI：
10.1007/s10637-010-9526-z
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发表时间：
2012-02
影响因子：
3.4
通讯作者：
Vokes, Everett E.
中科院分区：
文献类型：
--
作者：
Kindler, Hedy Lee;Wroblewski, Kristen;Wallace, James A.;Hall, Michael J.;Locker, Gershon;Nattam, Sreenivasa;Agamah, Edem;Stadler, Walter M.;Vokes, Everett E.
索拉非尼是B-raf、VEGFR 2和PDGFR-β的抑制剂，在临床前模型中具有抗胰腺癌活性。在吉西他滨联合索拉非尼的I期试验中，57%的胰腺癌患者病情稳定。我们在未经化疗且经组织学证实的晚期胰腺癌患者中进行了一项索拉非尼联合吉西他滨的多中心II期试验。患者在28天周期的第1、8和15天接受索拉非尼400 mg每日两次和吉西他滨1，000 mg/m2。17例患者在4家临床试验机构入组; 13例可评价缓解。没有客观反应; 18%的患者病情稳定。中位总生存期为4.0个月（95% CI：3.4，5.9）;中位无进展生存期为3.2个月（95% CI：1.6，3.6）。3/4级毒性包括18%的患者发生血栓形成，12%的患者发生脱水或手足综合征，6%的患者发生高血压或胃肠道出血。吉西他滨联合索拉非尼治疗晚期胰腺癌无效。
Sorafenib, an inhibitor of B-raf, VEGFR2, and PDGFR-β, has activity against pancreatic cancer in preclinical models. In a phase I trial of gemcitabine plus sorafenib, 57% of pancreatic cancer patients achieved stable disease. We conducted a multi-center phase II trial of sorafenib plus gemcitabine in chemo-naïve patients with histologicallyconfirmed, advanced pancreatic cancer. Patients received sorafenib 400 mg twice daily and gemcitabine 1,000 mg/m2 on days 1, 8 and 15 of a 28 day cycle. Seventeen patients enrolled at 4 centers; 13 were evaluable for response. There were no objective responses; 18% had stable disease. Median overall survival was 4.0 months (95% CI: 3.4, 5.9); median progression-free survival was 3.2 months (95% CI: 1.6, 3.6). Grade 3/4 toxicities included thrombosis in 18% of patients, dehydration or hand-foot syndrome in 12%, and hypertension or gastrointestinal bleeding in 6%. Gemcitabine plus sorafenib is inactive in advanced pancreatic cancer.
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影响因子：
254.7
作者：
Jemal, Ahmedin;Siegel, Rebecca;Thun, Michael J.
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