Lapatinib/Gemcitabine and Lapatinib/Gemcitabine/Oxaliplatin: A Phase I Study for Advanced Pancreaticobiliary Cancer

Lapatinib/Gemcitabine and Lapatinib/Gemcitabine/Oxaliplatin: A Phase I Study for Advanced Pancreaticobiliary Cancer
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拉帕替尼/吉西他滨和拉帕替尼/吉西他滨/奥沙利铂:晚期胰胆癌的 I 期研究

DOI:
10.1097/coc.0b013e318145b9a5
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发表时间:
2008
期刊:
American Journal of Clinical Oncology
影响因子:
--
通讯作者:
T. Kennedy
T. Kennedy
中科院分区:
--
文献类型:
--
作者:
H. Safran;T. Miner;M. Resnick;T. Dipetrillo;B. Mcnulty;Devon Evans;P. Joseph;A. Plette;R. Millis;Dina Sears;N. Gutman;T. Kennedy

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目的:评价拉帕替尼(剂量范围1000 - 1500 mg/d)联合吉西他滨和吉西他滨/奥沙利铂(GEMOX)治疗晚期胰胆管癌患者的安全性/耐受性和潜在抗肿瘤活性。材料和方法:晚期胰胆管癌患者被分配到拉帕替尼每日一次给药的4个队列之一。评估了毒性、反应和生存率。结果:25例患者入组,18例胰腺癌和7例胆管癌。拉帕替尼1500 mg/d与吉西他滨每周一次成功给药。在接受1500 mg/d拉帕替尼联合GEMOX治疗的5例患者中,有2例发生恶心和厌食的剂量限制性毒性。所有患者的中位生存期为11个月,1年生存率为48%。结论:拉帕替尼1500 mg/d可与吉西他滨每周给药。拉帕替尼的最大耐受剂量为1000 mg/d,GEMOX。将启动拉帕替尼和吉西他滨治疗转移性胰腺癌的II期研究。
Objective:To evaluate the safety/tolerability and potential antitumor activity of lapatinib, at dose ranges of 1000 to 1500 mg/d, in combination with gemcitabine and gemcitabine/oxaliplatin (GEMOX) in patients with advanced pancreaticobiliary cancer. Materials and Methods:Patients with advanced pancreaticobiliary cancer were assigned to 1 of 4 cohorts of lapatinib administered once daily. Toxicities, response, and survival were assessed. Results:Twenty-five patients were enrolled, 18 with pancreatic cancer and 7 with biliary cancer. Lapatinib, 1500 mg/d, was successfully administered with weekly gemcitabine. Dose limiting toxicities of nausea and anorexia occurred in 2 of 5 patients receiving 1500 mg/d lapatinib with GEMOX. The median survival of all patients was 11 months and the 1-year survival was 48%. Conclusion:Lapatinib, 1500 mg/d, can be administered with weekly gemcitabine. The maximum tolerated dose of lapatinib is 1000 mg/d with GEMOX. A phase II study of lapatinib and gemcitabine for metastatic pancreatic cancer will be initiated.
DOI: 10.1126/science.3798106
发表时间: 1987-01-09
期刊: SCIENCE
影响因子: 56.9
作者:
SLAMON, DJ;CLARK, GM;MCGUIRE, WL
通讯作者: MCGUIRE, WL