主页 > 医学前沿 >
【J Clin Oncol】mDCF联合贝伐单抗治疗晚期胃食管腺
Manish A. Shah, Minaxi Jhawer, David H. Ilson, Robert A. Lefkowitz, Edric Robinson, Marinela Capanu and David P. Kelsen
J Clin Oncol. 2011 Mar 1; 29(7):868-74
http://jco.ascopubs.org/content/early/2010/12/21/JCO.2010.32.0770.abstract
Purpose To evaluate the safety and efficacy of a modified administration schedule of docetaxel, cisplatin, and fluorouracil (mDCF) with bevacizumab in patients with advanced gastroesophageal malignancies.?
Patients and Methods Previously untreated patients with metastatic gastroesophageal adenocarcinoma received bevacizumab 10 mg/kg, docetaxel 40 mg/m2, fluorouracil 400 mg/m2, leucovorin 400 mg/m2 on day 1, fluorouracil 1,000 mg/m2/d × 2 days intravenous continuous infusion beginning on day 1, and cisplatin 40 mg/m2 on day 3. The primary objective was to improve 6-month progression-free survival (PFS) from 43% (historical DCF control) to 63% with the addition of bevacizumab. The target accrual was 44 patients to have 10% type I and II error rates.
Results In total, 44 eligible patients with cancer were enrolled from October 2006 to October 2008: 22 gastric, 20 gastroesophageal junction (GEJ), and two esophagus. In 39 patients with measurable disease, the confirmed response rate was 67% (95% CI, 50% to 81%). Six-month PFS was 79% (95% CI, 63% to 88%), and median PFS was 12 months (95% CI, 8.8 to 18.2 months). With 26-month follow-up, median overall survival (OS) was 16.8 months (95% CI, 12.1 to 26.1 months), and 2-year survival was 37%. Treatment-related grade 3 to 4 toxicity was as follows: neutropenia without fever (50%), fatigue (25%), venous thromboembolism (39%), and nausea, vomiting, mucositis, neuropathy, and febrile neutropenia less than 10% each. In subset analysis, diffuse gastric cancer had significantly worse PFS and OS, and the response rate in proximal/GEJ tumors was 85% (95% CI, 62% to 97%).
Conclusion mDCF with bevacizumab appears tolerable and has notable patient outcomes in patients with advanced gastroesophageal adenocarcinoma. Six-month PFS was 79%, surpassing our predefined efficacy end point, and median and 2-year OS were 16.8 months and 37%, respectively. Phase II Study of Modified Docetaxel, Cisplatin, and Fluorouracil With Bevacizumab in Patients With Metastatic Gastroesophageal Adenocarcinoma
改良DCF方案联合贝伐单抗治疗转移性胃食管腺癌的II期临床研究
Purpose To evaluate the safety and efficacy of a modified administration schedule of docetaxel, cisplatin, and fluorouracil (mDCF) with bevacizumab in patients with advanced gastroesophageal malignancies.
目的：评价多西他赛-顺铂-5-Fu改良方案（mDCF）联合贝伐单抗治疗晚期胃食管癌的疗效和安全性。
Patients and Methods Previously untreated patients with metastatic gastroesophageal adenocarcinoma received bevacizumab 10 mg/kg, docetaxel 40 mg/m2, fluorouracil 400 mg/m2, leucovorin 400 mg/m2 on day 1, fluorouracil 1,000 mg/m2/d × 2 days intravenous continuous infusion beginning on day 1, and cisplatin 40 mg/m2 on day 3. The primary objective was to improve 6-month progression-free survival (PFS) from 43% (historical DCF control) to 63% with the addition of bevacizumab. The target accrual was 44 patients to have 10% type I and II error rates.
患者和方法：先前未治疗的转移性胃食管腺癌患者，治疗方案为贝伐单抗10 mg/kg，多西他赛40 mg/m2，5-Fu 400mg/m2，亚叶酸钙400mg/m2 d1；5-Fu 1 000 mg/m2/d × 2静脉持续灌注；顺铂40 mg/m2 d3。主要预期是加入贝伐单抗后，6个月无进展生存(PFS)从43%（DCF方案）提高到63%。目标获益是44例患者有10% 的I和II型误差率。
Results In total, 44 eligible patients with cancer were enrolled from October 2006 to October 2008: 22 gastric, 20 gastroesophageal junction (GEJ), and two esophagus. In 39 patients with measurable disease, the confirmed response rate was 67% (95% CI, 50% to 81%). Six-month PFS was 79% (95% CI, 63% to 88%), and median PFS was 12 months (95% CI, 8.8 to 18.2 months). With 26-month follow-up, median overall survival (OS) was 16.8 months (95% CI, 12.1 to 26.1 months), and 2-year survival was 37%. Treatment-related grade 3 to 4 toxicity was as follows: neutropenia without fever (50%), fatigue (25%), venous thromboembolism (39%), and nausea, vomiting, mucositis, neuropathy, and febrile neutropenia less than 10% each. In subset analysis, diffuse gastric cancer had significantly worse PFS and OS, and the response rate in proximal/GEJ tumors was 85% (95% CI, 62% to 97%).
结果：2006.10-2008.10，共44例适宜患者入组，其中22例胃癌，20例胃食管交界癌，2例食管癌。39例有可测量病灶患者中，有效率为67% (95% CI, 50%-81%)；6个月PFS为79% (95% CI, 63% -88%)，中位PFS为12个月(95% CI, 8.8-18.2月)。通过26个月的随访，中位总生存(OS)为16.8 个月(95% CI, 12.1 -6.1月)，2年生存为37%。治疗相关Ⅲ/Ⅳ度毒性为：无发热中性粒细胞减少(50%)，疲劳(25%)，静脉血栓栓塞(39%)，恶心、呕吐、黏膜炎、神经病变、发热性中性粒细胞减少均少于10%。在亚组分析中，弥漫性胃癌的PFS和OS更差，近端/胃食管交界癌的有效率为85% (95% CI, 62%-97%)。
阅读本文的人还阅读：
作者:admin@医学,生命科学 2011-03-01 23:45
医学,生命科学网