Sahora Klaus, Schindl Martin, Kuehrer Irene, Eisenhut Axel, Werba Gregor, Brostjan Christine, Telek Bela, Ba'ssalamah Ahmed, Stift Judith, Schoppmann Sebastian F, Gnant Michael
MD FACS, Department of Surgery and Comprehensive Cancer Center Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria.
Anticancer Res. 2014 May;34(5):2377-84.
We report the results of a phase II trial of adding the anti-ascular endothelial growth factor (VEGF) bevacizumab to gemcitabine neoadjuvant chemotherapy for patients with borderline and unresectable non-metastatic pancreatic cancer.
Patients were assigned to one of the two treatment arms. Both groups received 1,000 mg/m(2) gemcitabine on days 1, 8, and 15 of a 4-week cycle for a total of four cycles. Group 1 received 5 mg/kg bevacizumab for six weeks (three doses), every second week, starting at week 6 of gemcitabine therapy. Group 2 received 5 mg/kg bevacizumab for 12 weeks (six doses), every second week, starting at week 1 of gemcitabine therapy. The objective of the present study was to assess the rate of complete radical resection and overall survival.
A total of 30 patients were enrolled: 19 patients had unresectable and 11 patients had borderline-resectable pancreatic cancer. Eleven patients (37%) underwent resection. The median overall survival of patients who underwent tumor resection was 13 months (95% confidence interval=11-15 months).
In general, adding bevacizumab to neoadjuvant gemcitabine does not improve outcomes for patients with locally advanced pancreatic cancer. However, in individual cases, surgery is consequently possible and prolonged survival may be observed.
我们报告了一项II期试验的结果，该试验旨在评估在吉西他滨新辅助化疗基础上添加抗血管内皮生长因子（VEGF）贝伐单抗对临界可切除和不可切除的非转移性胰腺癌患者的疗效。
患者被分配到两个治疗组之一。两组均在4周周期的第1、8和15天接受1000mg/m²吉西他滨治疗，共四个周期。第1组从吉西他滨治疗的第6周开始，每两周接受一次5mg/kg贝伐单抗治疗，持续六周（三剂）。第2组从吉西他滨治疗的第1周开始，每两周接受一次5mg/kg贝伐单抗治疗，持续12周（六剂）。本研究的目的是评估根治性切除率和总生存期。
共纳入30例患者：19例为不可切除的胰腺癌患者，11例为临界可切除的胰腺癌患者。11例患者（37%）接受了手术切除。接受肿瘤切除的患者的中位总生存期为13个月（95%置信区间=11-15个月）。
总体而言，在新辅助吉西他滨治疗中添加贝伐单抗并不能改善局部晚期胰腺癌患者的预后。然而，在个别情况下，手术是可行的，并且可能观察到生存期延长。
