A phase II trial of two durations of Bevacizumab added to neoadjuvant gemcitabine for borderline and locally advanced pancreatic cancer

Anticancer Res. 2014 May;34(5):2377-84.

Abstract

Background: 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 and methods: 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.

Results: 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).

Conclusion: 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.

Keywords: Bevacizumab; gemcitabine; neoadjuvant therapy; pancreatic cancer; resectability.

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Antibodies, Monoclonal, Humanized / administration & dosage
  • Antibodies, Monoclonal, Humanized / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Bevacizumab
  • Carcinoma, Pancreatic Ductal / drug therapy*
  • Carcinoma, Pancreatic Ductal / mortality
  • Carcinoma, Pancreatic Ductal / pathology
  • Deoxycytidine / administration & dosage
  • Deoxycytidine / adverse effects
  • Deoxycytidine / analogs & derivatives
  • Female
  • Gemcitabine
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Neoadjuvant Therapy*
  • Neoplasm Staging
  • Pancreatic Neoplasms / drug therapy*
  • Pancreatic Neoplasms / mortality
  • Pancreatic Neoplasms / pathology
  • Treatment Outcome

Substances

  • Antibodies, Monoclonal, Humanized
  • Deoxycytidine
  • Bevacizumab
  • Gemcitabine