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


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).


CONCLUSIONS
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.
MD FACS, Department of Surgery and Comprehensive Cancer Center Medical University of Vienna, Waehringer Guertel 18-20, 1090 Vienna, Austria. michael.gnant@meduniwien.ac.at.
Klaus
K
Sahora
Martin
M
Schindl
Irene
I
Kuehrer
Axel
A
Eisenhut
Gregor
G
Werba
Christine
C
Brostjan
Bela
B
Telek
Ahmed
A
Ba'ssalamah
Judith
J
Stift
Sebastian F
SF
Schoppmann
Michael
M
Gnant
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000068258:Bevacizumab; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D016896:Treatment Outcome; D000093542:Gemcitabine
D061067:Antibodies, Monoclonal, Humanized; D003841:Deoxycytidine; D000068258:Bevacizumab; D000093542:Gemcitabine
Bevacizumab; gemcitabine; neoadjuvant therapy; pancreatic cancer; resectability