Treatment of Colorectal Cancer with and without Bevacizumab: A Phase III Study

Objective: The objective of this phase III trial was to compare chemotherapy combined with bevacizumab versus chemotherapy alone in the treatment of patients with advanced colorectal cancer. Methods: From September 2004 till September 2008, 222 treatment-naive patients were enrolled and divided into 2 arms: 114 arm A patients were treated with leucovorin, 5-fluorouracil plus irinotecan in combination with bevacizumab, and 108 arm B patients were treated as above without bevacizumab. All patients were stage IV with histologically confirmed adenocarcinoma. Results: The median overall survival of arm A patients was 22.0 months (95% CI: 18.1–25.9) and 25.0 months (CI: 18.1–31.9) for arm B patients. There was no statistically significant difference between the 2 arms (p = 0.1391). No statistically significant difference between the 2 arms regarding the response rate was observed: partial response, 42 patients (36.8%) and 38 patients (35.2%) for arms A and B, respectively. Hematologic toxicity did not differ in the comparison of the 2 arms. Nonhematologic toxicity in arm A involved hypertension in 23 (20.2%) of the patients and proteinuria in 7 (6.1%); 3 patients experienced hemorrhage and 1 patient intestinal perforaReceived: January 18, 2010 Accepted after revision: April 9, 2010 Published online: August 27, 2010 Oncology G.P. Stathopoulos, MD First Oncology Clinic, Errikos Dunant Hospital Semitelou 2A GR–115 28 Athens (Greece) Tel. +30 210 775 2600, Fax +30 210 725 1736, E-Mail dr-gps @ ath.forthnet.gr © 2010 S. Karger AG, Basel 0030–2414/10/0786–0376$26.00/0 Accessible online at: www.karger.com/ocl D ow nl oa de d by : 54 .1 91 .4 0. 80 6 /6 /2 01 7 12 :4 0: 36 P M