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 withleucovorin, 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 perforation. None of these side effects was observed in arm B patients. CONCLUSION: No statistically significant difference in median overall survival in patients with advanced colorectal cancer treated withbevacizumab plus a combination therapy (arm A) and those treated with the combination only, without bevacizumab (arm B), was observed. Copyright 2010 S. Karger AG, Basel.
RCT Entities:
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 perforation. None of these side effects was observed in arm B patients. CONCLUSION: No statistically significant difference in median overall survival in patients with advanced colorectal cancer treated with bevacizumab plus a combination therapy (arm A) and those treated with the combination only, without bevacizumab (arm B), was observed. Copyright 2010 S. Karger AG, Basel.
Authors: Konstantinos Papadimitriou; Christian Rolfo; Elien Dewaele; Mick Van De Wiel; Jan Van den Brande; Sevilay Altintas; Manon Huizing; Pol Specenier; Marc Peeters Journal: Curr Treat Options Oncol Date: 2015-04
Authors: Humaid O Al-Shamsi; Abdulaziz Al Farsi; Mahraz Anjum; Hua Shen; Kevin Zbuk; Richard J Cook; Lori-Ann Linkins; Pierre Major Journal: J Gastrointest Oncol Date: 2015-06
Authors: C P Escalante; Y C Chang; K Liao; T Rouleau; J Halm; P Bossi; S Bhadriraju; N Brito-Dellan; S Sahai; S W Yusuf; A Zalpour; L S Elting Journal: Support Care Cancer Date: 2016-06-25 Impact factor: 3.603