PURPOSE: The current study aimed to evaluate the short-term efficacy and safety of endostar plus irinotecan/calcium folinate/5-fluorouracil (FOLFIRI) in treatment of advanced colorectal cancer (CRC). METHODS:Forty patients with advanced CRC were enrolled in this study and randomly assigned to two groups. The control group (n = 18) and tested group (n = 22) were received FOLFIRI alone and FOLFIRI plus endostar, respectively. The end points were overall response rate, progression-free survival (PFS) and toxicity. RESULTS: A total of 38 patients (17 in control group and 21 in tested group) completed two cycles of treatment and were deemed assessable for response. Patients treated with FOLFIRI plus endostar experienced a obviously higher overall response rate (42.9%) compared with patients who received FOLFIRI alone (29.4%) and a statistically significant improvement in median PFS (14.5 vs. 11.0 months). The toxicity of FOLFIRI/endostar was comparative to that of FOLFIRI with regard to gastrointestinal reactions, haematologic toxicity, peripheral neuropathy and cholinergic syndrome. Cardiovascular adverse reactions including electrocardiogram abnormality and hypertension, which might be ascribed to endostar treatment, were reversible and manageable. CONCLUSION: The addition of endostar to FOLFIRI resulted in a higher overall response rate and longer PFS and did not increase unacceptable adverse responses in patients with advanced CRC. Future randomised controlled clinical trials with a larger group of patients are warranted to further investigate the value of FOLFIRI plus endostar in CRC treatment.
RCT Entities:
PURPOSE: The current study aimed to evaluate the short-term efficacy and safety of endostar plus irinotecan/calcium folinate/5-fluorouracil (FOLFIRI) in treatment of advanced colorectal cancer (CRC). METHODS: Forty patients with advanced CRC were enrolled in this study and randomly assigned to two groups. The control group (n = 18) and tested group (n = 22) were received FOLFIRI alone and FOLFIRI plus endostar, respectively. The end points were overall response rate, progression-free survival (PFS) and toxicity. RESULTS: A total of 38 patients (17 in control group and 21 in tested group) completed two cycles of treatment and were deemed assessable for response. Patients treated with FOLFIRI plus endostar experienced a obviously higher overall response rate (42.9%) compared with patients who received FOLFIRI alone (29.4%) and a statistically significant improvement in median PFS (14.5 vs. 11.0 months). The toxicity of FOLFIRI/endostar was comparative to that of FOLFIRI with regard to gastrointestinal reactions, haematologic toxicity, peripheral neuropathy and cholinergic syndrome. Cardiovascular adverse reactions including electrocardiogram abnormality and hypertension, which might be ascribed to endostar treatment, were reversible and manageable. CONCLUSION: The addition of endostar to FOLFIRI resulted in a higher overall response rate and longer PFS and did not increase unacceptable adverse responses in patients with advanced CRC. Future randomised controlled clinical trials with a larger group of patients are warranted to further investigate the value of FOLFIRI plus endostar in CRC treatment.