Abstract:
OBJECTIVE To compare the efficacy of cetuximab as the first-line treatment for advanced colorectal cancer between the First Affiliated Hospital of Medical College of Zhejiang University and international multicenter randomized controlled trial(RCT), so as to discuss the suitability and feasibility of targeted drug therapy based on gene status in colorectal cancer treatment in China.
METHODS By adopting the method of real world research, a retrospective analysis was conducted on the first-line treatment with cetuximab in patients with advanced colorectal cancer hospitalized hospital from January 2014 to June 2018. The objective response rate, disease control rate, adverse reactions and so on were systematically evaluated, and compared with those from the existing international multicenter RCT FIRE-3.
RESULTS The data showed that chemotherapy regimens were different between real world sample cases and trial cases in the FIRE-3. The short-term efficacy of cetuximab as the first-line treatment for advanced colorectal cancer given was significantly lower than that of FIRE-3. For examples, the objective response rate was 47.1% compared to 71.3% in the FIRE-3(
P=0.006), disease control rate was 76.5% compared to 91.8% in the FIRE-3(
P=0.011), and the frequency and degree of adverse reactions were similar between the hospital and the FIRE-3.
CONCLUSION There is a gap between the real world research of the hospital and international multicenter RCT, which suggests that the efficacy of targeted therapy is related to baseline data, population difference, and other factors.