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Objective Colorectal cancer(CRC)is a common malignant tumor of digestive tract,with a poor prognosis.Currently,therapies combining chemotherapy with biologic monoclonal antibodies are the standard first-line treatments for patients with metastatic CRC(mCRC).Comparing with leucovorin,fluorouracil,and oxaliplatin(FOLFOX-4)alone,the combination of FOLFOX-4 with anti-epidermal growth factor receptor(EGFR)monoclonal antibody cetuximab has performed ascendant efficacy and tolerability for patients with RAS wide-type(wt)mCRC in the TAILOR trial.However,a huge amount of health care cost increased in the process of treatment.Thus,we aimed to explore the costeffectiveness of cetuximab plus FOLFOX-4 regimen and FOLFOX-4 regimen in patients with RAS wt mCRC.Methods For the sake of executing the cost-effectiveness analysis,we conducted a Markov model containing three health states(progression-free survival(PFS),progressive disease(PD),and death)to simulate the process of RAS wt mCRC.The data of efficacy and safety were primarily derived from the TAILOR trial.Total costs were computed from the perspective of the Chinese society.Sensitivity analysis was utilized to investigate the effect of uncertainties on the Markov model.Results Overall,393 patients with RAS wt mCRC were randomly assigned to receive cetuximab plus FOLFOX-4 arm or FOLFOX-4 arm.The combination of cetuximab with FOLFOX-4 significantly improved the PFS compared with FOLFOX-4 alone(hazard ratio,0.69; 95%CI,0.54 to 0.89; P =.004; median,9.2 months vs 7.4 months,respectively),and overall survival time(OS)(current assessment after 300 events: hazard ratio,0.76; 95%CI,0.61 to 0.96; P =.02; median,20.7 months vs 17.8 months,respectively)and overall response rate(ORR)(odds ratio,2.41; 95%CI,1.61 to 3.61; P =.001; 61.1%vs 39.5%,respectively).When the Markov process ended,combination of cetuximab and FOLFOX-4 provided 1.25 quality adjusted life years(QALYs)compared with 1.10 QALYs for FOLFOX-4 alone.The total cost was $40,000 for the cetuximab and FOLFOX-4 arm,which was remarkably higher than that of $20,921 for the the FOLFOX-4 arm,and the introduction of cetuximab overwhelmingly increased the total cost by $19,079.Finally,treatment of cetuximab plus FOLFOX-4 was estimated to provide an incremental 0.15 QALYs at an incremental cost of $19,079 compared with FOLFOX-4 alone,resulting in an incremental cost-effective ratio(ICER)of $127,193/QALY,which exceeded the threshold of willingness-to-pay(WTP)of $26,304/QALY in China.Sensitivity analysis showed that the cost of PFS state in cetuximab plus FOLFOX-4 arm was the most influential factor to the Markov model in the tornado diagram.Probabilistic sensitivity analysis noted that FOLFOX-4 regimen had a almost 100%probability of being cost-effective when the WTP was set at $26304/QALY in the cost-effectiveness acceptability curves.Conclusions Our results revealed that the combination of cetuximab and FOLFOX-4 is not a cost-effective strategy compared with FOLFOX-4 alone for the first-line treatment of patients with RAS wt mCRC when WTP is set at $26304/QALY from the perspective of the Chinese society.We believe that with the development of clinical trials,more and more high efficacy and low price regiments will be applied to clinical treatment.