Cost-effectiveness analysis of cetuximab combined with chemotherapy as a first-line treatment for patients with RAS wild-type metastatic colorectal cancer based on the TAILOR trial.

Huijuan Wang, Lingfei Huang, Peng Gao, Zhengyi Zhu, Weifeng Ye, Haiying Ding, Luo Fang
Author Information
  1. Huijuan Wang: Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China. ORCID
  2. Lingfei Huang: Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
  3. Peng Gao: Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
  4. Zhengyi Zhu: Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
  5. Weifeng Ye: Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China.
  6. Haiying Ding: Department of Pharmacy, Zhejiang Cancer Hospital, Hangzhou, China.
  7. Luo Fang: Department of Pharmacy, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, China fangluo@zju.edu.cn.

Abstract

OBJECTIVES: Cetuximab plus leucovorin, fluorouracil and oxaliplatin (FOLFOX-4) is superior to FOLFOX-4 alone as a first-line treatment for patients with metastatic colorectal cancer with RAS wild-type (RAS wt mCRC), with significantly improved survival benefit by TAILOR, an open-label, randomised, multicentre, phase III trial. Nevertheless, the cost-effectiveness of these two regimens remains uncertain. The following study aims to determine whether cetuximab combined with FOLFOX-4 is a cost-effective regimen for patients with specific RAS wt mCRC in China.
DESIGN: A cost-effectiveness model combined decision tree and Markov model was built to simulate pateints with RAS wt mCRC based on health states of dead, progressive and stable. The health outcomes from the TAILOR trial and utilities from published data were used respectively. Costs were calculated with reference to the Chinese societal perspective. The robustness of the results was evaluated by univariate and probabilistic sensitivity analyses.
PARTICIPANTS: The included patients were newly diagnosed Chinese patients with fully RAS wt mCRC.
INTERVENTIONS: First-line treatment with either cetuximab plus FOLFOX-4 or FOLFOX-4.
MAIN OUTCOME MEASURES: The primary outcomes are costs, quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratios (ICERs).
RESULTS: Baseline analysis disclosed that the QALYs was increased by 0.383 caused by additional cetuximab, while an increase of US$62 947 was observed in relation to FOLFOX-4 chemotherapy. The ICER was US$164 044 per QALY, which exceeded the willingness-to-pay threshold of US$28 106 per QALY.
CONCLUSIONS: Despite the survival benefit, cetuximab combined with FOLFOX-4 is not a cost-effective treatment for the first-line regime of patients with RAS wt mCRC in China.
TRIAL REGISTRATION NUMBER: TAILOR trial (NCT01228734); Post-results.

Keywords

Associated Data

ClinicalTrials.gov | NCT01228734

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MeSH Term

Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Immunological
Antineoplastic Combined Chemotherapy Protocols
Cetuximab
China
Colorectal Neoplasms
Cost-Benefit Analysis
Disease-Free Survival
Drug Therapy, Combination
Female
Fluorouracil
Humans
Leucovorin
Male
Markov Chains
Middle Aged
Organoplatinum Compounds
Prospective Studies
Treatment Outcome
Young Adult

Chemicals

Antineoplastic Agents, Immunological
Organoplatinum Compounds
Cetuximab
Leucovorin
Fluorouracil

Word Cloud

Created with Highcharts 10.0.0FOLFOX-4RASpatientscetuximabwtmCRCtreatmentTAILORtrialcost-effectivenesscombinedfirst-linemetastaticcolorectalcancerchemotherapypluswild-typesurvivalbenefitcost-effectiveChinamodelbasedhealthoutcomesChineseQALYsanalysisperQALYOBJECTIVES:Cetuximableucovorinfluorouraciloxaliplatinsuperioralonesignificantlyimprovedopen-labelrandomisedmulticentrephaseIIINeverthelesstworegimensremainsuncertainfollowingstudyaimsdeterminewhetherregimenspecificDESIGN:decisiontreeMarkovbuiltsimulatepateintsstatesdeadprogressivestableutilitiespublisheddatausedrespectivelyCostscalculatedreferencesocietalperspectiverobustnessresultsevaluatedunivariateprobabilisticsensitivityanalysesPARTICIPANTS:includednewlydiagnosedfullyINTERVENTIONS:First-lineeitherMAINOUTCOMEMEASURES:primarycostsquality-adjustedlife-yearsincrementalratiosICERsRESULTS:Baselinedisclosedincreased0383causedadditionalincreaseUS$62 947observedrelationICERUS$164 044exceededwillingness-to-paythresholdUS$28 106CONCLUSIONS:DespiteregimeTRIALREGISTRATIONNUMBER:NCT01228734Post-resultsCost-effectiveness

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