title: Cost effectiveness analysis of pharmacokinetically-guided 5-fluorouracil in FOLFOX chemotherapy for metastatic colorectal cancer.
abstract: BACKGROUND
  Dosing chemotherapy based on BSA results in marked interindividual variability in drug exposure. A randomized trial showed increased OS and decreased toxicity with PK-guided compared with BSA-based 5-FU dosing in patients with mCRC. The objective of this study was to compare the cost effectiveness of PK-based 5-FU dosing with BSA-based 5-FU dosing in patients with mCRC receiving FOLFOX (5-FU, leucovorin, and oxaliplatin).
  
  
  METHODS
  We developed a Markov model to evaluate the cost effectiveness of PK FOLFOX compared with BSA FOLFOX. Progression risks and cause-specific mortality were extrapolated from the fitted survival models. Costs for administration and management of adverse events were estimated based on 2013 Medicare reimbursement rates and average sale prices.
  
  
  RESULTS
  PK FOLFOX provided 2.03 QALYs at a cost of $50,205 compared with BSA FOLFOX, which provided 1.46 QALYs at a cost of $37,173. The incremental cost-effectiveness ratio (ICER) was $22,695 per QALY. The ICER remained < $50,000 per QALY in all univariate and multivariate sensitivity analyses.
  
  
  CONCLUSIONS
  At a $50,000 per QALY threshold, PK FOLFOX is cost effective for mCRC. Because of the cost effectiveness profile and OS advantage with PK FOLFOX, it should be evaluated further in comparative effectiveness studies.
authors.affiliation: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA. Electronic address: dgolds8@emory.edu.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Goldstein
authors.affiliation: H. Milton Stewart School of Industrial and Systems Engineering, Georgia Institute of Technology, Atlanta, GA.
authors.forename: Qiushi
authors.initials: Q
authors.lastname: Chen
authors.affiliation: H. Milton Stewart School of Industrial and Systems Engineering, Georgia Institute of Technology, Atlanta, GA.
authors.forename: Turgay
authors.initials: T
authors.lastname: Ayer
authors.affiliation: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA; Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, GA.
authors.forename: David H
authors.initials: DH
authors.lastname: Howard
authors.affiliation: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA; Department of Health Policy and Management, Rollins School of Public Health, Emory University, Atlanta, GA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Lipscomb
authors.affiliation: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.
authors.forename: R Donald
authors.initials: RD
authors.lastname: Harvey
authors.affiliation: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.
authors.forename: Bassel F
authors.initials: BF
authors.lastname: El-Rayes
authors.affiliation: Department of Hematology and Medical Oncology, Winship Cancer Institute, Emory University, Atlanta, GA.
authors.forename: Christopher R
authors.initials: CR
authors.lastname: Flowers
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000191:economics / Q000493:pharmacokinetics* / Q000627:therapeutic use*; D015179:Colorectal Neoplasms / Q000188:drug therapy* / Q000191:economics* / Q000401:mortality / Q000556:secondary; D003362:Cost-Benefit Analysis; D016903:Drug Monitoring / Q000379:methods*; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D005500:Follow-Up Studies; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008390:Markov Chains; D008875:Middle Aged; D017059:Models, Econometric; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D011379:Prognosis; D011788:Quality of Life; D019057:Quality-Adjusted Life Years; D015996:Survival Rate; D014018:Tissue Distribution
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D002955:Leucovorin; D005472:Fluorouracil
keywords: Body surface area; Colorectal neoplasms; Cost-benefit analysis; Fluorouracil; Quality-adjusted life years