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      Therapeutic Drug Monitoring in Oncology: International Association of Therapeutic Drug Monitoring and Clinical Toxicology Recommendations for 5‐Fluorouracil Therapy

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          Abstract

          5-Fluorouracil (5-FU) is dosed by body surface area, a practice unable to reduce the interindividual variability in exposure. Endorsed by the International Association of Therapeutic Drug Monitoring and Clinical Toxicology (IATDMCT), we evaluated clinical evidence and strongly recommend TDM for the management of 5-FU therapy in patients with colorectal or head-and-neck cancer receiving common 5-FU regimens. Our systematic methodology provides a framework to evaluate published evidence in support of TDM recommendations in oncology.

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          Efficacy according to biomarker status of cetuximab plus FOLFOX-4 as first-line treatment for metastatic colorectal cancer: the OPUS study.

          C Bokemeyer, I. Bondarenko, J.T. Hartmann … (2011)
          The randomized phase II OPUS (Oxaliplatin and Cetuximab in First-Line Treatment of Metastatic Colorectal Cancer) study showed that tumor KRAS mutation status was predictive for outcome in patients receiving cetuximab plus FOLFOX-4 (oxaliplatin/5-fluorouracil/folinic acid) as first-line therapy for metastatic colorectal cancer (mCRC). The biomarker analysis was extended through the use of additional DNA samples extracted from stained tissue sections. KRAS and BRAF tumor mutation status was determined for new (and for BRAF, existing) samples using a PCR technique. Clinical outcome was reassessed according to mutation status. Overall survival data are presented. Of 315 KRAS evaluable patient samples (93%), 179 tumors (57%) were KRAS wild type. Eleven of 309 (4%) KRAS/BRAF evaluable tumors (all KRAS wild type) carried BRAF mutations. The addition of cetuximab to FOLFOX-4 significantly improved progression-free survival (hazard ratio 0.567, P = 0.0064) and response (odds ratio 2.551, P = 0.0027) in patients with KRAS wild-type tumors. A favorable effect on survival was also observed. These results confirm the efficacy of cetuximab plus FOLFOX-4 in the first-line treatment of patients with KRAS wild-type mCRC and confirm KRAS mutation status as an effective predictive biomarker. The small number of tumors with BRAF mutations precluded the drawing of definitive conclusions concerning the predictive or prognostic utility of this biomarker.
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            Individual fluorouracil dose adjustment based on pharmacokinetic follow-up compared with conventional dosage: results of a multicenter randomized trial of patients with metastatic colorectal cancer.

            Erick Gamelin, Michèle Boisdron-Celle, Gilles Piot … (2008)
            A phase III, multicenter, randomized study compared conventional dosing of fluorouracil (FU) plus folinic acid with pharmacokinetically guided FU dose adjustment in terms of response, tolerability, and survival. Two hundred eight patients with measurable metastatic colorectal cancer were randomly assigned to one of two arms: arm A (104 patients; 96 assessable), in which the FU dose was calculated based on body-surface area; and arm B (104 patients; 90 assessable), in which the FU dose was individually determined using pharmacokinetically guided adjustments. The initial regimen was 1,500 mg/m(2) FU plus 200 mg/m(2) folinic acid infusion during a continuous 8-hour period administered once weekly. FU doses were adjusted weekly in arm B based on a single-point measurement of FU plasma concentrations at steady state until the therapeutic range (targeted area under the curve 20-25 mg x h x L(-1)) previously established in other studies was reached. An intent-to-treat analysis of the 208 patients showed the objective response rate was 18.3% in arm A and 33.7% in arm B (P = .004). Median overall survival was 16 months in arm A and 22 months in arm B (P = .08). The mean FU dose throughout treatment was 1,500 mg/m(2)/wk in arm A and 1,790 +/- 386 mg/m(2)/wk (range, 900 to 3,300 mg/m(2)/wk) in arm B. Toxic adverse effects were significantly more frequent and severe in arm A compared with arm B (P = .003). Individual FU dose adjustment based on pharmacokinetic monitoring resulted in significantly improved objective response rate, a trend to higher survival rate, and fewer grade 3/4 toxicities. These results support the value of pharmacokinetically guided management of FU dose in the treatment of metastatic colorectal patients.
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              Therapeutic drug monitoring of 5-fluorouracil.

              James Lee, Jan H. Beumer, Edward Chu (2016)
              For over 50 years, 5-FU has played a critical role in the systemic chemotherapy of cancer patients. 5-FU serves as the main backbone of combination chemotherapy for patients with colorectal cancer in both the adjuvant and metastatic disease settings. Herein, we review the current status of 5-FU therapeutic drug monitoring (TDM) and discuss its potential role in the clinical practice setting.
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                Author and article information

                Journal
                Title: Clinical Pharmacology & Therapeutics
                Abbreviated Title: Clin. Pharmacol. Ther.
                Publisher: Wiley
                ISSN (Print): 0009-9236
                ISSN (Electronic): 1532-6535
                Publication date Created: September 11 2018
                Publication date (Electronic): September 11 2018
                Affiliations
                [1 ]Cancer Therapeutics ProgramUPMC Hillman Cancer CenterPittsburgh Pennsylvania USA
                [2 ]Department of Pharmaceutical Sciences, School of PharmacyUniversity of PittsburghPittsburgh Pennsylvania USA
                [3 ]Division of Hematology‐Oncology, Department of MedicineUniversity of Pittsburgh School of MedicinePittsburgh Pennsylvania USA
                [4 ]University of FloridaGainesville Florida USA
                [5 ]Department of Clinical Pharmacokinetics and PharmacodynamicsKeio University School of MedicineTokyo Japan
                [6 ]Oncopharmacology UnitCentre Antoine LacassagneNice France
                [7 ]Developmental Therapeutics ProgramMayo Clinic Cancer CenterRochester Minnesota USA
                [8 ]Department of Molecular Pharmacology and Experimental TherapeuticsMayo Clinic School of MedicineRochester Minnesota USA
                [9 ]Department of OncologyUniversity of Ulsan College of Medicine, Asan Medical CenterSeoul Korea
                [10 ]Department of Medical OncologyErasmus MC Cancer Institute, Erasmus University Medical CenterRotterdam the Netherlands
                [11 ]Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer MedicineSun Yat‐Sen University Cancer CenterGuangzhou China
                [12 ]Department of Oncology, AK AltonaAsklepios Tumorzentrum HamburgHamburg Germany
                [13 ]Division of Oncology CenterNiitsu Medical Center HospitalNiigata City Japan
                [14 ]Department of Gastrointestinal Medical OncologyNational Cancer Center HospitalTsukiji, Chuo‐ku Tokyo Japan
                [15 ]Department of Medical Oncology & HematologyCantonal HospitalSt. Gallen Switzerland
                Article
                DOI: 10.1002/cpt.1124
                PMC ID: 6309286
                PubMed ID: 29923599
                SO-VID: 690a96ea-8ca7-4ea0-8efd-c1179742ace2
                Copyright © © 2018
                License:

                http://onlinelibrary.wiley.com/termsAndConditions#vor

                http://doi.wiley.com/10.1002/tdm_license_1.1

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