For Publishers
DiscoveryMetadataPeer reviewHostingPublishing
For Researchers
JoinPublishReviewCollect
Register
Blog
About
Search
Advanced search
My ScienceOpen
Search
For Publishers
For Researchers
Blog
About
9
views
76
references
 Top references
cited by
21
    
0 reviews
 Review
0
comments
 Comment
0
recommends
+1 Recommend
0 collections
    0
    shares
      1,272
      similar
       All similar
      • Record: found
      • Abstract: not found
      • Article: not found

      Therapeutic Drug Monitoring in Oncology: IATDMCT Recommendations for 5-Fluorouracil Therapy

      research-article

      Read this article at

      ScienceOpenPublisherPMC
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          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.

          Related collections

          Most cited references76

          • Record: found
          • Abstract: found
          • Article: not found

          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.
          Article 0 comments Cited 229 times – based on 0 reviews     Review now
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            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.
            Article 0 comments Cited 65 times – based on 0 reviews     Review now
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              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.
              Article 0 comments Cited 64 times – based on 0 reviews     Review now
                Bookmark
                All references

                Author and article information

                Journal
                Journal ID (nlm-journal-id): 0372741
                Journal ID (pubmed-jr-id): 3058
                Journal ID (nlm-ta): Clin Pharmacol Ther
                Journal ID (iso-abbrev): Clin. Pharmacol. Ther.
                Title: Clinical pharmacology and therapeutics
                ISSN (Print): 0009-9236
                ISSN (Electronic): 1532-6535
                Publication date Nihms-submitted: 2 June 2018
                Publication date (Electronic): 11 September 2018
                Publication date (Print): March 2019
                Publication date PMC-release: 01 March 2020
                Volume: 105
                Issue: 3
                Pages: 598-613
                Affiliations
                [1 ]Cancer Therapeutics Program, UPMC Hillman Cancer Center, Pittsburgh, PA, USA
                [2 ]Department of Pharmaceutical Sciences, School of Pharmacy, University of Pittsburgh, Pittsburgh, PA, USA
                [3 ]Division of Hematology-Oncology, Department of Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
                [4 ]University of Florida, Gainesville, FL
                [5 ]Department of Clinical Pharmacokinetics and Pharmacodynamics, Keio University School of Medicine, Tokyo, Japan
                [6 ]Oncopharmacology Unit, Centre Antoine Lacassagne, Nice, France
                [7 ]Developmental Therapeutics Program, Mayo Clinic Cancer Center, Rochester, MN
                [8 ]Department of Molecular Pharmacology and Experimental Therapeutics, Mayo Clinic School of Medicine, Rochester, MN, USA
                [9 ]Department of Oncology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
                [10 ]Department of Medical Oncology, Erasmus MC Cancer Institute, Erasmus University Medical Center, Rotterdam, the Netherlands
                [11 ]Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-Sen University Cancer Center, Guangzhou, China
                [12 ]Department of Oncology, AK Altona, Asklepios Tumorzentrum Hamburg, Hamburg, Germany
                [13 ]Division of Oncology Center, Niitsu Medical Center Hospital, Niigata City, Japan
                [14 ]Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tsukiji, Chuo-ku, Tokyo, Japan
                [15 ]Department of Medical Oncology & Hematology, Cantonal Hospital, St. Gallen, Switzerland
                Author notes
                Correspondence to: Jan H. Beumer, PharmD, PhD, DABT, University of Pittsburgh Cancer Institute, Room G27E, Hillman Research Pavilion, 5117 Centre Avenue, Pittsburgh, PA 15213-1863, USA, Tel.: +1-412-623-3216, Fax.: +1-412-623-1212, beumerj@ 123456gmail.com and Markus Joerger MD, PhD, ClinPharm, Dep. Medical Oncology & Hematology, Cantonal Hospital, 9007 St. Gallen, Switzerland, Tel.: +41 76 559 1070, markus.joerger@ 123456kssg.ch
                Article
                Accession ID: PMC6309286 Pmcid ID: PMC6309286 Pmc-uid ID: 6309286 Manuscript ID: nihpa972210
                DOI: 10.1002/cpt.1124
                PMC ID: 6309286
                PubMed ID: 29923599
                SO-VID: 690a96ea-8ca7-4ea0-8efd-c1179742ace2
                History
                Categories
                Subject: Article

                Keywords: plasma concentrations,toxicity,therapeutic drug monitoring,AUC,clinical benefit,TDM,drug exposure,5-fluorouracil,response,colorectal cancer,squamous-cell cancer of the head and neck
                Data availability:
                Keywords: plasma concentrations, toxicity, therapeutic drug monitoring, AUC, clinical benefit, TDM, drug exposure, 5-fluorouracil, response, colorectal cancer, squamous-cell cancer of the head and neck

                Comments

                Comment on this article

                scite_

                Similar content1,272

                See all similar

                Cited by19

                See all cited by

                Most referenced authors1,125

                See all reference authors