Articles of Interest on Saladax Assays



Imatinib Assay

An Automated Homogeneous Immunoassay for Quantitating Imatinib Concentrations in Plasma. 
Beumer JH, Kozo D, Harney RL, et al. Ther Drug Monit. 2015;37(4):486-92.


Imatinib Evidence for TDM

Relationship between imatinib trough concentration and outcomes in the treatment of advanced gastrointestinal stromal tumours in a real-life setting.
Bouchet S, Poulette S, Titier K, et al. Eur J Cancer. 2016;57:31-38.


Personalized Daily Doses of Imatinib By Therapeutic Drug Monitoring Increase the Rates of Molecular Responses in Patients with Chronic Myeloid Leukemia. Final Results of the Randomized OPTIM Imatinib Study. 
Rousselot P, Johnson-Ansah H, Huguet F, et al. Blood. 2015;126.



Practical Guidelines for Therapeutic Drug Monitoring of Anticancer Tyrosine Kinase Inhibitors: Focus on the Pharmacokinetic Targets. 
Yu H, Steeghs, N, Nijenhuis CM, et al. Clin Pharmacokinet. 2014;53:305-325.


Review of therapeutic drug monitoring of anticancer drugs part two--targeted therapies. 
Widmer N, Bardin C, Chatelut E, et al. Eur J Cancer. 2014;50:2020-2036.


Therapeutic drug monitoring of imatinib in chronic myeloid leukemia: experience from 1216 patients at a centralized laboratory. 
Bouchet S, Titier K, Moore N, et al. Fundam Clin Pharmacol. 2013;27:690-697.


Plasma concentrations of tyrosine kinase inhibitors imatinib, erlotinib, and sunitinib in routine clinical outpatient cancer care. 
Lankheet NA, Knapen LM, Schellens JH, et al. Ther Drug Monit. 2013;36:326-324.


Systematic review of population pharmacokinetic analyses of imatinib and relationships with treatment outcomes. 
Gotta V, Buclin T, Csajka C, and Widmer N. Ther Drug Monti. 2013;35:150-167.


Plasma Imatinib Trough Level Is a Predictor For 3-Month Early Molecular Response In New CP CML Patients. 
Lee S, Choi SY, Kim S, et al. Blood. 2013 Nov;122(21):2716.


Plasma exposure of imatinib and its correlation with clinical response in the Tyrosine Kinase Inhibitor Optimization and Selectivity Trial. 
Guilhot F, Hughes TP, Cortes J, et al. Haematologica. 2012;97(5):731-38.


Therapeutic drug monitoring of imatinib - new data strengthen the case. 
Judson IR. Clin Cancer Res. 2012;18(20):5517-19.


A Long-term Prospective Population Pharmacokinetic Study on Imatinib Plasma Concentrations in GIST Patients. 
Eechoute K, Fransson MN, Reyners AK, et al. Clin Cancer Res. 2012;18(20):5780-87.


Imatinib plasma trough levels in chronic myeloid leukaemia: results of a multicentre study CSTI571AIL11TGLIVEC.  
Koren-Michowitz M, Volchek Y, Naparstek E, et al. Hematol Oncol. 2012;30(4):200-05.


The role of therapeutic drug monitoring of imatinib in patients with chronic myeloid leukemia and metastatic or unresectable gastrointestinal stromal tumors. 
Teng JF, Mabasa VH, Ensom MH. Ther Drug Monit. 2012 Feb;34(1):85-97.


Correlations between imatinib pharmacokinetics, pharmacodynamics, adherence, and clinical response in advanced metastatic gastrointestinal stromal tumor (GIST): An emerging role for drug blood level testing? 
Von Mehren M, and Widmer N. Cancer Treat Rev. 2011;37(4):291-99.



Trough plasma imatinib levels are correlated with optimal cytogenetic responses at 6 months after treatment with standard dose of imatinib in newly diagnosed chronic myeloid leukemia. 
Sohn SK, Oh SJ, Kim BS, et al. Leuk Lymphoma. 2011;52(6):1024-29.


Trough plasma concentration of imatinib reflects BCR-ABL kinase inhibitory activity and clinical response in chronic-phase chronic myeloid leukemia: a report from the BINGO study.
 Ishikawa Y, Kiyoi H, Watanabe K, et al. Cancer Sci. 2010;101(10):2186-92.


Correlation Between Imatinib Pharmacokinetics and Clinical Response in Japanese Patients With Chronic-Phase Chronic Myeloid Leukemia. 
Takahashi N, Wakita H, Miura M, et al. Clin Pharmacol Ther. 2010 Dec;88(6):809-13.


Imatinib plasma levels are correlated with clinical benefit in patients with unresectable/metastatic gastrointestinal stromal tumors. 
Demetri GD, Wang Y, Wehrle E, et al. J Clin Oncol. 2009;27(19):3141-47.


Drug monitoring of imatinib levels in patients undergoing therapy for chronic myeloid leukaemia: comparing plasma levels of responders and non-responders. 
Singh N, Kumar L, Meena R and Velpandian T. Eur J Clin Pharmacol. 2009;65(6):545-49.


Pharmacokinetic/pharmacodynamic correlation and blood-level testing in imatinib therapy for chronic myeloid leukemia. 
Cortes JE, Egorin MJ, Guilhot F, Molimard M and Mahon FX. Leukemia. 2009;23:1537-44.


Imatinib pharmacokinetics and its correlation with response and safety in chronic-phase chronic myeloid leukemia: a subanalysis of the IRIS study. 
Larson RA, Druker BJ, Guilhot F, et al. Blood. 2008;111:4022-28.


Trough imatinib plasma levels are associated with both cytogenetic and molecular responses to standard-dose imatinib in chronic myeloid leukemia. 
Picard S, Titier K, Etienne G, et al. Blood. 2007;109:3496-99.


Drug plasma monitoring in CML and GIST: A case-based discussion. 
Egorin MJ, Mauro MJ, Trent JC. Clin Adv Hematol Oncol. 2009;7p. S1, S3-11


Population pharmacokinetics of imatinib and the role of alpha-acid glycoprotein. 
Widmer N, Decosterd LA, Csajka C, et al. Br J Clin Pharmacol. 2006;62(1):97-112.


Pharmacokinetic-pharmacodynamic relationships of imatinib and its main metabolite in patients with advanced gastrointestinal stromal tumors. 
Delbaldo C, Chatelut E, Ré M, et al. Clin Cancer Res. 2006;12(20 Pt 1):6073-78.


Pharmaokinetics and Pharmacodynamics of Imatinib in a Phase I Trial with Chronic Myeloid Leukemic Patients.
Peng B, Hayes M, Resta D, et al. J Clin Oncol. 2004;22(5):935-42.


Imatinib Pharmacoeconomics


Cost-effectiveness of Tyrosine Kinase Inhibitor Treatment Strategies for Chronic Myeloid Leukemia in Chronic Phase After Generic Entry of Imatinib in the United States. 
Padula WV, Larson RA, Dusetzina SB et al. J Natl Cancer Inst. 2016;108(7).


Changing the cost of care for chronic myeloid leukemia: the availability of generic imatinib in the USA and the EU. 
Conti RM, Padula WV, Larson RA. Ann Hematol. 2015;94(02):S249–S257



Imatinib Adherence

Poor adherence is the main reason for loss of CCyR and imatinib failure for chronic myeloid leukemia patients on long-term therapy. 
Ibrahim AR, Eliasson L, Apperley JF, et al. Blood. 2011;117(14):3733-36.


Adherence is the critical factor for achieving molecular responses in patients with chronic myeloid leukemia who achieve complete cytogenetic responses on imatinib. 
Marin D, Bazeos A, Mahon FX, et al. J Clin Oncol. 2010;28(14):2381-88. 


Treatment interruptions and non-adherence with imatinib and associated  healthcare costs: a retrospective analysis among managed care patients with chronic myelogenous leukaemia. 
Darkow T, Henk HJ, Thomas SK, et al. J. Pharmacoeconomics. 2007;25(6):481-96.


Prescription compliance and persistency in chronic myelogenous leukemia (CML) and gastrointestinal stromal tumor (GIST) patients (pts) on imatinib (IM). 
Tsang J, Rudychev I, and Pescatore SL. J Clin Oncol (ASCO Meeting Abstracts) 2006;24:6119.



5-FU Assay

Comparative evaluation of the My5-FU™ immunoassay and LC-MS/MS in monitoring the 5-fluorouracil plasma levels in cancer patients
Büchel B1, Sistonen J, Joerger M, et al. Clin Chem Lab Med. 2013;51(8):1681-88.


Multicenter evaluation of a novel nanoparticle immunoassay for 5-fluorouracil on the Olympus AU400 analyzer. 
Beumer JH, Boisdron-Celle M, Clarke, W, et al. Ther Drug Monit. 2009;31:688-694.


5-Flourouracil: evidence for TDM


Therapeutic drug monitoring of 5-fluorouracil.  
Lee JJ, Beumer JH, Chu E. Cancer Chemother Pharmacol. 2016 May 23. [Epub ahead of print] Review


Individual 5-Fluorouracil Dose Adjustment via Pharmacokinetic Monitoring Versus Conventional Body-Area-Surface Method: A Meta-Analysis.
Yang R, Zhang Y, Zhou H, et al. Ther Drug Monit. 2016;38(1):79-86.


Prospective, Multicenter Study of 5-Fluorouracil Therapeutic Drug Monitoring in Metastatic Colorectal Cancer Treated in Routine Clinical Practice.
Wilhelm, M, Mueller L, Miller CM, Et al. Clin Colorectal Cancer. 2016 May 7. [Epub ahead of print]


A  community-based multicenter trial of pharmacokinetically guided 5-fluorouracil dosing for personalized colorectal cancer therapy.
Patel JN, O’Neil BH, Deal AM, et al. Oncologist. 2014;19:959-65.


Personalized Dosing via Pharmacokinetic Monitoring of 5-Fluorouracil Might Reduce Toxicity in Early- or Late-Stage Colorectal Cancer Patients Treated With Infusional 5-Fluorouracil-Based Chemotherapy Regimens.
Kline CL, Schiccitano A, Zhu J, et al. Clin Colorectal Cancer. 2014;13(2):119-26.


Individual fluorouracil dose adjustment in FOLFOX based on pharmacokinetic follow-up compared with conventional body-area-surface dosing: a phase II, proof-of-concept study.
Capitain O1, Asevoaia A, Boisdron-Celle M et al. Clin Colorectal Cancer. 2012;11;263-267.


Modeling the 5-fluorouracil area under the curve versus dose relationship to develop a pharmacokinetic dosing algorithm for colorectal cancer patients receiving FOLFOX6.
Kaldate RR, Haregewoin A, Grier CE, Hamilton SA, McLeod HL. Oncologist. 2012;17(3):296-302.


Body surface area-based dosing of 5-fluoruracil results in extensive interindividual variability in 5-fluorouracil exposure in colorectal cancer patients on FOLFOX regimens.
Saam J, Critchfield GC, Hamilton SA, et al. Clin Colorectal Cancer. 2011;10(3):203-206.


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.
Gamelin E, Delva R, Jacob J et al. J Clin Oncol. 2008;26(13):2099-105.


5-Fluorouracil Pharmacokinetics Predicts Disease-free Survival in Patients Administered Adjuvant Chemotherapy for Colorectal Cancer.
Di Paolo A, Lencioni M, Amatori F, et al. Clin Cancer Res. 2008;14(9):2749-55.



Highlights from: 5-Fluorouracil Drug Management Pharmacokinetics and Pharmacogenomics Workshop; Orlando, Florida; January 2007.
Bertino J, Fleisher M, Beumer JH, et al. Clin Colorectal Cancer. 2007;6:407-422.


Dose monitoring of 5-fluorouracil in patients with colorectal or head and neck cancer--status of the art.
Gamelin E, Boisdron-Celle, M. Crit Rev Oncol Hematol. 1999;30(3):71-79.


Clinical Impact of Pharmacokinetically-guided Dose Adaptation of 5-Fluorouracil: Results from a Multicentric Randomized Trial in Patients with Locally Advanced Head and Neck Carcinomas.
Fety R, Rolland R, Barberi-Heyob M, et al. Clin Cancer Res. 1998;4(9):2039-2045.


Relationship Between Fluorouracil Systemic Exposure and Tumor Response and Patient Survival.
Milano G, Etienne M-C, Renee N, et al. J Clin Oncol. 1994;12:1291-1295.

5-Flourouracil: Economics


Cost effectiveness analysis of pharmacokinetically-guided
5-fluorouracil in FOLFOX chemotherapy for metastatic colorectal cancer. 
Goldstein DA, Chen Q, Ayer T, et al. Clin Colorectal Cancer. 2014;13(4):219-225.



Paclitaxel Assay

Development and evaluation of a nanoparticle-based immunoassay for determining paclitaxel concentrations on routine clinical analyzers
Cline DJ, Zhang H, Lundell GD, Ther Drug Monit 2013;35:809-815


Paclitaxel evidence for TDM

Open-Label, Randomized Study Of Individualized, Pharmacokinetically (PK)-Guided Dosing Of Paclitaxel Combined With Carboplatin In Advanced Non-Small Cell Lung Cancer (NSCLC) Patients.
Joerger M, Von Pawel J, Kraff S, et al.  Annals of Oncology 2016[Accepted for Publication]
Results presented at ASCO


Pharmacokinetically based dosing of weekly paclitaxel to reduce drug-related neurotoxicity based on a single sample strategy.
Kraff S, Nieuweboer AJ, Mathijssen RH, et al. Cancer Chemother Pharmacol. 2015;75:975-983.


Evaluation of a pharmacology-driven dosing algorithm of 3-weekly paclitaxel using therapeutic drug monitoring: a pharmacokinetic-pharmacodynamic simulation study. 
Joerger M, Kraff S, Huitema AD, et al. Clin Pharmacokinet. 2012;51:607-617.


Population Pharmacokinetics And Pharmacodynamics Of Paclitaxel And Carboplatin In Ovarian Cancer Patients: A Study By The European Organization For Research And Treatment Of Cancer-Pharmacology And Molecular Mechanisms Group And New Drug Development Group.
Joerger M, Huitema, AD, Richel DJ, et al Clin Cancer Res 2007;13:6410-6418



Paclitaxel Pharmacokinetics And Response To Chemotherapy In Patients With Advanced Cancer Treated With A Weekly Regimen.
Mielke S, Sparreboom A, Behringer D, Mross K Anticancer Res 2005;25: 4423-4427



Bayesian pharmacokinetically guided dosing of paclitaxel in patients with non-small cell lung cancer.
de Jonge ME, van den Bongard HJ, Huitema AD, et al. Clin Cancer Res. 2004;10;2237-2244.


Phase I targeted systemic exposure study of paclitaxel in children with refractory acute leukemias.
Woo MH, Relling MV, Sonnichsen DS, et al. Clin Cancer Res. 1999;5:543-549.


Nonlinear pharmacokinetics and metabolism of paclitaxel and its pharmacokinetic/pharmacodynamic relationships in humans.
Gianni L, Kearns CM, Giani A, et al. J Clin Oncol. 1995;13:180-190.



Docetaxel Assay

An automated nanoparticle-based homogeneous immunoassay for determining docetaxel concentrations in plasma.
Cline DJ, Zhang H, Lundell GD, Ther Drug Monit 2013;35:803-808.


Docetaxel Evidence for TDM

Therapeutic drug monitoring for the individualization of docetaxel dosing: a randomized pharmacokinetic study.
Engels FK, Loos WJ, van der Bol JM, et al. Clin Cancer Res. 2011;17:353-362.


Clinical pharmacokinetics of docetaxel : recent developments.  
Baker SD, Sparreboom A, Verweij J. Clin Pharmacokinet. 2006;45:235-252.


Prospective evaluation of the pharmacokinetics and toxicity profile of docetaxel in the elderly.
Ten Tije AJ, Verweij J, Carducci MA, et al. 2005. J Clin Oncol. 2005;20:1070-1077.


Factors affecting pharmacokinetic variability following doxorubicin and docetaxel-based therapy.
Rudek MA, Sparreboom A, Garrett-Mayer ES, et al. Eur J Cancer. 2004;40:1170-1178.


Comparative pharmacokinetics of weekly and every-three-weeks docetaxel.
Baker SD, Zhao M, Lee CK, et al. Clin Cancer Res. 2004;10:1976-1983.


Explaining interindividual variability of docetaxel pharmacokinetics and pharmacodynamics in Asians through phenotyping and genotyping strategies.
Goh BC, Lee SC, Wang LZ, et al. J Clin Oncol. 2002;20:3683-3890.


Population pharmacokinetics/pharmacodynamics of docetaxel in phase II studies in patients with cancer.
Bruno R, Hille D, Riva A et al. J Clin Oncol. 1998;16:187-196.