Dose individualisation in oncology using chemotherapy-induced neutropenia: Example of docetaxel in non-small cell lung cancer patients.
chemotherapy-induced neutropenia
docetaxel
neutrophil counts
non-small cell lung cancer
precision dosing
Journal
British journal of clinical pharmacology
ISSN: 1365-2125
Titre abrégé: Br J Clin Pharmacol
Pays: England
ID NLM: 7503323
Informations de publication
Date de publication:
04 2021
04 2021
Historique:
revised:
25
09
2020
received:
08
07
2020
accepted:
09
10
2020
pubmed:
20
10
2020
medline:
27
7
2021
entrez:
19
10
2020
Statut:
ppublish
Résumé
Chemotherapy-induced neutropenia has been associated with an increase in overall survival in non-small cell lung cancer patients. Therefore, neutrophil counts could be an interesting biomarker for drug efficacy as well as linked directly to toxicity. For drugs where neutropenia is dose limiting, neutrophil counts might be used for monitoring drug effect and for dosing optimisation. The relationship between drug effect on the first cycle neutrophil counts and patient survival was explored in a Phase III clinical trial where patients with non-small cell lung cancer were treated with docetaxel. Once the association has been established, dosing optimisation was performed for patients with severe toxicities (neutropenia) without compromising drug efficacy (overall survival). After taking into account baseline prognostic factors, such as Eastern Cooperative Oncology Group performance status, smoking status, liver metastasis, tumour burden, neutrophil counts and albumin levels, a model-predicted drug effect on the first cycle neutrophil counts was strongly associated with patient survival (P = .005). Utilising this relationship in a dose optimisation algorithm, 194 out of 366 patients would have benefited from a dose reduction after the first cycle of docetaxel. The simulated 1-year survival probabilities associated with the original dose and the individualised dose were not different. The strong relationship between drug effect on the first cycle neutrophil counts and patient survival suggests that this variable could be used to individualise dosing, possibly without needing pharmacokinetic samples. The algorithm highlights that doses could be reduced in case of severe haematological toxicities without compromising drug efficacy.
Substances chimiques
Antineoplastic Agents
0
Taxoids
0
Docetaxel
15H5577CQD
Banques de données
ClinicalTrials.gov
['NCT00076388', 'NCT00312377']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
2053-2063Subventions
Organisme : Centre for Applied Pharmacokinetic Research, Division of Pharmacy and Optometry, University of Manchester
Informations de copyright
© 2020 British Pharmacological Society.
Références
Mathijssen RHJ, Sparreboom A, Verweij J. Determining the optimal dose in the development of anticancer agents. Nat Rev Clin Oncol. 2014;11(5):272-281. https://doi.org/10.1038/nrclinonc.2014.40
Bailey JM. Dopamine: one size does not fit all. Anesthesiology. 2000;92(2):303-305. https://doi.org/10.1097/00000542-200002000-00007
Fischer K. Prophylaxis for adults with haemophilia: one size does not fit all. Blood Transfus. 2012;10(2):169-173. https://doi.org/10.2450/2012.0174-11
Gyurkocza B, Sandmaier BM. Conditioning regimens for hematopoietic cell transplantation: one size does not fit all. Blood. 2014;124(3):344-353. https://doi.org/10.1182/blood-2014-02-514778
Kulkarni V, Bhave A, Munshi RK, et al. Warfarin therapy--why one dose does not fit all. J Assoc Physicians India. 2013;61(8):571-573.
Genain CP, Zamvil SS. Specific immunotherapy: one size does not fit all. Nat Med. 2000;6(10):1098-1100. https://doi.org/10.1038/80424
Leja BM, Choi J, Sargel CL. Vancomycin dosing: one size does not fit all. Pediatr Crit Care Med. 2018;19(6):587-588. https://doi.org/10.1097/pcc.0000000000001501
Polotsky HN, Polotsky AJ. One size may not fit all: pondering antibiotic dosing in obesity. Maturitas. 2010;66(4):381-382. https://doi.org/10.1016/j.maturitas.2010.03.002
Pasero C. One size does not fit all: opioid dose range orders. J PeriAnesthesia Nursing. 2014;29(3):246-252. https://doi.org/10.1016/j.jopan.2014.03.004
Nurko S, Saps M. Treating constipation with prucalopride: one size does not fit all. Gastroenterology. 2014;147(6):1214-1216. https://doi.org/10.1053/j.gastro.2014.10.024
Ryan PJ. Vitamin D therapy in clinical practice. One dose does not fit all. Int J Clin Pract. 2007;61(11):1894-1899. https://doi.org/10.1111/j.1742-1241.2007.01477.x
Foster DA, Toschi A. Targeting mTOR with rapamycin: one dose does not fit all. Cell Cycle (Georgetown, Tex). 2009;8(7):1026-1029. https://doi.org/10.4161/cc.8.7.8044
Ravandi F. Gemtuzumab ozogamicin: one size does not fit all--the case for personalized therapy. J Clin Oncol. 2011;29(4):349-351. https://doi.org/10.1200/jco.2010.32.2693
Leonard RC, Miles D, Thomas R, Nussey F. Impact of neutropenia on delivering planned adjuvant chemotherapy: UK audit of primary breast cancer patients. Br J Cancer. 2003;89(11):2062-2068. https://doi.org/10.1038/sj.bjc.6601279
Moore DC. Drug-induced neutropenia: a focus on rituximab-induced late-onset neutropenia. P t. 2016;41(12):765-768.
Di Maio M, Gridelli C, Gallo C, et al. Chemotherapy-induced neutropenia and treatment efficacy in advanced non-small-cell lung cancer: a pooled analysis of three randomised trials. Lancet Oncol. 2005;6(9):669-677.
Kishida Y, Kawahara M, Teramukai S, et al. Chemotherapy-induced neutropenia as a prognostic factor in advanced non-small-cell lung cancer: results from Japan multinational trial organization LC00-03. Br J Cancer. 2009;101(9):1537-1542. https://doi.org/10.1038/sj.bjc.6605348
Nose Y, Kagawa Y, Hata T, et al. Neutropenia is an indicator of outcomes in metastatic colorectal cancer patients treated with FTD/TPI plus bevacizumab: a retrospective study. Cancer Chemother Pharmacol. 2020;86(3):427-433. https://doi.org/10.1007/s00280-020-04129-6
European Medecine Agency Approved Docetaxel Indications. <https://www.ema.europa.eu/en/medicines/human/EPAR/taxotere> (Assessed May 2020).
Quartino A, Friber L, Baker S, Karlsson M. A semi-mechanistic model of docetaxel-induced myelosuppression to support dosing recommendation in liver impaired patients. [Internet]. Available from: http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-150425
Bruno R, Olivares R, Berille J, et al. Alpha-1-acid glycoprotein as an independent predictor for treatment effects and a prognostic factor of survival in patients with non-small cell lung cancer treated with docetaxel. Clin Cancer Res. 2003;9(3):1077-1082.
Veyrat-Follet C, Bruno R, Olivares R, Rhodes GR, Chaikin P. Clinical trial simulation of docetaxel in patients with cancer as a tool for dosage. Optimization. 2000;68(6):677-687. https://doi.org/10.1067/mcp.2000.111948
Engels FK, Ten Tije AJ, Baker SD, et al. Effect of cytochrome P450 3A4 inhibition on the pharmacokinetics of docetaxel. Clin Pharmacol Ther. 2004;75(5):448-454. https://doi.org/10.1016/j.clpt.2004.01.001
European Medecine Agency. - Docetaxel Product Information https://www.ema.europa.eu/en/documents/product-information/taxotere-epar-product-information_en.pdf (Assessed September 2020).
Engels FK, Loos WJ, van der Bol JM, et al. Therapeutic drug monitoring for the individualization of docetaxel dosing: a randomized pharmacokinetic study. Clin Cancer Res. 2011;17(2):353-362.
Groenland SL, Mathijssen RHJ, Beijnen JH, Huitema ADR, Steeghs N. Individualized dosing of oral targeted therapies in oncology is crucial in the era of precision medicine. Eur J Clin Pharmacol. 2019;75(9):1309-1318. https://doi.org/10.1007/s00228-019-02704-2
Wallin JE, Friberg LE, Karlsson MO. A tool for neutrophil guided dose adaptation in chemotherapy. Comput Methods Programs Biomed. 2009;93(3):283-291. https://doi.org/10.1016/j.cmpb.2008.10.011
Kim ES, Hirsh V, Mok T, et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet. 2008;372(9652):1809-1818.
Herbst RS, Sun Y, Eberhardt WE, et al. Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial. Lancet Oncol. 2010;11(7):619-626. https://doi.org/10.1016/s1470-2045(10)70132-7
ProjectDataSphere. <https://www.projectdatasphere.org> (Assessed 14 April 2020).
R Core Team. (2017) R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. URL https://www.R-project.org/
Friberg LE, Henningsson A, Maas H, Nguyen L, Karlsson MO. Model of chemotherapy-induced myelosuppression with parameter consistency across drugs. J Clin Oncol. 2002;20(24):4713-4721.
Fidler M, Wilkins JJ, Hooijmaijers R, et al. Nonlinear mixed-effects model development and simulation using nlmixr and related R open-source packages. CPT Pharmacometrics Syst Pharmacol. 2019;8(9):621-633. https://doi.org/10.1002/psp4.12445
Fukae M, Shiraishi Y, Hirota T, et al. Population pharmacokinetic-pharmacodynamic modeling and model-based prediction of docetaxel-induced neutropenia in Japanese patients with non-small cell lung cancer. Cancer Chemother Pharmacol. 2016;78(5):1013-1023.
Bland J, Altman D. Statistical methods for assessing agreement between two methods of clinical measurement. Lancet. 1986;327(8476):307-310. https://doi.org/10.1016/S0140-6736(86)90837-8
Cox DR. Regression models and life-tables. J R Stat Soc B Methodol. 1972;34(2):187-220.
Therasse P, Arbuck SG, Eisenhauer EA, et al. New guidelines to evaluate the response to treatment in solid tumors. J Natl Cancer Inst. 2000;92(3):205-216. https://doi.org/10.1093/jnci/92.3.205
Meira-Machado L, Cadarso-Suarez C, Gude F. Araujo a (2013) smoothHR: an R package for pointwise nonparametric estimation of hazard ratio curves of continuous predictors. Comput Math Methods Med. 2013;2013:745742. https://doi.org/10.1155/2013/745742
Clark TG, Bradburn MJ, Love SB, Altman DG. Survival analysis part I: basic concepts and first analyses. Br J Cancer. 2003;89(2):232-238. https://doi.org/10.1038/sj.bjc.6601118
Cox DR. Note on grouping. J am Stat Assoc. 1957;52(280):543-547. https://doi.org/10.1080/01621459.1957.10501411
Royston P, Altman DG. External validation of a Cox prognostic model: principles and methods. BMC Med Res Methodol. 2013;13:33-33. https://doi.org/10.1186/1471-2288-13-33
Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 https://ctep.cancer.gov/protocoldevelopment/electronic_applications/docs/ctcae_v5_quick_reference_5x7.pdf (Assessed May 2020).
Culakova E, Poniewierski MS, Wolff DA, Dale DC, Crawford J, Lyman GH. The impact of chemotherapy dose intensity and supportive care on the risk of febrile neutropenia in patients with early stage breast cancer: a prospective cohort study. Springerplus. 2015;4:396-396. https://doi.org/10.1186/s40064-015-1165-6
Hansson EK, Ma G, Amantea MA, et al. PKPD modeling of predictors for adverse effects and overall survival in Sunitinib-treated patients with GIST. CPT Pharmacometrics Syst Pharmacol. 2013;2(12):e85-e85. https://doi.org/10.1038/psp.2013.62
Chen Z, Chen W, Wang J, Zhu M, Zhuang Z. Pretreated baseline neutrophil count and chemotherapy-induced neutropenia may be conveniently available as prognostic biomarkers in advanced gastric cancer. Intern Med J. 2015;45(8):854-859.
Grothey A, Yoshino T, Bodoky G, et al. Association of baseline absolute neutrophil counts and survival in patients with metastatic colorectal cancer treated with second-line antiangiogenic therapies: exploratory analyses of the RAISE trial and validation in an electronic medical record data set. ESMO Open. 2018;3(3):e000347. https://doi.org/10.1136/esmoopen-2018-000347
Brundage MD, Davies D, Mackillop WJ. Prognostic factors in non-small cell lung cancer: a decade of progress. Chest. 2002;122(3):1037-1057.
Pirker R, Pereira JR, Szczesna A, et al. Prognostic factors in patients with advanced non-small cell lung cancer: data from the phase III FLEX study. Lung Cancer (Amsterdam, Netherlands). 2012;77(2):376-382. https://doi.org/10.1016/j.lungcan.2012.03.010
Bilen MA, Shabto JM, Martini DJ, et al. Sites of metastasis and association with clinical outcome in advanced stage cancer patients treated with immunotherapy. BMC Cancer. 2019;19(1):857-857. https://doi.org/10.1186/s12885-019-6073-7
Sève P, Ray-Coquard I, Trillet-Lenoir V, et al. Low serum albumin levels and liver metastasis are powerful prognostic markers for survival in patients with carcinomas of unknown primary site. Cancer. 2006;107(11):2698-2705. https://doi.org/10.1002/cncr.22300
Viganó A, Bruera E, Jhangri GS, Newman SC, Fields AL, Suarez-Almazor ME. Clinical survival predictors in patients with advanced cancer. Arch Intern Med. 2000;160(6):861-868. https://doi.org/10.1001/archinte.160.6.861
Wallin JE, Friberg LE, Karlsson MO. Model-based neutrophil-guided dose adaptation in chemotherapy: evaluation of predicted outcome with different types and amounts of information. Basic Clin Pharmacol Toxicol. 2010;106(3):234-242. https://doi.org/10.1111/j.1742-7843.2009.00520.x