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A phase I pharmacokinetic and safety study of cabazitaxel in adult cancer patients with normal and impaired renal function.

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Azaro, Analía Rodón, Jordi Machiels, Jean-Pascal [UCL] Rottey, Sylvie Damian, Silvia de Jonge, Maja J A

PURPOSE: Limited data are available on cabazitaxel pharmacokinetics in patients with renal impairment. This open-label, multicenter study assessed cabazitaxel in patients with advanced solid tumors and normal or impaired renal function. METHODS: Cohorts A (normal renal function: creatinine clearance [CrCL] >80 mL/min/1.73 m2), B (moderate renal impairment: CrCL 30 to <50 mL/min/1.73 m2) and C (severe impairment: CrCL <30 mL/min/1.73 m2) received cabazitaxel 25 mg/m2 (A, B) or 20 mg/m2 (C, could be escalated to 25 mg/m2), once every 3 weeks. Pharmacokinetic parameters and cabazitaxel unbound fraction (F U) were assessed using linear regression and mixed models. Geometric mean (GM) and GM ratios (GMRs) were determined using mean CrCL intervals (moderate and severe renal impairment: 40 and 15 mL/min/1.73 m2) versus a control (90 mL/min/1.73 m2). RESULTS: Overall, 25 patients received cabazitaxel (median cycles: 3 [range 1-20]; Cohort A: 5 [2-13]; Cohort B: 3 [1-15]; and Cohort C: 5 [1-20]), of which 24 were eligible for pharmacokinetic analysis (eight in each cohort). For moderate and severe renal impairment versus normal renal function, GMR estimates were: clearance normalized to body surface area (CL/BSA) 0.95 (90% CI 0.80-1.13) and 0.89 (0.61-1.32); area under the curve normalized to dose (AUC/dose) 1.06 (0.88-1.27) and 1.14 (0.76-1.71); and F U 0.99 (0.94-1.04) and 0.97 (0.87-1.09), respectively. Estimated slopes of linear regression of log parameters versus log CrCL (renal impairment) were: CL/BSA 0.06 (-0.15 to 0.28); AUC/dose -0.07 (-0.30 to 0.16); and F U 0.02 (-0.05 to 0.08). Cabazitaxel safety profile was consistent with previous reports. CONCLUSIONS: Renal impairment had no clinically meaningful effect on cabazitaxel pharmacokinetics.

Document type Article de périodique (Journal article) – Article de recherche
Access type Accès libre
Publication date 2016
Language Anglais
Journal information "Cancer Chemotherapy and Pharmacology" - Vol. 78, no.6, p. 1185-1197 (2016)
Peer reviewed yes
Publisher Springer Verlag ((Germany) Berlin)
issn 0344-5704
e-issn 1432-0843
Publication status Publié
Affiliations UCL - SSS/IREC/MIRO - Pôle d'imagerie moléculaire, radiothérapie et oncologie
UCL - (SLuc) Unité d'oncologie médicale
Keywords Advanced solid tumors ; Cabazitaxel ; Pharmacokinetics ; Phase I ; Renal impairment
Links
  1. Aapro Matti, Launay-Vacher Vincent, Importance of monitoring renal function in patients with cancer, 10.1016/j.ctrv.2011.05.001
  2. Launay-Vacher Vincent, Oudard Stéphane, Janus Nicolas, Gligorov Joseph, Pourrat Xavier, Rixe Olivier, Morere Jean-François, Beuzeboc Philippe, Deray Gilbert, , Prevalence of Renal Insufficiency in cancer patients and implications for anticancer drug management : The renal insufficiency and anticancer medications (IRMA) study, 10.1002/cncr.22904
  3. Launay-Vacher Vincent, Etessami Reza, Janus Nicolas, Spano Jean-Philippe, Ray-Coquard Isabelle, Oudard Stéphane, Gligorov Joseph, Pourrat Xavier, Beuzeboc Philippe, Deray Gilbert, Morere Jean-François, , Lung Cancer and Renal Insufficiency: Prevalence and Anticancer Drug Issues, 10.1007/s00408-008-9123-5
  4. Launay-Vacher Vincent, , Gligorov Joseph, Le Tourneau Christophe, Janus Nicolas, Spano Jean-Philippe, Ray-Coquard Isabelle, Oudard Stéphane, Pourrat Xavier, Morere Jean-François, Deray Gilbert, Beuzeboc Philippe, Prevalence of renal insufficiency in breast cancer patients and related pharmacological issues, 10.1007/s10549-008-0131-1
  5. Launay-Vacher Vincent, Ayllon Jorge, Janus Nicolas, Spano Jean-Philippe, Ray-Coquard Isabelle, Gligorov Joseph, Pourrat Xavier, Morere Jean-François, Beuzeboc Philippe, Deray Gilbert, Oudard Stéphane, Drug Management of Prostate Cancer: Prevalence and Consequences of Renal Insufficiency, 10.3816/cgc.2009.n.029
  6. Janus N, Oudard S, Beuzeboc P, Gligorov J, Ray-Coquard I, Morere J, Spano J, Pourrat X, Deray G, Launay-Vacher V (2009) Prevalence of renal insufficiency in cancer patients: data from the IRMA-2 study. J Clin Oncol 27:9559
  7. Arellano Jorge, Hernandez Rohini K., Wade Sally W., Chen Kristina, Pirolli Melissa, Quach David, Quigley Jane, Liede Alexander, Shahinian Vahakn B., Prevalence of renal impairment and use of nephrotoxic agents among patients with bone metastases from solid tumors in the United States, 10.1002/cam4.403
  8. Bournakis Evangelos, Dimopoulos Meletios A, Bamias Aristotle, Management of advanced bladder cancer in patients with impaired renal function, 10.1586/era.10.197
  9. Finkel Kevin W, Foringer John R, Renal disease in patients with cancer, 10.1038/ncpneph0622
  10. Zhang Y, Zhang L, Abraham S, Apparaju S, Wu T-C, Strong JM, Xiao S, Atkinson Jr AJ, Thummel KE, Leeder JS, Lee C, Burckart GJ, Lesko LJ, Huang S-M, Assessment of the Impact of Renal Impairment on Systemic Exposure of New Molecular Entities: Evaluation of Recent New Drug Applications, 10.1038/clpt.2008.208
  11. Vaughn David J., Chemotherapeutic options for cisplatin-ineligible patients with advanced carcinoma of the urothelium, 10.1016/j.ctrv.2007.12.006
  12. US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) (2010) Guidance for industry, pharmacokinetics in patients with impaired renal function: Study design, data analysis, and impact on dosing and labelling. Revised March 2010. http://www.fda.gov/downloads/Drugs/…/Guidances/UCM204959.pdf . Accessed May 2016
  13. European Medical Agency (2014) Guideline on the evaluation of the pharmacokinetics of medicinal products in patients with impaired renal function. Revised February 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/02/WC500162133.pdf . Accessed May 2016
  14. de Bono Johann Sebastian, Oudard Stephane, Ozguroglu Mustafa, Hansen Steinbjørn, Machiels Jean-Pascal, Kocak Ivo, Gravis Gwenaëlle, Bodrogi Istvan, Mackenzie Mary J, Shen Liji, Roessner Martin, Gupta Sunil, Sartor A Oliver, Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial, 10.1016/s0140-6736(10)61389-x
  15. Ridoux Laurence, Sémiond Dorothée R., Vincent Carine, Fontaine Hélène, Mauriac Christine, Sanderink Ger-Jan, Oprea Corina, Kelly Lindsay, Clive Sally, A phase I open-label study investigating the disposition of [14C]-cabazitaxel in patients with advanced solid tumors : , 10.1097/cad.0000000000000185
  16. Ferron Géraldine M., Dai Yang, Semiond Dorothée, Population pharmacokinetics of cabazitaxel in patients with advanced solid tumors, 10.1007/s00280-012-2058-9
  17. Pivot X., Koralewski P., Hidalgo J. L., Chan A., Goncalves A., Schwartsmann G., Assadourian S., Lotz J. P., A multicenter phase II study of XRP6258 administered as a 1-h i.v. infusion every 3 weeks in taxane-resistant metastatic breast cancer patients, 10.1093/annonc/mdn171
  18. QxMD Online Calculator (2015) Chronic kidney disease: epidemiology collaboration formula—Calculator to estimate glomerular filtration rate using the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration). http://www.qxmd.com/calculate-online/nephrology/ckd-epi-egfr . Accessed May 2016
  19. Levey Andrew S., Stevens Lesley A., Schmid Christopher H., Zhang Yaping (Lucy), Castro Alejandro F., Feldman Harold I., Kusek John W., Eggers Paul, Van Lente Frederick, Greene Tom, Coresh Josef, , A New Equation to Estimate Glomerular Filtration Rate, 10.7326/0003-4819-150-9-200905050-00006
  20. Stevens Lesley A., Schmid Christopher H., Greene Tom, Zhang Yaping (Lucy), Beck Gerald J., Froissart Marc, Hamm Lee L., Lewis Julia B., Mauer Michael, Navis Gerjan J., Steffes Michael W., Eggers Paul W., Coresh Josef, Levey Andrew S., Comparative Performance of the CKD Epidemiology Collaboration (CKD-EPI) and the Modification of Diet in Renal Disease (MDRD) Study Equations for Estimating GFR Levels Above 60 mL/min/1.73 m2, 10.1053/j.ajkd.2010.03.026
  21. National Cancer Institute (2010) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. http://evs.nci.nih.gov/ftp1/CTCAE/About.html . Accessed May 2016
  22. de Bruijn Peter, de Graan Anne-Joy M., Nieuweboer Annemieke, Mathijssen Ron H.J., Lam Mei-Ho, de Wit Ronald, Wiemer Erik A.C., Loos Walter J., Quantification of cabazitaxel in human plasma by liquid chromatography/triple-quadrupole mass spectrometry: A practical solution for non-specific binding, 10.1016/j.jpba.2011.10.010
  23. Lockhart A. Craig, Sundaram Shankar, Sarantopoulos John, Mita Monica M., Wang-Gillam Andrea, Moseley Jennifer L., Barber Stephanie L., Lane Alex R., Wack Claudine, Kassalow Laurent, Dedieu Jean-François, Mita Alain C., Phase I dose-escalation study of cabazitaxel administered in combination with cisplatin in patients with advanced solid tumors, 10.1007/s10637-014-0145-y
  24. Mita A. C., Denis L. J., Rowinsky E. K., DeBono J. S., Goetz A. D., Ochoa L., Forouzesh B., Beeram M., Patnaik A., Molpus K., Semiond D., Besenval M., Tolcher A. W., Phase I and Pharmacokinetic Study of XRP6258 (RPR 116258A), a Novel Taxane, Administered as a 1-Hour Infusion Every 3 Weeks in Patients with Advanced Solid Tumors, 10.1158/1078-0432.ccr-08-0596
  25. Diéras V., Lortholary A., Laurence V., Delva R., Girre V., Livartowski A., Assadourian S., Semiond D., Pierga J.Y., Cabazitaxel in patients with advanced solid tumours: Results of a Phase I and pharmacokinetic study, 10.1016/j.ejca.2012.07.008
  26. Malik Laeeq, Mejia Alex, Weitman Steven, Eligibility of patients with renal impairment for Phase I trials: Time for a rethink?, 10.1016/j.ejca.2014.09.001
  27. Takimoto Chris H., Remick Scot C., Sharma Sunil, Mani Sridhar, Ramanathan Ramesh K., Doroshow James, Hamilton Anne, Mulkerin Daniel, Graham Martin, Lockwood Graham F., Ivy Percy, Egorin Merrill, Schuler Barbara, Greenslade Denis, Goetz Andrew, Knight Ronald, Thomas Rebecca, Monahan Brian P., Dahut William, Grem Jean L., Dose-Escalating and Pharmacological Study of Oxaliplatin in Adult Cancer Patients With Impaired Renal Function: A National Cancer Institute Organ Dysfunction Working Group Study, 10.1200/jco.2003.11.015
  28. Gibbons Joseph, Egorin Merrill J., Ramanathan Ramesh K., Fu Pingfu, Mulkerin Daniel L., Shibata Stephen, Takimoto Chris H.M., Mani Sridhar, LoRusso Patricia A., Grem Jean L., Pavlick Anna, Lenz Heinz-Josef, Flick Susan M., Reynolds Sherrie, Lagattuta Theodore F., Parise Robert A., Wang Yanfeng, Murgo Anthony J., Ivy S. Percy, Remick Scot C., Phase I and Pharmacokinetic Study of Imatinib Mesylate in Patients With Advanced Malignancies and Varying Degrees of Renal Dysfunction: A Study by the National Cancer Institute Organ Dysfunction Working Group, 10.1200/jco.2007.13.3819
  29. Isambert Nicolas, Delord Jean Pierre, Tourani Jean Marc, Fumoleau Pierre, Ravaud Alain, Pinel Marie Claire, Petain Aurelie, Nguyen Thierry, Nguyen Laurent, How to manage intravenous vinflunine in cancer patients with renal impairment: results of a pharmacokinetic and tolerability phase I study : Vinflunine pharmacokinetics and safety in renal impairment, 10.1111/bcp.12218
  30. Mita Alain C., Sweeney Christopher J., Baker Sharyn D., Goetz Andrew, Hammond Lisa A., Patnaik Amita, Tolcher Anthony W., Villalona-Calero Miguel, Sandler Alan, Chaudhuri Tuhin, Molpus Kathleen, Latz Jane E., Simms Lorinda, Chaudhary Ajai K., Johnson Robert D., Rowinsky Eric K., Takimoto Chris H., Phase I and Pharmacokinetic Study of Pemetrexed Administered Every 3 Weeks to Advanced Cancer Patients With Normal and Impaired Renal Function, 10.1200/jco.2004.00.9720
  31. US National Institutes for Health (ClinicalTrials.gov) (2015) Pharmacokinetics and safety of regorafenib (bay73-4506) in cancer subjects with severe renal impairment. https://clinicaltrials.gov/ct2/show/NCT01853046 . Accessed May 2016
  32. Tan AR, Sarantopoulos J, Lee L, Reyderman L, He Y, Olivo MS, Goel S (2015) Pharmacokinetics (PK) of eribulin mesylate in cancer patients (pts) with normal and impaired renal function. J Clin Oncol 32:2595
  33. Sanofi (2014) JEVTANA® (cabazitaxel) injection, Prescribing Information, FDA. http://products.sanofi.us/jevtana/jevtana.html . Accessed May 2016
Bibliographic reference Azaro, Analía ; Rodón, Jordi ; Machiels, Jean-Pascal ; Rottey, Sylvie ; Damian, Silvia ; et. al. A phase I pharmacokinetic and safety study of cabazitaxel in adult cancer patients with normal and impaired renal function.. In: Cancer Chemotherapy and Pharmacology, Vol. 78, no.6, p. 1185-1197 (2016)
Permanent URL http://hdl.handle.net/2078.1/182646