Dose Finding in Pediatric Patients

作者: G. Henze

DOI: 10.1007/978-3-540-49529-1_8

关键词:

摘要: It is generally agreed that satisfactory safety and effectiveness of pharmaceutical products for children adolescents have not yet been established. This applies in particular to anti-cancer drugs even those having successfully used many years multidrug chemotherapy protocols childhood cancer. For example, nephroblastoma or Wilms’ tumor one the typical frequent forms cancer occurring at a median age about 3 years. Standard therapy combination vincristine actinomycin D; survival 85%. D, summary product characteristics states contraindication aged below 6–12 months. If this would be considered respected it mean substantial proportion with treated thus proven curative withheld. The current situation pediatrics off-label use has become common practice: private practice 20% prescriptions are off-label, children’s hospitals approximately 40%–50% 50%–70% pediatric oncology more than 90% neonatology (Conroy et al. 1999, 2000, 2003; Turner 1996, 1998; McIntyre 2000). These conditions less tolerated by authorities although they beyond legality. reason appropriate clinical trials like adults conducted therefore licensed.

参考文章(13)
Merck Sharp and Dohme Research Laboratories (Rahway, N.J.), The Merck Manual of Diagnosis and Therapy ,(1982)
J. P. Vieira Pinheiro, E. Ahlke, U. Nowak-Göttl, G. Hempel, H. J. Müller, K. Lümkemann, M. Schrappe, B. Rath, G. Fleischhack, G. Mann, J. Boos, Pharmacokinetic dose adjustment of Erwinia asparaginase in protocol II of the paediatric ALL/NHL-BFM treatment protocols British Journal of Haematology. ,vol. 104, pp. 313- 320 ,(1999) , 10.1046/J.1365-2141.1999.01192.X
Sean Turner, Andrea Gill, Tony Nunn, Barbara Hewitt, Imti Choonara, Use of "off-label" and unlicensed drugs in paediatric intensive care unit The Lancet. ,vol. 347, pp. 549- 550 ,(1996) , 10.1016/S0140-6736(96)91182-4
S. Turner, A. Longworth, A. J Nunn, I. Choonara, Unlicensed and off label drug use in paediatric wards: prospective study BMJ. ,vol. 316, pp. 343- 345 ,(1998) , 10.1136/BMJ.316.7128.343
Ursula Creutzig, Martin Zimmermann, Julia Hannemann, Irene Krämer, Beate Pfistner, Ralf Herold, Günter Henze, Quality management for clinical trials within the German Competence Network Paediatric Oncology and Haematology. Onkologie. ,vol. 28, pp. 333- 336 ,(2005) , 10.1159/000085288
J. Boos, G. Werber, E. Ahlke, P. Schulze-Westhoff, U. Nowak-Göttl, G. Würthwein, E.J. Verspohl, J. Ritter, H. Jürgens, Monitoring of asparaginase activity and asparagine levels in children on different asparaginase preparations. European Journal of Cancer. ,vol. 32, pp. 1544- 1550 ,(1996) , 10.1016/0959-8049(96)00131-1
S. Conroy, J. McIntyre, I. Choonara;, P. S. D. HULL, Unlicensed and off label drug use in neonates Archives of Disease in Childhood-fetal and Neonatal Edition. ,vol. 80, ,(1999) , 10.1136/FN.80.2.F142
T. A. Carter, L. M. Wodicka, N. P. Shah, A. M. Velasco, M. A. Fabian, D. K. Treiber, Z. V. Milanov, C. E. Atteridge, W. H. Biggs, P. T. Edeen, M. Floyd, J. M. Ford, R. M. Grotzfeld, S. Herrgard, D. E. Insko, S. A. Mehta, H. K. Patel, W. Pao, C. L. Sawyers, H. Varmus, P. P. Zarrinkar, D. J. Lockhart, Inhibition of drug-resistant mutants of ABL, KIT, and EGF receptor kinases Proceedings of the National Academy of Sciences of the United States of America. ,vol. 102, pp. 11011- 11016 ,(2005) , 10.1073/PNAS.0504952102