A prospective, open-label, randomised, parallel design study of 4 generic formulations of intramuscular L-asparaginase in childhood precursor B-cell acute lymphoblastic leukaemia (ALL)

Egler RA, Ahuja SP, Matloub Y (2016) L-asparaginase in the treatment of patients with acute lymphoblastic leukemia. J Pharmacol Pharmacother 7:62–71. https://doi.org/10.4103/0976-500X.184769

Article  CAS  PubMed  PubMed Central  Google Scholar 

Avramis VI, Tiwari PN (2006) Asparaginase (native ASNase or pegylated ASNase) in the treatment of acute lymphoblastic leukemia. Int J Nanomedicine 1:241

CAS  PubMed  PubMed Central  Google Scholar 

Avramis VI, Panosyan EH (2005) Pharmacokinetic/pharmacodynamic relationships of asparaginase formulations: the past, the present and recommendations for the future. Clin Pharmacokinet 44:367–393. https://doi.org/10.2165/00003088-200544040-00003

Article  CAS  PubMed  Google Scholar 

Métayer LE, Brown RD, Carlebur S et al (2019) Mechanisms of cell death induced by arginase and asparaginase in precursor B-cell lymphoblasts. Apoptosis 24:145–156. https://doi.org/10.1007/S10495-018-1506-3/FIGURES/7

Article  PubMed  Google Scholar 

Radadiya A, Zhu W, Coricello A et al (2020) Improving the treatment of acute lymphoblastic leukemia. Biochemistry 59:3193–3200. https://doi.org/10.1021/ACS.BIOCHEM.0C00354

Article  CAS  PubMed  Google Scholar 

Pieters R, Hunger SP, Boos J et al (2011) L-asparaginase treatment in acute lymphoblastic leukemia: a focus on Erwinia asparaginase. Cancer 117:238–249. https://doi.org/10.1002/CNCR.25489

Article  CAS  PubMed  Google Scholar 

Lopes GL (2013) Cost comparison and economic implications of commonly used originator and generic chemotherapy drugs in India. Ann Oncol Off J Eur Soc Med Oncol 24:13–16. https://doi.org/10.1093/ANNONC/MDT323

Article  Google Scholar 

Mathew P (2015) Generic drugs: review and experiences from South India. J Fam Med Prim Care 4:319. https://doi.org/10.4103/2249-4863.161305

Article  Google Scholar 

Cameron A, Mantel-Teeuwisse AK, Leufkens HGM, Laing RO (2012) Switching from originator brand medicines to generic equivalents in selected developing countries: how much could be saved? Value Health 15:664–673. https://doi.org/10.1016/J.JVAL.2012.04.004

Article  PubMed  Google Scholar 

Cameron A, Ewen M, Ross-Degnan D et al (2009) Medicine prices, availability, and affordability in 36 developing and middle-income countries: a secondary analysis. Lancet (London, England) 373:240–249. https://doi.org/10.1016/S0140-6736(08)61762-6

Article  CAS  Google Scholar 

Sallan SE, Hitchcock-Bryan S, Gelber R, et al (1983) Influence of intensive asparaginase in the treatment of childhood non-T-cell acute lymphoblastic leukemia - PubMed. In: Cancer Res. https://pubmed.ncbi.nlm.nih.gov/6352020/. Accessed 28 Jun 2022

Pui C-H, Campana D, Pei D et al (2009) Treating childhood acute lymphoblastic leukemia without cranial irradiation. N Engl J Med 360:2730–2741. https://doi.org/10.1056/NEJMOA0900386

Article  CAS  PubMed  PubMed Central  Google Scholar 

Möricke A, Zimmermann M, Reiter A et al (2010) Long-term results of five consecutive trials in childhood acute lymphoblastic leukemia performed by the ALL-BFM study group from 1981 to 2000. Leukemia 24:265–284. https://doi.org/10.1038/LEU.2009.257

Article  PubMed  Google Scholar 

Abboud MR, Ghanem K, Muwakkit S (2014) Acute lymphoblastic leukemia in low and middle-income countries: disease characteristics and treatment results. Curr Opin Oncol 26:650–655. https://doi.org/10.1097/CCO.0000000000000125

Article  CAS  PubMed  Google Scholar 

Arora RS, Arora B (2016) Acute leukemia in children: a review of the current Indian data. South Asian J Cancer 5:155. https://doi.org/10.4103/2278-330X.187591

Article  PubMed  PubMed Central  Google Scholar 

Sankaran H, Sengupta S, Purohit V et al (2020) A comparison of asparaginase activity in generic formulations of E.coli derived L-asparaginase: in-vitro study and retrospective analysis of asparaginase monitoring in pediatric patients with leukemia. Br J Clin Pharmacol 86:1081–1088. https://doi.org/10.1111/BCP.14216

Article  CAS  PubMed  PubMed Central  Google Scholar 

Sidhu J, Gogoi MP, Agarwal P et al (2021) Unsatisfactory quality of E. coli asparaginase biogenerics in India Implications for clinical outcomes in acute lymphoblastic leukaemia. Pediatr Blood Cancer. https://doi.org/10.1002/PBC.29046

Article  PubMed  PubMed Central  Google Scholar 

Narula G, Arora B, Subramanian PG, et al. (2017) Outcome of B-ALL treated with a risk-stratified and response-adapted protocol: interim analysis of a single-institution pilot study for a multicenter collaborative protocol from India. the 49th congress of the international society of paediatric oncology (SIOP) Washington, DC, USA October 12–15, 2017. Pediatr Blood Cancer 64 Suppl 3: https://doi.org/10.1002/PBC.26772

Boos J, Werber G, Ahlke E et al (1996) Monitoring of asparaginase activity and asparagine levels in children on different asparaginase preparations. Eur J Cancer 32A:1544–1550. https://doi.org/10.1016/0959-8049(96)00131-1

Article  CAS  PubMed  Google Scholar 

Rizzari C, Zucchetti M, Conter V et al (2000) L-asparagine depletion and L-asparaginase activity in children with acute lymphoblastic leukemia receiving i.m. or i.v. Erwinia C. or E. coli L-asparaginase as first exposure. Ann Oncol Off J Eur Soc Med Oncol 11:189–193. https://doi.org/10.1023/A:1008368916800

Article  CAS  Google Scholar 

Riccardi R, Holcenberg JS, Glaubiger DL, et al (1981) L-asparaginase pharmacokinetics and asparagine levels in cerebrospinal fluid of rhesus monkeys and humans - PubMed. In: Cancer Res. 41(11 Pt 1). https://pubmed.ncbi.nlm.nih.gov/6895481/. Accessed 28 Jun 2022

Tsurusawa M, Chin M, Iwai A et al (2004) L-Asparagine depletion levels and L-asparaginase activity in plasma of children with acute lymphoblastic leukemia under asparaginase treatment. Cancer Chemother Pharmacol 53:204–208. https://doi.org/10.1007/S00280-003-0734-5

Article  CAS  PubMed  Google Scholar 

Pui CH, Yang JJ, Hunger SP et al (2015) Childhood acute lymphoblastic leukemia: progress through collaboration. J Clin Oncol 33:2938–2948. https://doi.org/10.1200/JCO.2014.59.1636

Article  CAS  PubMed  PubMed Central  Google Scholar 

Gota VS, Patial P (2014) Toward better quality of anticancer generics in India. Indian J Cancer 51:366–368. https://doi.org/10.4103/0019-509X.146723

Article  CAS  PubMed  Google Scholar 

Schore RJ, Devidas M, Bleyer A et al (2019) Plasma asparaginase activity and asparagine depletion in acute lymphoblastic leukemia patients treated with pegaspargase on children’s oncology group AALL07P4. Leuk Lymphoma 60:1740–1748. https://doi.org/10.1080/10428194.2018.1542146

Article  CAS  PubMed  PubMed Central  Google Scholar 

Rizzari C, Lanvers-Kaminsky C, Valsecchi MG et al (2019) Asparagine levels in the cerebrospinal fluid of children with acute lymphoblastic leukemia treated with pegylated-asparaginase in the induction phase of the AIEOP-BFM ALL 2009 study. Haematologica 104:1812. https://doi.org/10.3324/HAEMATOL.2018.206433

Article  CAS  PubMed  PubMed Central  Google Scholar 

Zenatti PP, Migita NA, Cury NM et al (2018) low bioavailability and high immunogenicity of a new brand of E. colil-asparaginase with active host contaminating proteins. EBioMedicine 30:158–166. https://doi.org/10.1016/J.EBIOM.2018.03.005

Article  PubMed  PubMed Central  Google Scholar 

Earl M. (2009) Incidence and management of asparaginase-associated adverse events in patients with acute lymphoblastic leukemia - PubMed. In: Clin Adv Hematol Oncol HO, 7(9). https://pubmed.ncbi.nlm.nih.gov/20020672/. Accessed 28 Jun 2022

Hijiya N, Van Der Sluis IM (2016) Asparaginase-associated toxicity in children with acute lymphoblastic leukemia. Leuk Lymphoma 57:748–757. https://doi.org/10.3109/10428194.2015.1101098

Article  CAS  PubMed  Google Scholar 

Rathore A (2012) Guidelines on similar biologics: regulatory requirements for marketing authorization in India. PDA J Pharm Sci Technol 66:393. https://doi.org/10.5731/PDAJPST.2012.00886

Article  PubMed  Google Scholar 

GUIDELINES ON SIMILAR BIOLOGICS: Regulatory requirements for marketing authorization in india (2016)

留言 (0)

沒有登入
gif