A evaluation of the early efficacy and safety of generic imatinib in treating children of chronic myeloid leukemia in chronic phase

doi:10.3969/j.issn.1006-7795.2019.02.004

Abstract

Abstract: Objective To evaluate the hematological, cytogenetic, molecular responses and safety of generic imatinib(Xinwei) in newly diagnosed patients with children of chronic phase of chronic myeloid leukemia (CP-CML). Methods Thirty-five CP-CML children patients diagnosed in Beijing Children's Hospital, Capital Medical University received oral imatinib 260-340 mg/m²,with domestic generic imatinib (Xinwei) and imported original imatinib (Gleevec), who were collected from Jan 2014 to Jan 2018 and followed up to May 2018. Compared with imported original imatinib (Gleevec) among which 20 cases were treacted with the domestic genenc imatinib (Xinwei) and 15 cases were treated with the imported original imatinib (Gleevec), hematological responses, cytogenetic examinations, BCR-ABL transcript levels, and the safety with domestic generic imatinib treatment were monitored after 3,6, and 12 month treatment. Results A total of 35 children CP-CML patients (18 males and 17 females with a median age of 10 years) were collected among which 20 cases were treated with the domestic generic imatinib (Xinwei), and 15 cases were treated with the imported original imatinib (Gleevec). At 3-month, the domestic generic imatinib group 75% (15/20) patients achieved the complete hematologic responses (CHR), and patients with minor cytogenetic response (MCyR) or BCR-ABL ≤ 10% were 80%(16/20) and 45%(9/20), respectively. At 6-month, 94%(15/16) patients achieved CHR, patients with complete cytogenetic response(CCyR) and BCR-ABL ≤ 1% was 62.5%(10/16) and 43.8%(7/16). At 12-month, 92.3%(12/13) CCyR and 77%(10/13)BCR-ABL ≤ 0.1%. There was no significant difference between two group at all stages (P>0.05). The hematologic toxicity occurred in 15%(3/20),with no grade Ⅲ hematologic toxicity. The non-hematologic toxicities included pain 35%(7/20),gastrointestinal reaction 25%(5/20), edema 15%(3/20), fever 10%(2/20),fatigue 5%(1/20), and rash 5%(1/20). Compared with imported original imatinib, CCyR was lower in generic imatinib group at 3-month (P=0.021). There was no other significant difference (P>0.05). The adverse reactions were easy to control and there were no drug-related deaths.Conclusion Generic imatinib has a good efficacy in the hematological, cytogenetic molecular reponses with CP-CMP patients in newly diagnosed, without serious adverse reactions. There is no significant difference in efficacy and safety between generic and imported original imatinib in our study.

Key words: children, myeloid, leukemia, imatinib, generic drug

CLC Number:

R733

Zhang Liqiang, Chen Zhenping, Zheng Jie, Ma Jie, Wu Runhui. A evaluation of the early efficacy and safety of generic imatinib in treating children of chronic myeloid leukemia in chronic phase[J]. Journal of Capital Medical University, 2019, 40(2): 174-178.

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URL: https://journal03.magtech.org.cn/Jweb_sdykdxxb/EN/10.3969/j.issn.1006-7795.2019.02.004

https://journal03.magtech.org.cn/Jweb_sdykdxxb/EN/Y2019/V40/I2/174

References

[1] 中华医学会血液学分会.中国慢性髓性白血病诊断与治疗指南(2016年版)[J]. 中华血液学杂志,2016,37(8):633-639.
[2] Baccarani M, Deininger M W, Rosti G, et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia[J]. Blood, 2013, 122(6):872-884.
[3] Pallera A, Altman J K, Berman E, et al.NCCN guidelines insights:chronic myeloid leukemia, version 1.2017[J]. J Natl Compr Canc Netw, 2016,14(12):1505-1512.
[4] Mauro M J. Goals for chronic myeloid leukemia TK inhibitor treatment:how little disease is too much?[J].Hematology Am Soc Hematol Educ Program, 2014(1):234-249.
[5] Kalmanti L,Saussele S,Lauseker M,et al. Safety and efficacy of imatinib in CML over a period of 10 years:data from the randomized CML-study IV[J]. Leukemia,2015,29(5):1123-1132.
[6] NCI, NIH, DHHS.Cancer Therapy Evaluation Program, Common Terminology Criteria for Adverse Events[EB/OL].(2006-08-31)[2018-10-01] http://ctep.cancer.gov.
[7] Saikia T. The cure of chronic myeloid leukemia:are we there yet?[J].Curr Oncol Rep, 2018,20(2):12.
[8] Horibe K, Tsukimoto I, Ohno R. Clinicopathologic characteristics of leukemia in Japanese children and young adults[J]. Leukemia,2001,15(8):1256-1261.
[9] Chen Y, Wang H, Kantarjian H, et al. Trends in chronic myeloid leukemia incidence and survival in the united states from 1975 to 2009[J].Leuk Lymphoma,2013, 54(7):1411-1417.
[10] Millot F, Baruchel A, Guilhot J, et al. Imatinib is effective inchildren with previously untreated chronic myelogenous leukemiain early chronic phase:Results of the French national phase IV trial[J]. J Clin Oncol,2011, 29(20):2827-2832.
[11] Suttorp M, Schulze P, Glauche I, et al. Front-line imatinib treatment in children and adolescents with chronic myeloid leukemia:results from a phase Ⅲ trial[J]. Leukemia, 2018,32(7):1657-1669.
[12] 江倩,赵东陆,金洁,等.国产甲磺酸伊马替尼治疗慢性髓性白血病慢性期早期疗效和安全性的前瞻性、多中心临床研究[J]. 中华血液学杂志,2015,36(8):651-655.
[13] Millot F,Baruehel A,Guilhot J,et al.Imatinibis effective inchildren with reviously untreated chronic myelogenous leukemia in early chronic phase:results of the French National Phase IV Trial[J]. J Clin Oncol,2011,29(20):2827-2832.
[14] Jaeger B A, Tauer J T, Ulmer A, et al. Changes in bone metabolic parameters in children with chronic myeloid leukemia on imatinib treatment[J]. Med Sci Monit, 2012, 18(12):CR721-8.
[15] Millot F, Guilhot J, Baruchel A, et al. Growth deceleration inchildren treated with imatinib for chronic myeloid leukaemia[J]. Eur J Cancer,2014,50(18):3206-3211.
[16] Narayanan K R, Bansal D, Walia R,et al. Growth failure in children with chronic myeloid leukemia receiving imatinib is due to disruption of GH/IGF-1 axis[J]. Pediatr Blood Cancer,2013, 60(7):1148-1153.
[17] Choeyprasert W, Yansomdet W, Natesirinilkul T,et al. Adverse effects of imatinib in children with chronic myelogenous leukemia[J]. Pediatr Int, 2017,59(3):286-292.