PMID- 29397828
OWN - NLM
STAT- MEDLINE
DCOM- 20181115
LR  - 20220114
IS  - 1009-2137 (Print)
IS  - 1009-2137 (Linking)
VI  - 26
IP  - 1
DP  - 2018 Feb
TI  - [Correlation of Serum Concentration of Nilotinib with Clinical Efficacy in 
      Patients with Chronic Myeloid Leukemia].
PG  - 116-120
LID - 10.7534/j.issn.1009-2137.2018.01.019 [doi]
AB  - OBJECTIVE: To investigate the correlation of the serum minimal concentrations 
      (Cmins) of nilotinib(NIL) with the clinical efficacy and adverse events (AEs) in 
      CML patients. METHODS: A total of 54 patients were divided into two groups 
      according to the dosage of nilotinib. 44 cases received dose of 600-800 mg/d were 
      classified as group A; while 10 cases received dose of 400 mg/d as group B. The 
      Cmins of nilotinib were determmined by liquid chromatography-tandem mass 
      spectrometry. RESULTS: Median Cmins of nilotinib in 54 patients was 1.71 
      (0.52-5.93) microg/ml. Cmins of nilotinib in group A and group B were 2.09+/- 1.21 
      microg/ml and 0.94+/- 0.27 microg/ml respectively, Cmins of group A was significantly 
      higher than that of group B (P=0.001). In group A, 24 out of 44 cases obtained 
      major molecular response (MMR) in 12 months, while 20 cases did not reach MMR in 
      12 months; the serum drug concentrations were 1.70+/- 0.75 microg/ml and 2.03+/- 0.82 
      microg/ml respectively, without statistically significant differences between these 2 
      subgroups(P=0.154). However, Cmins of nilotinib in patients with III-IV grade of 
      adverse events were significantly higher than those in patients with 0-II grade 
      of adverse events (3.09+/- 1.76 microg/ml vs 1.76+/- 0.68 microg/ml)(P=0.018). There was no 
      statistic diffence in Cmins of nilotinib with MMR in 12 months of group A MMR 
      1.15+/- 0.27 microg/ml vs no MMR 0.83+/- 0.24 microg/ml(P=0.051). The MMR rate at 12 months 
      in group A was 54.5%(24/44) and that in group B was 40%(4/10) (P=0.494). But the 
      incidence of grade III-IV adverse events in group A was 29.5%(13/44), which was 
      significantly higher than that of group B[0/10(0%)]. CONCLUSION: Cmins of 
      nilotinib shows significant individual differences. The Cmins of nilotinib relate 
      with the dosage and grade III-IV of adverse events. The lower dose of nilotinib 
      may maintain a good therapeutic effect and significantly reduce the adverse 
      events.
FAU - Wang, Tong
AU  - Wang T
AD  - Department of Hematology, The First Affiliated Hospital of Soochow University, 
      Suzhou 215000, Jiangsu Province, China.
FAU - Li, Cai-Xia
AU  - Li CX
AD  - Department of Hematology, The First Affiliated Hospital of Soochow University, 
      Suzhou 215000, Jiangsu Province, China. E-mail:licaixia@suda.edu.cn.
FAU - Chen, Xiao-Chen
AU  - Chen XC
AD  - Department of Hematology, The First Affiliated Hospital of Soochow University, 
      Suzhou 215000, Jiangsu Province, China.
FAU - Gu, Cai-Hong
AU  - Gu CH
AD  - Department of Hematology, The First Affiliated Hospital of Soochow University, 
      Suzhou 215000, Jiangsu Province, China.
FAU - Yang, Dan
AU  - Yang D
AD  - Department of Hematology, The First Affiliated Hospital of Soochow University, 
      Suzhou 215000, Jiangsu Province, China.
FAU - Wang, Pu
AU  - Wang P
AD  - Department of Hematology, The First Affiliated Hospital of Soochow University, 
      Suzhou 215000, Jiangsu Province, China.
FAU - Zou, Qiu
AU  - Zou Q
AD  - Department of Hematology, The First Affiliated Hospital of Soochow University, 
      Suzhou 215000, Jiangsu Province, China.
FAU - Wu, De-Pei
AU  - Wu DP
AD  - Department of Hematology, The First Affiliated Hospital of Soochow University, 
      Suzhou 215000, Jiangsu Province, China.
LA  - chi
PT  - Journal Article
PL  - China
TA  - Zhongguo Shi Yan Xue Ye Xue Za Zhi
JT  - Zhongguo shi yan xue ye xue za zhi
JID - 101084424
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Pyrimidines)
RN  - 8A1O1M485B (Imatinib Mesylate)
RN  - F41401512X (nilotinib)
SB  - IM
MH  - Antineoplastic Agents
MH  - Humans
MH  - Imatinib Mesylate
MH  - *Leukemia, Myelogenous, Chronic, BCR-ABL Positive
MH  - Pyrimidines
MH  - Treatment Outcome
EDAT- 2018/02/06 06:00
MHDA- 2018/11/16 06:00
CRDT- 2018/02/06 06:00
PHST- 2018/02/06 06:00 [entrez]
PHST- 2018/02/06 06:00 [pubmed]
PHST- 2018/11/16 06:00 [medline]
AID - 1009-2137(2018)01-0116-05 [pii]
AID - 10.7534/j.issn.1009-2137.2018.01.019 [doi]
PST - ppublish
SO  - Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2018 Feb;26(1):116-120. doi: 
      10.7534/j.issn.1009-2137.2018.01.019.