Efficacy and Safety of Generic Dasatinib as a Second-line Treatment for Patients with Chronic Myeloid Leukemia: a Multicenter Retrospective Study in Hubei Province, China
- 47 Downloads
Dasatinib is a second-generation tyrosine kinase inhibitor (TKI) and it could be used as a second-line treatment for patients with chronic myeloid leukemia (CML). Yinishu, a generic dasatinib made in China, was approved by the China Food and Drug Administration in 2013 and it costs much less than the patented dasatinib SPRYCEL. The present study aimed to examine the efficacy and safety of Yinishu as a second-line treatment for CML by comparing the baseline clinical characteristics, rates of adverse events and efficacy between Yinishu and SPRYCEL groups. The results showed that there were no significant differences in the rates of optimal response between Yinishu and SPRYCEL for patients who started second-line treatment because of treatment failure. For patients who started second-line treatment because of intolerance of first-line treatment, their levels of BCR-ABL1/ABL1 on the international scale (BCR-ABLIS) was maintained very low throughout the course of Yinishu treatment. Drug-related adverse events occurred with the same frequency in these two groups. It was confirmed that Yinishu was effective and safe as a secondline treatment for CML patients. Yinishu may be more suitable for patients who are economically unable to pay for the patented dasatinib SPRYCEL.
Key wordschronic myeloid leukemia generic dasatinib second-line treatment efficacy safety
Unable to display preview. Download preview PDF.
We would like to thank all the enrolled patients and their families as well as the investigators from the 11 contributing centers.
- 1.Deininger M, O'Brien SG, Guilhot F, et al. International randomized study of interferon vs STI571 (IRIS) 8-year follow up: sustained survival and low risk for progression or events in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) treated with imatinib. Blood, 2009,114:1126Google Scholar
- 4.Cortes JE, Saglio G, Baccarani M, et al. Final study results of the phase 3 dasatinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) trial (DASISION, CA180-056). Blood, 2014,124:152Google Scholar
- 13.Jiang Q, Zhao D, Jin J, et al. A prospective, multicentre clinical trial to evaluate the early clinical efficacy and safety of a generic imatinib in treating patients with chronic phase of chronic myelogenous leukemia. Zhonghua Xue Ye Xue Za Zhi (Chinese), 2015,36(8):651–655Google Scholar
- 14.Jiang CF, Luo F, Lin SS, et al. Treatment of domestic imatinib Mesylate on 36 patients with Ph positivechronic myeloid leukemia. J Clin Hematol (China), 2016,29(9):757–759Google Scholar
- 15.Lv JL, Chen YP, Xiao Q, et al. Curative effect and safety analysis of 47 patients with chronic myeloid leukemia after imatinib Mesylate treatment. J Clin Hematol (China), 2016,29(3):222–225Google Scholar
- 16.Kong J, Fu HX, Lai YH, et al. Dasatinib of china Tai-tianqing as second line treatment for chronic myelogenous leukemia in chronic phase. J Clin Hematol (Chinese), 2016,29(11):898–901Google Scholar
- 17.Min H, Kaifeng Y, Xiaoming L, et al. Clinical effect of imatinib, nero imatinib and dasatinib on chronic myeloid leukemia in chronic phase. Chin J Clin Pharmacol, 2016,32(6):511–513Google Scholar
- 18.Wang JX. The guidelines for diagnosis and treatment of chronic myelogenous leukemia in China (2016 edition). Zhonghua Xue Ye Xue Za Zhi (Chinese), 2016,37(8):633–639Google Scholar
- 19.Tan PF, Tan H, Luo XD. A case of chronic myeloid leukemia treated with dasatinib. J Clin Hematol (Chinese), 2016,29(1):69–70Google Scholar
- 20.Ferdinand R, Mitchell SA, Batson S, et al. Treatments for chronic myeloid leukemia: a qualitative systematic review. J Blood Med, 2012,3:51–76Google Scholar