Efficacy and safety of radotinib in chronic phase chronic myeloid leukemia patients with resistance or intolerance to BCR-ABL1 tyrosine kinase inhibitors

Kim, Sung Hyun; Menon, Hari; Jootar, Saengsuree; Saikia, Tapan; Kwak, Jae Yong; Sohn, Sang Kyun; Park, Joon Seong; Jeong, Seong Hyun; Kim, Hyeoung Joon; Kim, Yeo Kyeoung; Oh, Suk Joong; Kim, Hawk; Zang, Dae Young; Chung, Joo Seop; Shin, Ho Jin; Rok, Young; Kim, Jeong‐A; Kim, Dae Young; Choi, Chul Won; Park, Sa-Hee; Park, Hye Lin; Lee, Gong Yeal; Cho, Dae Jin; Shin, Jae-Suk; Kim, Dong Wook

doi:10.3324/haematol.2013.096776

Cited by 60 publications

(61 citation statements)

References 37 publications

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“…Ponatinib (45 mg once daily) has also been approved by the FDA for patients resistant or intolerant to prior TKI therapy. Also approved, for patients in whom prior TKI therapy fails, are radotinib, which is available in Korea, 110 and omacetaxine, which is a non-TKI drug approved by the US FDA. 111,112 Busulfan is not recommended.…”

Section: Treatment Recommendationsmentioning

confidence: 99%

European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013

Baccarani

Deininger

Rosti

et al. 2013

Blood

1,753

2,099

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Advances in chronic myeloid leukemia treatment, particularly regarding tyrosine kinase inhibitors, mandate regular updating of concepts and management. A European LeukemiaNet expert panel reviewed prior and new studies to update recommendations made in 2009. We recommend as initial treatment imatinib, nilotinib, or dasatinib. Response is assessed with standardized real quantitative polymerase chain reaction and/or cytogenetics at 3, 6, and 12 months. BCR-ABL1 transcript levels ≤10% at 3 months, <1% at 6 months, and ≤0.1% from 12 months onward define optimal response, whereas >10% at 6 months and >1% from 12 months onward define failure, mandating a change in treatment. Similarly, partial cytogenetic response (PCyR) at 3 months and complete cytogenetic response (CCyR) from 6 months onward define optimal response, whereas no CyR (Philadelphia chromosome–positive [Ph+] >95%) at 3 months, less than PCyR at 6 months, and less than CCyR from 12 months onward define failure. Between optimal and failure, there is an intermediate warning zone requiring more frequent monitoring. Similar definitions are provided for response to second-line therapy. Specific recommendations are made for patients in the accelerated and blastic phases, and for allogeneic stem cell transplantation. Optimal responders should continue therapy indefinitely, with careful surveillance, or they can be enrolled in controlled studies of treatment discontinuation once a deeper molecular response is achieved.

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Section: Treatment Recommendationsmentioning

confidence: 99%

European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013

Baccarani

Deininger

Rosti

et al. 2013

Blood

1,753

2,099

View full text Add to dashboard Cite

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“…[1,3,4] Our analytical method was used to measure plasma concentrations of radotinib in its phase 1 and 2 clinical trials. Briefly, the radotinib concentrations in plasma were higher than LLOQ and quantifiable at all the time points.…”

Section: Pharmacokinetic Applicationmentioning

confidence: 99%

“…[1][2][3][4] It is a BCR-ABL1 tyrosine kinase inhibitor with its chemical structure similar to that of imatinib. Recent clinical trials on the efficacy and safety of radotinib in patients with chronic myelogenous leukemia showed that it is effective and well tolerated, with major and complete cytogenetic response rates comparable to those of nilotinib and dasatinib.…”

Section: Introductionmentioning

confidence: 99%

Development and validation of analytical method for the determination of radotinib in human plasma using liquid chromatography-tandem mass spectrometry

Seo

Cho

Yoon

2017

Transl Clin Pharmacol

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“…The relationship between response and logistical organization of CML care is dramatically confirmed by the very low rate of CCyR at 1 year (27/151, or 18%) obtained with imatinib first-line treatment of CP-CML in Ife-Ife, Nigeria (M Durosinmi, personal communication), where important logistical problems (lack of RT-PCR, procurement of drug, power outages, general instability, cultural problems in the acceptance of chronic medical treatment) hampered the efforts of physicians in the past, in addition to the lack of a dedicated CML clinic. Thus the CCyR rates at 12 months show huge variations (Table I), from values close to 90% in recent single center experiences [23,30], to 65-72% in older multicenter registration studies [16,17], to 41% in older population based registries [29], to 18%, using the same drug but in different logistical/management contexts.…”

Section: Type Of Managementmentioning

confidence: 99%

How I treat newly diagnosed chronic myeloid leukemia in 2015

Gambacorti‐Passerini

Piazza

2014

American J Hematol

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The initial treatment for chronic myeloid leukemia in chronic phase (CP-CML) represents a complex process, which includes a prompt and precise diagnosis, the choice among three available tyrosine kinase inhibitors (TKIs), and the initial management of care for these patients, which will protract over a very long period of time. This manuscript summarizes different data on activity, side effects, and supportive measures available for each TKI, the need for particular care in the logistical organization of CML management, the scenario which will be opened by the future availability of generic imatinib. The opinion of the authors is that imatinib remains the first-line treatment for CP-CML; this strategy, accompanied by intensive monitoring and possible dose modification/drug switch after the initial 3-12 months of treatment presently assures a normal life expectancy to the population of newly diagnosed patients with CP-CML.

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Efficacy and safety of radotinib in chronic phase chronic myeloid leukemia patients with resistance or intolerance to BCR-ABL1 tyrosine kinase inhibitors

Cited by 60 publications

References 37 publications

European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013

European LeukemiaNet recommendations for the management of chronic myeloid leukemia: 2013

Development and validation of analytical method for the determination of radotinib in human plasma using liquid chromatography-tandem mass spectrometry

How I treat newly diagnosed chronic myeloid leukemia in 2015

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