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Article: Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia

TitleNilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia
Authors
Issue Date2008
PublisherAmerican Society of Hematology. The Journal's web site is located at http://bloodjournal.hematologylibrary.org/
Citation
Blood, 2008, v. 111 n. 4, p. 1834-1839 How to Cite?
AbstractPatients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia (CML-AP) have very limited therapeutic options. Nilotinib is a highly selective BCR-ABL tyrosine kinase inhibitor. This phase 2 trial was designed to characterize the efficacy and safety of nilotinib (400 mg twice daily) in this patient population with hematologic response (HR) as primary efficacy endpoint. A total of 119 patients were enrolled and had a median duration of treatment of 202 days (range, 2-611 days). An HR was observed in 56 patients (47%; 95% confidence interval [CI], 38%-56%). Major cytogenetic response (MCyR) was observed in 35 patients (29%; 95% CI, 21%-39%). The median duration of HR has not been reached. Overall survival rate among the 119 patients after 12 months of follow-up was 79% (95% CI, 70%-87%). Nonhematologic adverse events were mostly mild to moderate. Severe peripheral edema and pleural effusions were not observed. The most common grade 3 or higher hematologic adverse events were thrombocytopenia (35%) and neutropenia (21%). Grade 3 or higher bilirubin and lipase elevations occurred in 9% and 18% of patients, respectively, resulting in treatment discontinuation in one patient. In conclusion, nilotinib is an effective and well-tolerated treatment in imatinib-resistant and -intolerant CML-AP. This trial is registered at www.clinicaltrials. gov as NCT00384228. © 2008 by The American Society of Hematology.
Persistent Identifierhttp://hdl.handle.net/10722/76413
ISSN
2015 Impact Factor: 11.841
2015 SCImago Journal Rankings: 6.395
ISI Accession Number ID
References

 

DC FieldValueLanguage
dc.contributor.authorLe Coutre, Pen_HK
dc.contributor.authorOttmann, OGen_HK
dc.contributor.authorGiles, Fen_HK
dc.contributor.authorKim, DWen_HK
dc.contributor.authorCortes, Jen_HK
dc.contributor.authorGattermann, Nen_HK
dc.contributor.authorApperley, JFen_HK
dc.contributor.authorLarson, RAen_HK
dc.contributor.authorAbruzzese, Een_HK
dc.contributor.authorO'Brien, SGen_HK
dc.contributor.authorKuliczkowski, Ken_HK
dc.contributor.authorHochhaus, Aen_HK
dc.contributor.authorMahon, FXen_HK
dc.contributor.authorSaglio, Gen_HK
dc.contributor.authorGobbi, Men_HK
dc.contributor.authorKwong, YLen_HK
dc.contributor.authorBaccarani, Men_HK
dc.contributor.authorHughes, Ten_HK
dc.contributor.authorMartinelli, Gen_HK
dc.contributor.authorRadich, JPen_HK
dc.contributor.authorZheng, Men_HK
dc.contributor.authorShou, Yen_HK
dc.contributor.authorKantarjian, Hen_HK
dc.date.accessioned2010-09-06T07:20:58Z-
dc.date.available2010-09-06T07:20:58Z-
dc.date.issued2008en_HK
dc.identifier.citationBlood, 2008, v. 111 n. 4, p. 1834-1839en_HK
dc.identifier.issn0006-4971en_HK
dc.identifier.urihttp://hdl.handle.net/10722/76413-
dc.description.abstractPatients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia (CML-AP) have very limited therapeutic options. Nilotinib is a highly selective BCR-ABL tyrosine kinase inhibitor. This phase 2 trial was designed to characterize the efficacy and safety of nilotinib (400 mg twice daily) in this patient population with hematologic response (HR) as primary efficacy endpoint. A total of 119 patients were enrolled and had a median duration of treatment of 202 days (range, 2-611 days). An HR was observed in 56 patients (47%; 95% confidence interval [CI], 38%-56%). Major cytogenetic response (MCyR) was observed in 35 patients (29%; 95% CI, 21%-39%). The median duration of HR has not been reached. Overall survival rate among the 119 patients after 12 months of follow-up was 79% (95% CI, 70%-87%). Nonhematologic adverse events were mostly mild to moderate. Severe peripheral edema and pleural effusions were not observed. The most common grade 3 or higher hematologic adverse events were thrombocytopenia (35%) and neutropenia (21%). Grade 3 or higher bilirubin and lipase elevations occurred in 9% and 18% of patients, respectively, resulting in treatment discontinuation in one patient. In conclusion, nilotinib is an effective and well-tolerated treatment in imatinib-resistant and -intolerant CML-AP. This trial is registered at www.clinicaltrials. gov as NCT00384228. © 2008 by The American Society of Hematology.en_HK
dc.languageengen_HK
dc.publisherAmerican Society of Hematology. The Journal's web site is located at http://bloodjournal.hematologylibrary.org/en_HK
dc.relation.ispartofBlooden_HK
dc.subject.meshAdulten_HK
dc.subject.meshAgeden_HK
dc.subject.meshAntineoplastic Agents - therapeutic useen_HK
dc.subject.meshBlood Cell Counten_HK
dc.subject.meshDose-Response Relationship, Drugen_HK
dc.subject.meshDrug Administration Scheduleen_HK
dc.subject.meshDrug Resistanceen_HK
dc.subject.meshFemaleen_HK
dc.subject.meshFusion Proteins, bcr-ablen_HK
dc.subject.meshHumansen_HK
dc.subject.meshLeukemia, Myelogenous, Chronic, BCR-ABL Positive - blood - drug therapy - enzymologyen_HK
dc.subject.meshMaleen_HK
dc.subject.meshMiddle Ageden_HK
dc.subject.meshMutationen_HK
dc.subject.meshPiperazines - therapeutic use - toxicityen_HK
dc.subject.meshProtein-Tyrosine Kinases - antagonists & inhibitors - geneticsen_HK
dc.subject.meshPyrimidines - administration & dosage - therapeutic use - toxicityen_HK
dc.subject.meshSafetyen_HK
dc.titleNilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemiaen_HK
dc.typeArticleen_HK
dc.identifier.openurlhttp://library.hku.hk:4550/resserv?sid=HKU:IR&issn=0006-4971&volume=111&issue=4&spage=1834&epage=1839&date=2008&atitle=Nilotinib+(formerly+AMN107),+a+highly+selective+BCR-ABL+tyrosine+kinase+inhibitor,+is+active+in+patients+with+imatinib-resistant+or+-intolerant+accelerated-phase+chronic+myelogenous+leukemiaen_HK
dc.identifier.emailKwong, YL:ylkwong@hku.hken_HK
dc.identifier.authorityKwong, YL=rp00358en_HK
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1182/blood-2007-04-083196en_HK
dc.identifier.pmid18048643-
dc.identifier.scopuseid_2-s2.0-41349083969en_HK
dc.identifier.hkuros146486en_HK
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-41349083969&selection=ref&src=s&origin=recordpageen_HK
dc.identifier.volume111en_HK
dc.identifier.issue4en_HK
dc.identifier.spage1834en_HK
dc.identifier.epage1839en_HK
dc.identifier.isiWOS:000253251100026-
dc.publisher.placeUnited Statesen_HK
dc.identifier.scopusauthoridLe Coutre, P=6701832639en_HK
dc.identifier.scopusauthoridOttmann, OG=7006070257en_HK
dc.identifier.scopusauthoridGiles, F=34568568400en_HK
dc.identifier.scopusauthoridKim, DW=34975062000en_HK
dc.identifier.scopusauthoridCortes, J=24400826900en_HK
dc.identifier.scopusauthoridGattermann, N=7006290597en_HK
dc.identifier.scopusauthoridApperley, JF=7005558171en_HK
dc.identifier.scopusauthoridLarson, RA=35377459000en_HK
dc.identifier.scopusauthoridAbruzzese, E=6601991989en_HK
dc.identifier.scopusauthoridO'Brien, SG=7402355305en_HK
dc.identifier.scopusauthoridKuliczkowski, K=8847297400en_HK
dc.identifier.scopusauthoridHochhaus, A=35406412600en_HK
dc.identifier.scopusauthoridMahon, FX=7007066036en_HK
dc.identifier.scopusauthoridSaglio, G=7102391260en_HK
dc.identifier.scopusauthoridGobbi, M=7102295038en_HK
dc.identifier.scopusauthoridKwong, YL=7102818954en_HK
dc.identifier.scopusauthoridBaccarani, M=23007600900en_HK
dc.identifier.scopusauthoridHughes, T=7401458867en_HK
dc.identifier.scopusauthoridMartinelli, G=7202641775en_HK
dc.identifier.scopusauthoridRadich, JP=7006165074en_HK
dc.identifier.scopusauthoridZheng, M=36342159000en_HK
dc.identifier.scopusauthoridShou, Y=35262948800en_HK
dc.identifier.scopusauthoridKantarjian, H=7202247267en_HK
dc.identifier.citeulike2580687-

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