title: Nilotinib 300 mg BID as frontline treatment of CML: prospective analysis of the Xpert BCR-ABL monitor system and significance of 3-month molecular response.
abstract: Sixty patients with early chronic phase CML (ECPCML) received Nilotinib on a phase II study which included a comparison of the Xpert BCR-ABL Monitor™ PCR system with standardized (IS) BCR-ABL1 real-time quantitative PCR (RQ-PCR). 88% patients achieved MMR with 45% achieving MR4.5. At 3 months BCR-ABL1/ABL1 IS >1% and <10% was associated with a lower likelihood of subsequent MR4.5 compared to patients with lower levels (p = 0.018). No significant difference was observed between methodologies in identifying MMR. Nilotinib induces high molecular response rates in ECPCML and the Xpert BCR-ABL Monitor™ system merits further investigation in this setting.
authors: HRB Clinical Research Facility, National University of Ireland, Galway, Ireland. Electronic address: michael.odwyer@nuigalway.ie.
authors: Michael E
authors: ME
authors: O'Dwyer
authors: Leukemia Program, Sylvester Comprehensive Cancer Center, University of Miami, Miami, USA.
authors: Ronan
authors: R
authors: Swords
authors: Chaim Sheba Medical Center, Tel Hashomer, Israel.
authors: Arnon
authors: A
authors: Nagler
authors: Center for Cancer Research and Cell Biology, Queens University, Belfast, Northern Ireland, United Kingdom.
authors: Mary Frances
authors: MF
authors: McMullin
authors: Division of Oncology and Hematology, Charité Universitätsmedizin Berlin, Berlin, Germany.
authors: Philipp D
authors: PD
authors: le Coutre
authors: Department of Hematology, St. James's Hospital, Dublin, Ireland.
authors: Stephen E
authors: SE
authors: Langabeer
authors: HRB Clinical Research Facility, National University of Ireland, Galway, Ireland.
authors: Alberto
authors: A
authors: Alvarez-Iglesias
authors: Molecular Diagnostics Laboratory, University of Texas Health Science Center San Antonio, San Antonio, USA.
authors: Hongxin
authors: H
authors: Fan
authors: Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
authors: Richard C
authors: RC
authors: Woodman
authors: Northwestern Medicine Developmental Therapeutics Institute, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, USA.
authors: Francis J
authors: FJ
authors: Giles
authors: Department of Hematology, St. James's Hospital, Dublin, Ireland.
authors: Eibhlin
authors: E
authors: Conneally
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D016903:Drug Monitoring / Q000295:instrumentation / Q000379:methods* / Q000706:statistics & numerical data; D005260:Female; D016044:Fusion Proteins, bcr-abl / Q000235:genetics*; D006801:Humans; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis* / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology; D016013:Likelihood Functions; D008297:Male; D008875:Middle Aged; D018365:Neoplasm, Residual; D011446:Prospective Studies; D011743:Pyrimidines / Q000627:therapeutic use*; D060888:Real-Time Polymerase Chain Reaction; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; C581634:BCR-ABL1 fusion protein, human; D011743:Pyrimidines; D016044:Fusion Proteins, bcr-abl; C498826:nilotinib
keywords: CML BCR-ABL; Minimal residual disease; Molecular diagnostics; Nilotinib