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Nilotinib combined with multiagent chemotherapy for newly diagnosed Philadelphia-positive acute lymphoblastic leukemia

Title
Nilotinib combined with multiagent chemotherapy for newly diagnosed Philadelphia-positive acute lymphoblastic leukemia
Authors
Kim, Dae-YoungJoo, Young-DonLim, Sung-NamKim, Sung-DooLee, Jung-HeeLee, Je-HwanKim, Dong Hwan (Dennis)Kim, KihyunJung, Chul WonKim, InhoYoon, Sung-SooPark, SeonyangAhn, Jae-SookYang, Deok-HwanLee, Je-JungLee, Ho-SupKim, Yang SooMun, Yeung-ChulKim, HawkPark, Jae HooMoon, Joon HoSohn, Sang KyunLee, Sang MinLee, Won SikKim, Kyoung HaWon, Jong-HoHyun, Myung SooPark, JinnyLee, Jae HoonShin, Ho-JinChung, Joo-SeopLee, HyewonEom, Hyeon-SeokLee, Gyeong WonCho, Young-UkJang, SeongsooPark, Chan-JeoungChi, Hyun-SookLee, Kyoo-HyungKorean Soc Hematology
Ewha Authors
문영철
SCOPUS Author ID
문영철scopus
Issue Date
2015
Journal Title
BLOOD
ISSN
0006-4971JCR Link1528-0020JCR Link
Citation
vol. 126, no. 6, pp. 746 - 756
Publisher
AMER SOC HEMATOLOGY
Indexed
SCI; SCIE; SCOPUS WOS scopus
Abstract
We investigated the effects of nilotinib plus multiagent chemotherapy, followed by consolidation/maintenance or allogeneic hematopoietic cell transplantation (allo-HCT) for adult patients with newly diagnosed Philadelphia-positive (Ph-pos) acute lymphoblastic leukemia (ALL). Study subjects received induction treatment that comprised concurrent vincristine, daunorubicin, prednisolone, and nilotinib. After achieving complete hematologic remission (HCR), subjects received either 5 courses of consolidation, followed by 2-year maintenance with nilotinib, or allo-HCT. Minimal residual disease (MRD) was assessed at HCR, and every 3 months thereafter. The molecular responses (MRs) were defined as MR3 for BCR-ABL1/G6PDH ratios <= 10(-3) and MR5 for ratios <10(-5). Ninety evaluable subjects, ages 17 to 71 years, were enrolled in 17 centers. The HCR rate was 91%; 57 subjects received allo-HCT. The cumulative MR5 rate was 94%; the 2-year hematologic relapse-free survival (HRFS) rate was 72% for 82 subjects that achieved HCR, and the 2-year overall survival rate was 72%. Subjects that failed to achieve MR3 or MRS were 9.1 times (P=.004) or 6.3 times (P=.001) more prone to hematologic relapse, respectively, than those that achieved MR3 or MRS. MRD statuses just before allo-HCT and at 3 months after allo-HCT were predictive of 2-year HRFS. Adverse events occurred mainly during induction, and most were reversible with dose reduction or transient interruption of nilotinib. The combination of nilotinib with high-dose cytotoxic drugs was feasible, and it effectively achieved high cumulative complete molecular remission and HRFS rates. The MRD status at early postremission time was predictive of the HRFS. This trial was registered at www.clinicaltrials.gov as #NCT00844298.
DOI
10.1182/blood-2015-03-636548
Appears in Collections:
의과대학 > 의학과 > Journal papers
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