PMID- 31389383
OWN - NLM
STAT- MEDLINE
DCOM- 20200109
LR  - 20200109
IS  - 1998-4774 (Electronic)
IS  - 0019-509X (Linking)
VI  - 56
IP  - 3
DP  - 2019 Jul-Sep
TI  - A prospective, randomized study to compare the combination of imatinib and 
      cytarabine versus imatinib alone in newly diagnosed patients with chronic phase 
      chronic myeloid leukemia.
PG  - 211-215
LID - 10.4103/ijc.IJC_303_18 [doi]
AB  - INTRODUCTION: To compare the efficacy and safety of imatinib and cytarabine 
      (ara-c) combination versus imatinib monotherapy in newly diagnosed patients with 
      chronic phase chronic myeloid leukemia (CML-CP). MATERIALS AND METHODS: This 
      prospective, randomized study included adult patients (age >18 years) with newly 
      diagnosed CML-CP. Patients received either a single oral dose of imatinib 400 
      mg/day in combination with a subcutaneous injection of ara-c 20 mg/m(2)/day 
      (imatinib + ara-c) or a single oral dose of imatinib 400 mg/day. Primary 
      endpoints were hematological and molecular responses at 3 months and cytogenetic 
      responses at 6 and 12 months. Secondary endpoints included grade 3/4 
      hematological and nonhematological adverse events (AEs). RESULTS: Of 30 patients 
      included, 14 were randomized to imatinib + ara-c and 16 to imatinib alone. 
      Complete hematologic response (CHR) at 3 months was higher with imatinib + ara-c 
      vs. imatinib alone (100% vs. 87.5%, P = 0.48). The median time to achieve CHR was 
      significantly (P < 0.001) lower with imatinib + ara-c (32.07 vs. 23.43 days). 
      Molecular response at 3 months was significantly higher (P = 0.04) with imatinib 
      + ara-c vs. imatinib alone (100% vs. 68.75%). Complete cytogenetic response was 
      also higher with imatinib + ara-c vs. imatinib alone (42.85% vs. 25% at 6 months 
      and 71.4% vs. 62.5% at 12 months). Neutropenia followed by thrombocytopenia and 
      anemia were the most common AEs. Grade 3/4 hematological and nausea events were 
      significantly (P < 0.05) higher with imatinib + ara-c. Other nonhematological 
      events were not significantly different between the treatments. The median 
      follow-up duration was 20 months (range: 15-23 months). CONCLUSION: Imatinib with 
      low-dose ara-c can be considered as a potential first-line treatment option for 
      CML-CP.
FAU - Samal, Priyanka
AU  - Samal P
AD  - Institute of Hematology and Transfusion Medicine (IHTM), Kolkata, West Bengal, 
      India.
FAU - Chakrabarti, Prantar
AU  - Chakrabarti P
AD  - Institute of Hematology and Transfusion Medicine (IHTM), Kolkata, West Bengal, 
      India.
FAU - Nath, Uttam K
AU  - Nath UK
AD  - Institute of Hematology and Transfusion Medicine (IHTM), Kolkata, West Bengal, 
      India.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - India
TA  - Indian J Cancer
JT  - Indian journal of cancer
JID - 0112040
RN  - 04079A1RDZ (Cytarabine)
RN  - 8A1O1M485B (Imatinib Mesylate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Cytarabine/administration & dosage
MH  - Female
MH  - Follow-Up Studies
MH  - Humans
MH  - Imatinib Mesylate/administration & dosage
MH  - Leukemia, Myeloid, Chronic-Phase/*drug therapy/pathology
MH  - Male
MH  - Middle Aged
MH  - Prognosis
MH  - Prospective Studies
MH  - Safety
MH  - Young Adult
OTO - NOTNLM
OT  - Chronic myeloid leukemia
OT  - chronic phase
OT  - cytarabine
OT  - imatinib mesylate
COIS- None
EDAT- 2019/08/08 06:00
MHDA- 2020/01/10 06:00
CRDT- 2019/08/08 06:00
PHST- 2019/08/08 06:00 [entrez]
PHST- 2019/08/08 06:00 [pubmed]
PHST- 2020/01/10 06:00 [medline]
AID - IndianJournalofCancer_2019_56_3_211_263029 [pii]
AID - 10.4103/ijc.IJC_303_18 [doi]
PST - ppublish
SO  - Indian J Cancer. 2019 Jul-Sep;56(3):211-215. doi: 10.4103/ijc.IJC_303_18.