PMID- 31235325
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20240328
IS  - 2531-1387 (Electronic)
IS  - 2531-1379 (Print)
IS  - 2531-1379 (Linking)
VI  - 42
IP  - 1
DP  - 2020 Jan-Mar
TI  - A subgroup analysis of JUMP, a phase IIIb, expanded-access study evaluating the 
      safety and efficacy of ruxolitinib in patients with myelofibrosis in a Brazilian 
      cohort.
PG  - 46-53
LID - S2531-1379(19)30054-9 [pii]
LID - 10.1016/j.htct.2019.01.009 [doi]
AB  - INTRODUCTION: Ruxolitinib has been approved for the treatment of myelofibrosis 
      (MF). In this study, we present safety and efficacy findings from an analysis of 
      104 patients with intermediate- and high-risk MF in a Brazilian cohort of the 
      JUMP study who received treatment with ruxolitinib. METHODS: JUMP is a 
      single-arm, open-label, phase IIIb, expanded-access study. The primary endpoint 
      was to evaluate the safety and tolerability (frequency, duration, and severity of 
      adverse events [AEs]) of ruxolitinib. RESULTS: All of the 104 patients received 
      the treatment. Median duration of exposure was 35.8 months. The most common 
      hematologic AEs were anemia (57.7), thrombocytopenia (38.5%), neutropenia 
      (11.5%), and leukopenia (9.6%). Second malignancies (all grades) occurred in 
      19.2% of patients (n=20). Serious AEs were reported in 62.5% of patients (n=65). 
      The proportions of patients with >/=50% reduction from baseline in palpable spleen 
      length at weeks 24 and 48 were 62.7% and 69.2%, respectively. The mean change 
      from the baseline in the Functional Assessment of Cancer Therapy (FACT)-Lymphoma 
      total score was 10.8 [15.6%] at week 4, 12.6 [14.1%] at week 24, and 12.2 [14.3%] 
      at week 48. The mean change from the baseline for the Functional Assessment of 
      Chronic Illness Therapy (FACIT)-Fatigue scale was 3.9 [42.8%] at week 4, 4.9 
      [29.9%] at week 24, and 4.7 [28%] at week 48. At week 48, the estimated 
      progression-free survival, leukemia-free survival, and overall survival 
      probabilities were 91%, 91% and 93%, respectively Overall, 21 deaths were 
      observed in the present study. CONCLUSION: Findings from this study suggest that 
      ruxolitinib could be evaluated as a standard-of-care treatment for the MF 
      population in need of a viable treatment option. NCT01493414.
CI  - Copyright (c) 2019. Published by Elsevier Editora Ltda.
FAU - Tavares, Renato
AU  - Tavares R
AD  - Universidade Federal de Goias (UFG), Goiania, GO, Brazil. Electronic address: 
      renatosampaiotavares@gmail.com.
FAU - Souza, Carmino Antonio De
AU  - Souza CA
AD  - Universidade Estadual de Campinas (Unicamp), Campinas, SP, Brazil.
FAU - Paley, Carole
AU  - Paley C
AD  - Novartis Oncology, East Hanover, NJ, USA.
FAU - Bouard, Catherine
AU  - Bouard C
AD  - Novartis Pharma S.A.S., Paris, France.
FAU - Tiwari, Ranjan
AU  - Tiwari R
AD  - Novartis Healthcare Pvt Ltd, Hyderabad, India.
FAU - Pasquini, Ricardo
AU  - Pasquini R
AD  - Universidade Federal do Parana (UFPR), Curitiba, PR, Brazil.
LA  - eng
SI  - ClinicalTrials.gov/NCT01493414
PT  - Journal Article
DEP - 20190425
PL  - Brazil
TA  - Hematol Transfus Cell Ther
JT  - Hematology, transfusion and cell therapy
JID - 101725732
PMC - PMC7031100
OTO - NOTNLM
OT  - Brazil
OT  - JUMP
OT  - Myelofibrosis
OT  - Ruxolitinib
EDAT- 2019/06/27 06:00
MHDA- 2019/06/27 06:01
PMCR- 2019/04/25
CRDT- 2019/06/26 06:00
PHST- 2018/09/03 00:00 [received]
PHST- 2018/12/20 00:00 [revised]
PHST- 2019/01/17 00:00 [accepted]
PHST- 2019/06/27 06:00 [pubmed]
PHST- 2019/06/27 06:01 [medline]
PHST- 2019/06/26 06:00 [entrez]
PHST- 2019/04/25 00:00 [pmc-release]
AID - S2531-1379(19)30054-9 [pii]
AID - 10.1016/j.htct.2019.01.009 [doi]
PST - ppublish
SO  - Hematol Transfus Cell Ther. 2020 Jan-Mar;42(1):46-53. doi: 
      10.1016/j.htct.2019.01.009. Epub 2019 Apr 25.