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
Hematol., Transfus. Cell Ther. (Impr.)
;
42(1): 46-53, Jan.-Mar. 2020. tab, graf
Artigo
em Inglês
| LILACS
| ID: biblio-1090480
ABSTRACT
Abstract 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
Texto completo:
DisponíveL
Índice:
LILACS (Américas)
Assunto principal:
Tratamento Farmacológico
/
Mielofibrose Primária
Tipo de estudo:
Estudo de etiologia
/
Fatores de risco
Limite:
Adulto
/
Idoso
/
Aged80
/
Humanos
/
Masculino
País/Região como assunto:
América do Sul
/
Brasil
Idioma:
Inglês
Revista:
Hematol., Transfus. Cell Ther. (Impr.)
Assunto da revista:
Hematologia
/
TransfusÆo de Sangue
Ano de publicação:
2020
Tipo de documento:
Artigo
País de afiliação:
Brasil
/
França
/
Índia
/
Estados Unidos
Instituição/País de afiliação:
Novartis Healthcare Pvt Ltd/IN
/
Novartis Oncology/US
/
Novartis Pharma S.A.S/FR
/
Universidade Estadual de Campinas/BR
/
Universidade Federal de Goiás - UFG/BR
/
Universidade Federal do Paraná - UFPR/BR
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