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
Article
в En
| LILACS
| ID: biblio-1090480
Ответственная библиотека:
BR408.1
Локализация: BR408.1
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
Key words
Полный текст:
1
База данных:
LILACS
Основная тема:
Drug Therapy
/
Primary Myelofibrosis
Тип исследования:
Etiology_studies
/
Risk_factors_studies
Пределы темы:
Adult
/
Aged
/
Aged80
/
Humans
/
Male
Страна как тема:
America do sul
/
Brasil
Язык:
En
Журнал:
Hematol., Transfus. Cell Ther. (Impr.)
Тематика журнала:
Hematologia
/
TransfusÆo de Sangue
Год:
2020
Тип:
Article