Passamonti Francesco, Korgaonkar Siddhi, Parikh Rohan C, Chevli Manoj, Yucel Aylin, Rombi Julien, Jones Shalon, Zissler Dorothy, Davis Keith L, Slaff Samantha
Università degli Studi di Milano, Milan, Italy.
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Future Oncol. 2025 Feb;21(5):579-591. doi: 10.1080/14796694.2025.2454895. Epub 2025 Jan 26.
Assess real-world fedratinib (FEDR) treatment patterns and clinical outcomes in patients with primary or secondary myelofibrosis following discontinuation of ruxolitinib (RUX).
PATIENTS & METHODS: This study was a retrospective, noninterventional medical record review of patients in Canada, Germany, and the United Kingdom (UK). A total of 70 physicians (primarily hematologist-oncologists [78.6%]) provided data for 196 eligible patients.
Patients were mostly male (62.8%) with primary myelofibrosis (76.5%) and initiated FEDR at a mean age of 67.7 years. Median treatment duration was 11.5 months (median follow-up, 13.8 months), and nearly half (49.5%) of patients initiated FEDR at the label-indicated dose of 400 mg daily. Six months post-initiation, 77.7% and 66.8% of patients experienced symptom and spleen response, respectively. Kaplan-Meier estimates of median progression-free and overall survival from initiation were 23.8 months (95% CI, 21.1-27.6) and 29.8 months (95% CI, 23.9-NE), respectively.
These findings demonstrate real-world FEDR effectiveness among patients with myelofibrosis who discontinued RUX.
评估原发性或继发性骨髓纤维化患者停用芦可替尼(RUX)后使用fedratinib(FEDR)的真实世界治疗模式和临床结局。
本研究是对加拿大、德国和英国患者进行的一项回顾性、非干预性病历审查。共有70名医生(主要是血液肿瘤学家[78.6%])为196名符合条件的患者提供了数据。
患者大多为男性(62.8%),患有原发性骨髓纤维化(76.5%),开始使用FEDR时的平均年龄为67.7岁。中位治疗持续时间为11.5个月(中位随访时间为13.8个月),近一半(49.5%)的患者开始使用FEDR时的剂量为标签所示的每日400毫克。开始治疗6个月后,分别有77.7%和66.8%的患者出现症状缓解和脾脏反应。从开始治疗起,无进展生存期和总生存期的Kaplan-Meier估计值分别为23.8个月(95%CI,21.1 - 27.6)和29.8个月(95%CI,23.9 - 未达到)。
这些发现证明了在停用RUX的骨髓纤维化患者中,FEDR在真实世界中的有效性。