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In the Phase 3 PhALLCON trial (NCT03589326), ponatinib demonstrated superior efficacy and comparable safety profile versus imatinib in adults with newly diagnosed Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL).
在第三阶段PhALLCON试验(NCT03589326)中,ponatinib在新诊断的费城染色体阳性(Ph+)急性淋巴细胞白血病(ALL)成人患者中显示出优于伊马替尼的疗效和相当的安全性。
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Here we report patient-reported outcomes (PRO) from PhALLCON assessed as exploratory endpoints using the Functional Assessment of Cancer Therapy-Leukemia (FACT-Leu) and EQ-5D-5L .
在这里,我们报告了使用癌症治疗功能评估-白血病(FACT-Leu)和EQ-5D-5L评估的PhALLCON试验中的患者报告结果(PRO),作为探索性终点。
Primary PRO domains included FACT-G physical well-being , FACT-Leu subscale (FACT-LeuS), Trial Outcome Index (TOI), FACT-Leu total score , FACT-G total score , and EQ-5D visual analogue scale .
主要的患者报告结果(PRO)领域包括功能性评估癌症治疗-一般(FACT-G)身体福祉、白血病特定子量表(FACT-LeuS)、试验结果指数(TOI)、FACT-Leu总分、FACT-G总分以及欧洲五维健康量表(EQ-5D)视觉模拟量表。
Differences in least-squares mean score changes from baseline to the end of induction (EOI)/consolidation (EOC) and time to confirmed improvement/deterioration were analyzed .
分析了从基线到诱导治疗结束(EOI)/巩固治疗结束(EOC)的最小二乘平均分数变化差异,以及确认改善或恶化的时长。
Overall treatment tolerability was assessed using the FACT-GP5 .
使用FACT-GP5评估了整体治疗的耐受性。
Analyses included 238 patients (ponatinib 159, imatinib 79) with ≥1 PRO assessment .
分析包括了238名患者(ponatinib 159名,imatinib 79名),这些患者至少进行了1次患者报告结果(PRO)评估。
Least-squares mean changes from baseline favored ponatinib , with significant and meaningful differences in FACT-LeuS , TOI , and FACT-Leu total score at EOI and across the primary domains except for FACT-LeuS at EOC .
从基线开始的最小二乘平均变化更倾向于Ponatinib,在终点评估时,FACT-LeuS、TOI和FACT-Leu总分显示出显著且有意义的差异,并且在主要领域中也是如此,除了终点评估时的FACT-LeuS。
Median time to confirmed improvement was shorter with ponatinib versus imatinib for key measures .
与伊马替尼相比,Ponatinib的关键指标确认改善的中位时间更短。
Ponatinib-treated patients tended to report being less bothered by treatment side effects as assessed by FACT-GP5 .
根据FACT-GP5评估,接受Ponatinib治疗的患者倾向于报告较少受到治疗副作用的困扰。
These findings highlight ponatinib's potentially favorable impact on health-related quality of life , supporting its use as frontline treatment for Ph+ ALL .
这些发现突显了Ponatinib对健康相关生活质量可能产生的有利影响,支持将其作为Ph+ ALL的一线治疗药物。
本文献翻译由 AI 辅助生成,仅供文献精读与英语学习参考。临床决策请以 PubMed / PMC 原文为准。
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