Chaitra Ujjani, Anthony Mato, Brian T Hill, John N Allan, Frederick Lansigan, Ryan Jacobs, Alan Skarbnik, Hande Tuncer, John Pagel, Danielle Brander, Bruce Cheson, Paul Barr, Lindsey E Roeker, Jeffrey Pu, Nirav N Shah, Andre Goy, Stephen J Schuster, Nicole Lamanna, Alison Sehgal, Constantine S Tam, Mazyar Shadman
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引用次数: 6
摘要
最近的随机试验已经证明了以依鲁替尼为基础的治疗CLL患者的有效性。在联盟A041202中,与ECOG 1912相比,在65岁以上的患者群体中,前线伊鲁替尼报告的不明原因死亡人数高于预期,其中包括70岁以下的患者。方法:因此,我们进行了一项回顾性分析,以调查伊鲁替尼是否与临床试验环境外老年患者更高的死亡率相关。研究者在20个学术和社区实践中进行了多中心分析。结果:在纳入的391例患者中,年龄与缓解率、PFS或OS之间没有相关性。然而,65岁以上患者的死亡率有更高的趋势(8.7% vs 3.8%, p=0.097),早期死亡人数增加(13 vs 4, p=0.3)。结论:这些数据表明伊鲁替尼在老年人群中有更大的不耐受和可能的死亡率。应告知患者有关伊鲁替尼的潜在并发症和需要报告的症状。
The Impact of Age on Survival in CLL Patients Receiving Ibrutinib as Initial Therapy.
Introduction: Recent randomized trials have demonstrated the efficacy of ibrutinib-based therapy in the treatment of patients with CLL. In Alliance A041202, a higher than expected number of unexplained deaths were reported with front-line ibrutinib in a patient population aged at least 65 years compared to ECOG 1912, which included patients up to 70 years of age.
Methods: Therefore, we conducted a retrospective analysis to investigate whether ibrutinib was associated with a greater mortality in older patients outside of a clinical trial setting. This multicenter analysis was performed by investigators at 20 academic and community practices.
Results: Amongst the 391 patients included, there was no correlation between age and response rate, PFS, or OS. However, there was a trend to higher rate of deaths in patients >65-years-old (8.7% vs 3.8%, p=0.097), with an increased number of early deaths (13 vs 4, p=0.3).
Conclusion: These data suggest greater intolerance, and possibly mortality, with ibrutinib in an older population. Patients should be educated regarding the potential complications related to ibrutinib and symptoms of concern to report.
期刊介绍:
Blood and Lymphatic Cancer: Targets and Therapy is an international, peer reviewed, open access journal focusing on blood and lymphatic cancer research, identification of therapeutic targets, and the optimal use of preventative and integrated treatment interventions to achieve improved outcomes, enhanced survival, and quality of life for the cancer patient. Specific topics covered in the journal include: Epidemiology, detection and screening Cellular research and biomarkers Identification of biotargets and agents with novel mechanisms of action Optimal clinical use of existing anticancer agents, including combination therapies Radiation, surgery, bone marrow transplantation Palliative care Patient adherence, quality of life, satisfaction Health economic evaluations.