Event-Free Survival at 24 Months Is a Robust End Point for Disease-Related Outcome in Diffuse Large B-Cell Lymphoma Treated With Immunochemotherapy
Event-Free Survival at 24 Months Is a Robust End Point for Disease-Related Outcome in Diffuse Large B-Cell Lymphoma Treated With Immunochemotherapy
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DOI：
10.1200/jco.2013.51.5866
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发表时间：
2014-04-01
影响因子：
45.3
通讯作者：
Cerhan, James R.
中科院分区：
文献类型：
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作者：
Maurer, Matthew J.;Ghesquieres, Herve;Cerhan, James R.
目的 弥漫性大 B 细胞淋巴瘤 (DLBCL) 的研究通常使用事件发生时间方法进行评估，通常将复发、再治疗和死亡作为事件。我们评估了新诊断的 DLBCL 事件的发生时间和类型，并将患者结果与参考人群数据进行比较。 患者和方法 接受免疫化疗治疗的新诊断 DLBCL 患者前瞻性地参加 2002 年至 2009 年爱荷华大学/梅奥诊所分子流行病学资源卓越研究专业计划 (MER) 和北中心癌症治疗组 NCCTG-N0489 临床试验。 在诊断时以及诊断后 12 个月 (EFS12) 和 24 个月 (EFS24) 达到无事件状态的患者亚组中评估结果。将总生存率与年龄和性别匹配的人群数据进行比较。结果在来自成人淋巴瘤研究组 (GELA) Lymphome Non Hodgkinien 2003 (LNH2003) 计划和法国里昂登记处的外部验证队列中得到复制。 结果 总共有 767 名新诊断的 DLBCL 患者入组，其中中位年龄为 63 岁。 MER 和 NCCTG 研究。在中位随访 60 个月（范围为 8 至 116 个月）时，299 名患者发生事件，210 名患者死亡。达到 EFS24 的患者的总生存期与年龄和性别匹配的一般人群相当（标准化死亡率 [SMR]，1.18；P = .25）。这一结果在里昂 GELA 研究和登记的 820 名患者中得到证实（SMR，1.09；P = .71）。模拟研究表明，在评估 DLBCL 临床试验时，EFS24 具有与连续 EFS 相当的功效。 结论 达到 EFS24 的 DLBCL 患者随后的总生存期与年龄和性别匹配的一般人群相当。 EFS24 将有助于患者咨询，并应被视为未来新诊断 DLBCL 研究的终点。
Purpose Studies of diffuse large B-cell lymphoma (DLBCL) are typically evaluated by using a time-to-event approach with relapse, re-treatment, and death commonly used as the events. We evaluated the timing and type of events in newly diagnosed DLBCL and compared patient outcome with reference population data.Patients and Methods Patients with newly diagnosed DLBCL treated with immunochemotherapy were prospectively enrolled onto the University of Iowa/Mayo Clinic Specialized Program of Research Excellence Molecular Epidemiology Resource (MER) and the North Central Cancer Treatment Group NCCTG-N0489 clinical trial from 2002 to 2009. Patient outcomes were evaluated at diagnosis and in the subsets of patients achieving event-free status at 12 months (EFS12) and 24 months (EFS24) from diagnosis. Overall survival was compared with age- and sex-matched population data. Results were replicated in an external validation cohort from the Groupe d'Etude des Lymphomes de l'Adulte (GELA) Lymphome Non Hodgkinien 2003 (LNH2003) program and a registry based in Lyon, France.Results In all, 767 patients with newly diagnosed DLBCL who had a median age of 63 years were enrolled onto the MER and NCCTG studies. At a median follow-up of 60 months (range, 8 to 116 months), 299 patients had an event and 210 patients had died. Patients achieving EFS24 had an overall survival equivalent to that of the age- and sex-matched general population (standardized mortality ratio [SMR], 1.18; P = .25). This result was confirmed in 820 patients from the GELA study and registry in Lyon (SMR, 1.09; P = .71). Simulation studies showed that EFS24 has comparable power to continuous EFS when evaluating clinical trials in DLBCL.Conclusion Patients with DLBCL who achieve EFS24 have a subsequent overall survival equivalent to that of the age- and sex-matched general population. EFS24 will be useful in patient counseling and should be considered as an end point for future studies of newly diagnosed DLBCL.