Progression-free survival: An important end point in evaluating therapy for recurrent high-grade gliomas
Progression-free survival: An important end point in evaluating therapy for recurrent high-grade gliomas
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DOI：
10.1215/15228517-2007-062
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发表时间：
2008-04-01
期刊：
影响因子：
15.9
通讯作者：
Prados, Michael D.
中科院分区：
文献类型：
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作者：
Lamborn, Kathleen R.;Yung, W. K. Alfred;Prados, Michael D.
北美脑肿瘤联盟 (NABTC) 使用 6 个月无进展生存期 (6moPFS) 作为复发性高级别胶质瘤成人患者治疗试验的疗效终点。在这项研究中，我们调查了 6 个月时的进展状态是否可以预测从那时起的生存率，这意味着如果可以延迟进展，则有可能延长生存期。我们还评估了较早的时间点，以确定进展评估的时间是否会改变预测的强度。数据来自 1998 年 2 月至 2002 年 12 月期间 NABTC II 期方案中登记的 596 名患者（159 名患者患有 III 级胶质瘤，437 名患者患有 IV 级肿瘤）。使用 Kaplan-Meier 曲线和 Cox 比例风险模型对结果进行统计评估。 III 级和 IV 级肿瘤患者的中位生存期分别为 39 周和 30 周。 28% 的 III 级肿瘤患者和 16% 的 IV 级肿瘤患者的无进展生存期>26 周。第 9、18 和 26 周时的进展状态可预测 III 级或 IV 级肿瘤患者的生存期（所有病例中 p < 0.001，风险比 < 0.5）。包括 KPS、年龄、既往化疗次数和多变量模型中的反应在内，并未对结果产生实质性改变。 6 个月时的进展状态是生存的有力预测因子，6moPFS 是复发性恶性神经胶质瘤治疗试验的有效终点。对进展状态的早期评估也可以预测生存率，并可能纳入未来临床试验的设计中。
The North American Brain Tumor Consortium (NABTC) uses 6-month progression-free survival (6moPFS) as the efficacy end point of therapy trials for adult patients with recurrent high-grade gliomas. In this study, we investigated whether progression status at 6 months predicts survival from that time, implying the potential for prolonged survival if progression could be delayed. We also evaluated earlier time points to determine whether the time of progression assessment alters the strength of the prediction. Data were from 596 patient enrollments (159 with grade III gliomas and 437 with grade IV tumors) in NABTC phase II protocols between February 1998 and December 2002. Outcome was assessed statistically using Kaplan-Meier curves and Cox proportional hazards models. Median survivals were 39 and 30 weeks for patients with grade III and grade IV tumors, respectively. Twenty-eight percent of patients with grade III and 16% of patients with grade IV tumors had progression-free survival of >26 weeks. Progression status at 9, 18, and 26 weeks predicted survival from those times for patients with grade III or grade IV tumors (p < 0.001 and hazard ratios < 0.5 in all cases). Including KPS, age, number of prior chemotherapies, and response in a multivariate model did not substantively change the results. Progression status at 6 months is a strong predictor of survival, and 6moPFS is a valid end point for trials of therapy for recurrent malignant glioma. Earlier assessments of progression status also predicted survival and may be incorporated in the design of future clinical trials.