BACKGROUND AND PURPOSE The NVALT-11/DLCRG-02 phase III trial (clinicaltrials.gov identifier: NCT01282437) showed that, after standard curative intent treatment, prophylactic cranial irradiation (PCI) decreased the incidence of symptomatic brain metastases (BM) in stage III non-small cell lung cancer (NSCLC) patients compared to observation. In this study we assessed the impact of PCI on health-related quality of life (HRQoL). In addition, an exploratory analysis was performed to assess the impact of neurocognitive symptoms and symptomatic BM on HRQoL. MATERIALS AND METHODS Stage III NSCLC patients were randomized between PCI and observation. HRQoL was measured using the EuroQol 5D (EQ-5D-3L), EORTC QLQ-C30 and QLQ-BN20 instruments at completion of standard curative intent treatment and 4 weeks, 3, 6, 12, 24 and 36 months thereafter. Generalized linear mixed effects (GLM) models were used to assess the impact of PCI compared to observation over time on three HRQoL metrics: the EORTC QLQ-C30 global health status and the EQ-5D-3L utility and visual analogue scale (EQ VAS) scores. RESULTS In total, 86 and 88 patients were included in the PCI and observation arm, with a median follow-up of 48.5 months (95% CI 39-54 months). Baseline mean HRQoL scores were comparable between the PCI and observation arm for the three HRQoL metrics. In the GLM models, none of the HRQoL metrics were clinically relevant or statistically significantly different between the PCI and the observation arm (p-values ranged between 0.641 and 0.914). CONCLUSION No statistically significant nor a clinically relevant impact of PCI on HRQoL was observed.

中文翻译：

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III 期非小细胞肺癌患者预防性颅脑照射后的健康相关生活质量：来自 NVALT-11/DLCRG-02 III 期研究的结果

背景和目的 NVALT-11/DLCRG-02 III 期试验（clinicaltrials.gov 标识符：NCT01282437）表明，在标准治愈性治疗后，预防性颅脑照射 (PCI) 降低了 III 期症状性脑转移 (BM) 的发生率非小细胞肺癌 (NSCLC) 患者进行比较观察。在本研究中，我们评估了 PCI 对健康相关生活质量 (HRQoL) 的影响。此外，还进行了探索性分析以评估神经认知症状和症状性 BM 对 HRQoL 的影响。材料和方法 III 期 NSCLC 患者在 PCI 和观察之间随机分配。HRQoL 使用 EuroQol 5D (EQ-5D-3L)、EORTC QLQ-C30 和 QLQ-BN20 仪器在完成标准治疗意向治疗时以及之后的 4 周、3、6、12、24 和 36 个月进行测量。广义线性混合效应 (GLM) 模型用于评估 PCI 与随时间的观察相比对三个 HRQoL 指标的影响：EORTC QLQ-C30 全球健康状况和 EQ-5D-3L 效用和视觉模拟量表 (EQ VAS)分数。结果 总共有 86 和 88 名患者被纳入 PCI 和观察组，中位随访时间为 48.5 个月（95% CI 39-54 个月）。对于三个 HRQoL 指标，基线平均 HRQoL 分数在 PCI 和观察组之间具有可比性。在 GLM 模型中，没有一项 HRQoL 指标在 PCI 和观察组之间具有临床相关性或统计学上的显着差异（p 值介于 0.641 和 0.914 之间）。结论 未观察到 PCI 对 HRQoL 的统计学意义或临床相关影响。