Introduction: The LenaMain trial (NCT00891384) reported increased progression-free survival with 25 mg of lenalidomide maintenance compared to 5 mg. Here, we report the patient-reported outcomes. Materials and Methods: Scores obtained from the EORTC Quality of Life Questionnaire C30 were analyzed for longitudinal changes from baseline within the groups as well as cross-sectional scores. Results: Compliance rates were high, with 95.7% at baseline and 70% during maintenance. At study entry, scores were high for functioning and low for symptoms. During maintenance, the median global health status/quality of life (GHS/QoL) was constant, without significant differences over time (median GHS/QoL: 68 at baseline and 58 for Len high and 68 for Len low at 2 years) and between treatment arms (mean change < 2). Similarly, most functional scale domains were constant. Notably, diarrhea increased consistently for both treatment arms (baseline: −1.905 (range: −5.78–1.97); end of year 2: 16.071 (range: 5.72–26.42);p< 0.05). The subgroup analysis showed that neither disease activity, duration of treatment, nor adverse events affected the health-related quality of life (HR-QoL) or utility. Conclusion: High baseline scores were maintained throughout the trial without significant differences between the Len dosages, which supports continuous treatment with a dose tailored to patients’ HR-QoL.
引言：LenaMain试验（NCT00891384）报告显示，与5 mg剂量相比，25 mg来那度胺维持治疗可延长无进展生存期。本文报告患者报告结局结果。材料与方法：通过分析欧洲癌症研究与治疗组织生活质量问卷C30的评分，评估组内从基线的纵向变化及横向评分。结果：问卷依从率较高，基线时为95.7%，维持治疗期间为70%。研究开始时，功能维度评分较高，症状维度评分较低。维持治疗期间，总体健康状况/生活质量（GHS/QoL）中位数保持稳定，随时间推移（基线GHS/QoL中位数：68；2年时高剂量组58，低剂量组68）及治疗组间（平均变化<2）均无显著差异。多数功能量表领域同样保持稳定。值得注意的是，两组患者的腹泻症状均持续加重（基线：-1.905（范围：-5.78–1.97）；第2年末：16.071（范围：5.72–26.42）；p<0.05）。亚组分析显示，疾病活动度、治疗持续时间及不良事件均未影响健康相关生活质量（HR-QoL）或效用值。结论：试验全程保持较高的基线评分，不同来那度胺剂量组间无显著差异，这支持根据患者HR-QoL个体化调整剂量进行持续治疗。
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