OBJECTIVES To evaluate patient-reported outcomes (PROs) from a phase 1/2 study (NCT01970865) in patients with anaplastic lymphoma kinase (ALK)- or ROS1-positive advanced non-small cell lung cancer (NSCLC) treated with lorlatinib 100 mg once daily. MATERIALS AND METHODS PRO measures, including global quality of life (QoL), functioning domains and symptoms, were assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) and the 13-item Lung Cancer (QLQ-LC13) module. Mean changes of absolute scores from baseline were assessed. Percentages of patients showing improvement, stability or worsening on each scale were reported, with a change of ≥10 points considered clinically meaningful (CM). RESULTS 255 patients completed baseline and ≥1 post-baseline PRO assessment. Most patients had CM improvement (42.4 %) or stable (38.0 %) scores for global QoL. Functioning domains with the greatest proportion of patients with improved scores were role (37.6 %) and emotional (36.9 %); only one domain had more patients showing worsening than improving function (cognitive [24.3 % vs 22.4 %]). Most patients showed improved or stable scores for disease-related symptoms. No QLQ-C30 symptom domains had more patients worsening than improving. Symptoms on the QLQ-C30 scale with the greatest proportion of patients with improved scores were fatigue (49.4 %) and insomnia (46.3 %). Four QLQ-LC13 domains had more patients worsening than improving (two most affected were peripheral neuropathy [37.3 % vs 13.7 %] and alopecia [19.2 % vs 13.3 %]). Symptoms on the QLQ-LC13 scale with the greatest proportion of patients with improved scores were cough (42.7 %) and pain in other parts (32.9 %). CONCLUSIONS Lorlatinib treatment showed CM improvement from baseline in global QOL that was maintained over time. Additionally, there were improvements in physical, emotional, social, and role functioning. Improvements were shown in appetite loss and key symptoms such as pain, dyspnea, cough and fatigue; a worsening in peripheral neuropathy was noted.

中文翻译：

---

劳拉替尼对晚期 ALK 阳性或 ROS1 阳性非小细胞肺癌患者报告结局的影响。

目的 评估接受劳拉替尼 100 mg 一次治疗的间变性淋巴瘤激酶 (ALK) 或 ROS1 阳性晚期非小细胞肺癌 (NSCLC) 患者的 1/2 期研究 (NCT01970865) 的患者报告结果 (PROs)日常的。材料和方法 PRO 措施，包括全球生活质量 (QoL)、功能领域和症状，由欧洲癌症研究和治疗组织 (EORTC) 生活质量问卷核心 30 (QLQ-C30) 和 13- item 肺癌 (QLQ-LC13) 模块。评估了相对于基线的绝对分数的平均变化。报告了在每个量表上表现出改善、稳定或恶化的患者百分比，≥10 分的变化被认为具有临床意义 (CM)。结果 255 名患者完成了基线和≥1 次基线后 PRO 评估。大多数患者的 CM 改善 (42.4 %) 或整体 QoL 评分稳定 (38.0 %)。得分提高的患者比例最大的功能领域是角色（37.6 %）和情绪（36.9 %）；只有一个领域出现恶化的患者多于改善功能的患者（认知 [24.3 % vs 22.4 %]）。大多数患者的疾病相关症状评分有所改善或稳定。没有 QLQ-C30 症状域的患者恶化多于改善。在 QLQ-C30 量表中，得分提高的患者比例最高的症状是疲劳 (49.4 %) 和失眠 (46.3 %)。四个 QLQ-LC13 域的患者恶化多于改善（两个受影响最大的是周围神经病变 [37.3 % 对 13.7 %] 和脱发 [19.2 % 对 13.3 %]）。在 QLQ-LC13 量表中，得分提高的患者比例最高的症状是咳嗽（42.7%）和其他部位疼痛（32.9%）。结论 Lorlatinib 治疗显示 CM 在全球 QOL 中较基线有所改善，并且随着时间的推移保持不变。此外，身体、情感、社交和角色功能也有所改善。食欲减退和疼痛、呼吸困难、咳嗽和疲劳等主要症状有所改善；注意到周围神经病变恶化。咳嗽和疲劳；注意到周围神经病变恶化。咳嗽和疲劳；注意到周围神经病变恶化。