Department of Thoracic Medical Oncology, Lung Cancer Diagnosis and Treatment Centre, Key Laboratory of Cancer Prevention and Therapy, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Centre for Cancer, Tianjin, China.
Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai, China.
Cancer Med. 2023 Aug;12(16):17403-17412. doi: 10.1002/cam4.6361. Epub 2023 Aug 17.
This study examined the health-related quality of life (HRQoL) of patients with advanced non-small cell lung cancer (NSCLC) receiving tislelizumab versus docetaxel in the open-label, multicenter, Phase 3 trial called RATIONALE-303 (NCT03358875). HRQoL was assessed with the EORTC QLQ-C30, EORTC QLQ-LC13, and the EQ-5D-5L instruments. A longitudinal analysis of covariance assessed the change from baseline to Week 12 and from baseline to Week 18. A time to deterioration analysis was also performed using the Kaplan-Meier method. Eight hundred and five patients were randomized to either tislelizumab (n = 535) or docetaxel, respectively (535 and 270 to tislelizumab and docetaxel, respectively). The tislelizumab arm improved while the docetaxel arm worsened in the QLQ-C30 global health status/QoL scale score (difference LS mean change Week 18: 5.7 [95% CI: 2.38, 9.07, p = 0.0008]), fatigue (Week 12: -3.2 [95% CI: -5.95, -0.37, p < 0.0266]; Week 18: -4.9 [95% CI: -8.26, -1.61, p = 0.0037]), and QLQ-LC13 symptom index score (Week 12: -5.5 [95% CI: -6.93, -4.04, P < 0.0001]; Week 18: -6.6 [95% CI: -8.25, -4.95, p < 0.0001]). The tislelizumab arm had improvements in coughing versus the docetaxel arm (Week 12: -4.7 [95% CI: -8.57, -0.78, p = 0.0188]; Week 18: -8.3 [95% CI: -13.02, -3.51, p = 0.0007]). The patients who received tislelizumab were less at risk for clinically meaningful worsening in the overall lung cancer symptom index scale (hazard ratio (HR): 0.24 [95% CI: 0.162, 0.356], p < 0.0001), dyspnea (HR: 0.74 [95% CI: 0.567, 0.958], p = 0.0109), coughing (HR: 0.74 [95% CI: 0.534, 1.019], p = 0.0309), and peripheral neuropathy (HR: 0.55 [95% CI: 0.370, 0.810] p = 0.0011). In general, tislelizumab versus docetaxel was associated with improved HRQoL and symptoms of lung cancer in patients who previously failed treatment with platinum-containing chemotherapy.
这项研究考察了tislelizumab 与多西他赛相比，用于晚期非小细胞肺癌（NSCLC）患者的健康相关生活质量（HRQoL），这是一项开放标签、多中心的 3 期试验，称为 RATIONALE-303（NCT03358875）。HRQoL 通过 EORTC QLQ-C30、EORTC QLQ-LC13 和 EQ-5D-5L 工具进行评估。协方差的纵向分析评估了从基线到第 12 周和从基线到第 18 周的变化。还使用 Kaplan-Meier 方法进行了恶化时间分析。805 名患者被随机分配至 tislelizumab（n = 535）或多西他赛组（分别为 535 名和 270 名患者接受 tislelizumab 和多西他赛治疗）。与多西他赛组相比，tislelizumab 组在 QLQ-C30 全球健康状况/生活质量量表评分（第 18 周 LS 均值差异变化：5.7[95%CI：2.38，9.07，p=0.0008]）、疲劳（第 12 周：-3.2[95%CI：-5.95，-0.37，p<0.0266]；第 18 周：-4.9[95%CI：-8.26，-1.61，p=0.0037]）和 QLQ-LC13 症状指数评分（第 12 周：-5.5[95%CI：-6.93，-4.04，P<0.0001]；第 18 周：-6.6[95%CI：-8.25，-4.95，p<0.0001]）方面均有所改善。与多西他赛组相比，tislelizumab 组咳嗽症状改善（第 12 周：-4.7[95%CI：-8.57，-0.78，p=0.0188]；第 18 周：-8.3[95%CI：-13.02，-3.51，p=0.0007]）。与多西他赛相比，接受 tislelizumab 治疗的患者在整体肺癌症状指数量表（风险比（HR）：0.24[95%CI：0.162，0.356]，p<0.0001）、呼吸困难（HR：0.74[95%CI：0.567，0.958]，p=0.0109）、咳嗽（HR：0.74[95%CI：0.534，1.019]，p=0.0309）和周围神经病变（HR：0.55[95%CI：0.370，0.810]，p=0.0011）恶化方面的风险较低。总体而言，与多西他赛相比，tislelizumab 可改善铂类化疗失败的晚期非小细胞肺癌患者的 HRQoL 和肺癌症状。
