■在ORIENT-15研究中,在晚期食管鳞状细胞癌(ESCC)的一线治疗中,与安慰剂+化疗相比,sintilimab+化疗对总生存期(OS)有显著改善.这里,我们报告sintilimab联合化疗对晚期ESCC患者健康相关生活质量(HRQoL)的影响.
■从2018年12月14日至2022年8月28日,使用欧洲癌症研究与治疗组织(EORTC)生活质量问卷核心30项(QLQ-C30)对所有随机患者进行了HRQoL评估。EORTC生活质量问卷食管癌模块18项(QLQ-OES18),和EuroQol五维五级问卷(EQ-5D-5L)的视觉模拟量表(VAS)。每个量表的平均得分由治疗组描述至第60周。使用混合模型重复测量方法分析从基线到第24周的最小二乘均值(LSM)评分变化。估计每个量表的首次出现恶化的时间(TTD)和OS。临床试验注册:NCT03748134。
■截至2022年8月28日,690名入选患者中的689名进行了HRQoL分析(sintilimab组:340,安慰剂组:349)。中位随访时间为32.2个月。在QLQ-C30社会功能方面,LSM优于安慰剂(LSM差异:3.06,95%CI:0.55至5.57;P=0.0170),疼痛(-2.24,95%CI:-4.30至-0.17;P=0.0337),疲劳(-2.24,95%CI:-4.46至-0.02;P=0.0479),便秘(-3.27,95%CI-5.49至-1.05;P=0.0039),QLQ-OES18疼痛(-1.77,95%CI-3.11至-0.43;P=0.0097),吞咽困难唾液(-2.09,95%CI:-3.77至-0.42;P=0.0146),吞咽时窒息(-3.23,95%CI:-5.60至-0.86;P=0.0076)。对于QLQ-OES18吞咽困难,TTD比安慰剂更喜欢sintilimab(危害比[HR]:0.76,95%CI:0.61-0.94,P=0.0104),和吞咽困难唾液(HR:0.48,95%CI:0.35-0.67,P<0.0001)。在QLQ-C30和QLQ-QES18的几种功能和症状量表中表现更好的患者中,观察到OS改善。
■在我们的研究中观察到的几种HRQoL量表和延迟恶化改善的统计学显着差异进一步支持使用sintilimab加化疗作为晚期ESCC的一线治疗。
■这项研究由InnoventBiologics资助,并由礼来公司共同资助。
UNASSIGNED: In ORIENT-15 study, sintilimab plus chemotherapy demonstrated significant improvement on overall survival (OS) versus placebo plus chemotherapy in first-line treatment of advanced esophageal squamous cell carcinoma (ESCC). Here, we report effect of sintilimab plus chemotherapy on health-related quality of life (HRQoL) in patients with advanced ESCC.
UNASSIGNED: From December 14, 2018 to August 28, 2022, HRQoL was evaluated in all randomized patients using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 items (QLQ-C30), EORTC Quality of Life Questionnaire Oesophageal Cancer Module 18 items (QLQ-OES18), and visual analogue scale (VAS) of the EuroQol five-dimensional five-level questionnaire (EQ-5D-5L). Mean scores of each scale were described by treatment group through week 60. Least-squares mean (LSM) score change from baseline through week 24 were analyzed using the mixed-model repeated-measures method. Time to the first onset of deterioration (TTD) and OS for each scale were estimated. Clinical Trials Registration: NCT03748134.
UNASSIGNED: As of August 28, 2022, 689 of 690 enrolled patients were assessed for HRQoL analysis (sintilimab group: 340, placebo group: 349). Median follow-up was 32.2 months. Differences in LSM favored sintilimab over placebo for QLQ-C30 social functioning (LSM difference: 3.06, 95% CI: 0.55 to 5.57; P = 0.0170), pain (-2.24, 95% CI: -4.30 to -0.17; P = 0.0337), fatigue (-2.24, 95% CI: -4.46 to -0.02; P = 0.0479), constipation (-3.27, 95% CI -5.49 to -1.05; P = 0.0039), QLQ-OES18 pain (-1.77, 95% CI -3.11 to -0.43; P = 0.0097), trouble swallowing saliva (-2.09, 95% CI: -3.77 to -0.42; P = 0.0146), and choked when swallowing (-3.23, 95% CI: -5.60 to -0.86; P = 0.0076). TTD favored sintilimab over placebo for QLQ-OES18 dysphagia (Hazard ratio [HR]: 0.76, 95% CI: 0.61-0.94, P = 0.0104), and trouble swallowing saliva (HR: 0.48, 95% CI: 0.35-0.67, P < 0.0001). Improved OS were observed in patients with better performance in several functioning and symptom scales of QLQ-C30 and QLQ-QES18.
UNASSIGNED: The statistically significant differences of several HRQoL scales and improvements in delayed deterioration observed in our study further support the use of sintilimab plus chemotherapy as first-line treatment for advanced ESCC.
UNASSIGNED: This study was funded by Innovent Biologics and was co-funded by Eli Lilly.