PDF(Pubmed)
Abstract：
This study examined the real-world use of nivolumab in patients with recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN). This was a multinational retrospective study (VOLUME) assessing treatment effectiveness and safety outcomes and a prospective study (VOLUME-PRO) assessing HRQoL and patient-reported symptoms. There were 447 and 51 patients in VOLUME and VOLUME-PRO, respectively. Across both studies, the median age was 64.0 years, 80.9% were male, and 52.6% were former smokers. Clinical outcomes of interest included real-world overall survival (rwOS) and real-world progression-free survival (rwPFS). The median rwOS was 9.2 months. Among patients with at least one assessment, 21.7% reported their best response as \'partial response\', with 3.9% reporting \'complete response\'. The median duration of response (DoR) and median rwPFS were 11.0 months and 3.9 months, respectively. At baseline, VOLUME-PRO patients reported difficulties relating to fatigue, physical and sexual functioning, dyspnea, nausea, sticky saliva, dry mouth, pain/discomfort, mobility, and financial difficulties. There were improvements in social functioning and financial difficulties throughout the study; however, no other clinically meaningful changes were noted. No new safety concerns were identified. This real-world, multinational, multicenter, retrospective and prospective study supports the effectiveness and safety of nivolumab for R/M SCCHN patients.
摘要：
这项研究检查了nivolumab在头颈部复发性/转移性鳞状细胞癌（R/MSCCHN）患者中的实际使用情况。这是一项评估治疗有效性和安全性结果的跨国回顾性研究（VOLUME）和一项评估HRQoL和患者报告症状的前瞻性研究（VOLUME-PRO）。在VOLUME和VOLUME-PRO中有447和51名患者，分别。在这两项研究中，中位年龄为64.0岁,80.9%为男性，52.6%曾吸烟。感兴趣的临床结果包括真实世界总生存期(rwOS)和真实世界无进展生存期(rwPFS)。rwOS中位数为9.2个月。在至少有一项评估的患者中，21.7%报告他们的最佳反应为“部分反应”，3.9%报告“完成响应”。中位反应持续时间（DoR）和中位rwPFS分别为11.0个月和3.9个月，分别。在基线,VOLUME-PRO患者报告了与疲劳有关的困难，身体和性功能，呼吸困难,恶心,粘稠的唾液,口干,疼痛/不适，移动性,和财政困难。在整个研究过程中，社会功能和财政困难有所改善；然而，未发现其他有临床意义的变化.没有发现新的安全问题。这个现实世界,跨国公司,多中心，回顾性和前瞻性研究支持nivolumab对R/MSCCHN患者的有效性和安全性.
