Department of Pharmacy, Gifu University Hospital, Gifu, Japan
Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.
Anticancer Res. 2020 Dec;40(12):7067-7075. doi: 10.21873/anticanres.14734.
BACKGROUND/AIM: Nivolumab is effective against advanced gastric cancer (AGC) refractory to or in patients intolerant of standard chemotherapy. This study was designed to clarify the impact of cancer cachexia in patients with AGC who received nivolumab.
We recruited AGC patients who were treated with nivolumab from October 2017 to December 2019. Clinical outcomes were compared between patients with and without cancer cachexia at the start of nivolumab. Cancer cachexia was defined as weight loss >5%; weight loss >2% and body mass index (BMI) <20; or sarcopenia and BMI <20. Primary endpoints were median overall survival (OS) and median time to treatment failure (TTF), while secondary endpoints were overall response rate (ORR) and incidence of adverse events.
The study enrolled 44 patients. Median OS and TTF were significantly shorter in patients with cancer cachexia than in those without cancer cachexia (OS: 6.6 vs. 2.3 months; HR=2.65; 95%CI=1.28-5.49; p=0.008, TTF: 2.6 vs. 1.9 months; HR=2.17; 95%CI=1.09-4.32, p=0.027). On Cox proportional hazards analysis, cancer cachexia was significantly associated with shorter OS. The incidence of adverse events did not differ between the two groups. Nivolumab was associated with better OS and TTF outcomes in AGC patients without cachexia than in those with cachexia, albeit there was no difference in the incidence of adverse events.
Cancer cachexia may be associated with worse clinical outcomes in patients with AGC treated with nivolumab.
背景/目的:纳武利尤单抗对标准化疗耐药或不耐受的晚期胃癌(AGC)有效。本研究旨在阐明纳武利尤单抗治疗的 AGC 患者中癌症恶病质的影响。
我们招募了 2017 年 10 月至 2019 年 12 月接受纳武利尤单抗治疗的 AGC 患者。比较纳武利尤单抗起始时存在和不存在癌症恶病质的患者的临床结局。癌症恶病质定义为体重减轻>5%;体重减轻>2%且 BMI<20;或肌少症和 BMI<20。主要终点为中位总生存期(OS)和中位无进展生存期(TTF),次要终点为总缓解率(ORR)和不良事件发生率。
该研究纳入了 44 例患者。与无癌症恶病质的患者相比,有癌症恶病质的患者的中位 OS 和 TTF 明显更短(OS:6.6 与 2.3 个月;HR=2.65;95%CI=1.28-5.49;p=0.008,TTF:2.6 与 1.9 个月;HR=2.17;95%CI=1.09-4.32,p=0.027)。在 Cox 比例风险分析中,癌症恶病质与较短的 OS 显著相关。两组不良事件发生率无差异。纳武利尤单抗在无恶病质的 AGC 患者中的 OS 和 TTF 结局优于有恶病质的患者,尽管不良事件发生率无差异。
癌症恶病质可能与纳武利尤单抗治疗的 AGC 患者的临床结局更差相关。