Abstract：
BACKGROUND: This prospective observational study evaluated the real-world effectiveness of nivolumab monotherapy in previously treated advanced gastric cancer (GC). A preplanned 2-year final analysis was performed to confirm survival and tumor behavior with nivolumab monotherapy.
METHODS: The primary endpoint was overall survival (OS). The data regarding tumor size were prospectively collected and evaluated using the RECIST criteria. Exploratory analyses were performed for survival according to the tumor response and depth of response (DpR) in patients with measurable lesions who were receiving nivolumab monotherapy as third- or later-line therapy.
RESULTS: In 487 patients, the median OS and progression-free survival (PFS) were 5.8 (95% CI 5.3-6.9) months and 1.8 (95% CI 1.7-2.0) months, respectively. The response rate (RR) was 14.5% in 282 patients with measurable lesions. In 234 patients treated with third- or later-line, the DpR was found to be associated with PFS and OS in the Spearman analysis (r = 0.55 and 0.44, respectively) as well as using a discrete variable. When the DpR was divided into 5 groups (-20%≥DpR; -20%CONCLUSIONS: The final analysis confirmed the efficacy of nivolumab monotherapy for patients with advanced GC in routine clinical practice. The exploratory analysis indicated that increasing DpR was associated with longer median PFS and OS in nivolumab treatment at a later-line setting.
METHODS: The primary endpoint was overall survival (OS). The data regarding tumor size were prospectively collected and evaluated using the RECIST criteria. Exploratory analyses were performed for survival according to the tumor response and depth of response (DpR) in patients with measurable lesions who were receiving nivolumab monotherapy as third- or later-line therapy.
RESULTS: In 487 patients, the median OS and progression-free survival (PFS) were 5.8 (95% CI 5.3-6.9) months and 1.8 (95% CI 1.7-2.0) months, respectively. The response rate (RR) was 14.5% in 282 patients with measurable lesions. In 234 patients treated with third- or later-line, the DpR was found to be associated with PFS and OS in the Spearman analysis (r = 0.55 and 0.44, respectively) as well as using a discrete variable. When the DpR was divided into 5 groups (-20%≥DpR; -20%
摘要：
背景：这项前瞻性观察性研究评估了纳武单抗单药治疗先前治疗的晚期胃癌（GC）的真实世界有效性。进行了预先计划的2年最终分析，以确认使用纳武单抗单一疗法的生存率和肿瘤行为。
方法：主要终点是总生存期（OS）。使用RECIST标准前瞻性地收集和评估关于肿瘤大小的数据。根据患有可测量病变的患者的肿瘤反应和反应深度（DpR）进行了探索性分析，这些患者正在接受纳武单抗单一疗法作为三线或后期疗法。
结果：在487名患者中，中位OS和无进展生存期(PFS)分别为5.8(95%CI5.3-6.9)个月和1.8(95%CI1.7-2.0)个月,分别。282例具有可测量病变的患者的反应率（RR）为14.5％。在234名接受三线或后期治疗的患者中，在Spearman分析(r=0.55和0.44)以及使用离散变量时,发现DpR与PFS和OS相关.当DpR根据肿瘤缩小分为5组(-20%≥DpR;-20%结论：最终分析证实了在常规临床实践中，纳武单抗单药治疗晚期GC患者的疗效。探索性分析表明，在后期的纳武单抗治疗中，DpR的增加与较长的中位PFS和OS相关。
方法：主要终点是总生存期（OS）。使用RECIST标准前瞻性地收集和评估关于肿瘤大小的数据。根据患有可测量病变的患者的肿瘤反应和反应深度（DpR）进行了探索性分析，这些患者正在接受纳武单抗单一疗法作为三线或后期疗法。
结果：在487名患者中，中位OS和无进展生存期(PFS)分别为5.8(95%CI5.3-6.9)个月和1.8(95%CI1.7-2.0)个月,分别。282例具有可测量病变的患者的反应率（RR）为14.5％。在234名接受三线或后期治疗的患者中，在Spearman分析(r=0.55和0.44)以及使用离散变量时,发现DpR与PFS和OS相关.当DpR根据肿瘤缩小分为5组(-20%≥DpR;-20%
