Background

There is no large real-world data regarding efficacy and safety of immunotherapy in gastric cancer (GC). Although some tumors can grow rapidly after immunotherapy, the patient proportions and survival outcomes are unclear in GC.

Methods

A multicenter, prospective observational study was performed to evaluate clinical outcomes including survival time, safety, and tumor behavior of nivolumab treatment for patients with advanced GC. Primary endpoint was overall survival (OS), and secondary endpoints included response rate (RR), disease control rate (DCR), progression-free survival (PFS), tumor growth rate (TGR) at first evaluation, and safety.

Results

Of 501 enrolled patients, 487 were evaluable (median age 70 years, 71% male, performance status 0/1/2 [42%/44%/14%], 21% HER2-pos, 42% patients with ascites). Median OS was 5.82 months (95% CI 5.29–7.00) with a 1-year survival rate of 30% and median PFS of 1.84 months (95% CI 1.71–1.97). The DCR was 39.4% and the RR was 14.2% (95% CI 10.3–18.8) in 282 patients with measurable lesions. In 219 patients evaluable for TGR, 20.5% were identified as hyperprogressive disease (HPD). OS from the first evaluation of patients with HPD was shorter compared with non-HPD (HR 1.77, 95% CI 1.25–2.51, P = 0.001), but it was not worse than that of patients with progression and non-HPD (HR 1.05, 95% CI 0.72–1.53, P = 0.8). A multivariate analysis revealed the presence of peritoneal metastasis was a prognostic factor for OS and PFS.

Conclusions

Our real-world data demonstrated the comparable survival time to a previous clinical trial and revealed the frequency and prognosis of patients with HPD in advanced GC treated with nivolumab.

中文翻译：

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nivolumab 在晚期胃癌中的真实疗效：DELIVER 试验 (JACCRO GC-08)

背景

没有关于胃癌 (GC) 免疫疗法的有效性和安全性的大量真实数据。尽管一些肿瘤在免疫治疗后可以快速生长，但 GC 中的患者比例和生存结果尚不清楚。

方法

进行了一项多中心、前瞻性观察研究以评估临床结果，包括晚期 GC 患者纳武单抗治疗的生存时间、安全性和肿瘤行为。主要终点是总生存期 (OS)，次要终点包括缓解率 (RR)、疾病控制率 (DCR)、无进展生存期 (PFS)、首次评估时的肿瘤生长率 (TGR) 和安全性。

结果

在 501 名登记患者中，487 名可评估（中位年龄 70 岁，71% 男性，体能状态 0/1/2 [42%/44%/14%]，21% HER2-pos，42% 腹水患者）。中位 OS 为 5.82 个月（95% CI 5.29–7.00），1 年生存率为 30%，中位 PFS 为 1.84 个月（95% CI 1.71–1.97）。在 282 名具有可测量病变的患者中，DCR 为 39.4%，RR 为 14.2%（95% CI 10.3-18.8）。在 219 名可评估 TGR 的患者中，20.5% 被确定为过度进展性疾病 (HPD)。与非 HPD 患者相比，首次评估 HPD 患者的 OS 较短（HR 1.77，95% CI 1.25-2.51，P  = 0.001），但并不比进展和非 HPD 患者差（HR 1.05 , 95% CI 0.72–1.53, P = 0.8）。多变量分析显示腹膜转移的存在是 OS 和 PFS 的预后因素。

结论

我们的真实世界数据证明了与之前的临床试验相当的生存时间，并揭示了接受纳武单抗治疗的晚期 GC 中 HPD 患者的频率和预后。