帕博利珠单抗单药治疗晚期胃癌或胃食管结合部癌日本患者的疗效。
Efficacy of Pembrolizumab Monotherapy in Japanese Patients with Advanced Gastric or Gastroesophageal Junction Cancer.
机构信息
Department of Clinical Oncology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusaku, Nagoya, 464-8681, Japan.
Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
出版信息
J Gastrointest Cancer. 2023 Sep;54(3):951-961. doi: 10.1007/s12029-023-00920-9. Epub 2023 Apr 10.
PURPOSE
Pembrolizumab demonstrated antitumor activity in programmed death ligand 1 positive (combined positive score (CPS) ≥ 1) gastric/gastroesophageal junction cancer in KEYNOTE-059 (third line or beyond), KEYNOTE-061 (second line), and KEYNOTE-062 (first line). We characterized efficacy and safety of pembrolizumab monotherapy in Japanese patients across several lines of therapy in these studies.
METHODS
This analysis was conducted in 34 patients from KEYNOTE-059 cohort 1 (all pembrolizumab), including 13 patients with CPS ≥ 1, 65 patients with CPS ≥ 1 from KEYNOTE-061 (pembrolizumab, n = 27; chemotherapy, n = 38), and 70 patients with CPS ≥ 1 from KEYNOTE-062 (pembrolizumab, n = 38; chemotherapy, n = 32). Overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and safety were evaluated.
RESULTS
In KEYNOTE-059, ORR with pembrolizumab was 9%, median PFS was 2 months, and median OS was 10 months. In KEYNOTE-061, median OS was 12 months with pembrolizumab versus 10 months with chemotherapy (hazard ratio (HR), 0.67; 95% confidence interval (CI), 0.39-1.15). Median PFS (pembrolizumab vs. chemotherapy) was 2 months versus 4 months (HR, 1.21; 95% CI, 0.69-2.13); ORR was 7% versus 18%. In KEYNOTE-062, median OS was 20 months with pembrolizumab versus 18 months with chemotherapy (HR, 0.76; 95% CI, 0.43-1.33). Median PFS (pembrolizumab vs. chemotherapy) was 6 months versus 7 months (HR, 1.03; 95% CI, 0.61-1.74); ORR was 29% versus 34%.
CONCLUSIONS
The current analysis provides valuable information that anti-PD-1 therapies are worthy of further assessment for gastric cancer.
TRIAL REGISTRATION
ClinicalTrials.gov: NCT02335411 (KEYNOTE-059), NCT02370498 (KEYNOTE-061), and NCT02494583 (KEYNOTE-062).
目的
帕博利珠单抗在 KEYNOTE-059（三线或以上）、KEYNOTE-061（二线）和 KEYNOTE-062（一线）研究中显示出程序性死亡配体 1 阳性（综合阳性评分（CPS）≥1）胃癌/胃食管交界处癌的抗肿瘤活性。我们描述了在这些研究中来自 KEYNOTE-059 队列 1（所有帕博利珠单抗）的多种治疗线的日本患者中使用帕博利珠单抗单药治疗的疗效和安全性。
方法
本分析纳入了来自 KEYNOTE-059 队列 1 的 34 例患者（均接受帕博利珠单抗治疗），其中包括 13 例 CPS≥1 的患者，65 例 CPS≥1 的患者来自 KEYNOTE-061（帕博利珠单抗，n=27；化疗，n=38），70 例 CPS≥1 的患者来自 KEYNOTE-062（帕博利珠单抗，n=38；化疗，n=32）。评估了总生存期（OS）、无进展生存期（PFS）、客观缓解率（ORR）和安全性。
结果
在 KEYNOTE-059 中，帕博利珠单抗的 ORR 为 9%，中位 PFS 为 2 个月，中位 OS 为 10 个月。在 KEYNOTE-061 中，帕博利珠单抗的中位 OS 为 12 个月，化疗为 10 个月（风险比（HR），0.67；95%置信区间（CI），0.39-1.15）。中位 PFS（帕博利珠单抗 vs.化疗）分别为 2 个月和 4 个月（HR，1.21；95%CI，0.69-2.13）；ORR 分别为 7%和 18%。在 KEYNOTE-062 中，帕博利珠单抗的中位 OS 为 20 个月，化疗为 18 个月（HR，0.76；95%CI，0.43-1.33）。中位 PFS（帕博利珠单抗 vs.化疗）分别为 6 个月和 7 个月（HR，1.03；95%CI，0.61-1.74）；ORR 分别为 29%和 34%。
结论
目前的分析提供了有价值的信息，表明抗 PD-1 疗法值得进一步评估用于胃癌。
试验注册
ClinicalTrials.gov：NCT02335411（KEYNOTE-059）、NCT02370498（KEYNOTE-061）和 NCT02494583（KEYNOTE-062）。
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