Qiu Zhiyuan, Qin Rong, Zhang Ziyi, Zhang Ting, Zhang Zhao, Qiao Chunyue, Xi Yan, Tian Guangyu, Wang Yan
Department of Oncology, The Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, China.
Department of Geriatrics, The Affiliated People's Hospital of Jiangsu University, Zhenjiang, Jiangsu, China.
Front Oncol. 2023 Aug 15;13:1203980. doi: 10.3389/fonc.2023.1203980. eCollection 2023.
Apatinib has shown outstanding value in the treatment of advanced gastric cancer (AGC). However, no biomarkers are available to select AGC patients who will benefit from apatinib. The aim of the present study was to investigate the association between p53 and Ki67 expression of and the outcome in AGC patients treated with apatinib.
From December 2015 to December 2020, 92 AGC patients were enrolled and was retrospectively evaluated. They were given apatinib at a daily dose of 500 or 250 mg every 4 weeks to monitor clinical efficacy and adverse events (AEs). Kaplan-Meier method was used for survival analysis. Expression of p53 and Ki67 was detected by immunohistochemistry (IHC) and correlated with survival.
Among 92 evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 17.4% and 79.3%, respectively, and none of them achieved a CR, 16 achieved a PR (17.4%) (95% CI 9.8%-26.1%). Stable disease (SD) was observed in 57.6% of patients (95% CI 49.2%-69.9%) and PD in 21.7% of patients (95% CI 13.6%-31.3%). The median progression free survival (mPFS) was 122.7 ± 8.2 days, and the median overall survival (mOS) was 203.4 ± 11.9 days. P53 expression was observed in 35 patients (38.0%) and high expression of Ki67 was detected in 34 patients (37.0%). There was a statistically significant inverse relationship between p53 and Ki67 expression (=0.014). Moreover, p53 was significantly correlated with the OS (=0.018), but Ki67 had no significant influence on OS.
Apatinib showed promising efficiency and was well tolerated as a second-line treatment for AGC patients. AGC patients with p53-negative were likely to benefit from apatinib treatment; however, the expression of Ki67 proteins has no significant impact on the outcome of AGC patients.
阿帕替尼在晚期胃癌（AGC）治疗中已显示出卓越价值。然而，尚无生物标志物可用于筛选能从阿帕替尼治疗中获益的AGC患者。本研究旨在探讨p53和Ki67表达与接受阿帕替尼治疗的AGC患者预后之间的关联。
2015年12月至2020年12月，纳入92例AGC患者并进行回顾性评估。每4周给予他们每日剂量500或250 mg的阿帕替尼，以监测临床疗效和不良事件（AE）。采用Kaplan-Meier法进行生存分析。通过免疫组织化学（IHC）检测p53和Ki67的表达，并将其与生存情况相关联。
在92例可评估患者中，客观缓解率（ORR）和疾病控制率（DCR）分别为17.4%和79.3%，且无一例达到完全缓解（CR），16例达到部分缓解（PR）（17.4%）（95%CI 9.8%-26.1%）。57.6%的患者病情稳定（SD）（95%CI 49.2%-69.9%），21.7%的患者疾病进展（PD）（95%CI 13.6%-31.3%）。中位无进展生存期（mPFS）为122.7±8.2天，中位总生存期（mOS）为203.4±11.9天。35例患者（38.0%）观察到p53表达，34例患者（37.0%）检测到Ki67高表达。p53与Ki67表达之间存在显著的负相关关系（=0.014）。此外，p53与总生存期显著相关（=0.018），但Ki67对总生存期无显著影响。
阿帕替尼作为AGC患者的二线治疗显示出良好的疗效且耐受性良好。p53阴性的AGC患者可能从阿帕替尼治疗中获益；然而，Ki67蛋白表达对AGC患者的预后无显著影响。
