Sun Li, Wang Huijun, Liu Zhen, Meng Ying, Qiu Meiqing, Ju Yafei, Zhang Shu
Department of Gastroenterology, Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, People's Republic of China.
Department of Oncology, Zaozhuang Municipal Hospital, Zaozhuang, People's Republic of China.
Cancer Manag Res. 2020 Oct 27;12:10631-10638. doi: 10.2147/CMAR.S275990. eCollection 2020.
Many large-sample prospective randomized clinical trials investigating advanced gastric cancer (AGC) have confirmed the survival advantages of first-line, second-line, or third-line chemotherapy compared with their respective control groups. However, due to the ethical concerns of prospective clinical trials, it is impossible to conduct a randomized comparative study of patients who do not receive chemotherapy and those who receive a second-line or above chemotherapy. Few research reports have addressed the relationship between the number of chemotherapy lines and overall survival (OS) in patients with AGC. In the present study, we analyzed the impact of the number of chemotherapy lines on OS in AGC patients using real-world data.
This study collected the medical records of patients with AGC diagnosed at Shandong Cancer Hospital from December 2007 to December 2017. According to the treatment received, AGC patients were divided into groups that did not receive chemotherapy, those who received only 1 line, 2 lines, or 3 lines and above. Kaplan-Meier analysis was used to assess patient survival.
A total of 596 AGC patients were included in this study. The following patients were enrolled: 0 lines (did not receive chemotherapy), 77 (12.9%); 1 line, 235 (39.4%) patients; 2 lines, 185 (31.1%) patients; and ≥3 lines 99 (16.6%) patients. OS was significantly correlated with the number of chemotherapy lines (P<0.001), with a median OS from diagnosis of 3.3, 8.6, 15.6, and 21.0 months for patients receiving 0, 1, 2, ≥3 lines of chemotherapy, respectively.
This study showed that the more chemotherapy lines AGC patients received, the longer the OS. This study not only confirmed the impact of chemotherapy lines on OS but it also supplements the results of prospective clinical trials that cannot be completed due to the ethical implications.
许多针对晚期胃癌（AGC）的大样本前瞻性随机临床试验已证实，一线、二线或三线化疗相较于各自的对照组具有生存优势。然而，由于前瞻性临床试验的伦理问题，无法对未接受化疗的患者与接受二线及以上化疗的患者进行随机对照研究。很少有研究报告探讨AGC患者化疗线数与总生存期（OS）之间的关系。在本研究中，我们使用真实世界数据分析了化疗线数对AGC患者OS的影响。
本研究收集了2007年12月至2017年12月在山东省肿瘤医院确诊的AGC患者的病历。根据接受的治疗，AGC患者被分为未接受化疗组、仅接受1线、2线、3线及以上化疗组。采用Kaplan-Meier分析评估患者生存情况。
本研究共纳入596例AGC患者。纳入的患者如下：0线（未接受化疗），77例（12.9%）；1线，235例（39.4%）患者；2线，185例（31.1%）患者；≥3线，99例（16.6%）患者。OS与化疗线数显著相关（P<0.001），接受0、1、2、≥3线化疗的患者从诊断开始的中位OS分别为3.3、8.6、15.6和21.0个月。
本研究表明，AGC患者接受的化疗线数越多，OS越长。本研究不仅证实了化疗线数对OS的影响，还补充了因伦理问题无法完成的前瞻性临床试验的结果。
