Wang Xiang, Zhang Ruixing, Du Nan, Yang Mudan, Zang Aimin, Liu Likun, Yu Junyan, Gao Jinghua, Zhang Junping, Fu Zhanzhao, Ren Yuchuan, Ma Liwen, Guo Jun, Li Qingshan, Li Xiaomei, Fan Zaiwen, Song Xiang, Liu Zheng, Zhang Yan, Li Guozhong, Yu Zhonghe, Diao Jianfeng, Jia Junmei, Liang Feng, Wang Huaqing, Sun Junzhong, Gao Yunge, Yang Ping, Bai Chunmei, Ren Xiubao, Zhong Diansheng
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Department of Gastroenterology, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.
Ther Adv Med Oncol. 2020 Mar 19;12:1758835920905424. doi: 10.1177/1758835920905424. eCollection 2020.
Apatinib has been proved to be effective and well tolerated among patients in phase II and III studies. Here, we evaluated the safety and effectiveness of apatinib in advanced gastric cancer patients in a real-world setting.
This study enrolled advanced gastric cancer patients who had progressed or relapsed despite systemic chemotherapy. The primary outcome was safety and the secondary outcomes included overall survival (OS) and progression-free survival (PFS).
A total of 337 patients were included. In total, 62 (18.4%), 102 (30.3%), and 173 (51.3%) patients received first, second, and third or higher line apatinib therapy, respectively. Grade 3/4 treatment-emergent adverse events (AEs) were infrequent (<5%), with hypertension (6.8%) being the only grade 3/4 AE occurring in more than 5% of the patients and across the low-dose (250 mg, 7.3%), mid-dose (425-500 mg, 6.1%), and high-dose group (675-850 mg, 2/15, 13.3%). The median OS and PFS were 7.13 months (95% CI, 6.17-7.93) and 4.20 months (95% CI, 4.60-4.77), respectively, and were comparable among the low-, mid-, and high-dose groups.
Lower daily doses of apatinib achieved comparable OS and PFS higher daily doses of apatinib while maintaining a more benign safety profile in advanced gastric cancer patients.
ClinicalTrials.gov identifier: NCT02668380.
在II期和III期研究中，阿帕替尼已被证明对患者有效且耐受性良好。在此，我们评估了阿帕替尼在真实世界中晚期胃癌患者中的安全性和有效性。
本研究纳入了尽管接受了全身化疗仍进展或复发的晚期胃癌患者。主要结局是安全性，次要结局包括总生存期（OS）和无进展生存期（PFS）。
共纳入337例患者。分别有62例（18.4%）、102例（30.3%）和173例（51.3%）患者接受了一线、二线和三线或更高线的阿帕替尼治疗。3/4级治疗期间出现的不良事件（AE）并不常见（<5%），高血压（6.8%）是唯一在超过5%的患者中出现且在低剂量组（250mg，7.3%）、中剂量组（425 - 500mg，6.1%）和高剂量组（675 - 850mg，2/15，13.3%）中均有出现的3/4级AE。中位OS和PFS分别为7.13个月（95%CI，6.17 - 7.93）和4.20个月（95%CI，4.60 - 4.77），在低、中、高剂量组中相当。
在晚期胃癌患者中，较低日剂量的阿帕替尼与较高日剂量的阿帕替尼相比，在总生存期和无进展生存期方面相当，同时安全性更好。
ClinicalTrials.gov标识符：NCT02668380。
