Wang Xiang, Zhong Diansheng, Zhang Junping, Du Nan, Ren Yuchuan, Gao Jinghua, Liu Likun, Yu Junyan, Li Xiaomei, Ma Liwen, Zang Aimin, Yang Mudan, Zhang Yan, Guo Jun, Liu Zheng, Fu Zhanzhao, Jia Junmei, Diao Jianfeng, Fan Zaiwen, Song Xiang, Li Guozhong, Wang Huaqing, Bai Chunmei, Guan Mei, Ren Xiubao, Zhang Ruixing
Department of Medical Oncology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing, China.
Department of Medical Oncology, Tianjin Medical University General Hospital, Tianjin, China.
J Gastrointest Oncol. 2022 Aug;13(4):1679-1689. doi: 10.21037/jgo-22-727.
Apatinib was shown to improve the survival of Chinese patients with refractory metastatic gastric cancer (mGC). As an orally administered drug, it has been widely used in elderly patients because the dosing schedule can be adjusted flexibly. However, data on the efficacy and safety of apatinib in elderly patients is scarce. The aim of this study was to evaluate the toxicity and effectiveness of apatinib for elderly patients with mGC in a real-world setting.
Data from the sub-population of patients who were ≥65 years enrolled in the AHEAD-G202 trial were analyzed. Patients with mGC were prospectively registered and initially received ≤850 mg oral apatinib daily combined or not combined with chemotherapy, at the investigator's discretion. The primary endpoint was safety. The secondary endpoints were overall survival (OS) and progression-free survival (PFS).
A total of 117 patients were included. There were 51 (43.59%) patients in the low-dose (250 mg) group, 60 (51.28%) patients in the mid-dose (425 to 500 mg) group, and 6 (5.13%) patients in the high-dose (850 mg) group according to the initial daily doses. Hypertension (6.84%) was the only grade 3-4 adverse event (AE) with a prevalence of more than 5% and across the low-dose (11.76%), mid-dose (3.33%) and high-dose group (0%). The median OS and PFS were 7.13 months (95% CI: 5.04 to 9.22 months) and 4.27 months (95% CI: 3.24 to 5.29 months), respectively. The OS and PFS were similar among the 65-74 and ≥75 years groups (χ=1.406, P=0.306; χ=0.378, P=0.066, respectively). The OS and PFS were also comparable among the 3 dose groups.
Elderly patients with mGC can tolerate and benefit from apatinib therapy. A lower initial daily dosing strategy may be a suitable choice for elderly patients in clinical practice.
阿帕替尼已被证明可改善中国难治性转移性胃癌（mGC）患者的生存期。作为一种口服药物，由于其给药方案可灵活调整，已在老年患者中广泛应用。然而，关于阿帕替尼在老年患者中的疗效和安全性的数据却很匮乏。本研究的目的是在真实世界环境中评估阿帕替尼对老年mGC患者的毒性和有效性。
对AHEAD-G202试验中年龄≥65岁的患者亚组数据进行分析。mGC患者进行前瞻性登记，最初由研究者决定每日口服阿帕替尼≤850mg，联合或不联合化疗。主要终点是安全性。次要终点是总生存期（OS）和无进展生存期（PFS）。
共纳入117例患者。根据初始每日剂量，低剂量（250mg）组有51例（43.59%）患者，中剂量（425至500mg）组有60例（51.28%）患者，高剂量（850mg）组有6例（5.13%）患者。高血压（6.84%）是唯一发生率超过5%的3-4级不良事件（AE），在低剂量组（11.76%）、中剂量组（3.33%）和高剂量组（0%）中均有发生。中位OS和PFS分别为7.13个月（95%CI：5.04至9.22个月）和4.27个月（95%CI：3.24至5.29个月）。65-74岁组和≥75岁组的OS和PFS相似（χ=1.406，P=0.306；χ=0.378，P=0.066）。3个剂量组的OS和PFS也具有可比性。
老年mGC患者能够耐受阿帕替尼治疗并从中获益。较低的初始每日给药策略可能是临床实践中老年患者的合适选择。
