Zhang Yan, Xu Junying, Wang Qiong, Ling Guohong, Mao Yong, Cai Maohuai, Yang Yang, Mei Jingfeng, Han Zhengxiang, Feng Jifeng, Wu Yuan, Shi Lin, Wen Shaodi, Shen Bo
Department of Medical Oncology, The Affiliated Cancer Hospital of Nanjing Medical University & Jiangsu Cancer Hospital, Nanjing, China.
Department of Oncology, Wuxi People's Hospital, Wuxi, China.
Ann Transl Med. 2022 Jun;10(11):641. doi: 10.21037/atm-22-2752.
For advanced gastric cancer (GC) patients who fail first-line treatment, chemotherapy alone is of limited benefit. Ramucirumab combined with paclitaxel and apatinib combined with docetaxel provided clinical benefit in previous studies, but the feasibility of apatinib combined with other chemotherapy agents remains unknown. The aim of the present study was to evaluate the efficacy and safety of apatinib combined with chemotherapy as a second-line treatment for advanced GC.
Patients aged 18-75 years with histologically or cytologically confirmed advanced or metastatic GC or gastroesophageal junction adenocarcinoma that had progressed with first-line treatment were recruited and received apatinib 250 or 500 mg oral apatinib and chemotherapy regimens, including docetaxel, paclitaxel, tegafur, oxaliplatin, and capecitabine. Each treatment cycle was 28 days (4 weeks). During post-discontinuation follow-up, all patients were followed for survival [every 8 weeks (+0 to 7 days)] until disease progression, death, or study completion. Overall survival (OS) was the primary endpoint. Secondary endpoints were overall response rate (ORR), disease control rate (DCR), and progression-free survival (PFS). Adverse events (AEs) were also noted. Tumor response and progression were assessed according to RECIST 1.1. AEs were graded following the National Cancer Institute common terminology criteria for AEs (NCI-CTCAE 4.0).
Between August 31, 2016 and February 17, 2020, a total of 32 patients were enrolled in the present study, and 29 were evaluable. At the time of data cut-off, median follow-up was 7.00 months (IQR, 4.60-12.23 months). The ORR and DCR were 18.52% and 92.59%, respectively. The median PFS was 3.06 months, and the median OS was 6.93 months. In the population receipt of apatinib plus docetaxel, the median OS was 6.51 months. AEs were observed in 22 patients. Leukopenia was the most common AE (24.1%), followed by hypertension (24.1%) and neutropenia (17.2%). Patients did not develop any AEs that were grade 4 or higher.
The combination of apatinib and chemotherapy demonstrated clinical activity and acceptable toxicity as a second-line treatment for advanced GC, and may provide new second-line treatment options for advanced GC patients.
对于一线治疗失败的晚期胃癌（GC）患者，单纯化疗的获益有限。雷莫西尤单抗联合紫杉醇以及阿帕替尼联合多西他赛在既往研究中显示出临床获益，但阿帕替尼联合其他化疗药物的可行性仍不清楚。本研究的目的是评估阿帕替尼联合化疗作为晚期GC二线治疗的疗效和安全性。
招募年龄在18 - 75岁、经组织学或细胞学确诊为晚期或转移性GC或胃食管交界腺癌且一线治疗后病情进展的患者，给予阿帕替尼250或500 mg口服，并联合化疗方案，包括多西他赛、紫杉醇、替加氟、奥沙利铂和卡培他滨。每个治疗周期为28天（4周）。在停药后随访期间，所有患者均随访生存情况[每8周（+0至7天）]，直至疾病进展、死亡或研究结束。总生存期（OS）是主要终点。次要终点为总缓解率（ORR）、疾病控制率（DCR）和无进展生存期（PFS）。同时记录不良事件（AE）。根据RECIST 1.1评估肿瘤反应和进展情况。AE按照美国国立癌症研究所不良事件通用术语标准（NCI - CTCAE 4.0）进行分级。
2016年8月31日至2020年2月17日，本研究共纳入32例患者，其中29例可评估。在数据截止时，中位随访时间为7.00个月（四分位间距，4.60 - 12.23个月）。ORR和DCR分别为18.52%和92.59%。中位PFS为3.06个月，中位OS为6.93个月。在接受阿帕替尼加用多西他赛治疗的人群中，中位OS为6.51个月。22例患者观察到AE。白细胞减少是最常见的AE（24.1%），其次是高血压（24.1%）和中性粒细胞减少（17.2%）。患者未出现任何4级及以上的AE。
阿帕替尼与化疗联合作为晚期GC的二线治疗显示出临床活性和可接受的毒性，可能为晚期GC患者提供新的二线治疗选择。
