Zhou Na, Zhang Chuantao, Liu Dong, Liu Kewei, Wang Guanqun, Zhu Hua, Zhang Jianli, Jiang Man, Liu Ning, Zhang Xiaochun
Precision Medicine Center of Oncology, the Affiliated Hospital of Qingdao University, Qingdao, Shandong, People's Republic of China.
Department of Pathology, the Affiliated Hospital of Qingdao University, Qingdao, Shandong, People's Republic of China.
Oncologist. 2021 Mar;26(3):e374-e381. doi: 10.1002/onco.13613. Epub 2020 Dec 28.
Apatinib combined with S-1 was not superior to other chemotherapy regimens as first-line therapy for advanced gastric cancer. There was a tendency for patients with lymph node metastasis to have prolonged median progression-free survival and median overall survival, compared with patients with liver metastasis.
The best choice of first-line chemotherapy regimen for patients with metastatic gastric cancer is still debated. We combined apatinib and S-1 as a new first-line therapy to treat advanced gastric cancer. The efficacy and safety of the combination were assessed, with the goal of determining the most appropriate subgroup of patients who could benefit from this new regimen.
This study was an open, exploratory single-arm, phase II trial. Enrolled patients received apatinib plus S-1 treatment (apatinib, 500 mg, once a day [qd], days 1-21; S-1, 40 mg/m , bid, days 1-14). The primary endpoints were progression-free survival (PFS) and safety of this new regimen. Next-generation sequencing was used to explore potential biomarkers.
A total of 30 patients were enrolled. The median progression-free survival (mPFS) was 4.21 months (95% confidence interval [CI], 2.29-6.13 months). The median overall survival (mOS) was 7.49 months (95% CI, 4.81-10.17 months). Patients with lymph node metastasis had prolonged mPFS and mOS when compared with those with liver metastasis (mPFS, 4.21 vs. 1.84 months; mOS, 8.21 vs. 6.31 months, p = .08). The most common grade 3 to 4 adverse events were abdominal pain, dizziness, and diarrhea. Gene mutation profiles between the two subgroups were significantly different.
Apatinib combined with S-1 was not superior to other chemotherapy regimens as first-line therapy for advanced gastric cancer. Toxicity was consistent with known profiles when given as monotherapy. There was a tendency toward prolonged mPFS and mOS in patients with lymph node metastasis compared with patients with liver metastasis, which could support the need to design a future clinical trial with a better defined patient population.
对于晚期胃癌一线治疗，阿帕替尼联合S-1并不优于其他化疗方案。与肝转移患者相比，有淋巴结转移的患者有中位无进展生存期和中位总生存期延长的趋势。
转移性胃癌患者一线化疗方案的最佳选择仍存在争议。我们将阿帕替尼和S-1联合作为一种新的一线治疗方法来治疗晚期胃癌。评估了该联合方案的疗效和安全性，目的是确定能从这种新方案中获益的最合适患者亚组。
本研究是一项开放、探索性单臂II期试验。入组患者接受阿帕替尼加S-1治疗（阿帕替尼，500 mg，每日一次[qd]，第1 - 21天；S-1，40 mg/m²，每日两次，第1 - 14天）。主要终点是该新方案的无进展生存期（PFS）和安全性。采用二代测序探索潜在生物标志物。
共入组30例患者。中位无进展生存期（mPFS）为4.21个月（95%置信区间[CI]，2.29 - 6.13个月）。中位总生存期（mOS）为7.49个月（95% CI，4.81 - 10.17个月）。与肝转移患者相比，有淋巴结转移的患者mPFS和mOS延长（mPFS，4.21对1.84个月；mOS，8.21对6.31个月，p = 0.08）。最常见的3 - 4级不良事件是腹痛、头晕和腹泻。两个亚组之间的基因突变谱有显著差异。
对于晚期胃癌一线治疗，阿帕替尼联合S-1并不优于其他化疗方案。作为单药治疗时，毒性与已知情况一致。与肝转移患者相比，有淋巴结转移的患者有mPFS和mOS延长的趋势，这可能支持未来设计一项针对定义更明确患者群体的临床试验的必要性。
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