替吉奥胶囊联合奥沙利铂治疗中国老年晚期胃癌或胃食管结合部癌的一线治疗：一项单臂、Ⅱ期临床研究。
Biweekly oxaliplatin plus S1 for Chinese elderly patients with advanced gastric or gastroesophageal junction cancer as the first-line therapy: a single-arm, phase 2 study.
机构信息
Department of Medical Oncology, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. No, 17, Panjiayuannanli Street, Chaoyang District, Beijing, 100021, China.
出版信息
BMC Cancer. 2022 Mar 9;22(1):253. doi: 10.1186/s12885-022-09332-7.
BACKGROUND
SOX (oxaliplatin and S1, every 3 weeks) is one of the most common first-line chemotherapy for advanced or metastatic G/GEJ (gastric or gastroesophageal junction) cancer in Asia, but it has noticeable hematological and neurological toxicity. In China, the majority of gastric cancer patients are middle-aged and elderly with poor tolerance to 3-weekly chemotherapy. Therefore, we aimed to assess efficacy and safety of biweekly SOX for Chinese advanced G/GEJ cancer patients aged ≥ 60 years as the first-line treatment in a single arm phase 2 study.
METHODS
Oxaliplatin was administered intravenously on day 1 at 85 mg/m. S-1 was given at 80, 100 or 120 mg/day, depending on the body surface area (< 1.25 m, 1.25 to < 1.5 m, or ≥ 1.5 m), twice daily, on day 1-10, every 2 weeks. The primary endpoint was objective response rate (ORR), and the secondary endpoints included progression free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR) and safety.
RESULTS
Between May 2016 and Sep 2018, 42 patients were enrolled. The median follow-up was 43.6 months. The ORR and DCR were 52.4% and 85.7%, respectively. The median PFS was 4.6 months (95%CI 2.486-6.714), and the median OS was 11.1 months (95%CI 8.001-14.199). The most common treatment-related adverse events (TRAEs) of any grade included thrombocytopenia (59.5%), neutropenia (57.1%), appetite loss (57.1%) and nausea (54.8%). Only two patients suffered from grade 3 TRAEs (4.8%), including neutropenia (1 patient, [2.4%]) and diarrhea (1 patient, [2.4%]). No ≥ grade 4 TRAEs occurred.
CONCLUSIONS
Biweekly SOX seemed to have favorable tolerance without compromising the efficacy as the first-line therapy in Chinese elderly patients aged ≥ 60 years with advanced G/GEJ cancer.
TRIAL REGISTRATION
ClinicalTrials.gov ID: NCT04694404 (5/1/2021). This study was approved by the Ethical Committee of National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, (17-048/1303).
背景
SOX（奥沙利铂和 S1，每 3 周）是亚洲晚期或转移性 G/GEJ（胃或胃食管交界处）癌症最常用的一线化疗药物之一，但它具有明显的血液学和神经毒性。在中国，大多数胃癌患者为中老年人，对 3 周化疗的耐受性差。因此，我们旨在评估每 2 周接受 SOX 治疗的中国≥60 岁晚期 G/GEJ 癌症患者的疗效和安全性，作为一项单臂 2 期研究的一线治疗。
方法
奥沙利铂于第 1 天静脉注射，剂量为 85mg/m。S-1 根据体表面积（<1.25m、1.25 至<1.5m 或≥1.5m）给予 80、100 或 120mg/天，每天 2 次，第 1-10 天，每 2 周。主要终点为客观缓解率（ORR），次要终点包括无进展生存期（PFS）、总生存期（OS）、疾病控制率（DCR）、缓解持续时间（DOR）和安全性。
结果
2016 年 5 月至 2018 年 9 月期间，共纳入 42 例患者。中位随访时间为 43.6 个月。ORR 和 DCR 分别为 52.4%和 85.7%。中位 PFS 为 4.6 个月（95%CI 2.486-6.714），中位 OS 为 11.1 个月（95%CI 8.001-14.199）。任何级别的最常见治疗相关不良事件（TRAEs）包括血小板减少症（59.5%）、中性粒细胞减少症（57.1%）、食欲下降（57.1%）和恶心（54.8%）。只有 2 例患者发生 3 级 TRAE（4.8%），包括中性粒细胞减少症（1 例，[2.4%]）和腹泻（1 例，[2.4%]）。无≥4 级 TRAE 发生。
结论
对于中国≥60 岁的晚期 G/GEJ 癌症老年患者，每 2 周接受 SOX 治疗作为一线治疗，似乎具有良好的耐受性，同时不影响疗效。
临床试验注册
ClinicalTrials.gov ID：NCT04694404（2021 年 5 月 1 日）。这项研究得到了国家癌症中心/国家临床研究中心癌症/中国医学科学院北京协和医学院肿瘤医院伦理委员会的批准（17-048/1303）。
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