■目前,对于转移性胃癌,目前尚无推荐的标准三线化疗方案.
■在这项研究中,我们旨在评估伊立替康在一线和二线化疗失败后治疗转移性胃癌的疗效和安全性。
■预期单臂,两个中心,第二阶段试验。
■患者年龄为18-70岁,经组织学证实的胃腺癌,东部肿瘤协作组的表现状态为0-1,在最后一次接受二线化疗后3个月或3个月内进展,没有其他严重的血液学检查,心脏,肺,肝,或肾功能异常或免疫缺陷疾病。符合条件的患者接受了28天周期的伊立替康(静脉注射180mg/m2,第1天和第15天),每两个周期根据RECIST1.1标准进行评估。因任何原因停止治疗的患者每2个月随访一次直至死亡。主要终点是总生存期(OS),次要终点是无进展生存期(PFS),客观反应率(ORR),疾病控制率(DCR),和毒性。
■本研究共纳入98例符合条件的患者。在意向治疗人群中,中位OS为7.17个月,中位PFS为3.47个月,ORR和DCR分别为4.08%和47.96%,分别。在符合协议的人群中,中位OS为7.77个月,中位PFS为3.47个月,ORR和DCR分别为4.82%和50.60%,分别。3或4级血液学和非血液学毒性的发生率为19.4%,没有患者因不良事件死亡。Cox回归分析显示中性粒细胞减少和基线血小板水平与PFS和OS独立相关。
■伊立替康单药治疗是一种有效的,耐受性良好,和经济的三线治疗转移性胃癌患者作为三线治疗。
■ClinicalTrials.gov标识符:NCT02662959。
UNASSIGNED: Currently, there is no recommended standard third-line chemotherapy for metastatic gastric cancer.
UNASSIGNED: In this study, we aimed to evaluate irinotecan\'s efficacy and safety in treating metastatic gastric cancer after the failure of first- and second-line chemotherapy.
UNASSIGNED: Prospective single-arm, two-center, phase II trial.
UNASSIGNED: Patients were aged 18-70 years, with histologically confirmed gastric adenocarcinoma and an Eastern Cooperative Oncology Group performance status of 0-1, progressed during or within 3 months following the last administration of second-line chemotherapy and had no other severe hematologic, cardiac, pulmonary, hepatic, or renal functional abnormalities or immunodeficiency diseases. Eligible patients received 28-day cycles of irinotecan (180 mg/m2 intravenously, days 1 and 15) and were assessed according to the RECIST 1.1 criteria every two cycles. Patients who discontinued treatment for any reason were followed up every 2 months until death. The primary endpoint was overall survival (OS), and the secondary endpoints were progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and toxicity.
UNASSIGNED: A total of 98 eligible patients were enrolled in this study. In the intention-to-treat population, the median OS was 7.17 months, the median PFS was 3.47 months, and the ORR and DCR were 4.08% and 47.96%, respectively. In the per-protocol population, the median OS was 7.77 months, the median PFS was 3.47 months, and the ORR and DCR were 4.82% and 50.60%, respectively. The incidence of grade 3 or 4 hematological and non-hematological toxicities was 19.4%, and none of the patients died owing to adverse events. Cox regression analysis revealed neutropenia and baseline thrombocyte levels were independently correlated with PFS and OS.
UNASSIGNED: Irinotecan monotherapy is an efficient, well-tolerated, and economical third-line treatment for patients with metastatic gastric cancer as a third-line treatment.
UNASSIGNED: ClinicalTrials.gov identifier: NCT02662959.