未经批准:转移胰腺癌(mPC)的二线治疗方案有限。我们旨在探讨奥沙利铂联合伊立替康(IROX)在mPC患者中的疗效和安全性。
UNASSIGNED:这是一个开放标签,2期,使用吉西他滨联合S-1作为一线治疗失败的mPC患者(年龄18-75岁)的随机研究。在2015年10月至2017年12月之间,使用区组大小为4的区组随机分组(1:1)患者接受IROX(奥沙利铂85mg/m2和伊立替康160mg/m2)或伊立替康单一疗法(伊立替康180mg/m2),直至疾病进展。不可接受的不良事件,或同意撤回。主要终点是总生存期,次要终点是无进展生存期,总反应率,和不良事件发生率。
未经证实:本研究共纳入74名患者,包括44名男性和30名女性,平均年龄61岁。中位总生存期为10.2和6.7个月(调整后的风险比[HR],0.7;95%置信区间[CI],0.4-1.2;P=0.20),中位无进展生存期为5.1和2.3个月(校正后的HR,0.4;95%CI,0.2-0.6;P<0.01)在IROX组和伊立替康组中,分别。IROX组的总有效率为18.4%(7/38),伊立替康组为5.5%(2/36)(P=0.06)。IROX组34%(13/38)的患者和伊立替康组19%(7/36)的患者发生3-4级不良事件(P=0.15)。
未经证实:在我们的研究中,IROX与伊立替康单药治疗相比没有显著的生存获益。然而,IROX将疾病进展的风险降低了60%,具有可接受的毒性。
UNASSIGNED: Limited second-line therapeutic options are available for metastasis pancreatic cancer (mPC). We aimed to explore the efficacy and safety of oxaliplatin plus irinotecan (
IROX) in mPC patients.
UNASSIGNED: This is an open-label, Phase 2, randomized study of mPC patients (aged 18-75 years) who failed when using gemcitabine plus S-1 as first-line therapy. Block randomization with a block size of four was used to randomly assign patients (1:1) between October 2015 and December 2017 to receive either
IROX (oxaliplatin 85 mg/m2 and irinotecan 160 mg/m2) or irinotecan monotherapy (irinotecan 180 mg/m2) until disease progression, unacceptable adverse events, or consent withdrawal. The primary end point was overall survival, and the secondary end points were progression-free survival, overall response rate, and adverse event rate.
UNASSIGNED: A total of 74 patients were enrolled in this study, including 44 males and 30 females, with an average age of 61 years. The median overall survival was 10.2 and 6.7 months (adjusted hazard ratio [HR], 0.7; 95% confidence interval [CI], 0.4-1.2; P = 0.20) and the median progression-free survival was 5.1 and 2.3 months (adjusted HR, 0.4; 95% CI, 0.2-0.6; P < 0.01) in the IROX group and irinotecan group, respectively. The overall response rates were 18.4% (7/38) in the
IROX group and 5.5% (2/36) in the irinotecan group (P = 0.06). Grade 3-4 adverse events occurred in 34% (13/38) of patients in the IROX group and 19% (7/36) of patients in the irinotecan group (P = 0.15).
UNASSIGNED: IROX had no significant survival benefit over irinotecan monotherapy in our study. However,
IROX reduced the risk of disease progression by 60%, with acceptable toxicity.