A multicenter, phase I/II trial of biweekly S-1, leucovorin, oxaliplatin and gemcitabine in metastatic pancreatic adenocarcinoma-TCOG T1211 study.
一项双周 S-1 、亚叶酸钙、奥沙利铂和吉西他滨治疗转移性胰腺腺癌的多中心 I/II 期试验-TCOG T1211 研究。

摘要

BACKGROUND:This phase I/II study evaluated the feasibility and efficacy of S-1, leucovorin, oxaliplatin and gemcitabine (SLOG), a triplet regimen, for treating patients with metastatic pancreatic ductal adenocarcinoma (PDAC).
METHODS:Patients with chemo-naive, metastatic PDAC were eligible to receive fixed-rate infusion (10 mg/m2/min) of gemcitabine of 800 mg/m2 followed by oxaliplatin of 85 mg/m2 on day 1 plus oral S-1 and leucovorin (20 mg/m2) twice daily from days 1 to 7 in a 2-week cycle. The dose of S-1 would be escalated from 20, 30, 35 to 40 mg/m2 in a 3 + 3 designed phase I part to determine the maximum tolerated dose (MTD) for phase II study, in which the primary end-point was objective response rate (ORR). The recommended dose of S-1 was from phase I. This trial is registered at ClinicalTrials.gov: NCT01415713.
RESULTS:Seventy-three patients were enrolled. In the phase I study (n = 19), the MTD of S-1 was 35 mg/m2 twice daily. Of 54 patients in phase II, the ORR was 40.7% (95% confidence interval [CI], 28%-55%). The median progression-free survival and overall survival were 7.6 (95% CI, 5.6-11.0) and 11.4 (95% CI, 8.1-16.3) months, respectively. The most common grade III/IV adverse event was neutropenia (40.7%). Twenty-four percent of patients had SLOG treatment for more than 1 year. The mean relative dose intensities of gemcitabine, oxaliplatin, and S-1 were 92%, 92% and 89%, respectively.
CONCLUSION:Biweekly SLOG is a feasible regimen with promising activity and safety profiles. A randomised study comparing SLOG versus modified folinic acid, fluorouracil, irinotecan, and oxaliplatin (FOLFIRINOX) in advanced PDAC is ongoing (ClinicalTrials.gov: NCT03443492).

译文

背景: 这个 I/II 期研究评估了 S-1 、亚叶酸钙、奥沙利铂和吉西他滨 (SLOG) 的可行性和疗效, 用于治疗转移性胰腺导管腺癌 (PDAC) 患者。
方法: 未经化疗的转移性 PDAC 患者有资格接受固定剂量输注 (10 mg/m2/min) 吉西他滨 800 mg/m2,奥沙利铂 85 mg/m2,第 1 天加口服 S-1 和亚叶酸钙 (20 mg/m2) 在为期两周的周期中,从第 1 天到第 7 天每天两次。S-1 的剂量将从 20 、 30 、 35 mg/m2 增加到 40 mg/m2,在 3 3 设计阶段 I 部分确定阶段 II 研究的最大耐受剂量 (MTD), 其中主要终点是客观反应率 (ORR)。S-1 的推荐剂量来自第一阶段。该试验在 ClinicalTrials.gov 注册: nct01415713。
结果: 入组患者 73 例。在第一阶段研究 (n = 19) 中,S-1 的 MTD 为 35 mg/m2,每日两次。在 54 名 II 期患者中,ORR 为 40.7% (95% 置信区间 [CI],28%-55%)。中位无进展生存期和总生存期分别为 7.6 (95% 置信区间,5.6-11.0) 和 11.4 (95% 置信区间,8.1-16.3) 个月。最常见的 ⅲ/ⅳ 级不良事件是中性粒细胞减少症 (40.7%)。24% 的患者接受为期一年以上的艰苦治疗。吉西他滨、奥沙利铂和 S-1 的平均相对剂量强度分别为 92% 、 92% 和 89%。
结论: 双周 SLOG 是一种可行的方案,具有良好的活性和安全性。一项比较 SLOG 与改良亚叶酸、氟尿嘧啶、伊立替康和奥沙利铂 (FOLFIRINOX) 在晚期 PDAC 中的随机研究正在进行中 (ClinicalTrials.gov: NCT03443492)。

Oxaliplatin

肿瘤 结直肠癌 药物
概述  :  

奥沙利铂又称乐沙定、草酸铂,属于铂类衍生物,临床上用于治疗经氟脲嘧啶治疗失败后的结直肠癌转移的患者,可单独或联合氟尿嘧啶使用,是继顺铂、卡铂之后的第三代新型铂类抗肿瘤化合物,也是迄今为止唯一对结肠直肠癌具有显著活性的络铂类药物。作用原理是通过产生烷化结合物作用于DNA,形成链内和链间交联抑制DNA的合成及复制。同时也对卵巢癌及黑色素瘤细胞系有抑制增生作用。2002年8月,美国食品与药品管理局(FDA)批准了赛诺菲圣特拉堡公司的抗癌药奥沙利铂(oxaliplatin,Eloxatin)用于转移

Oxaliplatin 

释    义   n. 奥沙利铂(抗肿瘤药)

例    句   To observe the effects of oxaliplatin on proliferation in human colon carcinoma cell lines HT29 in vitro and investigate the mechanism. 观察抗肿瘤药物奥沙利铂对人结肠癌细胞株HT29体外增殖的影响,初步探讨其作用机制。

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