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)。

Gemcitabine

肿瘤 胰腺癌 药物
概述  :  

吉西他滨是一种破坏细胞复制的二氟核苷类抗代谢药物,为脱氧胞苷的水溶性类似物,是核糖核苷酸还原酶抑制剂。临床主要用于治疗局部进展性或转移性非小细胞肺癌和不能手术的晚期或转移性胰腺癌。其成份是盐酸吉西他滨。 适应症可用于局限晚期或已转移的非小细胞肺癌;局限晚期或已转移的胰腺癌。吉西他滨与紫杉醇联合可用于治疗经辅助/新辅助化疗后复发、不能切除的、局部复发或转移性乳腺癌。在有些国家也被批准用于膀胱癌、宫颈癌、卵巢癌、前列腺癌等实体肿瘤。 配制方法每瓶(含吉西他滨200 

Gemcitabine 

释    义   n. 吉西他滨或胞苷或健泽(药物名)

例    句   Many pancreatic tumor cells are resistant to gemcitabine, which makes the disease very difficult to treat. 很多胰腺肿瘤细胞对吉西他滨耐药,导致这种疾病现在很难得到有效治疗。

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