Raltitrexed (Tomudex) versus standard leucovorin-modulated bolus 5-fluorouracil: Results from the randomised phase III Pan-European Trial in Adjuvant Colon Cancer 01 (PETACC-1).
雷替曲塞 (Tomudex) 与标准亚叶酸钙调制的 5-氟尿嘧啶: 来自辅助结肠癌 01 (PETACC-1) 的随机 III 期泛欧洲试验的结果。

摘要

OBJECTIVES:PETACC-1 assessed if raltitrexed is non-inferior to 5-fluorouracil and leucovorin for relapse-free survival (RFS) and overall survival (OS) in adjuvant stage III colon cancer.
METHODS:Non-inferiority required both HR for RFS and OS<1.25 at 1-sided alpha=0.05. Patients (1921) were randomised to six cycles of 5-FU/LV (n=969) or eight cycles of raltitrexed (n=952). We report the final results in 993 eligible patients who started and completed the allocated treatment (489 5-FU/LV and n=504 Raltitrexed) of whom respectively 146 and 148 died, respectively.
RESULTS:The trial closed prematurely when 17 (1.9%) raltitrexed-related deaths were reported. Haematological and gastrointestinal toxicities were more frequent with 5-FU/LV, liver toxicities with raltitrexed. Raltitrexed was stopped for toxicity in 13.2% and 5-FU/LV in 8.5%. Sixty-day mortality was 9% versus 7%. With 4.1 years median follow-up, the HR for RFS was 1.16 (90% CI 0.99-1.37) and that for OS was 1.01 (90% CI 0.84-1.23).
CONCLUSION:The trial failed to demonstrate non-inferiority of raltitrexed.
FUNDING:Free drugs and financial support from AstraZeneca.

译文

目的: PETACC-1 评估在辅助 III 期结肠癌中,雷替曲塞在无复发生存期 (RFS) 和总生存期 (OS) 方面是否不逊于 5-氟尿嘧啶和亚叶酸钙。
方法: 在单侧 α = 1.25 时,非劣效性要求 RFS 的 HR 和 OS <0.05。患者 (1921) 被随机分为 6 个周期的 5-FU/LV (n = 969) 或 8 个周期的雷替曲塞 (n = 952)。我们报告了 993 名符合条件的患者的最终结果,他们开始并完成了分配的治疗 (489 5-FU/LV 和 n = 504 雷替曲塞),其中分别有 146 和 148 死亡。
结果: 当报告 17 例 (1.9%) 雷替曲塞相关死亡时,试验提前结束。5-FU/LV 的血液学和胃肠道毒性更常见,雷替曲塞的肝脏毒性更常见。雷替曲塞的毒性为 13.2%,5-FU/LV 为 8.5%。60 天死亡率为 9%,而 7%。中位随访时间为 4.1 年,RFS 的 HR 为 1.16 (90% CI 0.99-1.37),OS 的 HR 为 1.01 (90% CI 0.84-1.23)。
结论: 该试验未能证明雷替曲塞的非劣效性。
资金: 免费药物和阿斯利康的财政支持。

Raltitrexed

肿瘤 肠癌 药物
概述  :  

雷替曲塞,商品名赛维健,活性成份为雷替曲塞,辅料是甘露醇、磷酸氢二钠及氢氧化钠。是白色或类白色疏松块状物或粉末。其化学名称:N-[5-[N-甲基-N-(2-甲基-4-氧代-3,4-二氢喹唑啉-6-甲基)氨基]2-噻吩甲酰基]-L-谷氨酸。分子式:C21H22N4O6S,分子量:458.49。 适应症在患者无法接受联合化疗时,本品可单药用于治疗不适合5-Fu/亚叶酸钙的晚期结直肠癌患者。 用法用量成人:推荐剂量为3毫克/平方米,用50-250毫升0.9%氯化钠注射液或5%葡

Raltitrexed 

释    义   n. 雷替曲塞

例    句   Gel clot method of tachypleus amebocyte lysate(TAL) test was applied to detect bacterial endotoxins in Raltitrexed for injection. 应用凝胶凝块法检测注射用雷替曲塞中的细菌内毒素。

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