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S-1 in Patients with Advanced Esophagogastric Adenocarcinoma: Results from the Safety Compliance Observatory on Oral fluoroPyrimidines (SCOOP) Study.
Drugs in R&D ( IF 3 ) Pub Date : 2019-03-03 , DOI: 10.1007/s40268-019-0265-0
Marino Venerito 1
Affiliation  

BACKGROUND AND OBJECTIVES S-1-based regimens have been shown to be as effective as other fluoropyrimidine-based regimens with a better safety profile in patients with advanced esophagogastric adenocarcinoma. However, real-world data on S-1 in European patients with advanced esophagogastric adenocarcinoma are lacking. The Safety Compliance Observatory on Oral fluoroPyrimidines (SCOOP) study evaluated safety and relative dose intensities for patients treated with S-1-based regimens for advanced esophagogastric adenocarcinoma as part of daily practice. METHODS Overall, data for 125 patients with advanced esophagogastric adenocarcinoma were collected at 21 centers in five countries in Europe. Demographics, treatment, and adverse-event data were recorded over a planned treatment of six cycles. RESULTS Most patients (87%) received combination treatment of S-1 plus a platinum compound. Adverse events related to S-1 treatment were mostly grade 1 or 2 while reported grade 3-4 serious adverse events related to S-1 occurred in 12 patients and were most often grade 3 neutropenia (n = 4, 3.2%) or diarrhea (n = 5, 4%). The most common adverse events of any grade that were attributable to S-1 treatment included neutropenia, anemia, thrombocytopenia, diarrhea, nausea, vomiting, and fatigue. No patients experienced mucositis, dehydration, or febrile neutropenia, whereas 2% (3/125) of patients experienced hand-foot syndrome. CONCLUSION The overall relative dose intensity was 70%. In a real-world setting, patients with advanced esophagogastric adenocarcinoma tolerated S-1 treatment well with high compliance rates. The SCOOP study provides valuable information on S-1 relative dose intensity that can be used for treatment decision making.

中文翻译:

晚期食管胃腺癌患者中的S-1:来自口服氟嘧啶(SCOOP)研究的安全合规性观察站的结果。

背景和目的已证明,基于S-1的治疗方案与其他基于氟嘧啶的治疗方案一样有效,并且在晚期食管胃腺癌患者中具有更好的安全性。但是,缺乏欧洲晚期食管胃腺癌患者中S-1的真实数据。口服氟嘧啶安全合规性观察站(SCOOP)的研究评估了以S-1为基础的方案治疗晚期食管胃腺癌的患者的安全性和相对剂量强度,这是日常工作的一部分。方法总体上,在欧洲五个国家的21个中心收集了125例晚期食管胃腺癌患者的数据。在计划的六个疗程中记录了人口统计学,治疗和不良事件数据。结果大多数患者(87%)接受了S-1加铂化合物的联合治疗。与S-1治疗相关的不良事件多为1级或2级,而据报道与S-1相关的3-4级严重不良事件发生在12位患者中,最常见的是3级中性粒细胞减少(n = 4、3.2%)或腹泻( n = 5、4%)。归因于S-1治疗的任何级别的最常见不良事件包括中性粒细胞减少,贫血,血小板减少,腹泻,恶心,呕吐和疲劳。没有患者经历粘膜炎,脱水或发热性中性粒细胞减少,而2%(3/125)的患者经历了手足综合征。结论总体相对剂量强度为70%。在现实世界中,晚期食管胃腺癌患者对S-1的治疗耐受性好,依从性高。
更新日期:2019-11-01
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