Abstract：
OBJECTIVE: The CardioSwitch-study demonstrated that patients with solid tumors who develop cardiotoxicity on capecitabine or 5-fluorouracil (5-FU) treatment can be safely switched to S-1, an alternative fluoropyrimidine (FP). In light of the European Medicines Agency approval of S-1 in metastatic colorectal cancer (mCRC), this analysis provides more detailed safety and efficacy information, and data regarding metastasectomy and/or local ablative therapy (LAT), on the mCRC patients from the original study.
METHODS: This retrospective cohort study was conducted at 12 European centers. The primary endpoint was recurrence of cardiotoxicity after switch. For this analysis, safety data are reported for 78 mCRC patients from the CardioSwitch cohort (N = 200). Detailed efficacy and outcomes data were available for 66 mCRC patients.
RESULTS: Data for the safety of S-1 in mCRC patients were similar to the original CardioSwitch cohort and that expected for FP-based treatment, with no new concerns. Recurrent cardiotoxicity (all grade 1) with S-1-based treatment occurred in 4/78 (5%) mCRC patients; all were able to complete FP treatment. Median progression-free survival from initiation of S-1-based treatment was 9.0 months and median overall survival 26.7 months. Metastasectomy and/or LAT was performed in 33/66 (50%) patients, and S-1 was successfully used in recommended neoadjuvant/conversion or adjuvant-like combination regimens and schedules as for standard FPs.
CONCLUSIONS: S-1 is a safe and effective FP alternative when mCRC patients are forced to discontinue 5-FU or capecitabine due to cardiotoxicity and can be safely used in the standard recommended regimens, settings, and schedules.
METHODS: This retrospective cohort study was conducted at 12 European centers. The primary endpoint was recurrence of cardiotoxicity after switch. For this analysis, safety data are reported for 78 mCRC patients from the CardioSwitch cohort (N = 200). Detailed efficacy and outcomes data were available for 66 mCRC patients.
RESULTS: Data for the safety of S-1 in mCRC patients were similar to the original CardioSwitch cohort and that expected for FP-based treatment, with no new concerns. Recurrent cardiotoxicity (all grade 1) with S-1-based treatment occurred in 4/78 (5%) mCRC patients; all were able to complete FP treatment. Median progression-free survival from initiation of S-1-based treatment was 9.0 months and median overall survival 26.7 months. Metastasectomy and/or LAT was performed in 33/66 (50%) patients, and S-1 was successfully used in recommended neoadjuvant/conversion or adjuvant-like combination regimens and schedules as for standard FPs.
CONCLUSIONS: S-1 is a safe and effective FP alternative when mCRC patients are forced to discontinue 5-FU or capecitabine due to cardiotoxicity and can be safely used in the standard recommended regimens, settings, and schedules.
摘要：
目的：CardioSwitch研究表明，在卡培他滨或5-氟尿嘧啶（5-FU）治疗中出现心脏毒性的实体瘤患者可以安全地转换为S-1，一种替代氟嘧啶（FP）。鉴于欧洲药品管理局批准S-1用于转移性结直肠癌（mCRC），此分析提供了更详细的安全性和有效性信息，以及有关转移瘤切除术和/或局部消融治疗（LAT）的数据，来自原始研究的mCRC患者。
方法：这项回顾性队列研究在12个欧洲中心进行。主要终点是转换后心脏毒性的复发。对于这个分析，报告了来自CardioSwitch队列的78例mCRC患者的安全性数据(N=200).66例mCRC患者获得了详细的疗效和结果数据。
结果：关于S-1在mCRC患者中的安全性数据与最初的CardioSwitch队列相似，并且预期用于基于FP的治疗，没有新的担忧。在4/78（5％）mCRC患者中，以S-1为基础的治疗发生了复发性心脏毒性（均为1级）；所有人都能够完成FP治疗。从开始基于S-1的治疗开始的中位无进展生存期为9.0个月，中位总生存期为26.7个月。33/66（50％）患者进行了转移瘤切除术和/或LAT，与标准FPs一样,S-1成功用于推荐的新辅助/转换或佐剂样组合方案和方案.
结论：当mCRC患者因心脏毒性而被迫停用5-FU或卡培他滨时，S-1是一种安全有效的FP替代方案，可以安全地用于标准推荐方案，设置，和时间表。
方法：这项回顾性队列研究在12个欧洲中心进行。主要终点是转换后心脏毒性的复发。对于这个分析，报告了来自CardioSwitch队列的78例mCRC患者的安全性数据(N=200).66例mCRC患者获得了详细的疗效和结果数据。
结果：关于S-1在mCRC患者中的安全性数据与最初的CardioSwitch队列相似，并且预期用于基于FP的治疗，没有新的担忧。在4/78（5％）mCRC患者中，以S-1为基础的治疗发生了复发性心脏毒性（均为1级）；所有人都能够完成FP治疗。从开始基于S-1的治疗开始的中位无进展生存期为9.0个月，中位总生存期为26.7个月。33/66（50％）患者进行了转移瘤切除术和/或LAT，与标准FPs一样,S-1成功用于推荐的新辅助/转换或佐剂样组合方案和方案.
结论：当mCRC患者因心脏毒性而被迫停用5-FU或卡培他滨时，S-1是一种安全有效的FP替代方案，可以安全地用于标准推荐方案，设置，和时间表。
