Abstract：
OBJECTIVE: To describe the dosing patterns of regorafenib in a real-world population of patients with metastatic colorectal cancer (mCRC) in a routine clinical practice setting in Spain, focusing on the starting dose of regorafenib.
METHODS: An observational, retrospective, multicenter study that included patients ≥ 18 years old who had histologically documented mCRC and who had initiated treatment with regorafenib since January 2017. Post hoc categorization of dosing patterns revealed the following: initial dose < 160 mg and dose escalation, initial dose < 160 mg and maintenance, initial dose equal to 160 mg and maintenance, and initial dose equal to 160 mg and dose reduction.
RESULTS: Most patients (152/241, 63.8%) initiated treatment with regorafenib at doses < 160 mg. There was large variation in the starting dose of regorafenib over time: in 2017, most patients (59%) initiated regorafenib at a dose of 160 mg, this proportion decreased to 6% in 2021. There were no significant differences in the median progression-free survival according to the regorafenib dose patterns during the first two cycles. The proportion of patients who reported at least one adverse event (AE), had a grade 3-4 AE or had an AE leading to dose reduction was greater in the group of patients who received an initial dose equal to 160 and reduction.
CONCLUSIONS: Our results indicate that physicians in Spain have gradually adopted a dose-escalation approach during cycle 1, which is a common practice for starting treatment with a reduced dose (< 160 mg/day), a strategy that seems to improve tolerability while maintaining efficacy.
BACKGROUND: Not applicable.
METHODS: An observational, retrospective, multicenter study that included patients ≥ 18 years old who had histologically documented mCRC and who had initiated treatment with regorafenib since January 2017. Post hoc categorization of dosing patterns revealed the following: initial dose < 160 mg and dose escalation, initial dose < 160 mg and maintenance, initial dose equal to 160 mg and maintenance, and initial dose equal to 160 mg and dose reduction.
RESULTS: Most patients (152/241, 63.8%) initiated treatment with regorafenib at doses < 160 mg. There was large variation in the starting dose of regorafenib over time: in 2017, most patients (59%) initiated regorafenib at a dose of 160 mg, this proportion decreased to 6% in 2021. There were no significant differences in the median progression-free survival according to the regorafenib dose patterns during the first two cycles. The proportion of patients who reported at least one adverse event (AE), had a grade 3-4 AE or had an AE leading to dose reduction was greater in the group of patients who received an initial dose equal to 160 and reduction.
CONCLUSIONS: Our results indicate that physicians in Spain have gradually adopted a dose-escalation approach during cycle 1, which is a common practice for starting treatment with a reduced dose (< 160 mg/day), a strategy that seems to improve tolerability while maintaining efficacy.
BACKGROUND: Not applicable.
摘要：
目的：描述西班牙常规临床实践中转移性结直肠癌（mCRC）患者的真实世界人群中瑞戈非尼的给药模式，专注于瑞戈非尼的起始剂量。
方法：观察性，回顾性,多中心研究纳入组织学记录为mCRC且自2017年1月开始使用瑞戈非尼治疗的≥18岁患者.给药模式的事后分类显示：初始剂量<160mg和剂量递增，初始剂量<160毫克和维持，初始剂量等于160毫克和维持，和初始剂量等于160毫克和剂量减少。
结果：大多数患者（152/241，63.8%）开始接受剂量<160mg的瑞戈非尼治疗。随着时间的推移，瑞戈非尼的起始剂量有很大变化：2017年，大多数患者（59%）以160mg的剂量开始瑞戈非尼，这一比例在2021年下降到6%。根据前两个周期的regorafenib剂量模式，中位无进展生存期没有显着差异。报告至少一次不良事件（AE）的患者比例，在接受初始剂量等于160并减少剂量的患者组中,出现3-4级AE或导致剂量减少的AE更大.
结论：我们的结果表明，西班牙的医生在第1周期中逐渐采用了剂量递增方法，这是以减少剂量（<160mg/天）开始治疗的常见做法，一个策略，似乎提高耐受性，同时保持疗效。
背景：不适用。
方法：观察性，回顾性,多中心研究纳入组织学记录为mCRC且自2017年1月开始使用瑞戈非尼治疗的≥18岁患者.给药模式的事后分类显示：初始剂量<160mg和剂量递增，初始剂量<160毫克和维持，初始剂量等于160毫克和维持，和初始剂量等于160毫克和剂量减少。
结果：大多数患者（152/241，63.8%）开始接受剂量<160mg的瑞戈非尼治疗。随着时间的推移，瑞戈非尼的起始剂量有很大变化：2017年，大多数患者（59%）以160mg的剂量开始瑞戈非尼，这一比例在2021年下降到6%。根据前两个周期的regorafenib剂量模式，中位无进展生存期没有显着差异。报告至少一次不良事件（AE）的患者比例，在接受初始剂量等于160并减少剂量的患者组中,出现3-4级AE或导致剂量减少的AE更大.
结论：我们的结果表明，西班牙的医生在第1周期中逐渐采用了剂量递增方法，这是以减少剂量（<160mg/天）开始治疗的常见做法，一个策略，似乎提高耐受性，同时保持疗效。
背景：不适用。
