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Abstract：
To determine the relationship between chemotherapy dose delay/reduction with progression-free survival (PFS) and overall survival (OS) in colorectal cancer patients treated with FOLFIRI based first-line chemotherapy in real-world retrospectively study.
We identified 144 eligible patients with advanced CRC who received FOLFIRI as first-line based treatment. The study protocol was submitted to the institutional review board and was exempted. Dose delay was defined as an average delay of more than 3 days (>3 days vs. ≤3 days) from the intended date. Dose reduction (actual dose/standard dose * 100%) ≤85% was considered as chemotherapy reduction in the chemotherapy dose relative to the standard (mg/m2) regimen for all cycles. Relative dose intensity (RDI) ≤80% was described as chemotherapy reduction. OS and PFS were measured using Kaplan-Meier and Cox proportional hazard models.
There were 114 patients with chemotherapy dose delay (dose delay >3 days). PFS of patients without dose delay had better survival than patients with dose delay (p = 0.002). There were 28.47% patients treated with dose reduction of 5-Fu. PFS and OS were better in patients without 5-Fu dose reduction than in patients with 5-Fu dose reduction with p values of 0.024 and <0.001, respectively. Patients with high 5-FU RDI had better PFS than patients with low 5-FU RDI (p < 0.001). While, there was no statistical difference in OS between the two groups. Then we stratified the analysis by age. In <65 years cohort, both PFS and OS were better in patients with high 5-Fu RDI than in those with low 5-Fu RDI (p < 0.001, p = 0.005, respectively). But, in ≥65 years cohort, OS were better in patients with low 5-Fu RDI than in those with high 5-Fu RDI (p = 0.025). Moreover, both dose reduction and RDI of irinotecan had no statistically significant difference in both PFS and OS.
In the advanced colorectal cancer patients who received FOLFIRI based treatment as first-line regimen, chemotherapy dose delay and reduction dose of 5-Fu were associated with worse survival, especially among patients younger than 65 years.
We identified 144 eligible patients with advanced CRC who received FOLFIRI as first-line based treatment. The study protocol was submitted to the institutional review board and was exempted. Dose delay was defined as an average delay of more than 3 days (>3 days vs. ≤3 days) from the intended date. Dose reduction (actual dose/standard dose * 100%) ≤85% was considered as chemotherapy reduction in the chemotherapy dose relative to the standard (mg/m2) regimen for all cycles. Relative dose intensity (RDI) ≤80% was described as chemotherapy reduction. OS and PFS were measured using Kaplan-Meier and Cox proportional hazard models.
There were 114 patients with chemotherapy dose delay (dose delay >3 days). PFS of patients without dose delay had better survival than patients with dose delay (p = 0.002). There were 28.47% patients treated with dose reduction of 5-Fu. PFS and OS were better in patients without 5-Fu dose reduction than in patients with 5-Fu dose reduction with p values of 0.024 and <0.001, respectively. Patients with high 5-FU RDI had better PFS than patients with low 5-FU RDI (p < 0.001). While, there was no statistical difference in OS between the two groups. Then we stratified the analysis by age. In <65 years cohort, both PFS and OS were better in patients with high 5-Fu RDI than in those with low 5-Fu RDI (p < 0.001, p = 0.005, respectively). But, in ≥65 years cohort, OS were better in patients with low 5-Fu RDI than in those with high 5-Fu RDI (p = 0.025). Moreover, both dose reduction and RDI of irinotecan had no statistically significant difference in both PFS and OS.
In the advanced colorectal cancer patients who received FOLFIRI based treatment as first-line regimen, chemotherapy dose delay and reduction dose of 5-Fu were associated with worse survival, especially among patients younger than 65 years.
摘要：
■在真实世界回顾性研究中，确定在接受基于FOLFIRI的一线化疗的结直肠癌患者中，化疗剂量延迟/减少与无进展生存期（PFS）和总生存期（OS）之间的关系。
■我们确定了144例接受FOLFIRI作为一线治疗的晚期CRC患者。研究方案已提交给机构审查委员会，并获得豁免。剂量延迟定义为平均延迟超过3天(>3天与≤3天)自预定日期起。剂量减少(实际剂量/标准剂量*100%)≤85%被认为是所有周期的化疗剂量相对于标准(mg/m2)方案的化疗减少。相对剂量强度（RDI）≤80％被描述为化疗减少。使用Kaplan-Meier和Cox比例风险模型测量OS和PFS。
■有114例患者出现化疗剂量延迟（剂量延迟>3天）。无剂量延迟患者的PFS比有剂量延迟患者的生存率更好（p=0.002）。有28.47%的患者接受5-Fu剂量减少治疗。未减少5-Fu剂量的患者的PFS和OS优于减少5-Fu剂量的患者，p值分别为0.024和<0.001。高5-FURDI患者的PFS优于低5-FURDI患者（p<0.001）。同时,两组间OS无统计学差异。然后我们按年龄分层分析。在<65岁的队列中，高5-FuRDI患者的PFS和OS均优于低5-FuRDI患者(分别为p<0.001,p=0.005).但是,在≥65岁的队列中，低5-FuRDI患者的OS优于高5-FuRDI患者（p=0.025）。此外，伊立替康的剂量减少和RDI在PFS和OS方面均无统计学差异.
■在接受基于FOLFIRI的治疗作为一线治疗方案的晚期结直肠癌患者中，化疗剂量延迟和减少剂量的5-Fu与较差的生存率相关，尤其是65岁以下的患者。
■我们确定了144例接受FOLFIRI作为一线治疗的晚期CRC患者。研究方案已提交给机构审查委员会，并获得豁免。剂量延迟定义为平均延迟超过3天(>3天与≤3天)自预定日期起。剂量减少(实际剂量/标准剂量*100%)≤85%被认为是所有周期的化疗剂量相对于标准(mg/m2)方案的化疗减少。相对剂量强度（RDI）≤80％被描述为化疗减少。使用Kaplan-Meier和Cox比例风险模型测量OS和PFS。
■有114例患者出现化疗剂量延迟（剂量延迟>3天）。无剂量延迟患者的PFS比有剂量延迟患者的生存率更好（p=0.002）。有28.47%的患者接受5-Fu剂量减少治疗。未减少5-Fu剂量的患者的PFS和OS优于减少5-Fu剂量的患者，p值分别为0.024和<0.001。高5-FURDI患者的PFS优于低5-FURDI患者（p<0.001）。同时,两组间OS无统计学差异。然后我们按年龄分层分析。在<65岁的队列中，高5-FuRDI患者的PFS和OS均优于低5-FuRDI患者(分别为p<0.001,p=0.005).但是,在≥65岁的队列中，低5-FuRDI患者的OS优于高5-FuRDI患者（p=0.025）。此外，伊立替康的剂量减少和RDI在PFS和OS方面均无统计学差异.
■在接受基于FOLFIRI的治疗作为一线治疗方案的晚期结直肠癌患者中，化疗剂量延迟和减少剂量的5-Fu与较差的生存率相关，尤其是65岁以下的患者。
