Department of Gastroenterology, Clinical Medicine, Faculty of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan.
Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Kashiwa, Japan.
Int J Clin Oncol. 2024 Dec;29(12):1878-1886. doi: 10.1007/s10147-024-02613-0. Epub 2024 Aug 28.
FOLFOXIRI plus bevacizumab is a standard first-line chemotherapy for patients with metastatic colorectal cancer (mCRC). However, due to the severe toxicities, this regimen is not widely used. There is limited data on the real-world efficacy and safety.
We conducted a retrospective analysis of clinical data from mCRC patients who received FOLFOXIRI plus bevacizumab as first-line chemotherapy at 31 institutions. The initial dose was standardized according to the TRIBE regimen. Induction therapy was defined as a combination of oxaliplatin, irinotecan, and fluorouracil.
Out of 104 patients who met the criteria, the median age was 58 years (range, 16-72). 81% of patients had an eastern cooperative oncology group performance status (PS) of 0. An initial dose reduction was observed in 63% of patients. The median number of preplanned induction therapy cycles was 12 (range, 4-12). The completion of scheduled induction therapy cycles was observed in 45% of patients, with treatment-related toxicities being the main reason for discontinuation (63%). The median progression-free survival and overall survival were 12.8 months (95% CI, 10.6-15.0) and 27.9 months (95% CI 21.6-34.2), respectively. The objective response rate and disease control rate were 63.7% and 98.9%, respectively. The R0 resection rate was 21.2%. The main grade 3 or higher toxicities were neutropenia (51%), febrile neutropenia (10%), and nausea/vomiting (5%). No treatment-related deaths were observed.
In a real-world clinical setting, FOLFOXIRI plus bevacizumab demonstrated efficacy and safety comparable to previous clinical trials.
FOLFOXIRI 联合贝伐珠单抗是转移性结直肠癌（mCRC）患者的标准一线化疗方案。然而，由于毒性较大，该方案并未广泛应用。关于真实世界疗效和安全性的数据有限。
我们对 31 家机构的 mCRC 患者进行了 FOLFOXIRI 联合贝伐珠单抗作为一线化疗的回顾性分析。初始剂量根据 TRIBE 方案标准化。诱导治疗定义为奥沙利铂、伊立替康和氟尿嘧啶的联合治疗。
符合标准的 104 例患者中，中位年龄为 58 岁（范围 16-72 岁）。81%的患者 ECOG 体能状态（PS）评分为 0。63%的患者观察到初始剂量减少。计划诱导治疗周期的中位数为 12 个（范围 4-12 个）。45%的患者完成了计划诱导治疗周期，因治疗相关毒性而停药的主要原因（63%）。中位无进展生存期和总生存期分别为 12.8 个月（95%CI，10.6-15.0）和 27.9 个月（95%CI，21.6-34.2）。客观缓解率和疾病控制率分别为 63.7%和 98.9%。R0 切除率为 21.2%。主要的 3 级或更高级别的毒性为中性粒细胞减少症（51%）、发热性中性粒细胞减少症（10%）和恶心/呕吐（5%）。未观察到治疗相关死亡。
在真实临床环境中，FOLFOXIRI 联合贝伐珠单抗显示出与先前临床试验相当的疗效和安全性。
