College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.
Department of Surgery, University of Saskatchewan, Saskatoon, SK, Canada.
J Gastrointest Cancer. 2022 Jun;53(2):427-433. doi: 10.1007/s12029-021-00634-w. Epub 2021 Mar 29.
Recent evidence from randomized trials suggests that FOLFOXIRI (fluorouracil, oxaliplatin, and irinotecan) ± bevacizumab is associated with higher response rates, with the potential for conversion of unresectable to resectable disease in metastatic colorectal cancer (mCRC). However, limited evidence is available on the efficacy and safety of this regimen in real-world patients with mCRC. The current study aims to evaluate the conversion rate and safety of FOLFOXIRI ± bevacizumab in real-world patients with unresectable mCRC.
In this retrospective multicenter population-based cohort study, patients who were diagnosed with unresectable mCRC between January 2015 and December 2018 in Saskatchewan and received FOLFOXIRI ± bevacizumab were assessed. Kaplan-Meier survival methods and the log-rank test were performed.
A total of 28 eligible patients with a median age of 51 years (interquartile range 39-60) and a male:female ratio of 11:17 were identified; 39% had rectal cancer, 46% had extrahepatic disease, and 46% had bilobar liver metastases. Overall, 63% of the patients had a positive response to FOLFOXIRI ± bevacizumab and 53% underwent metastasectomy. Of all patients 60% had grade 3/4 toxicity and 32% required hospital admission. No treatment-related mortality was noted. After 4 years, 50% of the patients were alive. Median progression-free survival of patients who underwent surgery was 18 months (95% CI 11.3-24.7) versus 11 months (4-18.1) without surgery (p = 0.28). Median overall survival of patients with surgery was 33 months (17.5-48.5) versus 16 months (8.3-23.7) without surgery (p = 0.03).
The current study suggests that FOLFOXIRI ± bevacizumab therapy in real-world patients with mCRC is associated with a high rate of conversion from unresectable to resectable metastatic disease. Patients with metastasectomy had better survival.
最近来自随机试验的证据表明，FOLFOXIRI（氟尿嘧啶、奥沙利铂和伊立替康）联合贝伐珠单抗与更高的反应率相关，并有可能使转移性结直肠癌（mCRC）中的不可切除疾病转化为可切除疾病。然而，关于这种方案在 mCRC 真实世界患者中的疗效和安全性的证据有限。本研究旨在评估 FOLFOXIRI 联合贝伐珠单抗在 mCRC 不可切除患者中的转化率和安全性。
这是一项回顾性多中心基于人群的队列研究，评估了 2015 年 1 月至 2018 年 12 月期间在萨斯喀彻温省被诊断为不可切除 mCRC 并接受 FOLFOXIRI 联合贝伐珠单抗治疗的患者。采用 Kaplan-Meier 生存方法和对数秩检验进行分析。
共纳入 28 名中位年龄为 51 岁（四分位距 39-60）、男女比例为 11:17 的可评估患者；39%的患者为直肠肿瘤，46%的患者存在肝外疾病，46%的患者存在双侧肝转移。总体而言，63%的患者对 FOLFOXIRI 联合贝伐珠单抗有阳性反应，53%的患者接受了转移灶切除术。所有患者中 60%出现 3/4 级毒性，32%需要住院治疗。无治疗相关死亡。4 年后，50%的患者存活。接受手术的患者中位无进展生存期为 18 个月（95%CI 11.3-24.7），未接受手术的患者为 11 个月（4-18.1）（p=0.28）。接受手术的患者中位总生存期为 33 个月（17.5-48.5），未接受手术的患者为 16 个月（8.3-23.7）（p=0.03）。
本研究表明，在 mCRC 真实世界患者中，FOLFOXIRI 联合贝伐珠单抗治疗与不可切除转移性疾病向可切除疾病转化的高转化率相关。接受转移灶切除术的患者生存情况更好。
