Lavacchi Daniele, Roviello Giandomenico, Giommoni Elisa, Dreoni Lorenzo, Derio Silvia, Brugia Marco, Amedei Amedeo, Pillozzi Serena, Antonuzzo Lorenzo
Clinical Oncology Unit, Careggi University Hospital, 50134 Florence, Italy.
Department of Health Science, University of Florence, 50134 Florence, Italy.
Cancers (Basel). 2021 Jul 31;13(15):3863. doi: 10.3390/cancers13153863.
The addition of aflibercept to FOLFIRI has been demonstrated to improve survival in patients with metastatic colorectal cancer (mCRC) who progressed after receiving a standard oxaliplatin-based regimen. In this retrospective, single-institution, observational study we collected clinical data from mCRC patients who received aflibercept in combination with FOLFIRI in routine clinical practice from October 2012 to March 2021 to describe feasibility and efficacy of this regimen in a real-world population. Forty-nine patients receiving aflibercept-FOLFIRI as second-line treatment were identified, 40.8% of whom were aged over 65 years. The majority of patients had multi-organ metastases (73.5%), and had previously received bevacizumab in combination with chemotherapy (CT) as first-line treatment (79.6%). Median overall survival (OS) and progression-free survival (PFS) were 13 and 6 months, respectively; overall response rate (ORR) and disease control rate (DCR) were 12.3% and 49.1%, respectively. Several factors were associated with survival in univariate analysis, including PFS in first-line therapy, number of metastatic sites, bone metastases and others. However, in multivariate analysis, only PFS in first-line CT over 12 months was significantly associated with better OS (HR 0.32; 95% CI 0.13-0.79; = 0.01). Hypertension was the most commonly reported grade (G) 3-4 adverse event (AE), affecting 18.4% of the overall population. Thromboembolic events were observed in 16.3% of patients, hemorrhagic events in 10.2%, and proteinuria in 8.2%. Neutropenia was the most frequently observed hematological G3-4 AE with an incidence of 10.2%. Aflibercept-FOLFIRI has been confirmed as a feasible second-line treatment for mCRC in a re-al-life setting, and PFS in first-line therapy >12 months resulted as the only predictive marker of better survival.
在接受基于奥沙利铂的标准方案治疗后病情进展的转移性结直肠癌（mCRC）患者中，已证明在FOLFIRI方案中添加阿柏西普可改善生存。在这项回顾性、单机构观察性研究中，我们收集了2012年10月至2021年3月在常规临床实践中接受阿柏西普联合FOLFIRI治疗的mCRC患者的临床数据，以描述该方案在真实世界人群中的可行性和疗效。确定了49例接受阿柏西普 - FOLFIRI作为二线治疗的患者，其中40.8%的患者年龄超过65岁。大多数患者有多处器官转移（73.5%），并且先前曾接受贝伐单抗联合化疗（CT）作为一线治疗（79.6%）。中位总生存期（OS）和无进展生存期（PFS）分别为13个月和6个月；总缓解率（ORR）和疾病控制率（DCR）分别为12.3%和49.1%。单因素分析中有几个因素与生存相关，包括一线治疗中的PFS、转移部位数量、骨转移等。然而，多因素分析中，只有一线CT治疗中PFS超过12个月与更好的OS显著相关（HR 0.32；95%CI 0.13 - 0.79；P = 0.01）。高血压是最常报告的3 - 4级不良事件（AE），影响了18.4%的总体人群。16.3%的患者观察到血栓栓塞事件，10.2%的患者出现出血事件，8.2%的患者出现蛋白尿。中性粒细胞减少是最常观察到的3 - 4级血液学AE，发生率为10.2%。阿柏西普 - FOLFIRI已被确认为mCRC在真实世界环境中的一种可行的二线治疗方法，并且一线治疗中PFS>12个月是更好生存的唯一预测标志物。
