VIC Regimen (Vemurafenib/Irinotecan/Cetuximab) Versus Bevacizumab Plus Chemotherapy as First-Line Treatment for BRAF V600E-Mutated Unresectable or Metastatic Colorectal Cancer in Asian Patients: A Prospective Cohort Study

IF 3.3 3区医学 Q2 ONCOLOGY

Clinical colorectal cancer Pub Date : 2024-05-18 DOI:10.1016/j.clcc.2024.05.006

Yijiao Chen , Dexiang Zhu , Yiyi Yu , Wenju Chang , Lechi Ye , Qingyang Feng , Pingping Xu , Miao Chen , Meiling Ji , Ye Wei , Tianshu Liu , Jianmin Xu

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引用次数: 0

Abstract

Background

Colorectal cancers (CRC) with BRAF V600E mutation exhibit limited chemotherapy response and a poor prognosis. Safety and efficacy of the VIC (Vemurafenib/Irinotecan/Cetuximab) regimen in the first-line setting for patients with BRAF V600E-mutated CRC remain undetermined.

Methods

In the prospective cohort study, the untreated, BRAF V600E-mutated, unresectable or metastatic CRC patients were enrolled. The VIC regimen and bevacizumab plus chemotherapy were compared in the first-line setting. The objective response rate (ORR), disease control rate (DCR), conversion resection rate, progression-free survival (PFS), and overall survival (OS) were evaluated.

Results

In the intent-to-treat analysis, 38 patients received VIC regimen and 40 received bevacizumab plus chemotherapy. The ORR and DCR in the VIC group were significantly higher than in the bevacizumab-therapy group (ORR: 63.2% vs. 37.5%, P = .025; DCR: 94.7% vs. 75.0%, P = .019). The VIC regimen significantly outperformed bevacizumab plus chemotherapy in both PFS (11.9 vs. 7.7 months; hazard ratio [HR] = 0.51, 95% CI, 0.30-0.87; P = .010) and OS (25.3 vs. 14.6 months; HR = 0.43, 95% CI, 0.22-0.82; P = .011). In the VIC group, the conversion resection rate for liver metastases was 34.8% (8 of 23 patients), and for unresectable local CRC it was 54.5% (6 of 11 patients). The adverse events rates of Grade 3 to 4 were 34.2% and 32.5% for the VIC regimen and bevacizumab plus chemotherapy respectively.

Conclusions

Among Asian patients with BRAF V600E-mutated CRC, the VIC regimen showed favorable outcomes compared to bevacizumab plus chemotherapy in terms of tumor response and oncological survival, with a tolerable and manageable toxicity profile in the first-line setting.

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VIC方案（维莫非尼/伊立替康/西妥昔单抗）与贝伐单抗加化疗作为亚洲患者BRAF V600E突变的不可切除或转移性结直肠癌的一线治疗方案：前瞻性队列研究

背景BRAF V600E突变的结直肠癌（CRC）表现出有限的化疗反应和较差的预后。方法在这项前瞻性队列研究中，纳入了未经治疗、BRAF V600E突变、无法切除或转移的CRC患者。在一线治疗中，比较了VIC方案和贝伐单抗加化疗方案。结果在意向治疗分析中，38 名患者接受了 VIC 方案，40 名患者接受了贝伐单抗联合化疗。VIC组的ORR和DCR明显高于贝伐单抗治疗组（ORR：63.2% vs. 37.5%，P = .025；DCR：94.7% vs. 75.0%，P = .019）。VIC 方案在 PFS（11.9 个月 vs. 7.7 个月；危险比 [HR] = 0.51，95% CI，0.30-0.87；P = .010）和 OS（25.3 个月 vs. 14.6 个月；HR = 0.43，95% CI，0.22-0.82；P = .011）方面均明显优于贝伐单抗加化疗方案。在VIC组中，肝转移的转化切除率为34.8%（23例患者中的8例），无法切除的局部CRC转化切除率为54.5%（11例患者中的6例）。结论在亚洲 BRAF V600E 突变的 CRC 患者中，VIC 方案与贝伐珠单抗加化疗方案相比，在肿瘤反应和肿瘤学生存率方面显示出良好的疗效，并且在一线治疗中具有可耐受和可管理的毒性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical colorectal cancer 医学-肿瘤学

CiteScore

5.50

自引率

2.90%

发文量

审稿时长

27 days

期刊介绍： Clinical Colorectal Cancer is a peer-reviewed, quarterly journal that publishes original articles describing various aspects of clinical and translational research of gastrointestinal cancers. Clinical Colorectal Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of colorectal, pancreatic, liver, and other gastrointestinal cancers. The main emphasis is on recent scientific developments in all areas related to gastrointestinal cancers. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.