PDF(Pubmed)
Abstract：
UNASSIGNED: To explore the efficacy and safety of FOLFOXIRI plus cetuximab regimen as conversion therapy for patients with unresectable RAS/BRAF wild-type colorectal liver-limited metastases (CLM).
UNASSIGNED: This was a dual-center, phase II trial with the rate of no evidence of disease (NED) achieved as the primary endpoint. All enrolled patients with initially unresectable left-sided RAS/BRAF wild-type colorectal liver-limited metastases received a modified FOLFOXIRI plus cetuximab regimen as conversion therapy.
UNASSIGNED: Between October 2019 and October 2021, fifteen patients were enrolled. Nine patients (60%) achieved NED. The overall response rate (ORR) was 92.9%, and the disease control rate (DCR) was 100%. The median relapse-free survival (RFS) was 9 (95% CI: 0-20.7) months. The median progression-free survival (PFS) was 13.0 months (95% CI: 5.7-20.5), and the median overall survival (OS) was not reached. The most frequently occurring grade 3-4 adverse events were neutropenia (20%), peripheral neurotoxicity (13.3%), diarrhea (6.7%), and rash acneiform (6.7%).
UNASSIGNED: The FOLFOXIRI plus cetuximab regimen displayed tolerable toxicity and promising anti-tumor activity in terms of the rate of NED achieved and response rate in patients with initially unresectable left-sided RAS/BRAF wild-type CLM. This regimen merits further investigation.
UNASSIGNED: This was a dual-center, phase II trial with the rate of no evidence of disease (NED) achieved as the primary endpoint. All enrolled patients with initially unresectable left-sided RAS/BRAF wild-type colorectal liver-limited metastases received a modified FOLFOXIRI plus cetuximab regimen as conversion therapy.
UNASSIGNED: Between October 2019 and October 2021, fifteen patients were enrolled. Nine patients (60%) achieved NED. The overall response rate (ORR) was 92.9%, and the disease control rate (DCR) was 100%. The median relapse-free survival (RFS) was 9 (95% CI: 0-20.7) months. The median progression-free survival (PFS) was 13.0 months (95% CI: 5.7-20.5), and the median overall survival (OS) was not reached. The most frequently occurring grade 3-4 adverse events were neutropenia (20%), peripheral neurotoxicity (13.3%), diarrhea (6.7%), and rash acneiform (6.7%).
UNASSIGNED: The FOLFOXIRI plus cetuximab regimen displayed tolerable toxicity and promising anti-tumor activity in terms of the rate of NED achieved and response rate in patients with initially unresectable left-sided RAS/BRAF wild-type CLM. This regimen merits further investigation.
摘要：
■探讨FOLFOXIRI联合西妥昔单抗方案作为不可切除的RAS/BRAF野生型结直肠肝限制性转移（CLM）患者的转换治疗的疗效和安全性。
■这是一个双中心，II期试验，以无疾病证据（NED）作为主要终点。所有最初不可切除的左侧RAS/BRAF野生型结直肠肝限制性转移患者均接受改良的FOLFOXIRI加西妥昔单抗方案作为转换治疗。
■在2019年10月至2021年10月之间，招募了15名患者。9名患者（60％）达到NED。总有效率（ORR）为92.9％，疾病控制率(DCR)为100%。中位无复发生存期（RFS）为9个月（95％CI：0-20.7）。中位无进展生存期(PFS)为13.0个月(95%CI:5.7-20.5),未达到中位总生存期（OS）。最常见的3-4级不良事件是中性粒细胞减少症（20％），周围神经毒性（13.3%），腹泻(6.7%)，和痤疮样皮疹(6.7%)。
■FOLFOXIRI加西妥昔单抗方案在最初不可切除的左侧RAS/BRAF野生型CLM患者的NED实现率和反应率方面显示出可耐受的毒性和有希望的抗肿瘤活性。该方案值得进一步研究。
■这是一个双中心，II期试验，以无疾病证据（NED）作为主要终点。所有最初不可切除的左侧RAS/BRAF野生型结直肠肝限制性转移患者均接受改良的FOLFOXIRI加西妥昔单抗方案作为转换治疗。
■在2019年10月至2021年10月之间，招募了15名患者。9名患者（60％）达到NED。总有效率（ORR）为92.9％，疾病控制率(DCR)为100%。中位无复发生存期（RFS）为9个月（95％CI：0-20.7）。中位无进展生存期(PFS)为13.0个月(95%CI:5.7-20.5),未达到中位总生存期（OS）。最常见的3-4级不良事件是中性粒细胞减少症（20％），周围神经毒性（13.3%），腹泻(6.7%)，和痤疮样皮疹(6.7%)。
■FOLFOXIRI加西妥昔单抗方案在最初不可切除的左侧RAS/BRAF野生型CLM患者的NED实现率和反应率方面显示出可耐受的毒性和有希望的抗肿瘤活性。该方案值得进一步研究。
