Department of Abdominal Oncology, Cancer Center of West China Hospital, 34753Sichuan University, Chengdu, Sichuan, People's Republic of China.
Department of Biotherapy, Cancer Center of West China Hospital, 34753Sichuan University, Chengdu, Sichuan, People's Republic of China.
Cancer Control. 2022 Jan-Dec;29:10732748221080332. doi: 10.1177/10732748221080332.
Irinotecan-based doublet chemotherapy strategy was standard second-line backbone for patients with oxaliplatin-refractory metastatic colorectal cancer. The aim of this study was to evaluate tolerability and efficacy of raltitrexed combined with irinotecan biweekly administered as the second-line therapy for mCRC patients.
The study was a prospective, single-center, non-randomized, open-label phase II clinical trial. Patients with mCRC after failure with oxaliplatin and fluoropyrimidine or its derivatives were enrolled. Irinotecan (180 mg/m) and raltitrexed (2.5 mg/m) were given intravenously on day 1. Cycles were repeated every 2 weeks. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included overall response rate (ORR), disease control rate (DCR), overall survival (OS), and adverse events (AEs).
Between December 2012 and October 2016, 33 and 35 patients enrolled were assessed for response and safety, respectively. The ORR was 8.6%, and the DCR was 71.4%. The median PFS was 4.5 months (95% CI 3.8-5.2). The median OS was 12.0 months (95% CI 8.5-15.5). Four patients received conversion therapy to no evidence of disease (NED), and 2 patients were still alive with beyond 24 months survival. The most common grade 3/4 AEs were anorexia (14.3%), vomiting (14.3%), nausea (11.4%), fatigue (8.6%), and leukopenia (8.6%). No one died from treatment-related events. The incidence and severity of toxicity were irrelevant to UGT1A1 status.
The combination of irinotecan with raltitrexed is an efficient, convenient, and acceptable toxic regimen for second-line treatment for mCRC patients.
以伊立替康为基础的双联化疗方案是奥沙利铂耐药转移性结直肠癌患者的标准二线治疗骨干。本研究旨在评估雷替曲塞联合伊立替康每两周给药作为 mCRC 二线治疗的耐受性和疗效。
该研究是一项前瞻性、单中心、非随机、开放标签的 II 期临床试验。入组患者为奥沙利铂和氟嘧啶或其衍生物治疗失败的 mCRC 患者。伊立替康（180mg/m）和雷替曲塞（2.5mg/m）于第 1 天静脉给药。每 2 周重复一个周期。主要终点是无进展生存期（PFS），次要终点包括总缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）和不良事件（AE）。
2012 年 12 月至 2016 年 10 月，分别有 33 例和 35 例患者入组评估疗效和安全性。ORR 为 8.6%，DCR 为 71.4%。中位 PFS 为 4.5 个月（95%CI 3.8-5.2）。中位 OS 为 12.0 个月（95%CI 8.5-15.5）。4 例患者接受无疾病证据（NED）的转换治疗，2 例患者仍存活超过 24 个月。最常见的 3/4 级 AE 为厌食（14.3%）、呕吐（14.3%）、恶心（11.4%）、疲劳（8.6%）和白细胞减少（8.6%）。无患者因治疗相关事件死亡。毒性的发生率和严重程度与 UGT1A1 状态无关。
伊立替康联合雷替曲塞是一种有效、方便、可接受的 mCRC 二线治疗方案。
