Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Osaka, Japan.
Department of Surgery, Saito Yukoukai Hospital, Osaka, Japan.
Anticancer Res. 2022 Apr;42(4):1859-1865. doi: 10.21873/anticanres.15662.
BACKGROUND/AIM: This phase II study (MCSGO-1202) aimed to evaluate the initial dose reduction of oxaliplatin in XELOX plus bevacizumab therapy.
This was a phase II, multicenter, open-label, single-arm, prospective, study conducted at 14 Japanese institutions. The study included patients with metastatic colorectal cancer (mCRC) with performance status (PS) of 1 or 2 who had not undergone chemotherapy. Patients received oxaliplatin (100 mg/m) plus bevacizumab (7.5 mg/kg) on day 1 and capecitabine (2,000 mg/m2/day) on days 1-14 of a 21-day cycle. The primary endpoint was the objective response rate. The secondary endpoints were progression-free and overall survival, 1-year survival rate, disease control rate, dose intensity, and adverse events.
Between April 2012 and March 2016, 56 patients were enrolled. The median age was 71 years (range=44-85 years), and the majority (90.6%) had a PS of 1. A complete response was observed in three patients (5.7%), partial response in 24 (45.3%), stable disease in 22 (43.4%), and progressive disease in one (1.9%). The median progression-free survival and overall survival were 11.4 and 26.5 months, respectively. The most common grade 3-4 adverse events were leucopenia (15.1%), neutropenia (9.4%), neuropathy (9.4%).
The dose-reduction strategy of oxaliplatin was effective for elderly or vulnerable patients with mCRC.
背景/目的：这项 II 期研究（MCSGO-1202）旨在评估 XELOX 联合贝伐珠单抗治疗中奥沙利铂初始剂量的降低。
这是一项在 14 家日本机构进行的 II 期、多中心、开放标签、单臂、前瞻性研究。该研究纳入了体力状态（PS）为 1 或 2 分、未经化疗的转移性结直肠癌（mCRC）患者。患者接受奥沙利铂（100 mg/m）+贝伐珠单抗（7.5 mg/kg）于第 1 天，卡培他滨（2000 mg/m2/天）于第 1-14 天，每 21 天为一个周期。主要终点为客观缓解率。次要终点为无进展生存期和总生存期、1 年生存率、疾病控制率、剂量强度和不良事件。
2012 年 4 月至 2016 年 3 月期间，共纳入 56 例患者。中位年龄为 71 岁（范围=44-85 岁），大多数（90.6%）PS 评分为 1 分。3 例患者达到完全缓解（5.7%），24 例患者达到部分缓解（45.3%），22 例患者达到疾病稳定（43.4%），1 例患者出现疾病进展（1.9%）。中位无进展生存期和总生存期分别为 11.4 个月和 26.5 个月。最常见的 3-4 级不良事件为白细胞减少症（15.1%）、中性粒细胞减少症（9.4%）、周围神经病变（9.4%）。
对于老年或脆弱的 mCRC 患者，奥沙利铂的剂量降低策略是有效的。
