A Phase II Study of Dose-reductive XELOX Plus Bevacizumab in Elderly or Vulnerable Patients With Metastatic Colorectal Cancer (MCSGO-1202)
A Phase II Study of Dose-reductive XELOX Plus Bevacizumab in Elderly or Vulnerable Patients With Metastatic Colorectal Cancer (MCSGO-1202)
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DOI：
10.21873/anticanres.15662
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发表时间：
2022-03
影响因子：
2
通讯作者：
A. Kato;N. Miyoshi;Toru Ohtsuru;D. Sakai;J. Hasegawa;K. Nakata;M. Imasato;Takeshi Kato;M. Ikenaga;T. Kudo;M. Tei;Y. Kagawa;M. Uemura;H. Takahashi;T. Satoh;M. Mori;T. Mizushima;Hirofumi Yamamoto;K. Murata;Y. Doki;H. Eguchi
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文献类型：
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作者：
A. Kato;N. Miyoshi;Toru Ohtsuru;D. Sakai;J. Hasegawa;K. Nakata;M. Imasato;Takeshi Kato;M. Ikenaga;T. Kudo;M. Tei;Y. Kagawa;M. Uemura;H. Takahashi;T. Satoh;M. Mori;T. Mizushima;Hirofumi Yamamoto;K. Murata;Y. Doki;H. Eguchi
背景/目的：这项II期研究（MCSGO-1202）旨在评价XALIX联合贝伐珠单抗治疗中奥沙利铂初始剂量降低的情况。患者和方法：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。该研究包括未接受化疗的体能状态（PS）为1或2的转移性结直肠癌（mCRC）患者。患者在21天周期的第1天接受奥沙利铂（100 mg/m2）联合贝伐珠单抗（7.5 mg/kg），在第1-14天接受卡培他滨（2，000 mg/m2/天）。主要终点为客观缓解率。次要终点是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。结果：2012年4月至2016年3月期间，入组了56例患者。中位年龄为71岁（范围=44-85岁），大多数（90.6%）的PS为1。3例患者（5.7%）完全缓解，24例（45.3%）部分缓解，22例（43.4%）疾病稳定，1例（1.9%）疾病进展。中位无进展生存期和总生存期分别为11.4和26.5个月。最常见的3-4级不良事件是白细胞减少症（15.1%）、中性粒细胞减少症（9.4%）、神经病变（9.4%）。结论：奥沙利铂剂量减少策略对老年或体弱的mCRC患者有效。
Background/Aim: This phase II study (MCSGO-1202) aimed to evaluate the initial dose reduction of oxaliplatin in XELOX plus bevacizumab therapy. Patients and Methods: 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/m2) 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. Results: 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%). Conclusion: The dose-reduction strategy of oxaliplatin was effective for elderly or vulnerable patients with mCRC.