Scholarlink

<p>Cetuximab plus fluoropyrimidine every two weeks (Q2W) is a common maintenance approach for RAS/BRAF wild-type metastatic colorectal cancer, but is limited by infusion burden and schedule misalignment. We conducted a phase Ib, nonrandomized 3 + 3 dose-escalation study evaluating cetuximab (400-700 mg/m<sup>2</sup>) every three weeks (Q3W) synchronized with capecitabine (1000 mg/m<sup>2</sup> twice daily, days 1-14 every 21-day cycle) after first-line induction without disease progression. Six additional patients received standard cetuximab (500 mg/m<sup>2</sup>) plus infusional 5-fluorouracil/leucovorin every two weeks (Q2W) as a pharmacokinetic reference. Among 24 patients (18 every three weeks [Q3W]; 6 every two weeks [Q2W]), no maximum tolerated dose was reached up to 700 mg/m<sup>2</sup> every three weeks (Q3W), and safety was consistent with known cetuximab and capecitabine-related toxicity. At 700 mg/m<sup>2</sup> Q3W, cetuximab trough concentrations approached those observed with the Q2W reference regimen, and exploratory median progression-free survival was 13.4 months. These findings support cetuximab 700 mg/m<sup>2</sup> Q3W plus capecitabine as the proposed recommended phase II dose (RP2D) regimen for further prospective evaluation. ClinicalTrials.gov: NCT05775900.</p>

错误：搜索内容不能为空，请输入英文关键词
错误：关键词超出字数限制，请精简
高级检索

Cetuximab plus capecitabine every three weeks as first-line maintenance therapy for RAS/BRAF wild-type metastatic colorectal cancer: a phase Ib dose-escalation study

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2026年4月24日

查看全文
  • Xiaoyu Xie,
  • Ziqin Lin,
  • Weiwei Li,
  • Yuqian Xie,
  • Jianwei Zhang,
  • Huabin Hu,
  • Shanshan Li,
  • Xiaohui Zhai,
  • Lishuo Shi,
  • Yanhong Deng

摘要

Cetuximab plus fluoropyrimidine every two weeks (Q2W) is a common maintenance approach for RAS/BRAF wild-type metastatic colorectal cancer, but is limited by infusion burden and schedule misalignment. We conducted a phase Ib, nonrandomized 3 + 3 dose-escalation study evaluating cetuximab (400-700 mg/m2) every three weeks (Q3W) synchronized with capecitabine (1000 mg/m2 twice daily, days 1-14 every 21-day cycle) after first-line induction without disease progression. Six additional patients received standard cetuximab (500 mg/m2) plus infusional 5-fluorouracil/leucovorin every two weeks (Q2W) as a pharmacokinetic reference. Among 24 patients (18 every three weeks [Q3W]; 6 every two weeks [Q2W]), no maximum tolerated dose was reached up to 700 mg/m2 every three weeks (Q3W), and safety was consistent with known cetuximab and capecitabine-related toxicity. At 700 mg/m2 Q3W, cetuximab trough concentrations approached those observed with the Q2W reference regimen, and exploratory median progression-free survival was 13.4 months. These findings support cetuximab 700 mg/m2 Q3W plus capecitabine as the proposed recommended phase II dose (RP2D) regimen for further prospective evaluation. ClinicalTrials.gov: NCT05775900.