Department of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo, 1040045, Japan.
Department of Head and Neck, Esophageal Medical Oncology, National Cancer Center Hospital, Tsukiji 5-1-1, Chuo-ku, Tokyo, 1040045, Japan.
BMC Cancer. 2021 Oct 29;21(1):1159. doi: 10.1186/s12885-021-08890-6.
The ML18174 study, which showed benefits of bevacizumab (BEV) continuation beyond progression (BBP) for metastatic colorectal cancer (mCRC), excluded patients with first-line progression-free survival (PFS) shorter than 3 months. The present study was conducted to evaluate the efficacy of second-line chemotherapy after early disease progression during first-line chemotherapy containing bevacizumab.
The subjects of this study were mCRC patients who experienced disease progression < 100 days from commencement of first-line chemotherapy containing BEV initiated between Apr 2007 and Dec 2016. Second-line chemotherapy regimens were classified into two groups with and without BEV/other anti-angiogenic agents (BBP and non-BBP) and efficacy and safety were compared using univariate and multivariate analysis.
Sixty-one patients were identified as subjects of this study. Baseline characteristics were numerically different between BBP (n = 37) and non-BBP (n = 25) groups, such as performance status (0-1/> 2/unknown: 89/8/3 and 56/40/4%), RAS status (wild/mutant/unknown: 32/54/16 and 76/16/8%). Response rate was 8.6% in BBP group and 9.1% in non-BBP group (p = 1.00). Median PFS was 3.9 months in BBP group and 2.8 months in non-BBP group (HR [95%CI]: 0.79 [0.46-1.34], p = 0.373, adjusted HR: 0.87 [0.41-1.82], p = 0.707). Median overall survival was 8.5 months in BBP group and 5.4 months in non-BBP group (HR 0.66 [0.38-1.12], p = 0.125, adjusted HR 0.53 [0.27-1.07], p = 0.078).
In mCRC patients who experienced early progression in first-line chemotherapy, second-line chemotherapy showed poor clinical outcomes regardless use of anti-angiogenic agents.
ML18174 研究表明，转移性结直肠癌（mCRC）患者在一线治疗进展后继续使用贝伐珠单抗（BEV）治疗（BBP）可获益，该研究排除了一线无进展生存期（PFS）短于 3 个月的患者。本研究旨在评估在含有贝伐珠单抗的一线化疗中早期疾病进展后进行二线化疗的疗效。
本研究的对象是 mCRC 患者，这些患者在 2007 年 4 月至 2016 年 12 月期间开始接受含有 BEV 的一线化疗后 100 天内疾病进展。二线化疗方案分为含贝伐珠单抗/其他抗血管生成药物（BBP 和非 BBP）的两组，并使用单变量和多变量分析比较疗效和安全性。
本研究共纳入 61 例患者。BBP 组（n=37）和非 BBP 组（n=25）之间的基线特征存在数值差异，如体力状况（0-1/>2/未知：89/8/3 和 56/40/4%）、RAS 状态（野生/突变/未知：32/54/16 和 76/16/8%）。BBP 组的缓解率为 8.6%，非 BBP 组为 9.1%（p=1.00）。BBP 组的中位 PFS 为 3.9 个月，非 BBP 组为 2.8 个月（HR [95%CI]：0.79 [0.46-1.34]，p=0.373，调整 HR：0.87 [0.41-1.82]，p=0.707）。BBP 组的中位总生存期为 8.5 个月，非 BBP 组为 5.4 个月（HR 0.66 [0.38-1.12]，p=0.125，调整 HR 0.53 [0.27-1.07]，p=0.078）。
在一线化疗中早期进展的 mCRC 患者中，二线化疗无论是否使用抗血管生成药物，临床结局均较差。
