Abstract
BackgroundThe 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.MethodsThe 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.ResultsSixty-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).ConclusionIn mCRC patients who experienced early progression in first-line chemotherapy, second-line chemotherapy showed poor clinical outcomes regardless use of anti-angiogenic agents.
Highlights
The ML18174 study, which showed benefits of bevacizumab (BEV) continuation beyond progression (BBP) for metastatic colorectal cancer, excluded patients with first-line progression-free survival (PFS) shorter than 3 months
Since a randomized trial (ML18147) showed a survival benefit of BEV continuation beyond progression (BBP) compared to chemotherapy alone in the secondline setting (Hazard ratio [HR], 0.81; 95% confidence interval [confidence intervals (CI)], 0.69–0.94; p = 0.0062) [6], it has been adopted as one of the standard treatment strategies in second-line chemotherapy for metastatic colorectal cancer (mCRC) patients [3]
The ML18147 trial excluded mCRC patients whose progression-free survival (PFS) during first-line chemotherapy was less than 3 months, as well as those in whom progressive disease was observed later than 3 months after the last BEV administration, or those who were treated with first-line chemotherapy containing BEV for less than 3 months [6]
Summary
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 ML18147 trial excluded mCRC patients whose progression-free survival (PFS) during first-line chemotherapy was less than 3 months, as well as those in whom progressive disease was observed later than 3 months after the last BEV administration, or those who were treated with first-line chemotherapy containing BEV for less than 3 months [6]. Antiangiogenic agents are generally considered less likely to induce drug-resistance than cytotoxic agents because antiangiogenic agents act mainly on endothelial cells rather than on tumor cells [7] It is not known whether BBP would have clinical benefits for patients who experienced disease progression within 3 months during a first-line BEV-containing chemotherapy; this patient group may be intrinsically resistant to BEV
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