Abstract
The aim of this phase II study was to evaluate the efficacy and safety of combination therapy with five-cycle CAPOX (capecitabine plus oxaliplatin) plus bevacizumab, followed by five-cycle maintenance therapy with capecitabine plus bevacizumab and reintroduction of CAPOX plus bevacizumab for five cycles, with a preplanned intermittent oxaliplatin strategy in metastatic colorectal cancer (mCRC). Patients with untreated mCRC were administered CAPOX (130mg/m2 oxaliplatin on day 1, 2000mg/m2/day capecitabine on days 1-14, every 21days) + bevacizumab (7.5mg/kg) every 3weeks for five cycles, maintenance treatment without oxaliplatin for five cycles, and CAPOX + bevacizumab reintroduction for five cycles or upon tumor progression. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were the time to treatment failure (TTF), overall survival, response rate (RR), and safety. Forty-seven patients who fulfilled the inclusion criteria were enrolled in the evaluation of efficacy and safety. Median PFS was 14.1months (95% confidence interval [CI], 8.6-19.5), and median TTF was 12.3months (95% CI, 10.3-14.3). The objective RRs were 51.1% (24/47) during induction therapy, 58.3% (21/36) during maintenance therapy, and 63.6% (14/22) during reintroduction therapy. The frequency of patients with neutropenia, diarrhea, peripheral sensory neuropathy, venous thromboembolism, or grade ≥ 3 allergic reactions was 2.1%. CAPOX plus bevacizumab therapy with a preplanned intermittent oxaliplatin strategy consisting of brief five-cycle induction therapy, five-cycle maintenance therapy with capecitabine plus bevacizumab, and five-cycle reintroduction therapy consisting of CAPOX plus bevacizumab is safe and effective for mCRC patients. UMIN ID: 000,005,732, date of registration: June 7, 2011. https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000006695.
Highlights
In the first-line treatment of metastatic colorectal cancer patients with CAPOX plus bevacizumab, the optimal duration of maintenance treatment without oxaliplatin to avoid discontinuation of therapy due to peripheral sensory neuropathy (PSN) remains unknown
The addition of the monoclonal antibody drug bevacizumab, which is effective against vascular endothelial growth factor (VEGF), to irinotecan plus bolus 5-FU (IFL) resulted in significant benefits regarding overall survival (OS) and progression-free survival (PFS) [7], and combinations of oxaliplatin in combination with 5-fluorouracil (FOLFOX) or irinotecan + 5-FU/LV (FOLFIRI) with monoclonal antibodies against VEGF or epidermal growth factor receptor (EGFR) and FOLFOXIRI (5-FU/LV/oxaliplatin/irinotecan) with anti-VEGF monoclonal antibodies [8] are currently recommended as first-line treatments for patients with metastatic colorectal cancer (mCRC) in the National Comprehensive Cancer Center Network (NCCN) guidelines
Tezuka et al [24] reported the efficiency of the oxaliplatin stopand-go concept using a regimen of mFOLFOX7 plus bevacizumab for eight cycles followed by maintenance without oxaliplatin for eight cycles in Japanese patients with unresectable mCRC
Summary
In the first-line treatment of metastatic colorectal cancer (mCRC) patients with CAPOX plus bevacizumab, the optimal duration of maintenance treatment without oxaliplatin to avoid discontinuation of therapy due to peripheral sensory neuropathy (PSN) remains unknown. The aim of this phase II study was to evaluate the efficacy and safety of combination therapy with five-cycle CAPOX (capecitabine plus oxaliplatin) plus bevacizumab, followed by five-cycle maintenance therapy with capecitabine plus bevacizumab and reintroduction of CAPOX plus bevacizumab for five cycles, with a preplanned oxaliplatin intermittent strategy in mCRC. Tezuka et al [24] reported the efficiency of the oxaliplatin stopand-go concept using a regimen of mFOLFOX7 plus bevacizumab for eight cycles followed by maintenance without oxaliplatin for eight cycles in Japanese patients with unresectable mCRC
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