Abstract
BackgroundThe aim of this study was to evaluate the efficacy and safety of CapeOX plus bevacizumab with a planned oxaliplatin stop-and-go strategy in Japanese patients with metastatic colorectal cancer (mCRC).MethodsPatients with untreated mCRC were treated with 4 cycles of CapeOX plus bevacizumab therapy, followed by capecitabine plus bevacizumab maintenance therapy. Reintroduction of oxaliplatin was scheduled after 8 cycles of maintenance therapy or upon tumor progression. The primary endpoint was progression-free survival (PFS), and secondary end points included overall survival (OS), objective response rate to each treatment, reintroduction rate of oxaliplatin, frequency of peripheral sensory neuropathy (PSN), and safety.ResultsThe 52 patients who received the protocol treatment were included in the evaluation of efficacy and safety. Median PFS and OS were 12.4 months (95% confidence interval [CI], 10.0–14.8) and 30.6 months (95% CI, 27.6–33.5), respectively. The objective response rates were 55.8% for the initial CapeOX plus bevacizumab therapy, 17.8% for capecitabine plus bevacizumab maintenance therapy, and 31.0% for reintroduced CapeOX plus bevacizumab therapy. The frequency of PSN was 63.5%, including 3.8% of patients with grade 3 PSN. No patients required treatment discontinuation because of PSN during the induction or maintenance therapy.ConclusionsCapeOX plus bevacizumab therapy with a planned oxaliplatin stop-and-go strategy is a feasible first-line treatment for Japanese patients with mCRC.Trial registrationThis trial is registered with the University Hospital Medical Information Network in 15 March 2010 (UMIN000006478).
Highlights
The aim of this study was to evaluate the efficacy and safety of Capecitabine and oxaliplatin (CapeOX) plus bevacizumab with a planned oxaliplatin stop-and-go strategy in Japanese patients with metastatic colorectal cancer
The criteria for inclusion in this study were age at least 20 years; histologically proven adenocarcinoma of the colon or rectum; unresectable metastasis; no previous chemotherapy for metastatic disease; at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1; an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1; and adequate bone marrow, liver, and renal functions
Patient characteristics Fifty-four patients from 18 institutions were enrolled in this study between April 2010 and October 2011
Summary
The aim of this study was to evaluate the efficacy and safety of CapeOX plus bevacizumab with a planned oxaliplatin stop-and-go strategy in Japanese patients with metastatic colorectal cancer (mCRC). The first-line treatments for patients with metastatic colorectal cancer (mCRC) usually involves combination chemotherapies that include infusional 5-fluorouracil and leucovorin plus either irinotecan or oxaliplatin [1, 2]. The results of several prospective studies have suggested the intermittent use of oxaliplatin to avoid its cumulative toxicity and prolong the time to treatment failure [8,9,10,11]. Reports that describe details of the planned oxaliplatin stop-and-go strategy in bevacizumab containing regimens are limited [12–14]
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