Abstract
BackgroundThe aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy as maintenance treatment, in patients who have responded to 16–18 weeks first-line chemotherapy in metastatic colorectal cancer (mCRC).MethodsThe study design is a prospective, randomized, open label, phase II clinical trial. Those patients with mCRC who respond well after 16–18 weeks of standard doublet chemotherapy as induction may be enrolled into this study, and randomly assigned to the capecitabine metronomic group or standard dosage group. The duration of disease control after randomization and progression-free survival after enrollment are the primary endpoints. Overall survival, safety, and quality of life are the secondary endpoints. The sample size required to achieve the research objectives of this project is 79 patients in each group. The study recently started on 1 January 2018, and will last for 36 months.DiscussionThis project is intended to study the efficacy and safety of capecitabine metronomic chemotherapy in the maintenance treatment of advanced colorectal cancer, and to explore the strategy of “low toxicity, high efficiency, economy, and individualization”, which is suitable for China’s national conditions and pharmacoeconomics. It has great prospects for clinical application and a clear socioeconomic value.Trial registrationClinicalTrials.gov: NCT03158610. Registered on 15 May 2017.
Highlights
The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy as maintenance treatment, in patients who have responded to 16–18 weeks first-line chemotherapy in metastatic colorectal cancer
The OPTIMOX1 trial compared 5FU/LV maintenance treatment with a continuous FOLFOX4 regimen in patients with metastatic colorectal cancer (mCRC) and found that there were no significant difference in Progression-free survival (PFS), overall survival (OS), or incidence of adverse events between the two groups, which suggests that fluorouracil could be used as an alternative maintenance therapy during the standard regimen treatment without affecting the overall therapeutic effect [22]
The MACRO trial compared the efficacy and safety of bevacizumab alone with bevacizumab plus capecitabine and oxaliplatin as maintenance treatment after induction chemotherapy in patients with mCRC, which suggests that single-agent bevacizumab as maintenance therapy may be an appropriate option following induction XELOX plus bevacizumab in patients with mCRC with mild improvement in PFS [23]
Summary
The aim of this study is to demonstrate that capecitabine metronomic chemotherapy is non-inferior to capecitabine conventional chemotherapy as maintenance treatment, in patients who have responded to 16–18 weeks first-line chemotherapy in metastatic colorectal cancer (mCRC). Over 1.8 million new colorectal cancer cases and 881,000 deaths were estimated to occur in 2018. The incidence rates of colorectal cancer are about threefold higher in transitioned versus transitioning countries [1]. Standard screening and early detection programs have been conducted in the USA and Japan since the 1990s [2], and the 5-year survival rate in colorectal cancer increased from 51% (1990) to 65% (2012), while more and more patients were diagnosed with early-stage cancer [3]. How to prolong survival in these patients and inhibit the growth of tumors on the premise of guaranteeing the quality of life, and manage metastatic colorectal cancer (mCRC) as a chronic disease like diabetes mellitus or hypertension through longterm, low-toxicity, and effective drug treatment is of great clinical research value
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