Abstract
Objectives: Oxaliplatin can cause hepatic sinusoidal injury and splenomegaly. It remains unknown if the magnitude of injury would differ when oxaliplatin is combined with capecitabine or 5-FU with/without cetuximab. We investigated the impact of 1 st line CAPOX or FOLFOX4 and the additional cetuximab on spleen size, platelet count and liver function in patients with KRAS wild-type metastatic colorectal cancer (mCRC). Methods: 101 Patients planned to receive either CAPOX or FOLFOX4 with/without cetuximab as first-line treatment were prospectively recruited. Changes in spleen size by volumetric measurement after treatment were determined. Correlation studies were performed for factors associated with changes in spleen size, thrombocytopenia and impaired liver function. Results: The spleen enlarged (median +17.9%, P < 0.001) after treatment. Multivariable analysis revealed that capecitabine, its dose intensity and cumulative dose (per 10000mg increase) correlated with splenomegaly (P = 0.01, P = 0.02 and P = 0.006, respectively). Increase in spleen size (P = 0.004) and splenomegaly (P = 0.002) correlated with thrombocytopenia. Dose intensity and cumulative dose of capecitabine (per 10000mg increase) and increase in spleen size correlated with grade 1 impaired liver function (P = 0.01, P = 0.003 and P = 0.04, respectively). Use of cetuximab correlated with less splenic enlargement (+13.7% vs. +22.7%; P = 0.04), especially when coupled with FOLFOX4 rather than CAPOX (+1.1% vs. + 23.0%; P = 0.003). Conclusions: Capecitabine was associated with more splenomegaly which in turn correlated with thrombocytopenia and impaired liver function. Cetuximab offered some protection from further splenic enlargement especially when combined with FOLFOX4.
Highlights
Patients and study designFluoropyrimidines and oxaliplatin have beenThis study was initiated in January 2010 with used in metastatic colorectal cancer for more approval from local institutional review board
101 patients were recruited and evaluated (Table 1 & 2). 32, 24, 25 and 20 patients received CAPOX, FOLFOX4, CAPOX plus cetuximab and FOLFOX4 plus cetuximab respectively. 23, 17, 19 and 9 patients from CAPOX, FOLFOX4, CAPOX plus cetuximab and FOLFOX4 plus cetuximab respectively had their primary tumor resected before study entry (Table 1)
To the best of our knowledge, this is the first prospective study demonstrating the unfavorable coupling effect of CAPOX on the spleen size and its related complications when compared with FOLFOX4, and the difference was more distinguished when cetuximab was added
Summary
Patients and study designFluoropyrimidines and oxaliplatin have beenThis study was initiated in January 2010 with used in metastatic colorectal cancer (mCRC) for more approval from local institutional review board. Oxaliplatin when combined with consent was obtained from every patient recruited into capecitabine (CAPOX) or infusional 5-FU and folinic this study. Patients with histologically proven KRAS acid (FOLFOX regimen) was found efficacious wild-type mCRC who planned to receive either CAPOX in first-line setting [2,3,4]. Addition of targeted therapy or FOLFOX4 with or without cetuximab as first-line including anti-epidermal growth factor receptor (EGFR) systemic treatment were prospectively recruited into this or anti-vascular endothelial growth factor (anti-VEGF) study. Determination of KRAS mutations from formalinmonoclonal antibody further improves the response rate fixed paraffin-embedded tumor biopsies was made by and overall survival in first and subsequent lines of QIAmp Deoxyribonucleic acid (DNA) FFPE tissue kit treatment [5,6,7,8,9,10,11]. The Medical Research Council (MRC) (Qiagen, Hilden, Germany), followed by polymerase
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