Neoadjuvant Capecitabine Results in Similar Total Lymph Node Harvests as 5-Fluorouracil but an Increased Number of Lymph Nodes Containing Adenocarcinoma on Resection

Colorectal cancer is presently the 2nd overall leading cause of cancer-related deaths in the United States.1 Estimations, for 2018, predict there will be 97,220 new cases of colon cancer; 43,030 new cases of rectal cancer; and 50,630 deaths due to colorectal cancer.1 Worldwide, there is a projected 60 per cent increase to 2.2 million new cases and 1.1 million deaths by 2030.2 The aim of our study was to compare 5-FU with capecitabine and examine their influence on nodal harvest and nodal positivity. Secondary outcomes included mortality and disease recurrence during the study period. A retrospective cohort study was conducted using data from the Medical Center of Central Georgia, Navicent Health. The institutional tumor registry was queried for all patients that had a diagnosis of rectal cancer from 2008 to 2016. Patients were excluded if 1) they underwent surgical resection as the initial treatment modality, 2) if they underwent local treatment because nodal data would not be available for this cohort, and 3) if the therapeutic agent was not known in the neoadjuvant setting. Data collected and evaluated included age, gender, mortality and recurrence during the study period, grade of cancer, number of regional nodes examined, and number of regional nodes that were positive. Approval of the study was obtained from the hospital’s Institutional Review Board. Means and standard deviations or medians and interquartile ranges were reported for continuous variables, and frequencies and percentages were reported for categorical variables. The Fisher’s exact test was used to make comparisons between the two treatment groups for categorical variables. The unpaired t test and the Mann–Whitney U test were used to make comparisons between the two treatment groups for continuous variables. A two-tailed test and a P < 0.05 were used for all comparisons. SAS version 9.4 was used for all analyses (SAS Institute, Cary, NC). Sixty-three patients were identified that met the inclusion criteria. There were 26 patients who received 5-FU for treatment and 37 patients who received Xeloda. Demographic characteristics are reported in Table 1. There were no significant differences between the two treatment groups in age, gender, death, grade of cancer, or recurrence of cancer. There were 13 patients where regional node data were not applicable; therefore, only 50 patients were evaluated for regional node comparisons. There was no significant difference in the number of regional nodes examined. The number of positive nodes was analyzed as a continuous measure and a categorical measure, and there was a significant difference in the number of regional nodes that tested positive with both measures (Table 2). The median number of positive nodes was higher in the Xeloda group compared with the 5-FU group (0.50 (0.00, 3.00) vs 0.00 (0.00, 0.00), P 40.0088). The number range of nodes testing positive was zero to five for the 5-FU treatment group and zero to 15 for the Xeloda treatment group. The same trend occurred when categorizing the number of positive nodes. A greater percentage of patients treated with 5-FU had zero nodes test positive (85.00% vs 50.00%) whereas a greater percentage of patients treated with Xeloda had one or more nodes test positive (50.00% vs 15.00%) (Table 2, P 40.016). Using neoadjuvant chemoradiation in patients with locally advanced rectal cancer leads to decreases in local recurrence, increases in the rate of complete pathologic response, and may improve sphincter preservation rates. The national quality forum, in collaboration with several other organizations (American Society of Address correspondence and reprint requests to Michael D. Honaker, M.D., Department of Surgical Oncology and Colorectal Surgery, Mercer University School of Medicine, Navicent Health, 800 1st St Suite 240, Macon, GA 31201. E-mail: honaker. michael@navicenthealth.org.