Management of Crohn Disease

Abstract

In Reply We agree with Drs Du and Yuan that the optimal dosage of capecitabine is important and remains unclear.The regimen used in our study 1 (650 mg/m 2 twice daily continuously) was selected based on the study by Stockler et al 2 that demonstrated no difference in efficacy between this metronomic regimen and the intermittent regimen (1000 mg/m 2 twice daily on days 1-14 for 21 days).Our regimen resulted in fewer adverse effects, including diarrhea, compared with the standard dose used in the CREATE-X trial, 3 as mentioned by Dr Chakrabarti and colleagues.Capecitabine was given sequentially following adjuvant chemotherapy in the SYSUCC-001 study but concomitantly with adjuvant chemotherapy in the CBCSG-010 study. 4 In these 2 studies, none of the clinicopathological parameters, including nodal involvement, demonstrated a statistically significant interaction with capecitabine benefit.Therefore, it is difficult to identify patients who benefit more based on current studies.An exploratory analysis of pharmacokinetics and molecular biomarkers to predict the efficacy of capecitabine is ongoing by our group.We agree with Chakrabarti and colleagues that neoadjuvant chemotherapy (NAC) is widely used for TNBC, which helped identify patients with nonpathological complete response who may benefit from additional capecitabine in the CREATE-X study. 3However, the CREATE-X study did not include patients with nonpathological complete response who had received NAC containing platinum or immunotherapy.Therefore, whether conclusions can be extrapolated to other NAC regimens remains unknown.Our study was initiated 10 years ago, when most patients did not receive NAC.In fact, NAC was used in less than 20% of patients with stage I-II disease (accounting for 80% of patients in our study) in clinical practice during that era. 5 Our study provides evidence supporting the use of capecitabine without NAC, which accounts for a considerable proportion of patients currently.Overall survival in our study was numerically but not statistically significantly improved for several reasons, including limited sample size and potentially imbalanced salvage treatment.However, it is important to note that improvement in overall survival in the CREATE-X study was drawn from subgroup analysis, which limits its statistical power.Our study included patients with pathologic stage Ib-IIIc disease without internal mammary or supraclavicular node

Topics & Concepts