PD-0021 Hand-Foot-Syndrome (HFS) is a Clinical Predictor of Survival in Capecitabine Treated Patients (PTS) with Colorectal Cancer

Abstract

ABSTRACT Introduction HFS is a typical adverse event in capecitabine treated patients (pts). Post hoc analyses of the AIO KRK-0104 trial showed that HFS is associated with improved prognosis in capecitabine recipients in stage IV colorectal cancer. Here we evaluated the potential association of HFS and survival in a pooled analysis of pts with metastatic colorectal cancer and locally advanced rectal cancer (Mannheim rectal cancer trial). Methods Pts receiving capecitabine within the AIO KRK-0104 and Mannheim rectal cancer trials were analyzed. HFS was graded according to NCI-CTCAE. Occurrence and kinetics of occurrence per cycle were investigated defining “early HFS” as developing of any HFS during the fist two cycles. Groups (HFS versus non-HFS) were compared using Fisher’s exact test. Survival was compared using Kaplan-Meier estimation and logrank analysis. Overall survival (OS) and progression-free (PFS) or disease-free survival (DFS) were pooled. Results Of 374 pts a total of 29.3% developed HFS. The frequency of “early HFS” was 70.9%. Baseline characteristics were comparable between the HFS and the non-HFS groups. Multivariate analysis for age, gender, ECOG status and UICC stage on the occurrence of HFS was done but none of these factors had influence. The percentage of all-grade haematological toxicities did not differ between both groups. We observed in the HFS group a significantly higher rate of all grade (but not grade 3-4) diarrhoea, stomatitis/mucositis and fatigue (p Conclusion HFS as a sign of individual capecitabine metabolism is a clinical predictor of survival in colorectal cancer patients. Pts developing HFS had a higher probability of developing any-grade gastrointestinal toxicity and fatigue while no correlation with haematological toxicity was noticed.