晚期胃癌系列研究解读-ML17032讲解.ppt

* XP and FP were similar in terms of the percentage of patients with treatment-related AEs (all grades) [1]. AEs were reported in nearly all patients (96% of subjects) in both treatment arms and most were treatment-related. Characteristic of fluoropyrimidine-based therapy, GI AEs were among the most frequent AEs in both treatment groups. All-grade HFS was more frequent with XP than with FP (22% vs 4%) but led to discontinuation of trial treatment in only one?patient (1%) in the XP group. Overall, the safety profile of 希罗达-based therapy is similar to that of infusional 5-FU. 1. Kang Y-K et al. Proc ESMO 2006 (Abst O-003) * XP and FP were similar in terms of the percentage of patients experiencing haematological AEs (all grades) during the trial. These data represent changes from baseline values [1]. 1. Kang Y-K et al. Proc ESMO 2006 (Abst O-003) * AEs that led to modifications of 希罗达 treatment (interruptions, delays and dose modifications) occurred in 55% of the patients in the XP group, whereas 顺铂 was modified in 35% of those patients. AEs that led to modifications of 5-FU treatment (interruptions, delays and dose modifications) occurred in 41% of the patients in the FP group, whereas 顺铂 was modified in 40% of those patients. In both treatment groups, the most frequent AE requiring modification of trial treatment was neutropenia. For FP, AEs leading to dose modification were mainly due to haematological toxicities: 24% were for neutropenia and 11% were for leucopenia. For XP, anaemia, vomiting, nausea, diarrhoea, and HFS requiring modification of trial treatment were more frequent than in the FP group. Nausea leading to dose modification for 希罗达 would be expected to be more common because it is an oral medication and this phenomenon has been observed in other clinical trials of 希罗达 in comparison to 5-FU. Four patients had interruptions in 希罗达 dosage due to AEs during cycle?1, six patients had dose interruptions during cycle?2, and three or fewer patients ha