晚期胃癌系列研究解读-关于REAL-2和ML17032研究的Meta分析.pptVIP

* The baseline demographic and clinical characteristics were well balanced across all treatment groups [1]. The majority of patients in all trials were male; the median age was 61–65 years and PS scores were predominantly 0–1. The median number of cycles administered was six in each study group. Median actual dose intensities of the epirubucin, platinum and fluoropyrimidine drugs were similar in all treatment groups, as was the percentage of patients undergoing at least one dose reduction. The median follow-up was 17.5 months in the ECF group, 17.6 months in the ECX group, 19.3 months in the EOF group and 18.9 months in the EOX group. 1. Cunningham et al. N Engl J Med 2008 * The primary endpoint of the REAL-2 study was met, as the OS of patients receiving Xeloda-based regimens (EOX or ECX) was non-inferior to that of patients receiving 5-FU-based regimens (EOF or ECF) [1]. The HR comparing Xeloda triplets with 5-FU triplets was 0.86 (95% CI: 0.80–0.99). The upper limit of the HR was 0.99, significantly below the 1.23 predefined margin for non-inferiority (p0.0001; per protocol analysis). 1. Cunningham D et al. Proc ASCO 2006 (Abst LBA4017) * Xeloda-containing regimens were characterised by a favourable safety profile [1]. In particular, compared with the reference arm, patients in the EOX arm experienced less grade 3/4 neutropenia (p0.05), febrile neutropenia and hand-foot syndrome, but more diarrhoea (p0.05). The 60-day all-cause mortality was similar between arms (ECF: 7.2%, EOF: 5.7%, ECX: 5.6%, EOX: 6.1%). Thromboembolism, a common complication of oesophagogastric cancer, is associated with morbidity and mortality and may be increased by chemotherapy. The AE sections of the trial database were searched for thromboembolic events (TEs) in the treated (per protocol) population (n=964) [2]. TEs were classified as venous (VTE) and arterial (ATE). The overall incidence of TEs was 117/964 (12.1%). VTEs occurred in 98/964 patients (10.2%) and ATEs in 19/964 (1.97%)