Efficacy
The median OS was 9.6 months in the ramucirumab-paclitaxel group vs 7.4 months in the placebo-paclitaxel group (HR=0.807; 95% CI 0.678 to 0.962; p=0.017).r
Kaplan-meier curve of overall survival (OS)
© Lancet Oncol 2014
The median PFS was 4.4 months in the ramucirumab-paclitaxel group vs 2.9 months in the placebo-paclitaxel group (stratified HR 0.635; 95% CI 0.536 to 0.752; p<0.0001).r
Kaplain-meier analysis of progression-free survival (PFS)
© Lancet Oncol 2014
Objective response rates were higher in the ramucirumab-paclitaxel arm (28%), than the placebo-paclitaxel arm (16%); p=0.0001.r
Best overall response
© Lancet Oncol 2014
Quality of life data was obtained using the QLQ-C30 and EQ-5D at baseline and at six-weekly intervals during treatment. Baseline QoL was similar between the groups. Time to deterioration (worsening of ≥10 points on each scale) was not significantly different between the groups, with a trend towards improved QoL for the ramucirumab-paclitaxel group (HR 0.798, p=0.0941). Performance score data showed a significantly longer time to deterioration in PS by both ≥1 level (HR 0.802, P=0.0444), and ≥2 levels (HR = 0.608, P=0.0063).r
The results of a post hoc analysis demonstrate a sustained duration of response in the ramucirumab-paclitaxel arm compared to placebo-paclitaxel arm (median 4.4 vs 2.8 months). In patients with measurable disease, improved overall response (36% vs 20%), disease control (81% vs 61%) and tumor shrinkage (78% vs 60%) rates were observed in the ramucirumab-paclitaxel arm compared to the control arm. Improved fatigue, pain, appetite loss and global QoL was seen in the ramucirumab-paclitaxel arm in patients with both stable and responding disease. Greater symptom improvement was seen in patients with tumour shrinkage.r