Efficacy
Ramucirumab compared to placebo demonstrated a low magnitude benefit in terms of overall survival (grade 1 out of 5, where grades 4 and 5 represent substantial improvement, according to the European Society for Medical Oncology Magnitude of Clinical benefit Scale [ESMO-MCBS] v1.1). r
At the time of data cutoff, the median overall survival (OS) was 5.2 months in the ramucirumab group vs 3.8 months in the placebo group (HR=0.776; CI 95% 0.603 to 0.998 ; p=0.047). The estimated rates of 6 month overall survival were 41.8% (95% CI 35.4 to 48.1) in the ramucirumab group and 31.8% (23.3 to 40.2) in the placebo group; rates at 12 months were 17.6% (11.8 to 24.3) vs 11.8% (6.0 to19.7) respectively.r
Median progression-free survival was 2.1 months in patients receiving ramucirumab and 1.3 months in patients receiving placebo (HR=0.483; CI 95% 0.376 to 0.620 ; p=<0.0001).r
Kaplan-Meier analysis of A) Overall survival and B) Progression-free survival
© Lancet 2014
Objective tumour response
© Lancet 2014
Quality of life data was recorded but was not reliable due to a low proportion of patients reporting. There was a trend to improved quality of life of ramucirumab however this was not statistically significant (p=0.23).r