How May Ramucirumab Help Improve Treatment Outcome for Patients with Gastrointestinal Cancers?

Abstract

GI cancers are characterized by high recurrence rates and a dismal prognosis and there is an urgent need for new therapeutic approaches. This is a narrative review designed to provide a summary of the efficacy as measured by overall survival, progression free survival, and safety data from phase 3 randomized controlled GI clinical trials of ramucirumab including those from important pre-specified patient subgroups and evidence from real clinical practice worldwide. Quality of life (QOL) is discussed where data are available. Our aim was to summarize the efficacy and safety of ramucirumab in the treatment of GI cancers using these existing published data with a view to demonstrating how ramucirumab may help improve treatment outcome for patients with GI cancers. The data indicate that ramucirumab is efficacious, safe, and tolerable across the intent-to-treat patient populations as a whole and across several pre-specified subgroups, even those whose disease is traditionally more difficult to treat. Furthermore, survival outcomes observed in real-world clinical practice demonstrate similar data from phase 3 clinical trials even in patients with complications, suggesting that the benefits of ramucirumab translate in actual clinical practice.

Keywords: angiogenesis; colorectal cancer; gastric cancer; gastrointestinal; hepatocellular carcinoma; ramucirumab.

Figure 1

Forest plots for subgroup analyses of (a) overall survival (OS) and (b) progression-free survival (PFS) in the randomized controlled trails (RCTs) of ramucirumab in gastrointestinal (GI] cancers. Hazard ratios (HR] and 95% confidence intervals (CI) have been calculated using a stratified Cox model unless indicated with an asterisk (*) where an unstratified Cox model was used. The size of the diamond is proportional to the size of the subgroup. Data taken from REGARD [22,29,30,31], RAINBOW [24,32,33,34], RAISE [26,35,36], REACH [27], REACH 2 and pooled analysis [28,37,38,39,40,41].

Figure 1

Forest plots for subgroup analyses of (a) overall survival (OS) and (b) progression-free survival (PFS) in the randomized controlled trails (RCTs) of ramucirumab in gastrointestinal (GI] cancers. Hazard ratios (HR] and 95% confidence intervals (CI) have been calculated using a stratified Cox model unless indicated with an asterisk (*) where an unstratified Cox model was used. The size of the diamond is proportional to the size of the subgroup. Data taken from REGARD [22,29,30,31], RAINBOW [24,32,33,34], RAISE [26,35,36], REACH [27], REACH 2 and pooled analysis [28,37,38,39,40,41].

Figure 1

Forest plots for subgroup analyses of (a) overall survival (OS) and (b) progression-free survival (PFS) in the randomized controlled trails (RCTs) of ramucirumab in gastrointestinal (GI] cancers. Hazard ratios (HR] and 95% confidence intervals (CI) have been calculated using a stratified Cox model unless indicated with an asterisk (*) where an unstratified Cox model was used. The size of the diamond is proportional to the size of the subgroup. Data taken from REGARD [22,29,30,31], RAINBOW [24,32,33,34], RAISE [26,35,36], REACH [27], REACH 2 and pooled analysis [28,37,38,39,40,41].

Figure 1

Forest plots for subgroup analyses of (a) overall survival (OS) and (b) progression-free survival (PFS) in the randomized controlled trails (RCTs) of ramucirumab in gastrointestinal (GI] cancers. Hazard ratios (HR] and 95% confidence intervals (CI) have been calculated using a stratified Cox model unless indicated with an asterisk (*) where an unstratified Cox model was used. The size of the diamond is proportional to the size of the subgroup. Data taken from REGARD [22,29,30,31], RAINBOW [24,32,33,34], RAISE [26,35,36], REACH [27], REACH 2 and pooled analysis [28,37,38,39,40,41].

Figure 1

Forest plots for subgroup analyses of (a) overall survival (OS) and (b) progression-free survival (PFS) in the randomized controlled trails (RCTs) of ramucirumab in gastrointestinal (GI] cancers. Hazard ratios (HR] and 95% confidence intervals (CI) have been calculated using a stratified Cox model unless indicated with an asterisk (*) where an unstratified Cox model was used. The size of the diamond is proportional to the size of the subgroup. Data taken from REGARD [22,29,30,31], RAINBOW [24,32,33,34], RAISE [26,35,36], REACH [27], REACH 2 and pooled analysis [28,37,38,39,40,41].

Figure 1

Forest plots for subgroup analyses of (a) overall survival (OS) and (b) progression-free survival (PFS) in the randomized controlled trails (RCTs) of ramucirumab in gastrointestinal (GI] cancers. Hazard ratios (HR] and 95% confidence intervals (CI) have been calculated using a stratified Cox model unless indicated with an asterisk (*) where an unstratified Cox model was used. The size of the diamond is proportional to the size of the subgroup. Data taken from REGARD [22,29,30,31], RAINBOW [24,32,33,34], RAISE [26,35,36], REACH [27], REACH 2 and pooled analysis [28,37,38,39,40,41].