2. ONCOLOGYEDUCATION.COM ARTICLE SUMMARIES
Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a double-blind, randomised phase 3 trial
Wilke, H., et al., Lancet, doi: /S (14)

3. BACKGROUND
Ramucirumab is a novel VEGFR-2 receptor antibody that improves OS in gastric cancer when used as monotherapy in the 2nd line (REGARD trial, previously reviewed by OncologyEducation.com)
The RAINBOW study examines ramucirumab in combination with taxane.
Wilke, H., et al., Lancet, doi: /S (14)

4. *platinum plus fluoropyrimidine with or without an anthracycline
STUDY DESIGN
Primary Outcome: OS
N = 665
Ramucirumab (8 mg/kg IV on days 1 &15) + Paclitaxel (80 mg/m2 IV on days 1, 8, & 15)
28 day cycle
Patients with advanced gastric or gastro-esophageal junction adenocarcinoma with disease progression after/within 4 months of 1st Line chemotherapy*
Placebo + Paclitaxel
*platinum plus fluoropyrimidine with or without an anthracycline
Wilke, H., et al., Lancet, doi: /S (14)

5. Ramucirumab + Paclitaxel
RESULTS - EFFICACY
Ramucirumab + Paclitaxel
Placebo + Paclitaxel
Hazard Ratio
p-Value OS
9.6 mo
7.4 mo
0.807 ( )
0.0017
PFS
4.4 mo
2.9 mo
0.635
( )
p <
ORR
28%
16%
0.0001
Wilke, H., et al., Lancet, doi: /S (14)

6. RESULTS – SAFETY and QOL
Ramucirumab + Paclitaxel
Placebo + Paclitaxel
Grade III/IV Neutropenia
41%
19%
Grade III/IV Leucopenia
17% 7%
Grade III/IV Hypertension
14% 2%
Grade III/IV Fatigue
12% 5%
Grade III/IV Anaemia 9%
10%
Grade III/IV Abdominal Pain 6% 3%
Grade III/IV Febrile Neutropenia
Wilke, H., et al., Lancet, doi: /S (14)

7. SUMMARY
The RAINBOW trial has shown that the addition of ramucirumab to weekly paclitaxel produces a modest improvement in OS.
Wilke, H., et al., Lancet, doi: /S (14)

8. COMMENTARY
Clinicians will need to discuss with their patients whether the modest benefit (OS difference 2.2m, HR 0.8) observed justifies ramucirumab’s increased toxicity.
Wilke, H., et al., Lancet, doi: /S (14)