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Bending the Curve Trial by Trial
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RAINBOW

A Study of Paclitaxel With or Without Ramucirumab (IMC-1211B) in Metastatic Gastric Adenocarcinoma

Phase 3N = 665NCT01170663

Population
Patients aged 18 years or older with advanced gastric or gastro-oesophageal junction adenocarcinoma and disease progression on or within 4 months after first-line chemotherapy (platinum plus fluoropyrimidine with or without an anthracycline).
Design
Randomised placebo-controlled double-blind phase 3 trial at 170 centres in 27 countries, 1:1 to ramucirumab 8 mg/kg or placebo intravenously on days 1 and 15, plus paclitaxel 80 mg/m2 intravenously on days 1, 8 and 15 of a 28-day cycle; permuted block randomisation stratified by region, time to progression on first-line therapy and disease measurability. Primary endpoint: overall survival, analysed by intention to treat.
Primary endpoint
OS
Arms
  • Placebo plus paclitaxel (control, n = 335): Placebo with paclitaxel 80 mg/m2 on days 1, 8 and 15 of a 28-day cycle
  • Ramucirumab plus paclitaxel (experimental, n = 330): Ramucirumab 8 mg/kg on days 1 and 15 with the same paclitaxel
People
Wilke H, RAINBOW Study Group
OSHR 0.807 (95% CI 0.678–0.962)Δ median OS+2.2 months
Show the numbers
Results reported for RAINBOW
EndpointAnalysisRamucirumab plus paclitaxelPlacebo plus paclitaxelEffect
OSprimaryWilke 2014median 9.6 months (8.5–10.8)median 7.4 months (6.3–8.4)HR 0.807 (95% CI 0.678–0.962)P=0.017Grade 3 or higher hypertension 14% (46 of 327 patients) with ramucirumab plus paclitaxel versus 2% (8 of 329) with placebo plus paclitaxel; neutropenia 41% versus 19%.
Results reported for RAINBOW
EndpointAnalysisRamucirumab plus paclitaxelPlacebo plus paclitaxelEffect
OSprimaryWilke 2014median 9.6 months (8.5–10.8)median 7.4 months (6.3–8.4)HR 0.807 (95% CI 0.678–0.962)P=0.017Grade 3 or higher hypertension 14% (46 of 327 patients) with ramucirumab plus paclitaxel versus 2% (8 of 329) with placebo plus paclitaxel; neutropenia 41% versus 19%.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS0.8070.678–0.962
Illustrative — modelled from reported values, not trial data. OS, primary.
0%25%50%75%100%05101520Months (modelled)
  • Ramucirumab plus paclitaxel (experimental)
  • Placebo plus paclitaxel (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsRamucirumab plus paclitaxelPlacebo plus paclitaxel
0100.0%100.0%
664.8%57.0%
1242.0%32.5%
1827.3%18.5%
2417.7%10.6%
Primary publication: Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, et al. 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. Lancet Oncol. 2014;15(11):1224-35. PubMedDOI

Appears in

Sources

  1. Wilke H, Muro K, Van Cutsem E, Oh SC, Bodoky G, Shimada Y, et al. 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. Lancet Oncol. 2014;15(11):1224-35.

    PubMedDOI