For patients with advanced gastric cancer, second-line treatment with ramucirumab is safe and efficacious regardless of age compared with placebo, according to a study being presented at the 2017 Gastrointestinal Cancers Symposium.
The phase 3 REGARD (ClinicalTrials.gov Identifier: NCT00917384) and RAINBOW (NCT01170663) studies demonstrated significant improvements in survival with a manageable toxicity profile among patients with advanced gastric cancer who received second-line ramucirumab rather than placebo.
To examine outcomes by age, researchers assessed efficacy and the incidence of adverse events across age subgroups, including patients younger than 45 years, 45 to 70 years, 70 years or older, and 75 years or older for each clinical trial.
Among those aged 45 years or younger, patients treated with ramucirumab had a 41.4% lower risk of death in the REGARD study (hazard ratio [HR], 0.586; 95% CI, 0.274-1.257) and a 44.5% reduced risk of death in the RAINBOW study (HR, 0.555; 95% CI, 0.330-0.934). Similarly, these patients had a 41.7% (HR, 0.583; 95% CI, 0.270-1.260) and a 50.3% (HR, 0.497; 95% CI, 0.299-0.825) lower risk of progression or death in REGARD and RAINBOW, respectively.
Among patients aged 45 to 70 years, those treated with ramucirumab had a 22% decreased mortality risk (HR, 0.780; 95% CI, 0.573-1.061) and a 54.9% lower risk of progression or death (HR, 0.451; 95% CI, 0.335-0.609) compared with those who received placebo in the REGARD trial. In the RAINBOW study, patients in this subgroup who received ramucirumab had a 14% (HR, 0.860; 95% CI, 0.697-1.061) and a 35.1% (HR, 0.649; 95% CI, 0.531-0.792) reduced risk of death and progression or death, respectively.
Patients aged 70 years or older had a 27% lower risk of death (HR, 0.730; 95% CI, 0.435-1.225) and a 44.1% reduced risk of progression or death (HR, 0.559; 95% CI, 0.340-0.921) when treated with ramucirumab vs placebo in the REGARD trial. Researchers observed similar results in the RAINBOW study.
In a STEPP analysis, researchers identified no obvious patterns for differential risks with respect to efficacy or any grade adverse events.
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Although this analysis is limited by small patient numbers in some age subgroups, the findings suggest that ramucirumab is safe and efficacious regardless of age in this population.
- Muro K, Cho JY, Bodoky G, et al. Efficacy and safety of ramucirumab (RAM) for metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma across age subgroups in two global phase 3 trials. J Clin Oncol. 2017;35(suppl):4S. Abstract 3.