The investigational targeted agent ramucirumab prolongs survival in patients with advanced gastric cancer after standard treatments have failed, according to the results of a study published early online in The Lancet.
Gastric cancer refers to cancer of the stomach. Though gastric cancer has a relatively low incidence in the United States, it is the second leading cause of cancer death worldwide. The incidence of gastric cancer is quite high in Asian countries such as Korea, China, Taiwan, and Japan. Treatment of gastric cancer typically involves surgical removal of the cancer followed by the use of chemotherapy with or without radiation therapy.
Ramucirumab is a type of targeted agent known as a monoclonal antibody. It blocks VEGFR-2 and starves tumors of nutrients needed to grow.
Researchers conducted an international, double-blind, placebo-controlled, phase III trial known as the REGARD trial. It involved 472 patients with advanced gastric or gastroesophageal junction cancer who were treated at 119 medical centers in 29 countries. Patients were randomly assigned to receive ramucirumab every two weeks plus best supportive care (n = 355) or placebo plus best supportive care (n = 117).
Median overall survival was 5.2 months in the ramucirumab group compared with 3.8 months in the placebo group. The survival benefit with ramucirumab remained unchanged after multivariable adjustment for other prognostic factors. The estimated survival at six months was 41.8 percent in patients receiving ramucirumab and 31.6 percent in the patients who received placebo.
The drug delayed progression of the cancer by 52 percent. Patients treated with ramucirumab had a 12-week progression-free survival of 40 percent compared to 16 percent for the placebo group. The researchers reported that the disease was under control for a median of 4.2 months with ramucirumab and for 2.9 months in the placebo group.
Adverse events were mostly similar between the two groups; however, patients in the ramucirumab group had higher rates of hypertension—16 percent versus 8 percent.
The researchers concluded that ramucirumab prolonged survival in patients with advanced gastric cancer after other treatments had failed. It is the first biological treatment given has a single drug to show survival benefit in this population.
Fuchs CS, Tomasek J, Yong CJ, et al. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. The Lancet. Published early online October 3, 2013. doi:10.1016/S0140-6736(13)61719-5
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