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Ramucirumab improved survival for gastric, gastroesophageal junction adenocarcinoma
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Patients with advanced gastric or gastroesophageal junction adenocarcinoma experienced significant survival benefits after ramucirumab monotherapy in a recent study.
In the international, double blind phase 3 REGARD trial, researchers randomly assigned 355 patients aged 24 to 87 years with metastatic or unresectable, locally recurrent gastric or gastroesophageal junction adenocarcinoma to best supportive care with placebo (n=117) or 8 mg/kg ramucirumab (n=238) intravenously once every 2 weeks. Median duration was 8 weeks among ramucirumab patients and 6 weeks for placebo recipients. All patients had experienced disease progression after first-line chemotherapy.
Ramucirumab recipients had a median overall survival of 5.2 months vs. 3.8 months among placebo recipients (P=.047). The survival benefit observed among treated participants remained significant (HR=0.774; 95% CI, 0.605-0.991) upon multivariate analysis adjusting for primary tumor location, peritoneal metastases and ECOG performance status, among other factors, and was observed across nearly all evaluated subgroups.
At data cutoff, 75% of ramucirumab and 85% of placebo recipients had died. Treated patients had a median progression-free survival of 2.1 months, compared with 1.3 months among placebo recipients. Investigators calculated a 52% risk reduction for death or disease progression after ramucirumab treatment. Ramucirumab and progression-free survival remained associated after adjustment for confounders and across almost all subgroups.
Adverse events occurred in 94% of the ramucirumab and 88% of the placebo groups. Hypertension was more frequent among ramucirumab recipients (16% vs. 8%). Death considered related to treatment occurred in five ramucirumab and two placebo patients.
“The study revives the idea that inhibition of the angiogenesis process plays an important role in gastric cancer, which can be used to achieve results in these patients,” researcher Josep Tabernero, MD, PhD, director of the Vall d’Hebron Institute of Oncology in Barcelona, Spain, said in a press release. “New studies combining ramucirumab with chemotherapy drugs in gastric cancer are making us very optimistic about the outcome of these combinations, because of the synergies between the drugs. This is likely to change the way we treat gastric cancer in the future.”
Disclosure: See the study for a full list of relevant financial disclosures.
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