Adding ramucirumab to front-line mFOLFOX6 therapy in an intent-to-treat population of patients with advanced adenocarcinoma of the esophagus or gastric/gastroesophageal junction (GEJ) does not improve progression-free survival (PFS), according to a study published in the Annals of Oncology.1
Researchers led by Harry Yoon, MD, of the Mayo Clinic in Rochester, MN, conducted a phase 2 trial of 168 patients who were randomized to mFOLFOX6 plus ramucirumab or mFOLFOX6 plus placebo.
Of the observed patients, 52% of tumors were located in the stomach or GEJ, while 48% were located in the esophagus. The primary endpoint of PFS with an 80% power to detect a hazard ratio of 0.71 was not met, nor was the secondary endpoint of overall survival.
Objective response rates were similar between the 2 groups, though premature discontinuation of therapy was more common among patients treated with ramucirumab.
Upon an exploratory analysis that accounted for premature discontinuation, a hazard ratio for PFS of 0.76 was found to have favored patients treated with ramucirumab. Patients with a higher exposure to ramucirumab were also found to have longer overall survival in an exploratory exposure-response analysis.
- Yoon HH, Bendell JC, Braiteh FS, et al. Ramucirumab combined with FOLFOX as front-line therapy for advanced esophageal, gastroesophageal junction, or gastric adenocarcinoma: a randomized, double-blind, multicenter Phase II trial. Ann Oncol. 2016 Oct 20. doi: 10.1093/annonc/mdw423 [Epub ahead of print]