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Manish A. Shah, MD, director of gastrointestinal oncology and chief of Solid Tumor Service at Weill Cornell Medicine/NewYork-Presbyterian Hospital, discusses the BRIGHTER study in patients with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
Manish A. Shah, MD, director of gastrointestinal oncology and chief of Solid Tumor Service at Weill Cornell Medicine/NewYork-Presbyterian Hospital, discusses the BRIGHTER study in patients with gastric and gastroesophageal junction (GEJ) adenocarcinoma.
BRIGHTER is a phase III clinical trial that examined the role of the stem cell inhibitor napabucasin in patients with gastric and GEJ cancers. The aim was to target STAT3 in hopes of blocking cancer stem cell self-renewal. Patients randomized to the napabucasin arm received 480 mg twice daily. Paclitaxel was administered in the standard dose of 80 mg/mg2 on days 1, 8, and 15 in a 4-week cycle.
Although the study was negative, Shah says that a biomarker analysis is being done in a subset of patients with overexpression of the STAT3 target to see if they benefited from napabucasin. Currently, there are no data in colon cancer, where the phosphorylated STAT3 group did benefit from napabucasin, Shah explains.
There is an ongoing study in the second-line evaluating chemotherapy with or without napabucasin in patients with colon cancer. Shah says that he hopes to get some data in gastric cancer that will parallel that.