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In patients with HER2-positive metastatic gastroesophageal (GE) cancer, trastuzumab improves treatment response and survival when added to chemotherapy (NEJM JW Oncol Hematol Oct 2010, and Lancet 2010; 376:787). In an industry-sponsored, placebo-controlled, randomized trial, researchers have tested the efficacy of the HER2 tyrosine kinase inhibitor lapatinib for patients with GE cancer. (At trial initiation, trastuzumab had not yet been approved for HER2-positive disease.)
Patients with HER2-positive GE adenocarcinoma (confirmed by fluorescence in situ hybridization testing) received standard chemotherapy with capecitabine and oxaliplatin, plus either lapatinib or placebo. Of 487 patients in the primary efficacy population, 95% had metastati…