Dr. Shah on the HELOISE Study for Gastric Cancer

Manish A. Shah, MD, associate professor of Medicine, Joan and Sanford I. Weill Department of Medicine, Bartlett Family Associate Professor in Gastrointestinal Oncology, medical oncologist, Weill Cornell Medicine and New-York Presbyterian Hospital, discusses the phase IIIb HELOISE trial, which compared 2 dose regimens of trastuzumab combined with chemotherapy as a first-line treatment for patients with HER2-positive metastatic gastric/gastroesophageal junction adenocarcinoma (mGC/GEJC).

In this challenging subgroup of patients, treatment arms included loading dose trastuzumab at 8 mg/kg followed by standard trastuzumab maintenance therapy at 6 mg/kg every 3 weeks or loading dose trastuzumab at 8 mg/kg followed by high-dose trastuzumab maintenance therapy 10 mg/kg every 3 weeks until progression. Each arm was combined with cisplatin 80 mg/m² plus capecitabine 800 mg/m² in cycles 1 through 6.

Results showed that the high-dose regimen was associated with increased trastuzumab levels of concentration; however, this did not translate into an overall survival improvement, Shah explains. Additionally, no new safety events were observed. This study, though deemed to have negative findings, does demonstrate the importance of the standard of care approach, he adds.