The breast cancer drug Herceptin (trastuzumab) extends survival in certain gastric cancer patients by almost three months, according to a phase III international study.
Because research has shown that about 20 percent of gastric tumors overexpress HER2, investigators randomly assigned 594 patients with locally advanced, recurrent, or metastatic HER2-positive gastric cancer to receive chemotherapy (5-FU or Xeloda [capecitabine] and cisplatin) with or without Herceptin. Patients receiving Herceptin had a median overall survival of 13.8 months compared with 11.1 months in the chemotherapy-alone arm. For patients with the highest levels of HER2, median survival reached 16 months. Side effects were similar between the two arms, with no increased risk for heart damage, an effect sometimes seen with Herceptin.
“Based on these data, we should offer patients the option of [HER2] testing, and if they are HER2-positive … we should then offer these patients Herceptin,” said lead researcher Eric Van Cutsem, MD, PhD, of the University Hospital Gasthuisberg in Belgium, at a press briefing.
The Food and Drug Administration approved Herceptin more than a decade ago for HER2-positive breast cancer. Roche, which markets Herceptin internationally, said in a statement that it plans to file the drug for approval in advanced HER2-positive gastric cancer.