According to the results of a Phase III clinical trial presented at the 2009 annual meeting of the American Society of Clinical Oncology (ASCO), treatment with a combination of chemotherapy and the targeted drug Herceptin® (trastuzumab) results in better survival than chemotherapy alone among patients with advanced, HER2-positive gastric (stomach) cancer.
Gastric cancer develops in the lining of the stomach. Each year in the United States, there are approximately 21,000 new diagnoses of gastric cancer and 11,000 deaths from the disease.
Herceptin is a targeted therapy that has made important contributions to improved outcomes among women with HER2-positive breast cancer. The HER2 pathway is a biological pathway involved in cellular replication and growth. Approximately 20-25% of breast cancers overexpress the HER2 protein and are referred to as HER2-positive. Herceptin targets and blocks the HER2-protein, and is used for the treatment of both early-stage and more advanced HER2-positive breast cancer.
HER2 overexpression occurs roughly as often in gastric cancer as it does in breast cancer. To evaluate the safety and efficacy of Herceptin among patients with HER2-positive gastric cancer, researchers conducted a Phase III clinical trial. The study enrolled 594 patients with locally advanced, recurrent, or metastatic HER2-positive gastric cancer.
Study participants were assigned to receive either chemotherapy alone or chemotherapy plus Herceptin. Chemotherapy consisted of 5-fluorouracil or Xeloda® (capecitabine) and cisplatin.
In a prepared statement, the lead researcher on the study noted: “This is the first phase III study to report improved overall survival with a personalized, targeted treatment for gastric cancer. These data indicate that [Herceptin] has the potential to have a place in the treatment of a cancer other than breast cancer, and to become a common treatment for gastric cancer patients who are candidates for this drug.”
Reference: Van Cutsem E, Kang Y, Chung H et al. Efficacy results from the ToGA trial: a Phase III study of trastuzumab added to standard chemotherapy (CT) in first-line human epidermal growth factor receptor 2 (HER2)-positive advanced gastric cancer (GC). Presented at the 2009 annual meeting of the American Society of Clinical Oncology, May 29-June 2, 2009, Orlando, FL. Abstract LBA4509.