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Clinical Trial Results

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  • Posted: 06/19/2009
  • Updated: 10/01/2010

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Breast Cancer Drug Helps Patients with Gastric Cancer

Adapted from the NCI Cancer Bulletin.

The breast cancer drug trastuzumab (Herceptin) has been shown to improve the survival of patients with advanced gastric cancer. The addition of trastuzumab to standard chemotherapy helped patients live longer than similar patients who received chemotherapy alone, researchers said at the 2009 annual meeting of the American Society of Clinical Oncology. (The results were subsequently published in the Aug. 28, 2010, Lancet; see the journal abstract.)

The phase III ToGA trial compared the two treatments in 594 patients whose tumors showed elevated levels of the protein HER2, which is the target of trastuzumab. Patients who received trastuzumab plus chemotherapy lived 13.8 months, compared with 11.1 months for those who received chemotherapy alone, said lead investigator Eric Van Cutsem, M.D., Ph.D., of the University Hospital Gasthuisberg in Leuven, Belgium. The results translate into a 26 percent reduction in the rate of death.

Trastuzumab is the first targeted drug to improve overall survival for patients with gastric cancer in a phase III trial, he said. And while the survival benefit was small, he added, the findings represent a rare advance in gastric cancer.

The combination treatment was well tolerated and there were no unexpected side effects in the trastuzumab group, Dr. Van Cutsem said. The rate of congestive heart failure, which is routinely monitored in trials involving trastuzumab, was similar between the groups. The incidence of decreased ventricular ejection fraction (a measure of the heart's pumping ability) was 5.9 percent in the trastuzumab group, compared with 1.1 percent in the chemotherapy-alone group. The reason for the low rate of cardiac effects, he said, may be because trastuzumab was not used in conjunction with anthracycline-based chemotherapy, which is how trastuzumab is often administered to breast cancer patients.

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