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Adapted from the NCI Cancer Bulletin, vol. 6/no. 11, June 2, 2009 (see the current issue ³).

The breast cancer drug trastuzumab ⁴ (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 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.

Glossary Terms

A type of antibiotic that comes from certain types of Streptomyces bacteria. Anthracyclines are used to treat many types of cancer. Anthracyclines damage the DNA in cancer cells, causing them to die. Daunorubicin, doxorubicin, and epirubicin are anthracyclines.

A protein involved in normal cell growth. It is found on some types of cancer cells, including breast and ovarian. Cancer cells removed from the body may be tested for the presence of HER2/neu to help decide the best type of treatment. HER2/neu is a type of receptor tyrosine kinase. Also called c-erbB-2, human EGF receptor 2, and human epidermal growth factor receptor 2.

The percentage of people in a study or treatment group who are alive for a certain period of time after they were diagnosed with or treated for a disease, such as cancer. The overall survival rate is often stated as a five-year survival rate, which is the percentage of people in a study or treatment group who are alive five years after diagnosis or treatment. Also called survival rate.

A study to compare the results of people taking a new treatment with the results of people taking the standard treatment (for example, which group has better survival rates or fewer side effects). In most cases, studies move into phase III only after a treatment seems to work in phases I and II. Phase III trials may include hundreds of people.