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Positive Effects of Herceptin on Breast Cancer Outcomes Unrelated to Cardiac Dysfunction: Presented at SABCS

By Robert H. Carlson

SAN ANTONIO, TX -- December 13, 2001 -- The monoclonal antibody Herceptin (trastuzumab) can enhance the clinical benefit of chemotherapy in women with advanced breast cancer.

The benefits of Herceptin extend even to those women who develop cardiac dysfunction, according to researchers at the University of California at San Francisco (UCSF), in San Francisco, California, and Memorial Sloan-Kettering Cancer Center, in New York, New York.

Publication in 1998 of a pivotal trial on Herceptin, which led to the drug's approval in the United States, established its positive effects on time to progression, response, and survival, when used with chemotherapy in women with metastatic breast cancer that is positive for human epidermal growth factor receptor 2 (HER2).

That trial also showed that Herceptin treatment was associated with cardiac dysfunctions, such as congestive heart failure and decreased left-ventricular ejection fraction.

However, a new retrospective analysis of the pivotal 1998 trial has found that clinical improvements in women taking the drug occurred despite any development of cardiac dysfunction.

Debu Tripathy, MD, an associate professor of medicine at UCSF and first author of the new study, reported on the outcomes of 469 patients at the 24^th Annual San Antonio Breast Cancer Symposium, in San Antonio, Texas.

In the original trial, he noted, cardiac dysfunction occurred at greatest frequency (27 percent) in patients simultaneously receiving an anthracycline and Herceptin, compared with 8 percent in patients receiving an anthracycline alone. Cardiac dysfunction was less common and less severe in patients treated with paclitaxel and Herceptin -- 13 percent versus 1 percent of patients receiving paclitaxel alone.

In the latest study, Dr. Tripathy and colleagues found that 75 percent of patients who experienced cardiac dysfunction improved with treatment for congestive heart failure, and 77 percent of these patients continued to receive treatment for a median of 25 weeks.

Thirty-three patients who developed cardiac dysfunction continued to receive Herceptin, and 64 percent of these patients did not experience further deterioration of cardiac dysfunction.

Dr. Tripathy said therapy with Herceptin improved time to cancer-treatment failure even in patients with New York Heart Association (NYHA) grade 3 or 4 cardiac dysfunction, which did not improve to less than grade 3 with treatment.

"These results suggest that risk-benefit considerations in the metastatic disease setting favor the use of Herceptin plus paclitaxel in this patient population," Dr. Tripathy concluded.

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