Study Demonstrates Trastuzumab With Chemotherapy Increases Survival.

2001 APR 5 - (NewsRx.com & NewsRx.net) -- Genentech, Inc., announced March 14, 2001, that women with one of the most aggressive forms of metastatic breast cancer experienced a significant survival benefit when treated initially with Herceptin (Trastuzumab) and chemotherapy, compared to women treated with chemotherapy alone.

The findings, published in the New England Journal of Medicine, are based on the final results of a pivotal trial in women with HER2 (human epidermal growth factor receptor 2) positive metastatic breast cancer - a fast-growing and deadly form of the disease with approximately half the life expectancy of women with HER2 negative breast cancer.

"Herceptin represents a turning point in the treatment of breast cancer. The study results demonstrate that this targeted biologic approach is an important new treatment modality for metastatic breast cancer," said Dennis J. Slamon, MD, PhD, the study's lead author and chief of the Division of Hematology and Oncology at the University of California, Los Angeles, Jonsson Comprehensive Cancer Center. "These results confirm that Herceptin with chemotherapy used as a first-line therapy offers women with HER2 positive metastatic breast cancer their best chance at increasing survival."

In an accompanying editorial, Elizabeth A. Eisenhauer, MD, of Queen's University, Kingston, Ontario, called the Herceptin study by Slamon and colleagues a "landmark trial," and she concluded, "This is the beginning of an important new era in cancer treatment since many more targeted therapies are now undergoing clinical evaluation."

Larry Norton, MD, the study's senior author and head, Division of Solid Tumor Oncology at Memorial Sloan-Kettering Cancer Center commented: "The exciting results of this prospective, randomized study demonstrate the value of clinical trials in translating important laboratory observations into actual therapies that extend and save lives."

Final results from this pivotal Phase III trial of 469 women showed that those treated weekly with Herceptin and standard cycles of chemotherapy (anthracycline and cyclophosphamide (AC) or paclitaxel) as a first-line therapy had a 24% increase in median overall survival - almost five months (median 25.1 months compared to 20.3 months) - as compared to women treated with chemotherapy alone.

In this pivotal trial the increased efficacy with Herceptin was observed in both Herceptin plus chemotherapy subgroups. The combination of Herceptin and chemotherapy ...