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First-Line Treatment With Herceptin Improves Outcomes in Early-Stage HER-2-Positive Breast Cancer: Presented at SABCS

By Ed Susman

SAN ANTONIO, TX -- December 9, 2005 -- The use of trastuzumab (Herceptin) in combination with standard adjuvant breast cancer treatment results in statistically significant greater disease-free survival when compared with a regimen that did not include the targeted therapy.

The women in the study were diagnosed with early-stage breast cancer that was positive for HER-2 gene overexpression -- Herceptin is targeted specifically at breast cancer in which there is HER-2 overexpression.

"At 23 month median follow-up, doxorubicin plus cyclophosphamide and docetaxel and trastuzumab, and the regimen of trastuzumab, carboplatin, and docetaxel provide benefits over the standard treatment of doxorubicin plus cyclophosphamide and docetaxel," said Dennis Slamon, MD, director, clinical and translational research, Jonsson Comprehensive Cancer Center, University of California, Los Angeles, California.

The planned interim look at the data in The Breast Cancer International Research Group (BCIRG) 006 study indicated a relapse-free rate of 73% among 1075 women on the anthracycline regimen without trastuzumab, 80% in 1074 women who were taking the nonanthracycline regimen, and 84% in 1073 women taking the anthracycline regimen plus trastuzumab.

Dr. Slamon said 147 women on standard treatment had breast cancer recurrence events, compared with 77 patients getting the same treatment plus trastuzumab and 98 patients on the anthracycline-sparing treatment. He said those differences between the standard treatment and the trastuzumab regimes were highly significant. The difference between the 2 anthracycline-based treatments reached significance at the P = .0000005 level; and between the standard regimen and the nonanthracycline regimen with trastuzumab reached significance at the P = .000153 level.

He noted that previous trials had found what appeared to be an association between the combination of trastuzumab and anthracyclines and congestive heart failure. That association was also seen in the BCIRG trial. "The phenomenon is real and it is long lasting," Dr. Slamon said during his oral presentation on December 8^th at the 28^th Annual San Antonio Breast Cancer Symposium (SABCS).

Three patients on the standard regimen and 4 on the nonanthracycline regimens developed left ventricular dysfunction. There were 17 patients on doxorubicin and trastuzumab who developed left ventricular dysfunction that persisted for several months.

Dr. Slamon said it is too early in the data analysis to make any recommendations for or against use or nonuse of either of the trastuzumab regimens. He said other intriguing analyses of the data show that further molecule studies of the patients could indicate which patients are the best for individualized treatment.


[Presentation title: Phase III Randomized Trial Comparing Doxorubicin and Cyclophosphamide Followed by Docetaxel and Trastuzumab With Docetaxel, Carboplatin and Trastuzumab in HER2 Positive Early Abreast Cancer Patients: BCIRG 006 Study. Abstract 1]

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