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Trastuzumab Used as First-Line Therapy in Women Whose Cancer Has Metastasized: Presented at SABCS

By Cameron Johnston

SAN ANTONIO, TX -- December 12, 2005 -- Trastuzumab (Herceptin) used as first-line therapy in women whose breast cancer has metastasized provides much the same time to progression and overall survival as what has been seen in other studies using trastuzumab in combination with either docetaxel or paclitaxel.

The study involved 643 patents, 221 of whom were available for final evaluation. All patients were HER2-positive and their cancers had metastasized despite treatment with adjuvant therapies that included surgery, radiation, hormonal therapy, and chemotherapy.

Once their cancer had metastasized, patients were not given hormonal or palliative therapy. Trastuzumab was given in combination with commonly available agents, since this was intended to be a "real-life" study. Such agents included paclitaxel and docetaxel, vinorelbine, capecitabine cisplatin, and doxorubicin.

Lead author Moise Namer, MD, department of medical oncology and surgery, Centre Antoine Lacassagne, Nice, France, reported the results here on December 9^th at the 28^th Annual San Antonio Breast Cancer Symposium (SABCS).

After a mean follow-up of 24.4 months, the median time to progression was 314 days (range 1-1092 days). Disease progressed in 184 patients (83%). Sixty percent of patients continued to receive trastuzumab after disease progression, 30% stopped taking the drug once progression was identified, and 10% had stopped the drug at least 30 days prior to progression.

Mean overall survival from the time patients initiated trastuzumab to death from any cause was 923 days, or 30.3 months. In all, 106 deaths (48%) occurred within the minimum follow-up of 2 years.

Adverse effects with trastuzumab were primarily cardiac in nature. Sixteen percent of patients had left ventricular ejection fraction (LVEF) of less than 50% and 3% had LVEF of less than 40%. Sixteen cardiac events, including 6 cases of heart failure, were recorded in 14 patients.

The results of this study were similar to what has been seen in other studies in which mean time to progression varied between 11.7 and 7.1 months, according to the investigators. Overall survival in other studies varied between 28.8 months and 31.2 months. Cardiac adverse events were seen in more than 8% of patients in 1 previous study.

These findings are important because they show that trastuzumab can be effective and provide encouraging survival data among patents whose disease has spread to other areas of the body, Dr. Namer said.

He noted that the findings confirm other study results, including cardiac safety data, and therefore, suggest that this regimen can be continued in patients whose disease is no longer responsive to other therapies.


[Presentation title: Effect of Trastuzumab Treatment as First-Line on Metastatic Breast Cancer: Final Results of the French HERMINE Cohort After 2-Year Follow-Up (N = 221). Abstract 2036]

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