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Three-week Course of Herceptin (Trastuzumab) Appears Cardio-safe: Presented at SGOC

By Robert H. Carlson

ST. GALLEN, SWITZERLAND -- March 17, 2003 -- An interim report from an ongoing trial of trastuzumab (Herceptin) is showing it is heart-safe when given as adjuvant monotherapy in women with metastatic breast cancer, even at 3 times the standard dose in a once-every-3-week schedule.

This schedule is more convenient than the approved weekly schedule, researchers said, and it is being used in the large, ongoing Herceptin Adjuvant (HERA) trial.

Cardiotoxicity is a concern with Herceptin therapy because earlier trials involving women with advanced breast cancer found that adding the antibody to anthracycline-based chemotherapy reduced left-ventricular ejection fractions (LVEF) in some patients.

During a session here at the 8^th International Conference on Primary Therapy of Early Breast Cancer, José Baselga, MD, Director of Oncology at Hospital Universitario Vall d'Hebron, Barcelona, Spain, presented the ongoing phase 2 HERA trial (WO 16229), which tested a 3-week course of Herceptin in 105 women with metastatic breast cancer that overexpressed human epidermal growth factor receptor 2 (HER2).

According to Dr. Baselga, the study's principal investigator, there has been less than a 1% incidence of symptomatic heart failure in the patients available for analysis.

Asymptomatic LVEF decreases were noted in a substantial portion of patients regardless of whether they had received prior anthracycline chemotherapy, a risk factor for Herceptin-related cardiotoxicity, Dr. Baselga said. But LVEF reductions of greater than 15% occurred in only a minority of patients.

"The incidence and severity of cardiotoxicity when Herceptin is given every 3 weeks, at 3 times the standard dose, was no higher than when it is given in the standard weekly schedule," Dr. Baselga said. "These results are reassuring for the future of the ongoing HERA trial."

Herceptin was given by intravenous infusion over 90 minutes every 3 weeks, with a first-cycle dose of 8 mg/kg followed by a median of 5 cycles at 6 mg/kg. In his presentation here, Dr. Baselga said 47% of patients had received prior anthracyclines. LVEF in this ongoing trial was measured at baseline and then every 4 weeks by multiple gated acquisition scan or echocardiography. Median LVEF was 63% at baseline.

Among the 105 women, 36 who had no prior anthracycline therapy were available for analysis. The results showed that 64% of them had a decrease of less than 15% in LVEF, 8% had a decrease of 15% or greater, and 6% had a greater than 50% decrease.

In 29 patients available for analysis who had prior anthracycline therapy, LVEF decreased by less than 15% in 55%, by 15% or greater in 17%, and by more than 50% in 14%.

"Only one patient -- a woman who had received prior anthracycline therapy -- developed symptomatic cardiac failure, which resolved after specific therapy," Dr. Baselga reported. That patient's LVEF decreased from 59% at baseline to 33% at cycle 8, he said.

No other serious treatment-related side effects were noted, he added.


[Roche Products Ltd., of Welwyn Garden City, United Kingdom, sponsored the HERA trial.]

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