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First-Line Weekly Paclitaxel Plus Trastuzumab Safely Tops Paclitaxel Monotherapy in Metastatic Breast Cancer With High HER2 Expression: Presented at SABCS

By Bruce Sylvester

SAN ANTONIO, TX -- December 5, 2003 -- Addition of trastuzumab (Herceptin) to first-line weekly paclitaxel (Taxol) treatment improves therapeutic response among women with metastatic breast cancer with high levels of HER2 or with visceral disease, Italian researchers report.

"We know that paclitaxel is efficacious and well-tolerated in patients with metastatic breast cancer," co-investigator Allesandro Morabito, MD, clinical oncologist, San Filippo Neri Hospital, Rome, said here on December 4^th at the 26^th Annual San Antonio Breast Cancer Symposium.

"We wanted to see whether a combination treatment with trastuzumab would produce an even better result among patients with HER2 high expression," he explained. "We found that both paclitaxel monotherapy and paclitaxel-plus-trastuzumab had high response rates."

Eighty-nine subjects were enrolled in this ongoing study as of April of 2003. Enrolleees must have untreated metastatic breast cancer with HER-2/neu overexpression (2+/3+ by HercepTest), be 18 to 70 years old, have adequate organ function and be scale 2 on the Eastern Cooperative Oncology Group Performance Status Scale (ECOG PS).

The treatment schedules in the trial are weekly paclitaxel 80 mg/m² (Arm A) and paclitaxel plus trastuzumab, loading dose of 4mg/kg, followed by weekly doses of 2 mg/kg (Arm B).

So far, 34 subjects in arm A and 43 in arm B have been evaluable for response and/or side effects, with a median age of 53 years (30-69). Tumor involvement in two sites has been reported in 61.8% of Arm A and 51.2% of Arm B; visceral disease was reported in 79.4% of Arm A and 69.8% of Arm B. Median number of treatment cycles for both groups was 17.

Treatment has been well tolerated in both groups. The investigators reported grade 3 neuropathy at 3.1% in arm A and 2.3% in arm B, grade 3 neutropenia at 12.5% in arm A and 14.2% in arm B, with no grade 4 in either group. Left ventricular ejection fraction did not change significantly in either group, and investigators reported no symptomatic cardiac events.

So far, 24 subjects in Arm A and 38 in Arm B have been evaluated for response to treatment. Overall response (70.8% versus 73.7%, respectively) and preliminary median time to progression (171 versus-198 days) were similar in both groups. However the combination arm showed a higher overall response than monotherapy among subjects with HER2 3+ (83.4% versus 62.6%) or with visceral disease 74.1% versus 63.2%).

The authors concluded that both treatments are "feasible and active as first-line therapy of HER-2/neu positive [metastatic disease]."

Dr. Morabito added, "The paclitaxel-plus-trastuzumab response was significantly higher than monotherapy. And this difference was more significant in patients with visceral disease pretreated with anthracycline and in patients with HER2 high expression. We also found that the combination therapy caused no increase in toxicity."

The study is ongoing.


[Study title: Preliminary clinical results of a randomized phase IIb study of weekly paclitaxel (PCT) trastuzumab (T) as first-line therapy of patients (pts) with HER2/neu positive metastatic breast cancer (MBC). Abstract 227]

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