Source: Spine  |  Posted 10 years ago

A combination of weekly paclitaxel and trastuzumab is a safe and active regimen for patients with HER-2/neu overexpressing advanced breast cancer.

After 12 weeks of treatment, significant proportions of study patients receiving the regimen achieved complete or partial responses, report oncologists in Athens and other centres in Greece.

They noted that weekly paclitaxel had been shown to be highly active and well tolerated in patients with advanced breast cancer. Clinical trials with trastuzumab, a humanised anti-p185 HER-2/neu monoclonal antibody, had shown it to produce objective responses.

The oncologists recruited 34 patients with HER-2/neu overexpressing advanced breast cancer. The patients received weekly paclitaxel 90 mg/m? given by one-hour infusion immediately followed by trastuzumab 4 mg/kg as a loading dose and 2 mg/kg given intravenously over 30 minutes and thereafter weekly for at least 12 weeks.

Expression of HER-2/neu was determined by immunohistochemical analysis on fixed, paraffin-embedded tissues. Eligible patients were required to have 325 percent stained tumour cells. All but one of the 34 patients completed at least 12 weeks of combined treatment.

After 12 weeks of treatment, four patients (12.1 percent) achieved complete and 17 (51.5 percent) achieved partial response. The median duration of response was 11.6 months.

The most frequent side-effects included anaemia (56 percent), neutropenia (27 percent), peripheral neuropathy (78 percent), diarrhoea (30 percent), alopecia (70 percent), arthralgias/myalgias (62 percent), fatigue (59 percent) and hypersensitivity reactions (62 percent).

The median time to progression was nine months. Median survival had not been reached, the oncologists said.

The researchers considered that their findings justified randomised phase III studies with the paclitaxel-trastuzumab combination.