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Responses to Anti-HER2 MoAb Seen

Responses to Anti-HER2 MoAb Seen

ASCO LOS ANGELES--Two multi-institutional phase II studies of recombinant human anti-HER2/NEU antibody (rhuMAb HER2) in heavily pretreated stage IV breast cancer patients show some impressive responses, including some hepatic responses and a 25% response rate in patients given the antibody plus cisplatin (Platinol).

The antibody is directed at the product of the HER2 oncogene, a growth factor receptor, which is overexpressed in 30% of primary breast cancers and is associated with worse prognosis, said Jose Baselga, MD, of Memorial Sloan-Kettering Cancer Center.

As monotherapy in 43 patients, the antibody produced one complete and four partial responses (11.6%), including hepatic responses, Dr. Baselga said. Response duration ranged from 1 month to a still ongoing complete response at 23 months. The agent was well tolerated.

In the combination trial, presented by Dr. M. Pegram of UCLA, 9 of 36 evaluable patients responded, all with partial responses (median duration, 5.3 months).

This compares favorably with studies of single-agent cisplatin in similar patient populations, Dr. Pegram said. Of five such studies in the literature, the overall response rate was about 7% and responses were of brief duration.

A phase III trial is ongoing in which patients with measurable metastatic breast cancer will receive as front-line therapy a standard regimen based on cyclophosphamide and doxorubicin. In addition, they will be randomized to receive as concurrent therapy either weekly placebo or antibody to HER2.

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