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Serum HER-2/neu Predicts Response to Herceptin Therapy: Presented at SABCS

By Charlene Laino

SAN ANTONIO, TX -- December 13, 2002 -- Serum human epidermal growth factor receptor 2 (HER-2/neu) is a useful marker for monitoring clinical response in patients on trastuzumab-based therapy, suggests a small retrospective analysis.

Walter Carney, PhD, Head of Oncogene Science at Bayer Corporation in Cambridge, Massachusetts, United States, spoke about the study here on December 12^th on behalf of his colleagues at Bayer Corporation and Memorial Sloan-Kettering Cancer Center in New York, New York, United States, at the 25^th Annual San Antonio Breast Cancer Symposium.

The study group comprised 37 patients who were tissue positive for HER-2/neu at diagnosis and treated with trastuzumab (Herceptin®, Genentech) at recurrence.

HER-2/neu is associated with a higher cell proliferation rate, faster metastases and greater tumour burden. Trastuzumab is a humanized version of murine monoclonal antibody that inhibits Her-2/neu.

Serum samples were drawn before the initiation of drug therapy and at various intervals during therapy, and HER-2/neu levels were measured using the Bayer Immuno 1 system. Levels equal to or greater than 15 ng/mL were considered normal on the basis of an analysis of HER-2/neu levels in the sera of 242 healthy women.

Normal longitudinal variability in serum HER-2/neu was determined to be 15 percent by analysing six serial samples from 38 normal healthy females.

A total of 291 serial samples from the patients were evaluated. For each pair of serial measurements, an increase of 15 percent or greater was considered to indicate progression, and a change of less than 15 percent was considered to indicate lack of progression.

Clinical status was assessed using World Health Organization criteria.

Of 232 serial samples taken from women whose cancer did not progress on trastuzumab therapy, 191 had changes below 15 percent (i.e., lack of progression).

"This shows that serum HER-2/neu has a good correlation with clinical disease status, predicting drug response [in 87.1 percent] of patients," Dr. Carney said.

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