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ZD1839 Provides Some Clinical Benefit in Advanced Breast Cancer

ZD1839 Provides Some Clinical Benefit in Advanced Breast Cancer

CHICAGO—The novel biologic agent ZD1839 (gefitinib; Iressa) provided some
clinical benefit, and may have relieved bone pain, in heavily pretreated
patients with advanced breast cancer, according to results of a recent phase II
trial. Of 63 patients treated, 9 or 14.3% had a partial response or stable
disease, and 15% of patients remained on treatment for 4 to 8 months or longer

Some patients remained on therapy, even as disease progressed, because they
had marked relief of bone pain, said investigator Kathy S. Albain, MD,
professor of medicine at Loyola University Medical Center in Chicago. "A not
insignificant subset of patients may have achieved benefit…and additional
patients had major relief of bone pain, despite objective progression," said
Dr. Albain.

Early Clinical Data

The findings presented by Dr. Albain represent some of the first clinical
data for ZD1839 in breast cancer. ZD1839 is an inhibitor of epidermal growth
factor receptor tyrosine kinase (EGFR-TK), a key modulator of tumor cell
function. ZD1839 has already attracted considerable attention in the scientific
community and popular media for investigations in solid tumors, most notably
non-small-cell lung cancer.

In this multicenter study, 1839IL/0156, women with metastatic breast cancer
(median age 52 years) received ZD1839 at 500 mg/day until disease progression
or withdrawal due to toxicity. Twenty-seven women (43%) were hormone
receptor-positive and 50 (79%) had visceral disease.

Most of the women (49 patients, or 78%) had at least two prior chemotherapy
regimens for metastatic disease, while 34 (54%) had one or more prior hormonal
therapies. About one-third had received trastuzumab (Herceptin). In addition,
most patients also had prior adjuvant chemotherapy with or without hormonal
therapy.

Generally Well Tolerated

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