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Biologic Agent May Benefit Some Breast Cancer Patients: Presented at SABCS

By Andrew Bowser

SAN ANTONIO, TX -- December 13, 2002 -- The new oral biologic agent ZD1839 (Iressa) appears to be well tolerated and have activity in some women with advanced breast cancer, according to results from a phase II trial.

The trial showed that 9 of 63 (14.3 percent) women with metastatic breast cancer had a partial response or stable disease after being treated with the drug, which inhibits a key modulator of tumour cell function, epidermal growth factor receptor-tyrosine kinase (EGFR-TK).

"A not insignificant subset of patients may have achieved benefit," said Kathy S. Albain, MD, Professor of Medicine at Loyola University Medical Center, Chicago, Illinois, United States, during her presentation here December 12^th at the 25^th Annual San Antonio Breast Cancer Symposium.

In this nonrandomised, multicentre study, women with metastatic breast cancer received ZD1839 at a dosage of 500 mg daily until their disease progressed or they withdrew from the study due to toxicity or other reasons. Many of the patients had received prior chemotherapy and hormonal therapy, and about one-third had received Herceptin (trastuzumab).

The 500-mg dose of ZD1839 was well tolerated, and short treatment interruptions reduced toxicity, Dr. Albain said. The study protocol also allowed dose reduction to 250 mg for toxicity, and the dose was reduced in four patients.

An acne-like rash occurred in 28 patients (44 percent). Serious toxicities occurred in 25 percent of patients, which mainly included diarrhoea, nausea, vomiting and rash.

Investigators used stringent criteria to assess response. Patients were considered to have a clinical benefit only if they had response or stable disease for at least 6 months. Three patients (4.8 percent) met this criterion, including one who had partial response and two who had stable disease. However, an additional six patients had stable disease for less than 6 months.

Median progression-free survival was 57 days, and median survival was 144 days at the time of this analysis. Fifteen percent stayed on treatment for 4 months or longer, and 39 patients were still alive as of this analysis.

Interestingly, some patients had major relief from bone pain, despite the fact that their cancer progressed, Dr. Albain said. While investigators consider this finding to be preliminary, 5 of the 12 patients who entered the trial with bone pain reported marked relief, and several stopped taking narcotics altogether.

"These findings support additional study of this novel agent in breast cancer, but in different settings," such as in combination with chemotherapy, or perhaps even specifically in breast cancer patients with bone pain, Dr. Albain said.

Underway are a number of molecular studies that are looking at tumour receptor expression, skin biopsies and biomarkers. Investigators hope that the results of these trials will give them a better idea of which metastatic breast cancers would be most likely to benefit from this biologic therapy, according to Dr. Albain.

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