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Gefitinib (Iressa) Shown to Prolong Survival and Improve Quality of Life in Women with Recurrent Metastatic Breast Cancer: Presented at ECCO

By Cameron Johnston

COPENHAGEN, DENMARK -- September 29, 2003 -- Therapy with gefitinib (Iressa) has pushed median overall survival out to almost a year for women with recurrent metastatic breast cancer who have already failed heavy courses of other chemotherapeutic agents. This finding was reported here September 23^rd at ECCO 12: The European Cancer Conference.

In one of the first trials to look at the use of this drug in the treatment of breast cancer, it was found that these women had symptom improvements, an acceptable quality of life and minimal toxicities for the time they were taking the drug.

The open-label, non-randomised study was conducted among 58 women at the Klinikum der JWG-Universitaet, Frankfurt, Germany. The principal investigator was Gunter von Minckwitz, MD, at the university's Centre for Women's Health.

The women were all very sick with the disease at the time of enrolment, said Dr. von Minckwitz. Two-thirds had already tried and failed at least 3 courses of other therapies, including both anthracyclines and taxanes. More than half the women already had liver metastases, and 36% had bone metastases.

Patients received 500 mg/day of gefitinib until there was disease progression or they withdrew their consent, or until 6 months after the last patient was enrolled in the study.

Median time to progression was 84 days (range 62 to 92 days) and median overall survival was 357 days (range 257 to 441 days).

Adverse events were relatively mild, with 8.6% experiencing grade 3/4 diarrhoea and fewer than 2% each experiencing events such as leukopenia, wound injury, asthenia, and exanthema. Twenty-two percent required some dose reduction or interruption.

There were substantial improvements in quality of life among many of these patients. Even after their cancer had begun to recur, 30.8% of the 52 participants continued to show quality of life improvements on 2 well-validated measurements, Dr. von Minckwitz said.

He noted that, although gefitinib is an epithelial growth factor receptor inhibitor, these study results did not show any correlation between outcomes and the epidermal growth factor receptor (EGFR) status of the patient's primary tumour. This, according to the researchers, is consistent with the findings seen in non-small-cell lung cancer studies, which showed that EGFR status was not useful as a predictor of response to gefitinib.

In future trials, however, investigators would do well to look at EGFR status at the time of enrolment, rather than simply looking at the histological samples of the women's tumours, the researchers suggested.


[Study title: A Multicentre Phase II Trial to Evaluate Gefitinib (Iressa, ZD1839) (500 Mg/Day) in Patients with Metastatic Breast Cancer after Previous Chemotherap . Abstract 437]

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