Source: DGNews  |  Posted 8 years ago

SAN ANTONIO, TX -- December 5, 2003 -- Delegates at this year's San Antonio Breast Cancer Symposium today had an early glimpse of the therapeutic potential of the anti-cancer agent gefitinib (Iressa(TM), ZD1839) in the treatment of patients with advanced breast cancer.

In a phase II open-label trial, 68 patients received gefitinib 250 mg/day orally in combination with the breast cancer chemotherapy drugs paclitaxel and carboplatin (infused every 21 days for six cycles) as first-line treatment.

A clinical response was observed in 63% of patients (complete response 14%, partial response 49%) and, importantly, overall gefitinib tolerability has been favourable1.

Also presented at San Antonio were data showing that gefitinib has antiproliferative effects in ductal carcinoma in situ (DCIS) 2, a localised, pre-malignant form of breast cancer, which, if untreated, can progress to invasive disease. Results from 69 patients participating in this randomised, double-blind study show a trend of reduced cancer cell proliferation in gefitinib-treated tumours and may support the rational for EGFR inhibitors to be explored further in DCIS.

Gefitinib was well tolerated and no unexpected adverse events were observed. In addition, two pre-clinical studies3,4 indicate that gefitinib may also have a valuable role in overcoming resistance to the endocrine agent, tamoxifen, an established treatment for both early and advanced forms of the disease.

AstraZeneca's Dr. Alan Barge, Worldwide Medical Director for gefitinib, commented: "These promising early data presented here are encouraging and we are working with experts to identify the optimal role of gefitinib in advanced breast cancer," said Dr Barge. "A number of clinical trials with gefitinib in advanced breast cancer, both as monotherapy and in combination with hormonal or cytotoxic agents, have been initiated. These trials include the measurement of specific biomarkers before and after treatment to help identify those types of patients most likely to benefit from gefitinib".

About gefitinib
Gefitinib is the first in a novel class of anti-cancer drugs known as Epidermal Growth Factor Receptor (EGFR)