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Gefitinib (Iressa, Zd1839) Demonstrates Early Promise in Advanced Breast Cancer: Presented at SABCS

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) – Tyrosine Kinase (EGFR-TK) inhibitors. It is administered as a once-daily, oral tablet. As shown in the pivotal IDEAL studies5,6, gefitinib at 250mg/day can produce dramatic benefits in patients with refractory NSCLC for whom no other treatment options exist, while avoiding the adverse effects associated with conventional chemotherapy. The most common side effects with gefitinib – skin rash and diarrhoea – are typically mild and reversible. Gefitinib has been approved for the treatment of advanced NSCLC in 10 countries including the US and Japan, and is currently undergoing review with several other regulatory authorities worldwide. More than 100,000 patients have received gefitinib worldwide and AstraZeneca is committed to further investigating the potential for this novel treatment in multiple tumour and disease settings.

References
1. Fountzilas G, Pectasides D, Skarlos CV et al. Paclitaxel, carboplatin and gefitinib ('Iressa', ZD1839) as first-line chemotherapy in patients with advanced breast cancer: a phase II study. Poster 357. Presented on 4 December at 26th San Antonio Breast Cancer Symposium, 2003.
2. Bundred NJ, Anderson EA, Gee J et al. Randomised, double-blind, placebo-controlled trial of short-term effects of gefitinib ('Iressa', ZD1839) on ductal carcinoma in situ. Presented on 3 December at 26th San Antonio Breast Cancer Symposium, 2003.
3. Bharwani L, Schiff R, Mohsin SK et al. Inhibiting the EGFR / HER2 pathway with gefitinib and / or trastuzumab restores tamoxifen sensitivity in HER2-overexpressing tumours. Presented on 5 December at 26th San Antonio Breast Cancer Symposium, 2003.
4. Britton DJ, Hutcheson IR, Barrow D et al. Estrogen receptor phosphorylation in hormone sensitive and anti-hormone resistant breast cancer cells. Poster 259. Presented on 4 December at 26th San Antonio Breast Cancer Symposium, 2003.
5. Fukuoka M et al. A multi-institutional randomized phase II trial of ZD1839 ('Iressa') for previously treated patients with advanced Non-Small Cell Lung Cancer (the IDEAL 1 Trial). Journal of Clinical Oncology, 21 (12), 2237-2246.
6. Kris M et al. Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small-cell lung cancer. A randomized trial. JAMA, 2003;290(16):2149-2158.


SOURCE: AstraZeneca

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