Basel, 2 June 2003 - Extended pre-operative treatment with Femara (letrozole tablets) of post-menopausal women with locally advanced primary breast cancer was found to further reduce the size of tumors than a shorter 4-month course of Femara, according to data presented today at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, USA.
Study Details
The data demonstrated that Femara is highly effective primary systemic (pre-operative) treatment when taken for 4-to-8 months prior to surgery. In this trial, treatment resulted in a mean reduction in tumor size of 68%, which ultimately allowed 67% of patients to undergo breast-conserving surgery (BCS) during the timeframe evaluated. In addition to the significant reduction in mean tumor size, 6% of patients experienced a complete response; 64% had a partial response; and 13% had a minor response. In those women that had responded within the first 4 months, longer treatment led to a further reduction in tumor size. Based on these findings, the authors state that with additional research, prolonging pre-operative treatment with Femara could become an important therapeutic option.
The open clinical trial included 33 postmenopausal patients from six centers in Germany. At the start of the study, all participants had primary invasive ER/PgR positive breast cancer, and tumors that were deemed ineligible for BCS due to their size. Participants received Femara 2.5 mg daily for a minimum of four months and a maximum of eight months prior to surgery. Tumor assessment was performed monthly by clinical examination, mammography and ultrasound. The study was initiated after a larger, multinational trial in 324 patients had previously reported that after four months of treatment, 45% of patients on Femara were candidates for BCS, compared with 35% of those taking tamoxifen (P=0.022).
About Femara
Femara, an aromatase inhibitor, is an oral once-a-day first-line treatment for postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer. It is also approved for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy, and as neo-adjuvant (pre-operative) therapy. Femara is currently available in more than 75 countries worldwide. Not all indications are available in every country.
Femara Contraindications and Adverse Events
Femara is contraindicated in patients with known hypersensitivity to Femara or any of its excipients. Femara is generally well tolerated. In a first-line registration trial versus the antiestrogen tamoxifen, the most commonly reported adverse events for Femara were bone pain (22% vs. 21%), hot flushes (19% vs. 16%), back pain (18% vs. 19%), nausea (17% vs. 17%), dyspnea or labored breathing (18% vs. 17%), arthralgia (16% vs. 15%), fatigue (13% vs. 13%), coughing (13% vs. 13%), constipation (10% vs. 11%), chest pain (6% vs. 6%) and headache (8% vs. 6%). Femara may cause fetal harm when administered to pregnant women. There is no clinical experience to date on the use of Femara in combination with other anticancer agents. The incidence of peripheral thromboembolic events, cardiovascular events, and cerebrovascular events was 3-4% in each treatment arm.
The foregoing release contains forward-looking statements that can be identified by terminology such as "chance," "could become," or similar expressions, or by express or implied discussions regarding potential new indications for Femara or potential future sales of Femara, or regarding the long-term impact of a patient's use of Femara. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Femara to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantee that Femara will be approved for any additional indications in any market. Nor can there be any guarantee regarding potential future sales of Femara. Neither can there be any guarantee regarding the long-term impact of a patient's use of Femara. In particular, management's expectations regarding commercialization of Femara could be affected by, among other things, additional analysis of Femara clinical data; new clinical data; unexpected clinical trial results; unexpected regulatory actions or delays or government regulation generally; the company's ability to obtain or maintain patent or other proprietary intellectual property protection; competition in general; increased government pricing pressures; and other risks and factors referred to in the Company's current Form 20-F on file with the US Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those anticipated, believed, estimated or expected.
Novartis AG (NYSE: NVS) is a world leader in pharmaceuticals and consumer health. In 2002, the Group's businesses achieved sales of USD 20.9 billion and a net income of USD 4.7 billion. The Group invested approximately USD 2.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis Group companies employ about 77 200 people and operate in over 140 countries around the world. For further information please consult http://www.novartis.com.
ABSTRACT # 103718
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