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New 4-Year Data Confirm Letrozole Cuts Risk of Breast Cancer Recurrence and Spread of Disease

Femara (letrozole tablets) reduced risk of breast cancer returning, even in women more likely to suffer recurrence – node positive patients and those who received prior chemotherapy

Four-year efficacy and safety profile in nearly 5,000 patients consistent with two-year analysis

Data trend suggest emerging benefit in women whose cancer was not found in lymph nodes at time of diagnosis

EAST HANOVER, NJ -- October 5, 2006 -- New four-year data confirm that initial treatment with Femara® (letrozole tablets) following breast cancer surgery provides significantly greater reduction in risk of recurrence and spread of cancer to distant parts of the body than tamoxifen.

Longer-term data comparing two arms of the independent Breast International Group (BIG) 1-98 trial were presented yesterday at the European Society of Medical Oncology Congress in Istanbul, Turkey, by Alan Coates, MD, Clinical Professor in the School of Public Health at the University of Sydney in Australia.

Data in the presentation was based on a median follow-up of more than four years (51 months), postmenopausal women with hormone-sensitive early breast cancer taking Femara had an 18% reduction in their overall risk of breast cancer recurrence and a 19% reduction in the risk of their cancer spreading to another part of the body. Cancer that spreads to other parts of the body increases the likelihood of a poor prognosis.

Importantly, the use of Femara resulted in substantial risk reduction in two subgroups of women who are at an increased risk of recurrence – those whose cancer had already spread to the lymph nodes at the time of diagnosis (node positive) and those who had received chemotherapy. In these groups, the risk of recurrence was reduced in the study by 23% (P =.004) and 26% (P =.03), respectively. Node negative patients and those patients who did not receive chemotherapy were also evaluated.

"It is great news to see that in patients with more than four years of median follow-up from this important trial, the results clearly confirm earlier findings that letrozole offers these women an important choice in hormonal therapy to lower the risk of breast cancer returning or spreading after surgery," said Prof. Beat Thürlimann of St. Gallen, Switzerland, and the BIG 1-98 Trial study chair. "The data also confirm a safety profile consistent with the earlier analysis."

For the first time, results from BIG 1-98 revealed an emerging data trend suggesting that Femara may benefit women with node negative disease (i.e. those whose cancer is not detected in the lymph nodes at diagnosis). In this group at 51-month median follow-up, Femara reduced the risk of breast cancer coming back by 12%, although this measure did not reach statistical significance. The original analysis at 26 months showed a 2% reduction in the same population.

The current analysis included nearly 5,000 women assigned to receive five years of continuous Femara or tamoxifen. The primary core analysis conducted after a 26-month median follow-up included women assigned to two other arms of the study, where they received Femara or tamoxifen for two years followed by three years of the other agent.

"Longer-term data out to more than four years in 5,000 women provide the most compelling evidence to date that Femara helps to reduce breast cancer relapse in postmenopausal women," said Diane Young, Vice President and Global Head of Clinical Development at Novartis Oncology. "We are committed to ongoing research that will help define optimal treatment for women with breast cancer."

Femara (letrozole tablets) is the only medicine indicated for women with hormone-dependent breast cancer taken as either initial treatment immediately after surgery and after they have completed five years of tamoxifen therapy (extended adjuvant setting).
Adverse events for both Femara and tamoxifen were consistent with previously reported results from this trial, as well as current Femara prescribing information for adjuvant treatment. The most common side effects experienced by patients taking Femara in the trial were hot flushes, fatigue, joint pain and nausea.

About BIG 1-98
BIG 1-98 is the only clinical trial that incorporates both a head-to-head comparison and a sequencing of Femara and tamoxifen as adjuvant treatment for postmenopausal women with hormone receptor-positive breast cancer. The results of the primary core analysis of the head-to-head comparison based on a median follow up of 26 months were published in the New England Journal of Medicine on December 29, 2005. The BIG 1-98 trial was conducted by the International Breast Cancer Study Group (IBCSG) with many independent centers and was supported by Novartis.

About Femara
Femara® (letrozole tablets) is a once-daily oral prescription medication approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone-receptor positive early breast cancer. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, including safety and efficacy.

Femara is also approved for the extended adjuvant treatment of early stage breast cancer in postmenopausal women who are within three months of completion of five years of tamoxifen therapy. The benefits of Femara in the extended adjuvant setting are based on 24 months of treatment. Further follow-up will need to determine long-term results, including side effects.

Femara is also approved for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. Femara is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Important Safety Information
Patients should talk to their doctor if they are allergic to Femara or any of its ingredients. Patients should not take Femara if they are pregnant as it may cause fetal harm. Patients must be postmenopausal to take Femara. Some women reported fatigue and dizziness with Femara. Until a patient knows if Femara affects them, they should use caution before driving or operating machinery. Some patients taking Femara had an increase in cholesterol. Additional follow-up is needed to determine the risk of bone fracture associated with long-term use of Femara.

In the adjuvant setting, commonly reported side effects are generally mild to moderate. Side effects that are comparable between Femara and tamoxifen include night sweats, weight gain, nausea, and tiredness. Side effects seen more often with tamoxifen vs. Femara were hot flashes and vaginal bleeding. Joint pain was experienced more often with Femara vs. tamoxifen. The incidence of stroke was 1.1% for women on Femara and 1.0% for women on tamoxifen, and the incidence of other cardiovascular events was 6.6% for Femara vs. 6.2% for tamoxifen. The percentage of women on Femara reporting bone fracture was 5.6% vs. 4% for women on tamoxifen. The percentage of women reporting osteoporosis was 2% for Femara vs. 1.1% for tamoxifen.

In the extended adjuvant setting, commonly reported side effects are generally mild to moderate. Those seen more often with Femara vs. placebo were hot flashes (50% vs. 43%), joint pain (22% vs. 18%) and muscle pain (7% vs. 5%). Other side effects, which were comparable to placebo, include fatigue (34% vs. 32%), swelling due to fluid retention (18% vs. 16%), headache (20% vs. 20%), increase in sweating (24% vs. 22%) and increase in cholesterol (16% vs. 16%). The percentage of patients on Femara vs. placebo reporting a fracture was 5.9% vs. 5.5%. The percentage of patients reporting osteoporosis was 6.9% vs. 5.5%. Bisphosphonates, drugs to increase bone strength, were given to 21.1% of Femara patients and 18.7% of placebo patients.

In the metastatic setting, commonly reported side effects are generally mild to moderate and may include bone pain, hot flashes, back pain, nausea, joint pain, shortness of breath, fatigue, coughing, constipation, limb pain, chest pain, and headache.


SOURCE: Novartis

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