Breaking News From Pharma & Bio Ingredients
Femara Proved Effective as Breast Cancer Treatment
Posted on 2005-12-29 11:56:00
A major trial published today in the New England Journal of Medicine (NEJM) showed that Femara(letrozole) demonstrated a significant advantage in disease-free survival* versus tamoxifen when used after surgery (adjuvant) in postmenopausal women with hormone receptor-positive early breast cancer. The results were particularly impressive for women at higher risk—with around one third less chance of disease returning in women in this group taking Femara, compared with those taking 'gold standard' tamoxifen. Because of the successful results of the study the MHRA has now approved Femara, three months earlier than expected, for the adjuvant (post surgery) treatment of early breast cancer.
"These results are fantastic news and give hope to women with breast cancer - especially those at high risk of their cancer recurring" said Nigel Bundred, Professor in Surgical Oncology, Wythenshawe Hospital, Manchester. "They show that Femara is more effective than tamoxifen when given to women after surgery and offers even greater advantages to these particularly vulnerable women."
Liz Caroll, Head of Clinical Services at Breast Cancer Care commented: "These results further suggest the benefits of using aromatase inhibitors over tamoxifen in treating early invasive breast cancer and indicate that many more lives could be saved. Many women, like those we support, with breast cancer will welcome the news that they might benefit from this new treatment option, as will the healthcare professionals treating them."
The new trial showed a 29% reduction in recurrence with Femara, compared with tamoxifen, for those women with breast cancer that had already spread to lymph nodes (node-positive early breast cancer). These patients are at the highest risk of breast cancer recurrence and are more likely to develop distant metastases (secondary tumours), increasing their risk of dying. A 28% reduction in risk of recurrence with Femara over and above the benefit seen with tamoxifen, was also seen in those women who had received chemotherapy. (Chemotherapy use indicates that these women were considered to be in a high-risk group).
In the same trial, in all women taking Femara, there was a 27% reduction in the risk of cancer spreading to other parts of the body (distant metastases) and a significant reduction (19%) in the risk of breast cancer returning when compared with those taking tamoxifen.
The data comes from the Breast International Group (BIG) 1-98 trial - one of the largest ongoing studies in this setting. BIG 1-98 is a head-to-head comparison of Femara with tamoxifen involving more than 8,000 women. This independent, international study was conducted by the International Breast Cancer Study Group (IBCSG).
Unlike some other treatments, aromatase inhibitors (AIs) are effective in all types of hormone receptor-positive breast cancer - representing around 80% of all breast cancers. With its recent license, Femara is now the only AI licensed across the entire breast cancer treatment spectrum - before surgery, directly post-surgery, after five years of standard tamoxifen treatment and in advanced cancer.
This independent, Phase III, international randomised, double-blind, controlled clinical trial enrolled more than 8,000 postmenopausal women with early breast cancer in 29 countries. The median follow-up time was 26 months. The study was supported by Novartis.
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