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Published on 1 May 2007

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Letrozole boosts chances in postmenopausal early breast cancer relapse

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Postmenopausal women with hormone-sensitive early breast cancertreated with letrozole (Femara®) after two years of postsurgicaltherapy experienced 30% fewer early breast cancer recurrences at sitesaway from the breast (distant metastases) compared with tamoxifen,according to research just published.

The spread of breastcancer to other parts of the body means that it is extremely likelythat a woman will die from the disease. Recurrences that occur locally,regionally or contralaterally are more easily treated than those thatspread far from the original tumour and they are associated with betterlong-term outcomes.

In the retrospective analysis of morethan 7,700 women at a median follow-up of two years, some 75% of earlyrecurrences occurred at distant sites such as bone or vital organs.However, there were 30% fewer distant recurrences in the Femara groupthan the tamoxifen group (87 vs 125, respectively).

MariaLeadbeater, secondary breast cancer nurse specialist at UK charityBreast Cancer Care, commented: “Breast Cancer Care speaks to women withbreast cancer daily and knows that they welcome any treatmentdevelopment that could help to reduce the likelihood of their cancerrecurring. Having been treated for breast cancer the first time round,one of the greatest fears is that the disease might return. Thesefindings confirm earlier results from this trial, and suggest thatFemara may be a treatment option for postmenopausal women with earlybreast cancer that could help reduce the risk of this happening tothem.”

Compared with tamoxifen, Femara also demonstrated asignificant reduction in the risk of recurrence to the same breast(local recurrence), the other breast and to the lymph nodes (regionalrecurrence).

Dr Andrew Wardley, study investigator andconsultant medical oncologist at the Christie Hospital, Manchester, andthe South Manchester University Hospitals NHS Trust, UK, commented:”Femara is the only aromatase inhibitor shown to significantly reducethe risk of distant metastases versus tamoxifen as initial adjuvanttherapy in postmenopausal women with hormone-sensitive early breastcancer. This is particularly good news since we know that this type ofrecurrence significantly worsens the prognosis for these women.”

Theretrospective analysis also identified patients at higher risk ofrecurrence based on clinical and pathological disease characteristics.The results showed that patients with the highest risk of earlyrecurrence had tumours larger than 5cm, four or more positive nodes,positive oestrogen receptor status but negative progesterone status,grade three tumours and invasive disease. Notably, women withnode-positive disease, who are considered to be at a higher risk ofrecurrence, maintained this lower risk of relapse when treated withupfront Femara than with tamoxifen.

Hugh O’Dowd, businessunit director for Novartis Oncology UK, said: “These results are thetip of the iceberg and for the bigger picture, physicians will beeagerly awaiting the results of the BIG 1-98 sequencing arms, whichhope to indicate the optimal strategy for using Femara post-surgery andare to be ready for 2008.”

Press release, Novartis Oncology, 30/4/2007



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