Kanker-actueel Aromasin Exemestane = gives much better effect on overall survival and disease-free and reduced risk of recurrence than tamoxifen so large phase III study.

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Breast Cancer: Exemestane Exemestane = gives much better effect on overall survival and disease-free and reduced risk of recurrence than tamoxifen so large phase III study. Article updated March 28, 2011

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Breast Cancer: Exemestane Exemestane = gives much better effect on overall survival and disease-free and reduced risk of recurrence than tamoxifen so large phase III study. Article updated March 28, 2011

October 1, 2009: Source: 15th Congress of ECCO - the European Cancer Organization and the 34th ESMO European Society for Medical Oncology in Berlin

September 29, 2009 (Berlin, Germany) - Adjuvant therapy with exemestane (Aromasin) seems more effective than tamoxifen at reducing disease recurrence in patients with breast cancer , according to the study data of the Team Study and IES studies presented at the 15th Congress the European Cancer Organization and the 34th European Society for Medical Oncology Multidisciplinary Congress.

The conclusions from the TEAM study, the largest of three major phase III studeis the efficacy of an aromatase inhibitor compared with tamoxifen as first-line hormonal therapy.

The analysis shows that in postmenopausal patients with early invasive hormone-receptor positive breast cancer, the first adjuvant treatment with exemestane was superior to tamoxifen in improving disease-free survival and reducing a recurrence of the disease.

"On the measurement of 2.75 years, according exemestane - Aromasin to be associated with improved disease-free survival, long time time to distant metastases formation and relapse-free survival," said lead author Cornelis van de Velde, MD, PhD, professor of surgery Leiden University Medical Centre in the Netherlands.

Analysis of Trial TEAM

TEAM cohort consisted of 9779 postmenopausal patients with invasive estrogen-receptor positive and / or progesterone receptor-positive early breast cancer from nine countries that prospectively randomized to 20 mg tamoxifen wewrden per day or exemestane 25 mg a day - Aromasin. All patients had had primary surgery and if they had reached, chemotherapy.

The original measurements began in 2001 when the primary endpoint was disease-free survival. But in 2004, based on the results of the Intergroup Exemestane Study (IES), showing a strong advantage for exemestane - Aromasin appeared, the investigation was changed. All patients in the tamoxifen group were switched to exemestane - Aromasin after 2.5 to 3 years.

The modified design of the study, said Dr. Van de Velde had two endpoints. The first comparison would be disease-free survival in patients using tamoxifen or exemestane - Aromasin to 2.75 years. The second endpoint was disease-free survival compared with both women exemestane - Exemestane for 5 years of tamoxifen use in women who were switched to exemestane - Aromasin for a total of 5 years.

The current analysis focused on the first primary endpoint - disease-free survival at 2.75 years of tamoxifen or exemestane - Aromasin, said Dr. Van de Velde.

Their results showed that, compared with tamoxifen, exemestane is associated with better disease-free survival (hazard ratio [HR], 0.89, 95% confidence interval [CI], 0.77 to 1.03, P = .12) and relapse-free survival (HR, 0.85%, 95% CI, 0.72 to 1.00, P = .056). Time to first distant metastasis is better with exemestane (HR 0.81, 95% CI, 0.67 to 0.98, P = .028).

In total there were 11% fewer cases of local recurrence, metastasis, contralateral breast cancer, disease and death without relapse for patients in the exemestane - aroma application call.

There were no unexpected safety issues have been reported, but using exemestane was associated with a significantly higher incidence of arthralgia, carpal tunnel syndrome, diarrhea, and hypercholesterolemia. The incidence of cardiac ischemia and infarction was similar between the groups.

More data demonstrating the superiority of exemestane appears to be a long-term follow-up of the IES. IES compared the switch to exemestane after 2 to 3 years of tamoxifen have used the full five years. The new long-term data confirm a significant 18% reduction in disease-free survival in the group (HR 0.82, P = .0009) stepped on, and show a significant prolongation of overall survival, reducing the risk of death by 14% (HR, 0.86, P = .04) decreased.

The use of exemestane - Aromasin after 2 to 3 years tamoxifen therapy in postmenopausal women with estrogen receptor-positive early breast cancer is an approved indication in both the U.S. and Europe.

Both the Study Team and IES studies were funded by Pfizer, the manufacturer of exemestane.

15th Congress of the European Cancer Organisation (ECCO 15) and the 34th European Society for Medical Oncology (ESMO 34th) Multidisciplinary Congress: Abstracts 2BA (TEAM study) and 5010 (IES study). Organized 22September 2009.