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| |  Initial Adjuvant Therapy With Exemestane Superior to Tamoxifen in Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Presented at ECCO-ESMO By Chris Berrie BERLIN -- September 24, 2009 -- Initial adjuvant therapy with exemestane has a favourable safety profile, and with allowances made for compliance, it is significantly more effective than tamoxifen in postmenopausal patients with hormone receptor-positive early invasive breast cancer, according to a study presented here at the joint 15th Congress of the European Cancer Organisation (ECCO) and 34th Congress of the European Society for Medical Oncology (ESMO). The multicentre, prospective, randomised, open-label, phase 3 trial was presented on behalf of the Tamoxifen Exemestane Adjuvant Multinational (TEAM) study investigators by Cornelius J. H. van de Velde, MD, Leiden University Medical Centre, Leiden, the Netherlands, on September 22. The steroidal aromatase inhibitor exemestane is more effective than tamoxifen in patients with metastatic breast cancer, and has a role in adjuvant therapy following tamoxifen. Therefore, the aim was to evaluate exemestane as initial adjuvant endocrine therapy, in comparison with tamoxifen. Following diagnosis and adequate prior therapy, 9,779 postmenopausal patients with invasive oestrogen receptor-positive and/or progesterone receptor-positive early breast cancer were prospectively randomised to tamoxifen 20 mg/day or exemestane 25 mg/day, for a total of 5 years. The intent-to-treat populations for the analysis included 4,868 and 4,898 patients, respectively. The original design was modified following patient benefits for switching to exemestane from tamoxifen in the Intergroup Exemestane Study. Thus, as Dr. van de Velde said, the tamoxifen arm was amended to sequential therapy of tamoxifen and exemestane, with the coprimary endpoints set for disease-free survival (DFS) at 2.75 years and 5 years. In reporting here on the first planned analysis at 2.75 years, Dr. van de Velde indicated that compared with tamoxifen, exemestane showed a trend toward improved DFS (P = .12). Similarly, a near significant trend was seen for relapse-free survival (P = .056). DFS did, however, reach significance in Dutch and Belgian patients (P = .02). With the probability of compliance not event related, Dr. van de Velde noted that this illustrates how early discontinuation of the study drugs varied between countries. On the basis that at 2.75 years, 29.5% and 18.9% of the tamoxifen and exemestane intent-to-treat populations, respectively, had stopped treatment, analysis of censored DFS was carried out; here, exemestane benefit reached significance again (P = .022). The safety analysis revealed no specific safety concerns, although exemestane was associated with significantly higher incidences of arthralgia, carpal tunnel syndrome, diarrhoea, and hypercholesterolaemia. However, exemestane showed significantly lower rates of hot flushes, vaginal bleeding, vaginal discharge, and thromboembolism. “The incidence rate for cardiac ischaemia/infarction was similar between the groups,” said Dr. van de Velde. Fracture rates were also similar (0.8% for exemestane and 0.7% for tamoxifen). Cognitive functioning was also monitored, with worse performances seen compared with healthy controls for tamoxifen users for verbal memory and executive functioning scales, and lower information processing speed than for exemestane. In contrast, compared with healthy controls, exemestane users showed no differences for cognitive functioning. Funding for this study was provided by Pfizer Inc. [Presentation title: Results of the TEAM (Tamoxifen Exemestane Adjuvant Multinational) Prospective Randomized Phase III Trial in Hormone-Sensitive Post-Menopausal Early Breast Cancer. Abstract 2BA]
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