Endometrial effects of exemestane compared to tamoxifen within the Tamoxifen Exemestane Adjuvant Multicenter (TEAM) trial: results of a prospective gynecological ultrasound substudy.

OBJECTIVES: This study prospectively assessed the effects of exemestane and tamoxifen on the endometrium in patients receiving adjuvant treatment for postmenopausal hormone receptor-positive breast cancer within the Tamoxifen Exemestane Adjuvant Multicenter (TEAM) trial. METHODS: Patients were randomized to receive tamoxifen or exemestane. In a prespecified trial subprotocol, patients underwent transvaginal ultrasound to assess endometrial thickness at baseline and during a 1- to 3-year treatment period. RESULTS: Among 143 evaluable patients, there were no cases of endometrial thickness >10 mm with exemestane, vs. 11 cases with tamoxifen (p < 0.0003). There was a significant difference between the treatment groups regarding time to endometrial thickness >10mm, in favour of exemestane (p < 0.0001). Time to endometrial thickness > 5 mm was significantly longer for exemestane than for tamoxifen (p < 0.0001). Median time to endometrial thickness > 5 mm or censoring was 583 days in the exemestane group versus 315 days in the tamoxifen group. There were also significantly fewer incidences of endometrial thickness > 5 mm at month 6 and month 12 with exemestane compared to tamoxifen (tamoxifen: 6% and 2%; exemestane: 29% and 39%, respectively). After 12 months, mean increases in endometrial thickness from baseline were 2.64 mm and 6.0mm in the exemestane and tamoxifen groups, respectively (p < 0.0006). Moreover, 17 histologically confirmed endometrial changes were observed in the tamoxifen group, vs. one in the exemestane group. CONCLUSIONS: Exemestane was associated with significantly less endometrial thickening than tamoxifen during adjuvant endocrine therapy for postmenopausal hormone receptor-positive breast cancer.

The effect of exemestane or tamoxifen on markers of bone turnover: results of a German sub-study of the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial.

Adjuvant treatment of breast cancer with aromatase inhibitors has been associated with increased bone loss. In this study, postmenopausal patients with oestrogen receptor positive breast cancer were randomised to exemestane for 5 years or tamoxifen for 2-2.5 years, followed by exemestane for 2-2.5 years. Levels of bone formation markers (bone specific alkaline phosphatase, amino terminal propeptide of type I procollagen, osteocalcin), and the bone resorption marker (carboxyterminal crosslinked telopeptide of type I collagen), were assessed at baseline and after 3, 6 and 12 months of treatment. Exemestane (n=78) resulted in increases from baseline in all bone turnover marker levels at all timepoints. In contrast, levels of all bone marker turnovers decreased with tamoxifen (n=83). Differences between tamoxifen and exemestane were statistically significant for all bone turnover markers at all timepoints. In conclusion, exemestane results in increases in markers of bone formation and resorption, while decreases are observed with tamoxifen.

Effects of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial: results of a German, 12-month, prospective, randomised substudy.

BACKGROUND: Adjuvant treatment of hormone receptor-positive breast cancer in postmenopausal women with aromatase inhibitors may be associated with increased bone loss. PATIENTS AND METHODS: Two hundred patients were randomised to receive exemestane or tamoxifen as adjuvant treatment of hormone receptor-positive breast cancer. Bone mineral density (BMD) was assessed by dual-energy X-ray absorptiometry at baseline and after 6 and 12 months treatment. RESULTS: One hundred and sixty-one patients were assessable. Tamoxifen treatment resulted in a 0.5% increase from baseline in BMD at the spine, which was maintained at 12 months. Exemestane-treated patients experienced a 2.6% decrease from baseline in BMD at the spine at 6 months and a further 0.2% decrease at 12 months. There were significant differences in the changes in BMD between tamoxifen and exemestane at 6 and 12 months (P = 0.0026 and P = 0.0008, respectively). The mean changes in BMD from baseline at the total hip were also significantly different between exemestane and tamoxifen at 6 and 12 months (P = 0.0009 and P = 0.04, respectively). There was no difference between tamoxifen and exemestane in mean changes in BMD from baseline at the femoral neck. CONCLUSIONS: Exemestane treatment resulted in an increase in bone loss at 6 months; bone loss stabilised after 6- to 12-month treatment.

[Pregnancy-induced gigantomastia--a disease picture of uncertain origin]. / Die schwangerschaftsinduzierte Gigantomastie--ein Krankheitsbild unklarer Genese.

OBJECTIVE: Pregnancy induced gigantomastia is a rare condition (1:100.000 pregnancies) of unknown etiology. Regarding this condition we would like to discuss the possibilities of antenatal treatment, management during pregnancy and treatment after delivery. RESULTS: In our histological and immunological investigations we did not find any facts that will point out any specific etiology of this condition. The pregnancy induced gigantomastia could not be influenced by any conservative management or medical treatment. CONCLUSION: Therefore we would recommend plastic reconstructive surgery from medical as well as cosmetic point of view.

[Detection and localization of the ventricular septum defect using color Doppler echocardiography. Sensitivity, specificity, limitations]. / Nachweis und Lokalisation des Ventrikelseptumdefektes mittels Farb-Doppler-Echokardiographie. Sensitivität, Spezifität, Limitationen.

In part 1 of this study 50 healthy children and 56 patients with known VSD were examined by color-Doppler-echocardiography to derive criteria for the diagnosis of a VSD by this technique. Using a defined Nyquist velocity the healthy children showed a monochrome ventricular bloodflow pattern. In patients with VSD and an interventricular pressure gradient greater than 15 mm Hg a turquois-yellow jet could be seen additionally in the ventricle with the lower pressure. The same pattern could be observed within the defect itself, except for four patients, in whom the VSD could not be visualized by two-dimensional echocardiography. In these patients, however, the VSD could be localized by tracing the jet to the septal endocardium. In patients with equal left and right ventricular pressures a monochrome transseptal bloodflow could be seen. Its color pattern was not significantly different from the normal bloodflow pattern. In these cases it was difficult to diagnose a small VSD, if the defect itself could not be visualized. Thus, the following criteria for the diagnosis of a VSD by color-Doppler-echocardiography were derived depending on the interventricular pressure gradient: 1) Interventricular pressure gradient greater than 15 mm Hg: visualization of the VSD-jet including its origin at the septal endocardium. 2) Equal left and right ventricular pressures: visualization of the VSD as echo drop-out as well as a transseptal bloodflow. Using these criteria, sensitivity and specificity of color-Doppler-echocardiography in the detection of VSD were evaluated in part II; 234 consecutive patients, of which 119 had a VSD, were examined. All had undergone cardiac catheterisation. A high sensitivity of 98.3% and a specificity of 99.1% were found. Diagnostic problems remain in patients with a small VSD and also in patients with equal left and right ventricular pressures. In particular, multiple VSD with equal left and right ventricular pressures are difficult to visualize completely, as compared to cases with significant interventricular pressure gradients.