Changes of lipid profiles in Japanese postmenopausal women treated with tamoxifen were relatively favorable, while exemestane and anastrozole had no clinically significant effect on the serum lipids.
Health-related quality of life (HRQOL), symptoms of depression, and adverse events (AEs) were compared between Japanese postmenopausal patients with hormone-sensitive breast cancer (BC) who received adjuvant tamoxifen, exemestane, or anastrozole in an open-labeled, randomized, multicenter trial designated as the National Surgical Adjuvant Study of Breast Cancer (N-SAS BC) 04 substudy of the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial. During the first year of treatment, HRQOL and symptoms of depression were analyzed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and its Endocrine Symptom Subscale (ES), and the Center for Epidemiologic Studies Depression Scale (CES-D), respectively. In addition, predefined AEs were analyzed. A total of 166 eligible patients were randomly assigned to receive adjuvant tamoxifen, exemestane, or anastrozole. FACT-B scores increased after treatment began and remained significantly higher in the tamoxifen group than in the exemestane group or anastrozole group during the first year (P = 0.045). FACT-B scores were similar in the exemestane group and anastrozole group. ES scores and CES-D scores were similar in all treatment groups. Arthralgia and fatigue were less frequent, but vaginal discharge was more frequent in the tamoxifen group than in the exemestane group or anastrozole group. HRQOL was better in Japanese postmenopausal women treated with tamoxifen than those treated with exemestane or anastrozole. HRQOL and AEs were similar with exemestane and anastrozole. Given the results of the TEAM trial, upfront use of tamoxifen followed by an aromatase inhibitor (AI) may be an important option for adjuvant endocrine therapy in Japanese postmenopausal women.
The humanized monoclonal antibody trastuzumab has been in routine use for chemotherapy for human epidermal growth factor receptor II (HER2)-positive breast cancer. A major adverse effect of trastuzumab is cardiotoxicity. Well-established biomarkers or echocardiographic parameters to predict trastuzumab-induced cardiotoxicity have not yet been determined. We attempted to identify useful biomarkers and/or echocardiographic parameters to predict trastuzumab-induced cardiotoxicity.We prospectively investigated the cases of 19 women who received chemotherapy including anthracyclines and trastuzumab for HER2-positive breast cancer. We measured cardiac biomarkers and echocardiographic parameters before their chemotherapy and every 3 months up to 15 months until the end of the adjuvant trastuzumab therapy.We divided the patients into two groups: group R was the nine patients who showed a reduction of left ventricular ejection fraction (LVEF) ≥5%, and group N was the 10 patients who showed a reduction of LVEF <5%. The high-sensitivity troponin T (hs-TnT) level at 6 months was significantly higher in group R than in group N (11.0 ± 7.8 pg/mL vs. 4.0 ± 1.4 pg/mL, p < 0.01). The hs-TnT level with a cutoff value of 5.5 pg/mL at 6 months had 78% sensitivity and 80% specificity for predicting a reduction of LVEF at 15 months. In our evaluation of echocardiographic parameters at baseline, the diastolic function was more impaired in group R than in group N.The hs-TnT and echocardiographic parameters of diastolic function could be useful to predict trastuzumab-induced cardiotoxicity.
Blockade of CD40-CD154 pathway by CD40Ig gene therapy is a potent alloantigen-specific immunosuppressive strategy to induce permanent acceptance of liver allograft and would be a new therapeutic candidate in a clinical liver transplantation.
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