RESUMO
AIM AND BACKGROUND: A reduction of gynaecological adverse events has been reported in trials comparing aromatase inhibitors with tamoxifen as adjuvant treatment in postmenopausal women with early breast cancer, but there is a paucity of randomised studies specifically investigating their effects on the uterus. We report here the results of a prospective phase III trial comparing the effects of tamoxifen and exemestane by transvaginal ultrasound (TVUS). PATIENTS AND METHODS: Postmenopausal patients with ER+ early breast cancer were randomised to receive tamoxifen 20 mg once daily or exemestane 25 mg once daily as adjuvant hormone therapy. TVUS was performed at baseline and at 6 and 12 months to measure endometrial thickness (ET) and uterine volume (UV). RESULTS: A total of 123 women were randomised to tamoxifen (n = 61) or exemestane (n = 62). A significantly higher proportion of patients in the tamoxifen group had increased ET at 6 and 12 months from randomisation compared with the exemestane group (66.1% and 64.3% versus 12.1% and 6.8%, respectively; P < 0.0001). Mean ET and UV also significantly increased with tamoxifen compared to exemestane at both time points (P < 0.01 for all comparisons). CONCLUSION: Tamoxifen is associated with endometrial thickening and increased uterine volume in a significant proportion of postmenopausal women with early breast cancer. Our study confirms the lack of endometrial effects of exemestane, which may be of interest to patients and clinicians when choosing among adjuvant endocrine options for breast cancer.
Assuntos
Androstadienos/efeitos adversos , Antineoplásicos Hormonais/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Endossonografia , Tamoxifeno/efeitos adversos , Doenças Uterinas/prevenção & controle , Útero/efeitos dos fármacos , Útero/diagnóstico por imagem , Idoso , Androstadienos/administração & dosagem , Antineoplásicos Hormonais/administração & dosagem , Inibidores da Aromatase/efeitos adversos , Neoplasias da Mama/química , Quimioterapia Adjuvante , Esquema de Medicação , Endométrio/diagnóstico por imagem , Endométrio/efeitos dos fármacos , Endométrio/patologia , Endossonografia/métodos , Feminino , Humanos , Pessoa de Meia-Idade , Gradação de Tumores , Estadiamento de Neoplasias , Tamanho do Órgão/efeitos dos fármacos , Pós-Menopausa , Estudos Prospectivos , Tamoxifeno/administração & dosagem , Resultado do Tratamento , Doenças Uterinas/induzido quimicamente , Doenças Uterinas/diagnóstico por imagem , Útero/patologia , VaginaRESUMO
Our objective was to evaluate the activity and safety of the combination of cisplatin, epirubicin and vinorelbine (CEV) in advanced breast cancer patients. Patients with advanced breast cancer, locally advanced or metastatic, received epirubicin 75 mg/m2 and cisplatin 50 mg/m2 on day 1, and vinorelbine 25 mg/m2 on day 8. Cycles were repeated every 3 weeks. A total of 35 patients were treated. Thirty-one patients were evaluated for response. One hundred and fifty-five cycles of chemotherapy were administered overall. The objective response rate (ORR) was 84%, including complete response in 13% of patients. All stage III patients achieved a downstaging, with a pathological complete response in two out of 10 patients. Patients with stage IV disease obtained objective response in 67% of cases. Toxicity was mild to moderate. The most common grade 3-4 adverse event was febrile neutropenia, which occurred in 17% of patients. We conclude that CEV combination represents an effective treatment for patients with previously untreated advanced breast cancer, allowing an important ORR. Moreover this regimen appears to be well tolerated.