PURPOSE:Patients developing visceral breast cancer metastases generally receive chemotherapy rather than endocrine therapy. Recent aromatase inhibitor studies have reported activity in such patients; therefore, this study formally evaluated anastrozole and exemestane in postmenopausal patients in this setting. PATIENTS AND METHODS: Postmenopausal women with advanced breast cancer and > or = 1 visceral (liver or lung) lesion were randomized to anastrozole (1 mg/day orally) or exemestane (25 mg/day orally) for > or = 8 weeks. The primary endpoint was objective response in visceral lesions based on modified Response Evaluation Criteria in Solid Tumors. Secondary endpoints included clinical benefit (objective response plus stable disease > or = 180 days), overall survival, and adverse events. RESULTS: A total of 130 patients were enrolled, and 128 patients (64anastrozole, 64 exemestane) were included in the intent-to-treat analysis. Accrual delays caused study closure before the target enrollment (N = 200) was reached, limiting the statistical power of the study. Objective response in visceral sites was approximately 15% in both groups. Clinical benefit in visceral sites was 32% of the patients treated with anastrozole and 38% of the patients treated with exemestane. Median survival was 33.3 months and 30.5 months in the anastrozole and exemestane groups, respectively. Toxicities were similar to those previously reported; however, treatment-related adverse events were more frequent with anastrozole (41%) than with exemestane (31%). Both treatments were generally well tolerated in patients with postmenopausal breast cancer with visceral metastases. CONCLUSION:Efficacy was similar in both treatment groups for all endpoints. Aromatase inhibitors can be considered as a treatment option in postmenopausal patients with hormone receptor-positive visceral breast cancer metastases.
RCT Entities:
PURPOSE:Patients developing visceral breast cancer metastases generally receive chemotherapy rather than endocrine therapy. Recent aromatase inhibitor studies have reported activity in such patients; therefore, this study formally evaluated anastrozole and exemestane in postmenopausal patients in this setting. PATIENTS AND METHODS: Postmenopausal women with advanced breast cancer and > or = 1 visceral (liver or lung) lesion were randomized to anastrozole (1 mg/day orally) or exemestane (25 mg/day orally) for > or = 8 weeks. The primary endpoint was objective response in visceral lesions based on modified Response Evaluation Criteria in Solid Tumors. Secondary endpoints included clinical benefit (objective response plus stable disease > or = 180 days), overall survival, and adverse events. RESULTS: A total of 130 patients were enrolled, and 128 patients (64 anastrozole, 64 exemestane) were included in the intent-to-treat analysis. Accrual delays caused study closure before the target enrollment (N = 200) was reached, limiting the statistical power of the study. Objective response in visceral sites was approximately 15% in both groups. Clinical benefit in visceral sites was 32% of the patients treated with anastrozole and 38% of the patients treated with exemestane. Median survival was 33.3 months and 30.5 months in the anastrozole and exemestane groups, respectively. Toxicities were similar to those previously reported; however, treatment-related adverse events were more frequent with anastrozole (41%) than with exemestane (31%). Both treatments were generally well tolerated in patients with postmenopausal breast cancer with visceral metastases. CONCLUSION: Efficacy was similar in both treatment groups for all endpoints. Aromatase inhibitors can be considered as a treatment option in postmenopausal patients with hormone receptor-positive visceral breast cancer metastases.
Authors: Sadia Tasleem; Jarlath C Bolger; Michael E Kelly; Michael R Boland; Dermot Bowden; Karl J Sweeney; Carmel Malone Journal: Ir J Med Sci Date: 2018-02-01 Impact factor: 1.568
Authors: Giorgia Zucchini; Elena Geuna; Andrea Milani; Caterina Aversa; Rossella Martinello; Filippo Montemurro Journal: Int J Womens Health Date: 2015-05-27
Authors: Il Yong Chung; Jihyoun Lee; Suyeon Park; Jong Won Lee; Hyun Jo Youn; Jung Hwa Hong; Ho Hur Journal: J Korean Med Sci Date: 2018-10-01 Impact factor: 2.153