Safety and tolerability of adjuvant exemestane plus goserelin with or without tibolone in receptor-positive, node-negative primary breast cancer in premenopausal women: The final results of the randomized multicenter ADAGIO pilot study

Autor: D. Elling, H. Koelbl, W. Schoenegg, K. Pollow, G. Hoffmann, A. Dubois, Rolf Kreienberg, U. Koehler, K.-J. Winzer
Rok vydání: 2004
Předmět:
Zdroj: Journal of Clinical Oncology. 22:594-594
ISSN: 1527-7755
0732-183X
Popis: 594 Background: Goserelin (G) reduces ovarian production of luteinizing hormone and estrogen to postmenopausal values, but does not inhibit estrogens in peripheral tissues. Adding an agent that reduces peripheral estrogen production, such as the steroidal aromatase inactivator exemestane (E), may optimally decrease estrogen levels. The climacteric symptoms expected with a G/E regimen may be relieved with tibolone (T). The randomized, multicenter ADAGIO trial is testing the safety and tolerability of the combination of G and E, with or without T, in the adjuvant treatment of primary breast cancer in premenopausal women. We present the final results. Methods: Patients had histologically confirmed primary breast cancer (pT1, N0, M0 [grade 1–2]) and low or intermediate risk; they were age 35 to 55 years and estrogen- and/or progesterone-receptor positive. Patients were randomized to G 3.6 mg SC depot q 28 days for 6 doses; G and 2.5 mg E qd for 24 weeks; G and 1 tablet of 2.5 mg T; or G plus E plus T. Follow-...
Databáze: OpenAIRE