Avtor/Urednik		Regan, Meredith; Neven, Patrick; Giobbie-Hurder, Anita; Čufer, T
Naslov		Assessment of letrozole and tamoxifen alone and in sequence for postmenopausal women with steroid hormone receptor-positive breast cancer: the BIG 1-98 randomised clinical trial at 8-1 years median follow-up
Tip		članek
Vir		Lancet Oncol
Vol. in št.		Letnik 12, št. 12
Leto izdaje		2011
Obseg		str. 1101-8
Jezik		eng
Abstrakt		Background: Postmenopausal women with hormone receptor-positive early breast cancer have persistent, long-term risk of breast-cancer recurrence and death. Therefore, trials assessing endocrine therapies for this patient population need extended follow-up. We present an update of efficacy outcomes in the Breast International Group (BIG) 1-98 study at 8-1 years median follow-up. Methods: BIG 1-98 is a randomised, phase 3, double-blind trial of postmenopausal women with hormone receptor-positive early breast cancer that compares 5 years of tamoxifen or letrozole monotherapy, or sequential treatment with 2 years of one of these drugs followed by 3 years of the other. Randomisation was done with permuted blocks, and stratified according to the two-arm or four-arm randomisation option, participating institution, and chemotherapy use. Patients, investigators, data managers, and medical reviewers were masked. The primary efficacy endpoint was disease-free survival (events were invasive breast cancer relapse, second primaries [contralateral breast and non-breast], or death without previous cancer event). Secondary endpoints were overall survival, distant recurrence-free interval (DRFI), and breast cancer-free interval (BCFI). The monotherapy comparison included patients randomly assigned to tamoxifen or letrozole for 5 years. In 2005, after a significant disease-free survival benefit was reported for letrozole as compared with tamoxifen, a protocol amendment facilitated the crossover to letrozole of patients who were still receiving tamoxifen alone; Cox models and Kaplan-Meier estimates with inverse probability of censoring weighting (IPCW) are used to account for selective crossover to letrozole of patients (n=619) in the tamoxifen arm. (Abstract truncated at 2000 characters)
Deskriptorji		BREAST NEOPLASMS TAMOXIFEN POSTMENOPAUSE RECEPTORS, ESTROGEN RECEPTORS, PROGESTERONE DISEASE-FREE SURVIVAL SURVIVAL ANALYSIS DOUBLE-BLIND METHOD CLINICAL TRIALS, PHASE III