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Five years of letrozole compared with tamoxifen as initial adjuvant therapy for postmenopausal women with endocrine-responsive early breast cancer: update of study BIG 1-98.
- Source :
-
Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2007 Feb 10; Vol. 25 (5), pp. 486-92. Date of Electronic Publication: 2007 Jan 02. - Publication Year :
- 2007
-
Abstract
- Purpose: Previous analyses of the Breast International Group (BIG) 1-98 four-arm study compared initial therapy with letrozole or tamoxifen including patients randomly assigned to sequential treatment whose information was censored at the time of therapy change. Because this presentation may unduly reflect early events, the present analysis is limited to patients randomly assigned to the continuous therapy arms and includes protocol-defined updated results.<br />Patients and Methods: Four thousand nine hundred twenty-two of the 8,028 postmenopausal women with receptor-positive early breast cancer randomly assigned (double-blind) to the BIG 1-98 trial were assigned to 5 years of continuous adjuvant therapy with either letrozole or tamoxifen; the remainder of women were assigned to receive the agents in sequence. Disease-free survival (DFS) was the primary end point.<br />Results: At a median follow-up time of 51 months, we observed 352 DFS events among 2,463 women receiving letrozole and 418 events among 2,459 women receiving tamoxifen. This reflected an 18% reduction in the risk of an event (hazard ratio, 0.82; 95% CI, 0.71 to 0.95; P = .007). No predefined subsets showed differential benefit. Adverse events were similar to previous reports. Patients on tamoxifen experienced more thromboembolic events, endometrial pathology, hot flashes, night sweats, and vaginal bleeding. Patients on letrozole experienced more bone fractures, arthralgia, low-grade hypercholesterolemia, and cardiovascular events other than ischemia and cardiac failure.<br />Conclusion: The present updated analysis, which was limited to patients on monotherapy arms in BIG 1-98, yields results similar to those from the previous primary analysis but more directly comparable with results from other trials of continuous therapy using a single endocrine agent.
- Subjects :
- Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Hormonal adverse effects
Aromatase Inhibitors adverse effects
Breast Neoplasms chemistry
Breast Neoplasms pathology
Chemotherapy, Adjuvant
Disease-Free Survival
Double-Blind Method
Estrogen Antagonists adverse effects
Female
Follow-Up Studies
Humans
Kaplan-Meier Estimate
Letrozole
Middle Aged
Neoplasms, Hormone-Dependent chemistry
Neoplasms, Hormone-Dependent pathology
Nitriles adverse effects
Postmenopause
Proportional Hazards Models
Receptors, Estrogen analysis
Receptors, Progesterone analysis
Tamoxifen adverse effects
Time Factors
Treatment Outcome
Triazoles adverse effects
Antineoplastic Agents, Hormonal therapeutic use
Aromatase Inhibitors therapeutic use
Breast Neoplasms drug therapy
Estrogen Antagonists therapeutic use
Neoplasms, Hormone-Dependent drug therapy
Nitriles therapeutic use
Tamoxifen therapeutic use
Triazoles therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1527-7755
- Volume :
- 25
- Issue :
- 5
- Database :
- MEDLINE
- Journal :
- Journal of clinical oncology : official journal of the American Society of Clinical Oncology
- Publication Type :
- Academic Journal
- Accession number :
- 17200148
- Full Text :
- https://doi.org/10.1200/JCO.2006.08.8617