An open label, randomised multicentre comparative trial of five years adjuvant exemestane treatment versus adjuvant tamoxifen followed by exemestane in postmenopausal women with early breast cancer

2013 ◽  
Author(s):  
Jaspreet Babrah Babrah
2017 ◽  
Vol 18 (9) ◽  
pp. 1211-1220 ◽  
Author(s):  
Marloes G M Derks ◽  
Erik J Blok ◽  
Caroline Seynaeve ◽  
Johan W R Nortier ◽  
Elma Meershoek-Klein Kranenbarg ◽  
...  

The Lancet ◽  
2005 ◽  
Vol 366 (9484) ◽  
pp. 455-462 ◽  
Author(s):  
Raimund Jakesz ◽  
Walter Jonat ◽  
Michael Gnant ◽  
Martina Mittlboeck ◽  
Richard Greil ◽  
...  

Cancer ◽  
2008 ◽  
Vol 112 (7) ◽  
pp. 1437-1444 ◽  
Author(s):  
Hagen Kennecke ◽  
Heather McArthur ◽  
Ivo A. Olivotto ◽  
Caroline Speers ◽  
Chris Bajdik ◽  
...  

Maturitas ◽  
1991 ◽  
Vol 13 (1) ◽  
pp. 87-88
Author(s):  
T. Fornander ◽  
L.E. Rutqvist ◽  
H.E. Sjoberg ◽  
L. Blomqvist ◽  
A. Mattsson ◽  
...  

2007 ◽  
Vol 25 (19) ◽  
pp. 2664-2670 ◽  
Author(s):  
Manfred Kaufmann ◽  
Walter Jonat ◽  
Jörn Hilfrich ◽  
Holger Eidtmann ◽  
Günther Gademann ◽  
...  

Purpose In postmenopausal women with estrogen receptor–positive early breast cancer, surgery is usually followed by a 5-year course of tamoxifen. This report presents results of a prospective, open-label, randomized study, designed to evaluate the benefits of switching to anastrozole after 2 years of tamoxifen treatment, compared with continuing on tamoxifen for 5 years. Patients and Methods After receiving tamoxifen treatment for 2 years, eligible patients (n = 979) were randomly assigned to switch to anastrozole (1 mg/d) or continue tamoxifen (20 or 30 mg/d) for an additional 3 years. Patients were monitored every 6 months during years 1 to 3 and annually thereafter. The primary efficacy variable was disease-free survival, including local or distant recurrence, new contralateral breast cancer, or death. Secondary variables were overall survival and assessment of safety. Results Switching to anastrozole resulted in a significant reduction in the risk of disease recurrence (hazard ratio [HR], 0.66; 95% CI, 0.44 to 1.00; P = .049), and improved overall survival (HR, 0.53; 95% CI, 0.28 to 0.99; P = .045) compared with continuing on tamoxifen. Fewer patients who switched to anastrozole reported serious adverse events (22.7% v 30.8%) compared with those who continued on tamoxifen, mainly due to more patients in the tamoxifen group with endometrial events. The overall safety profile for anastrozole was consistent with previous reports and no new safety issues were identified. Conclusion Postmenopausal women who have taken tamoxifen for 2 years as adjuvant therapy are less likely to experience a recurrence of breast cancer and have improved overall survival if they switch to anastrozole compared with continuing to receive tamoxifen.


2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 646-646 ◽  
Author(s):  
A. A. Calabró ◽  
M. S. Portella ◽  
M. Garcia

646 Background: MA17 study wasa randomized double-blind placebo-controlled trial of 5 years of extended adjuvant therapy with letrozole (Femara) in 5187 postmenopausal women with early breast cancer after adjuvant tamoxifen. MA17 study demonstrated significant improvement in disease-free survival (93% vs. 87% at 4 yrs, HR 0.57) and a similar trend in overall survival (96% vs. 94% at 4 yrs, HR 0.76). Objective: To estimate the budget impact of adding extended adjuvant letrozole in the management of postmenopausal women with early breast cancer after 5 years adjuvant tamoxifen. Methods: A budget impact analysis over 4 years of letrozole vs. no extended adjuvant therapy was developed from the perspective of a health care payer in terms of total treatment costs following the introduction of letrozole. Model inputs included the overall survival, disease-free survival and probabilities of recurrence from the MA17 trial, additional cost of letrozole and the average annual cost to treat a given type of recurrence (contralateral, loncoregional, metastatic). Only direct medical costs were included using the consumer price index. Costs and cost-savings were reported as 2005 US dollars and discounted at 3%. The average annual cost to treat a recurrence was calculated through a retrospective analysis of a healthcare plan database with 147 postmenopausal women and data from published literature. The recurrence cost included chemotherapy in the first year (drug costs, dispensing fee, materials), health professional contacts, laboratory tests, diagnostic procedures, radiotherapy, bisphosphonate (metastatic recurrence), health professional contacts and hospitalization. Surgery costs were not considered in the study. Results: The average annual cost to treat a recurrence was estimated in US$83,064. For the base-case analysis of 100 patients, savings due to reduced recurrence were $1,006,446, in the letrozole patients. Subtracting the cost of letrozole treatment for 100 patients from savings yielded projected net savings of $36,314. Conclusions: In post-menopausal women who have completed 5 years adjuvant tamoxifen therapy, extended adjuvant letrozole is a cost-saving use of healthcare resources in additional to its clinical benefits. [Table: see text]


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