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. 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. RESULTS: At a median follow-up time of 51 months, we observed 352 DFS events among 2,463 women receivingletrozole 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. 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.
RCT Entities:
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. 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. 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. 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.
Authors: Peter Blaha; Ruth Exner; Andrea Dal Borgo; Sinda Bigenzahn; Peter Panhofer; Otto Riedl; Sebastian Schoppmann; Thomas Bachleitner-Hofmann; Emanuel Sporn; Ursula Pluschnig; Florian Fitzal; Guenther Steger; Raimund Jakesz; Peter Dubsky; Michael Gnant Journal: Breast Care (Basel) Date: 2009-06-23 Impact factor: 2.860
Authors: R Rizzoli; J J Body; A DeCensi; A De Censi; J Y Reginster; P Piscitelli; M L Brandi Journal: Osteoporos Int Date: 2012-01-20 Impact factor: 4.507
Authors: John M S Bartlett; Cassandra L Brookes; Tammy Robson; Cornelis J H van de Velde; Lucinda J Billingham; Fiona M Campbell; Margaret Grant; Annette Hasenburg; Elysée T M Hille; Charlene Kay; Dirk G Kieback; Hein Putter; Christos Markopoulos; Elma Meershoek-Klein Kranenbarg; Elizabeth A Mallon; Luc Dirix; Caroline Seynaeve; Daniel Rea Journal: J Clin Oncol Date: 2011-03-21 Impact factor: 44.544
Authors: V Craig Jordan; Joan Lewis-Wambi; Helen Kim; Heather Cunliffe; Eric Ariazi; Catherine G N Sharma; Heather A Shupp; Ramona Swaby Journal: Breast Date: 2007-08-24 Impact factor: 4.380
Authors: Olivia Pagani; Shari Gelber; Edda Simoncini; Monica Castiglione-Gertsch; Karen N Price; Richard D Gelber; Stig B Holmberg; Diana Crivellari; John Collins; Jurij Lindtner; Beat Thürlimann; Martin F Fey; Elizabeth Murray; John F Forbes; Alan S Coates; Aron Goldhirsch Journal: Breast Cancer Res Treat Date: 2008-10-25 Impact factor: 4.872