Update of the XXXX -98 Trial: where do we stand?

@entity1 @entity4672 @entity440 @entity0 @entity29906
BACKGROUND AND METHODS: There is accumulating data on the clinical benefit of aromatase inhibitors in the adjuvant treatment of @entity0 in postmenopausal @entity1 . The @entity29906 -98 study is a randomized, phase 3, double-blind trial comparing four adjuvant endocrine treatments of 5 years duration in postmenopausal @entity1 with hormone-receptor-positive @entity0 : @entity4672 or @entity440 monotherapy, sequential treatment with @entity440 followed by @entity4672 , or vice versa. This article summarizes data presented at the 2009 St. Gallen early @entity0 conference: an update on the monotherapy arms of the @entity29906 -98 study, and results from the sequential treatment arms. Implications for daily practice from @entity29906 -98 and from other adjuvant trials will be discussed. RESULTS: Despite cross-over from @entity440 to @entity4672 by 25% of the @entity1 after unblinding of the @entity440 monotherapy arm, the improvement of disease-free survival (HR 0.88, 0.78-0.99, p = 0.03) and time to distant recurrence (HR 0.85, 0.72-1.00, p = 0.05) for @entity4672 monotherapy as compared to @entity440 monotherapy remained significant in the intention-to-treat (ITT) analysis. A trend for an overall survival advantage for @entity4672 was seen in the ITT analysis (HR 0.87, 0.75-1.02, p = 0.08). No statistically significant differences were found for the sequential treatment arms versus @entity4672 monotherapy, with respect to disease-free survival, time to distant recurrence or overall survival. Cumulative incidence analysis of @entity0 recurrence favors the initiation of adjuvant endocrine treatment with @entity4672 instead of @entity440 , especially in @entity1 at higher risk for early recurrence. Similarly, data suggest that @entity1 commenced on @entity4672 can be switched to @entity440 after 2 years, if required. CONCLUSIONS: The @entity29906 -98 study update with median follow up of 76 months confirms a significant reduction in the risk of @entity0 recurrence and a trend towards improved overall survival with @entity4672 as compared to @entity440 , and no unexpected safety concerns with @entity4672 . Adjuvant endocrine treatment should preferentially be initiated with @entity4672 . For @entity1 unable to continue @entity4672 , switching to @entity440 appears to be an acceptable alternative.
