- Title
- Disease-related outcomes with long-term follow-up: an updated analysis of the Intergroup Exemestane Study
- Creator
- Bliss, Judith M.; Kilburn, Lucy S.; van de Velde, Cornelius J. H.; Lønning, Per. E.; Morden, James; Reise, Justine; Cisar, Laura; Menschik, Thomas; Coombes, R. Charles; Coleman, Robert E.; Forbes, John F.; Coates, Alan S.; Jones, Stephen E.; Jassem, Jack; Delozier, Thierry; Andersen, Jørn; Paridaens, Robert
- Relation
- Journal of Clinical Oncology Vol. 30, Issue 7, p. 709-717
- Publisher Link
- http://dx.doi.org/10.1200/JCO.2010.33.7899
- Publisher
- American Society of Clinical Oncology
- Resource Type
- journal article
- Date
- 2012
- Description
- Purpose: Intergroup Exemestane Study (IES), an investigator-led study in 4,724 postmenopausal patients with early-stage breast cancer has demonstrated clinically important benefits from switching adjuvant endocrine therapy after 2 to 3 years of tamoxifen to exemestane. Now, with longer follow-up, a large number of non–breast cancer–related events have been reported. Exploratory analyses describe breast cancer–free survival (BCFS) and explore incidence and patterns of the different competing events. Patients and Methods: Patients who were disease-free after 2 to 3 years of adjuvant tamoxifen were randomly assigned to continue tamoxifen or switch to exemestane to complete 5 years of adjuvant endocrine therapy. At this planned analysis, the median follow-up was 91 months. Principal analysis focuses on 4,052 patients with estrogen receptor (ER) –positive and 547 with ER-unknown tumors. Results: In all, 930 BCFS events have been reported (exemestane, 423; tamoxifen, 507), giving an unadjusted hazard ratio (HR) of 0.81 (95% CI, 0.71 to 0.92; P = .001) in favor of exemestane in the ER-positive/ER unknown group. Analysis partitioned at 2.5 years after random assignment showed that the on-treatment benefit of switching to exemestane (HR, 0.60; 95% CI, 0.48 to 0.75; P < .001) was not lost post-treatment, but that there was no additional gain once treatment had ceased (HR, 0.94; 95% CI, 0.80 to 1.10; P = .60). Improvement in overall survival was demonstrated, with 352 deaths in the exemestane group versus 405 deaths in the tamoxifen group (HR, 0.86; 95% CI, 0.75 to 0.99; P = .04). Of these, 222 were reported as intercurrent deaths (exemestane, 107; tamoxifen, 115). Conclusion: The protective effect of switching to exemestane compared with continuing on tamoxifen on risk of relapse or death was maintained for at least 5 years post-treatment and was associated with a continuing beneficial impact on overall survival.
- Subject
- Intergroup Exemestane Study (IES); postmenopausal patients; early-stage breast cancer; endocrine therapy
- Identifier
- http://hdl.handle.net/1959.13/1310785
- Identifier
- uon:22087
- Identifier
- ISSN:0732-183X
- Language
- eng
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