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Extending Aromatase Inhibitor Therapy: Uncertainty Remains
Many studies have addressed the optimal duration of adjuvant endocrine therapy for hormone-receptor–positive breast cancer. Recently, the optimal duration of aromatase inhibitor (AI) therapy for postmenopausal patients has been a focus of deliberation. Several studies have suggested a “sweet spot” of 7 to 8 years' duration. Now, a multicenter, prospective, randomized, open-label Japanese study (AERAS) evaluated the effect of extending anastrozole treatment for an additional 5 years in postmenopausal patients who were disease-free after treatment with either 5 years of anastrozole alone or 2 to 3 years of tamoxifen followed by 2 to 3 years of anastrozole. Between 2007 and 2012, 1697 patients were randomized to continue or stop anastrozole; 9% were previously treated with tamoxifen.
There were fewer cases of local recurrent disease and new primary breast cancers in the continue-anastrozole group than in the stop-anastrozole group (10 vs. 27 and 27 vs. 52, respectively). Disease-free survival (DFS) at 5 years, the primary outcome, was significantly higher in the continue group (91% vs. 86%). Overall survival and distant DFS did not differ significantly between groups. Although rates of bone fracture did not differ, the continue-anastrozole group had significantly higher incidence of arthralgias (37% vs. 29%) and new-onset osteoporosis (47% vs. 44%) and, consequently, higher use of oral bisphosphonates (31% vs. 21%).
Prior trials evaluating extended durations of adjuvant AI therapy have had mixed results, with only one showing an improvement in DFS, although the effect was largely due to fewer contralateral breast cancers (NEJM JW Oncol Hematol Jul 13 2016 and N Engl J Med 2016; 375:209). All the studies suggest greater cumulative toxicity with longer duration of AI treatment. The AERAS study shows an improvement in DFS favoring a longer duration of adjuvant AI therapy, but the follow-up remains too short to determine if this will translate into improved overall survival.
Iwase T et al.
Title: Postoperative adjuvant anastrozole for 10 or 5 years in patients with hormone receptor–positive breast cancer: AERAS, a randomized multicenter open-label phase III trial.
Source: J Clin Oncol 2023 Apr 20; [e-pub]. (Abstract/FREE Full Text)