Symptoms of endocrine treatment and outcome: A retrospective analysis of the monotherapy arms of the BIG 1-98 trial.

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522 Background: Conflicting data exist regarding the association of side effects related to estrogen manipulation with prognosis. We evaluated the outcome of patients (pts) according to the early incidence of vasomotor and arthralgia/myalgia symptoms. Methods: In the BIG 1-98 trial 8010 postmenopausal pts with hormone receptor-positive early breast cancer were randomized to a 5-year regimen of tamoxifen (T), letrozole (L), T followed by L, or the reverse. This evaluation included pts randomized to T or L alone who received at least one dose of trial therapy, had no disease-free survival (DFS) event during the first 3 months (mos), and had no known vasomotor or arthralgia/myalgia symptoms prior to treatment (N=4,798 of 4,922). Vasomotor symptoms included hot flushes, night sweats and vaginal dryness. Arthralgia/myalgia symptoms included arthralgia, myalgia and carpal tunnel syndrome. Symptoms occurring within 3 mos of treatment initiation were considered for landmark analyses of DFS from 3 mos. Results: Median follow-up was 77 months. Incidence rates were 18.8%, 8.5%, 0.5%, 3.0%, 1.4% and 0.1% for hot flushes, night sweats, vaginal dryness, arthralgia, myalgia, and carpal tunnel syndrome, respectively. Rates of any vasomotor and arthralgia/myalgia symptoms reported within 3 mos were 21.2% and 4.1%, respectively. Unadjusted (log-rank) tests, showed significant associations between increased DFS and occurrence of hot flushes (p=.03), arthralgia (p=.005), myalgia (p=.07), any vasomotor symptoms (p=.05), and arthralgia/myalgia symptoms (p=.001). Following adjustment (Cox model) for age, BMI, prior HRT use, nodal status, tumor grade, tumor size and treatment group, occurrence of arthralgia/myalgia symptoms remained significantly associated with increased DFS (hazard ratio=0.64, p=0.05). No significant interactions were found between the occurrence of these AEs and treatment group. Conclusions: Arthralgia/myalgia, but not vasomotor early symptoms, were associated with improved DFS, irrespective of endocrine treatment.

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