The present study examined long-term efficacy outcomes in a subgroup of postmenopausal, estrogen receptor-positive Japanese breast cancer patients from the Pre-Operative ''Arimidex'' Compared with Tamoxifen trial, following pre-operative (3 months) and post-operative (5 years) adjuvant treatment with either anastrozole or tamoxifen. Patients with large, potentially operable, locally-advanced breast cancer were randomized to receive anastrozole (1 mg ⁄ day) plus tamoxifen placebo or tamoxifen (20 mg ⁄ day) plus anastrozole placebo pre-operatively. After surgery at 3 months, patients continued on the same study medication as adjuvant therapy for up to 5 years or until recurrence, intolerable toxicity or withdrawal of patient consent. Recurrencefree survival and overall survival were measured from the date of randomization to the date of recurrence or death, whichever occurred first. Patients were monitored for adverse events throughout the study period and up to 30 days following administration of the last study medication. During post-operative adjuvant therapy, 4 ⁄ 48 (8%) anastrozole and 25 ⁄ 49 (51%) tamoxifen patients experienced recurrence. There was a significant difference in recurrence-free survival between the two groups (hazard ratio 0.14; 95% confidence interval 0.05-0.41; P = 0.0003). There was a significant increase in overall survival with anastrozole (0.21; 0.05-0.96; P = 0.0436) and there were 2 ⁄ 48 (4%) and 10 ⁄ 49 (20%) deaths with anastrozole and tamoxifen, respectively. Most patients responding to pre-operative therapy remained recurrence-free. Sequential pre-operative ⁄ post-operative treatment with anastrozole resulted in lower recurrence and death rates, compared with tamoxifen. (Cancer Sci 2012; 103: 491-496) A lthough several pre-operative trials comparing hormonal therapy with an aromatase inhibitor (AI) versus tamoxifen have reported the superior efficacy of AI in terms of primary tumor response, long-term follow-up outcomes from pre-operative and subsequent post-operative therapy have rarely been reported.(1-5) For instance, in the P024 neoadjuvant endocrine therapy trial, which compared 4 months' pre-operative letrozole versus tamoxifen, patients were treated with post-operative tamoxifen only, regardless of the randomized pre-operative treatment received.(6) Thus, it was not possible to evaluate the impact of a pre-operative and subsequent post-operative AI over tamoxifen on prognosis.The Pre-Operative Arimidex Compared with Tamoxifen (PROACT) trial was a randomized, double-blind, doubledummy, multicenter study, conducted in the USA (12 centers), in Europe and the rest of the world (44 centers) and in Japan (25 centers) that compared anastrozole versus tamoxifen as pre-operative (12 weeks' treatment prior to primary surgery), in terms of objective response (OR), and subsequent post-operative (adjuvant) treatments in 451 postmenopausal women with large, operable, or potentially operable, locally-advanced, hormone receptor-positive (HR+) breast cancer. PROACT demonstrated that anas...