TY - JOUR T1 - Switching to anastrozole versus continued tamoxifen treatment of early breast cancer: preliminary results of the Italian Tamoxifen Anastrozole Trial. AU - Boccardo,Francesco, AU - Rubagotti,Alessandra, AU - Puntoni,Matteo, AU - Guglielmini,Pamela, AU - Amoroso,Domenico, AU - Fini,Angela, AU - Paladini,Giuseppe, AU - Mesiti,Mario, AU - Romeo,Domenico, AU - Rinaldini,Michela, AU - Scali,Simona, AU - Porpiglia,Mauro, AU - Benedetto,Chiara, AU - Restuccia,Nunzio, AU - Buzzi,Franco, AU - Franchi,Roberto, AU - Massidda,Bruno, AU - Distante,Vito, AU - Amadori,Dino, AU - Sismondi,Piero, Y1 - 2005/07/11/ PY - 2005/7/13/pubmed PY - 2005/9/15/medline PY - 2005/7/13/entrez SP - 5138 EP - 47 JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JO - J Clin Oncol VL - 23 IS - 22 N2 - PURPOSE: Tamoxifen, which is actually the gold standard adjuvant treatment in estrogen receptor-positive early breast cancer, is associated with an increased risk of endometrial cancer and other life-threatening events. Moreover, many women relapse during or after tamoxifen therapy because of the development of resistance. Therefore new approaches are required. PATIENTS AND METHODS: We conducted a prospective randomized trial to test the efficacy of switching postmenopausal patients who were already receiving tamoxifen to the aromatase inhibitor anastrozole. After 2 to 3 years of tamoxifen treatment, patients were randomly assigned either to receive anastrozole 1 mg/d or to continue receiving tamoxifen 20 mg/d, for a total duration of treatment of 5 years. Disease-free survival was the primary end point. Event-free survival, overall survival, and safety were secondary end points. RESULTS: Four hundred forty-eight patients were enrolled. All women had node-positive, estrogen receptor-positive tumors. At a median follow-up time of 36 months, 45 events had been reported in the tamoxifen group compared with 17 events in the anastrozole group (P = .0002). Disease-free and local recurrence-free survival were also significantly longer in the anastrozole group (hazard ratio [HR] = 0.35; 95% CI, 0.18 to 0.68; P = .001 and HR = 0.15; 95% CI, 0.03 to 0.65; P = .003, respectively). Overall, more adverse events were recorded in the anastrozole group compared with the tamoxifen group (203 v 150, respectively; P = .04). However, more events were life threatening or required hospitalization in the tamoxifen group than in the anastrozole group (33 of 150 events v 28 of 203 events, P = .04). CONCLUSION: Switching to anastrozole after the first 2 to 3 years of treatment is well tolerated and significantly improves event-free and recurrence-free survival in postmenopausal patients with early breast cancer. SN - 0732-183X UR - https://www.unboundmedicine.com/medline/citation/16009955/Switching_to_anastrozole_versus_continued_tamoxifen_treatment_of_early_breast_cancer:_preliminary_results_of_the_Italian_Tamoxifen_Anastrozole_Trial_ DB - PRIME DP - Unbound Medicine ER -