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Article first published online: 24 OCT 2005
Copyright © 2005 American Cancer Society
Volume 104, Issue 11, pages 2334–2339, 1 December 2005
How to Cite
Belfiglio, M., Valentini, M., Pellegrini, F., De Berardis, G., Franciosi, M., Rossi, M. C.E., Sacco, M. and Nicolucci, A. (2005), Twelve-year mortality results of a randomized trial of 2 versus 5 years of adjuvant tamoxifen for postmenopausal early-stage breast carcinoma patients (SITAM 01). Cancer, 104: 2334–2339. doi: 10.1002/cncr.21474
Part of this study was presented in abstract form at the ASCO, 2005 Annual Meeting, Orlando, Florida 13–17 May, 2005.
Participating clinicians: Giampaolo Sacchetto, Loredana De Filippi, Alba (CN); Francesco Di Vito, Mariella Cucchi, Aosta; Giuseppe Di Biagio, Assisi (PG); Franco Testore, Asti; Luciano Isa, Gorgonzola (MI); Tonino Pedicini, Claudia Corbo, Antonio Febbraro, Benevento; Patrizia Marpicati, Giovanni Marini, Edda Simoncini, Brescia; Mario Costanzo, Catania; Ettore Cianchetti, Simona Grossi, Paolo Noccioli, Ortona (CH); Donata Tabiadon, Riccardo Valsecchi, Gino Luporini, Milano; Giordano Beretta, Cinisello Balsamo (MI); Fulvio Peradotto, Cuorgné (TO); Angelo Gambi, M. Cristina Cappelli, Flavia Foglietta, Faenza (RA); Monica Indelli, Caterina Modonesi, Ferrara; M. Antonietta De Meo, Giuseppe Cardi, Formia (LT); Giorgio Baratelli, Gravedona (CO); Liberato Di Lullo, Isernia; Giampaolo De Rubeis, L'Aquila; Stefano Graziani, Lanciano (CH); Michele Antonello, Giambeppi Pizzi, Mestre (VE); Elisa Locatelli, Milano; Vito Schena, Sergio Peonetto, Patrizia Grace Bianchi, Milano; Francesco Arceri, Novara; Paola Viola, Rho (MI); Mauro Antimi, Mauro Minelli, Vincenzo Bellini, Giuseppe Marinuzzi, Roma; Nina Olmeo, Antonio Contu, Sassari; Luciano Galletto, Marcella Sussio, Savigliano (CN); Fabrizio Fracchia, Raffaella Fiorella, Torino; Giorgio Giardina, Torino; Maria Grazia Pacquola, Anna Tava, Tortona (AL); Antonella Richetti, Marinella Molteni, Varese; Riccardo Samaritani, Roma; Attilio D'Arrigo, Ivrea (TO); Enrico Ansaldi, Cirié (TO); Sano Pasqualucci, Carlo Floris, Maria Cristina Cherchi, Enrichetta Valle, Cagliari; Italo Rasciale, Antonello Conte, Lorena Biasizzo, Udine; Antonio Tedde, Alberto Desogus, Marco Pintus, Cagliari; Giovanni Ambrosini, Orazio Caffo, Trento; Aurora Ferrari, Vittorio Corsetti, Ileana Capata, Calcinato (BS); Pietro Masullo, Francesco D'Episcopo, Vallo della Lucania (SA); Giorgio Mustacchi, Michela Muggia, Trieste; Maria Concetta Chetrí, Brindisi; Giuseppe Serravezza, Antonella Elia, Giuseppe Quarta, Casarano (LE); Stefano Bravi, Franco Biagioni, Città di Castello (PG); Antonio Rulli, Annarita Vento, Paola Naninato, Perugia; Virginia Liguori, Candida Mastroianni, Salvatore Palazzo, Cosenza; Enza Defabiani, Mario Campogrande, Torino.
- Issue published online: 18 NOV 2005
- Article first published online: 24 OCT 2005
- Manuscript Accepted: 6 JUL 2005
- Manuscript Revised: 8 JUN 2005
- Manuscript Received: 14 APR 2005
- AstraZeneca Italia
- breast neoplasms;
- survival rate;
This study evaluated the impact on overall survival (OS) of 2 versus 5 years adjuvant tamoxifen in early breast carcinoma patients after 12 years of follow-up.
Women with breast carcinoma T1–3, N0–3, M0, aged 50–70 years, were eligible for this multicenter randomized Phase III trial. Patients event-free after 2 years of tamoxifen therapy (TAM) were randomly assigned to stop or continue TAM (20 mg/day) for an additional 3 years. The primary endpoint was disease-free survival. Secondary endpoints included OS and toxicity.
From 1989 through 1996, 1901 patients were randomly assigned either to stop treatment (n = 958) or to continue TAM (n = 943). Overall, 98% of patients alive at the previous report (n = 1611) had updated information about OS, of whom 549 had died. The median duration of postrandomization follow-up was 115 months (interquartile range, 86–137). No statistically significant differences between the two arms were detected in the whole population (hazard ratio [HR], 1.02; 95% confidence interval [CI], 0.86–1.22) and in estrogen receptor (ER)-positive patients (HR, 0.90; 95% CI, 0.72–1.13). In the latter group, survival curves started to diverge after 90 months, showing a trend in favor of the 5-year arm. In younger (age ≤55 yrs) ER-positive patients longer TAM was associated with a 44% decrease in the risk of death (HR, 0.56; 95% CI, 0.31–1.00), while no clear benefit was documented in women older than 55 years of age (HR, 0.98; 95% CI, 0.77–1.25).
The benefits of longer TAM on OS start to emerge only after 9 years from diagnosis and seem to be more relevant in younger ER-positive women. Cancer 2005. © 2005 American Cancer Society.