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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)†‡

  1. Maurizio Belfiglio M.D.,
  2. Miriam Valentini M.D.,
  3. Fabio Pellegrini M.Sc.,
  4. Giorgia De Berardis M.Sc.,
  5. Monica Franciosi M.Sc.,
  6. Maria C.E. Rossi M.Sc.,
  7. Michele Sacco M.D.,
  8. Antonio Nicolucci M.D.§,*

Article first published online: 24 OCT 2005

DOI: 10.1002/cncr.21474

Issue

Cancer

Cancer

Volume 104, Issue 11, pages 2334–2339, 1 December 2005

Additional Information

How to Cite

Belfiglio, M., Valentini, M., Pellegrini, F., De Berardis, G., Franciosi, M., Rossi, M. C., 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

Author Information

  1. Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, S. Maria Imbaro, Italy

  1. §

    Fax (011) 39 0872 570263

*Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Via Nazionale, 8/A – 66030 S. Maria Imbaro, Italy

  1. †

    Part of this study was presented in abstract form at the ASCO, 2005 Annual Meeting, Orlando, Florida 13–17 May, 2005.

  2. ‡

    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.

Publication History

  1. Issue published online: 18 NOV 2005
  2. Article first published online: 24 OCT 2005
  3. Manuscript Accepted: 6 JUL 2005
  4. Manuscript Revised: 8 JUN 2005
  5. Manuscript Received: 14 APR 2005

Funded by

  • AstraZeneca Italia

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Keywords:

  • tamoxifen;
  • breast neoplasms;
  • survival rate;
  • chemotherapy;
  • adjuvant

This study evaluated the impact on overall survival of 2 versus 5 years adjuvant tamoxifen in early breast carcinoma patients after 12 years of follow-up.

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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).

CONCLUSIONS

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.

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