This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Nicolucci, A. Articles by Valentini, M. Search for Related Content PubMed Articles by Nicolucci, A. Articles by Valentini, M. Related Articles Related Article Related Correspondence Social Bookmarking                            What's this?

In Reply:

Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, Santa Maria Imbaro, Chieti, Italy

We agree with the comments of Diana Crivellari et al. Obviously, the results of our trial cannot be generalized to patients older than 70 years, for whom a substantial lack of data persists. Nevertheless, within the age range of the population enrolled onto our trial, the excess risk of thromboembolic events associated with longer tamoxifen duration was homogeneous across age strata. In fact, the absolute excess number of thromboembolic events in the 5-year arm as opposed to the 2-year arm was 2.48 of 1,000 woman-years for patients ages 50 to 55 years, 2.96 of 1,000 woman-years for those between 56 and 65 years of age, and 2.75 of 1,000 woman-years for those ages 66 to 70 years at diagnosis. Therefore, at least in patients age 70 years, prolonging tamoxifen over 2 years does not seem to substantially increase the risk of thromboembolic events in older patients as opposed to younger ones. Furthermore, in balancing the risks and benefits of longer tamoxifen duration, one should first consider the significant effect on disease recurrence. In this respect, although reliable information on the benefits of different durations of tamoxifen treatment in women older than 70 years is still lacking, the last overview by the Early Breast Cancer Trialists' Collaborative Group [1] showed that 5 years of tamoxifen versus no tamoxifen produced the same benefits in terms of disease-free survival and overall survival in all age classes, including women over 70 years. Therefore, in patients with moderate to high risk of relapse, the excess risk of thromboembolic events should first be weighted against the benefits deriving from postponing or avoiding local or distant recurrence. It is also reasonable to assume that benefit would exceed the harm in all women without established risk factors for thromboembolic events, irrespective of their age. As pointed out by Crivellari et al, other therapeutic options are currently available when an increased risk of thromboembolic events is present [2].

The ongoing Adjuvant Tamoxifen Longer Against Shorter trial, expected to enroll 20,000 post-menopausal women of any age with early breast cancer, will substantially contribute to elucidating the role of prolonged tamoxifen therapy in patients older than 70 years. To date, more than 2,500 women at least 70 years old have already been randomly assigned to longer versus shorter tamoxifen.

Authors' Disclosures of Potential Conflicts of Interest

The authors indicated no potential conflicts of interest.

REFERENCES

1. Early Breast Cancer Trialists' Collaborative Group: Tamoxifen for early breast cancer: An overview of the randomised trials. Lancet 351:1451-1467, 1998[CrossRef][Medline]

2. Baum M, Budzar AU, Cuzick J, et al: Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: First results of the ATAC randomised trial—The ATAC Trialists Group. Lancet 359:2131-2139, 2002[CrossRef][Medline]

CiteULike    Complore    Connotea    Del.icio.us    Digg    Facebook    Reddit    Technorati    Twitter    What's this?

Related Article

• Randomized Trial of 2 Versus 5 Years of Adjuvant Tamoxifen for Women Aged 50 Years or Older With Early Breast Cancer: Italian Interdisciplinary Group for Cancer Evaluation Study of Adjuvant Treatment in Breast Cancer 01
  M. Sacco, M. Valentini, M. Belfiglio, F. Pellegrini, G. De Berardis, M. Franciosi, and A. Nicolucci
  JCO 2003 21: 2276-2281 [Abstract] [Full Text]

Related Correspondence

• Hormonal Treatment Duration in Elderly Patients: An Open Question
  Diana Crivellari, Aron Goldhirsch, and Alan Coates
  JCO 2004 22: 1164-1165 [Full Text]

This article has been cited by other articles:

				M Montemurro, T Kiefer, F Schuler, H. Al-Ali, H-H Wolf, R Herbst, A Haas, K Helke, A Theilig, C Lotze, et al. Primary central nervous system lymphoma treated with high-dose methotrexate, high-dose busulfan/thiotepa, autologous stem-cell transplantation and response-adapted whole-brain radiotherapy: results of the multicenter Ostdeutsche Studiengruppe Hamato-Onkologie OSHO-53 phase II study Ann. Onc., April 1, 2007; 18(4): 665 - 671. [Abstract] [Full Text] [PDF]

				A.J.M. Ferreri, S. Dell'Oro, M. Foppoli, M. Bernardi, A. A. Brandes, A. Tosoni, M. Montanari, M. Balzarotti, M. Spina, F. Ilariucci, et al. MATILDE regimen followed by radiotherapy is an active strategy against primary CNS lymphomas Neurology, May 9, 2006; 66(9): 1435 - 1438. [Abstract] [Full Text] [PDF]

This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Nicolucci, A. Articles by Valentini, M. Search for Related Content PubMed Articles by Nicolucci, A. Articles by Valentini, M. Related Articles Related Article Related Correspondence Social Bookmarking                            What's this?