This Article Full Text 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 Toledano, A. Articles by Calais, G. Search for Related Content PubMed Articles by Toledano, A. Articles by Calais, G. Social Bookmarking                            What's this?

Phase III Trial of Concurrent or Sequential Adjuvant Chemoradiotherapy After Conservative Surgery for Early-Stage Breast Cancer: Final Results of the ARCOSEIN Trial

Alain Toledano, David Azria, Pascal Garaud, Alain Fourquet, Daniel Serin, Jean-François Bosset, Joelle Miny-Buffet, Anne Favre, Olivier Le Floch, Gilles Calais

From the Department of Radiation Oncology, Henry Kaplan, Hôpital Bretonneau, Tours; Centre Régional de Lutte Contre le Cancer Val d'Aurelle, Montpellier; Institut Sainte-Catherine, Avignon; Institut Curie, Paris; Hôpital Minjoz, Besançon; and Hôpital La Source, Orléans; France

Address reprint requests to Alain Toledano, MD, Department of Radiation Oncology, Henry Kaplan, Hôpital Bretonneau, 2 Bd Tonnellé, 37044 Tours Cedex 9, France; e-mail: alain.toledano{at}gmail.com

Purpose In 1996, we initiated the French multicenter phase III randomized trial to compare the effect on disease-free survival (DFS) of concurrent versus sequential chemotherapy (CT) and radiotherapy (RT) after breast-conserving surgery for stages I and II breast cancer. This report presents the clinical results with a median follow-up of 60 months.

Patients and Methods Between February 1996 and April 2000, 716 patients were entered onto this trial. Adjuvant treatment began within 6 weeks after surgery. Sequential treatment of CT administered first followed by RT was compared with concurrent treatment of CT administered with RT. The CT regimen consisted of mitoxantrone (12 mg/m²), fluorouracil (500 mg/m²), and cyclophosphamide (500 mg/m²) on day 1, and it was repeated every 21 days for six courses. RT was delivered to the breast and, when indicated, to the regional lymphatics.

Results There was no statistically significant difference in treatment in the 5-year DFS (80% in both groups; P = .83), locoregional recurrence-free survival (LRFS; 92% in sequential v 95% in concurrent; P = .76), metastasis-free survival (87% in sequential v 84% in concurrent; P = .55), or overall survival (90% in sequential v 91% in concurrent; P = .76). Nevertheless, in the node-positive subgroup, the 5-year LRFS was statistically better in the concurrent arm (97% in concurrent v 91% in sequential; P = .02), corresponding to a risk of locoregional recurrence decreased by 39% (hazard ratio, 0.61; 95% CI, 0.38 to 0.93).

Conclusion This treatment protocol remains an appealing clinical option for many women with operable breast cancer at a high risk of recurrence. Combination treatments with new drugs for breast cancer are warranted.

Presented in part at the Annual Meeting of the American Society for Therapeutic Radiology and Oncology, October 16-20, 2005, Denver, CO.

Both A.T. and D.A. contributed equally to this work.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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

This article has been cited by other articles:

				R. C. Zellars, V. Stearns, D. Frassica, F. Asrari, T. Tsangaris, L. Myers, S. DiPasquale, J. R. Lange, L. K. Jacobs, L. A. Emens, et al. Feasibility Trial of Partial Breast Irradiation With Concurrent Dose-Dense Doxorubicin and Cyclophosphamide in Early-Stage Breast Cancer J. Clin. Oncol., June 10, 2009; 27(17): 2816 - 2822. [Abstract] [Full Text] [PDF]