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Annals of Oncology Advance Access originally published online on May 19, 2005
Annals of Oncology 2005 16(8):1343-1351; doi:10.1093/annonc/mdi251
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© 2005 European Society for Medical Oncology

Secondary leukemia after epirubicin-based adjuvant chemotherapy in operable breast cancer patients: 16 years experience of the French Adjuvant Study Group

M. Campone1,*, H. Roché2, P. Kerbrat3, J. Bonneterre4, P. Romestaing5, P. Fargeot6, M. Namer7, A. Monnier8, P. Montcuquet9, M.-J. Goudier10, P. Fumoleau6 On behalf of the FASG (French Adjuvant Study Group), France

1 Centre René Gauducheau, Nantes; 2 Institut Claudius Régaud, Toulouse; 3 Centre Eugène Marquis, Rennes; 4 Centre Oscar Lambret, Lille; 5 Centre Hospitalier Jules Courmont, Lyon; 6 Centre Georges-François Leclerc, Dijon; 7 Centre Antoine Lacassagne, Nice; 8 Centre Hospitalier André Boulloche, Montbéliard; 9 Clinique Saint-Vincent, Besançon; 10 Centre Hospitalier de Bretagne Sud, Lorient, France

* Correspondence to: Dr M. Campone, Département d'Oncologie Médicale, Centre René Gauducheau, Boulevard Jacques Monod, 44805 Nantes-St-Herblain Cedex, France. Tel: +33-2-40-67-99-77; Fax: +33-2-40-63-96-61; Email: m-campone{at}nantes.fnclcc.fr

Background: The purpose of this study was to evaluate incidence and risk factors of secondary leukemia after adjuvant epirubicin-based chemotherapy in breast cancer patients.

Patients and methods: Among eight French Adjuvant Study Group trials, 3653 patients were assessable: 2603 received epirubicin; 682 received hormonotherapy; and 368 had no systemic treatment. Chemotherapy was FEC regimen in 85% of cases (fluorouracil 500 mg/m2, epirubicin 50, 75 or 100 mg/m2, cyclophosphamide 500 mg/m2, three or six cycles). Epirubicin cumulative dose was <300 mg/m2 in 1045 patients; 300–600 mg/m2 in 1187; and ≥600 mg/m2 in 286, followed by radiotherapy in 96% of cases. The median follow-up was 104 months.

Results: Eight cases of leukemia occurred in epirubicin-exposed patients and one in non-exposed patients. After 9 years, the risk of developing a leukemia was 0.34% (95% confidence interval 0.11–0.57) in epirubicin-exposed patients. In patients receiving chemotherapy, leukemia subtypes were: AML2 (two), AML3 (one), AML4 (three) and ALL (two). None of the classically recognized risk factors was significantly correlated with the occurrence of a leukemia.

Conclusion: Irrespective of the dose, the incidence of secondary leukemia after adjuvant epirubicin-based chemotherapy was low. After a long follow-up, the benefit/risk ratio for early breast cancer patients remained in favor of epirubicin-based adjuvant chemotherapy: eight cases (0.31%) occurred, and in some of them, treatment causality could be debatable.

Key words: adjuvant chemotherapy, breast cancer, epirubicin, secondary leukemia


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