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Long-Term Cardiac Follow-Up in Relapse-Free Patients After Six Courses of Fluorouracil, Epirubicin, and Cyclophosphamide, With Either 50 or 100 mg of Epirubicin, As Adjuvant Therapy for Node-Positive Breast Cancer: French Adjuvant Study Group

From the Centre Oscar Lambret, Lille; Institut Claudius Régaud, Toulouse; Centre Eugène Marquis, Rennes; Centre René Gauducheau, Nantes; Centre Hospitalier de Bretagne Sud, Lorient; Centre Georges-François Leclerc, Dijon; Clinique Saint-Vincent, Besançon; Centre Hospitalier Universitaire Dupuytren, Limoges; Centre Hospitalier Louis Pasteur, Colmar; Centre Hospitalier André Boulloche, Montbéliard; Centre Henri Becquerel, Rouen; Centre Hospitalier, Annecy; and Centre Jean Perrin, Clermont-Ferrand, France

Address reprint requests to Jacques Bonneterre, MD, Département de Sénologie, Centre Oscar Lambret, 3 Rue Frédéric Combemale, 59020 Lille Cedex, France; e-mail: j-bonneterre{at}o-lambret.fr

PURPOSE: To evaluate long-term cardiac function in patients without disease who had received six cycles of fluorouracil 500 mg/m², epirubicin 50 mg/m², and cyclophosphamide 500 mg/m² (FEC 50) or the same regimen with epirubicin 100 mg/m² (FEC 100) as adjuvant chemotherapy for node-positive breast cancer in the French Adjuvant Study Group–05 trial.

PATIENTS AND METHODS: One hundred fifty patients (FEC 50, n = 65; FEC 100, n = 85) who were without disease and who gave their informed consent were enrolled for long-term cardiac assessment. The assessment included cardiac events occurring after the end of chemotherapy, vital signs, concomitant disease, ECG, isotopic left ventricular ejection fraction (LVEF), and echographic parameters. Abnormal files were blindly reviewed by cardiologists and oncologists.

RESULTS: The median follow-up time was 102 months. After FEC 100, LVEF was less than 50% in five patients (radioisotopic method), and two patients experienced congestive heart failure (CHF) that was possibly related to treatment. Asymptomatic left ventricular dysfunction (LVD) was experienced in 18 patients after FEC 100 and in one patient after FEC 50. In these patients, treatment causality was probable in eight patients. Two additional years after this assessment, all 18 patients were still asymptomatic.

CONCLUSION: After more than 8 years of follow-up, the cardiac toxicity observed after adjuvant treatment with FEC 100 comprised two cases of well-controlled CHF and 18 cases of asymptomatic LVD. In the majority of women with primary breast cancer, the benefits of treatment with FEC 100 in terms of disease-free and overall survival outweigh the risks, and cardiac risk factors should be carefully evaluated in patient selection.

Supported by grants from Pharmacia SA, Saint-Quentin en Yvelines, France.

Presented at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 18-21, 2002 (abstract 154; poster display/discussion).

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

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