Addition of either lonidamine or granulocyte colony-stimulating factor does not improve survival in early breast cancer patients treated with high-dose epirubicin and cyclophosphamide

Paola Papaldo, Massimo Lopez, Enrico Cortesi, Eugenio Cammilluzzi, Mauro Antimi, Edmondo Terzoli, Giuseppe Lepidini, Patrizia Vici, Carlo Barone, Gianluigi Ferretti, Serena Di Cosimo, Cecilia Nisticò, Paolo Carlini, Francesca Conti, Luigi Di Lauro, Claudio Botti, Carlo Vitucci, Alessandra Fabi, Diana Giannarelli, Paolo Marolla

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity. Patients and Methods: From October 1991 to April 1994, 506 patients with stage I/II BC were randomly assigned to four groups: (A) epirubicin 120 mg/m 2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients). Results: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non-G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus non-LND arms (81.3%) and in G-CSF (80.6%) versus non-G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively). Conclusion: EC is active and well tolerated in patients with early breast cancer. The addition of LND or G-CSF does not improve DFS or OS.

Original languageEnglish
Pages (from-to)3462-3468
Number of pages7
JournalJournal of Clinical Oncology
Volume21
Issue number18
DOIs
Publication statusPublished - Sep 15 2003

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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