Clinical Study

Adjuvant Chemotherapy with High-Dose Cyclophosphamide, Etoposide and Cisplatin Intensification without Progenitor Cell Support in Breast Cancer Patients with Ten or More Involved Nodes: 5-Year Results of a Pilot Trial
Alberto Ballestrero^a, Alessandra Rubagotti^b, Paola Stura^a, Fabio Ferrando^a, Domenico Amoroso^c, Michela Rinaldini^d, Piero Sismondi^e, Franco Genta^f, Mario Mesiti^g, Fulvio Brema^h, Franco Patrone^a, Francesco Boccardo^c, on behalf of GROCTA (Italian Breast Cancer Adjuvant Study Group)

^aDepartment of Internal Medicine, Intensive Chemo-Immunotherapy Unit, University of Genoa;
^bBiostatistics Unit, and
^cProfessorial Unit of Medical Oncology, University and National Cancer Institute, Genoa;
^dOncologic Center, General Hospital, Arezzo;
^eDepartment of Gynecologic Oncology, University and Mauriziano Hospital, Turin;
^fDepartment of Gynecology and Obstetrics, Sant'Anna Gynecologic Hospital, Turin;
^gInstitute of Oncology, University of Messina, and
^hDepartment of Medical Oncology, San Paolo Hospital, Savona, Italy

Address of Corresponding Author

Oncology 2001;60:221-227 (DOI: 10.1159/000055322)

  Key Words

• Breast cancer, primary
• High-dose chemotherapy
• High-risk breast cancer
• Irradiation
• Progenitor cell support

  Abstract

Objectives: The purpose of this study was to evaluate the clinical efficacy and tolerability of high-dose (HD) chemotherapy with growth factor support in primary breast cancer with extensive nodal involvement. Patients and Methods: Fifty-three patients with ten or more involved nodes were recruited and were given three cycles of standard-dose fluorouracil, epidoxorubicin and cyclophosphamide followed by one single course of high-dose CEP (cyclophosphamide, etoposide and cisplatin). No autologous progenitor support was used. Results: Five-year actuarial disease-free and overall survival were 40 and 60%, respectively. High-dose CEP required a median of 22 days of hospitalization and was associated with grade G3-G4 nausea and vomiting in two thirds of the cases. Hematological toxicity was comparable to that of high-dose therapies delivered with autologous progenitor support. No therapy-related mortality was observed. Conclusions: The efficacy of treatment was comparable to the best results of conventional therapy, with only a trend for improved survival. High-dose CEP was feasible with acceptable toxicity. Although this regimen does not require stem cell harvesting and storage, it requires clinical support comparable to autotransplantation procedures and side effects are not so manageable to recommend its use outside specialized units.

Copyright © 2001 S. Karger AG, Basel

  Author Contacts

Francesco Boccardo, MD, GROCTA Headquarters
Professorial Unit of Medical Oncology
University and National Cancer Institute, Largo R. Benzi 10
I-16132 Genoa (Italy)
Tel. +39 010 5600503, Fax +39 010 352753, E-Mail boccardo@hp380.ist.unige.it

  Article Information

Number of Print Pages : 7
Number of Figures : 1, Number of Tables : 3, Number of References : 34