Clinical Study

Phase II Trial of Pegylated Liposomal Doxorubicin-Cyclophosphamide Combination as First-Line Chemotherapy in Older Metastatic Breast Cancer Patients
J.E. Kurtz^a, F. Rousseau^c, N. Meyer^a, T. Delozier^d, D. Serin^e, M. Nabet^f, L. Djafari^g, P. Dufour<sup>b

a</sup>Hôpitaux Universitaires de Strasbourg et
^bCentre Paul Strauss, Strasbourg,
^cInstitut Paoli-Calmettes, Marseille,
^dCentre F. Baclesse, Caen,
^eClinique Ste Catherine, Avignon,
^fClinique Claude Bernard, Metz, et
^gSchering-Plough, Levallois-Perret, France

Address of Corresponding Author

Oncology 2007;73:210-214 (DOI: 10.1159/000127411)

  Key Words

• Pegylated liposomal doxorubicin
• Cyclophosphamide
• Older
• Breast cancer

  Abstract

Objective: To evaluate the efficacy and toxicity of pegylated liposomal doxorubicin (PLD; Caelyx®)-cyclophosphamide combination in older metastatic breast cancer patients. Methods: A multicenter phase II trial was conducted. Inclusion criteria were age 65-75 years, ECOG 0-1 and left ventricular ejection fraction 50%. First-line chemotherapy was given to metastatic breast cancer patients resistant to hormonal therapy. The treatment schedule was PLD 40 mg/m² and cyclophosphamide 500 mg/m² on day 1 every 4 weeks. Efficacy was the primary endpoint, while response duration and tolerance were the secondary endpoints. Results: Thirty-five patients (median age 71.3 years) were enrolled. No treatment-related death, no congestive heart failure or decrease in left ventricular ejection fraction and no febrile neutropenia were reported. Toxicity: grade 3 dyspnea was found in 1 patient, neutropenia in 11 patients (7 grade 3, 4 grade 4), grade 3 mucositis in 4 patients, grade 3 hand-foot syndrome in 1 patient and a generalized rash in 1 patient. An objective response (complete and partial response) was achieved in 10 (28.6%) patients and disease control in 24 (69%) with a progression-free survival of 8.8 months and a median overall survival of 20.3 months. Conclusion: The PLD-cyclophosphamide combination is moderately active and safe in elderly metastatic breast cancer patients, but cannot be recommended routinely due to myelotoxicity and mucositis hazards.

Copyright © 2008 S. Karger AG, Basel

  Author Contacts

Prof. P. Dufour
Centre Paul Strauss, 3, rue de la porte de l'hôpital
FR-67000 Strasbourg (France)
Tel. +33 3 88 25 24 01, Fax +33 3 88 25 24 58
E-Mail pdufour@strasbourg.fnclcc.fr

  Article Information

Received: February 28, 2007
Accepted after revision: September 24, 2007
Published online: April 17, 2008
Number of Print Pages : 5
Number of Figures : 2, Number of Tables : 3, Number of References : 14