Phase II trial of pegylated liposomal doxorubicin-cyclophosphamide combination as first-line chemotherapy in older metastatic breast cancer patients.

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 > or =50%. First-line chemotherapy was given to metastatic breast cancer patients resistant to hormonal therapy. The treatment schedule was PLD 40 mg/m(2) and cyclophosphamide 500 mg/m(2) 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.

• Authors: J E Kurtz, F Rousseau, N Meyer, T Delozier, D Serin, M Nabet, L Djafari, P Dufour
• Journal: Oncology (Oncology) Vol. 73 Issue 3-4 Pg. 210-4 ( 2007) ISSN: 1423-0232 [Electronic] Switzerland
• PMID: 18424884 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study)
• Copyright: (c) 2008 S. Karger AG, Basel

Chemical References

• liposomal doxorubicin
• Polyethylene Glycols
• Doxorubicin
• Cyclophosphamide

Topics

• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects, therapeutic use)
• Bone Neoplasms (drug therapy, secondary)
• Breast Neoplasms (drug therapy, pathology)
• Cyclophosphamide (administration & dosage)
• Doxorubicin (administration & dosage, analogs & derivatives)
• Female
• Humans
• Liver Neoplasms (drug therapy, secondary)
• Lung Neoplasms (drug therapy, secondary)
• Lymphatic Metastasis
• Polyethylene Glycols (administration & dosage)
• Salvage Therapy
• Survival Rate
• Treatment Outcome