Phase II trial of pegylated liposomal doxorubicin-cyclophosphamide combination as first-line chemotherapy in older metastatic breast cancer patients.
Fiche publication
Date publication
janvier 2007
Auteurs
Membres identifiés du Cancéropôle Est :
Pr KURTZ Jean-Emmanuel, Pr MEYER Nicolas
Tous les auteurs :
Kurtz JE, Rousseau F, Meyer N, Delozier T, Serin D, Nabet M, Djafari L, Dufour P
Lien Pubmed
Résumé
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.
Référence
Oncology. 2007;73(3-4):210-4