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. (c) 2008 S. Karger AG, Basel
OBJECTIVE: To evaluate the efficacy and toxicity of pegylated liposomal doxorubicin (PLD; Caelyx)-cyclophosphamide combination in older metastatic breast cancerpatients. 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 cancerpatients 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 cancerpatients, but cannot be recommended routinely due to myelotoxicity and mucositis hazards. (c) 2008 S. Karger AG, Basel
Authors: Jens Huober; Werner Fett; Arnd Nusch; Michael Neise; Marcus Schmidt; Arthur Wischnik; Steffen Gerhardt; Thomas Goehler; Hans-Joachim Lück; Andreas Rost Journal: BMC Cancer Date: 2010-01-05 Impact factor: 4.430