PURPOSE: We aim to compare the efficacy and toxicity of liposomal doxorubicin and weekly docetaxel as first-line treatments for patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: Patients who had received no previous chemotherapy for MBC were eligible. Previous hormonal therapy, adjuvant chemotherapy, and radiation therapy were allowed. Patients were randomized to receive liposomal doxorubicin 40 mg/m(2) intravenously [I.V.] every 28 days or weekly docetaxel 36 mg/m(2) I.V. days 1, 8, and 15, repeated every 28 days. Patients with objective response or stable disease after 2 cycles continued treatment until tumor progression or unacceptable toxicity. At progression, patients were allowed to cross over to the other regimen. The trial was designed to detect a true difference of 10% in response rate with an 80% power. RESULTS:Between March 2001 and July 2007, 102 patients were randomized. The 2 groups had similar demographics; 68% of patients had received previous adjuvant chemotherapy. Liposomal doxorubicin and weekly docetaxel produced similar objective response rates (28% vs. 31%), disease control rates (48% vs. 44%), and progression-free survival (6.5 months vs. 5.5 months). Both agents were well tolerated. Both agents produced crossover responses as second-line treatment (liposomal doxorubicin, 35%; weekly docetaxel, 14%). CONCLUSION:Liposomal doxorubicin is well tolerated and has activity similar to weekly docetaxel in the first-line treatment of patients with MBC.
RCT Entities:
PURPOSE: We aim to compare the efficacy and toxicity of liposomal doxorubicin and weekly docetaxel as first-line treatments for patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: Patients who had received no previous chemotherapy for MBC were eligible. Previous hormonal therapy, adjuvant chemotherapy, and radiation therapy were allowed. Patients were randomized to receive liposomal doxorubicin 40 mg/m(2) intravenously [I.V.] every 28 days or weekly docetaxel 36 mg/m(2) I.V. days 1, 8, and 15, repeated every 28 days. Patients with objective response or stable disease after 2 cycles continued treatment until tumor progression or unacceptable toxicity. At progression, patients were allowed to cross over to the other regimen. The trial was designed to detect a true difference of 10% in response rate with an 80% power. RESULTS: Between March 2001 and July 2007, 102 patients were randomized. The 2 groups had similar demographics; 68% of patients had received previous adjuvant chemotherapy. Liposomal doxorubicin and weekly docetaxel produced similar objective response rates (28% vs. 31%), disease control rates (48% vs. 44%), and progression-free survival (6.5 months vs. 5.5 months). Both agents were well tolerated. Both agents produced crossover responses as second-line treatment (liposomal doxorubicin, 35%; weekly docetaxel, 14%). CONCLUSION: Liposomal doxorubicin is well tolerated and has activity similar to weekly docetaxel in the first-line treatment of patients with MBC.
Authors: Davina Ghersi; Melina L Willson; Matthew Ming Ki Chan; John Simes; Emma Donoghue; Nicholas Wilcken Journal: Cochrane Database Syst Rev Date: 2015-06-10
Authors: Shannon Cope; Jie Zhang; Stephen Saletan; Brielan Smiechowski; Jeroen P Jansen; Peter Schmid Journal: BMC Med Date: 2014-06-05 Impact factor: 8.775
Authors: Tomer Meirson; Alessandro Genna; Nikola Lukic; Tetiana Makhnii; Joel Alter; Ved P Sharma; Yarong Wang; Abraham O Samson; John S Condeelis; Hava Gil-Henn Journal: Oncotarget Date: 2018-04-24