The evidence supporting this regimen comes from a multicentre, phase II, randomised controlled trial comparing the efficacy and safety of trastuzumab with docetaxel in the first line treatment HER-2 positive metastatic breast cancer.r
Between April 2000 and October 2002, a total of 188 patients were randomly assigned (94 patients in each arm), to 6 cycles of docetaxel 100 mg/m2 every 3 weeks, with or without weekly trastuzumab (loading dose 4 mg/kg followed by 2 mg/kg.)
Baseline characteristics were generally balanced, the median duration of primary disease was 26.6 and 22.6 months and the median duration of metastatic disease was 1.3 months and 1 month in the combination arm and docetaxel alone arm respectively.r
Efficacy
The combination of trastuzumab with docetaxel was superior to docetaxel alone in all clinical efficacy parameters investigated as shown in the table and Kaplan-Meier estimates below.
Kaplan-Meier estimates of efficacy r
© Journal of Clinical Oncology 2005
Kaplan-Meier estimates of overall survival r
© Journal of Clinical Oncology 2005
Toxicity
Grade 3 to 4 neutropenia and febrile neutropenia were more common with the combination arm (32% and 23% respectively) than with docetaxel alone arm (22% and 17% respectively). There were 2 deaths as a result of septicaemia in the docetaxel alone arm and none in the combination arm.
Cardiac dysfunction is a concern with trastuzumab and 2 patients in the combined group developed symptomatic heart failure. Both patients had received prior adjuvant anthracyclines.r
Nonhaematologic adverse events r
© Journal of Clinical Oncology 2005