Gemcitabine plus docetaxel versus docetaxel in patients with predominantly human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer: A randomized, phase III study by the Danish breast cancer cooperative group
Journal of Clinical Oncology, 11/16/2011
Nielsen DL et al. – GD compared with docetaxel demonstrated increased TTP in metastatic breast cancer. RR and OS were similar. The addition of gemcitabine failed to demonstrate any clinically meaningful benefit when combined with docetaxel.
Predominantly human epidermal growth factor receptor 2 (HER2) –negative patients were randomly assigned to gemcitabine (1,000 mg/m2) on days 1 and 8 plus docetaxel (75 mg/m2) on day 8 or to docetaxel (100 mg/m2) on day 1, every 21 days
Patients were untreated or had prior (neo)adjuvant chemotherapy or a single anthracycline-based chemotherapy regimen for metastatic breast cancer
Primary end point was time to progression (TTP), and secondary end points were OS, response rate (RR), and toxicity
170 patients were allocated to GD, and 167 were allocated to docetaxel
Median TTP on GD was 10.3 months versus 8.3 months on docetaxel (HR, 0.77; 95% CI, 0.59 to 1.01; log-rank P = .06)
Adjusted Cox proportional model for TTP showed significant difference favoring combination (HR, 0.68; 95% CI, 0.51 to 0.90; P = .007)
RR was similar (GD, 36%; docetaxel, 34%), and OS was not different (P = .57)
Grades 3 to 4 neutropenia was common (GD, 75%; docetaxel, 69%); infection was reported in 26% and 21% of patients in the GD and docetaxel groups, respectively
Grades 3 to 4 thrombocytopenia was more frequent with GD (GD, 16%; docetaxel, 0.6%), and peripheral neuropathy was higher with docetaxel (GD, 5%; docetaxel, 16%)
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