The aim of this study was to assess the efficacy and toxicity of the combination of docetaxel(Drug information on docetaxel) (Taxotere) and vinorelbine (Navelbine), every 15 days, in anthracycline-pretreated metastatic breast cancer patients.
Forty-eight patients were enrolled in the study between December 1998 and January 1999. Their average age was 53.9 years (range: 29–72 years). Treatment consisted of docetaxel 60 mg/m² IV day 1 and vinorelbine 25 mg/m² IV day 1, every 15 days. If there was grade 3/4 neutropenia, we added prophylactic granulocyte colony-stimulating factor (G-CSF, filgrastim(Drug information on filgrastim) [Neupogen]).
Metastatic locations included breast (8 patients), bone (21), local chest wall (10), liver (16), node (10), lung and pleural effusion (9), lymphangitis (4), bone marrow (1), and peritoneal carcinomatosis (1). All patients had been treated previously with anthracyclines, 28 had received previous hormonotherapy, and 24 previous radiotherapy. Thirty-four patients were evaluable for clinical response.
Results were as follows: complete response, 2 patients (5.8%) (1 dermal lesion and 1 lung); partial response, 16 (47%); overall response, 18 (52.8%). We used prophylactic G-CSF in 80 cycles. Hematologic toxicity occurred in 209 cycles (without G-CSF): neutropenia (grade 1, 7.6%; grade 2, 10.5%; grade 3, 21.5%; grade 4, 7.6%) and neutropenic fever (22 episodes). Nonhematologic toxicity was seen in 289 cycles: dermal toxicity (grade 1, 2.4%, grade 2, 2.0%); paresthesias (grade 1, 2.0%; grade 2, 4.1%); conjunctivitis (4.8%); edemas (3 patients); asthenia (18.3%); constipation (2.7%); and alopecia (100%). There was one toxic death due to neutropenic enterocolitis and one anaphylactic reaction.
CONCLUSION: This is an effective combination. Hematologic toxicity was moderate; thus it is necessary to use prophylactic G-CSF.
Click here for Dr. Gabriel N. Hortobagyi’s commentary on this abstract.
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