Phase II trial of bevacizumab in combination with weekly docetaxel in metastatic breast cancer patients.

PURPOSE: To evaluate the safety and efficacy of bevacizumab and weekly docetaxel as first- or second-line therapy in patients with metastatic breast cancer (MBC). PATIENTS AND METHODS: Twenty-seven MBC patients received i.v. bevacizumab at 10 mg/kg on days 1 and 15 in combination with i.v. docetaxel 35 mg/m2 on days 1, 8, and 15 of a 28-day cycle. Primary end points were to assess toxicity, overall response rate, and progression-free survival. A secondary end point was to assess the relationship between plasma endothelial and cell adhesion markers and clinical outcomes. RESULTS: One-hundred fifty-eight treatment cycles were administered with a median of six cycles (range 1-15 cycles) per patient. The most common grade 4 toxicities per patient were as follows: 2 (7%)-pulmonary embolus, 1 (4%)-febrile neutropenia, and 1 (4%)-infection; grade 3 toxicities were 4 (15%)-neutropenia, 4 (15%)-fatigue, 2 (7%)-neuropathy, 2 (7%)-athralgias, 2 (7%)-stomatitis, 1 (7%)-pleural effusion, and 1 (4%)-hypertension. The overall response rate was 52% [95% confidence interval (95% CI), 32-71%], median response duration was 6.0 months (95% CI, 4.6-6.5 months), and the median progression-free survival was 7.5 months (95% CI, 6.2-8.3 months). In hypothesis-generating univariate and limited multivariate analyses, E-selectin was statistically significantly associated with response to the combination. CONCLUSION: Bevazicumab in combination with weekly docetaxel is active with acceptable toxicities in MBC. Additional studies evaluating E-selectin as a marker of response to bevacizumab-containing chemotherapy are warranted.

Ciprofloxacin as a representative of disk diffusion in vitro susceptibility of enrofloxacin for bacterial organisms from the middle-ear tissue of dogs with end-stage otitis externa.

The purposes of this study were to determine whether ciprofloxacin disk diffusion susceptibility test (DDT) results could be used to assess the in vitro susceptibility of otic bacterial organisms to enrofloxacin and to determine the effect of concurrent enrofloxacin administration on the DDT results for enrofloxacin and ciprofloxacin. Thirty dogs with end-stage otitis externa undergoing unilateral total ear canal ablation were enrolled. The dogs were randomized to one of four enrofloxacin-treatment groups or to the control group. Each dog in the treatment groups received two intravenous doses of enrofloxacin prior to surgical removal of the middle-ear tissue while the control group did not receive any enrofloxacin. One dog was excluded from the study as no middle-ear tissue was removed during surgery. Twenty-four dogs were in the enrofloxacin-treatment groups and five dogs were in the control group. In 12 of 29 dogs (41.4%), 14 of 82 (17.1%) of bacteria had discrepancies in DDT results for enrofloxacin and ciprofloxacin. Discrepancies between the control group and treatment groups were not significantly different even though the percentage of discrepancies for the combined treatment group was 19.4% compared to 6.7% for the control group. In this study, ciprofloxacin DDT results were not an accurate indicator of the in vitro susceptibility of enrofloxacin for bacteria isolated from the middle-ear tissue of dogs with end-stage otitis.