ABSTRACT
PURPOSE: Genexol-PM is a Cremophor EL–free formulation of low-molecular-weight, non-toxic, and biodegradable polymeric micelle-bound paclitaxel. We conducted a phase III study comparing the clinical efficacy and toxicity of Genexol-PM with conventional paclitaxel (Genexol). MATERIALS AND METHODS: Patients were randomly assigned (1:1) to receive Genexol-PM 260 mg/m² or Genexol 175 mg/m² intravenously every 3 weeks. The primary outcome was the objective response rate (ORR). RESULTS: The study enrolled 212 patients, of whom 105 were allocated to receive Genexol-PM. The mean received dose intensity of Genexol-PM was 246.8±21.3 mg/m² (95.0%), and that of Genexol was 168.3±10.6 mg/m² (96.2%). After a median follow-up of 24.5 months (range, 0.0 to 48.7 months), the ORR of Genexol-PM was 39.1% (95% confidence interval [CI], 31.2 to 46.9) and the ORR of Genexol was 24.3% (95% CI, 17.5 to 31.1) (p(non-inferiority)=0.021, p(superiority)=0.016). The two groups did not differ significantly in overall survival (28.8 months for Genexol-PM vs. 23.8 months for Genexol; p=0.52) or progression-free survival (8.0 months for Genexol-PM vs. 6.7 months for Genexol; p=0.26). In both groups, the most common toxicities were neutropenia, with 68.6% occurrence in the Genexol-PM group versus 40.2% in the Genexol group (p < 0.01). The incidences of peripheral neuropathy of greater than grade 2 did not differ significantly between study treatments. CONCLUSION: Compared with standard paclitaxel, Genexol-PM demonstrated non-inferior and even superior clinical efficacy with a manageable safety profile in patients with metastatic breast cancer.
Subject(s)
Humans , Breast Neoplasms , Breast , Disease-Free Survival , Follow-Up Studies , Incidence , Neutropenia , Paclitaxel , Peripheral Nervous System Diseases , Polymers , Treatment OutcomeABSTRACT
Visual perceptual dysfunction in stroke patients causes a failure in activties of daily living and learning. Therefore, the correct diagnosis and remediation of visual perceptual dysfunction are important. Since the mechanism of visual perception is not well studied, it is difficult to treat visual perceptual dysfunction effectively. In this study, we tried to correlate visual perceptual dysfunction with anatomical lesion of brain for the use of visual perceptual training. We assesed the visual perception and the brain lesions of fiftroke patients, with Motor-Free Visual Perception Test(MVPT), and brain computerized tommography respectively. The visual responses of contralateral side of the lesions were diminished. The raw score of MVPT was low in patients with lesions in both parietal and, right temporal lobes. The right parietal lobe lesions correlated with tests for figure-ground and visual closure, and the left parietal lobe lesions with visual processing time. The result suggests that the right parietal lobe has an important role in visual perceptions. The right temporal, and the left parietal lobes as well as the subcortex of both hemisphere also has significant roles in visual perceptions.