Tobacco use and clinical leukoplakia lesions among south Indian tribes.

OBJECTIVES: Leukoplakia is a white mucosal thickening and perhaps undermining change in the oral mucosa transcendently found in tobacco users. Since the tobacco utilization is extensively higher with the indigenous groups in the Asia Pacific locale, the current examination implicated the prevalence of tobacco consumption and leukoplakial lesions and the relationship between the two. METHODS: This cross-sectional study was conducted through six tribal hamlets of Chithalayath Forest range at Wayanad district of Kerala, South India. Leukoplakia screening was led by a senior consultant on the basis of a visual investigation and pathological evaluation was not done. An organized questionnaire was utilized to gather data on demographic details and tobacco usage status and frequency. The prevalence of clinical oral lesions among tobacco users and non users was determined using statistical analysis. RESULTS: Clinical oral leukoplakia was diagnosed in 27 (8.5%) subjects among the 317 individuals screened. The prevalence of lesions was considerably higher among tobacco consumers in comparison with non users (11 vs. 3.7%). Also, the tobacco chewers group had a higher percentage of leukoplakia. Another significant finding of this study is that the incidence of provisional leukoplakia was observed to be comparatively high among the most frequent tobacco consumers 15 (65.2%) in comparison with 8 (34.8%) in the frequent and nonfrequent users. CONCLUSIONS: Prevalence of abusive habits and clinical oral leukoplakial was substantial among the tribes. The cause and effect relationship and dose-response were also shown to have a significant association.

A multicenter phase II randomized study of Cremophor-free polymeric nanoparticle formulation of paclitaxel in women with locally advanced and/or metastatic breast cancer after failure of anthracycline.

AIMS: Paclitaxel is extensively used in the treatment of advanced carcinomas of the breast, ovary and non-small cell lung cancer. In clinical use it is formulated in the non-ionic surfactant polyethoxylated castor oil (Cremophor) and dehydrated alcohol to enhance drug solubility. Cremophor adds to toxic effects of paclitaxel by producing or contributing to the well-described hypersensitivity reactions that commonly occur during its infusion, affecting a large number of patients. This randomized trial was conducted to evaluate efficacy and safety of novel nanoparticle-based paclitaxel in the treatment of patients with advanced breast cancer. METHOD: Patients were randomized to receive either nanoparticle paclitaxel (NP) 300 mg/m(2) , (NP300) or NP220 mg/m(2) or Cremophor paclitaxel 175 mg/m(2) (CP 175). NP was administered as a 1-h infusion without premedication and CP as a 3-h infusion with premedication every 3 weeks. RESULTS: In total, 194 patients who had been administered at least one dose were included for safety analysis and 170 patients who completed at least two cycles of therapy were analyzed for efficacy. NP showed an overall response rate (complete response + partial response) of 40% in the NP220 and NP300 arms as compared to 31% in the CP arm. The incidence of neutropenia (all grades) was lowest in the NP220 arm (39.4%) compared to the NP300 (55%) and CP arm (50%). CONCLUSION: NP is well tolerated and can be safely administered without any premedication in comparison to conventional paclitaxel, which requires the use of premedication before administration. NP demonstrates promising efficacy with a favorable safety profile.