Etirinotecan Pegol (NKTR-102) in Third-line Treatment of Patients With Metastatic or Recurrent Non-Small-cell Lung Cancer: Results of a Phase II Study.

BACKGROUND: Third-line treatment options are limited for patients with metastatic non-small-cell lung cancer (NSCLC). Etirinotecan pegol (NKTR-102) is a long-acting topoisomerase-I inhibitor. We conducted a single-arm phase II trial to evaluate its efficacy in third-line treatment. PATIENTS AND METHODS: Patients aged ≥ 18 years with histologically proven NSCLC who had received 2 previous systemic therapy regimens, measurable disease, Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1, and adequate end-organ function were eligible. Etirinotecan pegol was administered at a dose of 145 mg/m2 intravenously once every 3 weeks until progression. The response was assessed every 6 weeks using Response Evaluation Criteria In Solid Tumors, version 1.1. The primary endpoint was the overall objective response rate. The secondary endpoints included progression-free survival (PFS), overall survival (OS) and safety. A Simon 2-stage design was implemented for futility. RESULTS: From January 2013 to January 2015, 40 patients were enrolled. Their median age was 66 years (range, 19-85 years), 45% were female, 30% had an ECOG performance status of 0, 96% were current and former smokers, and 31 had adenocarcinoma. Patients received a median of 3 cycles (range, 2-15) of protocol therapy. The best response was a partial response in 2 patients. The treatment was well tolerated; 3 patients had grade 3 gastrointestinal toxicity attributable to therapy. The median PFS was 2.3 months (95% confidence interval [CI], 1.3-4.4 months), and the median OS was 7.1 months (95% CI 4.2-11.4 months). CONCLUSIONS: Etirinotecan pegol was well tolerated and led to 2 partial responses and disease stabilization with this third-line treatment of metastatic NSCLC. However, the study failed to meet its prespecified response rate endpoint.

Prevalence of Dental Caries and Dental Fluorosis among 7-12-Year-Old School Children in an Indian Subpopulation: A Cross-Sectional Study

ABSTRACT Objective: To assess the prevalence of dental caries and fluorosis among 7-12-year-old school children in Muradnagar, India. An additional objective was to determine the relationship between dental caries and fluorosis in the studied population. Material and Methods: A total of 1500 school children aged between 7 to 12 years, and both genders were randomly selected for the present study. The selected participants were divided into three groups based upon age, viz 7-8 year (group I), 9-10 year (group II) and 11-12 year (group III). Sterile mouth mirrors and explorers were used for the detection of caries. The water samples were collected to assess the fluoride concentration. The data collected were tabulated and statistically analysed using Chi-square, ANOVA, Spearman's correlation and t-test wherever applicable. Results: Out of 1500 participants, 54.1% were females and 45.9% were males. The prevalence of dental caries and fluorosis was 89.3% and 93.7%, respectively. The prevalence of caries increased with age (p<0.05) and females showed a higher prevalence in both the dentitions. Most dental fluorosis was 'very mild' (40.1%). Prevalence of dental fluorosis increased with age and males showed more fluorosis than females. A negative relationship was found between dental caries and fluorosis (p<0.05). Conclusion: Dental caries and fluorosis are the public health problems in Muradnagar; therefore, preventive programs should be organized to increase awareness among the general people.