17 research outputs found

    BMC Med

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    BACKGROUND: Overall survival (OS) is the gold standard endpoint to assess treatment efficacy in cancer clinical trials. In metastatic breast cancer (mBC), progression-free survival (PFS) is commonly used as an intermediate endpoint. Evidence remains scarce regarding the degree of association between PFS and OS. Our study aimed to describe the individual-level association between real-world PFS (rwPFS) and OS according to first-line treatment in female patients with mBC managed in real-world setting for each BC subtype (defined by status for both hormone-receptor [HR] expression and HER2 protein expression/gene amplification). METHODS: We extracted data from the ESME mBC database (NCT03275311) which gathers deidentified data from consecutive patients managed in 18 French Comprehensive Cancer Centers. Adult women diagnosed with mBC between 2008 and 2017 were included. Endpoints (PFS, OS) were described using the Kaplan-Meier method. Individual-level associations between rwPFS and OS were estimated using the Spearman's correlation coefficient. Analyses were conducted by tumor subtype. RESULTS: 20,033 women were eligible. Median age was 60.0 years. Median follow-up duration was 62.3 months. Median rwPFS ranged from 6.0 months (95% CI 5.8-6.2) for HR-/HER2 - subtype to 13.3 months (36% CI 12.7-14.3) for HR + /HER2 + subtype. Correlation coefficients were highly variable across subtypes and first-line (L1) treatments. Among patients with HR - /HER2 - mBC, correlation coefficients ranged from 0.73 to 0.81, suggesting a strong rwPFS/OS association. For HR + /HER2 + mBC patients, the individual-level associations were weak to strong with coefficients ranging from 0.33 to 0.43 for monotherapy and from 0.67 to 0.78 for combined therapies. CONCLUSIONS: Our study provides comprehensive information on individual-level association between rwPFS and OS for L1 treatments in mBC women managed in real-life practice. Our results could be used as a basis for future research dedicated to surrogate endpoint candidates

    Artedomani 1992 : Punti di vista

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    Physical working conditions as covered in European monitoring questionnaires

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    Abstract Background The prevalence of workers with demanding physical working conditions in the European work force remains high, and occupational physical exposures are considered important risk factors for musculoskeletal disorders (MSD), a major burden for both workers and society. Exposures to physical workloads are therefore part of the European nationwide surveys to monitor working conditions and health. An interesting question is to what extent the same domains, dimensions and items referring to the physical workloads are covered in the surveys. The purpose of this paper is to determine 1) which domains and dimensions of the physical workloads are monitored in surveys at the national level and the EU level and 2) the degree of European consensus among these surveys regarding coverage of individual domains and dimensions. Method Items on physical workloads used in one European wide/Spanish and five other European nationwide work environment surveys were classified into the domains and dimensions they cover, using a taxonomy agreed upon among all participating partners. Results The taxonomy reveals that there is a modest overlap between the domains covered in the surveys, but when considering dimensions, the results indicate a lower agreement. The phrasing of items and answering categories differs between the surveys. Among the domains, the three domains covered by all surveys are “lifting, holding & carrying of loads/pushing & pulling of loads”, “awkward body postures” and “vibrations”. The three domains covered less well, that is only by three surveys or less, are “physical work effort”, “working sitting”, and “mixed exposure”. Conclusions This is the fırst thorough overview to evaluate the coverage of domains and dimensions of self-reported physical workloads in a selection of European nationwide surveys. We hope the overview will provide input to the revisions and updates of the individual countries’ surveys in order to enhance coverage of relevant domains and dimensions in all surveys and to increase the informational value of the surveys

    The Airways, a Novel Route for Delivering Monoclonal Antibodies to Treat Lung Tumors

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    International audienceLung cancer is the leading cause of cancer-related death worldwide. The efficacy of current systemic treatments is limited, with major side effects and only modest survival improvements. Aerosols routinely used to deliver drugs into the lung for treating infectious and inflammatory lung diseases have never been used to deliver monoclonal antibodies to treat lung cancer. We have shown that cetuximab, a chimeric anticancer anti-EGFR mAb, is suitable for airway delivery as it resists the physical constraints of aerosolization, and have evaluated the aerosol delivery of cetuximab in vivo

    Accommodating Pharmacy Students With Physical Disabilities During the Experiential Learning Curricula.

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    Accommodating pharmacy students with physical disabilities during the experiential learning portion of the Doctor of Pharmacy (PharmD) curriculum can present unique challenges for pharmacy schools. The available literature regarding accommodations for pharmacy students in the experiential learning environment is sparse, leaving programs with little guidance. This commentary from the Big Ten Academic Alliance calls on the Academy to create a community of shared resources and best practice examples and offers practical suggestions for accommodating pharmacy students with mobility, vision, and auditory disabilities during introductory pharmacy practice experiences (IPPEs) and advanced pharmacy practice experiences (APPEs)
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