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Abstract: The Adriatic-Ionian region (ADRION Region) shows strong development in terms of urban expansion in coastal and inland areas as well as increasing maritime traffic and offshore hydrocarbon extraction activities. A serious risk of pollution arises from hazardous substances requiring reliable and coherent monitoring and assessment programs. EU Directives (WFD – Water Framework Directive, MSFD – Marine Strategy Framework Directive) and Barcelona Convention protocols, aim to assess the level of pollution with the objective to implement measures to prevent and/or mitigate impacts on the marine environment. This high level integration process has to be based on common and agreed protocols for monitoring of contaminants. Aiming to share best practices to encourage a harmonized implementation of monitoring and assessment of contaminants, an extensive review of monitoring and analytical protocols adopted by six EU and non-EU countries along the Adriatic and Ionian seas was carried out in the framework of the Interreg Adrion project HarmoNIA (Interreg V-B Adriatic-Ionian (ADRION), 2018–2020). This paper presents a methodological proposal to define a common protocol for the evaluation of the metal contamination of seawater, sediment and biota. Contaminants have been chosen following preliminary consultations among countries of the ADRION area, considering objectives of WFD and MSFD, as well as Environmental Impact Assessment (EIA) procedures for offshore platforms. Information was gathered relative to matrix characteristics and quality assurance/quality control of the analytical performance (sample preservation, analytical methodology, reference materials, limit of detection, and limit of quantification, accuracy, reproducibility, etc.). The comparison of information provided by laboratories of nine institutions highlighted the request for harmonization in terms of sampling procedures, matrix characterization, preservation procedures, analytical methods and LOQ values. Although appropriate environmental quality standards for biota and sediment matrices should be established at national level and also through regional and sub-regional cooperation, as required by the WFD and MSFD, the proposed LOQ values, even if challenging, represent a benchmark and a stimulus to optimize analytical performance, to ensure the best level of protection to the coastal and offshore environment in the ADRION Region.
Keywords: hazardous substances, harmonized protocols, integrated approach, monitoring, assessment of contaminants, heavy metals, Adriatic-Ionian Sea region
Published in DiRROS: 22.07.2024; Views: 744; Downloads: 412
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Abstract: Background: Increasing the dose intensity of cytotoxic therapy by shortening the intervals between cycles, or by giving individual drugs sequentially at full dose rather than in lower-dose concurrent treatment schedules, might enhance efficacy. Methods: To clarify the relative benefits and risks of dose-intense and standard-schedule chemotherapy in early breast cancer, we did an individual patient-level meta-analysis of trials comparing 2-weekly versus standard 3-weekly schedules, and of trials comparing sequential versus concurrent administration of anthracycline and taxane chemotherapy. The primary outcomes were recurrence and breast cancer mortality. Standard intention-to-treat log-rank analyses, stratified by age, nodal status, and trial, yielded dose-intense versus standard-schedule first-event rate ratios (RRs). Findings: Individual patient data were provided for 26 of 33 relevant trials identified, comprising 37,298 (93%) of 40,070 women randomised. Most women were aged younger than 70 years and had node-positive disease. Total cytotoxic drug usage was broadly comparable in the two treatment arms; colony-stimulating factor was generally used in the more dose-intense arm. Combining data from all 26 trials, fewer breast cancer recurrences were seen with dose-intense than with standard-schedule chemotherapy (10-year recurrence risk 28.0% vs 31.4%; RR 0.86, 95% CI 0.82-0.89; p<0.0001). 10-year breast cancer mortality was similarly reduced (18.9% vs 21.3%; RR 0.87, 95% CI 0.83-0.92; p<0.0001), as was all-cause mortality (22.1% vs 24.8%; RR 0.87, 95% CI 0.83-0.91; p<0.0001). Death without recurrence was, if anything, lower with dose-intense than with standard-schedule chemotherapy (10-year risk 4.1% vs 4.6%; RR 0.88, 95% CI 0.78-0.99; p=0.034). Recurrence reductions were similar in the seven trials (n=10,004) that compared 2-weekly chemotherapy with the same chemotherapy given 3-weekly (10-year risk 24.0% vs 28.3%; RR 0.83, 95% CI 0.76-0.91; p<0.0001), in the six trials (n=11,028) of sequential versus concurrent anthracycline plus taxane chemotherapy (28.1% vs 31.3%; RR 0.87, 95% CI 0.80-0.94; p=0.0006), and in the six trials (n=6532) testing both shorter intervals and sequential administration (30.4% vs 35.0%; RR 0.82, 95% CI 0.74-0.90; p<0.0001). The proportional reductions in recurrence with dose-intense chemotherapy were similar and highly significant (p<0.0001) in oestrogen receptor (ER)-positive and ER-negative disease and did not differ significantly by other patient or tumour characteristics. Interpretation: Increasing the dose intensity of adjuvant chemotherapy by shortening the interval between treatment cycles, or by giving individual drugs sequentially rather than giving the same drugs concurrently, moderately reduces the 10-year risk of recurrence and death from breast cancer without increasing mortality from other causes.
Keywords: breast neoplasms, women, drug therapy, clinical protocols, meta-analysis, breast cancer, chemotherapy, treatment schedule, randomized trials
Published in DiRROS: 22.10.2020; Views: 1977; Downloads: 1669
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