Methoden zur Ermittlung besonderer Stoffe nach Nr. 3.2.4 TA Luft Abschlussbericht

Die TA Luft fordert unter Punkt 3.2.4 die Ermittlung von Tagesmittelwerten fuer besondere Stoffe. Hierzu wurden automatische Messsysteme entwickelt und erprobt. Der Zwischenbericht vom Dezember 1991 gibt die Ergebnisse mit den Probenahmesystemen NUMAS und Beta-Staubmeter wieder. Ergaenzende Untersuchungen wurden mit dem Staubsammelsystem LPS-E vorgenommen. Die getesteten Systeme sind fuer die Langzeitbeprobung von Staeuben sowie nachfolgende Bestimmung von Staubinhaltsstoffen geeignet. Parallel dazu wurde ein Vorschlag fuer Mindestanforderungen an Messsysteme fuer Langzeitbeprobung erarbeitet. Des weiteren wurde ueber die notwendige Haeufigkeit der Messung im Rahmen der fortlaufenden Ueberwachung eine Empfehlung vorgeschlagen. Der Schwerpunkt der Phase 2 des Vorhabens lag jedoch auf der Messung von Quecksilber. Dabei kamen die kontinuierlichen Messeinrichtungen HAGE-MAT-2, HAGE-Kontimeter HM 1400 sowie OPSIS AR 602 Z zum Einsatz. Dazu wurden manuelle Referenzverfahren zur Quckesilbermessung und zwar summarisch wie auch spezifiziert fuer Hg(0) und HgCl_2 erprobt und Pruefgasgeneratoren fuer Quecksilber entwickelt und eingesetzt. (orig.)In No. 3.2.4 of the TA Luft the determination of daily-mean-value for special substances is requested. For this aim automatic measuring systems have been developed and tested. The intermediate report describes the results with the sampling systems for particulate matter with NUMAS and Beta-Dustmeter. In addition measurements have been done with the LPS-E system. Automatic sampling systems for long-term measurements of particulate matter including methods to analyze relevant components are now available and type tested. A proposal of minimum requirements for these systems was proposed as well as a recommendation about the necessary frequency of the measurement. The NUMAS-system was expanded to measure gaseous components at the same time with particulate matter. But the main-task in part 2 of this work was the measurement of mercury. In this connection the automatic system HAGE-MAT-2, HAGE-Kontimeter HM 1400 as well as OPSIS AR 602 Z were tested. Manual reference methods for total mercury as well as specified as Hg(0) or HgCl_2 were proved. Simultaneously a method to generate mercury calibration gas was developed. (orig.)SIGLEAvailable from TIB Hannover: F94B1116 / FIZ - Fachinformationszzentrum Karlsruhe / TIB - Technische InformationsbibliothekUmweltbundesamt, Berlin (Germany); Bundesministerium fuer Umwelt, Naturschutz und Reaktorsicherheit, Bonn (Germany)DEGerman

West German Study PlanB Trial: Adjuvant Four Cycles of Epirubicin and Cyclophosphamide Plus Docetaxel Versus Six Cycles of Docetaxel and Cyclophosphamide in HER2-Negative Early Breast Cancer

PURPOSE The West German Study Group PlanB trial evaluated an anthracycline-free chemotherapy standard (six cycles of docetaxel and cyclophosphamide [TC]) in the routine treatment of human epidermal growth factor receptor 2-negative early breast cancer (EBC). PATIENTS AND METHODS Patients with pT1 to pT4c, all pN+, and pN0/high-risk EBC were eligible. High-risk pN0 was defined by one or more of the following: pT greater than 2, grade 2 to 3, high urokinase-type plasminogen activator/plasminogen activator inhibitor-1, hormone receptor (HR) negativity, and less than 35 years of age. After an early amendment, all HR-positive tumors underwent recurrence score (RS) testing, with chemotherapy omission recommended in RS less than or equal to 11 pN0 to pN1 disease. Patients were randomly assigned to four cycles of epirubicin (E)(90)/cyclophoshamide (C)(600) followed by four cycles of docetaxel (T)(100) or six cycles of T75C600 (administered once every 3 weeks). The primary end point was disease-free survival (DFS); secondary end points were overall survival (OS) and safety. The protocol specified P = .05 for a noninferiority margin of 4.4% for all patients combined. RESULT Of the 3,198 registered patients, 348 (RS <= 11) omitted chemotherapy, and 401 were not randomly assigned. The intention-to-treat population included 2,449 patients (1,227 EC-T v 1,222 TC: postmenopausal, 62.2% v60.8%; pNO, 58.2% v59.5%; pT1, 57.6% v52.3%; HR positive, 81.4% v82.2%; RS greater than 25 [in H.R-positive patients], 26.2% v 27.5%). Within the safety population (1,167 v 1,178 patients), 87.5% v 93.0% completed therapy. After a 60-month median follow-up, 5-year outcomes were similar in the EC-T and TC arms (DFS, 89.6% [95% CI, 87.9% to 91.5%] v89.9% [95% CI, 88.1% to 91.8%]; OS, 94.5% [95% CI, 93.1% to 95.9%] v94.7% [95% CI, 93.3% to 96.1%]). The DFS difference was within the noninferiority margin of the original trial design. Five treatment-related deaths were reported for TC (one for EC-T), despite a trend toward more-severe adverse events in the latter. Interaction analysis revealed no predictive trends with respect to key factors, including triple-negative, luminal A/B-like, pN, age, and RS status. CONCLUSION In the West German Study Group PlanB trial, 5-year outcomes for TC and EC-T were equally excellent. Six cycles of TC is an effective/safe option in human epidermal growth factor receptor 2-negative EBC with pN0 high genomic risk or pN1 EBC with genomically intermediate- to high-risk disease. (C) 2019 by American Society of Clinical Oncolog