Seventh supplement to the Federated Malay States Government Gazette of Friday, the 7th of December, 1925 (Vol. XVII, No. 24).

No. 779

A non-randomized comparison of gemcitabine-based chemoradiation with or without induction chemotherapy for locally advanced squamous cell carcinoma of the head and neck

<p>Abstract</p> <p>Background</p> <p>Concomitant chemotherapy and radiotherapy (chemoradiation; CRT) is the standard treatment for locoregionally advanced squamous cell carcinoma of the head and neck (LA-SCCHN). CRT improves local control and overall survival (OS) when compared to radiotherapy (RT) alone. Induction chemotherapy (IC) reduces the risk of distant metastases (DM) and improves OS by 5% with the use of cisplatin/infusional 5 fluorouracil (PF) in meta-analysis. Adding a taxane to PF in the IC regimen confers a better outcome. Sequential treatment (ST) of IC followed by CRT is therefore under active investigation in multiple phase III trials.</p> <p>Methods</p> <p>We compared the outcome of two cohorts of patients (pts) with LA-SCCHN treated at our institution with CRT (n = 27) or ST (n = 31), respectively. CRT consisted of GEM 100 mg/m²weekly + conventional RT (70 Gy); ST consisted of the same CRT preceded by platinum-based IC.</p> <p>Results</p> <p>Response to IC: complete 8 (26%), partial 20 (65%), stable 1, progressive 1, not evaluable 1. Median follow up of the surviving pts: for CRT 73 months, for ST 51 months. Median time to distant metastasis (TDM) was for CRT 23.6 months, for ST not reached. Median OS was for CRT 20.2 months, for ST 40.2 months. Cox regression analysis, taking into account age, T and N stage and tumor site, showed a hazard ratio with ST of 1.190 for time to locoregional failure (p = 0.712), 0.162 for TDM (p = 0.002), and 0.441 for overall survival (OS) (p = 0.026).</p> <p>Conclusion</p> <p>TDM and OS were found significantly longer in the ST cohort without a reduced locoregional control. Notwithstanding the limitations of a non-randomized single-center comparison, the results are in line with very preliminary data of randomized comparisons suggesting an improved outcome with ST.</p

Knowledge, perceptions and reporting practices of theoretical design in causal observational epidemiological studies on the role of antibiotic use in the occurrence of asthma in children

Abstract: Good research is driven by study design encompassing theoretical design, design of data collection and design of data processing. In epidemiological research, theoretical design is based on a functional relationship between the occurrence and determinants studied (occurrence function) and should also define that part of the theoretical population and the context to which the results pertain (domain). Both are essential for the design of data collection, the design of data processing and the interpretation of the study results and should be explicitly reported. In order to gain insight into the role of theoretical design in the entire research process before publication, it was decided to informally question the corresponding authors of a selection of 30 articles (20 most recent and 10 less recent) reporting on causal observational epidemiological studies on asthma and early life exposure to antibiotics. The objective was to appraise the perceived knowledgeability of theoretical design among the authors of the selected articles. Fifteen authors responded. Authors were asked to indicate their knowledgeability with the concepts of theoretical design, causal theory, confounding and effect modification on a 5-level Likert scale. Other questions were related to the theoretical design of their study. The vast majority of the authors perceived themselves to be moderately to extremely knowledgeable with confounding and effect modification. Perceived knowledgeability of theoretical design and causal theory was more diverse. When provided with options for an occurrence function, almost all authors indicated "current occurrence as a function of past exposure" for their study. Nevertheless, half of these authors conducted their study based on "future occurrence as a function of current exposure". Even though the authors perceive themselves to be knowledgeable with theoretical design, this is not reflected in their articles. Theoretical design should be well known, implemented and explicitly reported