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In 2005, several experts in tumor biomarker research publishe the REporting recommendations for Tumor MARKer prognostic studies (REMARK) criteria. Coupled with the subsequent Biospecimen Reporting for Improved Study Quality (BRISQ) criteria, these initiatives provide a framework for transparently reporting of the methods of study conduct and analyses. [ABSTRACT FROM AUTHOR]

Background: Cancer prognostic biomarkers have shown disappointing clinical applicability. The objective of this study was to classify and estimate how study results are overinterpreted and misreported in prognostic factor studies in oncology.Methods: This systematic review focused on 17 oncology journals with an impact factor above 7. PubMed was searched for primary clinical studies published in 2015, evaluating prognostic factors. We developed a classification system, focusing on three domains: misleading reporting (selective, incomplete reporting, misreporting), misleading interpretation (unreliable statistical analysis, spin) and misleading extrapolation of the results (claiming irrelevant clinical applicability, ignoring uncertainty).Results: Our search identified 10,844 articles. The 98 studies included investigated a median of two prognostic factors (Q1-Q3, 1-7). The prognostic factors' effects were selectively and incompletely reported in 35/98 and 24/98 full texts, respectively. Twenty-nine articles used linguistic spin in the form of strong statements. Linguistic spin rejecting non-significant results was found in 34 full-text results and 15 abstract results sections. One in five articles had discussion and/or abstract conclusions that were inconsistent with the study findings. Sixteen reports had discrepancies between their full-text and abstract conclusions.Conclusions: Our study provides evidence of frequent overinterpretation of findings of prognostic factor assessment in high-impact medical oncology journals. [ABSTRACT FROM AUTHOR]

Despite years of research and hundreds of reports on tumor markers in oncology, the number of markers that have emerged as clinically useful is pitifully small. Often initially reported studies of a marker show great promise, but subsequent studies on the same or related markers yield inconsistent conclusions or stand in direct contradiction to the promising results. It is imperative that we attempt to understand the reasons that multiple studies of the same marker lead to differing conclusions. A variety of methodologic problems have been cited to explain these discrepancies. Unfortunately, many tumor marker studies have not been reported in a rigorous fashion, and published articles often lack sufficient information to allow adequate assessment of the quality of the study or the generalizability of study results. The development of guidelines for the reporting of tumor marker studies was a major recommendation of the National Cancer Institute-European Organisation for Research and Treatment of Cancer (NCI-EORTC) First International Meeting on Cancer Diagnostics in 2000. As for the successful CONSORT initiative for randomized trials and for the STARD statement for diagnostic studies, we suggest guidelines to provide relevant information about the study design, pre-planned hypotheses, patient and specimen characteristics, assay methods, and statistical analysis methods. In addition, the guidelines suggest helpful presentations of data and important elements to include in discussions. The goal of these guidelines is to encourage transparent and complete reporting so that the relevant information will be available to others to help them to judge the usefulness of the data and understand the context in which the conclusions apply. [ABSTRACT FROM AUTHOR]

A mouse model of human ovarian cancer was used to investigate the effect of adenovirus-mediated thymidine kinase gene therapy (gt) in combination with chemotherapy. One hundred sixty female CD-1 nu/nu mice were injected intraperitoneally with Ov-ca-2774 cells. Onset of intraperitoneal treatment with either topotecan (6 or 12 mg/kg) or paclitaxel (18 or 36 mg/kg) was on day 4 or8 and was repeated once after 4 days. Animals scheduled for gt received intraperitoneal application of adv/rsv-tk 1 day prior to chemotherapy and were subsequently treated with ganciclovir (gcv; 10 mg/kg, every 12 hours for 6 days). Survival was chosen as study endpoint. Whereas tumor burden had hardly any effect on survival, the lower dose of either cytotoxic agent was seen to be more effective than the higher one. In the topotecan group, an interaction between topotecan and gt was present. Survival was best for animals treated with low dose of topotecan only, the addition of gt reduced survival time significantly. With the higher dose, gt did not affect survival time. With paclitaxel, only slight effects of gt on the survival times were seen. Due to treatment toxicity, this animal model may be problematic for the evaluation of gt and chemotherapy combinations. The effect of dose varied strongly with time. Mice treated with high-dose chemotherapy had a substantially increased risk of dying in the time period following application, whereas this advantage of the lower dose disappeared later. Cancer Gene Therapy (2002) 9, 478–481 DOI: 10.1038/sj/cgt/7700462 [ABSTRACT FROM AUTHOR]

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Copyright of Social & Preventive Medicine is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Local recurrence rates play an important role in the evaluation and judgement of local treatment modalities in breast cancer. In the medical literature different methods for the calculation of these rates have been used. In this note we discuss the methods, the observed differences, and the interpretation of the resulting estimates. [ABSTRACT FROM AUTHOR]

Several prognostic classification schemes in node negative breastcancer are proposed, but only the Nottingham PrognosticIndex (NPI) seems to be sufficiently validated. Validation,which is a prerequisite for a sensible assessment,is not published for two recent proposals accordingto Glick et al. [1] and Rubens [2].The German Breast Cancer Study Group (GBSG) entered662 eligible patients in a prospective observational study.603 of them had complete data for seven’standard‘ prognostic factors and median follow-up is about5 years. As there is no accepted andinformative measure of separation for classification schemes presentlyavailable, we propose a new one and useit additionally to the well known logrank-test andKaplan-Meier estimates to investigate the predictive power ofthe three schemes. Significant differences in survival andrecurrence-free survival could be established for the NPIsubgroups but not for others where even theordering of the groups was different. With theCox model and the classification and regression treeapproach we develop two new proposals for thedifferentiation of subgroups of node negative patients. Asin the NPI, tumor size and grade arethe most important factors, but with a differentweighting scheme. Young age (≤ 40 years) andvery high estrogen receptor values (> 300 fmol)in a small subgroup of patients were associatedwith worse prognosis. The new proposals showed abetter degree of separation, which demonstrates that animprovement seems possible using standard factors. Because themeasures of separation give an overoptimistic impression forthe new proposals, a validation with other studiesis necessary before a general recommendation can begiven. [ABSTRACT FROM AUTHOR]