Journal of the National Cancer Institute
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J. Natl. Cancer Inst. · May 2019
ReviewOverview of Oncology and Hematology Drug Approvals at US Food and Drug Administration Between 2008 and 2016.
We previously conducted an overview of oncology products reviewed by the Office of Oncology Drug Products in the Center for Drug Evaluation and Research at the US Food and Drug Administration for marketing approval and the regulatory actions taken during July 2005 to December 2007. There is a need to understand if the changes in the laws, regulations, and the organization that occurred after 2007 had any impact on the regulatory drug approvals. We present a detailed overview of hematology and oncology products reviewed by Office of Oncology Drug Products and Office of Hematology and Oncology Drug Products. ⋯ During the study period, despite changes in the regulations and organization, the Office of Hematology and Oncology Products consistently utilized regulatory mechanisms that expedite the development and approval of promising oncology and hematology drug products resulting in the approval of 260 new indications.
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J. Natl. Cancer Inst. · Dec 2018
Association Between Proportion of Nuclei With High Chromatin Entropy and Prognosis in Gynecological Cancers.
Nuclear texture analysis measuring differences in chromatin structure has provided prognostic biomarkers in several cancers. There is a need for improved cell-by-cell chromatin analysis to detect nuclei with highly disorganized chromatin. The purpose of this study was to develop a method for detecting nuclei with high chromatin entropy and to evaluate the association between the presence of such deviating nuclei and prognosis. ⋯ A novel method detected high-chromatin entropy nuclei, and an increased proportion of such nuclei was associated with poor prognosis. Chromatin entropy supplemented existing prognostic markers in multivariable analyses of three gynecological cancer cohorts.
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J. Natl. Cancer Inst. · Nov 2018
Lifetime Smoking History and Risk of Lung Cancer: Results From the Framingham Heart Study.
The relative risk of lung cancer decreases with years since quitting (YSQ) smoking, but risk beyond 25 YSQ remains unclear. Current lung cancer screening guidelines, which exclude smokers with more than 15 YSQ, may not detect lung cancers in this population. ⋯ Among heavy former smokers, lung cancer risk drops within five YSQ relative to continuing smokers, yet it remains more than threefold higher than never smokers after 25 YSQ. Four of ten lung cancers occurred in former smokers with more 15 YSQ, beyond the screening window of the current guideline.
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J. Natl. Cancer Inst. · Sep 2018
Meta AnalysisBreast Cancer Screening Using Tomosynthesis or Mammography: A Meta-analysis of Cancer Detection and Recall.
Tomosynthesis approximates a 3D mammogram of the breast, reducing parenchymal overlap that masks cancers or creates false "lesions" on 2D mammography, and potentially enabling more accurate detection of breast cancer. We compared breast cancer screening detection and recall in asymptomatic women for tomosynthesis vs 2D mammography. ⋯ Tomosynthesis improves CDR and reduces recall; however, effects are dependent on screening setting, with greater improvement in CDR in European/Scandinavian studies (biennial screening) and reduction in recall in US studies with high baseline recall.
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J. Natl. Cancer Inst. · Aug 2018
Overall and Central Obesity and Risk of Lung Cancer: A Pooled Analysis.
The obesity-lung cancer association remains controversial. Concerns over confounding by smoking and reverse causation persist. The influence of obesity type and effect modifications by race/ethnicity and tumor histology are largely unexplored. ⋯ The inverse BMI-lung cancer association is not entirely due to smoking and reverse causation. Central obesity, particularly concurrent with low BMI, may help identify high-risk populations for lung cancer.