Journal of the National Cancer Institute
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J. Natl. Cancer Inst. · Mar 2015
A statistical evaluation of dose expansion cohorts in phase I clinical trials.
Phase I trials often include a dose expansion cohort (DEC), in which additional patients are treated at the estimated maximum tolerated dose (MTD) after dose escalation, with the goal of ensuring that data are available from more than six patients at a single dose level. However, protocols do not always detail how, or even if, the additional toxicity data will be used to reanalyze the MTD or whether observed toxicity in the DEC will warrant changing the assigned dose. A DEC strategy has not been statistically justified. ⋯ Where feasible, a CRM design with no explicit DEC is preferred to designs that fix a dose for all patients in a DEC.
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J. Natl. Cancer Inst. · Mar 2015
Meta AnalysisAdult weight gain and adiposity-related cancers: a dose-response meta-analysis of prospective observational studies.
Adiposity, measured by body mass index, is implicated in carcinogenesis. While adult weight gain has diverse advantages over body mass index in measuring adiposity, systematic reviews on adult weight gain in relation to adiposity-related cancers are lacking. ⋯ Avoiding adult weight gain itself may confer protection against certain types of cancers, particularly among HRT nonusers.
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J. Natl. Cancer Inst. · Mar 2015
Primary tumor location as a prognostic factor in metastatic colorectal cancer.
We sought to clarify the prognostic impact of primary tumor location in metastatic colorectal cancer (mCRC). ⋯ These data demonstrate that primary tumor location is an important prognostic factor in previously untreated mCRC. Given the consistency across an exploratory set and two confirmatory phase III studies, side of tumor origin should be considered for stratification in randomized trials.