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NTP Monograph on the Systematic Review of Occupational Exposure to Cancer Chemotherapy Agents and Adverse Health Outcomes

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NTP Monograph on the Systematic Review of Occupational Exposure to Cancer Chemotherapy Agents and Adverse Health Outcomes NTP Monograph on the Systematic Review of Occupational Exposure to Cancer Chemotherapy Agents and Adverse Health Outcomes March 2019 NTP Monograph on the Systematic Review of Occupational Exposure to Cancer Chemotherapy Agents and Adverse Health Outcomes NTP Monograph 05 March 2019 National Toxicology Program Public Health Service U.S. Department of Health and Human Services ISSN: 2378-5144 Research Triangle Park, North Carolina, USA Systematic Review of Occupational Exposure to Cancer Chemotherapy Agents Foreword The National Toxicology Program (NTP), established in 1978, is an interagency program within the Public Health Service of the U.S. Department of Health and Human Services. Its activities are executed through a partnership of the National Institute for Occupational Safety and Health (part of the Centers for Disease Control and Prevention), the Food and Drug Administration (primarily at the National Center for Toxicological Research), and the National Institute of Environmental Health Sciences (part of the National Institutes of Health), where the program is administratively located. NTP offers a unique venue for the testing, research, and analysis of agents of concern to identify toxic and biological effects, provide information that strengthens the science base, and inform decisions by health regulatory and research agencies to safeguard public health. NTP also works to develop and apply new and improved methods and approaches that advance toxicology and better assess health effects from environmental exposures. NTP conducts literature-based evaluations to determine whether exposure to environmental substances (e.g., chemicals, physical agents, and mixtures) may be associated with adverse health effects. These evaluations result in hazard conclusions or characterize the extent of the evidence and are published in the NTP Monograph series, which began in 2011. NTP Monographs serve as an environmental health resource to provide information that can used to make informed decisions about whether exposure to a substance may be of concern for human health. NTP conducts these health effects evaluations following pre-specified protocols that apply the general methods outlined in the “Handbook for Conducting a Literature-Based Health Assessment Using the OHAT Approach for Systematic Review and Evidence Integration.” † The protocol describes project-specific procedures tailored to each systematic review in a process that facilitates evaluation and integration of scientific evidence from published human, experimental animal, and mechanistic studies. The key feature of the systematic review approach is the application of a transparent framework to document the evaluation methods and the basis for scientific judgements. This process includes steps to comprehensively search for studies, select relevant evidence, assess individual study quality, rate confidence in bodies of evidence across studies, and then integrate evidence to develop conclusions for the specific research question. Draft monographs undergo external peer review prior to being finalized and published. NTP Monographs are available free of charge on the NTP website and cataloged in PubMed, a free resource developed and maintained by the National Library of Medicine (part of the National Institutes of Health). Data for these evaluations are included in the Health Assessment and Workspace Collaborative. For questions about the monographs, please email NTP or call 984-287-3211. †OHAT is the abbreviation for Office of Health Assessment and Translation, which is within the Division of the National Toxicology Program at the National Institute of Environmental Health Sciences. ii Systematic Review of Occupational Exposure to Cancer Chemotherapy Agents Table of Contents Foreword ......................................................................................................................................... ii Tables ............................................................................................................................................. iv Figures............................................................................................................................................ iv About This Review ........................................................................................................................ vi Peer Review ................................................................................................................................... ix Publication Details ...........................................................................................................................x Acknowledgments............................................................................................................................x Conflict of Interest ...........................................................................................................................x Abstract .......................................................................................................................................... xi Introduction ......................................................................................................................................1 Objectives and Research Strategy ...............................................................................................4 Objectives ............................................................................................................................4 Specific Aims .......................................................................................................................4 Methods............................................................................................................................................6 Problem Formulation and Protocol Development ......................................................................6 PECO Statement .........................................................................................................................6 Literature Search .........................................................................................................................8 Study Selection ...........................................................................................................................8 Evidence Selection Criteria ..................................................................................................8 Screening Process ................................................................................................................8 Data Extraction ...........................................................................................................................9 Extraction Process ................................................................................................................9 Data Availability ..................................................................................................................9 Quality Assessment of Individual Studies ..................................................................................9 Rating Confidence in Bodies of Evidence ................................................................................10 Adjustment of Initial Confidence Ratings of Cross-sectional Studies Evaluating Genetic Toxicity .................................................................................................................11 Preparation of Level-of-evidence Conclusions .........................................................................12 Results and Evidence Synthesis .....................................................................................................14 Literature Search Results ..........................................................................................................14 Health Outcomes with Inadequate Evidence .....................................................................16 Spontaneous Abortion ........................................................................................................16 Genetic Toxicity: DNA Damage .......................................................................................31 Evidence of Occupational Exposure to Cancer Chemotherapy Agents .............................................47 Environmental Monitoring.................................................................................................48 Biomonitoring ....................................................................................................................49 Other Occupationally Exposed Populations ......................................................................51 Discussion ......................................................................................................................................53 Impact of Exposure Protection Efforts ......................................................................................55 iii Systematic Review of Occupational Exposure to Cancer Chemotherapy Agents Limitations of the Evidence Base .............................................................................................55 Study Design Limitations ..................................................................................................55 Exposure Characterization .................................................................................................56 Challenges in Evaluating Reproductive Toxicity ..............................................................57 Limitations of the Systematic Review ......................................................................................57
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