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Purpose: The increased number and expanded utilization of biosimilars raise important considerations for their safe and appropriate use in oncology practice. This report provides an update on currently approved oncology biosimilars and identifies current knowledge gaps in the management of patients with cancer., Methods: An Expert Panel was convened to review the medical literature and to provide a practical summary of currently approved biosimilar therapeutics for cancer treatment or supportive care in the United States., Results: A total of 17 cancer or cancer-related biosimilar products have been approved by the US Food and Drug Administration since 2015. Despite years of clinical experience with oncology biosimilars, variance in their use persists. ASCO supports that biosimilars and reference products are considered equally efficacious for the purpose of inclusion in ASCO clinical practice guideline recommendations., Conclusion: The use of biosimilars might provide competitive, lower-cost alternatives to biologics used in cancer care, and specific mention in ASCO guidelines and other evidence products is supported where appropriate., Competing Interests: Gary H. LymanConsulting or Advisory Role: G1 Therapeutics, Samsung Bioepis, BeyondSpring Pharmaceuticals, Sandoz, Jazz Pharmaceuticals, Partner Therapeutics, E.R. Squibb Sons, LLC, MSD, Seattle Genetics, Kallyope, TEVA, Spectrum Pharmaceuticals, Frensenius KabiResearch Funding: Amgen (Inst) Richard L. SchilskyLeadership: Clarified Precision MedicineConsulting or Advisory Role: Cellworks, Scandion Oncology, Bryologyx, Illumina, EQRxResearch Funding: AstraZeneca (Inst), Bayer (Inst), Bristol Myers Squibb (Inst), Genentech/Roche (Inst), Lilly (Inst), Merck (Inst), Pfizer (Inst), Boehringer Ingelheim (Inst), Seattle Genetics (Inst)Open Payments Link: https://openpaymentsdata.cms.gov/physician/1138818/summary Douglas E. PetersonStock and Other Ownership Interests: Allergan (I), Celgene (I), Gilead Sciences (I), Procter & Gamble (I), Roche (I), Bristol Myers Squibb (I), Johnson & Johnson (I)Honoraria: PierianDxConsulting or Advisory Role: Amgen, PSI Pharma Support America, Applied Glycan-Oral Health, AEC Partners, BrainCool, Medicxi Ventures (UK) LLP, Boston MedTech Advisors Scott T. TagawaConsulting or Advisory Role: Medivation, Astellas Pharma, Dendreon, Janssen, Genentech, Endocyte, Immunomedics, Karyopharm Therapeutics, AbbVie, Tolmar, QED Therapeutics, Amgen, Sanofi, Pfizer, Clovis Oncology, Novartis, Genomic Health, POINT Biopharma, Blue Earth Diagnostics, Seattle Genetics, AIkido Pharma, 4D Pharma, Clarity Pharmaceuticals, Gilead Sciences, Telix Pharmaceuticals, Bayer, Myovant Sciences, Convergent TherapeuticsResearch Funding: Lilly (Inst), Sanofi (Inst), Janssen (Inst), Astellas Pharma (Inst), Progenics (Inst), Millennium (Inst), Amgen (Inst), Bristol Myers Squibb (Inst), Dendreon (Inst), Rexahn Pharmaceuticals (Inst), Bayer (Inst), Genentech (Inst), Newlink Genetics (Inst), Inovio Pharmaceuticals (Inst), AstraZeneca (Inst), Immunomedics (Inst), Novartis (Inst), AVEO (Inst), Boehringer Ingelheim (Inst), Merck (Inst), Stem CentRx (Inst), Karyopharm Therapeutics (Inst), AbbVie (Inst), Medivation (Inst), Endocyte (Inst), Exelixis (Inst), Clovis Oncology (Inst), POINT Biopharma (Inst)Patents, Royalties, Other Intellectual Property: Patent Royalty from Immunomedics/GileadTravel, Accommodations, Expenses: Sanofi, Immunomedics, AmgenUncompensated Relationships: ATLAB Pharma, Phosplatin Therapeutics Mariana Chavez-MacGregorEmployment: MD Anderson Physicians NetworkHonoraria: Pfizer, EisaiConsulting or Advisory Role: Roche/Genentech, AstraZeneca, Novartis, Pfizer, asofar, Genomic Health, Exact Sciences, AstraZeneca/Daiichi SankyoResearch Funding: Novartis (Inst)Expert Testimony: Abbott Laboratories, PfizerTravel, Accommodations, Expenses: PfizerOther Relationship: RocheUncompensated Relationships: Legacy Healthcare Services, The Hope FoundationNo other potential conflicts of interest were reported.

Background: Specialty-based practice is a fundamental component of US medicine and dentistry, yet the recognition of new dental specialties has markedly diminished in the past 50 years while medical specialization has flourished., Methods: This article reviews the history of specialty development while focusing on the underlying scientific, educational, and cultural changes in both professions. The process of dental specialty recognition is also examined., Results: The current dental specialty recognition process provides a set of criteria aspiring specialties need to fulfill at the time of application, yet the relationship between the criteria and the sequence for attaining them is undefined. Scientific development and evidence-based practice have grown to become the cornerstone of contemporary health care specialization., Conclusions: A new paradigm for specialty and subspecialty development in dentistry is needed. A model is presented herein that recognizes scientific development as the basis for specialization and describes a formal, sequenced process for the development of emerging specialties and subspecialties., Practical Implications: This new paradigm for dental specialty recognition builds on the current criteria for specialization while encouraging cross-disciplinary interaction and nurturing the development of emerging specialties and subspecialties in dentistry. Doing so will allow dentistry to maintain its lead role in the maintenance of oral health and oral disease treatment in the US population., (Copyright © 2019 American Dental Association. Published by Elsevier Inc. All rights reserved.)

Purpose: Misoprostol, a synthetic analog of prostaglandin E1, has anti-inflammatory and mucosa-protecting properties. The objective of this study was to evaluate the efficacy of misoprostol oral rinse in reducing the severity of oral mucosal injury caused by high-dose chemotherapy., Methods: The study used a randomized, double-blind, placebo-controlled, parallel-group design. Oncology patients receiving myeloablative high-dose chemotherapy, in preparation for a hematopoietic stem cell transplant, were randomized to misoprostol or placebo rinse. The primary outcome measure was the severity of oral mucositis, measured using the modified Oral Mucositis Index. Additional outcome measures included the severity of mouth pain (measured using a Visual Analog Scale and the Pain Affect Faces Scale), duration of hospital stay, and days on total parenteral nutrition., Results: This study was originally planned to accrue 160 subjects but was terminated early due to revised sponsor research priorities. The intent-to-treat population consisted of 22 subjects randomized to misoprostol rinse and 26 subjects randomized to placebo rinse. There was no significant difference between the two groups in mucositis or pain severity. In both groups, duration of hospital stay was approximately 19 days, and number of days on total parenteral nutrition was 17-18 days. There were no serious adverse events attributable to misoprostol rinse., Conclusions: Although this study did not find a beneficial effect of a misoprostol rinse in mucositis secondary to high-dose chemotherapy, the small sample size limits the strength of this conclusion. Given the proposed importance of the prostaglandin pathway in the pathogenesis of oral mucositis, additional studies are warranted.

Evidence-based guidelines in clinical oncology practice are now prominent, with emphasis on clinical, health outcome and economic perspectives. Given the complexity of cancer management, a multidisciplinary approach is essential. Evidence-based guidelines to address supportive cancer care have merged expert opinion, systematic evaluation of clinical and research data, and meta-analyses of clinical trials. Production of supportive care guidelines by the interdisciplinary team is dependent on sufficient high-quality research studies. Once published, it is essential they be customized at institutional and national levels. Implementation in clinical practice is perhaps the greatest challenge. Optimal management occurs through integration of country-specific issues, including care access, healthcare resources, information technology, and national coordination of healthcare practices. The purpose of this article is to: (1) provide an overview of interdisciplinary cancer management using evidence-based guidelines; (2) delineate the theory and practice of guideline dissemination, utilization and outcome assessment; and (3) recommend future research strategies to maximize guidelines use in clinical practice., (Copyright © 2011 Elsevier Inc. All rights reserved.)

This study aimed to describe sore mouth (SM) severity and distress, associated symptoms, and consequences in cancer chemotherapy outpatients. Secondary analysis was used in this study. A total of 223 patients in 4 treatment centers participated in the study. Data from an intervention study using a computer-based telephone communication system to assess patients' daily symptom experience were analyzed to obtain highest, average, and lowest ratings of severity and distress for SM, fatigue, trouble sleeping, feeling down/blue, and feeling anxious. Consequence data included oral intake, time spent lying down, ability to work, and daily activity. Approximately 51% reported SM, with a mean highest, average, and lowest severity score of 3.1 in cycle 2 and 3.09 in cycle 3. Sore mouth severity was correlated with severity of fatigue, feeling down/blue, feeling anxious, and trouble sleeping. Sore mouth distress was correlated with the same symptoms. Sore mouth severity was correlated with the number of 8-oz glasses of liquid consumed, effect on daily activity, time spent lying down, but not with ability to work. Half of patients experienced SM, which was associated with several other symptoms and led to specific consequences. Understanding the complex symptom experience of patients with SM, including consequences, will assist nurses in developing more comprehensive clinical assessments and interventions. In addition, the association of multiple symptoms with SM will provide a foundation for further research investigation in oral mucositis.

Objective: To highlight selected research directed to new drug and device technologies to manage mucositis in cancer patients and to illustrate potential impact of successful therapies., Data Sources: Published research articles and abstracts, clinical experience., Conclusion: Advances in molecular modeling of mucosal injury in cancer patients have created new opportunities for therapy. Research is analyzing the impact of single-agent interventions; varying degrees of efficacy are being reported. Once optimal dosing strategies for single-agent management are defined, the opportunity for multi-agent therapies will emerge., Implications for Nursing Practice: The oncology nurse plays a pivotal role in assessing and managing mucositis in cancer patients.

As the most commonly used fluoroquinolone in the United States since 1987, ciprofloxacin has exerted the greatest selective pressure on S. pneumoniae and provides a valuable marker to evaluate the actual and potential emergence of fluoroquinolone resistance in this species. Analysis of susceptibility results obtained with 5,640 strains collected from throughout the United States showed that only 16 (0.3%) of the isolates demonstrated MICs of > or =4 microg/ml. The prevalence of this phenotype was significantly higher (P < 0.05) among penicillin-resistant populations, among isolates from patients >64 years old, and among respiratory isolates. However, >99% of strains had MICs of <4 microg/ml regardless of the risk group examined, and the MIC population distributions were the same for each risk group. These findings demonstrate that the phenotype of a MIC of > or =4 microg/ml remains uncommon after 10 years of ciprofloxacin use; however, these findings are no reason to become complacent with regard to appropriate use of fluoroquinolones and the need to carefully track resistance trends. Equally important is careful analysis of data that result from surveillance in terms of risk factors and other associated trends so that resistance and susceptibility, and their consequences, are neither over- nor underestimated.

A map of US COPD mortality rates by state suggested that the relative hypoxia of increased altitude may be independently associated with COPD mortality. This was investigated using linear regression analysis of 1986 state-specific data on COPD mortality rates, history of cigarette consumption, and altitude. County seat altitudes and county populations were used to calculate the median altitude of state residents. We found independent significant associations between COPD and both smoking and altitude. State COPD mortality rose by 1/10(5) for every 5.4 increase in mean packs consumed per capita per year or for each 95-m increase in resident altitude. There was no association between altitude and smoking. If increased altitude does contribute to COPD mortality, persons with this disease may benefit from down-migration.