Evaluation of NCI-Designated Cancer Center and Comprehensive Cancer Center Survivorship-Focused Websites: Information Provided and Accessibility.

BACKGROUND: Individuals with a history of cancer increasingly seek health information from online resources, including NCI-designated Cancer Center websites. Centers receive NCI designation because they provide excellent care and engage in cutting-edge research. However, the information presented on these webpages and their accessibility is unknown. An evaluation of the survivorship-focused webpages from NCI-designated Cancer Centers is needed to assess survivorship information and accessibility of these webpages. METHODS: We conducted an evaluation of the survivorship-focused webpages from 64 NCI-designated Cancer Centers. We evaluated where survivorship-focused webpages were housed, if there was a survivorship clinic or program, target audience of the webpage, how cancer survivor was defined, contact methods, and available resources. Accessibility outcomes included readability, font type, font size, color scheme, and alternative text (alt text) descriptors. An artificial intelligence (AI) audit was conducted to assess if the webpage was compliant with national accessibility guidelines. RESULTS: Most cancer centers had a survivorship-focused webpage, with 72% located on the cancer center's website and 28% on a health system website. Survivorship information available varied considerably and was often lacking in detail. Although three-quarters of webpages targeted patients only, variable definitions of cancer survivor were observed. Accessibility issues identified included inconsistent use of alt text descriptors, font size smaller than 15 points, and color schemes without adequate contrast. The average reading-level of information presented was above 12th grade. Only 9% of webpages were compliant with online accessibility guidelines; 72% semicompliant and 21% were noncompliant. CONCLUSIONS: Information presented on NCI-designated Cancer Center survivorship-focused webpages was inconsistent, often lacking, and inaccessible. NCI-designated Cancer Centers are role models for cancer research in the United States and have an obligation to provide survivorship information. Changes to content and website design are needed to provide better information for individuals seeking resources and health information relative to their cancer and care.

The Impact of Menthol Cigarette Bans: A Systematic Review and Meta-Analysis.

INTRODUCTION: This review investigates the impacts of banning the sale of menthol cigarettes at stores. METHODS: A systematic search of studies published in English up to November 2022 was conducted. The following databases were searched: PubMed/Medline, CINAHL, PsycINFO, Web of Science, and Embase, as well as a non-indexed journal. Studies evaluating either the impact of real-world or hypothesized menthol cigarette bans were included. Primary outcomes include tobacco use behaviors. Secondary outcomes include cigarette sales, retailer compliance, and the tobacco industry's response to a menthol ban. Data on tobacco use behavior after a menthol ban were pooled using random-effects models. Two pairs of reviewers independently extracted data and assessed study quality. RESULTS: Of the 964 articles that were identified during the initial search, 78 were included in the review and 16 were included in the meta-analysis. Cessation rates among menthol cigarette smokers were high after a menthol ban. Pooled results show that 24% (95% confidence interval [95% CI]: 20%, 28%) of menthol cigarette smokers quit smoking after a menthol ban, 50% (95% CI: 31%, 68%) switched to non-menthol cigarettes, 12% (95% CI: 3%, 20%) switched to other flavored tobacco products, and 24% (95% CI: 17%, 31%) continued smoking menthol cigarettes. Hypothesized quitting and switching rates were fairly close to real-world rates. Studies found the tobacco industry attempts to undermine menthol bans. National menthol bans appear more effective than local or state menthol bans. CONCLUSIONS: Menthol cigarette bans promote smoking cessation suggesting their potential to improve public health. IMPLICATIONS: Findings from this review suggest that menthol cigarette bans promote smoking cessation among menthol cigarette smokers and have the potential to improve public health.

Pharmacist-facilitated Patient Reported Outcome Measure (PROM) monitoring: developing an EHR SmartForm© to monitor side effects of oral oncolytics during routine telehealth encounters.

PURPOSE: Patient reported outcome measures (PROMs) are increasingly used in oncology care, but pharmacists providing direct patient care have been overlooked. We engaged pharmacists and adults receiving oral oncolytics (chemotherapy medication taken by mouth) to develop a SmartForm© in the electronic health record (EHR) for PROM monitoring. Pharmacists verbally ask the patient side effect questions during routine telehealth encounters and enter responses in real time. METHODS: Our development process was guided by the Knowledge to Action Framework. In phase 1 (Knowledge Inquiry), we prioritized side effects to assess in the EHR SmartForm© via interviews with patients and a Delphi panel with pharmacists. Adults receiving oral oncolytics for breast (n = 12), thoracic (n = 12), or hematological (n = 12) cancer were interviewed, with purposeful sampling for adults who were aged 65 + years or Black. Interviews were coded with content analysis. We conducted three Delphi rounds, with 11/19, 13/19, and 19/19 pharmacists, respectively. In phase 2 (Knowledge Synthesis), PROM items were selected and the EHR SmartForm© programmed. In phase 3 (Knowledge Tailoring), we conducted usability testing with pharmacists. RESULTS: Pharmacists and patients were consistent in prioritizing side effects of oral oncolytics and 10 were retained. Patients advocated asking whether they can do their usual activities, while pharmacists added medication adherence. Usability testing yielded suggestions to simplify the SmartForm©. CONCLUSION: By presenting screenshots of our SmartForm©, our findings are useful to other healthcare systems looking for a PROM solution integrated in the EHR, with a reasonable pharmacist/clinician workload, and no requirement for patients to have internet access/comfort.

Oncologists' Perspectives on Cancer Survivorship: What Role Should Primary Care Play?

Background: Despite calls for an enhanced role for primary care for individuals with a history of cancer, primary medical care's role in adult survivorship care continues to be marginal.Methods: We conducted in-depth interviews with 8 medical oncologists with interest in cancer survivorship from 7 National Cancer Institute designated comprehensive cancer centers to understand perspectives on the role of primary care in cancer survivorship.Results: Two salient overarching thematic patterns emerged. (1) Oncologist's perspectives diverge on if, how, and when primary care clinicians should be involved in survivorship, ranging from involvement of primary care throughout treatment to a standardized hand-off years post-therapy. (2) Oncologist's lack understanding about primary care's expertise and subsequent value in survivorship care.Conclusion: As oncology continues to be overwhelmed by rising numbers of aging cancer survivors with multi-morbidities, NCI-designated cancer centers should take a leadership role in integrating primary care engaged cancer survivorship.

The Impact of The Real Cost Vaping and Smoking Ads across Tobacco Products.

INTRODUCTION: Little research has examined the spillover effects of tobacco communication campaigns, such as how anti-smoking ads affect vaping. AIMS AND METHODS: Participants were a national sample of 623 U.S. adolescents (ages 13-17 years) from a probability-based panel. In a between-subjects experiment, we randomly assigned adolescents to view one of four videos online: (1) a smoking prevention video ad from the Food and Drug Administration's (FDA) The Real Cost campaign, (2) a neutral control video about smoking, (3) a vaping prevention video ad from The Real Cost campaign, or (4) a neutral control video about vaping. We present effect sizes as Cohen's d, standardized mean differences, with 95% confidence intervals (CIs). RESULTS: Exposure to The Real Cost vaping prevention ads led to more negative attitudes toward vaping compared with control (d = 0.30, 95% CI: 0.07, 0.53), while exposure to The Real Cost smoking prevention ads did not affect smoking-related outcomes compared with control (p-values > .05). Turning to spillover effects, exposure to The Real Cost smoking prevention ads led to less susceptibility to vaping (d = -0.34, 95% CI: -0.56, -0.12), more negative attitudes toward vaping (d = 0.43, 95% CI: 0.20, 0.65) and higher perceived likelihood of harm from vaping (d = 0.26, 95% CI: 0.04, 0.48), compared with control. Exposure to The Real Cost vaping prevention ads did not affect smoking-related outcomes compared with control (p-values > .05). CONCLUSIONS: This experiment found evidence of beneficial spillover effects of smoking prevention ads on vaping outcomes and found no detrimental effects of vaping prevention ads on smoking outcomes. IMPLICATIONS: Little research has examined the spillover effects of tobacco communication campaigns, such as how anti-smoking ads affect vaping. Using a national sample of 623 U.S. adolescents, we found beneficial evidence of spillover effects of smoking prevention ads on vaping outcomes, which is promising since it suggests that smoking prevention campaigns may have the additional benefit of reducing both smoking and vaping among adolescents. Additionally, we found that vaping prevention campaigns did not elicit unintended consequences on smoking-related outcomes, an important finding given concerns that vaping prevention campaigns could drive youth to increase or switch to using combustible cigarettes instead of vaping.

Development of the UNC Perceived Message Effectiveness Scale for Youth.

PURPOSE: Tobacco prevention media campaigns are an important tool to address youth tobacco use. We developed a theory-based perceived message effectiveness (PME) Scale to use when vetting messages for campaigns. METHODS: Participants were a national sample of N=623 US adolescents (ages 13-17 years) recruited from a national probability-based panel. In an online experiment, we randomised adolescents to view tobacco prevention ads. All participants viewed an ad on smoking or vaping from the US Food and Drug Administration's The Real Cost campaign and a control video, in a random order. After ad exposure, we assessed PME using nine candidate items and constructs for convergent and criterion validity analyses. We used confirmatory factor analysis and examined information curves to select the scale items. RESULTS: A brief PME scale with three items (α=0.95) worked equally well for demographically diverse adolescents with different patterns of tobacco use. The Real Cost ads generated higher PME scores than the control videos for both vaping and smoking (convergent validity; p<0.05). Higher PME scores were associated with greater attention, fear, cognitive elaboration and anticipated social interactions (convergent validity; r=0.31-0.66), as well as more negative attitudes toward and lower susceptibility to vaping and smoking (criterion validity; r=-0.14 to -0.37). A single-item PME measure performed similarly to the three-item version. CONCLUSIONS: The University of North Carolina PME Scale for Youth is a reliable and valid measure of the potential effectiveness of vaping and smoking prevention ads. Employing PME scales during message development and selection may help youth tobacco prevention campaigns deploy more effective ads.

Are Social Media Interventions for Health Behavior Change Efficacious among Populations with Health Disparities?: A Meta-Analytic Review.

While prior reviews have identified positive effects of social media interventions for health behavior change generally, it is unclear whether these effects persist in traditionally underrepresented populations that are at disproportionate risk of disease. The current meta-analysis examined the effectiveness of social media interventions for health behavior change among populations with health disparities. We analyzed 17 studies with a cumulative N = 3,561. Social media interventions had a significant moderate-sized effect on behavior change among populations with health disparities (d = 0.303, 95% CI: 0.156, 0.460, p < .001), and there was significant heterogeneity across the studies (Q = 64.48, p < .001, I2 = 75.19). Exploratory moderator analyses revealed larger effects in studies with smaller sample size (p < .05) and those using additional intervention channels, including e-mail and telephone (p < .05). Findings suggest that social media interventions may be a promising intervention tool for stimulating behavior change among populations with health disparities, but several gaps remain in the literature. Public health professionals and other health communicators should further explore ways to increase both the reach and impact of social media interventions among populations with health disparities.

Adolescents' Understanding of Smoking and Vaping Risk Language: Cognitive Interviews to Inform Scale Development.

INTRODUCTION: Perceived message effectiveness (PME) is a common metric to understand receptivity to tobacco prevention messages, yet most measures have been developed with adults. We examined adolescents' interpretation of language within candidate items for a new youth-targeted PME measure using cognitive interviewing. We sought to understand the meaning adolescents assigned to our candidate PME items to improve item wording. AIMS AND METHODS: Participants were 20 adolescents, ages 13-17 years from the United States. Cognitive interviews used a structured guide to elicit feedback on comprehension, answer retrieval, and language regarding a set of Reasoned Action Approach-based survey items that assessed the PME of smoking and vaping prevention ads. We employed thematic analysis to synthesize findings from the interviews. RESULTS: Interviews identified three main issues related to survey items: ambiguity of language, word choice (risk and other terminology), and survey item phrasing. Adolescents preferred direct, definitive language over more ambiguous phrasing which they saw as less serious (eg, "will" instead of "could"). For risk terminology, they preferred terms such as "harmful" and "dangerous" over "risky," which was viewed as easy to discount. The term "negative effects" was interpreted as encompassing a broader set of tobacco harms than "health effects." Adolescents said that the term "vape" was preferable to "e-cigarette," and identified ways to simplify item wording for greater clarity. CONCLUSIONS: Tobacco risk terms that appear similar differ in meaning to adolescents, and more direct and unambiguous language is preferred. Our findings informed changes to the PME scale items to improve clarity and reduce measurement error. IMPLICATIONS: This study adds to the literature on how adolescents interpret tobacco prevention language. Adolescents may interpret terminology differently than adults, which could lead to ambiguity in meaning and thus measurement error. Through cognitive interviewing, we identified and improved the language in a youth-focused PME measure for tobacco and vaping prevention.

Cultivating New Directions: The Changing Role of Tobacco in North Carolina's Economy.

Citing potential economic harm to the state, the tobacco industry has a history of opposing tobacco control efforts in North Carolina. This commentary discusses the changing role of tobacco in North Carolina's economy, argues that tobacco control causes little economic harm to the state, and explores development of alternative industries.

Recent Innovations in Primary Care Cancer Survivorship Roles.

BACKGROUND: Despite 2 decades of cancer survivorship research, policy, and advocacy, primary care in the United States has not fully integrated survivorship care into its generalist role. This manuscript describes innovative roles primary care physicians have adopted in survivorship care and how these roles emerged. METHODS: We conducted qualitative in-depth interviews with a snowball sample of 10 US primary care physician innovators in survivorship care. Interviews were recorded and professionally transcribed. Our team met weekly as interviews were completed to review transcripts and write summaries. We analyzed data using an immersion-crystallization process. RESULTS: Innovators did not receive formal survivorship training but gained knowledge experientially and through self-guided education. All worked in academic primary care and/or cancer centers; context strongly influenced role operationalization. We delineated 4 major role-types along a spectrum, with primary care generalist orientations at one end and cancer generalist orientations at the other. Primary care generalists applied survivorship guidelines during regular visits ("GENERALISTS+") or focused on cancer treatment effects amid other comorbidities during blocked clinic time ("oncoGENERALISTS"). Cancer generalists focused on cancer-related sequalae during and after treatment; some provided continuity care to survivors ("ONCOGENERALISTS"), while others incorporated unmet primary care needs into survivorship consults ("ONCOgeneralists"). CONCLUSIONS: Primary care survivorship innovations are occurring in academic primary care and cancer centers settings in the US. To move beyond the work of individual innovators, systematic investments are needed to support adoption of such innovations. For wider diffusion of survivorship care into community primary care, additional strategies that include primary care survivorship education and workforce development are needed to facilitate risk-stratified and shared-care models.

Identifying priority areas to support primary care engagement in breast cancer survivorship care: A Delphi study.

INTRODUCTION: Existing approaches in cancer survivorship care delivery have proven to be insufficient to engage primary care. This study aimed to identify stakeholder-informed priorities to improve primary care engagement in breast cancer survivorship care. METHODS: Experts in U.S. cancer survivorship care delivery were invited to participate in a 4-round online Delphi panel to identify and evaluate priorities for defining and fostering primary care's engagement in breast cancer survivorship. Panelists were asked to identify and then assess (ratings of 1-9) the importance and feasibility of priority items to support primary care engagement in survivorship. Panelists were asked to review the group results and reevaluate the importance and feasibility of each item, aiming to reach consensus. RESULTS: Respondent panelists (n = 23, response rate 57.5%) identified 31 priority items to support survivorship care. Panelists consistently rated three items most important (scored 9) but with uncertain feasibility (scored 5-6). These items emphasized the need to foster connections and improve communication between primary care and oncology. Panelists reached consensus on four items evaluated as important and feasible: (1) educating patients on survivorship, (2) enabling screening reminders and monitoring alerts in the electronic medical record, (3) identifying patient resources for clinicians to recommend, and (4) distributing accessible reference guides of common breast cancer drugs. CONCLUSION: Role clarity and communication between oncology and primary care were rated as most important; however, uncertainty about feasibility remains. These findings indicate that cross-disciplinary capacity building to address feasibility issues may be needed to make the most important priority items actionable in primary care.

Adapting and implementing breast cancer follow-up in primary care: protocol for a mixed methods hybrid type 1 effectiveness-implementation cluster randomized study.

BACKGROUND: Advances in detection and treatment for breast cancer have led to an increase in the number of individuals managing significant late and long-term treatment effects. Primary care has a role in caring for patients with a history of cancer, yet there is little guidance on how to effectively implement survivorship care evidence into primary care delivery. METHODS: This protocol describes a multi-phase, mixed methods, stakeholder-driven research process that prioritizes actionable, evidence-based primary care improvements to enhance breast cancer survivorship care by integrating implementation and primary care transformation frameworks: the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework and the Practice Change Model (PCM). Informed by depth interviews and a four round Delphi panel with diverse stakeholders from primary care and oncology, we will implement and evaluate an iterative clinical intervention in a hybrid type 1 effectiveness-implementation cluster randomized design in twenty-six primary care practices. Multi-component implementation strategies will include facilitation, audit and feedback, and learning collaboratives. Ongoing data collection and analysis will be performed to optimize adoption of the intervention. The primary clinical outcome to test effectiveness is comprehensive breast cancer follow-up care. Implementation will be assessed using mixed methods to explore how organizational and contextual variables affect adoption, implementation, and early sustainability for provision of follow-up care, symptom, and risk management activities at six- and 12-months post implementation. DISCUSSION: Study findings are poised to inform development of scalable, high impact intervention processes to enhance long-term follow-up care for patients with a history of breast cancer in primary care. If successful, next steps would include working with a national primary care practice-based research network to implement a national dissemination study. Actionable activities and processes identified could also be applied to development of organizational and care delivery interventions for follow-up care for other cancer sites. TRIAL REGISTRATION: Registered with ClinicalTrials.gov on June 2, 2022: NCT05400941.

Implementation of quality improvement coaching versus physician communication training for improving human papillomavirus vaccination in primary care: a randomized implementation trial.

Many US health departments (HDs) conduct in-person quality improvement (QI) coaching to help primary care clinics improve their HPV vaccine delivery systems and communication. Some HDs additionally conduct remote communication training to help vaccine prescribers recommend HPV vaccination more effectively. Our aim was to compare QI coaching and communication training on key implementation outcomes. In a cluster randomized trial, we offered 855 primary care clinics: 1) QI coaching; 2) communication training; or 3) both interventions combined. In each trial arm, we assessed adoption (proportion of clinics receiving the intervention), contacts per clinic (mean number of contacts needed for one clinic to adopt intervention), reach (median number of participants per clinic), and delivery cost (mean cost per clinic) from the HD perspective. More clinics adopted QI coaching than communication training or the combined intervention (63% vs 16% and 12%, both p < .05). QI coaching required fewer contacts per clinic than communication training or the combined intervention (mean = 4.7 vs 29.0 and 40.4, both p < .05). Communication training and the combined intervention reached more total staff per clinic than QI coaching (median= 5 and 5 vs 2, both p < .05), including more prescribers (2 and 2 vs 0, both p < .05). QI coaching cost $439 per adopting clinic on average, including follow up ($129/clinic), preparation ($73/clinic), and travel ($69/clinic). Communication training cost $1,287 per adopting clinic, with most cost incurred from recruitment ($653/clinic). QI coaching was lower cost and had higher adoption, but communication training achieved higher reach, including to influential vaccine prescribers.

Our cluster randomized trial compared two interventions that health departments commonly use to increase HPV vaccination coverage: quality improvement (QI) coaching and physician communication training. We found that QI coaching cost less and was more often adopted by primary care clinics, but communication training reached more staff members per clinic, including vaccine prescribers. Findings provide health departments with data needed to weigh the implementation strengths and challenges of QI coaching and physician communication training for increasing HPV vaccination coverage.

Partnering with healthcare systems to improve HPV vaccination:The perspective of immunization program managers.

The US's 64 CDC-funded immunization programs are at the forefront of efforts to improve the quality of adolescent vaccination services. We sought to understand immunization program managers' perspectives on partnering with healthcare systems to improve HPV vaccine uptake. Managers of 44 state and local immunization programs completed our online survey in 2019. Immunization managers strongly endorsed the importance of partnering with systems to improve HPV vaccine uptake (mean = 3.8/4.0), and most wanted to do so in the next year (mean = 3.5). Immunization managers reported that common barriers included difficulty contacting systems' leadership (57%), differing organizational cultures (52%), and time (52%). Many perceived systems as not prioritizing HPV vaccination (77%). Immunization managers expressed strong interest in participating in a training on partnering with systems (mean = 3.5). Overall, immunization managers are highly interested in partnering with systems to improve HPV vaccine uptake. Training and other support are needed to expand programs' capacity for such partnerships.

PLAIN LANGUAGE SUMMARYImmunization managers are interested in partnering with healthcare systems to improve HPV vaccination. However, support may be needed to facilitate partnerships between immunization programs and healthcare systems.

Stakeholder Perceptions of Key Aspects of High-Quality Cancer Care to Assess with Patient Reported Outcome Measures: A Systematic Review.

Performance measurement is the process of collecting, analyzing, and reporting standardized measures of clinical performance that can be compared across practices to evaluate how well care was provided. We conducted a systematic review to identify stakeholder perceptions of key symptoms and health domains to test as patient-reported performance measures in oncology. Stakeholders included cancer patients, caregivers, clinicians, and healthcare administrators. Standard review methodology was used, consistent with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses). MEDLINE/PubMed, EMBASE, and the Cochrane Library were searched to identify relevant studies through August 2020. Four coders independently reviewed entries and conflicts were resolved by a fifth coder. Efficacy and effectiveness studies, and studies focused exclusively on patient experiences of care (e.g., communication skills of providers) were excluded. Searches generated 1813 articles and 1779 were coded as not relevant, leaving 34 international articles for extraction. Patients, caregivers, clinicians, and healthcare administrators prioritize psychosocial care (e.g., distress) and symptom management for patient-reported performance measures. Patients and caregivers also perceive that maintaining physical function and daily activities are critical. Clinicians and administrators perceive control of specific symptoms to be critical (gastrointestinal symptoms, pain, poor sleep). Results were used to inform testing at six US cancer centers.

Disparities in retail marketing for menthol cigarettes in the United States, 2015.

This study describes retail marketing for menthol cigarettes and its relationship with neighborhood demographics in a national sample of tobacco retailers in the United States. Mixed-effects models were used to examine three outcomes: menthol cigarette exterior advertising, menthol cigarette price promotions, and the pack price of menthol and non-menthol cigarettes. Thirty-eight percent of retailers displayed at least one menthol advertisement on the store exterior and 69% advertised price promotions. Retail advertising was more common in neighborhoods in the second (OR = 1.5 [1.1, 2.0]) and fourth (OR = 1.9 [1.3, 2.7]) quartiles of Black residents as compared to the lowest quartile. Menthol advertising was more prevalent in the third (OR = 1.4 [1.0, 1.9]) and lowest (OR = 1.6 [1.2, 2.2]) income quartiles as compared to the highest quartile. Price promotions for Newport were more common in neighborhoods with the highest quartile of Black residents (OR = 1.8 [1.2, 2.7]). Prices of Newport were cheaper in neighborhoods with the highest quartiles of youth, Black residents, and lower-income households. Policies that restrict the sales and marketing of menthol cigarettes are needed to address disparities.

Pilot Study of a Web-based Decision Tool on Post-operative Use of Radioactive Iodine.

Background: The Thyroid Cancer Care Collaborative developed a web-based clinical decision-making module (CDMM) to inform risk-adjusted decisions on post-thyroidectomy radioactive iodine (RAI) use in papillary thyroid cancer (PTC). Methods: In a pilot study, we evaluated the CDMM in 19 PTC cases representing low- (five), intermediate- (seven) and high-risk (seven) disease. Two PTC experts and 10 PTC physicians reviewed cases and assigned risk level and RAI recommendation. The experts used a standard approach while the others used the CDMM. We assessed agreement between responses using a weighted Kappa. Results: Between experts, risk-assignment was concordant in 100%, 57% and 86% of low-, intermediate- and high-risk cases, respectively. Between CDMM users, risk-assignment was concordant in 100%, 29% and 14% in low-, intermediate- and high-risk cases, respectively (p=0.01). CDMM-assigned risk agreed with the expert-assigned risk in 100%, 25% and 0% of low-, intermediate- and high-risk cases, respectively (Kappa=0.69). For RAI use, the experts agreed in 15 cases while CDMM users agreed in eight. On further analysis, interpretation of extrathyroidal extension and lymph node staging led to discrepancies with the CDMM. Conclusions: For a web-based CDMM to accurately inform appropriate use of RAI in PTC, standard pathological and surgical reports are necessary.

Phase II trial of bevacizumab + cetuximab + cisplatin with concurrent intensity-modulated radiation therapy for patients with stage III/IVB head and neck squamous cell carcinoma.

BACKGROUND: The purpose of this study was to evaluate the efficacy and tolerability of the addition of 2 monoclonal antibodies, bevacizumab and cetuximab, to 2 cycles of high-dose cisplatin administered concurrently with intensity-modulated radiation therapy (IMRT) for head and neck squamous cell carcinoma (HNSCC). METHODS: Patients with newly diagnosed stage III/IVB (M0) HNSCC received cetuximab (400 mg/m(2) loading dose, followed by 250 mg/m(2) weekly), bevacizumab (15 mg/kg, days 1 and 22), and cisplatin (50 mg/m(2) , days 1, 2, 22, and 23) concurrently with IMRT (70 Gy). The primary endpoint was progression-free survival (PFS). Secondary endpoints were overall survival (OS) and safety and tolerability. RESULTS: Among 30 patients enrolled in this study, the primary tumor site was the oropharynx in 24 patients (p16 immunohistochemistry was positive in 17, negative in 1, and not done in 6 of the oropharyngeal tumors). Median age was 57 years (range, 38-77 years) and 27 patients had clinical stage IVA disease. All patients completed the full planned dose of radiation therapy. The most common ≥ grade 3 adverse events were lymphopenia, mucositis (functional), and dysphagia. With a median follow-up of 33.8 months, 2-year PFS was 88.5% (95% confidence interval [CI] = 68.1-96.1) and 2-year OS was 92.8% (95% CI = 74.2-98.1). CONCLUSION: The addition of bevacizumab and cetuximab to 2 cycles of cisplatin, given concurrently with IMRT, was well-tolerated and was associated with favorable efficacy outcomes in this patient population. © 2015 Wiley Periodicals, Inc. Head Neck 38: E566-E570, 2016.

Environmental health hazards of e-cigarettes and their components: Oxidants and copper in e-cigarette aerosols.

To narrow the gap in our understanding of potential oxidative properties associated with Electronic Nicotine Delivery Systems (ENDS) i.e. e-cigarettes, we employed semi-quantitative methods to detect oxidant reactivity in disposable components of ENDS/e-cigarettes (batteries and cartomizers) using a fluorescein indicator. These components exhibit oxidants/reactive oxygen species reactivity similar to used conventional cigarette filters. Oxidants/reactive oxygen species reactivity in e-cigarette aerosols was also similar to oxidant reactivity in cigarette smoke. A cascade particle impactor allowed sieving of a range of particle size distributions between 0.450 and 2.02 µm in aerosols from an e-cigarette. Copper, being among these particles, is 6.1 times higher per puff than reported previously for conventional cigarette smoke. The detection of a potentially cytotoxic metal as well as oxidants from e-cigarette and its components raises concern regarding the safety of e-cigarettes use and the disposal of e-cigarette waste products into the environment.