Reporting of tobacco use and tobacco-related analyses in cancer cooperative group clinical trials: a systematic scoping review.

BACKGROUND: Continued smoking after a diagnosis of cancer negatively impacts cancer outcomes, but the impact of tobacco on newer treatments options is not well established. Collecting and evaluating tobacco use in clinical trials may advance understanding of the consequences of tobacco use on treatment modalities, but little is known about the frequency of reporting and analysis of tobacco use in cancer cooperative clinical trial groups. PATIENTS AND METHODS: A comprehensive literature search was conducted to identify cancer cooperative group clinical trials published from January 2017-October 2019. Eligible studies evaluated either systemic and/or radiation therapies, included ≥100 adult patients, and reported on at least one of: overall survival, disease/progression-free survival, response rates, toxicities/adverse events, or quality-of-life. RESULTS: A total of 91 studies representing 90 trials met inclusion criteria with trial start dates ranging from 1995 to 2015 with 14% involving lung and 5% head and neck cancer patients. A total of 19 studies reported baseline tobacco use; 2 reported collecting follow-up tobacco use. Seven studies reported analysis of the impact of baseline tobacco use on clinical outcomes. There was significant heterogeneity in the reporting of baseline tobacco use: 7 reported never/ever status, 10 reported never/ex-smoker/current smoker status, and 4 reported measuring smoking intensity. None reported verifying smoking status or second-hand smoke exposure. Trials of lung and head and neck cancers were more likely to report baseline tobacco use than other disease sites (83% versus 6%, P < 0.001). CONCLUSIONS: Few cancer cooperative group clinical trials report and analyze trial participants' tobacco use. Significant heterogeneity exists in reporting tobacco use. Routine standardized collection and reporting of tobacco use at baseline and follow-up in clinical trials should be implemented to enable investigators to evaluate the impact of tobacco use on new cancer therapies.

Author Correction: Features of fragile people with SARS-CoV-2 infection in isolation in a COVID-19 hotel in Rome, Italy.

Correction to: European Review for Medical and Pharmacological Sciences 2022; 26 (7): 2631-2638-DOI: 10.26355/eurrev_202204_28501-PMID: 35442479, published online on 15 April 2022. After publication, at the request of the Italian Ministry of Health, the authors asked to insert the following statement in the Acknowledgments section: "This research was funded by the Italian Ministry of Health (RC 2022)". There are amendments to this paper. The Publisher apologizes for any inconvenience this may cause. https://www.europeanreview.org/article/28501.

Features of fragile people with SARS-CoV-2 infection in isolation in a COVID-19 hotel in Rome, Italy.

OBJECTIVE: Temporary COVID-19 hotels have been established in Italy to assist the homeless people that test positive for SARS-CoV-2 and require isolation. This observational study aimed to investigate the characteristics of the subjects who were isolated at the Casa tra Noi COVID-19 hotel in Rome between October 2020 and May 2021 and to estimate the duration of SARS-CoV-2 positivity according to their main socio-demographic, behavioural and clinical features. SUBJECTS AND METHODS: Socio-demographic data, clinical history, and anamnestic data of guests were collected by the clinicians reviewing the medical documentation and face-to-face interviewing. Nasopharyngeal swabs were performed every 7 days and the presence of SARS-CoV-2 was assessed by RT-PCR. Median duration of SARS-CoV-2 positivity according to socio-demographic, behavioral factors and clinical condition was calculated. RESULTS: The 196 guests (161 males, 82.1%) had a median age of 41 years (IQR: 30-53), and were mostly African (87, 44.4%). Only asymptomatic/paucisymptomatic infections were observed. Almost half of the individuals (84, 42.9%) were affected by at least one co-morbidity, the frequency of which was higher among women (57.1% vs. 39.8%, p=0.06). The date of the negative SARS-CoV-2 molecular test was known for 144 guests (73.5%). Among these, the median duration of positivity was 21 days (IQR: 14-26) and did not significantly vary with age, country of origin, smoking status, alcohol or drug abuse. Among the co-morbidities, only infectious diseases significantly modified the duration of positivity, which increased from 21 to 34 days (p=0.013). CONCLUSIONS: Hotel guests were frequently affected by physical/mental co-morbidities. Duration of SARS-CoV-2 positivity was significantly prolonged only in individuals affected by an infectious disease.

Strategic basin and delta planning increases the resilience of the Mekong Delta under future uncertainty.

The climate resilience of river deltas is threatened by rising sea levels, accelerated land subsidence, and reduced sediment supply from contributing river basins. Yet, these uncertain and rapidly changing threats are rarely considered in conjunction. Here we provide an integrated assessment, on basin and delta scales, to identify key planning levers for increasing the climate resilience of the Mekong Delta. We find, first, that 23 to 90% of this unusually productive delta might fall below sea level by 2100, with the large uncertainty driven mainly by future management of groundwater pumping and associated land subsidence. Second, maintaining sediment supply from the basin is crucial under all scenarios for maintaining delta land and enhancing the climate resilience of the system. We then use a bottom-up approach to identify basin development scenarios that are compatible with maintaining sediment supply at current levels. This analysis highlights, third, that strategic placement of hydropower dams will be more important for maintaining sediment supply than either projected increases in sediment yields or improved sediment management at individual dams. Our results demonstrate 1) the need for integrated planning across basin and delta scales, 2) the role of river sediment management as a nature-based solution to increase delta resilience, and 3) global benefits from strategic basin management to maintain resilient deltas, especially under uncertain and changing conditions.

The Potential Impact and Usability of the Eighth Edition TNM Staging Classification in Oral Cavity Cancer.

AIMS: In the current eighth edition head and neck TNM staging, extranodal extension (ENE) is an adverse feature in oral cavity squamous cell cancer (OSCC). The previous seventh edition N1 with ENE is now staged as N2a. Seventh edition N2+ with ENE is staged as N3b in the eighth edition. We evaluated its potential impact on patients treated with surgery and postoperative intensity-modulated radiotherapy (IMRT). MATERIALS AND METHODS: OSCC patients treated with primary surgery and adjuvant (chemo)radiotherapy between January 2005 and December 2014 were reviewed. Cohorts with pathological node-negative (pN-), pathological node-positive without ENE (pN+_pENE-) and pathological node-positive with ENE (pN+_pENE+) diseases were compared for local control, regional control, distant control and overall survival. The pN+ cohorts were further stratified into seventh edition N-staging subgroups for outcomes comparison. RESULTS: In total, 478 patients were evaluated: 173 pN-; 159 pN+_pENE-; 146 pN+_pENE+. Outcomes at 5 years were: local control was identical (78%) in all cohorts (P = 0.892), whereas regional control was 91%, 80% and 68%, respectively (P < 0.001). Distant control was 97%, 87%, 68% (P < 0.001) and overall survival was 75%, 53% and 39% (P < 0.001), respectively. Overall survival for N1 and N2a subgroups was not significantly different. In the seventh edition N2b subgroup of pENE- (n = 79) and pENE+ (n = 79) cohorts, overall survival was 67% and 37%, respectively. In the seventh edition N2c subgroups, overall survival for pENE- (n = 17) and pENE+ (n = 38) cohorts was 65% and 35% (P = 0.08), respectively. Overall, an additional 128 patients (42% pN+) were upstaged as N3b. CONCLUSIONS: When eighth edition staging was applied, stage migration across the N2-3 categories resulted in expected larger separations of overall survival by stage. Patients treated with primary radiation without surgical staging should have outcomes carefully monitored. Strategies to predict ENE preoperatively and trials to improve the outcomes of pENE+ patients should be explored.

Is subareolar intraoperative biopsy still necessary to predict nipple involvement?

OBJECTIVE: To predict the occult tumor involvement of nipple-areola complex (NAC) using preoperative MR imaging and to investigate whether the intraoperative histopathological examination of the subareolar tissue is still necessary. PATIENTS AND METHODS: Out of 712 patients submitted to nipple-sparing mastectomy (NSM) between 2014 and 2019, we selected 188 patients who underwent preoperative breast MRI. Breast MRI and intraoperative histopathological examination of the subareolar tissue were performed to predict NAC involvement at permanent pathology. All parameters were correlated with final pathological NAC assessment by univariate and multivariate analysis. RESULTS: Forty-three patients (22.9%) had tumor involvement of the NAC. At univariate analysis, non-mass enhancement type (p = 0.009), multifocality/multicentricity (p = 0.002), median tumor size (p < 0.001), median tumor-NAC distance measured by MRI (p < 0.001), tumor-NAC distance ≤ 10 mm (p < 0.001) and tumor-NAC distance ≤ 20 mm (p < 0.001), and lymphovascular invasion (p = 0.001) were significantly correlated with NAC involvement. At multivariate analysis, only tumor-NAC distance ≤ 10 mm retained statistical significance. The sensitivity and specificity of MRI tumor-NAC distance ≤ 10 mm were 79.1% and 97.2% and those of intraoperative pathologic assessment were 74,4% and 100%, respectively. CONCLUSIONS: Tumor-NAC distance is the only reliable MRI characteristic that can predict NAC involvement in breast cancer patients. Although several cut-offs showed promising performances, intraoperative pathologic assessment is still mandatory.

Immunological fingerprint of 4CMenB recombinant antigens via protein microarray reveals key immunosignatures correlating with bactericidal activity.

Serogroup B meningococcus (MenB) is a leading cause of meningitis and sepsis across the world and vaccination is the most effective way to protect against this disease. 4CMenB is a multi-component vaccine against MenB, which is now licensed for use in subjects >2 months of age in several countries. In this study, we describe the development and use of an ad hoc protein microarray to study the immune response induced by the three major 4CMenB antigenic components (fHbp, NHBA and NadA) in individual sera from vaccinated infants, adolescents and adults. The resulting 4CMenB protein antigen fingerprinting allowed the identification of specific human antibody repertoire correlating with the bactericidal response elicited in each subject. This work represents an example of epitope mapping of the immune response induced by a multicomponent vaccine in different age groups with the identification of protective signatures. It shows the high flexibility of this microarray based methodology in terms of high-throughput information and minimal volume of biological samples needed.

Phase I trial of alpelisib in combination with concurrent cisplatin-based chemoradiotherapy in patients with locoregionally advanced squamous cell carcinoma of the head and neck.

BACKGROUND: Deregulation of the PI3K signalling pathway is frequent in squamous cell carcinoma of the head and neck (SCCHN) and may be implicated in radioresistance. We report on the results from a phase I 3 + 3 dose escalation study of alpelisib, a class I α-specific PI3K inhibitor in combination with concurrent cisplatin-based chemoradiation (CRT) in patients with locoregionally advanced SCCHN (LA-SCCHN). METHODS: Eligible patients had previously untreated LA-SCCHN and were candidates for CRT. The primary objective was to evaluate safety and determine the recommended phase II dose (RP2D). Alpelisib was given orally once daily at two dose levels: 200 mg and 250 mg. CRT consisted of cisplatin 100 mg/m2 IV every three weeks and standard fractionation radiotherapy (IMRT) 70 Gy in 35 fractions. RESULTS: Nine patients were enrolled (six alpelisib 200 mg, three 250 mg). Oropharynx was the primary site in all patients (seven p16-positive; five T1-2N2M0, four T3-4N2-3M0 [AJCC 7th edition]). All patients completed CRT within seven weeks. Grade 3 alpelisib-related toxicities occurred in four patients. No dose-limiting toxicity (DLT) was observed at 200 mg among three DLT-evaluable patients. Two of two DLT-evaluable patients treated at 250 mg experienced DLTs (inability to complete ≥75% alpelisib secondary to radiation dermatitis and febrile neutropenia). Thus, RP2D was declared at 200 mg. After median follow-up of 39.7 months, two patients developed pulmonary metastases despite locoregional control. Three-year overall survival was 77.8% (95% CI 36.5%-93.9%). CONCLUSION: Alpelisib at 200 mg has a manageable safety profile in combination with cisplatin-based CRT in LA-SCCHN.

Humanism in global oncology curricula: an emerging priority.

Introduction: Training in humanism provides skills important for improving the quality of care received by patients, achieving shared decision-making with patients, and navigating systems-level challenges. However, because of the dominance of the biomedical model, there is potentially a lack of attention to humanistic competencies in global oncology curricula. In the present study, we aimed to explore the incorporation of humanistic competencies into global oncology curricula. Methods: This analysis considered 17 global oncology curricula. A curricular item was coded as either humanistic (as defined by the iecares framework) or non-humanistic. If identified as humanistic, the item was coded using an aspect of humanism, such as Altruism, from the iecares framework. All items, humanistic and not, were coded under the canmeds framework using 1 of the 7 canmeds competency domains: Medical Expert, Communicator, Collaborator, Leader, Scholar, Professional, or Health Advocate. Results: Of 7792 identified curricular items in 17 curricula, 780 (10%) aligned with the iecares humanism framework. The proportion of humanistic items in individual curricula ranged from 2% to 26%, and the proportion increased from 3% in the oldest curricula to 11% in the most recent curricula. Of the humanistic items, 35% were coded under Respect, 31% under Compassion, 24% under Empathy, 5% under Integrity, 2% under Excellence, 1% under Altruism, and 1% under Service. Within the canmeds domains, the humanistic items aligned mostly with Professional (35%), Medical Expert (31%), or Communicator (25%). Conclusions: The proportion of humanistic competencies has been increasing in global oncology curricula over time, but the overall proportion remains low and represents a largely Western perspective on what constitutes humanism in health care. The representation of humanism focuses primarily on the iecares attributes of Respect, Compassion, and Empathy.

Mentorship Needs for Radiation Oncology Residents: Implications for Programme Design.

AIMS: Mentorship during residency guides and supports professional and personal development. Despite this, mentorship programmes within many postgraduate medicine programmes, including radiation oncology, are not standard. The objective of this qualitative study was to carry out a needs assessment to determine the perceived mentorship needs and experiences of radiation oncology residents and faculty. MATERIALS AND METHODS: Radiation oncology residents and faculty from a single university were invited to participate in semi-structured interviews in September 2017. Interviews were audiotaped and transcribed verbatim. An inductive thematic analysis was carried out using NVivo Pro version 11. Data collection occurred until saturation. Codes were derived and a systematic framework was applied to yield emergent themes. Trustworthiness was verified through triangulation and member checking. RESULTS: Twenty interviews (10 residents and 10 faculty) took place between October and December 2017, at which point thematic saturation was achieved. Four major themes emerged: (i) the perceived experiences of residents and faculty with mentorship, (ii) the evolution of mentorship needs during residency training, (iii) the mechanisms of creating mentorship relationships and (iv) peer mentorship. CONCLUSIONS: In this study, the perceptions of mentorship from the perspective of radiation oncology residents and faculty were explored. Important areas of alignment and discordance were discovered. These insights will inform the development and implementation of a mentorship programme that can be adapted for use by other oncology training programmes.

Chemical hazard for dental hygienists: a systematic review.

OBJECTIVE: Dental hygienists (DHs) are professionals responsible for oral health. They deal with professional oral hygiene, counselling, and screening patients for oral health, as well as preventing and treating oral diseases. However, DH responsibilities and duties may vary worldwide, characterising changeable occupational exposure scenarios and making it difficult to achieve a suitable evaluation of workplace risks, particularly regarding chemical exposure. Therefore, the aim of the present work was to provide a comprehensive overview on the current knowledge on DH chemical risks. MATERIALS AND METHODS: According to the PRISMA guidelines, a systematic review of PubMed, Scopus, and Isi Web of Knowledge databases was performed to retrieve all articles assessing DH occupational chemical exposures. RESULTS: Fragmented data are currently available on DH chemical risk, due to the limited number of studies on the topic and few DHs enrolled, as well as their frequent assimilation to other oral healthcare professionals. The majority of the retrieved investigations focused on possible hypersensitivity reactions caused by natural rubber latex exposure, but not on potential risks derived from other currently employed substances or innovative wide-spreading compounds. CONCLUSIONS: Future research should be focused on assessing DH chemical risks according to a more comprehensive and toxicologically standardised approach to achieve an appropriate awareness among the DH workforce concerning the possibility for hazardous exposure and adverse health effects. Overall, this may lead to the adoption/implementation of adequate preventive measures to protect the health and safety of these oral healthcare professionals.

A Prospective Study of Magnetic Resonance Imaging Assessment of Post-radiation Changes Following Stereotactic Body Radiation Therapy for Non-small Cell Lung Cancer.

AIMS: Follow-up computed tomography scans after lung stereotactic body radiation therapy (SBRT) are difficult to interpret due to the presence of benign fibrosis, which can make the detection of local recurrence difficult. The objective of this study was to determine the feasibility of a novel thoracic magnetic resonance imaging (MRI) protocol incorporating diffusion-weighted imaging (DWI) and dynamic contrast-enhanced (DCE) imaging for the assessment of the treated lung parenchyma after SBRT. MATERIALS AND METHODS: On a prospective trial, post-treatment MR images were acquired in 30 patients treated with SBRT (divided into three different cohorts according to the likelihood of local recurrence as per an expert panel). These images were assessed by an expert thoracic radiologist blind to clinical data, who indicated local recurrence in a dichotomous manner. Local recurrence was confirmed by biopsy or subsequent growth on follow-up computed tomography scans. RESULTS: Thirty patients underwent MRI as part of this study; 27/30 patients were analysable for local recurrence. MRI was conducted at a median of 27.3 months (range 6.5-71 months) from SBRT. No side-effects resulted from either MRI or contrast administration. At a median follow-up time of 45 months after treatment, three local recurrence episodes have occurred. MRI assessment diagnosed seven patients as having a local recurrence, which was later confirmed in three and did not miss any of the true local recurrences. When comparing apparent diffusion coefficient (ADC) values according to local recurrence, the mean ADC value for the local recurrence-free group was 1770 × 10-3 mm/s2 (range 1038-3105 × 10-3 mm/s2) versus 981 × 10-3 mm/s2 (range 926.6-1065 × 10-3 mm/s2) for the local recurrence group (P = 0.0014). CONCLUSIONS: A novel 3.0 T MRI protocol incorporating DWI and DCE was feasible and confirmed the suspicion of local recurrence in patients with highly suspicious computed tomography scans. This imaging tool could potentially aid in selecting patients for salvage treatment after local SBRT failure. Future work should be pursued to validate these findings.

Usefulness of automated breast volume scanner (ABVS) for monitoring tumor response to neoadjuvant treatment in breast cancer patients: preliminary results.

OBJECTIVE: We investigated the accuracy of Automated Breast Volume Scanner (ABVS) compared to handheld ultrasound (HHUS) for monitoring tumor response to neoadjuvant treatment (NAT) in breast cancer (BC). PATIENTS AND METHODS: All the patients submitted to biopsy in our Institution, from January 2017 to May 2017, proven invasive BC and eligible for NAT, were enrolled in this prospective study. The participants underwent ABVS, HHUS, dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) and mammography at the beginning of NAT and ABVS, HHUS and DCE-MRI at the halfway point of therapy and before the surgery. DCE-MRI was considered the standard of reference. Two breast radiologists (R1, R2), with fifteen and five years of experience in breast imaging, independently assigned a visibility score (ordinal 5-point scale) to ABVS, HHUS, and DCE-MRI. Diagnostic performance of ABVS and HHUS as measured by sensitivity, specificity, positive and negative predictive values (PPV and NPV) was calculated. Correlations between ABVS and MRI, and between HHUS and MRI were analyzed using Pearson's correlation test. RESULTS: A total of 21 patients were enrolled. 189 examinations were performed. The comparison between ABVS and DCE-MRI was similar for the both readers: ABVS had a sensitivity of 63,16%, specificity of 83,58%, PPV of 76,60%, NPV of 72,73%, accuracy of 74,19% (R1) and a sensitivity of 54.54%, specificity of 85.51%, PPV of 75%, NPV of 70,24%, accuracy of 71.77% (R2). The comparison between HHUS and DCE-MRI showed that HHUS had a sensitivity of 63,16 %, specificity of 83,58%, PPV of 76,60%, NPV of 72,73%, accuracy of 74,19% (R1) and a sensitivity of 36.84%, specificity of 85.07%, PPV of 67.74%, NPV of 61.29%, accuracy of 62.90% (R2). The calculated Pearson's correlation coefficient r values were 7.8 for HHUS vs. DCE-MRI and 28.5 for ABVS vs. DCE-MRI (R1) and 7.8 for HHUS vs. DCE-MRI and 22.4 for ABVS vs. DCE-MRI (R2). Statistical significance of ABVS and HHUS was p < 0.0001 and 0.005 < p < 0.01, respectively (R1, R2). CONCLUSIONS: DCE-MRI is recommended for the tumor response assessment. ABVS, a product of the biotechnology development, providing reproducible images, in addition to DCE-MRI, can be a potentially useful tool for the monitoring of response to NAT.

Implementation of a comprehensive smoking cessation program in cancer care.

Background: Quitting smoking after a cancer diagnosis maximizes treatment-related effects, improves prognosis, and enhances quality of life. However, smoking cessation (sc) services are not routinely integrated into cancer care. The Princess Margaret Cancer Centre implemented a digitally-based sc program in oncology, leveraging an e-referral system (cease) to screen all new ambulatory patients, provide tailored education and advice on quitting, and facilitate referrals. Methods: We adopted the Framework for Managing eHealth Change to guide implementation of the sc program by integrating 6 key elements: governance and leadership, stakeholder engagement, communication, workflow analysis and integration, monitoring and evaluation, and training and education. Results: Incorporating elements of the Framework, we used extensive stakeholder engagement and strategic partnerships to establish a sc program with organizational and provincial accountability. Existing electronic patient-reported assessments were changed to integrate cease. Clinic audits and staff engagement allowed for analysis of workflow, ongoing monitoring and evaluation that aided in establishing a communication strategy, and development of cancer-specific education for patients and health care providers. From April 2016 to March 2018, 22,137 new patients were eligible for screening. Among those new patients, 13,617 (62%) were screened, with 1382 (10%) being current smokers and 532 (4%) having recently quit (within 6 months). Of the current smokers and those who had recently quit, all were advised to quit or to stay smoke-free, and 380 (20%) accepted referral to a sc counselling service. Conclusions: Here, we provide a comprehensive practice blueprint for the implementation of digitally based sc programs as a standard of care within comprehensive cancer centres with high patient volumes.

Postgraduate Global Health Competency Profile for Radiation Oncology.

AIMS: To identify core competencies for postgraduate radiation oncology trainees in global health and cancer that may inform revisions across radiation oncology residency specialty training curricula. MATERIALS AND METHODS: A review of the literature was conducted to identify all potential global health competency items. An international two-phase Delphi process was conducted with experts in oncology. In phase 1, all experts scored, on a nine-point Likert scale, the degree to which they agreed an item should be included in the competency profile. Items with a mean score ≥7 were included, those scoring 4-6 were reviewed in phase 2, and items scored ≤3 were excluded. In phase 2, items were discussed and subsequently ranked for inclusion or exclusion in the competency profile. Items with >75% voting for inclusion were included in the final competency profile. RESULTS: In total, 142 potential global health competency items were identified. Sixty-one items were removed as redundant or irrelevant, leaving 81 items for the Delphi process. Eighteen specialists were invited to participate, with 10 (56%) agreeing to participate in phase 1 of the Delphi process. Participants represented 10 centres in seven countries. Of the 81 items ranked in phase 1, 72 items (89%) had a mean score ≥7 and were automatically included in the final competency profile. The remaining nine items received a score of 4-6 and were discussed in phase 2 of the Delphi process, of which three received <75% agreement for inclusion and were excluded. The result was a final list of 78 enabling competency items. CONCLUSIONS: The radiation oncology global health competency profile represents an international consensus on the items that can inform radiation oncology training requirements.

Background parenchymal enhancement in breast magnetic resonance imaging: A review of current evidences and future trends.

Background parenchymal enhancement (BPE) on breast magnetic resonance imaging (MRI) is a dynamic process, which varies among women and within the same woman over time due to different factors. BPE has profound implications for women with or at risk of breast cancer. Breast radiologist should be aware of factors that could potentially influence BPE and have to be familiar with its typical appearance. Marked BPE could indeed affect the diagnostic accuracy of breast MRI, but this shortcoming can be minimized through evaluation by dedicated radiologists, in order to correctly interpret and properly manage the additional findings. BPE shows promise as an imaging biomarker but many issues need to be addressed before it can be used either to determine screening strategy or the value of risk-reducing interventions. This review analyzes the clinical influence of BPE on breast MRI interpretation, breast cancer staging and surgical outcome and discusses current available evidences about BPE as an imaging biomarker.