ABSTRACT
BACKGROUND: PHERGain was designed to assess the feasibility, safety, and efficacy of a chemotherapy-free treatment based on a dual human epidermal growth factor receptor 2 (HER2) blockade with trastuzumab and pertuzumab in patients with HER2-positive early breast cancer (EBC). It used an 18fluorine-fluorodeoxyglucose-PET-based, pathological complete response (pCR)-adapted strategy. METHODS: PHERGain was a randomised, open-label, phase 2 trial that took place in 45 hospitals in seven European countries. It randomly allocated patients in a 1:4 ratio with centrally confirmed, HER2-positive, stage I-IIIA invasive, operable breast cancer with at least one PET-evaluable lesion to either group A, where patients received docetaxel (75 mg/m2, intravenous), carboplatin (area under the curve 6 mg/mL per min, intravenous), trastuzumab (600 mg fixed dose, subcutaneous), and pertuzumab (840 mg loading dose followed by 420 mg maintenance doses, intravenous; TCHP), or group B, where patients received trastuzumab and pertuzumab with or without endocrine therapy, every 3 weeks. Random allocation was stratified by hormone receptor status. Centrally reviewed PET was conducted at baseline and after two treatment cycles. Patients in group B were treated according to on-treatment PET results. Patients in group B who were PET-responders continued with trastuzumab and pertuzumab with or without endocrine therapy for six cycles, while PET-non-responders were switched to receive six cycles of TCHP. After surgery, patients in group B who were PET-responders who did not achieve a pCR received six cycles of TCHP, and all patients completed up to 18 cycles of trastuzumab and pertuzumab. The primary endpoints were pCR in patients who were group B PET-responders after two treatment cycles (the results for which have been reported previously) and 3-year invasive disease-free survival (iDFS) in patients in group B. The study is registered with ClinicalTrials.gov (NCT03161353) and is ongoing. FINDINGS: Between June 26, 2017, and April 24, 2019, a total of 356 patients were randomly allocated (71 patients in group A and 285 patients in group B), and 63 (89%) and 267 (94%) patients proceeded to surgery in groups A and B, respectively. At this second analysis (data cutoff: Nov 4, 2022), the median duration of follow-up was 43·3 months (range 0·0-63·0). In group B, the 3-year iDFS rate was 94·8% (95% CI 91·4-97·1; p=0·001), meeting the primary endpoint. No new safety signals were identified. Treatment-related adverse events and serious adverse events (SAEs) were numerically higher in patients allocated to group A than to group B (grade ≥3 62% vs 33%; SAEs 28% vs 14%). Group B PET-responders with pCR presented the lowest incidence of treatment-related grade 3 or higher adverse events (1%) without any SAEs. INTERPRETATION: Among HER2-positive EBC patients, a PET-based, pCR-adapted strategy was associated with an excellent 3-year iDFS. This strategy identified about a third of patients who had HER2-positive EBC who could safely omit chemotherapy. FUNDING: F Hoffmann-La Roche.
Subject(s)
Antibodies, Monoclonal, Humanized , Antineoplastic Combined Chemotherapy Protocols , Breast Neoplasms , Docetaxel , Fluorodeoxyglucose F18 , Receptor, ErbB-2 , Trastuzumab , Humans , Female , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Middle Aged , Trastuzumab/therapeutic use , Trastuzumab/administration & dosage , Receptor, ErbB-2/metabolism , Docetaxel/therapeutic use , Docetaxel/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/adverse effects , Adult , Disease-Free Survival , Aged , Positron-Emission Tomography/methods , Carboplatin/administration & dosage , Carboplatin/therapeutic use , RadiopharmaceuticalsABSTRACT
A 76-year-old patient, admitted to the department of cardiac surgery, anticoagulated, started with acute dysphagia. An upper endoscopy revealed a blue mucosa from the upper to distal esophagus, with narrowing of the lumen caused by an extrinsic compression. A computed to¬mography (CT) of the thorax was performed, showing a 85x55 mm mediastinal hematoma causing extrinsic compression of the esophagus. Subsequently, a contrast-enhanced CT scan was performed, confirming a contained rupture of descending thoracic aortic dissection as the cause of the hematoma.
ABSTRACT
Hepatoid gastric adenocarcinoma (HGA) is a rare subtype of gastric cancer. It usually presents with non-specific digestive tract symptoms and is usually diagnosed in advanced stages. It has radiological and histological similarities to hepatocarcinoma (HCC), and serum elevation of alpha-fetoprotein (AFP) is characteristic, as is positive staining for this marker on immunohistochemistry. Given the low incidence and poor prognosis of this type of tumour, it is essential to make a correct differential diagnosis and to initiate early surgical treatment in localised stages and systemic treatment in those where the disease is disseminated. In this context, we present the case of a GHA diagnosed this year in our centre.
ABSTRACT
BACKGROUND: Convalescent plasma (CP) became a prominent treatment in the early stages of the SARS-CoV-2 pandemic. In Argentina, a randomized clinical trial was executed to compare the use of CP in inpatients with severe COVID-19 pneumonia versus placebo. No differences in clinical outcomes or overall mortality between groups were observed. We conducted a cohort study in outpatients enrolled in the trial to describe long-term antibody titer variations between CP and placebo recipients. METHODS: Patients' total SARS-CoV-2 IgG antibodies against spike protein were collected 3, 6 and 12 months after hospital discharge from August 2020 to December 2021. In addition, reinfections, deaths and vaccination status were retrieved. Statistical analysis was performed using antibody geometric mean titers (GMT). All estimations were made considering the date of the trial infusion (placebo or CP) as time 0. RESULTS: From the 93 patients included in the follow-up, 64 had received CP and 29 placebo. We excluded all 12-month measurements because they were collected after the patients' vaccination date. At 90 days post-infusion, patients had an antibody GMT of 8.1 (IQR 7.4-8.1) in the CP group and 8.8 (IQR 8.1-9.1) in the placebo group. At 180 days, both groups had a GMT of 8.1 (IQR 7.4-8.1). No statistical differences in GMT were found between CP and placebo groups at 90 days (p = 0.12) and 180 days (p = 0.25). No patients registered a new COVID-19 infection; one died in the CP group from an ischemic stroke. CONCLUSIONS: No differences were observed in long-term antibody titers in unvaccinated patients that received CP or placebo after severe COVID-19 pneumonia.
Subject(s)
COVID-19 , Humans , COVID-19/therapy , COVID-19/etiology , SARS-CoV-2 , Cohort Studies , Immunization, Passive/adverse effects , COVID-19 Serotherapy , Antibodies, ViralABSTRACT
Health information that is acquired through information scanning has been shown to play an important role in shaping individual beliefs and health behavior. This study examines the direct and indirect effects of the breadth of scanning from media and interpersonal sources about two risk behaviors (nonmedical use of amphetamines and marijuana) on subsequent drug use behavior through changes to perceived norms. We test effects of scanning using a longitudinal online survey design with data collected at six-month intervals over three time points among 800 Israeli undergraduate students in their freshman year. Of the 800 respondents who participated in the first wave, 62.4% completed the second wave (N = 499), among which 347 (69.5%) completed a follow-up 6 months later. Results of cross-lagged structural equation models find that scanning information about amphetamines from interpersonal sources at 6 months predicted an increased likelihood of nonmedical use of amphetamines at 12-months. In addition, young adults who scanned information about marijuana from media sources at 6 months reported greater nonmedical marijuana use at 12 months. Breadth of scanning about marijuana from media sources mediated the relationship between perceived norms and marijuana use at 12 months. Results also showed indirect effects of scanning at baseline on nonmedical drug use at 12 months through scanning from the same source at 6 months. These findings contribute to our understanding of the role of information scanning and perceived norms in shaping substance use behaviors, and suggest that scanning may serve as a potential early indicator of risk.
Subject(s)
Cannabis , Marijuana Smoking , Substance-Related Disorders , Young Adult , Humans , Longitudinal Studies , Substance-Related Disorders/epidemiology , Amphetamines , Students , UniversitiesABSTRACT
The COVID-19 pandemic represented a unique information seeking and sharing context for billions of Internet users across the globe. Although previous research has established that people often seek health information on the Internet, including through social media platforms, there was a political element to pandemic responses that is not typical of health issues such as seasonal influenza or heart conditions. This unique context, in conjunction with the public posting of the novel coronavirus DNA by Chinese scientists in January 2020, begs for analysis of how people used social media in the early phase of the pandemic to make sense of the role of genetics in COVID-19. This study represents such an analysis as a qualitative content analysis of Facebook posts concerning genetics and COVID-19. Data were collected from March through August of 2020 to identify how genetics issues were being shared on Facebook and the types of accounts that were sharing that information. Through analysis, four themes emerged representing Facebook posts about genetics and COVID-19: disease risk, testing, vaccines, and virus characteristics. These posts appeared on eight types of accounts, with five of those representing 88% of the data: education, health, lifestyle, news, and political. Results are interpreted with constructs from media dependency theory and implications for future research are presented.
Subject(s)
COVID-19 , Social Media , Humans , COVID-19/epidemiology , Pandemics/prevention & control , SARS-CoV-2ABSTRACT
BACKGROUND: The ideal technique for lymph node staging for patients with pathologically confirmed node-positive breast cancer at diagnosis and neoadjuvant chemotherapy (NAC) is unclear. OBJECTIVE: The aim of this study was to analyze the feasibility of wire/clip localization and sentinel lymph node biopsy (SLNB) for the axillary staging of these patients. METHODS: We conducted a prospective study in which lymph node staging was performed using wire localization of positive lymph nodes and an SLNB with dual tracer. All patients who presented no metastatic involvement of the sentinel lymph node (SLN) or clip/wire-marked lymph node were spared an axillary lymph node dissection (ALND). The multidisciplinary committee agreed on axillary treatment for patients with lymph node involvement. RESULTS: Forty-two patients met the inclusion criteria. We identified and extirpated the clip/wire-marked node in all patients (100%), with SLNB performed successfully in 95.3% of patients. The SLN and wire-marked node matched in 80% of patients; 73.8% of patients did not undergo ALND. DISCUSSION AND CONCLUSIONS: Several studies have evaluated the efficacy of various procedures for lymph node marking for women with prechemotherapy lymph node involvement. Most of the studies reported high identification rates (> 94.8%), with false negative rates of < 7%. Similarly, our study allows us to conclude that combined axillary marking (clip and SLNB) in patients with metastatic lymph node at diagnosis and NAC offers a high identification rate (100%) and a high correlation between the wire-marked lymph node and the SLN (80%). This procedure has enabled the suppression of ALND for a significant number of patients (73%).
Subject(s)
Breast Neoplasms , Sentinel Lymph Node Biopsy , Axilla/pathology , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Female , Follow-Up Studies , Humans , Lymph Node Excision , Lymph Nodes/pathology , Lymph Nodes/surgery , Neoadjuvant Therapy , Neoplasm Staging , Prospective Studies , Surgical InstrumentsABSTRACT
OBJECTIVE: patients are exposed to ionizing radiation during endoscopic retrograde cholangiopancreatography (ERCP). Radiation dose depends on multiple factors. The goal of this study was to assess fluoroscopy time (FT), radiation doses and effective dose (ED) during ERCP according to the condition being treated. MATERIALS AND METHODS: a descriptive study was performed of 369 consecutive ERCPs from January 2017 to June 2019. Patient demographic and procedure data were collected. FT, cumulative dose area product (DAP), fluoroscopy DAP, DA fluoroscopy, air kerma, and number of radiographs were assessed. ED was estimated using specific conversion factors. RESULTS: the mean age was 73.34 years and 193 subjects were male. Mean FT was 4.56 ± 0.17 min, cumulative DAP was 2,056.73 ± 188.83 cGycm2, fluoroscopy DAP was 1,722.90 ± 82.26 cGycm2 and air kerma was 85.84 ± 4.93 mGy. The number of radiographs was 2.10 ± 0.07 and the mean ED was 5.34 ± 0.49 mSv. FT was significantly longer for choledocholithiasis (CL), proximal malignant biliary stricture (PMBS) and distal malignant biliary stricture (DMBS) versus others (OT). Cumulative DAP was higher for PMBS (p < 0.002). FT, cumulative DAP, fluoroscopy DAP and air kerma values were significantly higher for complicated CL as compared to simple CL. ED was higher for CL, DMBS and PMBS, but only significantly (p < 0.002) for PMBS. CONCLUSIONS: FT for ERCP is variable and increases with exploration difficulty. Thus, it is longer in the case of PMBS, as well as with the amount of radiation received by the patients and ED.
Subject(s)
Cholangiopancreatography, Endoscopic Retrograde , Aged , Fluoroscopy , Humans , Male , Radiation DosageABSTRACT
Objectives. To examine how and what information is communicated via social media during an infectious disease outbreak.Methods. In the context of the 2016 through 2018 hepatitis A outbreak in San Diego County, California, we used a grounded theory-based thematic analysis that employed qualitative and quantitative approaches to uncover themes in a sample of public tweets (n = 744) from Twitter, a primary platform used by key stakeholders to communicate to the public during the outbreak.Results. Tweets contained both general and hepatitis A-specific information related to the outbreak, restatements of policy and comments critical of government responses to the outbreak, information with the potential to shape risk perceptions, and expressions of concern regarding individuals experiencing homelessness and their role in spreading hepatitis A. We also identified misinformation and common channels of content driving themes that emerged in our sample.Conclusions. Public health professionals may identify real-time public risk perceptions and concerns via social media during an outbreak and target responses that fulfill the informational needs of those who seek direction and reassurance during times of uncertainty.
Subject(s)
Disease Outbreaks , Health Communication , Hepatitis A , Public Health , Social Media , California , Grounded Theory , Hepatitis A/therapy , Hepatitis A/transmission , HumansABSTRACT
Prior theoretical models of information seeking have examined its role, primarily, as a determinant of recommended behaviors. In this study, we develop and test the "behavior and risk information engagement" (BRIE) model, which accounts for the reciprocal effects of information seeking from interpersonal and media sources on two risk behaviors - nonmedical marijuana and amphetamine use. We test the model among young Israeli adults (N = 800) using a three-wave prospective observational study (at 6-month intervals). Autoregressive cross-lagged structural equation models showed good fit. Information seeking from interpersonal sources at baseline predicted amphetamine use and marijuana use at 6 months. In both models, seeking drug-related information from interpersonal sources at baseline was also a predictor of seeking information from media sources at 6 months. Information seeking from media sources at 6 months was also a significant predictor of amphetamine use at 12 months. Implications for theory and practice are discussed.
Subject(s)
Information Seeking Behavior , Models, Psychological , Risk-Taking , Adolescent , Adult , Amphetamine-Related Disorders/psychology , Female , Humans , Israel , Male , Marijuana Use/psychology , Predictive Value of Tests , Prospective Studies , Young AdultABSTRACT
The liver stem cell niche is a specialized and dynamic microenvironment with biomechanical and biochemical characteristics that regulate stem cell behavior. This is feasible due to the coordination of a complex network of secreted factors, small molecules, neural, blood inputs and extracellular matrix (ECM) components involved in the regulation of stem cell fate (self-renewal, survival, and differentiation into more mature phenotypes like hepatocytes and cholangiocytes). In this review, we describe and summarize all the major components that play essential roles in the liver stem cell niche, in particular, growth factor signaling and the biomechanical properties of the ECM.
Subject(s)
Disease , Extracellular Matrix/metabolism , Intercellular Signaling Peptides and Proteins/metabolism , Stem Cells/cytology , Animals , Cell Differentiation , Cell Lineage , Humans , Signal Transduction , Stem Cells/metabolismABSTRACT
The current study examined conversations on Twitter related to use and perceptions of e-cigarettes in the United States. We employed the Social Media Analytic and Research Testbed (SMART) dashboard, which was used to identify and download (via a public API) e-cigarette-related geocoded tweets. E-cigarette-related tweets were collected continuously using customized geo-targeted Twitter APIs. A total of 193,051 tweets were collected between October 2015 and February 2016. Of these tweets, a random sample of 973 geocoded tweets were selected and manually coded for information regarding source, context, and message characteristics. Our findings reveal that although over half of tweets were positive, a sizeable portion was negative or neutral. We also found that, among those tweets mentioning a stigma of e-cigarettes, most confirmed that a stigma does exist. Conversely, among tweets mentioning the harmfulness of e-cigarettes, most denied that e-cigarettes were a health hazard. These results suggest that current efforts have left the public with ambiguity regarding the potential dangers of e-cigarettes. Consequently, it is critical to communicate the public health stance on this issue to inform the public and provide counterarguments to the positive sentiments presently dominating conversations about e-cigarettes on social media. The lack of awareness and need to voice a public health position on e-cigarettes represents a vital opportunity to continue winning gains for tobacco control and prevention efforts through health communication interventions targeting e-cigarettes.
Subject(s)
Public Opinion , Social Media , Vaping/psychology , Humans , United StatesABSTRACT
OBJECTIVE: rectal diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that is used to prevent pancreatitis in high-risk patients during endoscopic retrograde cholangiopancreatography (ERCP). The European Society of Gastrointestinal Endoscopy (ESGE) recommends the use of prophylaxis with indomethacin or diclofenac in all patients undergoing ERCP, including those at low or intermediate risk of pancreatitis. A study to investigate the efficacy of this recommendation was performed. METHODS: this was a mixed cohort study. A total of 1,512 ERCP procedures performed in our institution from January 2009 to July 2016 were included in the study. Until June 2012, 718 patients did not receive diclofenac. Subsequently, 794 patients without contraindications received 100 mg of rectal diclofenac at the onset of the procedure. Risk factors for post-ERCP pancreatitis (PEAP) and PEAP cases defined using consensus criteria were recorded. RESULTS: a total of 47 PEAP events (3.1%) were reported, 3.4% in the diclofenac group and 2.8% in the non-diclofenac group (p = 0.554); 26.1% of patients had risk factors for PEAP. In the diclofenac group, PEAP developed in 4.4%, 0.5% and 2.6% of subjects with intact papillae, prior sphincterotomy and extended sphincterotomy, respectively. The results were similar for the non-diclofenac group: 4% with intact papillae, 0.9% with prior sphincterotomy, and 2.5% with extended sphincterotomy, respectively. PEAP severity was similar in both groups. CONCLUSIONS: rectal diclofenac before ERCP did not prevent the development of post-ERCP acute pancreatitis in non-selected consecutive patients.
Subject(s)
Anti-Inflammatory Agents, Non-Steroidal/administration & dosage , Anti-Inflammatory Agents, Non-Steroidal/therapeutic use , Cholangiopancreatography, Endoscopic Retrograde/adverse effects , Diclofenac/administration & dosage , Diclofenac/therapeutic use , Pancreatitis/etiology , Pancreatitis/prevention & control , Administration, Rectal , Adult , Age Factors , Aged , Aged, 80 and over , Cohort Studies , Female , Humans , Male , Middle Aged , Risk FactorsABSTRACT
There is an increasing amount of drug-related information that is easily accessible from media and interpersonal sources. Recent research shows significant positive associations between information acquisition and nonmedical drug use intentions among college students. This study examines information about amphetamines and marijuana that was actively searched ("seeking") as well as information that was encountered during routine media use ("scanning"). Data are drawn from a cross-national comparative survey of college students in the United States (N = 734) and in Israel (N = 800). U.S. participants reported seeking and scanning information about marijuana across a broader range of sources than Israeli participants. Among U.S. and Israeli participants, the most frequently searched marijuana-related topics included the benefits of marijuana, negative effects of marijuana use, and political reasons why marijuana should be legal. Participants from both countries reported the benefits of amphetamines, and the negative effects of amphetamine use as the most frequently searched topics about amphetamines. Participants in both countries identified the internet and friends as the most popular sources of drug-related information and noted that physicians, friends, and the internet were the most trusted sources. Implications for research on information seeking and health communication are discussed.
Subject(s)
Amphetamines , Cannabis , Consumer Health Information/statistics & numerical data , Cross-Cultural Comparison , Information Seeking Behavior , Students/psychology , Female , Humans , Israel , Male , Students/statistics & numerical data , Surveys and Questionnaires , United States , Universities , Young AdultABSTRACT
Recent advances in endoscopic therapeutics allow conditions such as fistulas of the digestive system to be treated endoscopically. These cases were recently managed with surgery. The Padlock® system includes a nitinol clip that was recently introduced for endoscopic therapy. There are few reports with regard to its use in the daily clinical practice. We report a case of a colonic fistula that was endoscopically managed with this novel over-the-scope nitinol clip system.
Subject(s)
Colonic Diseases/surgery , Endoscopy, Gastrointestinal/methods , Intestinal Fistula/surgery , Liver Diseases/surgery , Aged , Alloys , Female , Humans , Surgical InstrumentsABSTRACT
INTRODUCTION: The impact of the accumulated experience of the capsule endoscopy (CE) reader on the accuracy of this test is discussed. AIM: To determine whether the negative predictive value of CE findings changes along the learning curve. METHODS: We reviewed the first 900 CE read by 3 gastroenterologists experienced in endoscopy over 8 years. These 900 CE were divided into 3 groups (300 CE each): group 1 consisted of the sum of the first 100 CE read by each of the 3 endoscopists; group 2, the sum of the second 100 and groups 3, the sum of the third 100. Patients with normal CE were monitored for at least 28 months to estimate the negative predictive value. RESULTS: A total of 54 (18%) CE in group 1, 58 (19.3%) in group 2 and 47 (15.6%) in group 3 were normal, although only 34 patients in group 1, 38 in group 2 and 36 in group 3 with normal CE completed follow up and were eventually studied. The negative predictive value was 88.2% in group 1, 89.5% in group 2 and 97% in group 3 (P>.05). CONCLUSION: The negative predictive value tended to increase, but remained high and did not change significantly after the first 100 when readers are experienced in conventional endoscopy and have preliminary specific training.
Subject(s)
Capsule Endoscopy , Gastroenterology , Adolescent , Adult , Aged , Aged, 80 and over , Clinical Competence , Female , Humans , Learning Curve , Male , Middle Aged , Predictive Value of Tests , Reproducibility of Results , Retrospective Studies , Young AdultABSTRACT
This study reports results from a large population-based survey of U.S. adults showing perceived behavioral control (PBC) moderations of associations between (a) attitude and intention and (b) perceived norms and intention to engage in 6 health behaviors. Results are based on data collected from a nationally representative sample of U.S. adults ages 40-70 (N = 2,489) and extend understanding of how behavioral theory can be used to guide the design and evaluation of health communication campaigns. Ordinary least squares regression analyses show evidence of a significant positive PBC moderation of (a) attitude and intention and (b) perceived norms and intention such that attitude or perceived norms toward the behavior is more strongly associated with behavioral intention among participants reporting higher levels of PBC. Implications for message design and the evaluation of communication campaigns are discussed.
Subject(s)
Health Behavior , Intention , Internal-External Control , Adult , Aged , Attitude , Female , Health Communication , Health Promotion , Humans , Male , Middle Aged , Psychological Theory , Social Norms , Surveys and Questionnaires , United StatesABSTRACT
This study investigates the impact of seeking information about the prostate-specific antigen (PSA) test on men's PSA test use during a period of conflicting recommendations. Analyses used longitudinal survey data collected in 2005 and 2006 from a nationally representative sample of U.S. males aged 40-70 years (n = 777). Cross-sectionally, nonmedical information seeking was significantly associated with increased odds of having a PSA test in the past year (Time 1 odds ratio [OR] = 9.74, p < .01, 95% confidence interval [CI] = 4.37, 21.70; Time 2 OR = 5.78, p < .01, 95% CI = 3.17, 10.55). However, lagged analyses showed that among men who had a PSA at Time 1, active seeking is associated with reduced odds of later having a PSA test (OR = 0.33, p < .05, 95% CI = 0.13, 0.85). Participants who had not had a PSA test in the past year very rarely sought information about PSA tests. Information acquisition in an environment of conflicting recommendations may influence adoption of cancer screening behaviors.