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Tumor Treating Fields With Gemcitabine and Nab-Paclitaxel for Locally Advanced Pancreatic Adenocarcinoma: Randomized, Open-Label, Pivotal Phase III PANOVA-3 Study
No full textPURPOSE: Tumor treating fields (TTFields) use alternating electric fields to disrupt cancer cell proliferation. Feasibility of TTFields therapy with gemcitabine/nab-paclitaxel was previously demonstrated in patients with advanced pancreatic adenocarcinoma. PANOVA-3 was designed to confirm safety and efficacy of TTFields in patients with unresectable locally advanced pancreatic adenocarcinoma (LA-PAC).
METHODS: In this global phase III trial, 571 patients with newly diagnosed LA-PAC were randomly assigned to receive gemcitabine 1,000 mg/m(2) and nab-paclitaxel 125 mg/m(2) by intravenous infusion once a day on days 1, 8, and 15 of a 28-day cycle with or without TTFields. The primary end point was overall survival (OS). Secondary end points included progression-free survival (PFS), local PFS, pain-free survival, and overall response rate (ORR). Distant PFS was analyzed post hoc.
RESULTS: OS was significantly prolonged using TTFields with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel (median, 16.2 months [95% CI, 15.0 to 18.0] v 14.2 months [95% CI, 12.8 to 15.4]; hazard ratio [HR], 0.82 [95% CI, 0.68 to 0.99]; P = .039). PFS, local PFS, and ORR were not improved. Pain-free survival was significantly prolonged with TTFields with gemcitabine/nab-paclitaxel (median, 15.2 months [95% CI, 10.3 to 22.8] v 9.1 months [95% CI, 7.4 to 12.7]; HR, 0.74 [95% CI, 0.56 to 0.97]; P = .027), as was distant PFS (median, 13.9 months [95% CI, 12.2 to 16.8] v 11.5 months [95% CI, 10.4 to 12.9]; HR, 0.74 [95% CI, 0.57 to 0.96]; P = .022). Device-related skin adverse events (AEs) were experienced by 76.3% of patients. Most device-related skin AEs were mild to moderate, with 7.7% of patients reporting a grade 3 AE.
CONCLUSION: This study demonstrated significant OS, pain-free survival, and distant PFS benefits for TTFields with gemcitabine/nab-paclitaxel versus gemcitabine/nab-paclitaxel in patients with unresectable LA-PAC, with no additive systemic toxicity
Evolving paradigms of treatment of allergic and nonallergic rhinitis
No full textAllergic rhinitis (AR) is a prevalent disease affecting approximately 15% of the US population, which is approximately 50 million individuals. More broadly, it is estimated that 400 to 500 million people worldwide experience AR. Not surprisingly, AR has a significant impact on quality of life due to increased fatigue, cognitive impairment, sleep disturbances, presenteeism or absenteeism, and impairment of performance, which all contribute to an increased cost burden to the medical system. Recent studies have identified social determinants of health including income level, age of migration from rural to urban areas or to high-income countries, and access to health care as important factors associated with the prevalence of allergic diseases. However, up to 25% of individuals have non-AR triggered by mechanical, osmotic, and chemical irritants, and 50% have mixed rhinitis characterized by allergic and nonallergic triggers. Uncontrolled chronic rhinitis subtypes have all been associated with asthma, eczema, chronic or recurrent sinusitis, cough, and both tension and migraine headaches. This review will address AR and non-AR with a focus on evolving treatments in adults
Sulbactam for carbapenem-resistant Acinetobacter baumannii infections: a literature review
No full textCarbapenem-resistant Acinetobacter baumannii (CRAB) is characterized as a critical priority pathogen with restricted therapeutic options. To date, the most effective antimicrobial treatment against this difficult-to-treat bacterial strain has not been established. Sulbactam is a β-lactamase inhibitor with intrinsic activity against this pathogen, however, as a β-lactam, it can be hydrolysed by β-lactamases produced by A. baumannii. High-dose, extended-infusion treatment with sulbactam can overcome this hydrolysis by β-lactamases and is considered an effective therapeutic strategy against CRAB. The aim of this review is to analyse primary and secondary research studies that compare sulbactam-based with other regimens, such as polymyxin-containing regimens, tigecycline-containing regimens and other antimicrobial combinations against CRAB infections, especially ventilator-associated pneumonia (VAP), hospital-acquired pneumonia (HAP) and bacteraemia. Our findings suggest that results are conflicting, mostly because of high heterogeneity among studies. However, in most studies, sulbactam-based regimens have demonstrated comparable, and in several studies more favourable results in contrast to other antimicrobial treatments with respect to clinical cure and mortality in CRAB-associated pneumonia, yet without reaching statistical significance in most cases. The auspicious novel β-lactam/β-lactamase inhibitor combination sulbactam/durlobactam is also discussed, although real-world clinical data regarding its efficacy in CRAB infections are still scarce. More randomized controlled trials comparing sulbactam-based with other regimens are warranted to determine the most effective antimicrobial combination against CRAB infections. Nevertheless, current data suggest that sulbactam could play a major role in this combination treatment
Comparison of the effectiveness of two prophylactic single-use negative pressure wound therapy devices in reducing surgical site complications after cesarean delivery: insights from a large US claims database
No full textBACKGROUND: Single-use negative pressure wound therapy (sNPWT) has emerged as a promising intervention for patients at high risk of surgical site complications (SSCs) after a cesarean delivery. However, the available studies primarily compare negative pressure wound therapy to standard dressings rather than evaluating differences between negative pressure wound therapy devices or pressure settings.
OBJECTIVE: To compare the effectiveness of 2 commonly used sNPWT devices, a -80 mm Hg device and a -125 mm Hg device, in reducing the risk of SSCs following cesarean delivery.
MATERIALS AND METHODS: Real-world data were obtained from a large claims database in the United States from January 2017 through June 2022. Adult patients who had an inpatient encounter in which the -80 mm Hg device or the -125 mm Hg device was used after a cesarean delivery were included. Propensity score matching was used to balance the cohorts. Study end points included incidence of overall surgical site infection (SSI), superficial SSI, dehiscence, seroma, hematoma, deep SSI, length of stay (LOS), and costs.
RESULTS: The study included 5332 cases in each group. Overall SSI, superficial SSI, dehiscence, seroma, and costs were significantly lower with the -80 mm Hg device compared with the -125 mm Hg device (P ≤ .05). No differences between the 2 devices were observed for hematoma, deep SSI, and LOS (P \u3e .05).
CONCLUSION: Of the 2 commonly used sNPWT devices, use of the -80 mm Hg device was associated with a lower likelihood of developing overall SSI, superficial SSI, dehiscence, and seroma, and was associated with lower costs after cesarean delivery compared with the -125 mm Hg device. There were nonsignificant differences in LOS, deep SSI, and hematoma. Further studies are required to confirm these findings
Thyroid Cancer Incidence and Trends in United States and Canadian Pediatric, Adolescent, and Young Adults
No full textBACKGROUND/OBJECTIVES: Thyroid cancer incidence has risen in both the United States and Canada, despite differing healthcare systems. While overdiagnosis likely partly explains this trend in adults, its impact on younger populations is unclear. We used the North American Association of Central Cancer Registries, which included 133,808 thyroid cancer cases from the United States and Canada, to assess incidence trends among pediatric, adolescent, and young adult (PAYA) populations.
METHODS: Age-adjusted incidence rates (AAIR) per 100,000 person-years (PY) were compared using rate ratios (RR), stratified by sex, age, race/ethnicity (United States only), and histology. Joinpoint regression estimated annual percentage changes (APC) and average APCs (AAPC) in AAIRs. From 1995 to 2014, thyroid cancer incidence increased by 137%. Significant increases occurred across all age groups (0-14, 15-24, 25-34, 35-39 years). The rate increase was highest for papillary thyroid cancer (AAPC = 5.50, 95% CI 5.06, 5.94), and among individuals aged 35-39 years (AAPC = 5.99, 95% CI 4.84, 7.15). Of racial/ethnic groups in the United States, non-Hispanic White individuals had the highest AAIR (6.22 per 100,000 PY). Mortality has changed minimally.
CONCLUSIONS: Over the past two decades, thyroid cancer incidence has increased in individuals under 40. While evidence suggests that overdiagnosis primarily accounts for this trend, other contributing factors cannot be ruled out. Further research and surveillance of the drivers of increased incidence are critical
Performance of a Xylazine Test Strip in Urine Biospecimens
No full textOBJECTIVE: Herein, we evaluate the performance of xylazine test strips (XTS) in urine samples. XTS is used for community drug checking (powders and liquids) but lacks regulatory approval for human specimen testing.
METHODS: We obtained n=85 human urine specimens from a toxicology laboratory in Philadelphia, originally submitted for qualitative mass spectrometry (MS) expanded drug analysis. Residual urine was tested for xylazine using XTS (BTNX Inc.), and results were then compared against the MS method. Synthetic urine spiked with xylazine standards was used to determine the XTS cutoff. An external quantitative MS method was used to investigate potential mismatches.
RESULTS: Of n = 85 human urine specimens, XTS demonstrated 86% sensitivity and 93% specificity using a XTS cutoff of 750 ng/mL established with synthetic urine samples. Six false negatives (14%) among 43 qualitative MS-positive samples were observed, primarily due to XTS\u27s lower sensitivity. Among 3 false positives (7%) observed in 42 qualitative MS-negative samples, lidocaine likely causes the interference. Interestingly, some XTS-positive samples were found to have xylazine concentration lower than 750 ng/mL using quantitative MS, suggesting cross-reactivity with unknown metabolites or analogs.
CONCLUSIONS: XTS requires further refinement to achieve lab-quality performance, with a focus on improving sensitivity and minimizing false positives caused by nonspecific interactions with urine components. Further research is necessary to optimize their design, establish accurate detection thresholds, supporting clinical decision-making, and obtain regulatory validation
Delayed Presentation of Metastatic Solid Pseudopapillary Epithelial Neoplasm in a Pregnant Woman: A Case Report
No full textSolid pseudopapillary epithelial neoplasm (SPEN) is a rare, low-grade malignant pancreatic tumor usually found incidentally on imaging, most commonly in young women. Its association with women suggests that hormones may play a significant role in tumor pathogenesis. Surgical resection is the mainstay of treatment in all stages of disease, and few other treatment options have been thoroughly explored. This case demonstrates the unique therapeutic challenges involved in the management of a pregnant woman with new liver metastasis and significant disease burden following remote resection of the primary SPEN tumor. The patient was treated with chemotherapy, radiation, and hormone therapy, followed by hepatic trisegmentectomy without recurrence during surveillance. This case presents a unique therapeutic approach to a situation where no established treatment guidelines exist
Knowledge of Head and Neck Cancer Risk Factors and Symptoms: A Cross-Sectional Survey Among Arab Americans
No full textWe examined head and neck cancer (HNC) risk factors and symptoms knowledge among Arab Americans in Michigan. A survey of 295 adult Arab Americans (≥ 18 years) was conducted between March and July 2023. Knowledge of HNC risk factors and symptoms were assessed using 10 and 14 questions, respectively. For each question, we asked, Do you know that the following can be risk factors/symptoms of HNC? and respondents chose yes, no, or don\u27t know/not sure. Regarding risk factors- tobacco smoking and chewing were the most recognized risk factors, identified by 78.9% and 72.8%, respectively. Less than half identified human papillomavirus (HPV) (40.6%) as risk factor. Regarding symptom knowledge, only 40-50% identified the most common HNC symptoms: nonhealing ulcers (41%), dysphagia or odynophagia (51.4%), and voice changes (48.6%); while 60.6% identified swelling or lump in neck/throat. Approximately, half of the respondents recognized persistent mass or lesion on the tongue (53.3%) and bleeding in the mouth/throat (50.3%) as symptoms of HNC. Education level, household income, and number of sexual partners were associated with knowledge regarding some common symptoms of HNC. While there is higher knowledge about tobacco as a risk factor for HNC, knowledge about HPV as a risk factor is very low. Similarly, knowledge about HNC symptoms is suboptimal in the Arab American community. Findings support the development of interventions for this community to help improve HNC knowledge and related health outcomes
What is lost in an average? Identifying distinct post-radical prostatectomy functional recovery profiles
No full textOBJECTIVE: To describe, via latent variable mixture modelling, distinct post-radical prostatectomy (RP) patient-reported outcome (PRO) recovery profiles, which are positioned to complement currently disseminated statistical averages for shared decision-making.
PATIENTS AND METHODS: Patients undergoing RP and completing the 26-item Expanded Prostate Cancer Index Composite 12 months after surgery were identified from the Michigan Urological Surgery Improvement Collaborative data registry. Hierarchical cluster analysis and latent variable mixture modelling was applied to urinary incontinence (UI) and sexual function (SF) recovery scores, and final models chosen based on optimal performance.
RESULTS: A total of 3956 patients comprised the study cohort. Three distinct UI profiles were identified with prevalence of 49%, 37% and 14% from best to worst recovery, respectively. Four distinct SF profiles were identified with prevalence of 14%, 24%, 42%, and 20%, from best to worst recovery, respectively. The last two SF profiles had similar function scores but differed based on perception of function being bothersome. Limitations include incomplete PRO capture, which may introduce bias.
CONCLUSIONS: We identify distinct UI and SF recovery profiles and their prevalence from a large, prospectively maintained registry, potentially improving interpretability of PRO data for decision making