Category: Cancer and neoplasms

2023 Most Promising New Product of the Year by The Phoenix: The Medical Device and Diagnostic Conference for Chief Executive Officers TEMPE, Ariz., Oct. 13, 2023 /PRNewswire/ — GT Medical Technologies, Inc. a medical device company dedicated to improving the lives of patients with brain tumors, today announced that its FDA-cleared GammaTile® Therapy was awarded the 2023 Most Promising New Product of the Year by The Phoenix: The Medical Device and Diagnostic Conference for Chief Executive Officers. Continue Reading GammaTile® Therapy was awarded the 2023 Most Promising New Product of the Year Tweet this GT Medical Technologies CEO Matthew Likens accepts the award for GammaTile® Therapy. Awarded the 2023 Most Promising New Product of the Year by The Phoenix: The Medical Device and Diagnostic Conference for Chief Executive Officers. “We are honored to win this prestigious award from our industry peers,” said GT Medical Technologies CEO Matthew Likens. “It’s rewarding to be recognized by the Phoenix Conference as we all work together to help make the lives of our patients better.” GammaTile® Therapy is a Surgically Targeted Radiation Therapy (STaRT) for patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms. GammaTile® Therapy delivers immediate radiation that eradicates brain tumor cells before they can replicate post-surgery while helping to protect healthy brain tissue. GammaTiles are bioresorbable collagen embedded with radioactive seeds, Cesium 131. The award was announced at the 28th Annual Phoenix Conference on Thursday, October 12, 2023, in Half Moon Bay, Calif. GT Medical Technologies’ GammaTile® Therapy joins past winners for Most Promising New Product of the Year, including the Intracept® System by Relievant, FlowTriever by Inari Medical, the Willow Pump by Willow and the Synthetic Cartilage Implant by Cartiva, The Phoenix Awards are presented for outstanding achievements in the medical device and diagnostic industry to individuals and companies selected by industry CEOs. The conference is an invitation-only gathering of executives from large and small healthcare companies to discuss critical issues regarding the medical device industry. Since GammaTile® Therapy received FDA clearance in 2018 for recurrent brain tumors and in 2020 for newly diagnosed tumors, more than 1,000 patients have benefitted from its innovative design that targets any remaining cancer cells after a tumor is surgically removed. About GT Medical Technologies, Inc. Driven to raise the standard of care and improve the lives of patients with brain tumors, a team of brain tumor specialists formed GT Medical Technologies. FDA-cleared GammaTile Therapy is a Surgically Targeted Radiation Therapy (STaRT) for patients undergoing brain tumor removal surgery of newly diagnosed malignant and recurrent brain tumors. This treatment eliminates the need for one to six weeks of daily external beam radiation therapy, allowing patients to go about their daily lives without the burden of additional trips to the hospital or clinic for ongoing treatment. Since its full market release in the United States in March 2020, GammaTile has been offered in more than 95 hospitals, with more centers being added each month. For more information, visit www.gtmedtech.com and follow @GammaTile on Twitter and LinkedIn. Media Contacts: Lori KaganGT Medical Technologies[email protected] Dawn FallonNew Dawn Communications[email protected] SOURCE GT Medical Technologies

When addressing gaps in remote cancer care, older adults with cancer, cancer-related bereavement, oncology provider wellness, and implementation outcomes were identified as areas of concern in need of continued innovation in a digital health setting. Telemedicine chat, telehealth meeting| Image Credit: insta_photos – stock.adobe.com “The spread of digital health and telehealth in cancer care during the COVID-19 pandemic necessitated an overview of the state of this science, to identify gaps in what is known about remote cancer care delivery,” wrote the researchers of the study. “Our scoping review revealed an extensive and recent body of review literature on digital health and telehealth interventions in cancer care.” The meta-analysis study is published in The Lancet Digital Health. An electronic literature search was conducted for systemic reviews from database inception to May 1, 2022, from PubMed, Cumulated Index to Nursing and Allied Health Literature, PsycINFO, Cochrane Reviews, and Web of Science. Eligibility criteria of reviews included exposure to cancer, whether as a patient, survivor, at risk for the disease, care giver, or health care provider, and evaluation of a digital health or telehealth intervention as defined by the US Health Resources and Services Administration. A total of 1196 records were screened. After exclusion, 134 systemic reviews were included in the analysis. Of these records, 128 reviews summarized interventions intended for patients, 18 addressed family caregivers, and 5 addressed health care providers. Fifty-sixreviews did not target a specific phase of the cancer continuum, compared with 48 reviews that addressed the active treatment phase. The reviews in the analysis included 128 (95.5%) patients, 18 family members (13.4%), and 5 (3.7%) health care personnel. Cancer types covered were brain (0.7%), breast (12.7%), colorectal (3.7%), gynecological (5.2%), hematological (3%), lung (2.2%), prostate (3%), skin (4.5%), and multiple or not specified (70.9%). Telehealth components included synchronous telehealth (58.2%), text messaging or short messaging service (27.6%), email or secure messaging (29.1%), e-Health (64.9%), and mobile application (58.2%). Types of intervention or care included health behavior change (17.9%), psychosocial support or distress management (13.4%), disease detection or management (10.4%), medical decision-making (1.5%), and multiple or not specified (54.5%). Additionally, 29 of these reviews included a meta-analysis and showed positive effects on quality of life, psychological outcomes, and screening behaviors. On the other hand, 83 reviews did not review intervention implementation outcomes. However, when reported, reviews included acceptability (n = 36), feasibility (n = 32), and fidelity outcomes (n = 29). The researchers also noted several gaps in digital cancer care. None of the reviews specifically addressed older adults with cancer, cancer-related bereavement, or sustainability of interventions. Furthermore, only 2 reviews compared telehealth with in-person interventions. The researchers acknowledged some limitations to the study. First, the review was a scoping review of reviews, in which identified gaps in the literature only established that a review was not identified in any given area of remote cancer care and may not be generalized in primary literature. Furthermore, the researchers did not include patient information that may be important when evaluating health equity, such as race and ethnicity, as well as rurality. Despite these limitations, the researchers believe this study was able to summarize existing literature on digital health and telehealth interventions across cancer care, as well as identify possible gaps in remote cancer care. “Establishing the state of the science in these areas with high-quality reviews might help guide continued innovation in remote care delivery, particularly for older adults and bereaved families, and support the integration and sustainability of these interventions within standard oncology practice,” wrote the researchers. “This work will support continued growth in the reach and effects of digital health and telehealth interventions to reduce cancer risk and improve cancer care for all individuals.” Reference Shaffer KM, Turner KL, Siwik C, et al. Digital health and telehealth in cancer care: a scoping review of reviews. Lancet Digit Health. 2023;5(5):e316-e327. doi:10.1016/S2589-7500(23)00049-3

The use of a consensus-based preoperative risk stratification algorithm has been shown to significantly decrease unnecessary oophorectomies for benign ovarian neoplasms in pediatric patients, according to a study published in JAMA. Surgeon holding scalpel near ovary | Image Credit: shidlovski – stock.adobe.com The preoperative risk assessment algorithm can identify ovarian lesions with a strong likelihood of being non-cancerous and suitable for ovary-preserving surgery. According to the study authors, the adoption of such an algorithm has the potential to mitigate the risk of unnecessary oophorectomy—the surgical removal of one or both ovaries, also referred to as ovariectomy—during adolescence and subsequent lifelong consequences of the procedure. Additional research is required to investigate the obstacles that may hinder compliance with this algorithm. The study was conducted across 11 children’s hospitals in the United States, including 519 patients aged between 6 and 21 years with a median (IQR) age of 15.1 (13-16.8) years. The intervention consisted of 3 phases: 6 months of preintervention assessment, followed by 6 months of intervention adoption, and 18 months of active intervention. There were 96 children included in the preintervention phase, 105 in the adoption phase, and 318 in the intervention phase. The intervention adoption group was excluded from statistical comparisons. Nearly all children had a benign neoplasm, present in 93 (96.9%) children in the preintervention cohort and 298 (93.7%) in the intervention cohort. The study demonstrated a substantial decrease in unnecessary oophorectomies during the intervention phase, with a notable absolute reduction of 7.7% (95% CI, 0.4%-15.9%; P = .03). While 15 of the 93 (16.1%) children with a benign neoplasm in the preintervention group received an unnecessary oophorectomy, only 25 of 298 (8.4%) children underwent the surgery during the intervention period. The algorithm’s test performance in identifying benign lesions showed a sensitivity of 91.6% (95% CI, 88.5%-94.8%) and a specificity of 90.0% (95% CI, 76.9%-100%), underlining its accuracy in distinguishing between benign and malignant cases. The researchers also noted a positive predictive value of 99.3% (95% CI, 98.3%-100%) and a negative predictive value of 41.9% (95% CI, 27.1%-56.6%). During the intervention phase, there was a misclassification rate of 0.7%, referring to instances where malignant disease was mistakenly treated with ovary-sparing surgery. The algorithm demonstrated a strong adherence rate of 95.0% during this phase, indicating surgeons’ willingness to adhere to the algorithm, though the lower fidelity level of 81.8% suggests there were obstacles hindering complete implementation. “Adherent cases with incomplete fidelity with the algorithm were often due to a discrepancy between the initial and final interpretations of imaging,” the authors noted. “Additionally, many patients had an incomplete panel of tumor marker data available, which may have resulted from clinicians not having certain tumor markers evaluated based on clinical judgment.” On this note, the authors said further investigation is needed to explore ways to enhance algorithm implementation for the benefit of a larger patient population. For example, a notable finding was that among the 25 unnecessary oophorectomies during the intervention phase, 9 occurred in patients with suspected torsion. According to the authors, this implies that improved adherence to the algorithm’s directives for detorsion and the thorough completion of preoperative risk stratification, followed by a definitive procedure, could potentially further decrease the incidence of unnecessary oophorectomies. A short list of limitations was included in the study. First, the clinical practices at the participating sites started evolving during the study’s planning phase, which led to a reduction in the anticipated percentage of unnecessary oophorectomies from an expected 27% to 16% in the preintervention cohort. Second, this study was conducted exclusively at tertiary children’s hospitals with pediatric surgical subspecialists, which may limit the broader generalizability of the results. Reference Minneci PC, Bergus KC, Lutz C, et al. Reducing unnecessary oophorectomies for benign ovarian neoplasms in pediatric patients. JAMA. 2023;330(13):1247-1254. doi:10.1001/jama.2023.17183

ROCKVILLE, Md. and SUZHOU, China, Oct. 12, 2023 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved a global pivotal registrational Phase III study designed to evaluate a key drug candidate in Ascentage Pharma’s pipeline, Bcl-2 inhibitor APG-2575 (Lisaftoclax), in combination with the Bruton’s tyrosine kinase (BTK) inhibitor acalabrutinib, versus immunochemotherapy in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), aiming to validate the combination regimen as a first-line treatment for CLL/SLL. This approval marks another major milestone in the clinical development of the drug candidate following the clearance from the US Food and Drug Administration (FDA) in August 2023 for the global registrational Phase III study in patients with CLL/SLL who have received prior therapies. This global multi-center, randomized-controlled, open-label, pivotal Phase III confirmatory trial (APG2575CC301) is designed to evaluate the efficacy and safety of APG-2575 (lisaftoclax) combined with acalabrutinib versus immunochemotherapy in treatment-naïve patients with CLL/SLL. CLL/SLL is a hematologic malignancy caused by mature B-cell neoplasms. It primarily affects older populations and is among the most common leukemia subtypes in adults, accounting for a quarter of all leukemia cases in the Western World, with over 100,000 new diagnoses reported globally each year1. In China, CLL/SLL is occurring at a rapidly rising incidence rate, with a younger age of onset and higher aggressiveness2, thus posing a serious threat to public health in the country. Advancements in basic research and targeted therapies have brought significant survival benefit to patients with CLL/SLL. However, CLL/SLL still presents major clinical challenges and urgent medical needs for new treatment options that can offer both efficacy and safety. APG-2575 (Lisaftoclax) is a novel, orally administered small-molecule Bcl-2 selective inhibitor being developed by Ascentage Pharma to treat the patients with malignancies by selectively blocking the antiapoptotic protein Bcl-2 and hence restoring the normal apoptosis process in cancer cells. With strong global best-in-class potential, lisaftoclax is the first Bcl-2 inhibitor in China and the second anywhere globally that has demonstrated compelling clinical activity and entered a pivotal registrational study. At present, lisaftoclax is being evaluated in multiple clinical studies across the world and more than 300 patients with CLL/SLL have already been treated with the drug either as a monotherapy or in combinations. Interim results suggest that lisaftoclax offers potent efficacy to patients with CLL/SLL and has the potential as a safe, efficacious, and convenient treatment option. The preliminary results from a global Phase II study have already showed therapeutic potential of lisaftoclax in combination with acalabrutinib, with an objective response rate (ORR) of 98% in patients with relapsed/refractory (R/R) CLL/SLL, an ORR of 100% in treatment-naïve patients with CLL/SLL, and an excellent safety profile that is on par with that of lisaftoclax monotherapy. In the study, lisaftoclax was initiated on a daily ramp-up that simplified the dosing schedule and allowed patients receive the treatment dose more quickly3. Moreover, the study adopted a dosing regimen that was improved on that of existing Bcl-2 inhibitor plus BTK inhibitor combinations as it eliminated the lead-in for the BTK inhibitor, thus allowed patients to begin receiving the combination therapy more quickly. Those results were being released as an Oral Presentation at the 2022 American Society of Hematology (ASH) Annual Meeting. “In earlier studies, lisaftoclax combined with acalabrutinib has already demonstrated impressive efficacy and safety, validating the combination regimen’s therapeutic potential and its promise as a patient-centric treatment strategy,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “We are very encouraged by this approval for the global registrational Phase III study of lisaftoclax combined with acalabrutinib. In terms of the dose ramp-up schedule for the Bcl-2 inhibitor and no lead-in of the BTK inhibitor, this trial adopts an innovative and optimized dosing regimen that is more convenient and allows for a faster onset of actions compared to studies of similar combinations. Fulfilling our mission of addressing unmet clinical needs in China and around the world, we will vigorously advance those clinical programs of lisaftoclax to expedite the drug’s journey to market for the benefit of more patients.” References 1. Yao, Y., Lin, X., Li, F. et al. The global burden and attributable risk factors of chronic lymphocytic leukemia in 204 countries and territories from 1990 to 2019: analysis based on the global burden of disease study 2019. BioMed Eng OnLine 21, 4 (2022). https://doi.org/10.1186/s12938-021-00973-6 2. 刘澎. 复旦大学附属中山医院慢性淋巴细胞白细胞/小淋巴细胞淋巴瘤诊疗规范（v1.2018）[J].中国临床医学, 2018, 25(1). 3. Davids M, Chanan-Khan A, Mudenda B, et al. Lisaftoclax (APG-2575) Safety and Activity As Monotherapy or Combined with Acalabrutinib or Rituximab in Patients (pts) with Treatment-Naïve, Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (R/R CLL/SLL): Initial Data from a Phase 2 Global Study. Blood (2022) 140 (Supplement 1): 2326–2328. 4. Ailawadhi S, Chen Z, Huang B, Paulus A, Collins MC, Fu LT, Li M, Ahmad M, Men L, Wang H, Davids MS, Liang E, Mekala DJ, He Z, Lasica M, Yannakou CK, Parrondo R, Glass L, Yang D, Chanan-Khan A, Zhai Y. Novel BCL-2 Inhibitor Lisaftoclax in Relapsed or Refractory Chronic Lymphocytic Leukemia and Other Hematologic Malignancies: First-in-Human Open-Label Trial. Clin Cancer Res. 2023 Jul 5;29(13):2385-2393. About Ascentage Pharma Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK. Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company

Patients with essential thrombocythemia and polycythemia vera (PV) who also had arterial hypertension experienced a higher cumulative incidence of thrombotic adverse effects (AEs) compared with those without hypertension and fewer thrombotic complications following treatment with renin‑angiotensin system (RAS) inhibitors, according to findings from a retrospective study published in Annals of Hematology. In the overall cohort of patients with myeloproliferative neoplasms (MPNs; n = 404), treatment with RAS inhibitors conferred a protective effect from thrombotic AEs (HR, 0.46; 95% CI, 0.21-0.98; P = .04), including those with a thrombotic high-risk score (n = 272; HR, 0.49; 95% CI, 0.24-1.01; P = .04). Moreover, patients with essential thrombocythemia and a thrombotic high-risk score experienced an especially defined benefit following treatment with RAS inhibitors (HR, 0.27; 95% CI, 0.07-1.01; P = .03). “The main goal of managing MPNs is to prevent thrombotic incidents,” study authors wrote. “The results indicated that patients [with MPNs] had a significantly higher risk [4.9-fold] of arterial thrombosis than the healthy controls. We found a protective association between the use of RAS inhibitors and the reduction in thrombotic AEs in our cohort of patients [with MPNs].” To conduct their study, investigators collected data from patients diagnosed with PV or essential thrombocythemia by WHO 2016 classification who were treated at the Hematology Unit of the Businco Hospital in Cagliari, Italy, from November 2000 through August 2021. Patients with PV were stratified by low risk of developing thrombosis (age < 60 years and no history of thrombosis) and high risk of developing thrombosis (age ≥ 60 years or a history of thrombosis). Patients with essential thrombocythemia were stratified by International Prognostic Score for Essential Thrombocythemia score, cardiovascular risk factors, age over 60 years, thrombosis history, and the presence of a JAK2 V617F mutation. Study authors also collected clinical data at the time of diagnosis, including constitutional symptom, performance status, hemoglobin, white blood cell counts, and the presence of somatic driver gene mutations among other data. Patients had PV (n = 133) or essential thrombocythemia (n = 271). The median age at diagnosis was 63 years (range, 17-98) and the median follow-up was 5.5 years (range, 0-24) in the overall population. Most patients had comorbidities at diagnosis (70%) and a high thrombotic risk score (67.3%). Cardiovascular AEs experienced before (66.3%) MPN diagnosis included ischemic heart disease (7.7%), peripheral arterial disease (3.5%), cerebrovascular event (6.9%), atrial fibrillation (6.2%), deep vein thrombosis (4.7%), and other (4.2%); after diagnosis, thrombotic AEs (15.0%) that occurred were ischemic heart disease (3.5%), peripheral arterial disease (2.9%), cerebrovascular event (3.7%), and deep vein thrombosis (4.4%). Advertisement Most patients also had a positive mutational status (89.3%), including mutations in JAK2 V617F (78.5%), calreticulin (8.9%), and MPL (1.5%); 48.2% of patients also had essential thrombocythemia JAK2 V617F positivity. The therapies received for MPNs were low-dose aspirin (72.3%), phlebotomy (30.0%), cytoreduction therapy (62.9%), and IFN-2a (0.2%). Median values were 10.5 × 103 /μL (range, 1.0-96.1) for leukocytes, 15.0 g/dL (range, 7.0–15.0) for hemoglobin, and 696 × 103/μL (range, 87–2320) for platelets. Median hematocrit was 48% (range, 29.0%-77.0%). Investigators noted that “there was a significant difference in the JAK2 V617F mutation status within the group of patients [with essential thrombocythemia] with hypertension (27% vs 21.2%, P = .01).” Most patients in the study had hypertension (53.7%) and in this subgroup, patients had PV (n = 78/217) and essential thrombocythemia (n = 139/217). Those with positive mutational status (n = 197/217) had JAK2 V617F (n = 182/217), calreticulin (n = 12/217), MPL (n = 3/217), and essential thrombocythemia– positive JAK2 V617F (n = 109/217) mutations. Median values were 10.9 × 103/μL (range, 1.09-19.2) for leukocytes, 15.2 g/dL (range, 10.4-21.0) for hemoglobin, and 720 × 103/μL (139–1170) for platelets. Median hematocrit was 47.6% (range, 33.1%-69.0%). The majority of patients with hypertension had cardiovascular AEs before being diagnosed with an MPN (n = 216/217) including ischemic heart disease (n = 20/217), peripheral arterial disease (n = 7/217), cerebrovascular event (n = 19/217), atrial fibrillation (n = 15/217), deep vein thrombosis (n = 11/217), and other (n = 9/217); after diagnosis, 39 patients experienced thrombotic AEs; these included ischemic heart disease (n = 10/217), peripheral arterial disease (n = 6/217), cerebrovascular event (n = 12/217), and deep vein thrombosis (n = 11/217). Additionally, patients with hypertension underwent prior hypertension therapy with a RAS inhibitor (n = 147/217) including angiotensin receptors blockers (n = 87/217), angiotensin-converting enzyme inhibitors (n = 59/217), and inhibitors without association (n = 116/217). Calcium antagonists were given to 52 patients and other agents including thiazide diuretics, beta-blockers, and doxazosin were given to 101 patients. Patients with hypertension also received treatment with low-dose aspirin (148/217), phlebotomy (70/217), cytoreduction therapy (159/217) and IFN-2a (1/217) as therapy for their MPN. Additional findings showed that the cumulative incidence of thrombotic AEs over 15 years was significantly higher among patients with hypertension (66.8% ± 10.3%) compared with those without (38.5% ± 8.4%; HR, 1.83; 95% CI, 1.08-3.1). Findings from a multivariate analysis also revealed that hypertension (HR, 1.8; 95% CI, 0.983-3.550; P = .05) and PV diagnosis (HR, 3.5; 95% CI, 1.928-6.451; P < .001) were both associated with an increased risk of developing thrombotic AEs. Considering only patients with MPNs and hypertension, diagnosis of PV displayed a predictive role in developing thrombotic AEs (HR, 4.4; 95% CI, 1.92-10.09; P < .01). “In conclusion, to improve the treatment of patients with MPNs, it is crucial to pay close attention to their cardiovascular risk factors, as these factors play a significant role in the complications of the disease. A more targeted approach could provide more effective and personalized care for patients with MPNs. Although the study’s retrospective nature poses limitations, the robust connections between the RAS system and hematological disorders make it crucial to conduct a more comprehensive analysis of the effects of RAS inhibitors on MPNs,” investigators wrote in summary. Reference Mulas O, Mola B, Costa A, et al. Renin-angiotensin inhibitors reduce thrombotic complications in essential thrombocythemia and polycythemia vera patients with arterial hypertension. Ann Hematol. Published

A study on overall survival after Mohs micrographic surgery (MMS) for early-stage Merkel cell carcinoma (MCC) found MMS was associated with significant improvement compared with survival in patients who underwent conventional wide local excision (WLE). This national retrospective cohort study was published in JAMA Dermatology. The authors limited their analysis to Tumor 1/Tumor 2 (T1/T2) MCC because these tumors are more amenable to any surgical approach. “For those with localized disease, it is generally accepted that surgery is the most effective definitive treatment option,” they explained. “However, there is some controversy as to the optimal surgical approach for these cases.” MCC is a rare type of skin cancer with a propensity to rapidly metastasize to regional lymph nodes, in which current National Comprehensive Cancer Network guidelines recommend sentinel lymph node biopsy. This study compared the use of MMS with WLE to assess overall survival in patients with localized MCC with pathologically confirmed negative lymph nodes. Doctor screening a patient for skin cancer. The study included data from the National Cancer Database (NCDB) in adults with T1/T2 MCC who were diagnosed from January 1, 2004, to December 31, 2018, who had been treated with surgery. A total of 22,610 patients were identified. Patients were excluded if they had positive lymph node disease, were missing data on clinical lymph node status, had clinically negative distant metastatic disease, were not treated with surgical excision, without T1/T2 disease, and did not have confirmed pathologically negative lymph node(s). Furthermore, patients were excluded if they had other nonkeratinocyte malignant neoplasms or were diagnosed after 2019 because of a lack of survival data on these patients. Advertisement After exclusion, 2313 patients were met all inclusion criteria. The mean (SD) age of patients was 71 (10.6) years, with 1340 (57.9%) of them men. The statistical analysis showed excision with MMS had the best unadjusted survival, with mean (SE) survival rates of 87.4% (3.4%) at 3 years, 84.5% (3.9%) at 5-years, and 81.8% (4.6%) at 10 years compared with WLE, which had mean (SE) survival rates of 86.1% (0.9%) at 3 years, 76.9% (1.2%) at 5-years, and 60.9% (2%) at 10 years. Additionally, similar results were observed in patients who received narrow-margin excision, with mean (SE) survival rates of 84.8% (1.4%) at 3 years, 78.3% (1.7%) at 5 years, and 60.8% (3.6%) at 10 years. Multivariable survival analysis showed excision with MMS was associated with significant improved survival outcomes compared with WLE (hazard ratio [HR], 0.59; 95% CI, 0.36-0.97; P = .014). Furthermore, high-volume MCC centers were significantly more likely to use MMS over WLE compared with other centers (odds ratio [OR], 1.99; 95% CI, 1.63-2.44; P < .001) However, the researchers acknowledged some limitations to the study, such as being unable to collect data on locoregional recurrence of disease specific survival, the analysis was not controlled for patient immunosuppression status, and the MSS group had much fewer patients than in the WLE group. Furthermore, the researchers believe that further studies need to be done, given the lack of randomization and potential for selection bias. “These data suggest that MMS may provide a survival benefit in the treatment of localized MCC, although further prospective work studying this issue is required,” wrote the researchers. “Future directions may also focus on elucidating the benefit of adjuvant radiotherapy in localized cases treated with MMS.” Despite these limitations, the study shows the use of MMS may be a better treatment option for patients with early-stage MCC with pathologically confirmed negative regional lymph node disease, compared with WLE. Reference Cheraghlou S, Doudican NA, Criscito MC, Stevenson ML, Carucci JA. Overall survival after Mohs surgery for early-stage Merkel cell carcinoma. JAMA Dermatology. Published online August 23, 2023. doi:10.1001/jamadermatol.2023.2822

NEWTON, Mass., Sept. 5, 2023 /PRNewswire/ — Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Company’s senior management team will participate in the following investor conferences in September: H.C. Wainwright 25th Annual Global Investment ConferenceFormat: Podium presentationDate: Monday, September 11, 2023Time: 12:30 p.m. ET Morgan Stanley 21st Annual Global Healthcare ConferenceFormat: Fireside chatDate: Tuesday, September 12, 2023Time: 5:30 p.m. ET Baird 2023 Global Healthcare ConferenceFormat: Fireside chatDate: Wednesday, September 13, 2023Time: 2:00 p.m. ET A live webcast of the presentation and fireside chats, along with accompanying slides, can be accessed under “Events & Presentations” in the Investor section of the Company’s website, http://investors.karyopharm.com/events-presentations, and will be available for replay for 90 days following each presentation. About Karyopharm Therapeutics Karyopharm Therapeutics Inc. (Nasdaq: KPTI) is a commercial-stage pharmaceutical company pioneering novel cancer therapies. Since its founding, Karyopharm has been an industry leader in oral Selective Inhibitor of Nuclear Export (SINE) compound technology, which was developed to address a fundamental mechanism of oncogenesis: nuclear export dysregulation. Karyopharm’s lead SINE compound and first-in-class, oral exportin 1 (XPO1) inhibitor, XPOVIO® (selinexor), is approved in the U.S. and marketed by the Company in three oncology indications and has received regulatory approvals in various indications in a growing number of ex-U.S. territories and countries, including Europe and the United Kingdom (as NEXPOVIO®) and China. Karyopharm has a focused pipeline targeting multiple high unmet need cancer indications, including in multiple myeloma, endometrial cancer, myelodysplastic neoplasms and myelofibrosis. For more information about our people, science and pipeline, please visit www.karyopharm.com, and follow us on Twitter at @Karyopharm and LinkedIn. SOURCE Karyopharm Therapeutics Inc.

Hypovitaminosis D, or too little vitamin D, is fairly common in patients with systemic lupus erythematosus (SLE) and is linked with high inflammatory activity and decline in bone mineral density (BMD), according to study findings published in Lupus Science and Medicine. Status of vitamin D was not linked with patient age or disease course. Vitamin D deficiency in patients with SLE is known to be linked with decreased BMD, but scientific information on the relationships between vitamin D level and markers of bone turnover, disease duration, and glucocorticoid (GC) therapy is limited. sun in a blue sky with clouds Researchers aimed to ascertain vitamin D levels in patients with SLE and analyze their relationship to BMD and the disease course. They hypothesized that vitamin D deficiency and insufficiency is widespread among patients with SLE and might be linked with long-term use of GCs and sunscreens, kidney damage, vitamin D antibody presence, and more. A total of 101 patients with SLE and 29 people in the control group were included in the study. Study participants were tested for vitamin D level, erythrocyte sedimentation rate (ESR), C reactive protein (CRP), IL-6, osteocalcin (OC), and collagen type I C-terminal telopeptide (CTX), and dual-energy X-ray absorptiometry was performed to evaluate BMD in the lumbar spine and hip. The mean (SD) serum vitamin D level was 18.98 (0.88) ng/mL, and women possessed 25.42% lower vitamin D levels than men (P < .05). No correlation was observed between vitamin D levels and cumulative dose of GCs (r = ­­–0.26) and serum inflammatory markers, especially CRP (r =­–0.39). IL-6 (r = –0.37) and ESR (r =–0.15). Vitamin D level was linked with bone turnover markers (BTMs). In women of reproductive age with vitamin D deficiency, BMD of the lumbar spine and the hip was 9.5% to 23.1% greater than in those with no vitamin deficiency, respectively, and the mean lumbar spine Z-score in those with vitamin D insufficiency and deficiency was 2.0 and 2.9 times lower, respectively, than in patients with normal vitamin D level. Advertisement “Although the lowest 25(OH)D level was found in the group with the shortest disease duration, in general, the levels of the vitamin tested had no associative relation to disease duration,” explained the researchers. Additionally, the literature data also presented no correlation between disease duration and vitamin D levels. The researchers also found a strong associative inverse correlation (r = –0.26) of cumulative dose of GCs with vitamin D levels, so in the group of patients with a cumulative dose of GCs greater than 42.8 g, the average vitamin D level was 31.7% lower than in the patient group with a cumulative dose less than 42.8 g. The proportion of people in the high-dose GC group with vitamin D deficiency was 72.5%, while it was 52% in the low-dose GC group. “Another pathogenetic factor adversely affecting vitamin D levels in patients with SLE is the systemic inflammatory process,” said the researchers. Correlation analyses uncovered more evidence that the lowered 25(OH)D level is linked with inflammatory activity. Since excessive autoantibody synthesis by B lymphocytes is a main element in pathogenesis of multiple autoimmune diseases, especially SLE, it can be determined that vitamin D influence on B cells causes inhibition of autoantibody synthesis. “Thus, it is obvious that vitamin D can regulate at least some immune reactions, and its role is predominantly anti-inflammatory, which helps to prevent hyperinflammation and autoimmunity,” continued the researchers. The researchers noted that all mechanisms of a relationship between SLE activity, vitamin D levels, BMD, and bone synthesis markers and resorption are not specifically known and need further investigation. This study had some limitations. First, it was undertaken with only 1 measurement of serum 25 (OH)D levels, and it included mostly patients with high inflammatory activity. “Hypovitaminosis D was associated with high inflammatory activity (SLEDAI, ESR, CRP, IL-6), severity of organ damage (DI), cumulative dose of GCs, BTMs (OC, CTX) and BMD. Vitamin D status was not associated with the patient’s age or disease duration,” concluded the researchers. Reference Shevchuk S, Marynych L, Malovana T, Denyshchych L. Vitamin d level in patients with systemic lupus erythematosus: its relationship to disease course and bone mineral density. Lupus Sci Med. Published online August 9, 2023. doi:10.1136/lupus-2023-000968

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There is insufficient evidence that probiotics prevent Clostridioides difficile infection (CDI) in older hospitalized patients taking antibiotics, according to a study published in Frontiers in Medicine. The researchers noted that CDI is most prevalent in older patients receiving broad-spectrum antibiotics, nursing home residents, and hospitalized older patients. They explained that intestinal microbiota disruption, particularly in older adults, is a significant risk factor for CDI, as the microbiota protect against pathogenic bacteria. A patient’s intestinal microbiota balance could be disturbed by various factors, including antibiotic therapy exposure and the natural aging process. Despite this, the current standard therapeutic measure is antibiotic therapy, which the researchers noted increases the recurrence risk of infection. Because of this, probiotics are emerging as a potential alternative preventive and therapeutic strategy for managing gastrointestinal conditions like diarrhea. Some past studies found positive effects of probiotics on patients with CDI, while others found that probiotics were ineffective. Consequently, the researchers conducted a review to find a more definitive consensus on whether probiotics prevent CDI by reviewing more recent studies. The researchers conducted their search between September 2021 and January 2022, limiting their search to English studies published between 2011 and 2021 across databases PubMed, the Web of Science, and Scopus using specific keyword combinations. Advertisement They included studies with clinical and cohort trials that addressed the effect of probiotic microorganism intervention in preventing CDI in older adults using a concurrent or retrospective control group that received no treatment or only a placebo; studies with outcomes like watery stools, stool consistency, self-reported diarrhea, and physician-defined diarrhea were also included in this analysis. On the other hand, the researchers excluded articles not available in full, dissertations, review articles, letters, opinions, commentaries, and reviews. The researchers categorized data from the studies analyzed based on their respective publications, research objectives, study types, and levels of evidence. They also recorded study population demographics, sample sizes, outcome variables, probiotics used, and the dose administered. The researchers narrowed their population by grading each article “according to its level of evidence and assessed for study quality in the domains of sample selection, analysis of exposures and outcomes, and data analysis.” Digestive system | Image credit: sdecoret – stock.adobe.com Through their literature search, the researchers found 7 eligible studies, 3 of which were conducted in the United States, 2 in the United Kingdom, 1 in Denmark, and 1 in Japan. Each study’s population consisted of hospitalized patients. The mean age of the probiotic group was 74.8 years and the mean age of the placebo group was 74.6 years (P = .693). Three studies demonstrated that older patients using probiotics could decrease CDI. The studies evaluated a variety of probiotic strains, but Saccharomyces boulardii was found to be most beneficial as it “can produce a protease that inactivates the receptor site for C difficile toxin A, conferring biological plausibility to its use in CDI.” Despite this, the researchers did not find consensus among all studies analyzed that probiotic use could decrease CDI. The researchers noted several limitations to their study, including possible selection biases. They mostly reviewed retrospective cohort studies, meaning the results of the included clinical trials may not apply to the general population due to their strict eligibility criteria. Because of the study’s limitations and insufficient findings, the researchers explained that more evidence is needed to prove that probiotics prevent CDI in older, hospitalized patients taking antibiotics. In terms of future research, they concluded that “robust clinical studies that include the S boulardii strain are needed to address the scientific and clinical gaps on the potential protective effect of probiotics on CDI.” Reference Barbosa MLL, Albano MO, Martins CDS, Warren CA, Brito GAC. Role of probiotics in preventing Clostridioides difficile infection in older adults: an integrative review. Front Med (Lausanne). 2023;10:1219225. doi:10.3389/fmed.2023.1219225