Diagnostic Algorithm Research Articles

Treponema Pallidum rapid syphilis compared diagnostic algorithm syphilis in men who have sex with men (MSM).

Syphilis infection can be asymptomatic and difficult to diagnose based on clinical symptoms. Early detection and treatment are critical for preventing and controlling syphilis as well as long-term serious complications. A serological examination based on the diagnostic algorithm was used to confirm the diagnosis of syphilis. Syphilis is frequent in high-risk groups, such as men who have sex with men (MSM). Treponema pallidum (TP) rapid can be used for early syphilis detection. The diagnostic value of TP rapid with diagnostic algorithm (RPR-TPHA) utilizing whole blood in MSM should be studied. To determine the diagnostic value of TP rapid syphilis test compared to a diagnostic algorithm (RPR-TPHA) among MSM. A diagnostic test with a cross-sectional design at Dr Mohammad Hoesin Palembang General Hospital from November 2022 to January 2023. The sampling method was consecutive sampling with a total sample of 83 MSM based on inclusion and exclusion criteria. All samples were tested for RPR, TPHA, and TP rapid. The diagnostic value of TP rapid was evaluated with RPR-TPHA as a diagnostic algorithm for syphilis. The sensitivity and specificity value of the TP rapid compare diagnostic algorithm as gold standard were 95.8% and 96.6% respectively. Other metrics: positive predictive value (PPV) 92%, negative predictive value (NPV) 98%, positive likelihood ratio (PLR) 28.27, negative likelihood ratio (NLR) 0.04, accuracy 96% and AUC 0.962. The TP rapid test has a high diagnostic value and can be used to establish an early diagnosis of syphilis in MSM.

Estimating the Proportion of People Living With HIV Who May Benefit From the Reverse Algorithm for the Diagnosis of Incident Syphilis.

Among 8455 people engaged in HIV care in 4 US cities, 4925 (58%) had treponemal testing at care entry. Of the 4925 tested, 3795 (77%) had a nonreactive result and might benefit from the reverse algorithm for a future incident syphilis diagnosis. Furthermore, low-barrier treponemal testing as a first step in the reverse algorithm may increase syphilis screening and decrease time to treatment.

ПРИОБРЕТЕННАЯ ГЕМОФИЛИЯ А В РЕАЛИЯХ СОВРЕМЕННОЙ МЕДИЦИНЫ: ОПЫТ КЛИНИЧЕСКОЙ ПРАКТИКИ

Abstract. Introduction. Acquired hemophilia A is a rare form of severe coagulopathy with an autoimmune mechanism of development. It occurs due to the formation of circulating inhibitory factor VIII (FVIII) antibodies, which leads to impaired activation of factor X and the occurrence of spontaneous bleeding in patients without previous hemostasis system pathology. In about a half of the cases, FVIII autoantibodies appear in patients without any comorbidities. It should be noted that the average age of patients was 74 years at the time of diagnosis. However, the occurrence of the disease in young women is rare and may be associated with pregnancy and childbirth. Given the rarity of this disease, the management of these patients is a challenging clinical problem. Aim. To describe a clinical case of diagnosis and treatment of a patient with the inhibitor form of acquired hemophilia A (AHA). Materials and Methods. A 38–year–old female patient had acute hemorrhagic syndrome of the hematoma type, manifested by large hematomas in different areas of the body. During the patient’s stay in the hospital, standard lab tests were made, the test results were evaluated over time, and instrumental diagnostics was performed. Results and Discussion. The typical hematoma type of bleeding detected during diagnosing, prolongation of coagulation parameters, presence of factor VIII inhibitor (605 BU), and a decrease in factor VIII level down to 0.5%) verified the AHA diagnosis. Methods of substitution, immunosuppressive therapy, and monoclonal antibodies were successfully used to treat AHA in this patient. The patient is followed up by a hematologist at the place of residence. Hematomas did not recur. Conclusions. This clinical observation demonstrates the peculiarities of the course, diagnostic algorithm, and management of patients with AHA without any concomitant pathology, with a history of only prolonged postpartum uterine bleeding, and with no autoimmune or malignant diseases.

EuroGuiderm guideline on lichen sclerosus-Treatment of lichen sclerosus.

Lichen sclerosus (LS) is an inflammatory skin disease affecting all ages. LS typically involves the anogenital site where it causes itching and soreness; it may lead to sexual and urinary dysfunction in females and males; however, it may be asymptomatic. First signs of LS are usually a whitening of the genital skin, sometimes preceded by redness and oedema; fissuring, scarring, shrinkage and fusion of structures may follow in its course. LS is associated with an increased risk of genital cancer. LS has a huge impact on the quality of life of affected patients, and it is important to raise more awareness of this not uncommon disease in order to diagnose and treat it early. The guideline intends to provide guidance on the diagnostic of LS (part 1), highlight important aspects in the care of LS patients, generate recommendations and treatment algorithms (part 2) on topical, interventional and surgical therapy, based on the latest evidence, provide guidance in the management of LS patients during pregnancy, provide guidance for the follow-up of patients with LS and inform about new developments and potential research aspects. The guideline was developed in accordance with the EuroGuiDerm Methods Manual v1.3 https://www.edf.one/de/home/Guidelines/EDF-EuroGuiDerm.html. The wording of the recommendations was standardized (as suggested by the GRADE Working Group). The guideline development group is comprised of 34 experts from 16 countries, including 5 patient representatives. Ultrapotent or potent topical corticosteroids in females and males, adults and children remain gold standard of care for genital LS; co-treatment with emollients is recommended. If standard treatment fails in males, a surgical intervention is recommended, complete circumcision may cure LS in males. UV light treatment is recommended for extragenital LS; however, there is limited scientific evidence. Topical calcineurin inhibitors are second line treatment. Laser treatment, using various wave lengths, is under investigation, and it can currently not be recommended for the treatment of LS. Treatment with biologics is only reported in single cases. LS has to be diagnosed and treated as early as possible in order to minimize sequelae like scarring and cancer development. Topical potent and ultrapotent corticosteroids are the gold standard of care; genital LS is often a lifelong disease and needs to be treated long-term.

EuroGuiderm guideline on lichen sclerosus-introduction into lichen sclerosus.

Lichen sclerosus (LS) is an inflammatory skin disease affecting all ages. LS typically involves the anogenital site where it causes itching and soreness. It may lead to sexual and urinary dysfunction in females and males; however, it may be asymptomatic. First signs of LS are redness and oedema, typically followed by whitening of the genital skin; sometimes fissuring, scarring, shrinkage and fusion of structures may follow in its course. LS is associated with an increased risk of genital cancer. LS has a huge impact on the quality of life of affected patients, and it is important to raise more awareness of this not uncommon disease in order to diagnose and treat it early. The guideline intends to provide guidance on the diagnostic of LS, highlight important aspects in the care of LS patients (part 1), generate recommendations and treatment algorithms (part 2) on topical, interventional and surgical therapy, based on the latest evidence, provide guidance in the management of LS patients during pregnancy, provide guidance for the follow-up of patients with LS and inform about new developments and potential research aspects. The guideline was developed in accordance with the EuroGuiDerm Methods Manual v1.3 https://www.edf.one/de/home/Guidelines/EDF-EuroGuiDerm.html. The wording of the recommendations was standardized (as suggested by the GRADE Working Group). The guideline development group is comprised of 34 experts from 16 countries, including 5 patient representatives. Ultrapotent or potent topical corticosteroids in females and males, adults and children remain gold standard of care for genital LS; co-treatment with emollients is recommended. If standard treatment fails in males, a surgical intervention is recommended, complete circumcision may cure LS in males. UV light treatment is recommended for extragenital LS; however, there is limited scientific evidence. Topical calcineurin inhibitors are second line treatment. Laser treatment, using various wave lengths, is under investigation, and it can currently not be recommended for the treatment of LS. Treatment with biologics is only reported in single cases. LS has to be diagnosed and treated as early as possible in order to minimize sequelae like scarring and cancer development. Topical potent and ultrapotent corticosteroids are the gold standard of care; genital LS is often a lifelong disease and needs to be treated long-term.

Reproducible and high sample throughput isomiR next-generation sequencing for cancer diagnosis.

e15013 Background: Next-generation sequencing (NGS) can produce up to 6 Tb of data per run with single-nucleotide accuracy, making it ideal for quantifying isomiRs, which encompass both canonical miRNAs and their variants, for clinical applications. However, NGS has poor reproducibility and low sample throughput in quantifying circulating isomiRs due to significant technical variations and the limitations of the multiplex strategy, as evidenced by the fact that no isomiR NGS technique has been successfully used to diagnose cancer. Methods: To address these challenges, a library construction method including a dual unique-dual-index (DUDI) technology was developed. DUDI uses a pair of Inner UDI (IUDI) and outer UDI (OUDI) to label a sample. Twelve independent batches of isomiR NGS were carried out, including three repeated batches. Each batch included 100 gastric cancer and 100 control plasma samples. Batch effect, correlation coefficient (R), and principal component (PCA) analyses were used to evaluate technical reproducibility. Machine learning binary classification was used to assess biological reproducibility, with each pair of batch data serving interchangeably as both training and testing data. Results: In this multicenter study, over 700G of isomiR data were generated from 402 gastric cancer and 498 control samples, with a maximum error rate of 1 in 7 million isomiRs being assigned to wrong samples. The PCA plot indicates high technical reproducibility across the three repeated batches, shown by the extensive intermingling of data points from each batch and the lack of distinct batch-wise clustering. This observation is reinforced by that the R value for each of 239 isomiRs between the repeated batches are close to 1. While the mutual machine learning validations between the repeated batches yielded ~95% accuracy, indicating high biological reproducibility. The accuracies of the validations between the different batches of different samples range from 70% to 82%. The lower accuracy is as expected, given the high genetic heterogeneity of cancer and the small sample size. Furthermore, the IsomiR differentiated expression profiles from the current NGS study closely match those from prior qPCR studies. Conclusions: The DUDI library construction method can produce reproducible high sample throughput NGS data, yet it is cost-effective and straightforward. The maximum number of samples that can be multiplexed in an NGS project is almost one million, i.e., 976 * 976, as IUDI and OUDI can be any of the 976 designed DUDIs. This number far exceeds the high sample throughput requirements of any NGS application. While the capability to distinguish true biological variations of IsomiRs from technical noise, demonstrated by the high technical and biological reproducibility and concordance with the qPCR data, enables the development of robust machine learning algorithms for cancer diagnostics.

Primary central nervous system lymphomas: EHA-ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up.

This EHA-ESMO Clinical Practice Guideline provides key recommendations for managing primary DLBCL of the CNS.The guideline covers clinical, imaging and pathological diagnosis, staging and risk assessment, treatment and follow-up.Algorithms for first-line and salvage treatments are provided.The author group encompasses a multidisciplinary group of experts from different institutions and countries in Europe.Recommendations are based on available scientific data and the authors' collective expert opinion.

Enhancing Tumor Classification Through Machine Learning Algorithms for Breast Cancer Diagnosis

Enhancing Tumor Classification Through Machine Learning Algorithms for Breast Cancer Diagnosis

Gestion des patients avec protéine C réactive élevée après chirurgie colorectale élective : étude pilote sur une attitude diagnostique et thérapeutique proactive (GESPACE)

Study objective. To evaluate the feasibility and benefit of a diagnostic and therapeutic algorithm for management of patients presenting with a high C-reactive protein (CRP) level after colorectal surgery.Patients and methods. Prospective study including patients with CRP > 125 mg/L at the 4th postoperative day following elective colorectal surgery. The protocol involved CT-scan of which the results were to orient subsequent management: antibiotics, radiological drainage, endoscopy or surgical redo. Success (primary endpoint) consisted in the proportion of patients with total duration of hospitalization fewer than 15 days. Secondary endpoints were: applicability of the protocol in real-life conditions, number of stomas created, duration of hospitalization in an intensive care unit.Results. One hundred and six (106) patients were included: 51 patients (48%) presented with postoperative complications, of which 21 (41%) were severe. No death occurred. Among the included patients, 68% had a hospital stay < 15 days. Major deviations from the management algorithm occurred in 38% of cases. Early endoscopy was not applicable. There was no significant difference with regard to the secondary endpoints according to whether or not the protocol was strictly observed.Conclusion. It is necessary to define a protocol for management of patients presenting with high CRP levels after colorectal surgery, the objective being to reduce the impact of complications and to avoid excessive lengthening of hospital stay. The protocol begins with CT-scan, which is to orient subsequent management.

Educating and empowering health care teams who present to the hospital to recognize and intervene on cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) in patients on bispecific t-cell engager therapy (BiTEs): A quality improvement study.

e23212 Background: Treatment of oncologic disease with Bispecific T-Cell Engager antibodies (BiTEs) are an emerging novel immunotherapy with demonstrated efficacy in multiple hematologic malignancies. Notable side effects of BiTE therapy include cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), which can be life-threatening and must be rapidly identified. We aim to fill knowledge gaps surrounding CRS and ICANS for medical providers, particularly considering increased use of BiTE therapy. We hope that educating providers will allow faster recognition and treatment and will improve patient outcomes. Methods: Our study focused on the impact of educational presentations on awareness and identification of CRS/ICANS. Our intervention targeted the residents and attendings in the emergency department and the nurses, advanced practice providers, and hospitalists in the bone marrow transplant (BMT) unit at Stony Brook University Hospital. Anonymous surveys consisting of 9 multiple choice questions were conducted to assess baseline foundational knowledge of CRS/ICANS. QI consisted of a 15-minute educational presentation for both groups. The same surveys were repeated following the presentations to assess improvement in overall knowledge of CRS/ICANS. A two tailed independent T test was used to calculate significance. Results: The average pre-survey score for the emergency department (N = 37) was 39%. The average presurvey score for the BMT department (N = 13) was 45%. Significant improvements in scores after intervention were shown in both the emergency department (39% vs 66%, p = 0.0001) and the BMT department (45% vs 68%, p = 0.0006). Conclusions: Education among emergency department and hospitalist providers is essential in improving management of CRS and ICANS in patients treated with BiTEs. This quality improvement initiative confirmed a knowledge gap in CRS and ICANS amongst our healthcare teams. By providing educational resources to both departments, there was a significant improvement in this gap. Future directions for continued improvement in the detection and management of CRS/ICANS include patient medication identification cards, a central repository of treatment protocols, algorithms, and toxicities associated with BiTEs, and expanding our educational curriculum which are all currently under development at Stony Brook University Hospital.

Staying in the Game: Interventions for Managing Achilles Tendinopathy in the In-Season Athlete.

Achilles tendinopathy is a common overuse injury that is traditionally managed with activity modification and a progressive eccentric strengthening program. This narrative review describes the available evidence for adjunctive procedural interventions in the management of midportion and insertional AT, specifically in the athletic population. Safety and efficacy data from available literature on extracorporeal shockwave therapy, platelet-rich plasma, high-volume injectate with or without tendon scraping, and percutaneous needle tenotomy are used to propose an algorithm for treatment of Achilles tendinopathy for the in-season athlete.

MVCNet: Multiview Contrastive Network for Unsupervised Representation Learning for 3-D CT Lesions.

With the renaissance of deep learning, automatic diagnostic algorithms for computed tomography (CT) have achieved many successful applications. However, they heavily rely on lesion-level annotations, which are often scarce due to the high cost of collecting pathological labels. On the other hand, the annotated CT data, especially the 3-D spatial information, may be underutilized by approaches that model a 3-D lesion with its 2-D slices, although such approaches have been proven effective and computationally efficient. This study presents a multiview contrastive network (MVCNet), which enhances the representations of 2-D views contrastively against other views of different spatial orientations. Specifically, MVCNet views each 3-D lesion from different orientations to collect multiple 2-D views; it learns to minimize a contrastive loss so that the 2-D views of the same 3-D lesion are aggregated, whereas those of different lesions are separated. To alleviate the issue of false negative examples, the uninformative negative samples are filtered out, which results in more discriminative features for downstream tasks. By linear evaluation, MVCNet achieves state-of-the-art accuracies on the lung image database consortium and image database resource initiative (LIDC-IDRI) (88.62%), lung nodule database (LNDb) (76.69%), and TianChi (84.33%) datasets for unsupervised representation learning. When fine-tuned on 10% of the labeled data, the accuracies are comparable to the supervised learning models (89.46% versus 85.03%, 73.85% versus 73.44%, 83.56% versus 83.34% on the three datasets, respectively), indicating the superiority of MVCNet in learning representations with limited annotations. Our findings suggest that contrasting multiple 2-D views is an effective approach to capturing the original 3-D information, which notably improves the utilization of the scarce and valuable annotated CT data.

Overuse of antibiotics for urinary tract infections in pregnant refugees, Lebanon.

To determine whether adding urine culture to urinary tract infection diagnosis in pregnant women from refugee camps in Lebanon reduced unnecessary antibiotic use. We conducted a prospective, cross-sectional study between April and June 2022 involving pregnant women attending a Médecins Sans Frontières sexual reproductive health clinic in south Beirut. Women with two positive urine dipstick tests (i.e. a suspected urinary tract infection) provided urine samples for culture. Bacterial identification and antimicrobial sensitivity testing were conducted following European Committee on Antimicrobial Susceptibility Testing guidelines. We compared the characteristics of women with positive and negative urine culture findings and we calculated the proportion of antibiotics overprescribed or inappropriately used. We also estimated the cost of adding urine culture to the diagnostic algorithm. The study included 449 pregnant women with suspected urinary tract infections: 18.0% (81/449) had positive urine culture findings. If antibiotics were administered following urine dipstick results alone, 368 women would have received antibiotics unnecessarily: an overprescription rate of 82% (368/449). If administration was based on urine culture findings plus urinary tract infection symptoms, 144 of 368 women with negative urine culture findings would have received antibiotics unnecessarily: an overprescription rate of 39.1% (144/368). The additional cost of urine culture was 0.48euros per woman. A high proportion of pregnant women with suspected urinary tract infections from refugee camps unnecessarily received antibiotics. Including urine culture in diagnosis, which is affordable in Lebanon, would greatly reduce antibiotic overprescription. Similar approaches could be adopted in other regions where microbiology laboratories are accessible.

Specific Features of Diagnostic and Treatment Tactics in Patients with Crushed Abdominal Hernias Without Resection of a Hollow Organ.

The purpose of the work is to analyze the results of the use of optimized diagnostic and therapeutic tactics in patients with strangulated abdominal hernias without resection of the hollow organ. Materials and methods: The work is based on the analysis of the results of surgical treatment of 665 patients with strangulated abdominal hernias without resection of the hollow organ, who were divided into 2 groups depending on the features of the diagnostic and treatment tactics. Unlike the patients of group 1, the following diagnostic tactics were used in group 2: substantiated laparoscopic diagnosis of abdominal organs; mandatory biochemical assessment of hernia water; mandatory intraoperative instrumental assessment of the state of the strangulated organ; expansion of indications for the use of laparoscopic interventions and components of the comprehensive Fast track program; substantiated complex prevention of malignancy. The clinical diagnostic algorithm included laboratory, instrumental and biochemical research methods. Results: The use of priority diagnostic and therapeutic tactics in the patients of group 2 allowed to increase the number of laparoscopic hernioplasty by 49.34%, the number of allohernioplasty by 18.62%, among which the "Sublay" technique was preferred for strangulated ventral hernias. This was accompanied by a decrease in the pain syndrome on the VAS scale during the four days of observation, both during coughing and at rest, and amounted to only 2.21 ± 0.29 points on the fourth day when at rest. In addition, and after 12 months, the patients of group 2 observed a better recovery according to the SF-36 questionnaire, which amounted to 76.77±6.63 points for the assessment of the general state of health, 70.81±5.86 points for the assessment of physical functioning, 68.88±5.37 points for the assessment of role functioning due to physical condition, 68.03±5.92 points for the assessment of role functioning due to emotional state, and social activity was characterized by 72.82±5.52 points. Conclusions: 1. The proposed diagnostic and treatment tactics in the patients of group 2 with strangulated abdominal hernias without resection of a hollow organ, in contrast to patients in group 1, made it possible to increase the number of laparoscopic operations to 227 (66.37%) in contrast to 55 (17.03%) in the first group, which was accompanied by a decrease in pain syndrome on the VAS scale on the fourth day when coughing from 4.35 ± 0.38 points to 2.97 ± 0.43 points. 2. The expansion of indications for the use of laparoscopic operations in patients of group 2, in contrast to patients of group 1, led to a decrease in the postoperative complications by 10.48% and the postoperative mortality by 2.29% and was characterized by better postoperative rehabilitation according to the assessment of the patients' condition after 12 months according to the SF-36 questionnaire..

ОПЫТ ЛЕЧЕНИЯ ПАЦИЕНТОВ СО СВИЩАМИ ОБОДОЧНОЙ КИШКИ ДИВЕРТИКУЛЯРНОГО ПРОИСХОЖДЕНИЯ

Abstract. Introduction. In the 21st century, a massive increase was noted in the incidence of diverticular disease (DD) by more than 10 times with an increase in the frequency of its complications ranging from 5 to 25%. According to the literature, the colon fistulation frequency is 5-30%, over a half of such formations being colovesical fistulas. The problem of surgical approaches to the purulent-inflammatory complications of DD is far from being resolved. Despite the fact that diverticular disease is a benign pathology, inflammatory process often creates serious technical difficulties in surgery due to the violation of the anatomical relationship of the intestine with the surrounding organs, while surgeries often affect several organs with a high infection risk. Aim. Analysis of the results of the treatment of patients with diverticular colon fistulas in a specialized department of a multidisciplinary hospital. Materials and Methods. Treatment outcomes were analyzed retrospectively in 347 patients with diverticular colon disease complications for the period from 2013 to 2022. The study included 17 patients with diverticular fistulas: 14 (82.4%) patients with internal (intestinal-urinary (13) and intestinal-vaginal (1)) fistulas and 3 (17.6%) with external ones. Results and Discussion. The therapeutic and diagnostic algorithm for diverticular fistulas required a wide range of diagnostic methods and a multidisciplinary approach. Surgery remains the single treatment option for this pathology. The choice of the surgical procedure depended on the inflammatory process severity, its spread to the surrounding abdominal organs, and the largest diverticula accumulation in the gut. In the group of patients with intestinal-urinary fistulas, the resection was not limited to the removal of the colon segment only. In 9 (52.9%) cases, it was expanded to the anterior rectum resection due to the inflammation transition to its upper ampullary region. We are supporters of the one-stage surgical procedures with forming the primary anastomosis in patients with diverticular fistulas. We give preference to the Sigal-Ramazanov invagination anastomosis that allows avoiding the anastomosis due to creating a duplicate of the intestinal wall hiding the anastomosis zone. The paper identifies probable predictors of complicating diverticular disease with fistulation. Conclusions. Choosing the optimal treatment option for patients with diverticular disease complications is a difficult problem. It is better to operate on them in the coloproctology departments of multidisciplinary hospitals with the established good interaction among the members of a multidisciplinary team.

The Diagnostic Impact of Contrast-Enhanced Computed Tomography (CECT) in Evaluating Lymph Node Involvement in Colorectal Cancer: A Comprehensive Review.

Colorectal cancer (CRC) remains a significant global health burden, necessitating accurate staging and treatment planning for optimal patient outcomes. Lymph node involvement is a critical determinant of prognosis in CRC, emphasizing the importance of reliable imaging techniques for its evaluation. Contrast-enhanced computed tomography (CECT) has emerged as a cornerstone in CRC imaging, offering high-resolution anatomical detail and vascular assessment. This comprehensive review synthesizes the existing literature to evaluate the diagnostic impact of CECT in assessing lymph node involvement in CRC. Key findings highlight CECT's high sensitivity and specificity in detecting lymph node metastases, facilitating accurate staging and treatment selection. However, challenges such as limited resolution for small lymph nodes and potential false-positives call for a cautious interpretation. Recommendations for clinical practice suggest the integration of CECT into multidisciplinary treatment algorithms, optimizing imaging protocols and enhancing collaboration between radiologists and clinicians. Future research directions include refining imaging protocols, comparative effectiveness studies with emerging modalities, and prospective validation of CECT's prognostic value. Overall, this review stresses the pivotal role of CECT in CRC management and identifies avenues for further advancements in imaging-guided oncology care.

The results of adding immunotherapy to chemotherapy in patients with small cell lung cancer: Registurk-Lung study—Real-world data.

e20006 Background: Evaluation of real-world data together with data in clinical studies is very important in the evaluation of treatment algorithms. In real life, treatments are applied to the elderly, patients with poor performance and unusual groups with comorbidities. Determining these treatment results is important in the creation of treatment algorithms. The studies on the addition of immunotherapeutic agents to the standard chemotherapy regimen in patients with small cell lung cancer have found a significant survival advantage. In this study, we evaluated the real-life reflections of the results of these clinical trials. Methods: In our country, within the scope of the Registurk-Lung observational study (NCT05254119), a total of 1008 patients with extensive stage small cell lung cancer were evaluated between December 2021 and December 2023 in 42 centers representing the whole country. The demographic, histopathological, molecular and clinical data of the patients were recorded. The relationship between progression-free survival (PFS) time and overall survival (OS) time with these characteristics was investigated. Results: The median age was 64 (31-88) years and 17.6% of the patients were female. The proportion of patients who never smoked was only 4.7 %. Histopathologically, 36.4% of the patients were diagnosed with squamous cell carcinoma. At the time of diagnosis, brain metastases were present in 13.9 % of the patients and liver metastases were present in 12.1% of the patients. Only 19.4 percent of patients received chemoimmunotherapy. Eighty-three percent of the patients received atezolizumab as immunotherapy in combination with chemotherapy and as maintenance treatment. The other patients received durvalumab and pembrolizumab.Patients who did not receive immunotherapy received platinum plus etoposide chemotherapy regimen as a medyan 4 cycle. The overall response rate was 49.0 % in the chemotherapy group and 52.8 % in the combination group. The PFS was 7.6 (95% CI: 6.9-8.3) months in chemoimmunotherapy group and 7.3 (95% CI: 6.5-8.1) months in chemotherapy group. Also, the OS was 15.5 months (95% CI: 11.1-19.9) in chemoimmunotherapy group and 11.8 (95% CI: 10.5-13.2) months in chemotherapy group. When the two groups were compared, there was a positive trend in terms of PFS in the immunochemotherapy group, but this difference was not statistically significant (p:0,802). In terms of overall survival, there was a statistically significant improvement in the chemoimmunotherapy group (p:0,049). Conclusions: The addition of immunotherapy to the treatment of patients with small cell lung cancer, which we have been treating with dual combination chemotherapy for many years, has provided a survival benefit. This situation brings with it new hopes for future studies.

Are the results of clinical trials in patients with NSCLC reflected in real life? The Registurk-Lung study.

e20512 Background: Evaluation of real-world data together with data in clinical studies is very important in the evaluation of treatment algorithms. In real life, treatments are applied to the elderly, patients with poor performance and unusual groups with comorbidities. Determining these treatment results is important in the creation of treatment algorithms. Methods: In our country, within the scope of the Registurk-Lung observational study (NCT05254119), a total of 4250 patients without driver mutation, metastatic non-small cell lung cancer were recorded between December 2021 and December 2023 in 42 centers representing the whole country. The demographic, histopathological, molecular and clinical data of the patients were recorded. The relationship between progression-free survival (PFS) time and overall survival (OS) time with these characteristics was investigated. Results: 4250 patients were evaluated. The median age was 64 (26-90) years and 15.1% of the patients were female. The proportion of patients who never smoked was 10.4 %. Histopathologically, 36.4% of the patients were diagnosed with squamous cell carcinoma. PDL-1 level was higher than 50% in 24.0% of patients and &lt; 1 in 40.4% of patients. Only 11.8 percent of patients received single agent immunotherapy or chemoimmunotherapy. Other patients had received only a combination of doublet chemotherapy. The PFS was 6.9 months (95% CI: 6.4-7.3) and OS 14.6 (95% CI: 12.3-16.8) months in the whole patient group. Compared to the group that received chemotherapy alone, PFS and overall survival were longer in the group that received chemoimmunotherapy. This difference between the two groups was found to be statistically significant (p:0,001 and 0,031 respectively). Conclusions: As shown in clinical studies, immunotherapy alone or chemoimmunotherapy according to PDL-1 expression status provides a significant survival contribution compared to chemotherapy alone.

Slipped vertebrae (Spondylolysis): the underestimated weak point of the (pre)professional football player-an algorithm

Isthmic spondylolysis represents the most common cause of spinal pain in adolescent athletes. This article provides an overview of the classification, diagnosis, and treatment options for these conditions, including conservative and operative measures. It also provides atreatment pathway to how young athletes with spondylolysis should be treated. Diagnostic imaging techniques are essential for an accurate diagnosis, with CT scans providing additional information for surgical planning. Conservative treatment focuses on activity modification and physiotherapy, with aphased approach tailored to individual patient needs. Operative intervention may be considered if conservative measures fail, with minimally invasive techniques such as Buck's screw fixation showing promising results. The decision between conservative and operative management should consider factors of the patients' individual profile. In this paper, we present the first treatment algorithm for the treatment of isthmic spondylolysis. Long-term prognosis varies, with most athletes able to return to sport following treatment.

BGB-11417-203: An ongoing, phase 2 study of sonrotoclax (BGB-11417), a next-generation BCL2 inhibitor, in patients with Waldenström macroglobulinemia.

TPS7090 Background: Bruton tyrosine kinase (BTK) inhibitors and anti-CD20 antibody-based systemic therapy are included within the preferred treatment algorithms for Waldenström macroglobulinemia (WM). However, to date, no treatments have been approved for patients with WM that is refractory to both BTK inhibitors and anti-CD20 therapy. Venetoclax, the first-generation BCL2 inhibitor, has demonstrated clinical activity in patients with relapsed/refractory (R/R) WM (Castillo et al. J Clin Oncol. 2022), but it has no regulatory approvals in WM. Sonrotoclax, a next generation BCL2 inhibitor, is more selective and a more pharmacologically potent inhibitor of BCL2 than venetoclax. In a phase 1 trial, sonrotoclax monotherapy was well tolerated at all dose levels tested up to 640 mg and showed promising evidence of antitumor activity in patients with R/R WM (Soumerai et al. Blood. 2022). Based on the data from these earlier studies, a phase 2 study of sonrotoclax monotherapy in patients with WM has been initiated and is currently recruiting. Methods: BGB-11417-203 (NCT05952037) is an open-label, international, phase 2 study. Eligible patients have histologically confirmed WM that is R/R to both BTK inhibitor therapy and anti-CD20–based systemic therapy combined with chemotherapy or a proteasome inhibitor (PI; Cohort 1); R/R to anti-CD20–based systemic therapy combined with chemotherapy or a PI and who are intolerant to BTK inhibitor therapy (Cohort 2); or R/R to a BTK inhibitor and who are unsuitable for chemoimmunotherapy (Cohort 3). Patients who have received previous treatment with a BCL2 inhibitor are ineligible. Approximately 85 patients will be enrolled across cohorts and will receive sonrotoclax until disease progression, death, unacceptable toxicity, patient withdrawal, loss to follow-up, or study termination. The primary endpoint is major response rate (MRR; defined as partial response or better) in Cohort 1 per IWWM-11 criteria, as assessed by independent review committee (IRC). Key secondary endpoints include MRR assessed by investigator (INV) in Cohort 1 and by IRC and INV in both Cohorts 2 and 3; overall response rate, duration of response, and progression-free survival by IRC and INV; overall survival; and safety and tolerability. Patient recruitment is ongoing in Australia, the US, China, and Europe. Clinical trial information: NCT05952037 .