Treatment Decisions For Patients Research Articles

Comparative analysis of treatment decision-making in patients with localized prostate and cervical cancer: what influences receiving surgery or radiotherapy?

PurposeThis study focused on identifying the factors influencing the decision-making process in patients with localized prostate and cervical cancer in Japan and specifically examining the choice between surgery and radiotherapy.MethodsPatients with specific cancer stages registered with a healthcare research company for whom radical surgery or radiotherapy was equally effective and recommended participated in this cross-sectional online survey.ResultsThe responses of 206 and 231 patients with prostate and cervical cancer, respectively, revealed that both groups relied heavily on the physicians’ recommendations (prostate: odds ratio (OR) = 40.3, p < 0.001; cervical: OR = 5.59, p < 0.001) and their impression of radiotherapy (prostate: OR = 9.22, p < 0.001; cervical: OR = 2.31, p < 0.001). Factors such as hypertension (OR = 6.48, p < 0.05), diabetes mellitus (OR = 9.68, p < 0.05), employment status (OR = 0.08, p < 0.01), and impressions of surgery (OR = 0.14, p < 0.01) also played a significant role in patients with prostate cancer. In contrast, the specialty of the physician (OR = 4.55, p < 0.05) proposing the treatment influenced the decision-making process of patients with cervical cancer. Information sources varied between the two groups: patients with prostate cancer were more inclined towards printed materials, whereas patients with cervical cancer were more inclined towards interpersonal relationships.ConclusionAlthough several limitations, such as the sample and recall bias, were noted, this study emphasizes the role of psychosocial factors in the decision-making process and the requirement for tailored information sources.

Differential Outcomes of Placebo Treatment Across 9 Psychiatric Disorders: A Systematic Review and Meta-Analysis.

Placebo is the only substance systematically evaluated across common psychiatric diagnoses, but comprehensive cross-diagnostic comparisons are lacking. To compare changes in placebo groups in recent high-quality randomized clinical trials (RCTs) across a broad spectrum of psychiatric disorders in adult patients. MEDLINE and the Cochrane Database of Systematic Reviews were systematically searched in March 2022 for the latest systematic reviews meeting predetermined high-quality criteria for 9 major psychiatric diagnoses. Using these reviews, the top 10 highest-quality (ie, lowest risk of bias, according to the Cochrane Risk of Bias tool) and most recent placebo-controlled RCTs per diagnosis (totaling 90 RCTs) were selected, adhering to predetermined inclusion and exclusion criteria. Following the Cochrane Handbook, 2 authors independently carried out the study search, selection, and data extraction. Cross-diagnosis comparisons were based on standardized pre-post effect sizes (mean change divided by its SD) for each placebo group. This study is reported following the Meta-analysis of Observational Studies in Epidemiology (MOOSE) reporting guideline. The primary outcome, pooled pre-post placebo effect sizes (dav) with 95% CIs per diagnosis, was determined using random-effects meta-analyses. A Q test assessed statistical significance of differences across diagnoses. Heterogeneity and small-study effects were evaluated as appropriate. A total of 90 RCTs with 9985 placebo-treated participants were included. Symptom severity improved with placebo in all diagnoses. Pooled pre-post placebo effect sizes differed across diagnoses (Q = 88.5; df = 8; P < .001), with major depressive disorder (dav = 1.40; 95% CI, 1.24-1.56) and generalized anxiety disorder (dav = 1.23; 95% CI, 1.06-1.41) exhibiting the largest dav. Panic disorder, attention-deficit/hyperactivity disorder, posttraumatic stress disorder, social phobia, and mania showed dav between 0.68 and 0.92, followed by OCD (dav = 0.65; 95% CI, 0.51-0.78) and schizophrenia (dav = 0.59; 95% CI, 0.41-0.76). This systematic review and meta-analysis found that symptom improvement with placebo treatment was substantial in all conditions but varied across the 9 included diagnoses. These findings may help in assessing the necessity and ethical justification of placebo controls, in evaluating treatment effects in uncontrolled studies, and in guiding patients in treatment decisions. These findings likely encompass the true placebo effect, natural disease course, and nonspecific effects.

#1686 How do older people with advanced kidney disease and their family members approach kidney treatment decision-making? A qualitative study

Abstract Background and Aims Chronic kidney disease (CKD) is common in the UK, especially amongst frail older people with multiple health problems. The survival benefit of kidney replacement therapy (KRT) for such patients is uncertain and the burdens significant, meaning patients make difficult decisions between planning for dialysis or opting for conservative kidney management (CKM). People close to individuals with advanced CKD are known to play an important role in treatment decision-making, but data exploring their perspectives are limited. This qualitative study aimed to explore older, comorbid patients’ and family members’ understanding of and views regarding treatment decision-making. Method In-depth interviews were conducted in person in 2018-2019 among older patients with advanced CKD (&amp;gt;80 years old or &amp;gt;65 with evidence of frailty or comorbidity) and least one family member (partner/spouse/child/grandchild) per patient. Interviews used open-ended questioning, supported by a topic guide based on patient input and the literature. Transcripts were analysed using inductive thematic analysis and constant comparison to identify concepts and meanings from participants’ views and reported experiences. Codes and interviews were discussed and compared among study investigators, with consideration of wider meaning, alongside reorganisation and recoding, and thematic development. Results Ten patients and 12 family members (6 spouses/partners, 5 adult children and 1 adult grandchild) were interviewed. Four themes were identified: (1) “whose decision is it anyway?”; (2) “facing uncertainty”; (3) “on death and dying” and (4) “caring and being cared for”. “Whose decision is it anyway?” speaks to perceived nuances around the ownership of decisions about kidney therapy. While some interviewees described the decision belonging solely to the patient, others described varying degrees of collaboration with and persuasion from family members (particularly partners/spouses). Clinician influence was also described by patients and family members. “Facing uncertainty” captures patients’ and their family members’ view that decisions are contingent upon largely uncertain future circumstances. “On death and dying” describes the pivotal role in treatment decision-making of patients’ and family members’ sense of life completion and feelings about death and dying. KRT was perceived as life-prolonging, while an acceptance of death and dying was seen to be important for consideration of CKM. “Caring and being cared for” elucidates the importance of caring roles between patients and their family members for decisions about the future, including the specific effect of loving relationships on the value patients and their family members assign to living. Conclusion We found both patients and family members influence treatment decisions, which they tend to view as flexible in the face of uncertainty. The desire to prolong important family relationships was a motivator for favouring KRT, in light of an understanding of KRT as life-prolonging. Kidney services should recognise the significance of family relationships to older patients’ treatment decision-making. Clinicians must ensure that patients and family members understand the implications of treatment choice for quality-of-life, prognosis, and end-of-life care. This is likely to include understanding which family members or close ones are important, involving these people in decision-making and recognising that changes in family situations may necessitate re-visiting previous decisions.

Real-world efficacy and safety of capecitabine with oxaliplatin in patients with advanced adenocarcinoma of the ampulla of Vater

BackgroundAdenocarcinoma of the ampulla of Vater (AoV) is one of the rare periampullary cancers, and due to its anatomical location, it is categorized into various histologic subtypes. Its rarity and diversity pose challenges in treatment decision-making for patients with advanced AoV carcinoma. This study investigated the efficacy and safety of the combined regimen of capecitabine and oxaliplatin (CAPOX) in a real-world clinical setting.MethodsThis investigation encompassed patients with advanced AoV carcinoma who underwent CAPOX treatment. Histologic phenotypes were identified through a combination of histopathological analysis and protein expression markers, including MUC1, CDX2, CK20, and MUC2. The correlation between histopathological determinants and survival outcomes was explored, in addition to an evaluation of the safety profile of CAPOX therapy.ResultsFrom January 2010 to June 2023, 42 patients received CAPOX. Of these, 14 patients (33.3%) had not received any prior palliative chemotherapy, while 28 patients (66.7%) had undergone one prior line of chemotherapy. At a median follow up of 9.0 months, the median progression-free survival (PFS) was 4.38 months (95% CI, 2.78–5.69) and the median overall survival (OS) was 9.57 months (95% CI 7.56–11.6). The objective response and disease control rates were 38.1% and 61.9%, respectively. Patients who received CAPOX as a second-line treatment had poorer PFS (HR = 2.62; 95% CI, 1.49–4.90, p = 0.003) and OS (HR = 2.82, 95% CI, 1.47–5.38, p = 0.001) compared to those who received CAPOX as a first-line chemotherapy. There were no statistically significant differences in PFS (p = 0.185) and OS (p = 0.097) between groups based on histologic subtypes. Neutropenia (14.3%) emerged as the predominant grade 3–4 toxicity. Notably, treatment cessation occurred in select instances owing to grade 3 fatigue (9.5%) and peripheral neuropathy (9.5%).ConclusionsThis study confirmed the therapeutic efficacy and safety of CAPOX in a real-world setting, consistent with prior phase II trial results. While CAPOX proved feasible for advanced AoV carcinoma regardless of histologic subtype, its reduced effectiveness in second-line settings necessitates further research to determine its optimal palliative use.

#1089 Urinary Protein Biomarkers for Assessing Disease Activity and Chronicity in IgA Nephropathy

Abstract Background and Objectives IgA nephropathy (IgAN) is a progressive kidney disease characterized by the mesangial deposition of galactose-deficient IgA1, leading to kidney damage and may eventually lead to end-stage kidney disease. Current treatment decisions for IgAN patients rely on the degree of proteinuria. However, this is a non-specific parameter that can be the result of inflammatory disease activity and/or chronic glomerular damage. In this study, we employed the Olink proximity extension assay to comprehensively analyze the urinary proteome of IgAN patients. Our goal was to identify biomarkers capable of distinguishing between IgAN disease activity and disease chronicity. Method Urine samples were collected from 41 IgAN patients and 41 age- and eGFR-matched controls. Patient characteristics are shown in Table 1. Using Olink Proteomics, we measured 276 proteins in urine, from the inflammation, organ damage, and cardiometabolic panels. Comparisons were made between IgAN patients and controls, as well as between those with mild (eGFR ≥ 60 ml/min/1.73 m2 and uPCR &amp;lt; 100 mg/mmol) and active IgAN (eGFR ≥ 60 ml/min/1.73 m2 and uPCR ≥ 100 mg/mmol) to identify biomarkers for disease activity. Additionally, we compared IgAN patients with eGFR ≥ 60 ml/min/1.73 m2 to those with eGFR ≤ 30 ml/min/1.73 m2 to identify biomarkers associated with disease chronicity. Mann-Whitney U tests were used for group comparisons. Correction for multiple testing was performed using the Benjamini-Hochberg procedure. Disease activity and chronicity scores were calculated by averaging the z-scores of the identified biomarkers. Results L-Selectin (SELL), leukocyte inhibitory factor (LIF), interleukin-6 (IL-6), and carbonic anhydrase 1 (CA1) were most prominently elevated in IgAN patients compared to controls (Fig. 1A). SELL and CA1 were also markedly elevated in the active versus mild IgAN patients, and were therefore selected as biomarkers of disease activity (Fig. 1B). Contactin 2 (CNTN2) and chemokine (C-C motif) ligand 25 (CCL25) were most prominently elevated in IgAN patients with eGFR ≤ 30 ml/min/1.73 m2, and were selected as biomarkers of disease chronicity (Fig. 1C). We plotted the disease activity and chronicity scores calculated from the identified biomarkers to distinguish the different IgAN disease stages (Fig. 1D). Conclusion This study identified urine biomarkers indicative of IgAN disease activity and chronicity. Calculating an activity and chronicity score using these biomarkers offers a new approach to distinguish between inflammatory disease activity and chronicity, providing an alternative to proteinuria for guiding treatment decisions in IgAN patients. Validation of these biomarkers, and the scores calculated from them, in a larger cohort of IgAN patients is currently underway.

Construction of a mortality risk prediction model for patients with acute diquat poisoning based on clinically accessible data

BackgroundTo examine the risk factors associated with mortality in individuals suffering from acute diquat poisoning and to develop an effective prediction model using clinical data.MethodsA retrospective review was conducted on the clinical records of 107 individuals who were hospitalized for acute diquat poisoning at a tertiary hospital in Sichuan Province between January 2017 and September 30, 2023, and further categorized into survivor and nonsurvivor groups based on their mortality status within 30 days of poisoning. The patient’s demographic information, symptoms within 24 h of admission, and details of the initial clinical ancillary examination, as well as the APACHE II score, were documented. The model was developed using backward stepwise logistic regression, and its performance was assessed using receiver operating characteristic curves, calibration curves, Brier scores, decision curve analysis curves, and bootstrap replicates for internal validation.ResultsMultifactorial logistic regression analysis revealed that blood pressure (hypertension, OR 19.73, 95% CI 5.71–68.16; hypotension, OR 61.38, 95% CI 7.40–509.51), white blood count (OR 1.35, 95% CI 1.20–1.52), red cell distribution width-standard deviation (OR 1.22, 95% CI 1.08–1.38), and glomerular filtration rate (OR 0.96, 95% CI 0.94–0.97) were identified as independent risk factors for mortality in patients with diquat. Subsequently, a nomogram with an area under the curve of 0.97 (95% CI: 0.93–1) was developed. Internal bootstrap resampling (1000 repetitions) confirmed the model’s adequate discriminatory power, with an area under the curve of 0.97. Decision curve analysis demonstrated greater net gains for the nomogram, while the clinical impact curves indicated greater predictive validity.ConclusionThe nomogram model developed in this study using available clinical data enhances the prediction of risk for DQ patients and has the potential to provide valuable clinical insights to guide patient treatment decisions.

68Ga]Ga-FAPI-04 PET/MR imaging strategy in management of Krukenberg tumors (KTs) from gastric signet-ring-cell carcinoma: to overcome limitation of [68Ga]Ga-FAPI-04 PET imaging in KTs.

To compare performance of whole-body [68Ga]Ga-FAPI-04 and [18F]FDG PET imaging in the detection of Krukenberg tumors (KTs), primary site and extra-ovarian metastases of gastric signet-ring-cell carcinoma (GSRCC), and evaluate the value of [68Ga]Ga-FAPI-04 PET/MR imaging strategy and its potential impact on the management of KTs from GSRCC. Twelve patients with twenty-three KTs from GSRCC, who underwent both [68Ga]Ga-FAPI-04 pelvic PET/MR and whole-body [68Ga]Ga-FAPI-04 and [18F]FDG PET imaging were retrospectively analyzed. [68Ga]Ga-FAPI-04 and [18F]FDG uptakes were compared by using Wilcoxon signed-rank test or paired t test. McNemar's test was used to compare lesion detectability between two modalities. Two-tailed P<0.05 was considered statistically significant. Immunohistochemistry staining was utilized to analyze the fibroblast activation protein (FAP) expression in KTs. A total of 12 patients with 23 KTs from GSRCC (8 synchronous and 4 metachronous) were evaluated. [68Ga]Ga-FAPI-04 was superior to [18F]FDG PET in detecting primary sites of GSRCC (100% [11/11] vs. 18.2% [2/11], p = 0.002), involved lymph nodes (90.9% [10/11] vs. 54.5% [6/11], p = 0.046) and peritoneal metastases (100% [12/12] vs. 41.7% [5/12], p = 0.008), with higher SUVmax and TBR (all p < 0.005). Both tracers had limited value in identifying KTs, with 100% false negative rate on [68Ga]Ga-FAPI-04 PET and a low detection rate of 8.7% on [18F]FDG PET. Fap immunohistochemistry showed negative or slight FAP expression in neoplastic signet ring cells and ovarian stroma. [68Ga]Ga-FAPI-04 PET/MR imaging strategy greatly improved the detection rate of Krukenberg tumors (87%, 20/23). After adding diffusion-weighted imaging (DWI), the detection rate was further improved (87.5% vs. 100%, p = 0.083). [68Ga]Ga-FAPI-04 PET/MR imaging strategy either upgraded TNM staging or changed treatment management in twelve patients. [68Ga]Ga-FAPI-04 PET outperformed [18F]FDG PET in detecting primary site and most extra-ovarian metastases of GSRCC, but both tracers had limited value in identifying Krukenberg tumors. Pelvis MRI should be applied to compensate the limitation of [68Ga]Ga-FAPI-04 PET imaging to identify Krukenberg tumours. The [68Ga]Ga-FAPI-04 PET/MR imaging strategy has the potential to impact treatment decisions for GSRCC patients with KTs.

Pituitary and COVID-19 vaccination: a systematic review.

This systematic review aims to examine the latest research findings and assess the impact of COVID-19 vaccination on the pituitary gland. PubMed and Tripdatabase were searched from January 1st, 2020 to February 12th, 2024. Case reports, case series and reviews related to post COVID-19 vaccination pituitary disease were included. Eligible articles were tabulated and analysed in the attempt to provide an overview on the epidemiology, clinical presentation, imaging, treatment, outcomes and pathophysiological background of post COVID-19 vaccination pituitary disease. Among the 23 case reports included in this review, post COVID-19 vaccination hypophysitis was reported in 9 patients, pituitary apoplexy (PA) in 6 cases, SIADH in 5 cases and Isolated ACTH deficiency in 2 cases. Additionally, precipitating adrenal crisis was registered in 7 patients and pituitary tumor enlargement in 1 patient after receiving COVID-19 vaccination. Despite the rarity of these events, our research findings suggest an association between COVID-19 vaccination and the subsequent development of pituitary diseases. The most common manifestations include hypophysitis with ADH deficiency, PA and SIADH, with symptoms typically emerging shortly after vaccine administration. Potential pathogenetic mechanisms include molecular mimicry, vaccine adjuvants and vaccine-induced thrombotic thrombocytopenia (VITT), with the presence of ACE2 receptors in the hypothalamus-pituitary system contributing to the process. These findings can aid in diagnostic and treatment decisions for patients presenting with these syndromes. Nevertheless, given the rarity of these events, safety and efficacy of the currently available COVID-19 vaccines remain robust and we strongly advocate continuing pursuing vaccination efforts.

Predictive models-assisted diagnosis of AIDS-associated Pneumocystis jirovecii pneumonia in the emergency room, based on clinical, laboratory, and radiological data.

We assessed predictive models (PMs) for diagnosing Pneumocystis jirovecii pneumonia (PCP) in AIDS patients seen in the emergency room (ER), aiming to guide empirical treatment decisions. Data from suspected PCP cases among AIDS patients were gathered prospectively at a reference hospital's ER, with diagnoses later confirmed through sputum PCR analysis. We compared clinical, laboratory, and radiological data between PCP and non-PCP groups, using the Boruta algorithm to confirm significant differences. We evaluated ten PMs tailored for various ERs resource levels to diagnose PCP. Four scenarios were created, two based on X-ray findings (diffuse interstitial infiltrate) and two on CT scans ("ground-glass"), incorporating mandatory variables: lactate dehydrogenase, O2sat, C-reactive protein, respiratory rate (> 24bpm), and dry cough. We also assessed HIV viral load and CD4 cell count. Among the 86 patients in the study, each model considered either 6 or 8 parameters, depending on the scenario. Many models performed well, with accuracy, precision, recall, and AUC scores > 0.8. Notably, nearest neighbor and naïve Bayes excelled (scores > 0.9) in specific scenarios. Surprisingly, HIV viral load and CD4 cell count did not improve model performance. In conclusion, ER-based PMs using readily available data can significantly aid PCP treatment decisions in AIDS patients.

Oropharyngeal Cancer Staging Health Record Extraction Using Artificial Intelligence

Accurate, timely, and cost-effective methods for staging oropharyngeal cancers are crucial for patient prognosis and treatment decisions, but staging documentation is often inaccurate or incomplete. With the emergence of artificial intelligence in medicine, data abstraction may be associated with reduced costs but increased efficiency and accuracy of cancer staging. To evaluate an algorithm using an artificial intelligence engine capable of extracting essential information from medical records of patients with oropharyngeal cancer and assigning tumor, nodal, and metastatic stages according to American Joint Committee on Cancer eighth edition guidelines. This retrospective diagnostic study was conducted among a convenience sample of 806 patients with oropharyngeal squamous cell carcinoma. Medical records of patients with staged oropharyngeal squamous cell carcinomas who presented to a single tertiary care center between January 1, 2010, and August 1, 2020, were reviewed. A ground truth cancer stage dataset and comprehensive staging rule book consisting of 135 rules encompassing p16 status, tumor, and nodal and metastatic stage were developed. Subsequently, 4 distinct models were trained: model T (entity relationship extraction) for anatomical location and invasion state, model S (numerical extraction) for lesion size, model M (sequential classification) for metastasis detection, and a p16 model for p16 status. For validation, results were compared against ground truth established by expert reviewers, and accuracy was reported. Data were analyzed from March to November 2023. The accuracy of algorithm cancer stages was compared with ground truth. Among 806 patients with oropharyngeal cancer (mean [SD] age, 63.6 [10.6] years; 651 males [80.8%]), 421 patients (52.2%) were positive for human papillomavirus. The artificial intelligence engine achieved accuracies of 55.9% (95% CI, 52.5%-59.3%) for tumor, 56.0% (95% CI, 52.5%-59.4%) for nodal, and 87.6% (95% CI, 85.1%-89.7%) for metastatic stages and 92.1% (95% CI, 88.5%-94.6%) for p16 status. Differentiation between localized (stages 1-2) and advanced (stages 3-4) cancers achieved 80.7% (95% CI, 77.8%-83.2%) accuracy. This study found that tumor and nodal staging accuracies were fair to good and excellent for metastatic stage and p16 status, with clinical relevance in assigning optimal treatment and reducing toxic effect exposures. Further model refinement and external validation with electronic health records at different institutions are necessary to improve algorithm accuracy and clinical applicability.

Usage of Weka Software Based On Machine Learning Algorithms for Prediction of Liver Fibrosis/Cirrhosis

The liver, a life-sustaining organ, plays a substantial role in many body functions. Liver diseases have become an important world health problem in terms of prevalence, incidences, and mortalities. Liver fibrosis/cirrhosis is great of importance, because if not treated in time liver cancer could be occurred and spread to other parts of the body. For this reason, early diagnosis of liver fibrosis/cirrhosis gives significance. Accordingly, this study investigated the performances of different machine learning algorithms for prediction of liver fibrosis/cirrhosis based on demographic and blood values. In this context, random forest, k nearest neighbour, C4.5 decision tree, K-star, random tree and reduced error pruning tree algorithms were used. Two distinct approaches were employed to evaluate the performances of machine learning algorithms. In the first approach, the entire features of dataset were utilized, while in the second approach, only the features selected through principal component analysis were used. Each approach was rigorously assessed using both 10-fold cross-validation and data splitting (70% train and 30% test) techniques. By conducting separate evaluations for each approach, a comprehensive understanding of the effectiveness of utilizing all features versus extracted features based principal component analysis was attained, providing valuable insights into the impact of feature dimensionality reduction on model performance. In this study, all analyses were implemented on WEKA data mining tool. In the first approach, the classification accuracies of random forest algorithm were 89.72% and 90.75% with the application of data splitting (70%-30%) and cross-validation techniques, respectively. In the second approach, where feature reduction is performed using principal component analysis technique, the accuracy values obtained from data splitting and cross-validation techniques of random forest algorithm were 88.61% and 88.83%, respectively. The obtained results revealed out that random forest algorithm outperformed for both approaches. Besides, the application of principal component analysis technique negatively affected the classification performance of used machine learning algorithms. It is thought that the proposed model will guide specialist physicians in making appropriate treatment decisions for patients with liver fibrosis/cirrhosis, potentially leading to death in its advanced stages.

Stellae-123 gene expression signature improved risk stratification in taiwanese acute myeloid leukemia patients

The European Leukemia Net recommendations provide valuable guidance in treatment decisions of patients with acute myeloid leukemia (AML). However, the genetic complexity and heterogeneity of AML are not fully covered, notwithstanding that gene expression analysis is crucial in the risk stratification of AML. The Stellae-123 score, an AI-based model that captures gene expression patterns, has demonstrated robust survival predictions in AML patients across four western-population cohorts. This study aims to evaluate the applicability of Stellae-123 in a Taiwanese cohort. The Stellae-123 model was applied to 304 de novo AML patients diagnosed and treated at the National Taiwan University Hospital. We find that the pretrained (BeatAML-based) model achieved c-indexes of 0.631 and 0.632 for the prediction of overall survival (OS) and relapse-free survival (RFS), respectively. Model retraining within our cohort further improve the cross-validated c-indexes to 0.667 and 0.667 for OS and RFS prediction, respectively. Multivariable analysis identify both pretrained and retrained models as independent prognostic biomarkers. We further show that incorporating age, Stellae-123, and ELN classification remarkably improves risk stratification, revealing c-indices of 0.73 and 0.728 for OS and RFS, respectively. In summary, the Stellae-123 gene expression signature is a valuable prognostic tool for AML patients and model retraining can improve the accuracy and applicability of the model in different populations.

Preferences of physicians for treatment-related toxicity vs. recurrence in melanoma (GERMELATOX-A): the doctors’ perspective

IntroductionAdjuvant treatment with immune checkpoint inhibitors, such as PD1-antibodies (ICI) ± CTLA4-antibodies (cICI) or targeted therapy with BRAF/MEK inhibitors (TT), has shown a significant improvement in disease-free survival (DFS) for high-risk melanoma patients. However, due to specific side effects, the choice of treatment is often influenced by the risk of toxicity. Therefore, the role of physicians in treatment decisions of patients is crucial. This study investigated for the first time in a multicenter setting the attitudes and preferences of dermatooncologists in Germany and Switzerland regarding adjuvant treatment with (c)ICI and TT.MethodsIn the GERMELATOX-A study, 108 physicians (median age: 32 yrs, 67.6% female) from 11 skin cancer centers were surveyed to rate typical side effect scenarios of (c)ICI and TT treatments and then compared to patients’ ratings evaluated in a previous analysis from the same centers. The scenarios described mild-to-moderate or severe toxicity and included melanoma relapse leading to death. The physicians were asked about the level of side effects they would tolerate in exchange for a reduction in melanoma relapse and an increase in survival at 5 years.ResultsThe preferences of physicians and patients revealed significant differences regarding adjuvant melanoma treatment with (c)ICI and TT (p < 0.05). Compared to patients, physicians tend to value a melanoma relapse less severe, according to a visual analog scale. They were also less threatened by all scenarios of side effects during adjuvant treatment with (c)ICI or TT, compared to patients. Physicians required lower risk reductions for disease-free survival (DFS) and overall survival (OS) for both ICI and TT and their drug-related side effects to accept these treatments. In case of severe side effects, physicians required similar 5-year DFS rates for ICI and TT (60–65%), while patients needed a 15% improvement of 5-year DFS for ICI compared to TT (80%/65%). For survival, physicians expected an OS improvement of + 10% for all three treatment modalities, whereas patients required a higher increase: + 18–22% for ICI and + 15% for TT.ConclusionOur study highlights the importance of understanding the patient’s perspective and a potential difference to the doctor’s view when making decisions about adjuvant melanoma treatment with (c)ICI and TT, especially as these treatments are increasingly being implemented in earlier stages.

Palliative care in kidney transplant recipients with graft failure.

Kidney transplantation is the best renal replacement therapy for patients with end stage kidney disease. It provides longer patient survival and better quality of life than dialysis. The clinical course after kidney transplantation could be complex and variable. Patients may develop various complications or even kidney graft failure. Symptom burden related to uraemia in patients with graft failure, and the side-effects of immunosuppression, cause psychological distress and adversely affect the quality of life of patients. Treatment decisions in patients with graft failure can be challenging to patients and their caregivers. Renal palliative care is an emerging field, but its adoption remains relatively low among kidney transplant recipients with progressive graft failure. In this context, timely consideration and referral for palliative care can improve symptom burden, reduce stress in patients and their caregivers, and facilitate treatment goal setting and advanced care planning. Common barriers to bring palliative care to suitable patients include: (I) misconception in patients, caregivers and healthcare providers that palliative care means abandonment of life sustaining treatment; (II) over-optimistic prognostic assessment and over-aggressive management approach; (III) insufficient awareness and training in palliative care of healthcare professionals; (IV) inadequate access to and insufficient resources in palliative care. Enhanced training and awareness, and further studies, would be needed to optimize the decision process and delineate the benefit of palliative care, and to guide evidencebased practice in the transplant population.

Predictors of Metastasis in 68GA-Prostate Specific Membrane Antigen Pet-CT in the Primary Staging of Prostate Cancer.

Background: The objective of this study was to investigate factors influencing Gallium 68 Prostate Specific Membrane Antigen Positron Emission Tomography (Ga68 PSMA PET-CT) uptake for primary staging in prostate cancer. Methods: Retrospective analysis was conducted on 499 non-metastatic and 243 de novo metastatic prostate cancer cases undergoing Ga68 PSMA PET-CT. Demographic, clinical, and imaging data were collected and analyzed. Multivariate logistic regression determined independent risk factors for metastasis detection on Ga68 PSMA PET-CT. Results: Metastatic cases showed higher levels of total PSA, PSA density (dPSA) and biopsy ISUP grade group compared to non-metastatic cases. Multivariate analysis identified cT2 stage and dPSA as independent predictors of metastasis detection on Ga68 PSMA PET-CT. Conclusions: Ga68 PSMA PET-CT plays a crucial role in prostate cancer staging, with identified factors such as clinical T stage and dPSA significantly impacting its diagnostic accuracy. These findings underscore the importance of Ga68 PSMA PET-CT in refining clinical staging and guiding treatment decisions for prostate cancer patients.

Development and Validation of a Prognostic Nomogram for Breast Cancer Patients With Multi-Organ Metastases: An Analysis of the Surveillance, Epidemiology, and End Results Program Database.

Multi-organ metastases represent a substantial life-threatening risk for breast cancer (BC) patients. Nonetheless, the current dearth of assessment tools for patients with multi-organ metastatic BC adversely impacts their evaluation. We conducted a retrospective analysis of BC patients with multi-organ metastases using data from the SEER database from 2010 to 2019. The patients were randomly allocated into a training cohort and a validation cohort in a 7:3 ratio. Univariate COX regression analysis, the LASSO, and multivariate Cox regression analyses were performed to identify independent prognostic factors in the training set. Based on these factors, a nomogram was constructed to estimate overall survival (OS) probability for BC patients with multi-organ metastases. The performance of the nomogram was evaluated using C-indexes, ROC curves, calibration curves, decision curve analysis (DCA) curves, and the risk classification system for validation. A total of 3626 BC patients with multi-organ metastases were included in the study, with 2538 patients in the training cohort and 1088 patients in the validation cohort. Age, grade, metastasis location, surgery, chemotherapy, and subtype were identified as significant independent prognostic factors for OS in BC patients with multi-organ metastases. A nomogram for predicting 1-year, 3-year, and 5-year OS was constructed. The evaluation metrics, including C-indexes, ROC curves, calibration curves, and DCA curves, demonstrated the excellent predictive performance of the nomogram. Additionally, the risk grouping system effectively stratified BC patients with multi-organ metastases into distinct prognostic categories. The developed nomogram showed high accuracy in predicting the survival probability of BC patients with multi-organ metastases, providing valuable information for patient counseling and treatment decision making.

Implementing a shared decision-making intervention to support treatment decisions for patients following an anterior cruciate ligament rupture — a protocol for the POP-ACLR feasibility study

BackgroundTreatment for anterior cruciate ligament (ACL) rupture may follow a surgical or nonsurgical pathway. At present, there is uncertainty around treatment choice. Two shared decision-making tools have been codesigned to support patients to make a decision about treatment following an ACL rupture. The shared decision-making tools include a patient information leaflet and an option grid. We report the protocol for a mixed-methods feasibility study, with nested qualitative interviews, to understand feasibility, acceptability, indicators of effectiveness and implementation factors of these shared decision-making tools (combined to form one shared decision-making intervention).MethodsA single-centre non-randomised feasibility study will be conducted with 20 patients. Patients diagnosed with an ACL rupture following magnetic resonance imaging will be identified from an orthopaedic clinic. The shared decision-making intervention will be delivered during a clinical consultation with a physiotherapist. The primary feasibility outcomes include the following: recruitment rate, fidelity, acceptability and follow-up questionnaire completion. The secondary outcome is the satisfaction with decision scale. The nested qualitative interview will explore experience of using the shared decision-making intervention to understand acceptability, implementation factors and areas for further refinement.DiscussionThis study will determine the feasibility of using a newly developed shared decision-making intervention designed to support patients to make a decision about treatment of their ACL rupture. The acceptability and indicators of effectiveness will also be explored. In the long term, the shared decision-making intervention may improve service and patient outcomes and ensure cost-effectiveness for the NHS; ensuring those most likely to benefit from surgical treatment proceed along this pathway.Trial registrationPending registration on ISRCTN.

Does a dedicated endocrine surgery unit impact treatment decision in patients with thyroid disorders? experiences from an endocrine-surgeon naive area in southern india

Does a dedicated endocrine surgery unit impact treatment decision in patients with thyroid disorders? experiences from an endocrine-surgeon naive area in southern india

Abstract PO3-01-09: Results of a prospective observational study evaluating the impact of the Prosigna assay on neoadjuvant treatment decision-making in patients with early-stage HR+/HER2- breast cancer

Abstract Background. Prosigna (PAM50) is an FDA-approved prognostic test that measures the expression of 50 classifier genes in breast cancer tissue samples. It provides intrinsic subtyping, which classifies the biology of an individual patient's tumor, as well as a risk of recurrence (ROR) score that predicts the probability of distant recurrence over 10 years. Currently, the Prosigna assay is only approved for use in postoperative specimens. Given studies demonstrating that Prosigna can identify tumors that are more likely to benefit from chemotherapy, this decision-impact study sought to evaluate whether the assay could influence physicians' choices and patients' confidence in the neoadjuvant treatment plan. Methods. This prospective observational study was conducted at a single institution and included patients with HR+/HER2- breast cancer measuring ≥ 0.5 cm, any nodal status, who were deemed candidates for neoadjuvant systemic treatment based on physician’s choice. Formalin-fixed paraffin-embedded core biopsy specimens were centrally analyzed using Prosigna. Patients' tumors were classified according to intrinsic tumor subtype (Luminal A, Luminal B, HER2-enriched, Basal-like) and ROR score (low, intermediate, or high). Physicians and patients were surveyed before and after performing Prosigna, regarding neoadjuvant therapy recommendations. The primary endpoint was assessment of the effect of Prosigna on oncologists' treatment recommendations and the actual treatment received (neoadjuvant hormonal therapy [NAHT], neoadjuvant chemotherapy [NACT], or upfront surgery). Secondary endpoints included determining whether treatment changes were based on ROR score, intrinsic subtype, or both, as well as assessing physicians' and patients' confidence in the treatment plan. Results. A total of 54 patients were enrolled in the study between March 2019 and April 2023. The distribution of intrinsic tumor subtypes was as follows: 15 patients (28%) had a Luminal A subtype, 34 (63%) had a Luminal B subtype, 3 (6%) had a HER2-enriched subtype, and 2 (4%) had a Basal-like subtype. Thirty-three patients (61%) were classified as ROR-low, 11 (20%) as ROR-intermediate, and 10 (19%) as ROR-high. Out of the 43 patients who had both pre- and post-assay survey results available, a change in the treatment decision was observed in 28% of cases. Specifically, 14% of patients transitioned from NAHT to NACT, 7% from NACT to NAHT, and 5% from NACT to upfront surgery, as shown in the Table. Treatment changes were based on the ROR score, intrinsic subtype, and both in 33%, 3%, and 64% of cases, respectively. Overall, 45% of physicians experienced an increase in confidence for the treatment plan after Prosigna testing, while 16% reported a decrease and 39% maintained the same level of confidence. Sixty-two percent of patients experienced a reduction in anxiety about treatment. Associations of ROR score and intrinsic subtypes will be presented at the meeting. Conclusion. Prosigna performed on presurgical core biopsies influenced oncologists' treatment recommendations regarding neoadjuvant treatment and reduced patient anxiety about treatment among patients with early-stage HR+/HER2- breast cancer. Table. Neoadjuvant treatment recommendations before and after Prosigna assay, overall and according to nodal status. Data are presented as frequencies (%). Abbreviations: NACT, neoadjuvant chemotherapy; NAHT, neoadjuvant hormonal therapy. Citation Format: Chiara Corti, Xiangying Chu, Pedro Exman, Danielle Kline, Nolan Priedigkeit, Nabihah Tayob, Erica Mayer, Adrienne Waks, Melissa Hughes, Antonio Giordano, Giuseppe Curigliano, Nancy Lin, Tari King, Rinath Jeselsohn, Deborah Dillon, Elizabeth Mittendorf, Sara Tolaney. Results of a prospective observational study evaluating the impact of the Prosigna assay on neoadjuvant treatment decision-making in patients with early-stage HR+/HER2- breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-01-09.

Abstract ED04-02: Combination endocrine therapy following progression on first-line therapy

Abstract Assessing genomic status is critical to make treatment decisions in patients who have experienced disease progression following a CDK 4/6 inhibition with endocrine therapy. Three trials have evaluated CDK 4/6 inhibition with endocrine therapy through progression and show that switching CDK 4/6 inhibitor results in modest efficacy while continuing the same CDK 4/6 inhibitor is not effective. The optimal therapy for patients whose tumors have a PI3-kinase mutation is alpelisib and fulvestrant. Other PIK3-ca inhibitors have not shown efficacy to date. Everolimus with endocrine therapy is an effective second line approach. Emerging data demonstrate efficacy of AKT inhibition with endocrine therapy. Several other agents are in clinical development. Citation Format: R. O'Regan. Combination endocrine therapy following progression on first-line therapy [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr ED04-02.