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1.
Ophthalmol Sci ; 5(1): 100584, 2025.
Article in English | MEDLINE | ID: mdl-39318711

ABSTRACT

Purpose: To develop and validate machine learning (ML) models to predict choroidal nevus transformation to melanoma based on multimodal imaging at initial presentation. Design: Retrospective multicenter study. Participants: Patients diagnosed with choroidal nevus on the Ocular Oncology Service at Wills Eye Hospital (2007-2017) or Mayo Clinic Rochester (2015-2023). Methods: Multimodal imaging was obtained, including fundus photography, fundus autofluorescence, spectral domain OCT, and B-scan ultrasonography. Machine learning models were created (XGBoost, LGBM, Random Forest, Extra Tree) and optimized for area under receiver operating characteristic curve (AUROC). The Wills Eye Hospital cohort was used for training and testing (80% training-20% testing) with fivefold cross validation. The Mayo Clinic cohort provided external validation. Model performance was characterized by AUROC and area under precision-recall curve (AUPRC). Models were interrogated using SHapley Additive exPlanations (SHAP) to identify the features most predictive of conversion from nevus to melanoma. Differences in AUROC and AUPRC between models were tested using 10 000 bootstrap samples with replacement and results. Main Outcome Measures: Area under receiver operating curve and AUPRC for each ML model. Results: There were 2870 nevi included in the study, with conversion to melanoma confirmed in 128 cases. Simple AI Nevus Transformation System (SAINTS; XGBoost) was the top-performing model in the test cohort [pooled AUROC 0.864 (95% confidence interval (CI): 0.864-0.865), pooled AUPRC 0.244 (95% CI: 0.243-0.246)] and in the external validation cohort [pooled AUROC 0.931 (95% CI: 0.930-0.931), pooled AUPRC 0.533 (95% CI: 0.531-0.535)]. Other models also had good discriminative performance: LGBM (test set pooled AUROC 0.831, validation set pooled AUROC 0.815), Random Forest (test set pooled AUROC 0.812, validation set pooled AUROC 0.866), and Extra Tree (test set pooled AUROC 0.826, validation set pooled AUROC 0.915). A model including only nevi with at least 5 years of follow-up demonstrated the best performance in AUPRC (test: pooled 0.592 (95% CI: 0.590-0.594); validation: pooled 0.656 [95% CI: 0.655-0.657]). The top 5 features in SAINTS by SHAP values were: tumor thickness, largest tumor basal diameter, tumor shape, distance to optic nerve, and subretinal fluid extent. Conclusions: We demonstrate accuracy and generalizability of a ML model for predicting choroidal nevus transformation to melanoma based on multimodal imaging. Financial Disclosures: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

2.
J Orthop ; 59: 36-40, 2025 Jan.
Article in English | MEDLINE | ID: mdl-39351270

ABSTRACT

Background: Proximal femoral replacement (PFR) is a reconstruction technique after tumor resection or for revision of failed total hip arthroplasty (THA). However, despite acceptable long-term oncologic and functional outcomes, extensive soft tissue or bone loss increases the risk for prosthetic instability. Instability may depend on the construct chosen for reconstruction, with current options including bipolar, constrained, or dual mobility implants. Clinical studies comparing patient outcomes after PFR with these three different constructs are limited. Methods: This study retrospectively examined a single tertiary academic institution's experience with PFR over a fifteen-year period. The medical records of patients who underwent PFR for indications such as tumor and failed THA with bone loss were reviewed. Patients were stratified into cohorts based on use of bipolar, constrained, or dual mobility implants. Patient demographics, disease characteristics, perioperative data, and data on prosthetic dislocations were recorded. ANOVA and chi-square testing was performed for continuous and categorical variables, respectively. The threshold for statistical significance was set to p < 0.05. Results: 106 patients were identified who underwent PFR. 46 underwent PFR with bipolar prosthesis (follow-up: 20 ± 24.57 months), 42 with constrained liner (follow-up: 30.45 ± 35.32 months), and 18 with dual mobility (follow-up: 15.38 ± 15.67 months). Only BMI (p = 0.036) and smoking history (P = 0.002) differed between groups. Dislocations occurred in 4 (8.7 %) patients who underwent reconstruction with bipolar prosthesis, compared to 8 (19.0 %) with constrained liner, and 3 (16.7 %) patients with dual mobility. Mean time to dislocation was significantly longer in dual mobility patients (P = 0.009). There were no differences in instances of early dislocation between groups (P = 00.238). Conclusion: While study numbers are low, mean time to dislocation was significantly longer with dual mobility. Additional large-scale longitudinal studies are needed to fully elucidate the differences in outcomes amongst these three treatments.

3.
Referência ; serVI(3): e32771, dez. 2024. tab, graf
Article in Portuguese | LILACS-Express | BDENF - Nursing | ID: biblio-1569440

ABSTRACT

Resumo Enquadramento: A literacia em saúde (LS) é a capacidade da pessoa obter e traduzir informações a fim de manter e melhorar a saúde. Objetivo: Caracterizar o nível de LS da pessoa internada num hospital oncológico; avaliar a fiabilidade do instrumento European Health Literacy Survey in Portuguese (HLS-EU-PT). Metodologia: Estudo transversal, quantitativo, descritivo e metodológico. Amostra de 188 pessoas internados num serviço de cirurgia oncológica entre maio e setembro de 2020, os dados foram colhidos através de formulário de caracterização sociodemográfica, de saúde e instrumento de avaliação da LS. Resultados: O HLS-EU-PT apresentou elevado nível de consistência interna. Todos os domínios e níveis de processamento do instrumento se correlacionam positivamente entre si. Os participantes apresentam em média um nível problemático de LS. Conclusão: Os resultados indiciam a necessidade de um maior investimento na capacitação da LS. São necessários mais estudos nesta e noutras populações e contextos de prestação de cuidados de saúde, de forma a direcionar a prática de cuidados na resposta eficaz aos problemas de saúde.


Abstract Background: Health literacy (HL) is the ability of an individual to obtain and translate information in order to maintain and improve their health. Objective: To characterize the level of HL of patients admitted to an oncology hospital and assess the reliability of the Portuguese version of the European Health Literacy Survey (HLS-EU-PT). Methodology: Cross-sectional, quantitative, descriptive, and methodological study. Sample of 188 patients admitted to a surgical oncology unit between May and September 2020. Data were collected through a sociodemographic and health characterization form and a HL assessment tool. Results: The HLS-EU-PT had a high level of internal consistency. All domains and information-processing levels correlated positively with each other. Participants had on average a problematic level of HL. Conclusion: The results indicate the need for greater investment in HL training. Further studies are needed in this population and in other populations and healthcare settings to provide an effective response to health problems.


Resumen Marco contextual: La alfabetización en salud (AS) es la capacidad de una persona para obtener y traducir información con el fin de mantener y mejorar su salud. Objetivo: Caracterizar el nivel de AS de las personas ingresadas en un hospital oncológico; evaluar la fiabilidad del instrumento European Health Literacy Survey in Portuguese (HLS-EU-PT). Metodología: Estudio transversal, cuantitativo, descriptivo y metodológico. Muestra de 188 personas ingresadas en un servicio de cirugía oncológica entre mayo y septiembre de 2020, se recogieron datos mediante un formulario de caracterización sociodemográfica y de salud, y una herramienta de evaluación de AS. Resultados: El HLS-EU-PT mostró un alto nivel de consistencia interna. Todos los dominios y niveles de procesamiento del instrumento correlacionaron positivamente entre sí. Por término medio, los participantes tienen un nivel problemático de AS. Conclusión: Los resultados indican la necesidad de una mayor inversión en formación en AS. Son necesarios más estudios en esta y otras poblaciones, y en entornos sanitarios para orientar la práctica asistencial hacia una respuesta eficaz a los problemas de salud.

4.
Life Sci ; 357: 123087, 2024 Oct 02.
Article in English | MEDLINE | ID: mdl-39366553

ABSTRACT

Being a member of the EGFR tyrosine kinase family, HER3 has been shown to be overexpressed in a number of cancers, including breast cancer (BC). The kinase activity of HER3 is extremely low, and it forms heterodimers with partners, HER2 in particular, that promote biological processes like cell migration, survival, and proliferation by activating downstream carcinogenic signaling pathways. The overexpression of HER3 is also directly linked to tumor invasion, metastasis, and a poor prognosis. Despite the relatively low expression of HER3 compared to EGFR and HER2, a lot of targeted drugs are making their way into clinical trials and seem to have a bright further. This review aims to summarize the relationship between HER3 overexpression, mutations, and carcinogenicity and drug resistance, starting from the unique structure and kinase activity of HER3. Simultaneously, numerous approaches to HER3 targeted therapy are enumerated, and the clinical detection methods for HER3 that are commonly employed in pathology are sorted and contrasted to offer physicians a range of options. We think that a better knowledge of the mechanisms underlying HER3 in tumors and the advancement of targeted HER3 therapy will contribute to an improved prognosis for cancer patients and an increase in the efficacy of anticancer therapies.

5.
J Geriatr Oncol ; 15(8): 102076, 2024 Oct 04.
Article in English | MEDLINE | ID: mdl-39368335

ABSTRACT

INTRODUCTION: Older cancer survivors consistently express the need for interventions to reduce cancer-related fatigue (CRF) and maintain quality of life (QOL). Yoga is a promising treatment to address CRF and QOL. However, research comparing the efficacy of yoga for improving fatigue and QOL in older survivors (60+) vs. younger adult survivors (≤59)is limited. Our objective was to examine the effects of yoga on CRF and QOL in older survivors vs. younger survivors. MATERIALS AND METHODS: We conducted a secondary analysis of a nationwide, multicenter, phase 3 randomized controlled trial. For this study, participants who provided evaluable pre- and post-intervention data on the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F) and the Functional Assessment for Cancer Therapy-General (FACT-G) were eligible. The yoga intervention comprises gentle Hatha and Restorative Yoga and includes breathing exercises, physical alignment postures, and mindfulness. RESULTS: Of the 177 participants included in the study, 30.1 % were aged 60+ and 69.9 % were aged ≤59. More younger participants had breast cancer (82.0 % vs. 59.2 %. p = 0.009), surgery (98.9 % vs. 77.8 %, p < 0.001), and chemotherapy (80.5 % vs. 55.6 %, p = 0.001). There were no differences in the cancer stage (66.1 % stage I or II). There were statistically significant and clinically meaningful within-group improvements from baseline to post-intervention in CRF for participants aged ≤59 and participants aged 60+ (4.0 ± 0.7, p < 0.001 vs. 3.1 ± 1.0, p = 0.003). Both age groups also demonstrated improvements in QOL (3.2 ± 0.8, p < 0.001 vs. 2.1 ± 1.2, p = 0.078), physical (1.6 ± 0.3, p < 0.001 vs. 0.8 ± 0.5, p = 0.084), functional (0.7 ± 0.3, p = 0.048 vs. 1.0 ± 0.5, p = 0.037), and emotional well-being. There were no significant between-group differences between the age groups. Most younger and older participants reported that yoga helped improve their sleep quality (92.8 % vs 88.5 %) and they would recommend it to other survivors (98.2 % vs 90.4 %). DISCUSSION: Older cancer survivors who undergo gentle Hatha and restorative yoga performed two to three times per week for four weeks at a low to moderate level of intensity have similar improvements in CRF and QOL compared to participants aged ≤59. For older survivors experiencing these toxicities, it is reasonable for clinicians to prescribe yoga. CLINICALTRIALS: govidentifier: NCT00397930.

6.
Article in English | MEDLINE | ID: mdl-39368899

ABSTRACT

AIMS: During the COVID-19 public health emergency, we previously identified decreased rates of radiotherapy (RT) peer review (PR) discussion and plan changes in virtual versus in-person PR conferences. To expand on these findings, we continued to prospectively collect data on all PR conferences from 2021 to 2023 and performed a follow-up analysis before and after the transition back to in-person PR. MATERIALS AND METHODS: A prospectively maintained database of weekly PR cases was queried for consecutive cases reviewed before and after the transition from virtual to in-person conferences. Rates of PR discussion and change recommendations were summarized and compared between the virtual and in-person groups. A survey was developed and administered to assess participants' perceived levels of engagement, opinions on optimal PR format, and preferences for future meetings before and 3 months after the transition back to in-person PR. RESULTS: In total, 2,103 RT plans were reviewed: 1,590 virtually and 513 after the transition back to in-person. There was no difference in faculty attendance between groups. The proportion of cases with PR discussion increased from virtual (9.8%) to in-person (25.5%) format (p < 0.001). In the virtual group, 8.1% of cases had 1 topic and 1.7% had 2+ topics discussed. This increased to 15.8% and 9.7% during in-person PR, respectively (p < 0.001). The rate of change recommendation also increased from 1.5% (virtual) to 3.3% (in-person, p = 0.016). Among cases with at least 1 topic discussed, there was no difference in changes. Survey-reported distraction significantly decreased from virtual to in-person PR (p < 0.001). CONCLUSION: Upon returning to in-person PR conferences, peer discussion and plan change recommendations significantly increased and returned to pre-pandemic levels, and participants' perceived levels of distraction were reduced. In an increasingly virtual world, additional efforts to develop best practices that maximize PR discussion and minimize distraction outside virtual conferences are warranted.

7.
Cancer Immunol Immunother ; 73(12): 251, 2024 Oct 03.
Article in English | MEDLINE | ID: mdl-39358611

ABSTRACT

INTRODUCTION: This study assesses the effectiveness of durvalumab with platinum and gemcitabine for biliary tract cancers (BTC). It aims to confirm the TOPAZ-1 trial results in a real-world context and explore the link between BTC molecular profiles and patient outcomes. METHODS: A retrospective analysis was conducted on 102 BTC patients treated with durvalumab, platinum, and gemcitabine at five cancer centers in Austria and one in Germany from 2022 to 2024. Molecular profiling used targeted DNA and RNA assays. Clinical endpoints, including progression-free survival (PFS) and overall survival (OS), were assessed using log-rank tests and Cox regression, with correlations to second-line molecular-targeted therapies. RESULTS: Among 102 patients, 60.8% had intrahepatic cholangiocarcinoma. The treatment achieved a disease control rate of 71.57% and an overall response rate of 35.11%. Median PFS was 6.51 months, and OS was 13.61 months. Patients under 65 had significantly better OS. Alterations in chromatin remodeling or homologous recombination repair genes were not predictive of survival benefit (HR: 0.45; p = 0.851 and HR: 1.63; p = 0.26, respectively). Patients with molecular-informed second-line therapy showed a trend toward survival benefit (HR: 0.23; p = 0.052). CONCLUSION: This study confirms the phase 3 trial results of durvalumab with platinum and gemcitabine, providing a substantial real-world dataset with detailed molecular characterization. No specific patient subgroup showed a markedly better response to durvalumab based on conventional NGS panels. Further research is needed to explore the link between immunotherapy responses and molecular subgroups.


Subject(s)
Antibodies, Monoclonal , Antineoplastic Combined Chemotherapy Protocols , Biliary Tract Neoplasms , Humans , Male , Female , Biliary Tract Neoplasms/drug therapy , Biliary Tract Neoplasms/mortality , Middle Aged , Aged , Retrospective Studies , Antibodies, Monoclonal/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Adult , Gemcitabine , Deoxycytidine/analogs & derivatives , Deoxycytidine/therapeutic use , Aged, 80 and over
8.
BMC Health Serv Res ; 24(1): 1165, 2024 Oct 02.
Article in English | MEDLINE | ID: mdl-39358740

ABSTRACT

BACKGROUND: Compassion is a crucial aspect in the management of pediatric oncology patients as it has the potential to enhance nurse satisfaction levels, thereby further enhancing the quality and safety of the care they deliver. This study aimed to investigate nurses' understanding and experience of compassionate care when working in pediatric oncology departments. METHODS: This research utilized a qualitative descriptive design. Content analysis was used to make sense of data collected via individual and semi-structured interviews conducted with nurses (n = 32) working in pediatric oncology departments. RESULTS: Nurses' understanding of compassionate care for children with cancer was organized into two categories: Humanistic compassionate care and compassionate end-of-life care. The humanistic compassionate care category comprised of three subcategories: (1) empathy, (2) altruism, and (3) respect for the cultural values and beliefs of the family. The compassionate end-of-life care category comprised of two subcategories: (1) facilitating parents' presence at the child's bedside and (2) creating suitable conditions for accepting the death of a child. CONCLUSION: Compassionate care for children with cancer is marked by a strong emphasis on humanistic, cultural, and end-of-life considerations. Our findings further emphasize the paramount importance of taking families' presence, wishes and beliefs into consideration within this context.


Subject(s)
Attitude of Health Personnel , Empathy , Interviews as Topic , Oncology Nursing , Qualitative Research , Terminal Care , Humans , Female , Male , Adult , Terminal Care/psychology , Child , Neoplasms/psychology , Neoplasms/nursing , Neoplasms/therapy , Pediatric Nursing , Middle Aged , Nurse-Patient Relations
9.
J Cancer Sci Clin Ther ; 8(3): 265-270, 2024.
Article in English | MEDLINE | ID: mdl-39364266

ABSTRACT

Glioblastoma (GBM) is one of the most aggressive forms of brain cancer that presents with a median survival rate of 14-30 months and along with a discouraging five-year survival rate of 4-5%. Standard treatment of newly diagnosed GBM, also known as the Stupp protocol, includes a maximally safe surgical resection followed by radiation and chemotherapy. Despite these treatment regimens, recurrence is almost inevitable, emphasizing the need for new therapies to combat the aggressive nature of GBMs. Tumor Treating Fields (TTFs) are a relatively new application to the treatment of GBMs, and results have been promising with both progression-free survival and overall survival when TTFs have been used in combination with temozolomide. This article critically reviews the biophysical and biological mechanisms of TTFs, their clinical efficacy, and discusses the results in clinical trials, including EF-11 and EF-14. Both trials have demonstrated that TTFs can enhance progression free survival and overall survival without compromising quality of life or causing severe adverse effects. Despite the high cost associated with TTFs and the need for further analysis to determine the most effective ways to integrate TTFs into GBM treatments, TTFs represent a significant advancement in GBM therapy and offer hope for improved patient prognosis.

10.
Gynecol Oncol ; 191: 80-85, 2024 Oct 03.
Article in English | MEDLINE | ID: mdl-39366033

ABSTRACT

OBJECTIVE: Targeted therapy in folate receptor alpha (FOLR1)-positive high grade serous ovarian carcinoma (HGSOC) is now a mainstay for platinum-resistant disease. However, the rate of FOLR1-positivity in low grade serous ovarian carcinoma (LGSOC) is not well documented. Less common than HGSOC, LGSOC tends to respond poorly to traditional platinum-based chemotherapeutic regimens, particularly in recurrence. Thus, there is an urgent need to identify molecular targets that may assist in identifying more efficacious treatments for LGSOC. In this work, we assessed the genomic and transcriptomic landscapes in FOLR1-positive/negative LGSOC compared to its high-grade counterpart. METHODS: Using a large precision oncology database, next-generation sequencing and immunohistochemistry was performed on a cohort of 281 LGSOC and 5086 HGSOC. Associated MAPK activation was calculated based on NGS results and patient survival analysis was completed stratified by molecular alteration. RESULTS: Compared with LGSOC (24.6 %), HGSOC tumors have significantly higher prevalence of FOLR1+ status (43.5 %) and significantly higher PD-L1+ status. Conversely, LGSOC had higher prevalence of KRAS and NRAS mutations, with a near exclusivity for BRAF mutation compared to HGSOC. FOLR1- LGSOC and HGSOC had similar prevalences of T cell-inflamed tumors, though FOLR1+ LGSOC had a significantly lower prevalence of T-Cell inflamed tumors than FOLR1+ HGSOC. MAPK activation, quantified via MAPK activation score (MPAS), was significantly higher in low-grade tumors compared to HGSOC, yet no difference between FOLR1+ vs FOLR1- LGSOC was observed. CONCLUSIONS: Though less than in high-grade disease, a notable portion of low-grade tumors were FOLR1+, suggesting FOLR1 expression in LGSOC could be a viable target for this rare histology, particularly in the recurrent setting.

11.
ESMO Open ; 9(10): 103706, 2024 Oct 03.
Article in English | MEDLINE | ID: mdl-39366294

ABSTRACT

Biliary tract cancer, the second most common type of liver cancer, remains a therapeutic challenge due to its late diagnosis and poor prognosis. In recent years, it has become evident that classical chemotherapy might not be the optimal treatment for patients with biliary tract cancer, especially after failure of first-line therapy. Finding new treatment options and strategies to improve the survival of these patients is therefore crucial. With the rise and increasing availability of genetic testing in patients with tumor, novel treatment approaches targeting specific genetic alterations have recently been proposed and have demonstrated their safety and efficacy in numerous clinical trials. In this review, we will first consider chemotherapy options and the new possibility of combining chemotherapy with immune checkpoint inhibitors in first-line treatment. We will then provide an overview of genomic alterations and their potential for targeted therapy especially in second-line therapy. In addition to the most common alterations such as isocitrate dehydrogenase 1 or 2 (IDH1/2) mutations, fibroblast growth factor receptor 2 (FGFR2) fusions, and alterations, we will also discuss less frequently encountered alterations such as BRAF V600E mutation and neurotrophic tyrosine kinase receptor gene (NTRK) fusion. We highlight the importance of molecular profiling in guiding therapeutic decisions and emphasize the need for continued research to optimize and expand targeted treatment strategies for this aggressive malignancy.

12.
Eur J Cancer ; 212: 115056, 2024 Sep 30.
Article in English | MEDLINE | ID: mdl-39368226

ABSTRACT

BACKGROUND: Adjuvant anti-PD-1 therapy improves relapse free survival in stage III melanoma, but also leads to immune-related adverse events (irAEs). Older patients are of particular interest due to comorbidities and frailty, which may impact their ability to tolerate irAEs and benefit from anti-PD-1 therapy. This study aimed to explore associations between clinical parameters and the occurrence of grade ≥ 3 irAEs and recurrence-free survival (RFS) in older patients with radically resected stage III/IV cutaneous melanoma treated with adjuvant anti-PD-1 therapy. METHODS: Patients aged ≥ 65 with resected stage III/IV cutaneous melanoma treated with adjuvant anti-PD-1 therapy between 2018 and 2022 were selected using real-world data from the nationwide Dutch Melanoma Treatment Registry (DMTR). A univariate and multivariable logistic regression was used to compare determinants of grade ≥ 3 irAEs, and univariate and multivariable Cox-proportional hazard models were fitted to identify factors influencing RFS. RESULTS: The study included 885 patients, with 280 aged 75 and older. The incidence of grade ≥ 3 irAEs was 15.5 % in the 65-74 age group and 13.9 % in the ≥ 75 age group. No significant correlation was found between age and grade ≥ 3 irAEs. However, an increasing number of comorbidities was associated with a higher risk of grade ≥ 3 irAEs (multivariable analyses: OR 1.83, 95 % C.I. 0.99-3.40). The 1-year RFS rate of 80.0 % of this study was comparable to those reported in previous registration trials and real-world data. Having ≥ 3 comorbidities was significantly associated with a decrease in RFS (HR: 1.68, 95 % C.I. 1.15-2.44). CONCLUSION: Older patients had similar benefit of adjuvant immunotherapy compared to older subgroups in previous trials. However, patients with multiple comorbidities were at increased risk of grade ≥ 3 irAEs and had a lower RFS. This should be considered when deciding upon adjuvant treatment.

13.
Cancer Radiother ; 2024 Oct 04.
Article in French | MEDLINE | ID: mdl-39368919

ABSTRACT

The term "event" covers a wide range of concrete situations in radiation oncology, from particularly intense radiation-related side effects to the possibility of technical or human error. Although quality procedures are an integral part of radiotherapy oncology department operations ensuring the analysis and prevention of such events, their occurrence during radiation treatment still has a significant impact on patients and their experience of the treatment process, as well as on health professionals. These practical, emotional and symbolic impacts are all the greater when the event occurs in the aftermath of an error. The ethical approach therefore comprises three essential stages: recognizing the event as such, informing those involved of the event and, finally, creating conditions for the continuation of care. Each of these stages is marked by specific issues and questions, requiring a complex ethical approach that constantly involves reconciling the possible divergent perceptions of patients and health professionals. The occurrence of an event can also lead to a genuine crisis of confidence with multiple dimensions, which health professionals will also have to face and to support. Finally, the occurrence of an event calls into question not only our responsibility towards patients, but also our ideal of control. We need to criticize our culture of performance, rethink our approach to events and errors, and see them also as opportunities for positive change.

14.
Ther Innov Regul Sci ; 2024 Oct 06.
Article in English | MEDLINE | ID: mdl-39369117

ABSTRACT

INTRODUCTION: Recent research has raised questions about potential unintended consequences of the Inflation Reduction Act's Drug Price Negotiation Program (DPNP), suggesting that the timelines introduced by the law may reduce manufacturer incentives to invest in post-approval research towards additional indications. Given the role of multiple indications in expanding treatment options in patients with cancer, IRA-related changes to development incentives are especially relevant in oncology. This study aimed to describe heterogeneous drug-level trajectories and timelines of subsequent indications in a cohort of recently approved, multi-indication oncology drugs, including overall, across subgroups of drugs characterized by the timing and pace of additional indications, and by drug type (i.e., small molecule vs. biologic). METHODS: This cross-sectional study evaluated oncology drugs first approved by the FDA from 2008 to 2018 and later approved for one or more additional indications. Numbers, types, and approval timelines of subsequent indications were recorded at the drug level, with drugs grouped by quartile based on the pacing of post-approval development (i.e., "rapid pace" to "measured pace"). RESULTS: Multi-indication oncology drugs (N = 56/86, 65.1%) had one or more subsequent indication approved in a new: cancer type (60.7%), line of treatment (50.0%), combination (41.1%), mutation (32.1%), or stage (28.6%). The median time between FDA approvals for indications increased from 0.6 years (IQR: 0.48, 0.74) in the "rapid pace" group to 1.6 years (IQR: 1.32, 1.66), 2.4 years (IQR: 2.29, 2.61), and 4.9 years (IQR: 3.43, 6.23) in the "moderate," "measured-moderate," and "measured" pace groups, respectively. Drugs in the "rapid pace" group often received their first subsequent indication approval within 9 months of initial approval (median: 0.7 years; IQR: 0.54, 1.59), whereas the "measured pace" group took a median of 5.7 years (IQR: 3.43, 6.98). Across all multi-indication drugs, the median time to the most recent approval for a subsequent indication was 5.5 years (IQR: 3.18, 7.95). One quarter (25%) of drugs were approved for their most recent subsequent indication after the time at which they would be DPNP-eligible. CONCLUSION: Approval histories of new oncology drugs demonstrate the role of post-approval indications in expanding treatment options towards new cancer types, stages, lines, combinations, and mutations. Heterogeneous clinical development pathways provide insights into potential unintended consequences of IRA-related changes surrounding post-approval research and development.

15.
J Cancer Educ ; 2024 Oct 06.
Article in English | MEDLINE | ID: mdl-39369377

ABSTRACT

The objective of this study is to examine the efficacy of the flipped classroom blended teaching method in the context of massive open online courses (MOOCs) for implementing standardized training and teaching of residents in oncology radiotherapy. A total of 48 junior residents who received standardized training at the Oncology Radiology Department of Harbin Medical University Cancer Hospital between September 2021 and August 2023 were randomly divided into two groups-i.e., the research group (24 cases) and the control group (24 cases)-using the random number table method. The control group received conventional didactic training, whereas the research group participated in a blended learning approach based on the MOOC model. The assessment results, along with the evaluations of teaching effectiveness, self-learning ability, and teaching satisfaction questionnaires, were observed and compared for the two groups of students. Compared with the control group, the research group presented significantly higher scores on theoretical foundations, skill operation, and case analysis (P < 0.05). The research group also showed greater outcomes than the control group in terms of improved theoretical knowledge, problem-solving skills, self-learning ability, teamwork, and communication (P < 0.05). The students in the research group presented significantly higher scores on measures of self-motivation beliefs, task analysis, self-monitoring and adjustment, and self-evaluation than those in the control group (P < 0.05). The research group also demonstrated significantly higher levels of satisfaction than the control group in terms of improvements in learning interest and initiative, clinical thinking ability, problem-solving ability, team cooperation ability, and the level of radiotherapy target delineation (P < 0.05). The implementation of MOOC-based flipped classroom blended teaching was shown to have positive effects on the standardized training and teaching of residents in the field of oncology radiotherapy. This approach can undoubtedly enhance students' academic performance, problem-solving abilities, and self-learning aptitudes while effectively stimulating their learning interests and initiative. Therefore, MOOC-based flipped classroom blended teaching is a valuable candidate for clinical application and promotion.

16.
Front Rehabil Sci ; 5: 1384782, 2024.
Article in English | MEDLINE | ID: mdl-39363992

ABSTRACT

Background: Bone metastases are common in patients with progressive cancer and often present in long bones, leading to adverse events such as pathologic fractures. In the acute care setting, physical therapists (PTs) may be the initial providers who identify symptoms associated with fracture risk and communicate concerns to help prevent such adverse events. Case description: A 39-year-old female patient with metastatic breast cancer was admitted to the hospital due to uncontrolled pain. She had a history of bone metastases to the left femur; however, no restrictions or precautions were noted during the initial PT examination. During this initial PT examination, she reported worsening hip pain with weight-bearing activities. Outcomes: With the PT's recognition of red flag symptoms, an MRI was completed, which revealed extensive metastatic disease in her left femur with concern for an imminent fracture; as a result, prophylactic fixation was performed. Her functional abilities improved after surgery and consistent therapeutic intervention, allowing her to achieve a level of independence sufficient to return home safely. Discussion and conclusion: This case demonstrates the successful identification of imminent fracture risk by a PT in a patient with metastatic breast cancer, as well as the therapeutic management that accompanied this process in the acute care setting.

17.
Cureus ; 16(9): e68524, 2024 Sep.
Article in English | MEDLINE | ID: mdl-39364492

ABSTRACT

Glomus tumors arise from a neuromyoarterial plexus origin, typically demonstrating branching vascular channels and aggregates of specialized glomus cells. They are characteristically identified in the subungual region of the hand, with the presentation of firm, red or blue nodules that are painful and sensitive to temperature. However, very few cases of malignant glomus tumors of the skin have been reported in the medical literature, making this case quite unique. This case report aims to identify an additional case of this rare condition, discuss the treatment plan pursued, and bring awareness to this distinct oncological entity. A 41-year-old female patient initially presented to her primary care physician with an enlarging and painful nodule on her left temple that had been present for the last two months. The patient was then referred to plastic surgery for excision and pathological workup of the mass. The pathology report of the excised specimen revealed a malignant glomus tumor of the skin. The patient was subsequently scheduled for an oncologic workup with medical oncology and radiation oncology, and a wide excision was performed after the pathologic diagnosis. With negative margins from the wide excision and no evidence of disease spread, it was determined that there was no role for systemic therapy or radiation therapy at that time. Biannual dermatologic examination and monitoring are indicated for follow-up. With very few reports of similar cases and little information in the medical literature on the treatment of this type of neoplasm, this is a unique and rare case that warrants discussion and exposure. Making the correct diagnosis, performing a complete workup, and removing the malignant glomus tumor are all essential parts of medical management in this case, and this type of neoplasm should not be excluded when evaluating the presentation of unusual cutaneous lesions.

18.
Pediatr Blood Cancer ; : e31354, 2024 Oct 04.
Article in English | MEDLINE | ID: mdl-39367580

ABSTRACT

Pediatric surgeons engaged in oncology will inevitably treat patients receiving palliative care, but their role in this context is poorly described. This article identifies some of the challenges and opportunities of surgical involvement in pediatric oncology palliative care, underscoring how the surgeon's expertise can be exploited to significantly benefit children with cancer. Specific examples of skills (procedural, communication, and coordination) that surgeons can provide to the multidisciplinary palliative care teams are described and the importance of collaboration is highlighted.

19.
Cureus ; 16(8): e68314, 2024 Aug.
Article in English | MEDLINE | ID: mdl-39350828

ABSTRACT

Benign metastasizing leiomyoma (BML) is a rare medical condition characterized by metastasis of fibroid tissue from uterine leiomyomas to other areas of the body, most commonly the lungs. While BML is mostly prevalent in women with a prior history of uterine leiomyomas who underwent surgical intervention, this case report explores the case of a 50-year-old female who was diagnosed with pulmonary benign metastasizing leiomyoma (PBML) with no prior history of confirmed leiomyomas. After initially presenting with worsening cough and congestion, chest radiograph and computed tomography revealed multiple bilateral pulmonary nodules, initially raising concerns for malignancy. Further, a workup with bronchoscopy with fine needle aspiration and pulmonary lesion biopsy revealed the presence of smooth muscle tissue suggestive of PBML. Subsequent uterine ultrasonography revealed a 3-cm intramural uterine fibroid, supporting the diagnosis. This case highlights the diagnostic challenge posed by PBML due to its asymptomatic manifestation and radiological similarity with other serious conditions such as malignancy and sarcoidosis. The case further highlights the importance of recognizing typical radiological features of PBML and the necessity of histological examination for accurate diagnosis. Finally, the critical role of a multidisciplinary approach in managing such rare conditions and the need for individualized treatment are also explored.

20.
Ann Med Surg (Lond) ; 86(10): 6198-6202, 2024 Oct.
Article in English | MEDLINE | ID: mdl-39359825

ABSTRACT

Introduction and importance: Renal cell carcinoma (RCC) is the most common primary renal malignancy in patients between the ages of 50 and 70. A rare described variant of RCC is transcription factor for immunoglobulin heavy-chain enhancer 3 (TFE3) rearranged RCC. Osseous metaplasia, which refers to the occurrence of normal bone tissue in soft tissue, has been observed in all subtypes of renal cell carcinoma (RCC); however, only three previous case reports have documented the occurrence of osseous metaplasia in TFE3-rearranged RCC. Case presentation: We present a case of a 65-year-old woman presenting with an incidentally discovered calcified Bi-lobed renal mass detected on bone densitometry composed of a calcified thick-walled cyst measuring 7×6.5×6.5 cm showing intraluminal densities and heterogeneous content, and a lobulated partially exophytic renal mass measuring 4.5×5.5×4.5 cm. The patient underwent robotic-assisted radical nephrectomy confirming the diagnosis of RCC with osseous metaplasia extending into the pelvic calyces and renal sinus fat implicating a pathological stage of T3a. Clinical discussion: TFE3-rearranged RCCs represent a rare sub-classification in adult RCCs. It may be associated with unfavorable prognosis and aggressive patterns of disease in the presence of osseous metaplasia. Conclusion: This is the first case in the literature of TFE3-rearranged RCC with osseous metaplasia on bone mass densitometry scan and the fourth case of TFE3-rearranged RCC with osseous metaplasia. The patient is to be treated as a high-risk patient and to be monitored closely for recurrence of malignancy, as indicated in the EAU guidelines.

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