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1.
J Urol ; 210(2): 273-279, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37167628

RESUMO

PURPOSE: The clinical course of patients being placed on surveillance in a cohort of systemic therapy-naïve patients who undergo cytoreductive nephrectomy is not well documented. Thus, we evaluated the clinical course of patients placed on surveillance following cytoreductive nephrectomy and identified predictors of survival. MATERIALS AND METHODS: In this large single-institution study, we retrospectively analyzed metastatic renal cell carcinoma patients who underwent cytoreductive nephrectomy followed by surveillance. Predictors of survival were evaluated using the Kaplan-Meier method with a log-rank test. Patients were risk stratified based on IMDC (International mRCC Database Consortium) and number of metastatic sites (Rini score), with IMDC score ≤1 and ≤2 metastatic organ sites considered favorable risk. Primary end point was systemic therapy-free survival. Secondary end points included intervention-free survival, cancer-specific survival, and overall survival. RESULTS: Median systemic therapy-free survival was 23.6 months (95% CI: 15.1-40.6), intervention-free survival was 11.8 months (95% CI: 8.0-18.4), cancer-specific survival was 54.2 months (95% CI: 46.2-71.4), and overall survival 52.4 months (95% CI: 40.3-66.8). Favorable-risk patients compared to unfavorable-risk patients had longer systemic therapy-free survival (50.6 vs 11.1 months, P < .01), survival (25.2 vs 7.3, P < .01), and cancer-specific survival (71.4 vs 46.2 months, P = .02). CONCLUSIONS: Using risk stratification based on IMDC and number of metastatic sites, surveillance in favorable-risk patients can be utilized for a period without the initiation of systemic therapy. This approach can delay patients' exposure to the side effects of systemic therapy.


Assuntos
Carcinoma de Células Renais , Neoplasias Renais , Humanos , Carcinoma de Células Renais/patologia , Neoplasias Renais/patologia , Prognóstico , Estudos Retrospectivos , Procedimentos Cirúrgicos de Citorredução/métodos , Nefrectomia/métodos , Progressão da Doença
2.
Urol Int ; 106(1): 51-55, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-33902060

RESUMO

INTRODUCTION: Injuries to surrounding structures during radical prostatectomy (RP) are rare but serious complications. However, it remains unknown if injuries to intestines, rectum, or vascular structures occur at different rates depending on the surgical approach. METHODS: We compared the frequency of these outcomes in open RP (ORP) and minimally invasive RP (MIS-RP) using the national American College of Surgeons National Surgical Quality Improvement Program database (2012-2017). Along with important metrics of clinical and surgical outcomes, patients were identified as undergoing surgical repair of small or large bowel, vascular structures, or hernias based on Current Procedural Terminology codes. RESULTS: In our propensity matched analysis, a total of 13,044 patients were captured. Bowel injury occurred more frequently in ORP than in MIS-RP (0.89 vs. 0.26%, p < 0.01). By intestinal segment, rectal and large bowel injuries were more common in ORP than MIS-RP (0.41 vs. 0.11% and 0.31 vs. 0.05%, both p < 0.01). However, there was no statistically significant difference between the groups for small bowel injury (0.17 vs. 0.11%, p = 0.39). Vascular injury was more common in MIS-RP (0.18 vs. 0.08%, p = 0.08). Hernias requiring repair were only identified in the MIS-RP group (0.12%). CONCLUSION: When considering surgical approach, rectal and large bowel injuries were more common in ORP, while vascular injuries and hernia repair were more common in MIS-RP. Our findings can be used in counseling patients and identifying risk factors and strategies to reduce these complications.


Assuntos
Intestinos/lesões , Intestinos/cirurgia , Complicações Intraoperatórias/etiologia , Complicações Intraoperatórias/cirurgia , Prostatectomia/efeitos adversos , Prostatectomia/métodos , Neoplasias da Próstata/cirurgia , Idoso , Idoso de 80 Anos ou mais , Humanos , Masculino , Pessoa de Meia-Idade , Procedimentos Cirúrgicos Minimamente Invasivos , Estudos Retrospectivos
3.
Lung ; 199(2): 199-211, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33616727

RESUMO

PURPOSE: To characterize pulmonary toxicities associated with the use of novel immune checkpoint inhibitors METHODS: Adverse event reports from immune checkpoint inhibitors targeting PD-1/L1 and CTLA-4 were captured from the W.H.O pharmacovigilance database (VigiBase) up until Dec. 31st 2019 and were analyzed to evaluate for measures of association between the use of immune checkpoint inhibitors and pulmonary toxicities. Disproportionality analysis using both frequentist and Bayesian approaches were used to detect signals between pulmonary immune-related adverse events and the use of these agents. RESULTS: A total of 9202 adverse pulmonary immune checkpoint inhibitor-related events were captured up until 2019. Adverse pulmonary events were compromised of 1305 airway, 18 alveolar, 5491 interstitial, 898 pleural, 560 vascular and 939 non-specific pulmonary events. We found a common association between all immune checkpoint inhibitors studied and pneumonitis, interstitial lung disease, pulmonary embolism and respiratory failure. We also noted other associations between immune checkpoint inhibitors, however not as uniformly across agents. Most of these immune-related adverse drug reactions were noted to be severe and accounted for a significant source of mortality in the reported cases. CONCLUSION: Immune checkpoint inhibitors are associated with a spectrum of inflammatory pulmonary toxicities. The breadth of pulmonary complications and prevalence may be underappreciated with the use of these agents.


Assuntos
Inibidores de Checkpoint Imunológico/efeitos adversos , Pneumopatias/induzido quimicamente , Pneumopatias/epidemiologia , Bases de Dados Factuais , Humanos , Pneumopatias/diagnóstico , Farmacovigilância , Estudos Retrospectivos
4.
J Surg Oncol ; 121(3): 578-583, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-31916588

RESUMO

BACKGROUND: Venous thromboembolism (VTE) is a significant source of postoperative morbidity and mortality in patients undergoing common oncologic procedures. We sought to estimate the effect of surgical approach on the risk of developing a VTE. METHODS: IBM Watson Health Marketscan Database was used to conduct this retrospective study. In total, 12 938 patients who underwent either a radical prostatectomy, partial colectomy, or hysterectomy via a minimally invasive or open approach. We used a propensity-weighted logistic regression analysis to assess the independent effect of surgical approach on VTE. The primary outcome of interest was the 90-day rate of VTE after surgery. RESULTS: Patients undergoing minimally invasive surgery across all three surgical procedures were noted to have a lower odds of developing a VTE: (radical prostatectomy, odds ratio [OR]: 0.667, 95% confidence interval [CI]: 0.500-0.891; P = .006 |partial colectomy: OR, 0.620, 95% CI: 0.477-0.805; P < .001| hysterectomy: OR, 0.549 95% CI: 0.353-0.854; P = .008). CONCLUSION: We found that a minimally invasive approach was associated with significantly lower odds of VTE compared with undergoing the same open procedure. This study highlights how surgical approach may be an independent risk factor for development of VTE and may elucidate potential risk mitigation strategy.


Assuntos
Colectomia/métodos , Histerectomia/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Neoplasias/cirurgia , Complicações Pós-Operatórias , Prostatectomia/métodos , Tromboembolia Venosa/epidemiologia , Adulto , Feminino , Seguimentos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Neoplasias/patologia , Prognóstico , Estudos Retrospectivos , Fatores de Risco
6.
Am J Otolaryngol ; 38(2): 204-207, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28139320

RESUMO

PURPOSE: Many head and neck surgical procedures are considered clean-contaminated wounds and antibiotic prophylaxis is recommended. Despite prophylaxis, the incidence of surgical site infections remains significant - especially in the setting of free tissue transfer. The antibiotic course is often of a longer duration after free tissue transfer than the recommended 24hour post-operatively. Currently, there is no consensus on appropriate antibiotic regimen or duration at this time. This study investigates the outcomes of a 7-day perioperative antibiotic regimen after microvascular reconstruction of the head and neck at our institution. MATERIALS AND METHODS: A retrospective review was performed of 72 patients undergoing microvascular free tissue at our institution between 09/2011 and 03/2014. The antibiotic regimen, post-operative surgical (including surgical site infections) and medical complications were noted. Our rates of complications and adverse events were compared to all surgical patients, as well as all inpatients hospital-wide with use of the University Health System Consortium database. RESULTS: Seventy-two subjects met inclusion criteria for this study. The majority of subjects received cefazolin/metronidazole (69.4%). Subjects with beta-lactam allergy received clindamycin (12.5%). The remainder received an alternative regimen (18.1%). All received at least 7days of antibiotics. The rate of hospital acquired C. difficile diarrhea was 0.57% hospital-wide, 1.13% in Otolaryngology patients, and 1.4% in this study. There were no instances of a multi-drug resistant infection or any adverse reactions to the administration of antibiotics. When compared with other antibiotic regimens, clindamycin was associated with a significantly increased rate of either medical or surgical infections (OR 14.38, p=0.02) and longer hospital stay (average=18days, p<0.05). CONCLUSION: The use of a 7-day prophylactic antibiotic regimen is not associated with an increased risk of antibiotic-associated infections, multi-drug resistant infections, or antibiotic-associated complications. The use of clindamycin is associated with increased risk of medical and surgical infections post-operatively and should be avoided in the prophylactic perioperative phase after free tissue transfer of the head and neck.


Assuntos
Antibioticoprofilaxia , Neoplasias de Cabeça e Pescoço/cirurgia , Procedimentos de Cirurgia Plástica/métodos , Infecção da Ferida Cirúrgica/prevenção & controle , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Retalhos de Tecido Biológico , Humanos , Masculino , Microcirurgia , Pessoa de Meia-Idade , Estudos Retrospectivos
10.
BJU Int ; 115(5): 713-21, 2015 May.
Artigo em Inglês | MEDLINE | ID: mdl-24674655

RESUMO

OBJECTIVES: To evaluate the relationship between surgeon volume of radical cystectomy (RC) and postoperative morbidity, and to assess the economic burden of bladder cancer in the USA. METHODS: We captured all patients who underwent RC (International Classification of Diseases, ninth revision, code 57.71) between 2003 and 2010, using a nationwide hospital discharge database. Patient, hospital and surgical characteristics were evaluated. The annual volume of RCs performed by the surgeons was divided into quintiles. Multivariable regression models were developed, adjusting for clustering and survey weighting, to evaluate the outcomes, including 90-day major complications (Clavien grade III-V) and direct patient costs. We adjusted for clustering and weighting to achieve a nationally representative analysis. RESULTS: The weighted cohort included 49,792 patients who underwent RC, with an overall 90-day major complication rate of 16.2%. Compared with surgeons performing one RC annually, surgeons performing ≥7 RCs each year had 45% lower odds of major complications (odds ratio [OR] 0.55; P < 0.001) and lower costs by $1690 (P = 0.02). Results were consistent when we analysed surgeon volume as a continuous variable and when we examined the surgeons with the highest volumes (≥28 cases annually), which showed markedly lower odds of major complications compared with the surgeons with the lowest volumes (OR 0.45, 95% CI 0.31-0.67; P < 0.001). Compared with patients who did not have any complications, those who had a major complication were associated with significantly higher 90-day median direct hospital costs ($43,965 vs $24,341; P < 0.001). CONCLUSIONS: We showed that there was an inverse relationship between surgeon volume and the development of postoperative 90-day major complication rates as well as direct hospital costs. Centralisation of RC to surgeons with higher volumes may reduce the development of postoperative major complications, thereby decreasing the burden of bladder cancer on the healthcare system.


Assuntos
Cistectomia/economia , Cistectomia/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Neoplasias da Bexiga Urinária/economia , Neoplasias da Bexiga Urinária/cirurgia , Idoso , Custos e Análise de Custo , Feminino , Humanos , Masculino , Estudos Retrospectivos , Estados Unidos
11.
J Urol ; 191(3): 842-9, 2014 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-24035881

RESUMO

PURPOSE: DNA damage responses are relevant to prostate cancer initiation, progression and treatment. Few models of the normal and malignant human prostate that maintain stromal-epithelial interactions in vivo exist in which to study DNA damage responses. We evaluated the feasibility of maintaining tissue slice grafts at subcutaneous vs subrenal capsular sites in RAG2(-/-)γC(-/-) mice to study the DNA damage responses of normal and malignant glands. MATERIALS AND METHODS: We compared the take rate and histology of tissue slice grafts from fresh, precision cut surgical specimens that were maintained for 1 to 4 weeks in subcutaneous vs subrenal capsular sites. Induction of γH2AX, p53, ATM and apoptosis was evaluated as a measure of the DNA damage response after irradiation. RESULTS: The take rate of subcutaneous tissue slice grafts was higher than typically reported but lower than at the subrenal capsular site. Subcutaneous tissue slice grafts frequently showed basal cell hyperplasia, squamous metaplasia and cystic atrophy, and cancer did not survive. In contrast, normal and malignant histology was well maintained in subrenal capsular tissue slice grafts. Regardless of implantation site the induction of γH2AX and ATM occurred in tissue slice graft epithelium 1 hour after irradiation and decreased to basal level by 24 hours, indicating DNA damage recognition and repair. As observed previously in prostatic ex vivo models, p53 was not activated. Notably, tumor but not normal cells responded to irradiation by undergoing apoptosis. CONCLUSIONS: To our knowledge this is the first study of DNA damage responses in a patient derived prostate tissue graft model. The subrenal capsular site of RAG2(-/-)γC(-/-) mice optimally maintains normal and malignant histology and function, permitting novel studies of DNA damage responses in a physiological context.


Assuntos
Dano ao DNA , Neoplasias da Próstata/genética , Transplante de Tecidos/métodos , Animais , Apoptose , Reparo do DNA , Humanos , Imuno-Histoquímica , Masculino , Camundongos , Microscopia de Fluorescência , Gradação de Tumores , Próstata/patologia , Neoplasias da Próstata/patologia
12.
Urol Pract ; : 101097UPJ0000000000000623, 2024 Jun 12.
Artigo em Inglês | MEDLINE | ID: mdl-38913557

RESUMO

INTRODUCTION: Oncological outcomes in patients with nonclear cell renal cell carcinoma (non-ccRCC) treated with surgery for locoregional nodal disease (ND) remain incompletely characterized. The objective was to investigate the characteristics and outcomes of non-ccRCC patients treated with lymph node dissection (LND) and salvage-LND (S-LND). METHODS: A total of 1627 patients underwent nephrectomy for nonmetastatic non-ccRCC at Memorial Sloan Kettering Cancer Center between 2007 and 2023. Histology was grouped as papillary, chromophobe, unclassified, and rare subtypes. Retrospective evaluation identified 2.5% (n = 40) of patients with nodal disease at time of nephrectomy (synchronous-ND) and 1.1% (n = 18) with metachronous nodal disease limited to the retroperitoneum (metachronous-ND). Patients' demographics and tumor characteristics were recorded and evaluated by univariate and multivariate cox regression models. Recurrence-free survival (RFS) and overall survival (OS) were estimated by the Kaplan-Meier method. Patients who underwent tumor DNA sequencing during their clinical course were considered for genomic analysis. RESULTS: OS trended toward longer in metachronous-ND (51 vs 105 months; P = .2), though 23% of patients with synchronous-ND were recurrence-free at 45 months median follow-up. In multivariate analysis, rare histologies were associated with decreased OS (P = .030) and metachronous-ND with improved OS (P = .036). RFS and OS after S-LND was 15 and 96 months, respectively. Late onset of metachronous-ND/recurrence was associated with improved OS (P = .008). Genetic alterations in SETD2, TP53, B2M, and FGFR3 were exclusively seen in synchronous-ND, and tumor mutation burden (TMB) was also higher in patients with synchronous-ND (P = .016). CONCLUSIONS: Patients with metachronous-ND tend to have prolonged OS compared to synchronous-ND, but a substantial portion of patients with synchronous-ND still enter a durable disease-free state following LND. S-LND can likewise provide long-term survival, particularly in patients with longer time to metachronous nodal recurrence. Synchronous-ND was associated with SETD2, TP53, and NF2 alteration as well as higher TMB.

13.
Urol Oncol ; 42(2): 32.e9-32.e16, 2024 02.
Artigo em Inglês | MEDLINE | ID: mdl-38135627

RESUMO

PURPOSE: The use of systemic immune checkpoint blockade before surgery is increasing in patients with metastatic renal cell carcinoma, however, the safety and feasibility of performing consolidative cytoreductive nephrectomy after the administration of systemic therapy are not well described. PATIENTS AND METHODS: A retrospective review of patients undergoing nephrectomy was performed using our prospectively maintained institutional database. Patients who received preoperative systemic immunotherapy were identified, and the risk of postoperative complications were compared to those who underwent surgery without upfront systemic treatment. Perioperative characteristics and surgical complications within 90 days following surgery were recorded. RESULTS: Overall, we identified 220 patients who underwent cytoreductive nephrectomy from April 2015 to December 2022, of which 46 patients (21%) received systemic therapy before undergoing surgery. Unadjusted rates of surgical complications included 20% (n = 35) in patients who did not receive upfront systemic therapy and 20% (n = 9) in those who received upfront systemic immunotherapy. In our propensity score analysis, there was no statistically significant association between receipt of upfront immunotherapy and 90-day surgical complications [odds ratio (OR): 1.82, 95% confidence interval (CI): 0.59-5.14; P = 0.3]. This model, however, demonstrated an association between receipt of upfront immunotherapy and an increased odds of requiring a blood transfusion [OR: 4.53, 95% CI: 1.83-11.7; P = 0.001]. CONCLUSION: In our cohort, there was no significant difference in surgical complications among patients who received systemic therapy before surgery compared to those who did not receive upfront systemic therapy. Cytoreductive nephrectomy is safe and with low rates of complications following the use of systemic therapy.


Assuntos
Carcinoma de Células Renais , Neoplasias Renais , Humanos , Carcinoma de Células Renais/cirurgia , Carcinoma de Células Renais/etiologia , Neoplasias Renais/cirurgia , Neoplasias Renais/etiologia , Procedimentos Cirúrgicos de Citorredução , Imunoterapia , Resultado do Tratamento , Nefrectomia/efeitos adversos , Estudos Retrospectivos
14.
J Transl Med ; 11: 199, 2013 Aug 28.
Artigo em Inglês | MEDLINE | ID: mdl-23985008

RESUMO

BACKGROUND: Effective eradication of high-risk primary prostate cancer (HRPCa) could significantly decrease mortality from prostate cancer. However, the discovery of curative therapies for HRPCa is hampered by the lack of authentic preclinical models. METHODS: We improved upon tumorgraft models that have been shown to predict drug response in other cancer types by implanting thin, precision-cut slices of HRPCa under the renal capsule of immunodeficient mice. Tissue slice grafts (TSGs) from 6 cases of HRPCa were established in mice. Following androgen deprivation by castration, TSGs were recovered and the presence and phenotype of cancer cells were evaluated. RESULTS: High-grade cancer in TSGs generated from HRPCa displayed characteristic Gleason patterns and biomarker expression. Response to androgen deprivation therapy (ADT) was as in humans, with some cases exhibiting complete pathologic regression and others showing resistance to castration. As in humans, ADT decreased cell proliferation and prostate-specific antigen expression in TSGs. Adverse pathological features of parent HRPCa were associated with lack of regression of cancer in corresponding TSGs after ADT. Castration-resistant cancer cells remaining in TSGs showed upregulated expression of androgen receptor target genes, as occurs in castration-resistant prostate cancer (CRPC) in humans. Finally, a rare subset of castration-resistant cancer cells in TSGs underwent epithelial-mesenchymal transition, a process also observed in CRPC in humans. CONCLUSIONS: Our study demonstrates the feasibility of generating TSGs from multiple patients and of generating a relatively large number of TSGs from the same HRPCa specimen with similar cell composition and histology among control and experimental samples in an in vivo setting. The authentic response of TSGs to ADT, which has been extensively characterized in humans, suggests that TSGs can serve as a surrogate model for clinical trials to achieve rapid and less expensive screening of therapeutics for HRPCa and primary CRPC.


Assuntos
Androgênios/deficiência , Neoplasias da Próstata/terapia , Androgênios/farmacologia , Animais , Biomarcadores Tumorais/metabolismo , Caderinas/metabolismo , Proliferação de Células/efeitos dos fármacos , Transição Epitelial-Mesenquimal/efeitos dos fármacos , Transição Epitelial-Mesenquimal/genética , Regulação Neoplásica da Expressão Gênica/efeitos dos fármacos , Humanos , Imuno-Histoquímica , Masculino , Camundongos , Orquiectomia , Neoplasias da Próstata/genética , Neoplasias da Próstata/patologia , Receptores Androgênicos/metabolismo , Fatores de Risco , Vimentina/metabolismo , Ensaios Antitumorais Modelo de Xenoenxerto
15.
Urol Clin North Am ; 50(1): 151-159, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36424079

RESUMO

Renal cell carcinoma biomarkers include serum, urine, liquid, and tissue biomarkers. There is currently an ongoing search for predictive biomarkers in the detection, recurrence, and treatment of renal cell carcinoma. Emerging signatures in the transcriptomic and translational biomarker space seem promising, although additional work is needed to validate candidates in a larger and more generalizable patient population.


Assuntos
Carcinoma de Células Renais , Neoplasias Renais , Humanos , Carcinoma de Células Renais/diagnóstico , Carcinoma de Células Renais/genética , Carcinoma de Células Renais/terapia , Biomarcadores Tumorais , Neoplasias Renais/diagnóstico , Neoplasias Renais/terapia , Neoplasias Renais/patologia
16.
Radiol Case Rep ; 18(8): 2768-2770, 2023 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-37334328

RESUMO

A 73-year-old man with biopsy-proven Gleason 3+3 prostate cancer presented with a new mass centered in the seminal vesicles with invasion of the base of the prostate on surveillance prostate MRI. Targeted biopsy showed atypical lymphoid proliferation, suspicious for lymphoma. The patient was referred to the nuclear medicine department for [18F]fluoro-D-glucose positron emission tomography/computed tomography (18F-FDG PET/CT). Multisite 18F-FDG-avid lymphadenopathy observed, as well as FDG uptake in the new mass. Core biopsy from dominant mesenteric mass revealed follicular lymphoma.

17.
Cancers (Basel) ; 15(2)2023 Jan 05.
Artigo em Inglês | MEDLINE | ID: mdl-36672304

RESUMO

Cross-sectional imaging is the standard diagnostic tool to determine underlying biology in renal masses, which is crucial for subsequent treatment. Currently, standard CT imaging is limited in its ability to differentiate benign from malignant disease. Therefore, various modalities have been investigated to identify imaging-based parameters to improve the noninvasive diagnosis of renal masses and renal cell carcinoma (RCC) subtypes. MRI was reported to predict grading of RCC and to identify RCC subtypes, and has been shown in a small cohort to predict the response to targeted therapy. Dynamic imaging is promising for the staging and diagnosis of RCC. PET/CT radiotracers, such as 18F-fluorodeoxyglucose (FDG), 124I-cG250, radiolabeled prostate-specific membrane antigen (PSMA), and 11C-acetate, have been reported to improve the identification of histology, grading, detection of metastasis, and assessment of response to systemic therapy, and to predict oncological outcomes. Moreover, 99Tc-sestamibi and SPECT scans have shown promising results in distinguishing low-grade RCC from benign lesions. Radiomics has been used to further characterize renal masses based on semantic and textural analyses. In preliminary studies, integrated machine learning algorithms using radiomics proved to be more accurate in distinguishing benign from malignant renal masses compared to radiologists' interpretations. Radiomics and radiogenomics are used to complement risk classification models to predict oncological outcomes. Imaging-based biomarkers hold strong potential in RCC, but require standardization and external validation before integration into clinical routines.

18.
Prostate Cancer Prostatic Dis ; 26(2): 331-337, 2023 06.
Artigo em Inglês | MEDLINE | ID: mdl-35436999

RESUMO

BACKGROUND: Conflicting evidence exists regarding whether hormone therapy for prostate cancer is associated with neurotoxicity. Thus, we aim to characterize the association between different types of hormone therapy and neurocognitive impairment in a real-world pharmacovigilance database. METHODS: We queried VigiBase, the World Health Organization's international pharmacovigilance database, for reports of neurocognitive impairment among men who took hormone therapy from 1968 to 2021. We performed disproportionality analysis comparing rates of neurocognitive impairment with different types of hormone therapy versus other VigiBase drugs. Traditional hormonal therapy was defined as androgen deprivation therapy (ADT: gonadotropin-releasing-hormone agonists or antagonists) or first-generation androgen receptor (AR) antagonists. Novel AR signaling inhibitors (ARSIs) were defined as ARSIs with or without ADT. Differences were assessed using reporting odds ratio (ROR) with 95% confidence intervals (CI) and Empirical Bayes Estimator (EBE) values ≥1.0 signifying statistical significance. RESULTS: Odds of neurocognitive impairment were significantly elevated with traditional hormone therapy (ROR 1.47, 95% CI 1.34-1.62, EBE = 1.35) and novel ARSIs (ROR 2.40, 95% CI 2.28-2.54, EBE = 2.26). Odds of neurocognitive impairment were significantly elevated with enzalutamide (ROR 2.89, 95% CI 2.73-3.05, EBE = 2.70) and numerically increased with apalutamide (ROR 3.31, 95% CI 1.57-7.00, EBE = 0.98), but were decreased with abiraterone (ROR 0.68, 95% CI 0.55-0.84, EBE = 0.57). CONCLUSIONS: This study demonstrates elevated odds of neurocognitive impairment with hormone therapy in a real-world data set. Neurotoxicity risk was higher with novel ARSIs than traditional agents, and higher with enzalutamide than abiraterone. Due to limitations inherent to disproportionality analysis (measuring associations, not risk) and incomplete data prohibiting the ability to control for factors such as age or use of secondary drugs (e.g., concurrent use of novel ARSIs with ADT), results are exploratory in nature. The amalgamation of these and other conflicting data may contribute to clinical decision-making for men with prostate cancer eligible for treatment with these therapies, especially those with significant neurologic comorbidities.


Assuntos
Neoplasias da Próstata , Masculino , Humanos , Neoplasias da Próstata/tratamento farmacológico , Antagonistas de Androgênios/efeitos adversos , Farmacovigilância , Androgênios/uso terapêutico , Receptores Androgênicos , Teorema de Bayes
19.
Clin Genitourin Cancer ; 21(1): 63-68, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36517393

RESUMO

BACKGROUND: Sarcomatoid differentiation in patients diagnosed with renal cell carcinoma (sRCC) imply aggressive behavior and often metastatic disease at the time of diagnosis. We aim to examine the overall survival (OS) in patients with sRCC using the National Cancer Database (NCDB). MATERIALS AND METHODS: We identified patients diagnosed with sRCC between 2010-2015. We employed Kaplan-Meier curves and multivariable Cox proportional hazards regression models to examine the impact of several potential risk factors on OS in patients diagnosed with sRCC. RESULTS: In total, 8582 patients with renal cancer were found to have sarcomatoid differentiation, with 4105 patients (47.8%) being diagnosed with AJCC stage IV disease. The median OS was 17.2 months (IQR 5.4, 68.7 months). Compared to patients who did not undergo surgery, OS was significantly longer in patients undergoing partial or total nephrectomy across all stages. This result remained consistent on multivariable Cox proportional hazards regression adjusting for patient and tumor characteristics (Surgery: Hazard ratio 0.54, 95%Confidence interval 0.43 - 0.68, P < .001). CONCLUSION: In our cohort sRCC was found to have an unfavorable median OS, which was mainly caused by the high number of cases diagnosed with late-stage disease. Additionally, surgery was associated with favorable OS across all stages. This study supports the notion that surgical therapy, even in the setting of cytoreductive surgery, provides a survival benefit in patients with sRCC.


Assuntos
Carcinoma de Células Renais , Neoplasias Renais , Humanos , Carcinoma de Células Renais/patologia , Prognóstico , Estudos Retrospectivos , Neoplasias Renais/patologia , Nefrectomia , Diferenciação Celular
20.
Urol Oncol ; 41(8): 354.e19-354.e26, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37286403

RESUMO

PURPOSE: To report the trends, predictors, and patient outcomes of same-day discharge (SDD) versus non-SDD for robot-assisted laparoscopic radical prostatectomy (RALP). MATERIALS AND METHODS: We queried our centralized data warehouse to identify men with prostate cancer who underwent RALP between January 2020 and May 2022. Patient demographics and clinical characteristics were compared between SDD and non-SDD. Then, we examined the utilization of SDD in a univariable logistic regression. Then, we fitted a logistic regression model to identify the predictors of SDD. To examine the safety profile of SDD, an inverse probability of treatment weighting (IPTW) adjusted logistic regression was fitted to examine the effect of SDD on 30-day postoperative complications and readmissions. RESULTS: Overall, 1,153 patients underwent RALP, of which 224 (19.4%) were SDD. The proportion of SDD increased from 4.4% in the fourth quarter of 2020 to 45% in the second quarter of 2022 (p < 0.01). The predictors of SDD were the facility where the surgery was performed (OR: 1.57; 95%CI [1.08-2.28]; p = 0.02) and whether a high-volume surgeon performed it (OR: 1.96; 95%CI [1.09-3.54]; p = 0.03). After IPTW, SDD compared to non-SDD was not associated with a difference in complications (OR: 1.07; 95%CI [0.38-2.95]; p = 0.90) or readmissions (OR: 1.22; 95%CI [0.40-3.74]; p = 0.72). CONCLUSION: In our health system, the use of SDD is safe and currently composes of half of our RALP volume. With the advent of the hospital-at-home services, we anticipate that almost all our RALP cases will be SDD.


Assuntos
Laparoscopia , Neoplasias da Próstata , Procedimentos Cirúrgicos Robóticos , Robótica , Masculino , Humanos , Estudos Retrospectivos , Alta do Paciente , Prostatectomia/efeitos adversos , Procedimentos Cirúrgicos Robóticos/efeitos adversos , Neoplasias da Próstata/cirurgia , Neoplasias da Próstata/complicações , Laparoscopia/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/cirurgia , Resultado do Tratamento
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