55 results on '"Jannello LMI"'
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2. Differences in life expectancy of adrenocortical carcinoma patients vs. age‑ and sex-matched population controls.
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Jannello LMI, Baudo A, Scheipner L, de Angelis M, Siech C, Di Bello F, Goyal JA, Vitucci K, Tian Z, Luzzago S, Mistretta FA, Ferro M, Saad F, Chun FKH, Briganti A, Carmignani L, Longo N, de Cobelli O, Musi G, and Karakiewicz PI
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- Humans, Female, Male, Middle Aged, Adult, Aged, Survival Rate, Case-Control Studies, Age Factors, Adrenocortical Carcinoma mortality, Adrenocortical Carcinoma pathology, Life Expectancy, Adrenal Cortex Neoplasms mortality, Adrenal Cortex Neoplasms pathology
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Purpose: To quantify to what extent the 5-year overall survival (OS) of adrenocortical carcinoma (ACC) patients differs from age- and sex-matched population-based controls, especially when stage is considered., Methods: We relied on the Surveillance, Epidemiology, and End Results database (2004-2020) to identify newly diagnosed (2004-2014) ACC patients. Subsequently, we compared OS between ACC patients relative to simulated age- and sex-matched controls (Monte Carlo simulation), according to Social Security Administration Life Tables (2004-2020)., Results: Of all 742 ACC patients, 301 (41%) harbored localized stage, 173 (23%) locally advanced stage, and 268 (36%) metastatic stage. At 5-years follow-up, ACC patients' OS was 33%. After stratification for stage, the 5-years OS was 55 vs. 31 vs. 8% in localized, locally advanced, and metastatic stages, respectively. Conversely, after Monte Carlo simulation of age- and sex-matched controls, OS at five-years was 93% in the entire simulated cohort vs. 94% in the simulated localized cohort vs. 92 and 92% in locally advanced and metastatic stage, respectively. The resulting differences in OS between ACC patients and age- and sex-matched population-based controls were 60 vs. 39 vs. 61 vs. 84% respectively in the overall cohort vs. localized vs. locally advanced vs. metastatic stage., Conclusion: The most pronounced life expectancy detriment (84%) was recorded in metastatic ACC followed by locally advanced ACC patients (61%). Unfortunately, even in patients with localized ACC, life expectancy was 39% lower than that of the general population. Therefore, regardless of stage, ACC diagnosis results in a very pronounced detriment in life expectancy relative to the general population., Competing Interests: Declarations. Conflict of interest: The authors have declared no conflicts of interest., (© 2024. The Author(s), under exclusive licence to Springer Nature B.V.)
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- 2025
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3. Critical Care Therapy After Cytoreductive Nephrectomy for Metastatic Kidney Cancer.
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Siech C, de Angelis M, Jannello LMI, Di Bello F, Rodriguez Peñaranda N, Goyal JA, Tian Z, Saad F, Shariat SF, Puliatti S, Longo N, de Cobelli O, Briganti A, Hoeh B, Mandel P, Kluth LA, Chun FKH, and Karakiewicz PI
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- Humans, Aged, Female, Male, Middle Aged, Kidney Neoplasms pathology, Kidney Neoplasms surgery, Kidney Neoplasms mortality, Nephrectomy methods, Cytoreduction Surgical Procedures methods, Critical Care statistics & numerical data, Hospital Mortality
- Abstract
Objectives: To examine critical care therapy rates after cytoreductive nephrectomy in metastatic kidney cancer patients., Design, Setting, and Patients: Relying on the National Inpatient Sample (2000-2019), we addressed critical care therapy use (total parenteral nutrition, invasive mechanical ventilation, renal replacement therapy, percutaneous endoscopic gastrostomy tube insertion, and tracheostomy) and in-hospital mortality in surgically treated metastatic kidney cancer patients. Estimated annual percentage changes and multivariable logistic regression models were fitted., Interventions: None., Measurements and Main Results: Of 10,915 patients, 802 (7.3%) received critical care therapy and 249 (2.4%) died in-hospital. Over time, critical care therapy rates did not differ significantly (6.6% in 2000 to 5.7% in 2019; p = 0.07), while in-hospital mortality decreased from 2.3% to 1.9% (p = 0.004). Age 71 years old or older (odds ratio [OR], 1.43; p < 0.001) and higher comorbidity burden (Charlson Comorbidity Index [CCI] ≥ 3: OR, 2.92; p < 0.001 and CCI 1-2: OR, 1.45; p < 0.001) independently predicted higher critical care therapy rates. Conversely, partial nephrectomy (OR, 0.51; p = 0.003) and minimally invasive surgery (OR, 0.33; p < 0.001) predicted lower critical care therapy rates. Virtually the same associations were recorded for in-hospital mortality., Conclusions: After cytoreductive nephrectomy, critical care therapy rate was 7.3% vs. in-hospital mortality was 2.4%. Of patients at highest risk of critical care therapy need were those with CCI greater than or equal to 3 and those 71 years old or older. Ideally, these patients should represent targets for thorough assessment of risk factors for complications before cytoreductive nephrectomy., Competing Interests: Dr. Siech was awarded a scholarship by the Stiftung Giersch. The remaining authors have disclosed that they do not have any potential conflicts of interest., (Copyright © 2024 by the Society of Critical Care Medicine and Wolters Kluwer Health, Inc. All Rights Reserved.)
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- 2025
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4. Neoadjuvant chemotherapy before radical cystectomy in patients with organ-confined and non-organ-confined urothelial carcinoma.
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de Angelis M, Jannello LMI, Siech C, Baudo A, Di Bello F, Goyal JA, Tian Z, Longo N, de Cobelli O, Chun FKH, Saad F, Shariat SF, Carmignani L, Gandaglia G, Moschini M, Montorsi F, Briganti A, and Karakiewicz PI
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- Humans, Male, Female, Aged, Middle Aged, Chemotherapy, Adjuvant methods, Neoplasm Staging, Retrospective Studies, Survival Rate, Cystectomy methods, Neoadjuvant Therapy methods, Urinary Bladder Neoplasms surgery, Urinary Bladder Neoplasms drug therapy, Urinary Bladder Neoplasms pathology, Carcinoma, Transitional Cell surgery, Carcinoma, Transitional Cell drug therapy, Carcinoma, Transitional Cell pathology
- Abstract
Introduction: Neoadjuvant chemotherapy (NAC) before radical cystectomy (RC) is guideline-recommended in patients with cT2-T4N0M0 urothelial carcinoma of urinary bladder (UCUB). However, no population-based study validated the survival benefit of NAC recorded in clinical trials in a stage-specific fashion. We addressed this knowledge gap., Methods: Within the Surveillance, Epidemiology, and End Results database (2007-2020), we identified patients with cT2-T4N0M0 UCUB treated with NAC before RC versus RC alone. Cumulative incidence plots and multivariable competing risks regression (CRR) models were fitted. Survival analyses were performed according to organ confined (OC: cT2N0M0) versus nonorgan confined stages (NOC: cT3-T4N0M0)., Results: Of 3,743 assessable patients, 1,020 (27%) underwent NAC versus 2,723 (73%) RC alone. NAC rates increased over time in OC stage (EAPC = 11.9%, P < 0.001) and NOC stage (EAPC = 8.6%, P < 0.001). In OC stage, cumulative incidence plots derived 5-year CSM was 15.6% in NAC and 19.9% in RC alone patients (P = 0.008). In multivariable CRR models, NAC independently predicted lower CSM (hazard ratio (HR): 0.74, P = 0.01). Similarly, in NOC stage, cumulative incidence plots derived 5-year CSM was 36.1% in NAC and 46.0% in RC alone patients (P = 0.01). In multivariable CRR models, NAC independently predicted lower CSM (HR: 0.66, P < 0.001)., Conclusion: NAC is associated with improved CSM compared to RC alone, both in OC and NOC stages. Specifically, the magnitude of the protective NAC effect was greater in NOC than OC patients. Thus, NAC should always be administered in all eligible patients before RC., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)
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- 2025
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5. Microwave vs radiofrequency ablation for small renal masses: perioperative and oncological outcomes.
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Jannello LMI, Orsi F, Luzzago S, Mauri G, Mistretta FA, Piccinelli ML, Vaccaro C, Tozzi M, Maiettini D, Varano G, Caramella S, Della Vigna P, Ferro M, Bonomo G, Tian Z, Karakiewicz PI, De Cobelli O, and Musi G
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- Humans, Male, Female, Retrospective Studies, Middle Aged, Aged, Treatment Outcome, Neoplasm Recurrence, Local, Operative Time, Carcinoma, Renal Cell surgery, Carcinoma, Renal Cell pathology, Kidney Neoplasms surgery, Kidney Neoplasms pathology, Microwaves therapeutic use, Radiofrequency Ablation methods
- Abstract
Objective: To conduct a comprehensive comparison of microwave ablation (MWA) vs radiofrequency ablation (RFA) outcomes in the treatment of small renal masses (SRMs), specifically: TRIFECTA ([i] complete ablation, [ii] absence of Clavien-Dindo Grade ≥III complications, and [iii] absence of ≥30% decrease in estimated glomerular filtration rate) achievement, operative time (OT), and local recurrence rate (LRR)., Patients and Methods: We retrospectively analysed 531 patients with SRMs (clinical T1a-b) treated with MWA or RFA at a single centre (2008-2022). First, multivariable logistic regression models were used for testing TRIFECTA achievement. Second, multivariable Poisson regression models were used to evaluate variables associated with longer OT. Finally, Kaplan-Meier plots depicted LRR over time. All analyses were repeated after 1:1 propensity score matching (PSM)., Results: Of 531 patients with SRMs, 373/531 (70.2%) underwent MWA and 158/531 (29.8%) RFA. MWA demonstrated superior TRIFECTA achievement (314/373 [84.2%]) compared to RFA (114/158 [72.2%], P = 0.001). These differences were driven by higher rates of complete ablation in MWA- vs RFA-treated patients (348/373 [93.3%] vs 137/158 [86.7%], P < 0.001). In multivariable logistic regression models, MWA was associated with higher TRIFECTA achievement, compared to RFA, before (odds ratio [OR] 1.92, P = 0.008) and after PSM (OR 1.99, P = 0.023). Finally, the median OT was shorter for MWA vs RFA (105 vs 115 min; P = 0.002). At Poisson regression analyses, MWA predicted shorter OT before (incidence rate ratio [IRR] 0.86, P < 0.001) and after PSM (IRR 0.85, P < 0.001). Local recurrence occurred in 17/373 (4.6%) MWA-treated patients and 21/158 (13.3%) RFA-treated patients (P = 0.29) after a median (interquartile range) follow-up of 24 (8-46) months. There were no differences in the LRR in Kaplan-Meier plots before (P = 0.29) and after PSM (P = 0.42)., Conclusion: Microwave ablation provides higher TRIFECTA achievement, and shorter OT than RFA. No significant differences were found regarding the LRR., (© 2024 BJU International.)
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- 2025
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6. Life expectancy in rare histological prostate cancer subtypes.
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Siech C, de Angelis M, Jannello LMI, Di Bello F, Rodriguez Peñaranda N, Goyal JA, Tian Z, Saad F, Shariat SF, Puliatti S, Longo N, de Cobelli O, Briganti A, Wenzel M, Mandel P, Kluth LA, Chun FKH, and Karakiewicz PI
- Abstract
Survival differences in rare histological prostate cancer (PCa) subtypes relative to age-matched population-based controls are unknown. Within Surveillance, Epidemiology, and End Results database (2004-2020), newly diagnosed (2004-2015) PCa patients were identified. Relying on the Social Security Administration Life Tables (2004-2020) with 5 years of follow-up, age-matched population-based controls (Monte Carlo simulation) were simulated for each patient. Kaplan-Meier analyses addressed survival rates. Of 582,220 patients, 580,368 (99.68%) harbored acinar, 867 (0.15%) ductal, 534 (0.09%) neuroendocrine, 368 (0.07%) mucinous, and 83 (0.01%) signet ring cell carcinoma. The metastatic stage was most prevalent in neuroendocrine (62%). In the localized stage, the overall survival difference at 5 years of follow-up was greatest in neuroendocrine (22% vs. 72%), signet ring cell (78% vs. 84%), and ductal carcinoma (71% vs. 77%). In the locally advanced stage, overall survival difference was greatest in neuroendocrine (16% vs. 79%), signet ring cell (75% vs. 91%), ductal (78% vs. 84%), and mucinous carcinoma (84% vs. 90%). In the metastatic stage, the overall survival difference was greatest in neuroendocrine (3% vs. 81%), mucinous (26% vs. 84%), and acinar carcinoma (27% vs. 85%). Regardless of stage, neuroendocrine carcinoma patients exhibit the least favorable life expectancy compared with population-based controls. Conversely, all other rare histological PCa subtypes do not meaningfully affect life expectancy in localized or locally advanced stages, except for locally advanced signet ring cell adenocarcinoma., (© 2024 The Author(s). International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.)
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- 2024
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7. Characteristics of incidental prostate cancer in the United States.
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Scheipner L, Incesu RB, Morra S, Baudo A, Assad A, Jannello LMI, Siech C, de Angelis M, Barletta F, Tian Z, Saad F, Shariat SF, Briganti A, Chun FKH, Tilki D, Longo N, Carmignani L, De Cobelli O, Ahyai S, and Karakiewicz PI
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- Humans, Male, Aged, United States epidemiology, Middle Aged, Prostatectomy statistics & numerical data, Aged, 80 and over, Survival Rate, Prognosis, Prostatic Neoplasms therapy, Prostatic Neoplasms epidemiology, Prostatic Neoplasms diagnosis, Prostatic Neoplasms pathology, Prostatic Neoplasms mortality, SEER Program statistics & numerical data, Incidental Findings, Neoplasm Grading, Prostate-Specific Antigen blood
- Abstract
Background: Data regarding North-American incidental (cT1a/b) prostate cancer (PCa) patients is scarce. To address this, incidental PCa characteristics (age, PSA values at diagnosis, Gleason score [GS]), subsequent treatment and cancer-specific survival (CSS) rates were explored., Methods: Incidental PCa patients were identified within the Surveillance, Epidemiology, and End Results (SEER) database (2004-2015). Descriptive statistics, annual percentage changes (EAPC), Kaplan-Meier estimates, as well as Cox regression models were used. Bootstrapping technique was used to generate 95% confidence intervals for CSS at 6 years., Results: Of all 344,031 newly diagnosed non metastatic PCa patients, 5155 harbored incidental PCa. Annual rates of incidental PCa increased from 1.9% (2004) to 2.5 % (2015; p = 0.02). PSA values at diagnosis were 0-4 ng/ml in 48% vs. 4-10 ng/ml in 31% vs. > 10 ng/ml in 21%. Of all incidental PCa patients, 64% harbored GS 6 vs. 25% GS 7 vs. 11% GS ≥ 8. Of all incidental PCa patients, 47% were aged < 70, 35% were between 70 and 79 and 18% were ≥ 80 years. Subsequently, 71% underwent no local treatment (NLT) vs. 16% radical prostatectomy (RP) vs. 14% radiotherapy (RT). Proportions of patients with NLT increased from 65 to 81% (p = 0.0001) over the study period (2004-2015). CSS at six years ranged from 58% in GS ≥ 8 patients with NLT to 100% in patients who harbored GS 6 and underwent either RP or RT., Conclusion: Incidental PCa in the United States is rare. Most incidental PCa patients are diagnosed in men aged less than 80 years of age. The majority of incidental PCa patients undergo NLT and enjoy excellent CSS., (© 2023. The Author(s), under exclusive licence to Springer Nature Limited.)
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- 2024
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8. Trends and Disparities in Inpatient Palliative Care Use in Metastatic Renal Cell Carcinoma Patients Receiving Critical Care Therapy.
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Siech C, Morra S, Scheipner L, Baudo A, de Angelis M, Jannello LMI, Touma N, Goyal JA, Tian Z, Saad F, Shariat SF, Longo N, Carmignani L, de Cobelli O, Ahyai S, Briganti A, Cano Garcia C, Kluth LA, Chun FKH, and Karakiewicz PI
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Purpose: Temporal trends in and predictors of inpatient palliative care use in patients with metastatic renal cell carcinoma (mRCC) undergoing critical care therapy are unknown., Methods: Relying on the National Inpatient Sample (2008-2019), we identified mRCC patients undergoing critical care therapy, namely invasive mechanical ventilation, percutaneous endoscopic gastrostomy tube insertion, dialysis for acute kidney failure, total parenteral nutrition, or tracheostomy. Estimated annual percentage changes (EAPC) analyses and multivariable logistic regression models addressed inpatient palliative care use., Results: Of 3802 mRCC patients undergoing critical care therapy, 817 (21.5%) received inpatient palliative care. Overall, inpatient palliative care use increased from 4.9% to 31.5% between 2008 and 2019 (EAPC +9.2%). In subgroup analyses, the highest increase in inpatient palliative care use was observed in the Midwest (EAPC: +11.9%), in the South (EAPC +10.4%), and in teaching hospitals (EAPC +9.0%; all P ≤ .004). In logistic regression models, teaching hospital status (odds ratio [OR] 1.41) and contemporary year interval (OR 2.12; all P < .001) independently predicted higher inpatient palliative care rates. Conversely, hospital admission in the Northeast (OR 0.53) or in the South (OR 0.79; all P ≤ .03) was associated with lower inpatient palliative care rates than in the West., Conclusion: In mRCC patients, inpatient palliative care rates have improved over time, with the highest increase in hospitals in the Midwest and in the South. Moreover, admission to teaching hospitals or in the West is associated with higher inpatient palliative care rates. In consequence, regional disparities, as well as differences according to teaching hospital status represent targets to achieve comprehensive inpatient palliative care coverage in mRCC patients receiving critical care therapy., Competing Interests: Disclosure The authors have no competing interests to declare that are relevant to the content of this article., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2024
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9. Contemporary survival in metastatic bladder cancer patients: A population-based study.
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Di Bello F, Siech C, Jannello LMI, de Angelis M, Rodriguez Peñaranda N, Tian Z, Goyal JA, Baudo A, Collà Ruvolo C, Califano G, Creta M, Saad F, Shariat SF, Acquati P, de Cobelli O, Briganti A, Chun FKH, Micali S, Longo N, and Karakiewicz PI
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- Humans, Male, Female, Aged, Middle Aged, Kaplan-Meier Estimate, Aged, 80 and over, Neoplasm Metastasis, Proportional Hazards Models, Carcinoma, Transitional Cell mortality, Carcinoma, Transitional Cell secondary, Carcinoma, Transitional Cell drug therapy, Carcinoma, Transitional Cell pathology, Urinary Bladder Neoplasms mortality, Urinary Bladder Neoplasms pathology, SEER Program
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The overall survival (OS) improvement after the advent of several novel systemic therapies, designed for treatment of metastatic urothelial carcinoma of the urinary bladder (mUCUB), is not conclusively studied in either contemporary UCUB patients and/or non-UCUB patients. Within the Surveillance, Epidemiology, and End Results database, contemporary (2017-2020) and historical (2000-2016) systemic therapy-exposed metastatic UCUB and, subsequently, non-UCUB patients were identified. Separate Kaplan-Meier and multivariable Cox regression (CRM) analyses first addressed OS in mUCUB and, subsequently, in metastatic non-UCUB (mn-UCUB). Of 3443 systemic therapy-exposed patients, 2725 (79%) harbored mUCUB versus 709 (21%) harbored mn-UCUB. Of 2725 mUCUB patients, 582 (21%) were contemporary (2017-2020) versus 2143 (79%) were historical (2000-2016). In mUCUB, median OS was 11 months in contemporary versus 8 months in historical patients (Δ = 3 months; p < .0001). After multivariable CRM, contemporary membership status (2017-2020) independently predicted lower overall mortality (OM; hazard ratio [HR] = 0.68, 95% confidence interval [CI] = 0.60-0.76; p < .001). Of 709 mn-UCUB patients, 167 (24%) were contemporary (2017-2020) and 542 (76%) were historical (2000-2016). In mn-UCUB, median OS was 8 months in contemporary versus 7 months in historical patients (Δ = 1 month; p = .034). After multivariable CRM, contemporary membership status (2017-2020) was associated with HR of 0.81 (95% CI = 0.66-1.01; p = .06). In conclusion, contemporary systemic therapy-exposed metastatic patients exhibited better OS in UCUB. However, the magnitude of survival benefit was threefold higher in mUCUB and approximated the survival benefits recorded in prospective randomized trials of novel systemic therapies., (© 2024 UICC.)
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- 2024
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10. Primary tumor ablation in metastatic renal cell carcinoma.
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Scheipner L, Incesu RB, Morra S, Baudo A, Jannello LMI, Siech C, de Angelis M, Assad A, Tian Z, Saad F, Shariat SF, Briganti A, Chun FKH, Tilki D, Longo N, Carmignani L, De Cobelli O, Pichler M, Ahyai S, and Karakiewicz PI
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Background: The role of primary tumor ablation (pTA) in metastatic renal cell carcinoma (mRCC) is unknown. We compared pTA-treated mRCC patients to patients who underwent no local treatment (NLT), as well as patients who underwent cytoreductive nephrectomy (CN)., Methods: Within the Surveillance, Epidemiology, and End Results database (SEER, 2004-2020), we identified mRCC patients who underwent either pTA, NLT or CN. Endpoints consisted of overall survival (OM) and other-cause mortality (OCM). Propensity score 1:1 matching (PSM), multivariable cox regression models (OM), as well as, multivariable competing risk regressions (CRR) models (OCM) were used., Results: We identified 27,087 mRCC patients, of whom 82 (0.3%) underwent pTA, 17,266 (64%) NLT and 9,739 (36%) CN. In comparisons of pTA vs. NLT mRCC patients addressing OM, after 1:1 PSM, median survival was 19 months for pTA vs. 4 months for NLT patients (multivariable HR 0.3, 95% CI 0.22-0.47, P < 0.001). No statistically significant OCM differences were recorded in multivariable CRR (HR 1.13 95%, CI 0.52-2.44, P = 0.8). In comparisons of pTA vs. CN, after 1:1 PSM, no statistically significant differences in OM (HR 1.22, 95% CI 0.81-1.83, P = 0.32), as well as OCM (HR 1.4, 95% CI 0.56-3.48, P = 0.5) were recorded., Conclusion: In mRCC patients, pTA is associated with significantly lower mortality compared to NLT. Interestingly, OM rates between pTA and CN mRCC patients do not exhibit statistically significant differences. This preliminary report may suggest that pTA may provide a comparable survival benefit to CN in highly selected mRCC patients., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2024
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11. ASO Author Reflections: Survival Benefit of Adjuvant Systemic Therapy After Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma.
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Di Bello F, Jannello LMI, Siech C, de Angelis M, Rodriguez Peñaranda N, Tian Z, Goyal JA, Ruvolo CC, Califano G, Creta M, Morra S, Saad F, Shariat SF, de Cobelli O, Briganti A, Chun FKH, Puliatti S, Longo N, and Karakiewicz PI
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- Humans, Survival Rate, Chemotherapy, Adjuvant, Carcinoma, Transitional Cell surgery, Carcinoma, Transitional Cell mortality, Carcinoma, Transitional Cell pathology, Prognosis, Urologic Neoplasms surgery, Urologic Neoplasms mortality, Urologic Neoplasms pathology, Nephroureterectomy methods
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- 2024
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12. Life Expectancy in High-Grade Incidental Prostate Cancer Patients Versus Population-Based Controls According to Treatment Type.
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Di Bello F, Jannello LMI, Baudo A, de Angelis M, Siech C, Tian Z, Goyal JA, Creta M, Califano G, Celentano G, Acquati P, Saad F, Shariat SF, Carmignani L, de Cobelli O, Briganti A, Chun FKH, Longo N, and Karakiewicz PI
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- Humans, Male, Aged, Middle Aged, Case-Control Studies, Incidental Findings, Prostatic Neoplasms therapy, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Prostatic Neoplasms diagnosis, Life Expectancy, Neoplasm Grading, SEER Program, Prostatectomy mortality
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Objective: To quantify the differences in 5-year overall survival (OS) between high-grade (Gleason sum 8-10) incidental prostate cancer (IPCa) patients and age-matched male population-based controls, according to treatment type: no active versus active treatment., Materials and Methods: We relied on the Surveillance, Epidemiology, and End Results (SEER) database (2004-2015) to identify not actively treated and actively treated high-grade IPCa patients. For each case, we simulated an age-matched male control (Monte Carlo simulation), relying on Social Security Administration Life Tables (2004-2020) with 5 years of follow-up. Additionally, we relied on Kaplan-Meier plots to display OS for each treatment type. Multivariable Cox regression models were fitted to predict overall mortality (OM)., Results: Of 564 high-grade IPCa patients, 345 (61%) were not actively treated versus 219 (39%) were actively treated, either with radical prostatectomy or radiotherapy. Median OS was 3 years for not actively treated high-grade IPCa patients, with OS difference at 5 years follow-up of 27% relative to their age-matched male population-based controls (37% vs. 64%). Median OS was 8 years for actively treated high-grade IPCa patients, with OS difference at 5 years follow-up of 6% relative to their age-matched male population-based controls (68% vs. 74%). In the multivariable Cox regression model, active treatment independently predicted lower OM (hazard ratio = 0.6; 95% confidence interval = 0.4-0.8; p < 0.001)., Conclusion: Relative to Life Tables' derived age-matched male controls, not actively treated high-grade IPCa patients exhibit drastically worse OS than their actively treated counterparts. These observations may encourage clinicians to consider active treatment in newly diagnosed high-grade IPCa patients., (© 2024 Wiley Periodicals LLC.)
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- 2025
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13. The European Network for the Study of Adrenal Tumors Staging System (2015): A United States Validation.
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Jannello LMI, Incesu RB, Morra S, Scheipner L, Baudo A, de Angelis M, Siech C, Tian Z, Goyal JA, Luzzago S, Mistretta FA, Ferro M, Saad F, Shariat SF, Chun FKH, Briganti A, Tilki D, Ahyai S, Carmignani L, Longo N, de Cobelli O, Musi G, and Karakiewicz PI
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- Humans, United States epidemiology, Male, Female, Middle Aged, Aged, Adult, Prognosis, Adrenal Gland Neoplasms pathology, Adrenal Gland Neoplasms mortality, Adrenal Gland Neoplasms epidemiology, Europe epidemiology, Neoplasm Staging, SEER Program, Adrenocortical Carcinoma pathology, Adrenocortical Carcinoma mortality, Adrenocortical Carcinoma diagnosis, Adrenal Cortex Neoplasms pathology, Adrenal Cortex Neoplasms mortality, Adrenal Cortex Neoplasms diagnosis
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Objective: To test the ability of the 2015 modified version of the European Network for the Study of Adrenal Tumors staging system (mENSAT) in predicting cancer-specific mortality (CSM), as well as overall mortality (OM) in adrenocortical carcinoma (ACC) patients of all stages, in a large-scale, and contemporary United States cohort., Methods: We relied on the Surveillance, Epidemiology, and End Results (SEER) database (2004-2020) to test the accuracy and calibration of the mENSAT and subsequently compared it to the 8th edition of the American Joint Committee on Cancer staging system (AJCC)., Results: In 858 ACC patients, mENSAT accuracy was 74.7% for 3-year CSM predictions and 73.8% for 3-year OM predictions. The maximum departures from ideal predictions in mENSAT were +17.2% for CSM and +11.8% for OM. Conversely, AJCC accuracy was 74.5% for 3-year CSM predictions and 73.5% for 3-year OM predictions. The maximum departures from ideal predictions in AJCC were -6.7% for CSM and -7.1% for OM., Conclusion: The accuracy of mENSAT is virtually the same as that of AJCC in predicting CSM (74.7% vs 74.5%) and OM (73.7% vs 73.5%). However, calibration is lower for mENSAT than for AJCC. In consequence, no obvious benefit appears to be associated with the use of mENSAT relative to AJCC in US ACC patients., (© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)
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- 2024
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14. Survival of Metastatic Urothelial Carcinoma of Urinary Bladder According to Number and Location of Visceral Metastases.
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Di Bello F, de Angelis M, Siech C, Jannello LMI, Peñaranda NR, Tian Z, Goyal JA, Ruvolo C, Califano G, La Rocca R, Saad F, Shariat SF, de Cobelli O, Briganti A, Chun FKH, Puliatti S, Longo N, and Karakiewicz PI
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- Humans, Male, Female, Aged, Middle Aged, Prognosis, Survival Rate, Retrospective Studies, Aged, 80 and over, Urinary Bladder Neoplasms pathology, Urinary Bladder Neoplasms mortality, SEER Program, Carcinoma, Transitional Cell mortality, Carcinoma, Transitional Cell secondary
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Objective: To test the association between number as well as locations of organ-specific metastatic sites and overall survival (OS) in systhemic-therapy exposed metastatic urothelial carcinoma of urinary bladder (mUCUB) patients., Methods: Within Surveillance, Epidemiology and End Results database (2010-2020), all systhemic therapy-exposed mUCUB patients were identified. Kaplan-Meier and multivariable Cox regression (CRM) models first addressed OS in patients according to number of metastatic organ-locations: solitary versus 2 versus 3 or more. Subsequently, separate analyses stratified according to location type were completed in patients with solitary metastatic organ-location as well as in patients with 2 metastatic organ-locations., Results: Of 1,310 mUCUB, 1,069 (82%) harbored solitary metastatic organ-location versus 193 (15%) harbored 2 separate metastatic organ-locations versus 48 (3%) harbored 3 or more metastatic organ-locations. Median OS decreased with increasing number of metastatic organ-locations (solitary vs. 2 vs. 3 or more, P < .0001). In multivariable CRM, relative to solitary metastatic organ-location, 2 (HR: 1.57, 95 Confidence interval [CI], 1.33-1.85) as well as 3 or more (HR: 1.69, 95% CI, 1.23-2.31) metastatic organ-locations independently predicted higher overall mortality (OM) (P = .001). In patients with solitary metastatic organ-location, brain metastases independently predicted higher OM (HR 1.67; 95% CI, 1.05-2.67; P = .03) than other locations. In patients with 2 metastatic organ-locations, no differences in OM were recorded according to organ type location., Conclusion: In systemic therapy exposed mUCUB, number of metastatic organ-locations (solitary vs. 2 vs. 3 or more), independently predicted increasingly worse prognosis. In patients with solitary metastatic organ-location, brain purported worse prognosis than others., Competing Interests: Disclosure The authors declare no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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15. Neoadjuvant Versus Adjuvant Chemotherapy in Non-Metastatic Locally-Advanced Stage Radical Cystectomy Candidates.
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de Angelis M, Siech C, Jannello LMI, Bello FD, Peñaranda NR, Goyal JA, Touma N, Tian Z, Longo N, de Cobelli O, Chun FKH, Micali S, Saad F, Shariat SF, Gandaglia G, Moschini M, Montorsi F, Briganti A, and Karakiewicz PI
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- Humans, Male, Female, Chemotherapy, Adjuvant methods, Aged, Middle Aged, SEER Program, Retrospective Studies, Treatment Outcome, Cystectomy, Neoadjuvant Therapy methods, Urinary Bladder Neoplasms drug therapy, Urinary Bladder Neoplasms surgery, Urinary Bladder Neoplasms pathology, Neoplasm Staging
- Abstract
Introduction: Administration of chemotherapy before radical cystectomy (RC) in neoadjuvant setting (NAC) or after RC in adjuvant setting (ADJ) are both associated with a survival benefit relative to RC alone. However, no study directly compared the magnitude of such benefit associated with NAC versus ADJ in locally-advanced UCUB patients (T3-T4N0M0). We addressed this knowledge gap., Methods: Within the Surveillance, Epidemiology, and End Results database (2007-2020), we identified T3-T4N0M0 UCUB patients who underwent NAC+RC or RC+ADJ. Cumulative incidence plots and multivariable competing risks regression (CRR) models were fitted. The same methodology was then re-applied in T3 and then T4 patient subgroups., Results: Of 875 assessable patients, 603 harbored T3 stage (69.0%) and 272 harbored T4 stage (31.0%). Of all 875, 563 (64.0%) underwent RC+ADJ versus 312 (36.0%) NAC+RC. NAC+RC rates increased over time (EAPC=+6.1%, P = .001). Cumulative incidence plots derived five-year CSM rates were 40.3% in NAC+RC versus 36.1% in RC+ADJ patients (P = .2). In multivariable CRR models that also adjusted for OCM, no statistically significant difference in CSM was recorded when NAC+RC was compared to RC+ADJ (HR:0.85, P = .1). Virtually the same observations were made in subgroup analyses where CSM associated with NAC+RC was not different from that recorded in RC+ADJ (HR: 0.89 and P = .4 in T3 stage and HR:0.8 and P = .2 in T4 stage)., Conclusion: In locally-advanced UCUB, NAC rates have sharply increased over time. However, the approach based on neoadjuvant chemotherapy prior to RC have not resulted in a statistically significant CSM benefit relative to RC+ADJ., Competing Interests: Disclosure None., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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16. Rates of Systemic Therapy for Metastatic Bladder Cancer Are Lower in Unmarried Males and Females.
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Vitucci K, Siech C, Baudo A, Jannello LMI, de Angelis M, Bello FD, Goyal JA, Tian Z, Saad F, Shariat SF, Longo N, Carmignani L, de Cobelli O, Briganti A, Kluth LA, Chun FKH, and Karakiewicz PI
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- Humans, Female, Male, Aged, Middle Aged, Carcinoma, Transitional Cell drug therapy, Carcinoma, Transitional Cell epidemiology, Carcinoma, Transitional Cell pathology, Aged, 80 and over, United States epidemiology, Single Person statistics & numerical data, Sex Factors, Retrospective Studies, Neoplasm Metastasis, Urinary Bladder Neoplasms pathology, Marital Status, SEER Program
- Abstract
Objective: Systemic therapy is guideline-recommended for metastatic urothelial carcinoma of the urinary bladder (UCUB). Unmarried status represents an important barrier to treatment access in many primaries. The importance of married status is unknown in the context of systemic therapy in metastatic UCUB and was addressed in the current study., Methods: We relied on the Surveillance, Epidemiology, and End Results database (2004-2020) to identify patients with metastatic UCUB. Univariable and multivariable logistic regression models were fitted to address systemic therapy rates. Additionally, temporal trends were plotted., Results: Overall, 6873 patients with stage IV UCUB were identified. Of those, 4853 (71%) were male. Of males, 2993 (62%) were married vs. 797 (39%) of females. The rates of systemic therapy were 55% in both married males and married females. Married males and females differed from their unmarried counterparts regarding age and race/ethnicity. In males, prior to any adjustment, married status was associated with an odds ratio of 1.46 (P < .001). After adjustment for age and race/ethnicity, the odds ratio increased to 1.73 (P < .001). In females, prior to any adjustment, married status was associated with an odds ratio of 1.94 (P < .001). After adjustment for age and race/ethnicity, the odds ratio decreased to 1.57 (P < .001)., Conclusion: Unmarried males and unmarried females are significantly exposed to lower access to systemic therapy compared to their married counterparts. In consequence, both unmarried men and unmarried women should be given very careful consideration when use of systemic therapy in metastatic UCUB is contemplated., Competing Interests: Disclosure The authors have stated that they have no conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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17. Trimodal therapy effect on survival in urothelial vs non-urothelial bladder cancer.
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de Angelis M, Baudo A, Siech C, Jannello LMI, Di Bello F, Goyal JA, Tian Z, Longo N, de Cobelli O, Chun FKH, Saad F, Shariat SF, Carmignani L, Gandaglia G, Moschini M, Montorsi F, Briganti A, and Karakiewicz PI
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- Humans, Male, Female, Aged, Middle Aged, Combined Modality Therapy, Neoplasm Staging, SEER Program, Survival Rate, Aged, 80 and over, Cystectomy, Urinary Bladder Neoplasms therapy, Urinary Bladder Neoplasms mortality, Urinary Bladder Neoplasms pathology, Carcinoma, Transitional Cell therapy, Carcinoma, Transitional Cell mortality, Carcinoma, Transitional Cell pathology
- Abstract
Objective: To address cancer-specific mortality free-survival (CSM-FS) differences in patients with urothelial carcinoma of the urinary bladder (UCUB) vs non-UCUB who underwent trimodal therapy (TMT), according to organ confined (OC: T2N0M0) vs non-organ confined (NOC: T3-4NanyM0 or TanyN1-3M0) clinical stages., Patients and Methods: Within the Surveillance, Epidemiology, and End Results database (2004-2020), we identified patients with cT2-T4N0-N3M0 bladder cancer treated with TMT, defined as the combination of transurethral resection of bladder tumour, chemotherapy, and radiotherapy. Temporal trends described TMT use over time. Kaplan-Meier plots and multivariable Cox regression (MCR) models addressed CSM in UCUB vs non-UCUB according to OC vs NOC stages., Results: Of 5130 assessable TMT-treated patients, 425 (8%) harboured non-UCUB vs 4705 (92%) who had UCUB. The TMT rates increased for patients with OC UCUB from 92.4% to 96.8% (estimated annual percentage change of 0.4%, P < 0.001), but not in the NOC stages (P = 0.3). In the OC stage, the median CSM-FS was 36 months in patients with non-UCUB vs 60 months in those with UCUB, respectively (P = 0.01). Conversely, in the NOC stage, the median CSM-FS was 23 months both in UCUB and non-UCUB (P = 0.9). In the MCR models addressing OC stage, non-UCUB histology independently predicted higher CSM (hazard ratio 1.45, P = 0.004), but not in the NOC stage (P = 0.9)., Conclusion: In OC UCUB, TMT rates have increased over time in a guideline-consistent fashion. Patients with OC non-UCUB treated with TMT showed a CSM disadvantage relative to OC UCUB. In the NOC stage, use of TMT resulted in dismal CSM, regardless of UCUB vs non-UCUB histology., (© 2024 BJU International.)
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- 2024
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18. Adjuvant Systemic Therapy Improved Survival After Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma.
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Di Bello F, Jannello LMI, Siech C, de Angelis M, Rodriguez Peñaranda N, Tian Z, Goyal JA, Ruvolo CC, Califano G, Creta M, Morra S, Saad F, Shariat SF, de Cobelli O, Briganti A, Chun FKH, Puliatti S, Longo N, and Karakiewicz PI
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- Humans, Female, Male, Aged, Survival Rate, Chemotherapy, Adjuvant, Follow-Up Studies, Middle Aged, Prognosis, Kidney Neoplasms surgery, Kidney Neoplasms mortality, Kidney Neoplasms pathology, Kidney Neoplasms drug therapy, Ureteral Neoplasms mortality, Ureteral Neoplasms surgery, Ureteral Neoplasms pathology, Ureteral Neoplasms drug therapy, Retrospective Studies, Neoplasm Staging, Nephroureterectomy, Carcinoma, Transitional Cell surgery, Carcinoma, Transitional Cell mortality, Carcinoma, Transitional Cell pathology, Carcinoma, Transitional Cell drug therapy, SEER Program
- Abstract
Background: The purpose of this study was to test for survival differences according to adjuvant chemotherapy (AC) status in radical nephroureterectomy (RNU) patients with pT2-T4 and/or N1-2 upper tract urothelial carcinoma (UTUC)., Patients and Methods: Within the Surveillance, Epidemiology, and End Results database (SEER, 2007-2020), patients with UTUC treated with AC versus RNU alone were identified. Kaplan-Meier plots and multivariable Cox regression models addressed cancer-specific mortality (CSM)., Results: Of 1995 patients with UTUC, 804 (40%) underwent AC versus 1191 (60%) RNU alone. AC rates increased from 36.1 to 57.0% over time in the overall cohort [estimated annual percentage changes (EAPC) ± 4.5%, p < 0.001]. The increase was from 28.8 to 50.0% in TanyN0 patients (EAPC ± 7.8%, p < 0.001) versus 50.0-70.9% in TanyN1-2 patients (EAPC ± 2.3%, p = 0.002). Within 698 patients harboring TanyN1-2 stage, median CSM was 31 months after AC versus 16 months in RNU alone (Δ = 15 months, p < 0.0001) and AC independently predicted lower CSM [hazard ratio (HR) 0.64; p < 0.001]. Similarly, within subgroup analyses according to stage, relative to RNU alone, AC independently predicted lower CSM in T2N1-2 (HR 0.49; p = 0.04), in T3N1-2 (HR 0.72; p = 0.015), and in T4N1-2 (HR 0.49, p < 0.001) patients. Conversely, in all TanyN0 as well as in all stage-specific subgroup analyses addressing N0 patients, AC did not affect CSM rates (all p > 0.05)., Conclusions: In RNU patients, AC use is associated with significantly lower CSM in lymph-node-positive (N1-2) patients but not in lymph-node-negative patients (N0). The distinction between N1-2 and N0 regarding the effect of AC on CSM applied across all T stages from T2 to T4, inclusively., (© 2024. Society of Surgical Oncology.)
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- 2024
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19. Radiotherapy Versus Partial Penectomy for T1 Squamous Cell Carcinoma of the Penis.
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Jannello LMI, Siech C, de Angelis M, Di Bello F, Rodriguez Peñaranda N, Tian Z, Goyal JA, Luzzago S, Mistretta FA, Montanari E, Saad F, Chun FKH, Briganti A, Micali S, Longo N, de Cobelli O, Musi G, and Karakiewicz PI
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- Humans, Male, Aged, Survival Rate, Follow-Up Studies, Middle Aged, Prognosis, Neoplasm Staging, Retrospective Studies, Propensity Score, Penile Neoplasms surgery, Penile Neoplasms pathology, Penile Neoplasms radiotherapy, Penile Neoplasms mortality, Carcinoma, Squamous Cell surgery, Carcinoma, Squamous Cell pathology, Carcinoma, Squamous Cell radiotherapy, Carcinoma, Squamous Cell mortality, SEER Program
- Abstract
Background: Radiotherapy (RT) represents an alternative treatment option for patients with T1 squamous cell carcinoma of the penis (SCCP), with proven feasibility and tolerability. However, it has never been directly compared with partial penectomy (PP) using cancer-specific mortality (CSM) as an end point., Methods: In the Surveillance, Epidemiology, and End Results database (2000-2020), T1N0M0 SCCP patients treated with RT or PP were identified. This study relied on 1:4 propensity score-matching (PSM) for age at diagnosis, tumor stage, and tumor grade. Subsequently, cumulative incidence plots as well as multivariable competing risks regression (CRR) models addressed CSM. Additionally, the study accounted for the confounding effect of other-cause mortality (OCM)., Results: Of 895 patients with T1N0M0 SCCP, 55 (6.1%) underwent RT and 840 (93.9%) underwent PP. The RT and PP patients had a similar age distribution (median age, 70 vs 70 years) and more frequently harbored grade I or II tumors (67.3% vs 75.8%) as well as T1a-stage disease (67.3% vs 74.3%). After 1:4 PSM, 55 (100%) of the 55 RT patients versus 220 (26.2%) of the 840 PP patients were included in the study. The 10-year CSM derived from the cumulative incidence plots was 25.4% for RT and 14.4% for PP. In the multivariable CRR models, RT independently predicted a higher CSM than PP (hazard ratio, 1.99; 95% confidence interval, 1.05-3.80; p = 0.04)., Conclusion: For the T1N0M0 SCCP patients treated in the community, RT was associated with nearly a twofold higher CSM than PP. Ideally, a validation study based on tertiary care institution data should be conducted to test whether this CSM disadvantage is operational only in the community or not., (© 2024. Society of Surgical Oncology.)
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- 2024
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20. Race/Ethnicity Affects Access and Survival Differences After Neoadjuvant or Adjuvant Chemotherapy at Radical Cystectomy in Urothelial Carcinoma Patients.
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de Angelis M, Jannello LMI, Siech C, Di Bello F, Peñaranda NR, Goyal JA, Tian Z, Longo N, de Cobelli O, Chun FKH, Puliatti S, Saad F, Shariat SF, Gandaglia G, Moschini M, Montorsi F, Briganti A, and Karakiewicz PI
- Abstract
Introduction: It is unknown whether race/ethnicity affects access and/or survival after neoadjuvant (NAC) or adjuvant chemotherapy (ADJ) at radical cystectomy (RC). We addressed these knowledge gaps., Material and Methods: Within the Surveillance, Epidemiology, and End Results database (2007-2020), we identified NAC candidates (T2-T4N0M0) and ADJ candidates (T3-T4 and/or N1-3). We focused on the four most prevalent race/ethnicities: Caucasians, Hispanics, African American (AA), and Asian/Pacific Islanders (API). Multivariable logistic regression models (MLR) tested access to NAC and ADJ. Subsequently, within NAC-exposed patients, survival analyses consisting of Kaplan-Meier plots and multivariable Cox regression models addressed CSM according to race/ethnicity were fitted. We repeated the same methodology in ADJ-exposed patients., Results: In 6418 NAC candidates, NAC was administered in 1011 (19.0%) Caucasians, 88 (21.0%) Hispanics, 65 (17.0%) AA, and 53 (18.0%) API. In MLR, AA exhibited lower access rates to NAC (OR 0.83, p = 0.04). In NAC-exposed patients, AA independently predicted higher CSM (HR 1.3, p < 0.001) and API independently predicted lower CSM (HR 0.83, p = 0.03). Similarly, in 5195 ADJ candidates, ADJ was administered to 1387 (33.0%) Caucasians, 100 (28.0%) Hispanics, 105 (29.0%) AA, and 90 (37.0%) API. In MLR, AA (OR 68, p = 0.003) and Hispanics (OR 0.69, p = 0.004) exhibited lower access rates to ADJ. In ADJ-exposed patients, AA independently predicted lower CSM (HR 1.32, p < 0.001), while API showed better CSM (HR 0.82, p = 0.01)., Conclusion: Relative to Caucasians, AA are less likely to receive either NAC or ADJ. Moreover, relative to Caucasians, AA exhibit higher CSM even when treated with either NAC or ADJ., (© 2024. W. Montague Cobb-NMA Health Institute.)
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- 2024
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21. Perioperative Complications and In-Hospital Mortality in Partial and Radical Nephrectomy Patients with Heart-Valve Replacement.
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Siech C, Baudo A, de Angelis M, Jannello LMI, Di Bello F, Goyal JA, Tian Z, Saad F, Shariat SF, Longo N, Carmignani L, de Cobelli O, Briganti A, Kosiba M, Mandel P, Kluth LA, Chun FKH, and Karakiewicz PI
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- Humans, Male, Female, Middle Aged, Aged, Follow-Up Studies, Heart Valve Prosthesis Implantation mortality, Heart Valve Prosthesis Implantation adverse effects, Survival Rate, Prognosis, Length of Stay statistics & numerical data, Intraoperative Complications mortality, Risk Factors, Nephrectomy mortality, Nephrectomy adverse effects, Nephrectomy methods, Hospital Mortality, Postoperative Complications mortality, Postoperative Complications etiology, Kidney Neoplasms surgery, Kidney Neoplasms mortality, Kidney Neoplasms pathology
- Abstract
Background: In-hospital mortality and complication rates after partial and radical nephrectomy in patients with history of heart-valve replacement are unknown., Patients and Methods: Relying on the National Inpatient Sample (2000-2019), kidney cancer patients undergoing partial or radical nephrectomy were stratified according to presence or absence of heart-valve replacement. Multivariable logistic and Poisson regression models addressed adverse hospital outcomes., Results: Overall, 39,673 patients underwent partial nephrectomy versus 94,890 radical nephrectomy. Of those, 248 (0.6%) and 676 (0.7%) had a history of heart-valve replacement. Heart-valve replacement patients were older (median partial nephrectomy 69 versus 60 years; radical nephrectomy 71 versus 63 years), and more frequently exhibited Charlson comorbidity index ≥ 3 (partial nephrectomy 22 versus 12%; radical nephrectomy 32 versus 23%). In partial nephrectomy patients, history of heart-valve replacement increased the risk of cardiac complications [odds ratio (OR) 4.33; p < 0.001), blood transfusions (OR 2.00; p < 0.001), intraoperative complications (OR 1.53; p = 0.03), and longer hospital stay [rate ratio (RR) 1.25; p < 0.001], but not in-hospital mortality (p = 0.5). In radical nephrectomy patients, history of heart-valve replacement increased risk of postoperative bleeding (OR 4.13; p < 0.001), cardiac complications (OR 2.72; p < 0.001), intraoperative complications (OR 1.53; p < 0.001), blood transfusions (OR 1.27; p = 0.02), and longer hospital stay (RR 1.12; p < 0.001), but not in-hospital mortality (p = 0.5)., Conclusions: History of heart-valve replacement independently predicted four of twelve adverse outcomes in partial nephrectomy and five of twelve adverse outcomes in radical nephrectomy patients including intraoperative and cardiac complications, blood transfusions, and longer hospital stay. Conversely, no statistically significant differences were observed in in-hospital mortality., (© 2024. The Author(s).)
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- 2024
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22. Temporal Trends and Cancer-Specific Mortality in Nonmetastatic Muscle-Invasive Urothelial Carcinoma of the Urinary Bladder Treated With Trimodal Therapy.
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de Angelis M, Scheipner L, Siech C, Jannello LMI, Baudo A, Bello FD, Goyal JA, Vitucci K, Tian Z, Longo N, Ahyai S, de Cobelli O, Chun FKH, Saad F, Shariat SF, Carmignani L, Gandaglia G, Moschini M, Montorsi F, Briganti A, and Karakiewicz PI
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- Humans, Male, Female, Aged, Middle Aged, Neoplasm Staging, Combined Modality Therapy, Cystectomy, Aged, 80 and over, Retrospective Studies, Neoplasm Invasiveness, Kaplan-Meier Estimate, Urinary Bladder Neoplasms mortality, Urinary Bladder Neoplasms therapy, Urinary Bladder Neoplasms pathology, SEER Program, Carcinoma, Transitional Cell mortality, Carcinoma, Transitional Cell therapy, Carcinoma, Transitional Cell pathology
- Abstract
Introduction: Trimodal therapy (TMT) is guideline-recommended for the management of organ confined urothelial carcinoma of urinary bladder (UCUB). However, temporal trends in TMT use and cancer-specific mortality free-survival (CSM-FS) between historical TMT versus contemporary TMT have not been assessed. We addressed this knowledge gap., Material and Methods: Within the Surveillance, Epidemiology, and End Results database (2004-2020), we identified nonmetastatic UCUB patients with cT2-T4aN0-N2 treated with TMT, defined as the combination of transurethral resection of bladder tumor, chemotherapy and radiotherapy. Temporal trends described TMT use over time. Subsequently, patients were divided between historical (2004-2012) versus contemporary (2013-2020) cohorts. Survival analyses consisting of Kaplan-Meier plots and multivariable Cox regression (MCR) models addressed CSM-FS. Separate analyses addressed patients with organ confined (OC: cT2N0M0) versus nonorgan confined (NOC: cT3-4a and/or cN1-2) clinical stages., Results: Of 4,097 assessable UCUB TMT patients, 1744 (43%) were treated in the historical period (2004-2012) versus 2353 (58%) in the contemporary period (2013-2020). TMT use increased over time in OC patients (EAPC:+3.4%, P < .001), as well as in NOC (EAPC:+2.7%, P < .001). In OC stage, median CSM-FS was 55.3% in historical versus 49.0% in contemporary patients (HR:0.75, P < .001). Similarly, in NOC stage, 5-year median CSM-FS was 43.0% in historical versus 32.8% in contemporary patients (HR:0.78, P = .01)., Conclusion: TMT rates have increased over time in both OC and NOC patients. Contemporary TMT patients benefit of better cancer-specific survival. Interestingly, this benefit applies equally to OC and NOC TMT-treated patients., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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23. Critical care therapy use after radical cystectomy in patients with non-metastatic bladder cancer.
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Siech C, Jannello LMI, de Angelis M, Di Bello F, Goyal JA, Tian Z, Saad F, Shariat SF, Longo N, de Cobelli O, Briganti A, Kosiba M, Mandel P, Kluth LA, Chun FKH, and Karakiewicz PI
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- Humans, Postoperative Care methods, Cystectomy methods, Urinary Bladder Neoplasms surgery, Urinary Bladder Neoplasms pathology, Urinary Bladder Neoplasms therapy, Critical Care methods
- Abstract
Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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- 2024
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24. Unmarried Status Effect on Stage at Presentation and Treatment Patterns in Non-Metastatic Upper Tract Urothelial Carcinoma Patients.
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Morra S, Scheipner L, Baudo A, Jannello LMI, de Angelis M, Siech C, Goyal JA, Touma N, Tian Z, Saad F, Califano G, Di Bello F, La Rocca R, Ruvolo CC, Mangiapia F, Shariat SF, Ahyai S, Carmignani L, de Cobelli O, Musi G, Briganti A, Chun FKH, Longo N, and Karakiewicz PI
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- Humans, Male, Female, Aged, Middle Aged, Urologic Neoplasms pathology, Urologic Neoplasms surgery, Kidney Neoplasms pathology, Kidney Neoplasms surgery, Aged, 80 and over, Ureteral Neoplasms pathology, Ureteral Neoplasms surgery, SEER Program, Marital Status, Neoplasm Staging, Carcinoma, Transitional Cell surgery, Carcinoma, Transitional Cell pathology, Nephroureterectomy
- Abstract
Background: Unmarried status has been associated with higher proportions of locally advanced stage and lower treatment dose intensification rates in several urological and non-urological malignancies. However, no previous investigators focused on the association between unmarried status and advanced stage (T
3-4 N0-2 ) at presentation and lower nephroureterectomy (RNU) and systemic therapy (ST) rates in non-metastatic upper tract urothelial carcinoma (UTUC) patients., Methods: Using the Surveillance, Epidemiology, and End Results (SEER) database 2000-2020, all non-metastatic UTUC patients were identified. Multivariable logistic regression models (LRMs) tested for differences in stage at presentation and treatment (RNU and ST) according to marital status (married vs unmarried), in a sex-specific fashion., Results: Of all 8544 non-metastatic UTUC patients, 4748 (56%) were male vs 3190 (44%) were female. Of all 4748 male UTUC patients, 1191 (25%) were unmarried. Of all 3190 female UTUC patients, 1608 (50%) were unmarried. In multivariable LRMs predicting RNU, unmarried status was an independent predictor of lower RNU rates in male (Odds Ratio [OR]: 0.56; P < .001), but not in female (OR: 0.81; P = .1) non-metastatic UTUC patients. In multivariable LRMs predicting ST exposure, unmarried status was an independent predictor of lower ST rates in both male (OR:0.73; P = .03) and female (OR:0.64; P < .001) UTUC patients. In multivariable LRMs predicting locally advanced stage (T3-4 N0-2 ), unmarried status was not associated with an increased risk of locally advanced stage at presentation in either male (OR: 0.95; P = .5) or female (OR: 0.99; P = .9) UTUC patients., Conclusions: Unmarried male UTUC patients appear at risk of less being able to access RNU, relative to their married counterparts. Moreover, unmarried UTUC patients appear to less benefit from ST, regardless of sex. Conversely, unmarried status was not associated with an increased risk of locally advanced stage at presentation in either male or female UTUC patients., Competing Interests: Disclosure Shahrokh F. Shariat: Horonraria: Astellas, Astra Zeneca, Bayer, BMS, Cepheid, Ferring, lpsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda, Urogen. Consulting or Advisory Role: Astellas, Astra Zeneca, Bayer, BMS, Cepheid, Ferring, lpsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda, Urogen. Speakers’ Bureau: Astellas, Astra Zeneca, Bayer, BMS, Cepheid, Ferring, lpsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda, Urogen, Movember Foundation. Patents: Method to determine prognosis after therapy for prostate cancer - granted 2002-09-06, Methods to determine prognosis after therapy for bladder cancer - granted 2003-06-19, Prognostic methods for patients with prostatic disease - granted 2004-08-05; Soluble Fas urinary marker for the detection of bladder transitional cell carcinoma - granted 2010-07-20. Our research was conducted without any other potential conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)- Published
- 2024
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25. Rare histological prostate cancer subtypes: Cancer-specific and other-cause mortality.
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Siech C, de Angelis M, Jannello LMI, Di Bello F, Rodriguez Peñaranda N, Goyal JA, Tian Z, Saad F, Shariat SF, Puliatti S, Longo N, de Cobelli O, Briganti A, Hoeh B, Mandel P, Kluth LA, Chun FKH, and Karakiewicz PI
- Abstract
Background: To assess cancer-specific mortality (CSM) and other-cause mortality (OCM) rates in patients with rare histological prostate cancer subtypes., Methods: Using the Surveillance, Epidemiology, and End Results database (2004-2020), we applied smoothed cumulative incidence plots and competing risks regression (CRR) models., Results: Of 827,549 patients, 1510 (0.18%) harbored ductal, 952 (0.12%) neuroendocrine, 462 (0.06%) mucinous, and 95 (0.01%) signet ring cell carcinoma. In the localized stage, five-year CSM vs. OCM rates ranged from 2 vs. 10% in acinar and 3 vs. 8% in mucinous, to 55 vs. 19% in neuroendocrine carcinoma patients. In the locally advanced stage, five-year CSM vs. OCM rates ranged from 5 vs. 6% in acinar, to 14 vs. 16% in ductal, and to 71 vs. 15% in neuroendocrine carcinoma patients. In the metastatic stage, five-year CSM vs. OCM rates ranged from 49 vs. 15% in signet ring cell and 56 vs. 16% in mucinous, to 63 vs. 9% in ductal and 85 vs. 12% in neuroendocrine carcinoma. In multivariable CRR, localized neuroendocrine (HR 3.09), locally advanced neuroendocrine (HR 9.66), locally advanced ductal (HR 2.26), and finally metastatic neuroendocrine carcinoma patients (HR 3.57; all p < 0.001) exhibited higher CSM rates relative to acinar adenocarcinoma patients., Conclusions: Compared to acinar adenocarcinoma, patients with neuroendocrine carcinoma of all stages and locally advanced ductal carcinoma exhibit higher CSM rates. Conversely, CSM rates of mucinous and signet ring cell adenocarcinoma do not differ from those of acinar adenocarcinoma., (© 2024. The Author(s).)
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- 2024
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26. Use of inpatient palliative care in metastatic urethral cancer.
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Siech C, Baudo A, de Angelis M, Jannello LMI, Di Bello F, Goyal JA, Tian Z, Saad F, Shariat SF, Longo N, Carmignani L, de Cobelli O, Briganti A, Banek S, Mandel P, Kluth LA, Chun FKH, and Karakiewicz PI
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- Humans, Male, Female, Aged, Middle Aged, Hospitalization statistics & numerical data, Inpatients statistics & numerical data, Neoplasm Metastasis, Retrospective Studies, Palliative Care statistics & numerical data, Urethral Neoplasms therapy
- Abstract
Background: In metastatic urethral cancer, temporal trends, and patterns of inpatient palliative care (IPC) use are unknown., Methods: Relying on the National Inpatient Sample (2006-2019), metastatic urethral cancer patients were stratified according to IPC use. Estimated annual percentage changes (EAPC) analyses and multivariable logistic regression models (LRM) for the prediction of IPC use were fitted., Results: Of 1,106 metastatic urethral cancer patients, 199 (18%) received IPC. IPC use increased from 5.8 to 28.0% over time in the overall cohort (EAPC +9.8%; P < 0.001), from <12.5 to 35.1% (EAPC +11.2%; P < 0.001), and from <12.5 to 24.7% (EAPC +9.4%; P = 0.01) in respectively females and males. Lowest IPC rates were recorded in the Midwest (13.5%) vs. highest in the South (22.5%). IPC patients were more frequently female (44 vs. 37%), and more frequently exhibited bone metastases (45 vs. 34%). In multivariable LRM, female sex (multivariable odds ratio [OR] 1.46, 95% confidence interval [CI] 1.05-2.02; P = 0.02), and bone metastases (OR 1.46, 95%CI 1.02-2.10; P = 0.04) independently predicted higher IPC rates. Conversely, hospitalization in the Midwest (OR 0.53, 95%CI 0.31-0.91; P = 0.02), and in the Northeast (OR 0.48, 95%CI 0.28-0.82; P = 0.01) were both associated with lower IPC use than hospitalization in the West., Conclusion: IPC use in metastatic urethral cancer increased from a marginal rate of 5.8% to as high as 28%. Ideally, differences according to sex, metastatic site, and region should be addressed to improve IPC use rates., Competing Interests: Declaration of competing interest The authors declare no conflict of interest., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)
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- 2024
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27. Improved Survival in Contemporary Community-Based Patients With Metastatic Clear-Cell Renal Cell Carcinoma Undergoing Active Treatment.
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Incesu RB, Morra S, Scheipner L, Baudo A, Jannello LMI, de Angelis M, Siech C, Assad A, Tian Z, Saad F, Shariat SF, Chun FKH, Briganti A, de Cobelli O, Carmignani L, Ahyai S, Longo N, Tilki D, Graefen M, and Karakiewicz PI
- Subjects
- Humans, Female, Male, Middle Aged, Aged, SEER Program statistics & numerical data, Nephrectomy, Combined Modality Therapy, Adult, Cytoreduction Surgical Procedures, Treatment Outcome, Carcinoma, Renal Cell mortality, Carcinoma, Renal Cell drug therapy, Carcinoma, Renal Cell therapy, Carcinoma, Renal Cell pathology, Kidney Neoplasms mortality, Kidney Neoplasms pathology, Kidney Neoplasms therapy, Kidney Neoplasms drug therapy
- Abstract
Background: We hypothesized that the evolving treatment paradigms recommended based on phase III trials may have translated into improved overall survival (OS) in contemporary community-based patients with clear-cell metastatic renal cell carcinoma (ccmRCC) undergoing active treatment., Patients and Methods: Within the SEER database, contemporary (2017-2020) and historical (2010-2016) patients with ccmRCC treated with either systemic therapy (ST), cytoreductive nephrectomy (CN), or both (ST+CN) were identified. Univariable and multivariable Cox-regression models were used., Results: Overall, 993 (32%) contemporary versus 2,106 (68%) historical patients with ccmRCC were identified. Median OS was 41 months in contemporary versus 25 months in historical patients (Δ=16 months; P<.001). In multivariable Cox-regression analyses, contemporary membership was independently associated with lower overall mortality (hazard ratio [HR], 0.7; 95% CI, 0.6-0.8; P<.001). In patients treated with ST alone, median OS was 17 months in contemporary versus 10 months in historical patients (Δ=7 months; P<.001; multivariable HR, 0.7; P=.005). In patients treated with CN alone, median OS was not reached in contemporary versus 33 months in historical patients (Δ=not available; P<.001; multivariable HR, 0.7; P<.001). In patients treated with ST+CN, median OS was 38 months in contemporary versus 26 months in historical patients (Δ=12 months; P<.001; multivariable HR, 0.7; P=.003)., Conclusions: Contemporary community-based patients with ccmRCC receiving active treatment clearly exhibited better survival than their historical counterparts, when examined as one group, as well as when examined as separate subgroups according to treatment type. Treatment advancements of phase III trials seem to be applied appropriately outside of centers of excellence.
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- 2024
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28. Perioperative complications and in-hospital mortality in radical cystectomy patients with heart-valve replacement.
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Siech C, Baudo A, de Angelis M, Jannello LMI, Di Bello F, Goyal JA, Tian Z, Saad F, Shariat SF, Longo N, Carmignani L, de Cobelli O, Briganti A, Kosiba M, Mandel P, Kluth LA, Chun FKH, and Karakiewicz PI
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- Humans, Male, Female, Aged, Middle Aged, Length of Stay statistics & numerical data, Intraoperative Complications epidemiology, Aged, 80 and over, Hospital Mortality, Cystectomy methods, Urinary Bladder Neoplasms surgery, Urinary Bladder Neoplasms mortality, Postoperative Complications epidemiology, Heart Valve Prosthesis Implantation methods
- Abstract
Purpose: To assess in-hospital mortality and complication rates after radical cystectomy (RC) in patients with history of heart-valve replacement., Materials and Methods: Using the National Inpatient Sample (2000-2019), non-metastatic bladder cancer patients undergoing RC were stratified according to history of heart-valve replacement. Regression models (RM) predicted hospital outcomes., Results: Of 25,535 RC patients, 250 (1.0%) harbored history of heart-valve replacement. Heart-valve replacement patients were older (median 74 vs. 70 years), more frequently male (87.2 vs. 80.6%), and more frequently had Charlson comorbidity index ≥3 (26.8 vs. 18.9%). In RC patients with history of heart-valve replacement vs. others, 62 vs. 2634 (24.8 vs. 10.4%) experienced cardiac complications, 28 vs. 3092 (11.2 vs. 12.2%) intraoperative complications, 11 vs. 1046 (4.4 vs. 4.1%) infections, <11 vs. 594 (<4.4 vs. 2.3%) perioperative bleeding, <11 vs. 699 (<4.4 vs. 2.8%) vascular complications, 74 vs. 6225 (29.6 vs. 24.7%) received blood transfusions, 37 vs. 3054 (14.8 vs. 12.1%) critical care therapy (CCT), and in-hospital mortality was recorded in <11 vs. 463 (<4.4 vs. 1.8%) patients. In multivariable RM, history of heart-valve replacement independently predicted cardiac complications (odds ratio 2.20, 95% confidence interval 1.62-2.99; p < 0.001). Conversely, no statically significant association was recorded between history of heart-valve replacement and length of stay, estimated hospital cost, intraoperative complications, perioperative bleeding, vascular complications, infections, blood transfusions, CCT use, and in-hospital mortality., Conclusions: Radical cystectomy patients with history of heart-valve replacement exhibited a 2.2-fold higher risk of cardiac complications, but no other complications, including no significantly higher in-hospital mortality., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (© 2024 Published by Elsevier Ltd.)
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- 2024
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29. Contemporary conditional cancer-specific survival rates in surgically treated nonmetastatic primary urethral carcinoma.
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Morra S, Scheipner L, Baudo A, Jannello LMI, de Angelis M, Siech C, Goyal JA, Touma N, Tian Z, Saad F, Shariat SF, Creta M, Califano G, Celentano G, Colla' Ruvolo C, Ahyai S, Carmignani L, de Cobelli O, Musi G, Briganti A, Chun FKH, Longo N, and Karakiewicz PI
- Subjects
- Humans, Male, Female, Survival Rate, Middle Aged, Aged, Follow-Up Studies, Prognosis, Adult, Neoplasm Staging, Disease-Free Survival, Urethral Neoplasms mortality, Urethral Neoplasms surgery, Urethral Neoplasms pathology, SEER Program
- Abstract
Background: We examined the effect of disease-free interval (DFI) duration on cancer-specific mortality (CSM)-free survival, otherwise known as the effect of conditional survival, in radical urethrectomy nonmetastatic primary urethral carcinoma (PUC) patients., Methods: Using the Surveillance, Epidemiology, and End Results (SEER) database 2000-2020, patient (age, sex, race/ethnicity, and marital status) and tumor (stage and histology) characteristics, as well as systemic therapy exposure status of nonmetastatic PUC patients were tabulated. Conditional survival estimates at 5-year were assessed based on DFI duration and according to stage at presentation (T
1 -2 N0 vs. T3-4 N0-2 )., Results: Of all 512 radical urethrectomy PUC patients, 278 (54%) harbored T1-2 N0 stage versus 234 (46%) harbored T3-4 N0-2 stage. In 512 PUC patients, 5-year CSM-free survival at initial diagnosis was 61.8%. Provided a DFI duration of 36 months, 5-year CSM-free survival was 85.6%. In 278 T1-2 N0 PUC patients, 5-year CSM-free survival at initial diagnosis was 68.4%. Provided a DFI duration of 36 months, 5-year CSM-free survival was 86.9%. In 234 T3-4 N0-2 PUC patients, 5-year CSM-free survival at initial diagnosis was 53.8%. Provided a DFI duration of 36 months, 5-year CSM-free survival was 83.6%., Conclusions: Although intuitively, clinicians and patients are well aware of the concept that increasing DFI duration improves survival probability, only a few clinicians can accurately estimate the magnitude of survival improvement, as was done within the current study. Such information is crucial to survivors, especially in those diagnosed with rare malignancies, where the survival estimation according to DFI duration is even more challenging., (© 2024 Wiley Periodicals LLC.)- Published
- 2024
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30. Other-cause mortality in incidental prostate cancer.
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Di Bello F, Baudo A, de Angelis M, Jannello LMI, Siech C, Tian Z, Goyal JA, Collà Ruvolo C, Califano G, La Rocca R, Morra S, Acquati P, Saad F, Shariat SF, Carmignani L, de Cobelli O, Briganti A, Chun FKH, Longo N, and Karakiewicz PI
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- Humans, Male, Aged, Middle Aged, Cause of Death, Neoplasm Grading, Aged, 80 and over, United States epidemiology, Incidence, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Prostatic Neoplasms drug therapy, SEER Program, Incidental Findings
- Abstract
Background: In incidental prostate cancer (IPCa), elevated other-cause mortality (OCM) may obviate the need for active treatment. We tested OCM rates in IPCa according to treatment type and cancer grade and we hypothesized that OCM is significantly higher in not-actively-treated patients., Methods: Within the Surveillance, Epidemiology, and End Results database (2004-2015), IPCa patients were identified. Smoothed cumulative incidence plots as well as multivariable competing risks regression models were fitted to address OCM after adjustment for cancer-specific mortality (CSM)., Results: Of 5121 IPCa patients, 3655 (71%) were not-actively-treated while 1466 (29%) were actively-treated. Incidental PCa not-actively-treated patients were older and exhibited higher proportion of Gleason sum (GS) 6 and clinical T1a stage. In smoothed cumulative incidence plots, 5-year OCM was 20% for not-actively-treated versus 8% for actively-treated patients. Conversely, 5-year CSM was 5% for not-actively-treated versus 4% for actively-treated patients. No active treatment was associated with 1.4-fold higher OCM, even after adjustment for age, cancer characteristics, and CSM. According to GS, OCM reached 16%, 27%, and 35% in GS 6, 7, and 8-10 not-actively-treated IPCa patients, respectively and exceeded CSM recorded for the same three groups (2%, 6%, and 28%, respectively)., Conclusion: Our results quantified OCM rates, confirming that in not-actively-treated IPCa patients OCM is indeed significantly higher than in their actively-treated counterparts (HR: 1.4). These observations validate the use of no active treatment in IPCa patients, in whom OCM greatly surpasses CSM (20% vs. 5%)., (© 2024 Wiley Periodicals LLC.)
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- 2024
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31. Survival benefit of nephroureterectomy in systemic therapy exposed metastatic upper tract urinary urothelial carcinoma patients.
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Morra S, Incesu RB, Scheipner L, Baudo A, Jannello LMI, Siech C, de Angelis M, Tian Z, Creta M, Califano G, Collà Ruvolo C, Saad F, Shariat SF, Chun FKH, de Cobelli O, Musi G, Briganti A, Tilki D, Ahyai S, Carmignani L, Longo N, and Karakiewicz PI
- Subjects
- Humans, Female, Male, Aged, Survival Rate, Middle Aged, Retrospective Studies, Combined Modality Therapy, Neoplasm Staging, Aged, 80 and over, Nephroureterectomy, Ureteral Neoplasms surgery, Ureteral Neoplasms mortality, Ureteral Neoplasms pathology, Ureteral Neoplasms therapy, Carcinoma, Transitional Cell surgery, Carcinoma, Transitional Cell mortality, Carcinoma, Transitional Cell secondary, Kidney Neoplasms pathology, Kidney Neoplasms surgery, Kidney Neoplasms mortality, Kidney Neoplasms therapy
- Abstract
Background: It is unknown whether the stage of the primary may influence the survival (OS) of metastatic upper tract urothelial carcinoma (mUTUC) patients treated with nephroureterectomy (NU) and systemic therapy (ST). We tested this hypothesis within a large-scale North American cohort., Methods: Within Surveillance Epidemiology and End Results database 2000-2020, all mUTUC patients treated with ST+NU or with ST alone were identified. Kaplan-Maier plots depicted OS. Multivariable Cox regression (MCR) models tested for differences between ST+NU and ST alone predicting overall mortality (OM). All analyses were performed in localized (T1-T2) and then repeated in locally advanced (T3-T4) patients., Results: Of all 728 mUTUC patients, 187 (26%) harbored T1-T2 vs 541 (74%) harbored T3-T4. In T1-T2 patients, the median OS was 20 months in ST+NU vs 10 months in ST alone. Moreover, in MCR analyses that also relied on 3 months' landmark analyses, the combination of ST+NU independently predicted lower OM (HR 0.37, p < 0.001). Conversely, in T3-T4 patients, the median OS was 12 in ST+NU vs 10 months in ST alone. Moreover, in MCR analyses that also relied on 3 months' landmark analyses, the combination of ST+NU was not independently associated with lower OM (HR 0.85, p = 0.1)., Conclusions: In mUTUC patients, treated with ST, NU drastically improved survival in T1-T2 patients, even after strict methodological adjustments (multivariable and landmark analyses). However, this survival benefit did not apply to patients with locally more advanced disease (T3-T4)., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2024
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32. Unmarried status effect on stage at presentation and treatment patterns in primary urethral carcinoma patients.
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Morra S, Scheipner L, Baudo A, Jannello LMI, de Angelis M, Siech C, Goyal JA, Touma N, Tian Z, Saad F, Califano G, Celentano G, la Rocca R, Napolitano L, Shariat SF, Ahyai S, Carmignani L, de Cobelli O, Musi G, Briganti A, Chun FKH, Longo N, and Karakiewicz PI
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- Humans, Male, Female, Marital Status, SEER Program, Single Person, Carcinoma
- Abstract
Background: Unmarried status has been associated with advanced stage at presentation and lower treatment dose intensification rates in several urological and non-urological malignancies. However, no previous investigators focused of the association of unmarried status with locally advanced stage (T
3-4 N0-2 ) at presentation and lower bi-/trimodal therapy rates in primary urethral carcinoma (PUC) patients. To address these knowledge gaps, we relied on the Surveillance, Epidemiology, and End Results (SEER) database., Methods: Within the SEER database 2000 to 2020, all non-metastatic PUC patients were identified. Logistic regression models (LRMs) tested for differences in stage at presentation and treatment modality in the overall cohort and then in a sex-specific fashion, according to marital status (married vs unmarried)., Results: Of all 1,430 non-metastatic PUC patients, 1,004 (70%) were male vs 426 (30%) were female. Of 1,004 male PUC patients, 272 (27%) were unmarried. Of all 426 female PUC patients, 239 (56%) were unmarried. In multivariable LRMs predicting T3-4 N0-2 , unmarried status was independently associated with an increased risk of locally advanced stage at presentation in the overall cohort (odds ratio [OR]:1.31; P = 0.03) and in female patients (OR:1.62; P = 0.02), but not in male PUC patients (P = 0.6). In multivariable LRMs predicting bi-/trimodal therapy, unmarried status was an independent predictor of lower bi-/trimodal therapy rates in the overall cohort (OR:0.73; P = 0.02) and in male patients (OR:0.60; P = 0.007), but not in female PUC patients (P = 0.6)., Conclusions: Unmarried female PUC patients more likely harbored locally advanced stage at presentation. Conversely, unmarried male PUC patients are less likely to benefit from bi-/trimodal therapy., Competing Interests: Declaration of competing interest Shahrokh F. Shariat: Horonraria: Astellas, Astra Zeneca, Bayer, BMS, Cepheid, Ferring, lpsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda, Urogen. Consulting or Advisory Role: Astellas, Astra Zeneca, Bayer, BMS, Cepheid, Ferring, lpsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda, Urogen. Speakers’ Bureau: Astellas, Astra Zeneca, Bayer, BMS, Cepheid, Ferring, lpsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda, Urogen, Movember Foundation. Patents: Method to determine prognosis after therapy for prostate cancer—granted 2002-09-06, Methods to determine prognosis after therapy for bladder cancer—granted 2003-06-19, Prognostic methods for patients with prostatic disease—granted 2004-08-05; Soluble Fas urinary marker for the detection of bladder transitional cell carcinoma—granted 2010-07-20. Our research was conducted without any other potential conflicts of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)- Published
- 2024
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33. Regional differences in upper tract urothelial carcinoma patients across the United States.
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Morra S, Scheipner L, Baudo A, Jannello LMI, de Angelis M, Siech C, Goyal JA, Touma N, Tian Z, Saad F, Califano G, la Rocca R, Capece M, Shariat SF, Ahyai S, Carmignani L, de Cobelli O, Musi G, Briganti A, Chun FKH, Longo N, and Karakiewicz PI
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- Humans, United States epidemiology, SEER Program, Retrospective Studies, Carcinoma, Transitional Cell pathology, Ureteral Neoplasms pathology, Urinary Bladder Neoplasms, Kidney Neoplasms pathology
- Abstract
Background: It is unknown whether regional differences in patient, tumor, and treatment characteristics of upper tract urothelial carcinoma (UTUC) patients exist and may potentially result in regional overall mortality (OM) differences. We tested for inter-regional differences, according to Surveillance, Epidemiology, and End Results (SEER) registries., Methods: Using SEER database 2000 to 2016, patient (age, sex, race/ethnicity), tumor (location, grade) and treatment (nephroureterectomy, systemic therapy [ST]) characteristics of UTUC patients of all-stages were tabulated and graphically depicted in a stage-specific fashion (T
1-2 N0 M0 vs. T3-4 N0 M0 vs. Tany N1-2 M0 /Tany Nany M1 ). Multivariable Cox regression (MCR) models tested for inter-regional differences in OM., Results: Regarding T1-2 N0 M0 patients, statistically significant differences existed for race/ethnicity (Caucasian 71 vs. 98%), location (renal pelvis: 55 vs. 67%), grade (high 60 vs. 83%) and ST (5.5 vs. 13.9%). In MCR models, registries 3 (Hazard ratio [HR]:1.39; P < 0.001) and 4 (HR:1.31; P = 0.01) independently predicted higher OM and Registry 8 (HR:0.64; P = 0.001) lower OM. Regarding T3-4 N0 M0 patients, statistically significant differences existed for race/ethnicity (Caucasian 70 vs. 98%), location (renal pelvis: 67 vs. 76%), grade (high 84 vs. 94%) and ST (18.7 vs. 29.5%). In MCR models, registries 3 (HR:1.42; P < 0.001) and 4 (HR:1.31; P = 0.009) independently predicted higher OM. Regarding Tany N1-2 M0 /Tany Nany M1 patients, statistically significant differences existed for location (renal pelvis: 63 vs. 82%), grade (high 92 vs. 98%) and ST (53.4 vs. 58.8%). In MCR models, Registry 3 (HR:1.37; P = 0.004) independently predicted higher OM and Registry 2, (HR:0.78; P = 0.02) lower OM., Conclusions: Inter-regional differences were recorded in patients, tumor, and treatment characteristics. Even after adjustment for these characteristics, OM differences persisted which may be indicative of regional differences in quality of care or expertise in UTUC management., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier Inc. All rights reserved.)- Published
- 2024
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34. Contemporary validation of cT1a vs. cT1b substaging of incidental prostate cancer.
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Scheipner L, Baudo A, Jannello LMI, Siech C, de Angelis M, Tian Z, Saad F, Shariat SF, Briganti A, Chun FKH, Carmignani L, De Cobelli O, Mischinger J, Ahyai S, and Karakiewicz PI
- Subjects
- Humans, Male, Aged, Middle Aged, SEER Program, Neoplasm Grading, Survival Rate, Retrospective Studies, Kaplan-Meier Estimate, Prostatic Neoplasms pathology, Prostatic Neoplasms mortality, Prostatic Neoplasms therapy, Incidental Findings, Neoplasm Staging
- Abstract
Objective: The cT1a vs. cT1b substratification was introduced in 1992 but never formally tested since. We tested the discriminative ability of cT1a vs. cT1b substaging on cancer-specific survival (CSS) in contemporary incidental prostate cancer (PCa) patients., Design, Setting and Participants: Incidental (cT1a/cT1b) PCa patients were identified within the Surveillance, Epidemiology, and End Results (SEER) database (2004-2015)., Outcome Measurements and Statistical Analysis: Kaplan-Meier estimates, as well as uni- and multivariable Cox regression models predicted CSS at five years. Subgroup analyses addressed CSS at five years according to active vs. no local treatment (NLT) as well as Gleason score sum (GS; 6 vs. 7 vs. ≥ 8)., Results and Limitation: We identified a total of 5,155 incidental prostate cancer patients of which 3,035 (59%) were stage cT1a vs. 2,120 (41%) were stage cT1b. In all incidental PCa patients, CSS at five years was 95% (95% CI 0.94-0.96). In cT1a patients, CSS at five years was 98 vs. 90% in cT1b patients (p < 0.001). In multivariable Cox regression analyses, cT1b independently predicted 2.8-fold higher CSM than cT1a (HR 2.5, 95% CI 1.8-3.6, p < 0.001) for incidental PCa patients who underwent NLT. In subgroup analyses, cT1b represented an independent predictor of higher CSM in GS ≥ 8 (HR 3.0, 95% CI 1.4-6.2, p = 0.003), and GS 7 (HR 3.9, 95% CI 1.6-9.7 p = 0.002) patients who underwent NLT. For actively treated patients, cT1b was not independently associated with worse CSM., Conclusion: The historical subclassification of cT1a vs. cT1b in incidental PCa patients displayed a strong ability to discriminate CSS in contemporary GS 7 and GS ≥ 8 patients who underwent NLT. However, no statistically significant difference was recorded in actively treated patients. In consequence, the importance of the current substage stratification predominantly applies to GS ≥ 8 patients who undergo a non-active treatment approach., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2024
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35. Anxiety, depression, urinary continence, and sexuality in patients undergoing radical prostatectomy: preliminary findings.
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Tozzi M, Jannello LMI, Silvaggi M, and Michetti PM
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- Male, Humans, Retrospective Studies, Sexuality, Anxiety, Prostatectomy, Depression, Erectile Dysfunction
- Abstract
Objectives: Evaluate the relationship between psychological distress, namely anxiety and depression, with urinary continence and recovery of erectile function in patients undergoing radical prostatectomy (RP)., Methods: We retrospectively analyzed data from 33 consecutive patients who underwent RP in a single tertiary-referral academy between 01/2018 to 01/2019. We used the International Index of Erectile Function (IIEF-15), the Sexual Complaints Screener for Men (SCS-M), and the Hospital Anxiety and Depression Scale (HADS), validated questionnaires for the assessment of sexual function, anxiety, and depression experiences, respectively. These questionnaires were administered at the pre-surgical visit, after surgery, and at intermediate follow-ups (three, six, and twelve months)., Results: The analysis of the questionnaires completed during follow-up shows that erectile function is the most affected, with 90% erectile dysfunction (ED) at three months after surgery. In terms of emotional states, anxiety prevails in the first months following surgery and is statistically significantly associated with incontinence (p = 0.02). Depressive symptoms, on the other hand, appear later and prevail over anxiety at six months after surgery, although not statistically significant., Conclusions: In the early post-surgical phase anxiety and ED are the most frequently detected components, while depressive experiences and decreased desire, typical of later stages, have not yet fully emerged., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2024
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36. Prognostic Significance of Radiographic Lymph Node Invasion in Contemporary Metastatic Renal Cell Carcinoma Patients.
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Scheipner L, Incesu RB, Morra S, Baudo A, Assad A, Jannello LMI, Siech C, de Angelis M, Tian Z, Saad F, Shariat SF, Briganti A, Chun FKH, Tilki D, Longo N, Carmignani L, De Cobelli O, Pichler M, Ahyai S, and Karakiewicz PI
- Subjects
- Humans, Prognosis, Lymph Nodes pathology, Nephrectomy methods, Carcinoma, Renal Cell diagnostic imaging, Carcinoma, Renal Cell surgery, Carcinoma, Renal Cell pathology, Kidney Neoplasms diagnostic imaging, Kidney Neoplasms surgery, Kidney Neoplasms pathology
- Abstract
Purpose: To test the prognostic significance of radiographic cN-stage in metastatic renal cell carcinoma (mRCC) patients with low metastatic burden (1 site of metastasis), relying on the Surveillance, Epidemiology, and End Results database (SEER 2010-2020)., Methods: Included were mRCC patients with 1 site of metastasis, treated with systemic therapy without cytoreductive nephrectomy (CN). Kaplan-Meier plots and multivariable Cox-regression models addressed cancer-specific mortality (CSM) according to radiographic cN-stage (ccN1 vs. ccN0). Separate subgroup analyses were performed, addressing radiographic N-stage in patients with distinct histology (clear-cell vs. RCC not otherwise specified [RCC NOS])., Results: Of 1756 mRCC patients, 545 (31%) were radiographic cN1. Overall, the median CSM-free survival of the cohort was 11 months. Median CSM-free survival was 8 vs. 14 months in radiographic cN1 vs. cN0 mRCC patients (HR 1.49, P < .0001). In multivariable Cox regression analyses, radiographic cN1 status was an independent predictor of higher CSM (HR 1.39; P = .01). In subgroup analyses, addressing patients with clear-cell histology and patients with RCC NOS separately, radiographic cN1 status remained independently associated with a higher CSM in both groups (clear-cell: HR 1.36; P = .03; RCC NOS: HR 2.06; P = .009)., Conclusion: In mRCC patients with low metastatic burden, presence or absence of radiographic lymph node invasion results in a clinically meaningful discrimination between those with poor prognosis and others. In consequence, consideration of radiographic lymph node invasion might be of great value in this specific population of mRCC patients., Competing Interests: Disclosure The authors have stated that they have no conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2024
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37. Married Status Affects Rates of Treatment and Mortality in Male and Female Renal Cell Carcinoma Patients Across all Stages.
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Siech C, Morra S, Scheipner L, Baudo A, Jannello LMI, de Angelis M, Goyal JA, Tian Z, Saad F, Shariat SF, Longo N, Carmignani L, de Cobelli O, Ahyai S, Briganti A, Mandel P, Kluth LA, Chun FKH, and Karakiewicz PI
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- Humans, Male, Female, Nephrectomy methods, Logistic Models, Survival Analysis, SEER Program, Carcinoma, Renal Cell surgery, Kidney Neoplasms surgery
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Introduction: The association between treatment rates and cancer specific mortality (CSM) according to married status in male and female clear cell renal cell carcinoma (ccRCC) patients across all stages is unknown., Patient and Methods: Using the Surveillance, Epidemiology, and End Results database (2004-2020), ccRCC patients were stratified according to married status (married vs. unmarried). Logistic regression models addressed treatment rates; Cox regression models addressed CSM rates., Results: Of 98,142 patients, 43,999 (72%) males and 20,287 (55%) females were married. In stage-specific analyses, married status independently predicted higher nephrectomy rates in males and females (all P ≤ .03). In stage IV, married status predicted higher systemic therapy rate in males (P < .001), but not in females. In survival analyses, married males exhibited lower CSM rates relative to unmarried males (all P ≤ .02). Conversely, married females exhibited lower CSM rates only in stages I and III (all P ≤ .02), but not in stages II and IV. In subgroup analyses of T1aN0M0 patients, married status was associated with higher partial nephrectomy rates in both males and females (all P ≤ .005)., Conclusion: In ccRCC, married status invariably predicts higher rates of guideline recommended surgical management (nephrectomy and partial nephrectomy). Moreover, even after adjustment for treatment type, married status independently predicted lower CSM rates in males across all stages. However, the effect of married status in females is only operational in stages I and III. Lack of association between married status in stages II and IV may potentially be explained by stronger association with treatment assignment which reduces the residual effect on survival., Competing Interests: Disclosure The authors declare no conflict of interest., (Copyright © 2024 Elsevier Inc. All rights reserved.)
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- 2024
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38. Other-Cause Mortality, According to Partial vs. Radical Nephrectomy: Age and Stage Analyses.
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Baudo A, Incesu RB, Morra S, Scheipner L, Jannello LMI, de Angelis M, Siech C, Tian Z, Acquati P, Tilki D, Longo N, Ahyai S, de Cobelli O, Briganti A, Chun FKH, Saad F, Shariat SF, Carmignani L, and Karakiewicz PI
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- Humans, Middle Aged, Neoplasm Staging, Nephrectomy methods, Incidence, Carcinoma, Renal Cell pathology, Kidney Neoplasms pathology
- Abstract
Introduction: We tested the association between other-cause mortality and partial vs. radical nephrectomy in patients with T1a, T1b, and T2 renal cell carcinoma, across all patient ages., Material and Methods: Within the Surveillance, Epidemiology, and End Results database (2010-2020), patients with localized renal cell carcinoma stages (T1a-T1b-T2, N0, M0), who underwent partial or radical nephrectomy were identified. Only patients with tumor size 2 to 10 cm were included. Cumulative incidence plots and multivariable competing risks regression models were used., Results: Of 68,195 patients, 28,845 (42%) underwent partial nephrectomy vs. 39,350 (58%) radical nephrectomy. In T1a patients, 5-year other-cause mortality rates were 6% for partial nephrectomy vs. 11% for radical nephrectomy (Δ=5%). In T1a patients, partial nephrectomy independently predicted lower other-cause mortality, across all ages (HR: 0.73, P < .001). In age category subgroup analyses addressing T1a patients, in all age categories, partial nephrectomy invariably predicted lower other-cause mortality than radical nephrectomy: ≤59 years (HR: 0.67, P < .001); 60 to 69 years (HR: 0.70, P < .001); and ≥70 years (HR: 0.79, P < .001). Finally, in T1b patients, as well as in T2 patients, no other-cause mortality advantage was recorded for partial vs. radical nephrectomy: T1b (8 vs. 10%, Δ=2%); T2 (8 vs. 9%, Δ=1%)., Conclusions: Relative to radical nephrectomy, partial nephrectomy is associated with lower other-cause mortality in stage T1a renal cell carcinoma patients across all age categories, including the oldest patients. Conversely, no clinically meaningful other-cause mortality benefit was associated with partial nephrectomy in stages T1b or T2, regardless of age, including youngest patients., Competing Interests: Disclosure The authors declare that there are no conflict of interests., (Copyright © 2023 Elsevier Inc. All rights reserved.)
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- 2024
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39. Differences in other-cause mortality in metastatic renal cell carcinoma according to partial vs. radical nephrectomy and age: A propensity score matched study.
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Siech C, Incesu RB, Morra S, Scheipner L, Baudo A, Jannello LMI, de Angelis M, Goyal JA, Tian Z, Saad F, Shariat SF, Tilki D, Longo N, Carmignani L, de Cobelli O, Ahyai S, Briganti A, Mandel P, Kluth LA, Chun FKH, and Karakiewicz PI
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- Humans, Propensity Score, SEER Program, Nephrectomy methods, Carcinoma, Renal Cell surgery, Carcinoma, Renal Cell pathology, Kidney Neoplasms surgery, Kidney Neoplasms pathology
- Abstract
Introduction: It is unknown whether the benefit from partial nephrectomy regarding lower other-cause mortality is applicable to older patients with metastatic renal cell carcinoma., Materials and Methods: Using Surveillance Epidemiology and End Results database, patients with metastatic renal cell carcinoma, undergoing partial or radical nephrectomy, were stratified according to age (<60, 60-69, and ≥70 years). After propensity score matching, Kaplan-Meier survival analyses and multivariable Cox regression models were used., Results: Of 2,390 patients with metastatic renal cell carcinoma, 885 (37%) were aged <60 years, and 90 (10%) underwent partial nephrectomy; 824 (34%) were aged 60-69 years, and 61 (7%) underwent partial nephrectomy; and 681 (29%) were aged ≥70 years, and 64 (9%) underwent partial nephrectomy. After propensity score matching, in patients aged <60 years, partial nephrectomy was associated with lower other-cause mortality (hazard ratio 0.22; p = 0.02); in patients aged 60-69 years, partial nephrectomy was associated with lower other-cause mortality (hazard ratio 0.38; p = 0.03); but not in patients aged ≥70 years., Discussion: In metastatic renal cell carcinoma, partial nephrectomy is associated with lower other-cause mortality in patients aged <60 years and in patients aged 60-69 years, but not in patients aged ≥70 years. In consequence, consideration of partial nephrectomy might be of great value in younger metastatic renal cell carcinoma patients., Competing Interests: Declaration of competing interest The authors declare no conflicts of interest., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)
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- 2024
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40. Non-Surgical Bladder-Sparing Multimodal Management in Organ-Confined Urothelial Carcinoma of the Urinary Bladder: A Population-Based Analysis.
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de Angelis M, Baudo A, Siech C, Jannello LMI, Di Bello F, Goyal JA, Tian Z, Longo N, de Cobelli O, Chun FKH, Saad F, Shariat SF, Carmignani L, Gandaglia G, Moschini M, Montorsi F, Briganti A, and Karakiewicz PI
- Abstract
Background: Trimodal therapy is considered the most validated bladder-sparing treatment in patients with organ-confined urothelial carcinoma of the urinary bladder (T2N0M0). However, scarce evidence exists regarding cancer-specific mortality (CSM) differences between trimodal therapy and other non-extirpative multimodal treatment options such as radiotherapy alone after transurethral resection (TURBT + RT) or chemotherapy alone after transurethral resection (TURBT + CT)., Methods: Within the Surveillance, Epidemiology, and End Results database (2004-2020), we identified T2N0M0 patients treated with either trimodal therapy, TURBT + CT, or TURBT + RT. Temporal trends described trimodal therapy vs. TUBRT + CT vs. TURBT + RT use over time. Survival analyses consisting of Kaplan-Meier plots and multivariable Cox regression (MCR) models addressed CSM according to each treatment modality., Results: 3729 (40%) patients underwent TMT vs. 4030 (43%) TURBT + CT vs. 1599 (17%) TURBT + RT. Over time, trimodal therapy use (Estimating annual percent change, EAPC: +1.2%, p = 0.01) and TURBT + CT use increased (EAPC: +1.5%, p = 0.01). In MCR models, relative to trimodal therapy, TURBT + CT exhibited 1-14-fold higher CSM and TURBT + RT 1.68-fold higher CSM. In a subgroup analysis, TURBT + RT was associated with 1.42-fold higher CSM than TURBT + CT ( p < 0.001)., Conclusions: Strict trimodal therapy that includes both CT and RT after TURBT offers the best cancer control. When strict trimodal therapy cannot be delivered, cancer-specific survival outcomes appear to be superior with TURBT + chemotherapy compared to TURBT + RT.
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- 2024
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41. Cancer-specific mortality in non-metastatic T1a renal cell carcinoma treated with radiotherapy versus partial nephrectomy.
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de Angelis M, Morra S, Scheipner L, Siech C, Jannello LMI, Baudo A, Goyal JA, Tian Z, Longo N, Ahyai S, de Cobelli O, Chun FKH, Saad F, Shariat SF, Carmignani L, Montorsi F, Briganti A, and Karakiewicz PI
- Subjects
- Humans, Aged, Nephrectomy methods, Proportional Hazards Models, Incidence, Carcinoma, Renal Cell pathology, Kidney Neoplasms pathology
- Abstract
Purpose: Radiotherapy (RT) represents a treatment option for small renal masses with proven feasibility and tolerability. However, it has never been directly compared to partial nephrectomy (PN) with cancer-specific mortality (CSM) as an endpoint., Methods: Within the Surveillance, Epidemiology, and End Results database (2004-2020), we identified T1aN0M0 renal cell carcinoma (RCC) patients treated with RT or PN. We relied on 1:1 propensity score matching (PSM) for age, tumor size and histology. Subsequently, cumulative incidence plots and multivariable competing risks regression (CRR) models were fitted. The same methodology was then re-applied to a subset of patients with tumor size 21-40 mm., Results: Of 40,355 patients with T1aN0M0 RCC, 40,262 underwent PN (99.8%) vs 93 underwent RT (0.2%). RT patients were older (median age 72 vs 60 years, p < 0.001) and harbored larger tumor size (median size 28 vs 25 mm, p < 0.001) and a higher proportion of non-clear cell RCC (49% vs 22%, p < 0.001). After 1:1 PSM (92 RT versus 92 PN patients), cumulative incidence plots' derived CSM was 21.3 vs 4%, respectively. In multivariable CRR models, RT independently predicted higher CSM (hazard ratio (HR) 4.3, p < 0.001). In the subgroup with tumor size 21-40 mm, after 1:1 PSM (72 RT versus 72 PN patients), cumulative incidence plots derived CSM was 21.3% vs 4%, respectively. In multivariable CRR models, RT also independently predicted higher CSM (HR 4.7, p = 0.001)., Conclusions: In T1aN0M0 RCC patients, relative to PN, RT is associated with significantly higher absolute and relative CSM, even in patients with tumor size 21-40 mm., (© 2024. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2024
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42. The effect of race/ethnicity on cancer-specific mortality after trimodal therapy.
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de Angelis M, Baudo A, Siech C, Jannello LMI, Di Bello F, Goyal JA, Tian Z, Longo N, de Cobelli O, Chun FKH, Saad F, Shariat SF, Carmignani L, Gandaglia G, Moschini M, Montorsi F, Briganti A, and Karakiewicz PI
- Abstract
Introduction: Trimodal therapy (TMT) is the most validated bladder-sparing treatment for organ-confined urothelial carcinoma of the urinary bladder (OC UCUB, namely cT2N0M0). However, it is unknown if barriers to the use of TMT or cancer-specific mortality (CSM) differences exist according to race/ethnicity. We addressed this knowledge gap., Material and Methods: Within the Surveillance, Epidemiology, and End Results database (2004-2020), we identified OC UCUB patients aged from 18 to 85 treated with radical cystectomy (RC) or TMT. Temporal trends described TMT versus RC use over time. Subsequently, in the subgroup of TMT-treated patients, survival analyses consisting of Kaplan-Meier plots and multivariable Cox regression (MCR) models addressed CSM according to race/ethnicity., Results: Among 19,501 assessable patients, 15,336 (79%) underwent RC versus 4165 TMT (21%). Overall, of all races/ethnicities, 16,245 (83.3%) were White Americans, 1215 (6.3%) Hispanics, 1160 (5.9%) African Americans, and 881 (4.5%) Asian/Pacific Islanders. Among TMT-treated patients, 3460 (83.1%) were White Americans, 298 (7.1%) African Americans, 218 (5.3%) Hispanics, and 189 (4.5%) Asian/Pacific Islanders. The lowest rate of TMT use relative to RC and TMT patients was recorded in Hispanics (17.9%). Over time, TMT use increased in White Americans (EAPC: + 4.5%, p = 0.001) and Asians/Pacific Islanders (EAPC: + 5.2%, p = 0.003), but not in others. Kaplan-Meier analyses showed median CSM of 49 months, 41 months, and 34 months and not reached in White Americans, Hispanics, African Americans, and Asian/Pacific Islanders, respectively (p = 0.02). In MCR models, two race/ethnicity subgroups independently predicted either worse (African Americans, HR: 1.20, p = 0.02) or better CSM (Asian/Pacific Islanders, HR: 0.75, p = 0.02)., Conclusion: Race/ethnicity affects both access to TMT (lower access in Hispanics) as well as survival after TMT (better in Asians/Pacific Islanders and worse in African Americans)., (© 2024. W. Montague Cobb-NMA Health Institute.)
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- 2024
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43. Multivariable model versus AJCC staging system: cancer-specific survival predictions in adrenocortical carcinoma.
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Jannello LMI, Morra S, Scheipner L, Baudo A, Siech C, de Angelis M, Touma N, Tian Z, Goyal JA, Luzzago S, Mistretta FA, Piccinelli ML, Saad F, Chun FKH, Briganti A, Ahyai S, Carmignani L, Longo N, de Cobelli O, Musi G, and Karakiewicz PI
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- Humans, Middle Aged, Neoplasm Staging, Proportional Hazards Models, Prognosis, Adrenocortical Carcinoma, Adrenal Cortex Neoplasms
- Abstract
We developed a novel contemporary population-based model for predicting cancer-specific survival (CSS) in adrenocortical carcinoma (ACC) patients and compared it with the established 8th edition of the American Joint Committee on Cancer staging system (AJCC). Within the Surveillance, Epidemiology, and End Results database (2004-2020), we identified 1056 ACC patients. Univariable Cox regression model addressed CSS. Harrell's concordance index (C-index) quantified accuracy after 2000 bootstrap resamples for internal validation. The multivariable Cox regression model included the most informative, statistically significant predictors. Calibration and decision curve analyses (DCAs) tested the multivariable model as well as AJCC in head-to-head comparisons. Age at diagnosis (>60 vs ≤60 years), surgery, T, N, and M stages were included in the multivariable model. Multivariable model C-index for 3-year CSS prediction was 0.795 vs 0.757 for AJCC. Multivariable model outperformed AJCC in DCAs for the majority of possible CSS-predicted values. Both models exhibited similar calibration properties. Finally, the range of the multivariable model CSS predicted probabilities raged 0.02-75.3% versus only four single AJCC values, specifically 73.2% for stage I, 69.7% for stage II, 46.6% for stage III, and 15.5% for stage IV. The greatest benefit of the multivariable model-generated CSS probabilities applied to AJCC stage I and II patients. The multivariable model was more accurate than AJCC staging when CSS predictions represented the endpoint. Additionally, the multivariable model outperformed AJCC in DCAs. Finally, the AJCC appeared to lag behind the multivariable model when discrimination addressed AJCC stage I and II patients.
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- 2024
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44. Contemporary sex-specific analysis of the association of marital status with cancer-specific mortality in primary urethral carcinoma patients.
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Morra S, Scheipner L, Baudo A, Jannello LMI, de Angelis M, Siech C, Goyal JA, Touma N, Tian Z, Saad F, Creta M, Califano G, Celentano G, Shariat SF, Ahyai S, Carmignani L, de Cobelli O, Musi G, Briganti A, Chun FKH, Longo N, and Karakiewicz PI
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- Humans, Male, Female, Marital Status, Proportional Hazards Models, SEER Program, Adenocarcinoma
- Abstract
Background: It is unknown whether married status may be associated with lower cancer-specific mortality (CSM) rates in primary urethral carcinoma (PUC) patients. To test for differences in CSM rates, according to marital status, we relied on the Surveillance, Epidemiology, and End Results (SEER) database 2000-2020., Methods: Patient (age, sex, race/ethnicity, marital status), tumor (stage, histology), and treatment (surgery, systemic therapy) characteristics of PUC patients were tabulated. Then, Kaplan-Meier plots, as well as univariable and multivariable Cox regression (MCR) models tested for differences in CSM rates according to marital status in overall cohort and then in sex-specific subgroup analyses., Results: Of all 1,571 PUC patients, 70% were male vs. 30% female. Females were statistically significantly younger (68 vs. 73 years), more frequently unmarried (54 vs. 28%), non-Caucasian (43 vs. 24%), more frequently harbored T
3-4 N0 M0 (39 vs. 18%) and less frequently T1-2 N0 M0 (53 vs. 69%) or Tany N1-2 M0 /Tany Nany M1 (8 vs. 13%), relative to males. Moreover, we recorded differences in histotype proportions in females vs. males (urothelial 30 vs. 64%; squamous 24 vs. 22%; adenocarcinoma 36 vs. 7%; others 10 vs. 6%) and surgical treatment (none 22 vs. 17%; excisional biopsy 22 vs. 36%; partial urethrectomy 14 vs. 16%; radical urethrectomy 42 vs. 31%). In MCR models focusing on the entire cohort, married status independently predicted lower CSM (hazard ratio [HR]:0.82; P = 0.02). Similarly, in MCR models focusing on females, married status independently predicted lower CSM (HR:0.73; P = 0.03). Conversely, in MCR models focusing on males, married status failed to independently predict lower CSM (HR:0.89; P = 0.3)., Conclusions: Married status was associated with lower CSM in PUC patients. However, this benefit applies to female PUC patients, but not to their male counterparts., Competing Interests: Declaration of Competing Interest Shahrokh F. Shariat: Honoraria: Astellas, Astra Zeneca, Bayer, BMS, Cepheid, Ferring, lpsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda, Urogen. Consulting or Advisory Role: Astellas, Astra Zeneca, Bayer, BMS, Cepheid, Ferring, lpsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda, Urogen. Speakers’ Bureau: Astellas, Astra Zeneca, Bayer, BMS, Cepheid, Ferring, lpsen, Janssen, Lilly, MSD, Olympus, Pfizer, Pierre Fabre, Richard Wolf, Roche, Sanochemia, Sanofi, Takeda, Urogen, Movember Foundation. Patents: Method to determine prognosis after therapy for prostate cancer—granted September 6, 2002, Methods to determine prognosis after therapy for bladder cancer—granted June 19, 2003, Prognostic methods for patients with prostatic disease—granted August 5, 2004; Soluble Fas urinary marker for the detection of bladder transitional cell carcinoma—granted July 20, 2010., (Copyright © 2023 Elsevier Inc. All rights reserved.)- Published
- 2024
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45. The Association between Urinary Diversion Type and Other-Cause Mortality in Radical Cystectomy Patients.
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Morra S, Scheipner L, Baudo A, Jannello LMI, de Angelis M, Siech C, Goyal JA, Touma N, Tian Z, Saad F, Califano G, Creta M, Celentano G, Shariat SF, Ahyai S, Carmignani L, de Cobelli O, Musi G, Briganti A, Chun FKH, Longo N, and Karakiewicz PI
- Abstract
Background: It is unknown whether more complex UD, such as orthotopic neobladder and abdominal pouch, may be associated with higher OCM rates than ileal conduit. We addressed this knowledge gap within the SEER database 2004-2020., Methods: All T1-T4aN
0 M0 radical cystectomy (RC) patients were identified. After 1:1 propensity score matching (PSM), cumulative incidence plots, univariable and multivariable competing-risks regression (CRR) models were used to test differences in OCM rates according to UD type (orthotopic neobladder vs. abdominal pouch vs. ileal conduit)., Results: Of all 3008 RC patients, 2380 (79%) underwent ileal conduit vs. 628 (21%) who underwent continent UD (268 orthotopic neobladder and 360 abdominal pouch). After PSM relative to ileal conduit, neither continent UD (13 vs. 15%; p = 0.1) nor orthotopic neobladder (13 vs. 16%; p = 0.4) nor abdominal pouch (13 vs. 15%; p = 0.2) were associated with higher 10-year OCM rates. After PSM and after adjustment for cancer-specific mortality (CSM), as well as after multivariable adjustments relative to ileal conduit, neither continent UD (Hazard Ratio [HR]:0.73; p = 0.1), nor orthotopic neobladder (HR:0.84; p = 0.5) nor abdominal pouch (HR:0.77; p = 0.2) were associated with higher OCM., Conclusions: It appears that more complex UD types, such as orthotopic neobladder and abdominal pouch are not associated with higher OCM relative to ileal conduit.- Published
- 2024
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46. The effect of married status on cancer-specific mortality in nonmetastatic pelvic liposarcoma patients according to sex.
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Baudo A, Morra S, Scheipner L, Jannello LMI, de Angelis M, Siech C, Touma N, Goyal JA, Tian Z, Acquati P, Longo N, Ahyai S, de Cobelli O, Briganti A, Chun FKH, Saad F, Shariat SF, Carmignani L, and Karakiewicz PI
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Sex Factors, SEER Program, Adult, Retrospective Studies, Liposarcoma mortality, Marital Status statistics & numerical data, Pelvic Neoplasms mortality
- Abstract
Background: In nonmetastatic pelvic liposarcoma patients, it is unknown whether married status is associated with better cancer-control outcome defined as cancer-specific mortality (CSM). We addressed this knowledge gap and hypothesized that married status is associated with lower CSM rates in both male and female patients., Methods: Within the Surveillance, Epidemiology, and End Results database (2000-2020), nonmetastatic pelvic liposarcoma patients were identified. Kaplan-Meier plots and univariable and multivariable Cox regression models (CRMs) predicting CSM according to marital status were used in the overall cohort and in male and female subgroups., Results: Of 1078 liposarcoma patients, 764 (71%) were male and 314 (29%) female. Of 764 male patients, 542 (71%) were married. Conversely, of 314 female patients, 192 (61%) were married. In the overall cohort, 5-year cancer-specific mortality-free survival (CSM-FS) rates were 89% for married versus 83% for unmarried patients (Δ = 6%). In multivariable CRMs, married status did not independently predict lower CSM (hazard ratio [HR]: 0.74, p = 0.06). In males, 5-year CSM-FS rates were 89% for married versus 86% for unmarried patients (Δ = 3%). In multivariable CRMs, married status did not independently predict lower CSM (HR: 0.85, p = 0.4). In females, 5-year CSM-FS rates were 88% for married versus 79% for unmarried patients (Δ = 9%). In multivariable CRMs, married status independently predicted lower CSM (HR: 0.58, p = 0.03)., Conclusions: In nonmetastatic pelvic liposarcoma patients, married status independently predicted lower CSM only in female patients. In consequence, unmarried female patients should ideally require more assistance and more frequent follow-up than their married counterparts., (© 2023 International Society of Surgery/Société Internationale de Chirurgie (ISS/SIC).)
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- 2024
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47. Ischaemic Priapism: A Complication of Self-Administered Hyaluronic Acid Gel as an Injectable Filler for Penile Augmentation.
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Tozzi M, Talso M, Romanò ALL, Palmisano F, Marchesotti F, Fumagalli G, Jannello LMI, Incarbone GP, and Gregori A
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- Male, Humans, Adult, Hyaluronic Acid adverse effects, Penis surgery, Administration, Oral, Priapism chemically induced, Priapism therapy, Plastic Surgery Procedures
- Abstract
Background: Injectable hyaluronic acid (HA) gel has emerged as a widely used soft tissue filler for surgeries. In penile reconstructive surgery, HA gel has been employed for penile or glans augmentation in selected patients diagnosed with micropenis. This augmentation technique involves injecting the gel into submucosal tissue and increasing the size of the penis for approximately 1 year. A few studies have investigated the possible complications correlated with medically assisted penile injections of HA gel. However, no previous reports have shown the complications of self-administered HA injection. This case report aims to present the first documented case of ischaemic priapism as a complication of self-administered HA injection., Case Presentation: We present the case of a 43-year-old male who self-administered a 20 mL injection of HA into the dorsal side of his penis. The injected material probably reached the corpora cavernosa, leading to priapism within a few hours. However, the patient did not seek medical attention until 72 h later. The first two initial conservative attempts of blood drainage were unsuccessful because the gel had obstructed vein drainage, causing the penis to remain in a state of priapism. The final treatment approach involved shunting, high enoxaparin doses and oral Effortil administration., Conclusions: While complications from medically assisted HA injections have been documented, this case report sheds light on the complications arising from self-administered penile injections. Priapism is a severe medical condition that requires immediate treatment to avoid potentially serious long-term consequences. Healthcare providers and patients must acknowledge its symptoms and its appropriate course of treatment, especially in the context of penile medical injections., Competing Interests: Given his role as Reviewer Board member, Marco Tozzi had no involvement in the peer-review of this article and has no access to information regarding its peer-review., (© 2023 The Author(s).)
- Published
- 2023
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48. Demographics, Clinical Characteristics and Survival Outcomes of Primary Urinary Tract Malignant Melanoma Patients: A Population-Based Analysis.
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Morra S, Incesu RB, Scheipner L, Baudo A, Jannello LMI, de Angelis M, Siech C, Goyal JA, Tian Z, Saad F, Califano G, la Rocca R, Capece M, Shariat SF, Ahyai S, Carmignani L, de Cobelli O, Musi G, Tilki D, Briganti A, Chun FKH, Longo N, and Karakiewicz PI
- Abstract
All primary urinary tract malignant melanoma (ureter vs. bladder vs. urethra) patients were identified from within the Surveillance, Epidemiology, and End Results (SEER) database 2000-2020. Kaplan-Maier plots depicted the overall survival (OS) rates. Univariable and multivariable Cox regression (MCR) models were fitted to test the differences in overall mortality (OM). In the overall cohort (n = 74), the median OS was 22 months. No statistically significant or clinically meaningful differences were recorded according to sex (female vs. male; p = 0.9) and treatment of the primary (endoscopic vs. surgical; p = 0.6). Conversely, clinically meaningful but not statistically significant ( p ≥ 0.05) differences were recorded according to the patient's age at diagnosis (≤80 vs. ≥80 years old; p = 0.2), marital status (married 26 vs. unmarried 16 months; p = 0.2), and SEER stage (localized 31 vs. regional 14 months; p = 0.4), and the type of systemic therapy (exposed 31 vs. not exposed 20 months; p = 0.06). Finally, in univariable and MCR analyses, after adjustment for the SEER stage and type of systemic therapy, tumor origin within the bladder was associated with a three-fold higher OM (Hazard ratio: 3.00; p = 0.004), compared to tumor origin within the urethra. In conclusion, primary urinary tract malignant melanoma patients have poor survival. Specifically, tumor origin within the bladder independently predicted a higher OM, even after adjustment for the SEER stage and systemic therapy status.
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- 2023
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49. Clinical and time-related predictors of sepsis in patients with obstructive uropathy due to ureteral stones in the emergency setting.
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Silvani C, Bebi C, De Lorenzis E, Lucignani G, Turetti M, Jannello LMI, Zanetti SP, Longo F, Albo G, Salonia A, Montanari E, and Boeri L
- Subjects
- Humans, Female, Retrospective Studies, Ureteroscopy adverse effects, C-Reactive Protein, Ureteral Calculi complications, Ureteral Calculi surgery, Sepsis complications, Sepsis epidemiology, Sepsis diagnosis
- Abstract
Purpose: Well-defined clinical predictors of sepsis after upper tract drainage for obstructive uropathy due to ureteral stones are needed. We aim to determine whether sepsis after decompression of the upper urinary tract may be predicted by clinical and time-related factors, specifically delay time from symptom onset to hospital presentation (StH) and from hospital presentation to surgical decompression (HtD)., Methods: In this single-center retrospective study, data from 196 consecutive patients presenting to the emergency department for obstructive uropathy due to ureteral stones and submitted to surgical decompression were evaluated. Postoperative sepsis was defined as an acute increase in ≥ 2 SOFA points and documented blood or urine cultures., Results: Median StH and HtD were 24 (6-48) and 17 (10-30) hours, respectively. Thirty-three (16.8%) patients developed sepsis. Septic patients were more frequently female (75.8% vs. 37.4%, p < 0.001), had higher preoperative max body temperature (p < 0.001), white blood cells (WBC) count (p < 0.01), C-reactive protein (CRP) values (p < 0.001) and larger stone diameter (7.2 vs. 6 mm, p = 0.02). StH and HtD did not differ according to sepsis status. Time for WBC normalization and CRP halving were longer for septic patients (all p < 0.02). At multivariable logistic regression analysis, max body temperature ≥ 38 °C (OR 21.5; p < 0.001), female gender (OR 3.6; p = 0.02) and higher CRP (OR 1.1; p < 0.001) were independently associated with sepsis status., Conclusion: Clinical and laboratory parameters are associated with an increased risk of sepsis after decompression. StH and HtD timing are not associated with higher sepsis rates. In selected patients, urinary decompression could be delayed or primary ureteroscopy could be considered., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)
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- 2023
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50. Validation of the Trifecta Scoring Metric in Vacuum-Assisted Mini-Percutaneous Nephrolithotomy: A Single-Center Experience.
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Pozzi E, Malfatto M, Turetti M, Silvani C, Jannello LMI, Garbagnati S, Galbiati G, Zanetti SP, Longo F, De Lorenzis E, Albo G, Salonia A, Montanari E, and Boeri L
- Abstract
Background: Scoring metrics to assess and compare outcomes of percutaneous nephrolithotomy (PCNL) are needed. We aim to evaluate prevalence and predictors of trifecta in a cohort of patients treated with vacuum-assisted mini-percutaneous nephrolithotomy (vmPCNL) for kidney stones. Methods: Data from 287 participants who underwent vmPCNL were analysed. Patients’ and stones’ characteristics as well as operative data were collected. Stone-free was defined as no residual stones. The modified Clavien classification was used to score postoperative complications. Trifecta was defined as stone-free status without complications after a single session and no auxiliary procedures. Descriptive statistics and logistic regression models tested the association between predictors and trifecta outcome. Results: After vmPCNL, 219 (76.3%) patients were stone-free, and 81 (28.2%) had postoperative complications (any Clavien). Of 287, 170 (59.2%) patients achieved trifecta criteria. Patients who achieved trifecta status had smaller stone volume (p < 0.001), a higher rate of single stones (p < 0.001), shorter operative time (p < 0.01), and a higher rate of single percutaneous tract (p < 0.01) than −trifecta patients. Trifecta status decreased with the number of calyces involved, being 77.1%, 18.8%, and 4.1% in patients with 1, 2, or 3 calyces with stones, respectively (p < 0.001). Multivariable logistic regression analysis showed that stone volume (OR 1.1, p = 0.02) and multiple calyces being involved (OR 2.8 and OR 4.3 for two- and three-calyceal groups, respectively, all p < 0.01) were independent unfavourable risk factors for trifecta after accounting for age, BMI, gender, operative time, and number of access tracts. Conclusions: Trifecta status was achieved in 6 out of 10 patients after vmPCNL. Stone distribution in multiple calyceal groups and stone volume were independent unfavourable risk factors for trifecta.
- Published
- 2022
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