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1.
World J Urol ; 42(1): 213, 2024 Apr 06.
Artículo en Inglés | MEDLINE | ID: mdl-38581466

RESUMEN

INTRODUCTION: There is limited evidence on the outcomes of robotic partial nephrectomy (RPN) and open partial nephrectomy (OPN) in obese patients (BMI ≥ 30 kg/m2). In this study, we aimed to compare perioperative and oncological outcomes of RPN and OPN. METHODS: We relied on data from patients who underwent PN from 2009 to 2017 at 16 departments of urology participating in the UroCCR network, which were collected prospectively. In an effort to adjust for potential confounders, a propensity-score matching was performed. Perioperative outcomes were compared between OPN and RPN patients. Disease-free survival (DFS) and overall survival (OS) were estimated using the Kaplan-Meier method and compared using the log-rank test. RESULTS: Overall, 1277 obese patients (932 robotic and 345 open were included. After propensity score matching, 166 OPN and 166 RPN individuals were considered for the study purposes; no statistically significant difference among baseline demographic or tumor-specific characteristics was present. A higher overall complication rate and major complications rate were recorded in the OPN group (37 vs. 25%, p = 0.01 and 21 vs. 10%, p = 0.007; respectively). The length of stay was also significantly longer in the OPN group, before and after propensity-score matching (p < 0.001). There were no significant differences in Warm ischemia time (p = 0.66), absolute change in eGFR (p = 0.45) and positive surgical margins (p = 0.12). At a median postoperative follow-up period of 24 (8-40) months, DFS and OS were similar in the two groups (all p > 0.05). CONCLUSIONS: In this study, RPN was associated with better perioperative outcomes (improvement of major complications rate and LOS) than OPN. The oncological outcomes were found to be similar between the two approaches.


Asunto(s)
Neoplasias Renales , Procedimientos Quirúrgicos Robotizados , Humanos , Neoplasias Renales/complicaciones , Neoplasias Renales/cirugía , Procedimientos Quirúrgicos Robotizados/métodos , Puntaje de Propensión , Nefrectomía/métodos , Obesidad/complicaciones , Resultado del Tratamiento , Estudios Retrospectivos
2.
BJU Int ; 132(5): 575-580, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37433580

RESUMEN

OBJECTIVE: To evaluate prospectively the effects of surgical excision of renal tumours on blood pressure (BP). PATIENTS AND METHODS: In a multicentre prospective study, we evaluated 200 patients who underwent nephrectomy for renal tumour between 2018 and 2020 at seven departments of the French Network for Kidney Cancer, the UroCCR. All patients had localized cancer without pre-existing hypertension (HTN). Blood pressure was measured the week before nephrectomy, and at 1 month and 6 months after nephrectomy, according to the recommendations for home BP monitoring. Plasma renin was measured 1 week before surgery and 6 months after surgery. The primary endpoint was the occurrence of de novo HTN. The secondary endpoint was clinically significant increase in BP at 6 months, defined by an increase in systolic and/or diastolic ambulatory BP ≥10 mmHg or requirement for medical antihypertensive treatment. RESULTS: Blood pressure and renin measurements were available for 182 (91%) and 136 patients (68%), respectively. We excluded from the analysis 18 patients who had undeclared HTN detected on preoperative measurements. At 6 months, 31 patients (19.2%) had de novo HTN and 43 patients (26.3%) had a significant increase in their BP. Type of surgery was not associated with an increased risk of HTN (21.7% partial nephrectomy [PN] vs 15.7% radical nephrectomy [RN]; P = 0.59). There was no difference between plasmatic renin levels before and after surgery (18.5 vs 16; P = 0.46). In multivariable analysis, age (odds ratio [OR] 1.07, 95% confidence interval [CI] 1.02-1.12; P = 0.03) and body mass index (OR 1.14, 95% CI 1.03-1.26; P = 0.01) were the only predictors of de novo HTN. CONCLUSION: Surgical treatment of renal tumours is associated with significant changes in BP, with de novo HTN occurring in almost 20% of the patients. These changes are not impacted by the type of surgery (PN vs RN). Patients who are scheduled to undergo kidney cancer surgery should be informed of these findings and have their BP closely monitored after the operation.

3.
BJU Int ; 132(2): 160-169, 2023 08.
Artículo en Inglés | MEDLINE | ID: mdl-36648124

RESUMEN

OBJECTIVES: To assess the impact of pathological upstaging from clinically localized to locally advanced pT3a on survival in patients with renal cell carcinoma (RCC), as well as the oncological safety of various surgical approaches in this setting, and to develop a machine-learning-based, contemporary, clinically relevant model for individual preoperative prediction of pT3a upstaging. MATERIALS AND METHODS: Clinical data from patients treated with either partial nephrectomy (PN) or radical nephrectomy (RN) for cT1/cT2a RCC from 2000 to 2019, included in the French multi-institutional kidney cancer database UroCCR, were retrospectively analysed. Seven machine-learning algorithms were applied to the cohort after a training/testing split to develop a predictive model for upstaging to pT3a. Survival curves for disease-free survival (DFS) and overall survival (OS) rates were compared between PN and RN after G-computation for pT3a tumours. RESULTS: A total of 4395 patients were included, among whom 667 patients (15%, 337 PN and 330 RN) had a pT3a-upstaged RCC. The UroCCR-15 predictive model presented an area under the receiver-operating characteristic curve of 0.77. Survival analysis after adjustment for confounders showed no difference in DFS or OS for PN vs RN in pT3a tumours (DFS: hazard ratio [HR] 1.08, P = 0.7; OS: HR 1.03, P > 0.9). CONCLUSIONS: Our study shows that machine-learning technology can play a useful role in the evaluation and prognosis of upstaged RCC. In the context of incidental upstaging, PN does not compromise oncological outcomes, even for large tumour sizes.


Asunto(s)
Carcinoma de Células Renales , Neoplasias Renales , Humanos , Carcinoma de Células Renales/patología , Neoplasias Renales/patología , Estudios Retrospectivos , Estadificación de Neoplasias , Riñón/patología , Nefrectomía
4.
World J Urol ; 41(2): 295-302, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33765164

RESUMEN

PURPOSE: To assess the oncological outcomes of renal cell carcinoma (RCC) associated with tumor thrombus and identify predictive factors of recurrence. METHODS: Multi-institutional study that included patients with cT3-4N0-1M0 RCC with tumoral thrombus identified in the prospective UroCCR database (CNIL DR 2013-206; NCT03293563). pT3a without involvement of the renal vein were excluded. All patients underwent radical nephrectomy and a thrombectomy of the renal vein ± inferior vena cava ± right atrium. The primary endpoint was recurrence-free survival (RFS). Thirty-two patients who had adjuvant therapies (tyrosine kinase inhibitors or mTOR inhibitor) were compared to control group (surveillance) in a propensity score-matched 1:1 sub-analysis RESULTS: A total of 432 patients were included: 70.4% pT3a, 20.1% pT3b, 4.2% pT3c and 5.3% pT4. Tumor characteristics were: 90.7% clear cell RCC, 13.9% pN1, and 87.1% high Fuhrman grade. 173 patients (40%) had disease recurrence, and median RFS was 37.3 months (95% CI, 26.4-46.7). In a multivariate analysis (Cox model), predictive factors of recurrence were: pT4 (HR 2.66; 95% CI, 1.42-4.99; p = 0.002), pN1 (HR 2.53; 95% CI, 1.46-4.39; p < 0.001), tumor necrosis (HR 2.92; 95% CI, 1.85-4.62; p < 0.001), tumor size > 10 cm (HR 1.56; 95% CI, 1.08-2.24; p = 0.018). Adjuvant therapy was a protective factor of cancer recurrence (HR 0.33; 95% CI, 0.17-0.66; p = 0.002). Propensity score-matched sub-analysis of adjuvant vs control (surveillance) confirmed adjuvant treatment as a protective factor of cancer recurrence (Log rank p = 0.015). CONCLUSIONS: In this contemporary multi-institutional cohort of RCC + tumor thrombus, we reported higher recurrence rate shortly after surgical excision and demonstrated an oncological benefit of adjuvant treatment.


Asunto(s)
Carcinoma de Células Renales , Neoplasias Renales , Trombosis , Trombosis de la Vena , Humanos , Carcinoma de Células Renales/patología , Neoplasias Renales/patología , Estudios Prospectivos , Trombosis de la Vena/etiología , Pronóstico , Recurrencia Local de Neoplasia/epidemiología , Recurrencia Local de Neoplasia/patología , Vena Cava Inferior/patología , Vena Cava Inferior/cirugía , Nefrectomía , Trombectomía , Estudios Retrospectivos
5.
World J Urol ; 41(9): 2405-2411, 2023 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-37507528

RESUMEN

PURPOSE: To evaluate the feasibility, safety, and early oncologic outcomes after post-chemotherapy robot-assisted retroperitoneal lymph node dissection (PC-RARPLND) for metastatic germ cell tumors (mGCT). METHODS: We retrospectively analyzed patients from four tertiary centers who underwent PC-RARPLND for mGCT, from 2011 to 2021. Previous treatment of mGCT, intraoperative and postoperative complications, and early oncologic outcomes were assessed. RESULTS: Overall, 66 patients were included. The majority of patients had non-seminoma mTGCT (89%). Median size of retroperitoneal lymph node (RLN) before surgery was 26 mm. Templates of PC-RARPLND were left modified, right modified, and full bilateral in 56%, 27%, and 14%, respectively. Median estimated blood loss and length of stay were 50 mL [50-150] and 2 [1-3] days. Four patients (6.1%) had a vascular injury, only one with significant blood loss and conversion to open surgery (OS). Two other patients had a conversion to OS for difficulty of dissection. No patient had transfusion, most frequent complications were ileus (10.6%) and symptomatic lymphorrea (7.6%) and no complications grade IIIb or more occurred. With a median follow-up of 16 months, two patients had a relapse, all outside of the surgical template (one in the retrocrural space with reascending markers, one in lungs). CONCLUSION: PC-RARPLND is a challenging surgery. In expert centers and for selected patients, it seemed safe and feasible, with a low morbidity. Further prospective evaluation of this procedure and long-term oncologic results are needed.


Asunto(s)
Neoplasias de Células Germinales y Embrionarias , Robótica , Neoplasias Testiculares , Masculino , Humanos , Estudios Retrospectivos , Neoplasias Testiculares/tratamiento farmacológico , Neoplasias Testiculares/cirugía , Neoplasias Testiculares/patología , Metástasis Linfática/patología , Escisión del Ganglio Linfático/métodos , Ganglios Linfáticos/patología , Neoplasias de Células Germinales y Embrionarias/tratamiento farmacológico , Neoplasias de Células Germinales y Embrionarias/cirugía , Espacio Retroperitoneal/cirugía
6.
World J Urol ; 41(2): 287-294, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33606044

RESUMEN

PURPOSE: To compare off-clamp vs on-clamp robotic partial nephrectomy (RPN) for renal cell carcinoma (RCC) in terms of oncological outcomes, and to assess the impact of surgical experience (SE). METHODS: We extracted data of a contemporary cohort of 1359 patients from the prospectively maintained database of the French national network of research on kidney cancer (UROCCR). The primary objective was to assess the positive surgical margin (PSM) rate. We also evaluated the oncological outcomes regardless of the surgical experience (SE) by dividing patients into three groups of SE as a secondary endpoints. SE was defined by the caseload of RPN per surgeon per year. For the continuous variables, we used Mann-Whitney and Student tests. We assessed survival analysis according to hilar control approach by Kaplan-Meier curves with log rank tests. A logistic regression multivariate analysis was used to evaluate the independent factors of PSM. RESULTS: Outcomes of 224 off-clamp RPN for RCC were compared to 1135 on-clamp RPN. PSM rate was not statistically different, with 5.6% in the off-clamp group, and 11% in the on-clamp group (p = 0.1). When assessing survival analysis for overall survival (OS), local recurrence-free survival (LR), and metastasis-free survival (MFS) according to hilar clamping approach, there were no statistically significant differences between the two groups with p value log rank = 0.2, 0.8, 0.1, respectively. In multivariate analysis assessing SE, hilar control approach, hospital volume (HV), RENAL score, gender, Age, ECOG, EBL, BMI, and indication of NSS, age at surgery was associated with PSM (odds ratio [OR] 1.03 (95% CI 1.00-1.04), 0.02), whereas SE, HV, and type of hilar control approach were not predictive factors of PSM. CONCLUSION: Hilar control approach seems to have no impact on PSM of RPN for RCC. Our findings were consistent with randomized trials.


Asunto(s)
Carcinoma de Células Renales , Neoplasias Renales , Procedimientos Quirúrgicos Robotizados , Humanos , Carcinoma de Células Renales/cirugía , Carcinoma de Células Renales/patología , Neoplasias Renales/cirugía , Neoplasias Renales/patología , Nefrectomía , Riñón/patología , Resultado del Tratamiento , Estudios Retrospectivos
7.
World J Urol ; 41(2): 303-313, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33811291

RESUMEN

PURPOSE: Robot-assisted partial nephrectomy (RAPN) is a difficult procedure with risk of significant perioperative complications. The objective was to evaluate the impact of preoperative planning and intraoperative guidance with 3D model reconstructions on perioperative outcomes of RAPN. METHODS: We conducted a retrospective analysis of all patients who underwent RAPN for kidney tumor by three high-volume expert surgeons from academic centers. Clinical data were collected prospectively after written consent into the French kidney cancer network database UroCCR (CNIL-DR 2013-206; NCT03293563). Our cohort was divided into two groups: 3D-Image guided RAPN group (3D-IGRAPN) and control group. A propensity score according to age, pre-operative renal function and RENAL tumor complexity score was used. Both surgical techniques were compared in terms of perioperative outcomes. RESULTS: The initial study cohort included 230 3D-IGRAPN and 415 control RAPN. Before propensity-score matching, patients in the 3D-IGRAPN group had a larger tumor (4.3 cm vs. 3.5 cm, P < 0.001) and higher RENAL complexity score (9 vs. 8, P < 0.001). Following propensity-score matching, there were 157 patients in both groups. The rate of major complications was lower for patients in the 3D-IGRAPN group (3.8% vs. 9.5%, P = 0.04). The median percentage of eGFR variation recorded at first follow-up was lower in the 3D-IGRAPN group (- 5.6% vs. - 10.5%, P = 0.002). The trifecta achievement rate was higher in the 3D-IGRAPN group (55.7% vs. 45.1%; P = 0.005). CONCLUSION: Three-dimensional kidney reconstructions use for pre-operative planning and intraoperative surgical guidance lowers the risk of complications and improve perioperative clinical outcomes of RAPN.


Asunto(s)
Neoplasias Renales , Procedimientos Quirúrgicos Robotizados , Humanos , Estudios Retrospectivos , Procedimientos Quirúrgicos Robotizados/métodos , Puntaje de Propensión , Nefrectomía/métodos , Neoplasias Renales/patología , Resultado del Tratamiento
8.
World J Urol ; 41(8): 2281-2288, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-37407720

RESUMEN

PURPOSE: To describe the practice of robotic-assisted partial nephrectomy (RAPN) in France and prospectively assess the late complications and long-term outcomes. METHODS: Prospective, multicenter (n = 16), observational study including all patients diagnosed with a renal tumor who underwent RAPN. Preoperative, intraoperative, postoperative, and follow-up data were collected and stored in the French research network for kidney cancer database (UroCCR). Patients were included over a period of 12 months, then followed for 5 years. RESULTS: In total, 466 patients were included, representing 472 RAPN. The mean tumor size was 3.4 ± 1.7 cm, most of moderate complexity (median PADUA and RENAL scores of 8 [7-10] and 7 [5-9]). Indication for nephron-sparing surgery was relative in 7.1% of cases and imperative in 11.8%. Intraoperative complications occurred in 6.8% of patients and 4.2% of RAPN had to be converted to open surgery. Severe postoperative complications were experienced in 2.3% of patients and late complications in 48 patients (10.3%), mostly within the first 3 months and mainly comprising vascular, infectious, or parietal complications. At 5 years, 29 patients (6.2%) had chronic kidney disease upstaging, 21 (4.5%) were diagnosed with local recurrence, eight (1.7%) with contralateral recurrence, 25 (5.4%) with metastatic progression, and 10 (2.1%) died of the disease. CONCLUSION: Our results reflect the contemporary practice of French expert centers and is, to our knowledge, the first to provide prospective data on late complications associated with RAPN. We have shown that RAPN provides good functional and oncologic outcomes while limiting short- and long-term morbidity. TRIAL REGISTRATION: NCT03292549.


Asunto(s)
Neoplasias Renales , Procedimientos Quirúrgicos Robotizados , Humanos , Procedimientos Quirúrgicos Robotizados/métodos , Estudios Prospectivos , Resultado del Tratamiento , Nefrectomía/efectos adversos , Nefrectomía/métodos , Neoplasias Renales/patología , Francia/epidemiología , Complicaciones Posoperatorias/etiología , Estudios Retrospectivos
9.
World J Urol ; 41(2): 483-489, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36633650

RESUMEN

PURPOSE: To describe clinical features of patients with oncocytoma on renal biopsy (RMB), correlation with final histology on surgically treated patients, and predictive factors of discrepancy between RMB and final histology. METHODS: This was a retrospective study conducted in the framework of the UroCCR project (NCT03293563). All tumors with oncocytoma on RMB were selected and all pathological reports were reviewed. Patients with the RMB simultaneously performed with a focal treatment, synchronous bilateral tumors and ambiguous RMB report were excluded. Discrepancy between RMB and definitive histology was evaluated using a uni- and multivariable logistic regression analyses model. RESULTS: Overall, 119 tumors with oncocytoma on RMB, from 15 centers, were included. Of those, 54 (45.4%) had upfront surgery and 65 (54.6%) had active surveillance (AS). In renal masses with initial active surveillance, with a median follow-up of 28 months, 23 (19.3%) underwent surgery, 4 (3.4%) received focal treatment and 38 (31.9%) remained on AS. On final pathology, only 51 of the 75 surgically treated tumors (68.0%) had oncocytoma, while 24 presented malignant tumors (mainly chromophobe carcinoma (19.2%), and hybrid oncocytic/chromophobe tumor (HOCT) (6.8%)) leading to a discrepancy of 32.0% between RMB and final pathology. The only predictive factor of a discrepancy between RMB and definitive histology was a biopsy done outside of the center (Odds ratio: 3.22 [95%-confidence interval: 1.08-9.61], p = 0.03). CONCLUSION: Despite the increase of RMB in more and more centers, histologic discrepancy between RMB and definitive histology remains significant. This information should be discussed with patients and taken into consideration before treatment decision.


Asunto(s)
Adenoma Oxifílico , Carcinoma de Células Renales , Neoplasias Renales , Neoplasias Primarias Múltiples , Humanos , Neoplasias Renales/patología , Estudios Retrospectivos , Adenoma Oxifílico/patología , Carcinoma de Células Renales/patología , Biopsia , Nefrectomía , Neoplasias Primarias Múltiples/cirugía
10.
World J Urol ; 41(12): 3559-3566, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37792008

RESUMEN

PURPOSE: Partial nephrectomy (PN) for large or complex renal tumors can be difficult and associated with a higher risk of recurrence than radical nephrectomy. We aim to evaluate the clinical useful of nephrometry scores for predicting oncological outcomes in a large cohort of patients who underwent PN for renal cell carcinomas. METHODS: Our analysis included patients who underwent PN for renal cell carcinoma in 21 French academic centers (2010-2020). RENAL, PADUA, and SPARE scores were calculated based on preoperative imaging. Uni- and multivariate cox models were performed to identify predictors of recurrence-free survival and overall survival. The area under the curve (AUC) was used to identify models with the highest discrimination. Decision curve analyses (DCAs) determined the net benefit associated with their use. RESULTS: A total of 1927 patients were analyzed with a median follow-up of 32 months (14-45). RENAL score (p = 0.01), age (p = 0.002), histological type (p = 0.001), high nuclear grade (p = 0.001), necrotic component (p < 0.001), and positive margins (p = 0.005) were significantly related to recurrence in multivariate analyses. The discriminative performance of the 3 radiological scores was modest (65, 63, and 63%, respectively). All 3 scores showed good calibration, which, however, deteriorated with time. Decision curve analysis of the three models for the prediction of overall and recurrence-free survival was similar for all three scores and of limited clinical relevance. CONCLUSION: The association between nephrometry scores and oncological outcomes after NP is very weak. The use of these scores for predicting oncological outcomes in routine practice is therefore of limited clinical value.


Asunto(s)
Carcinoma de Células Renales , Neoplasias Renales , Humanos , Neoplasias Renales/patología , Nefrectomía , Carcinoma de Células Renales/patología , Riñón/diagnóstico por imagen , Riñón/patología , Diagnóstico por Imagen , Estudios Retrospectivos , Resultado del Tratamiento
11.
Eur Radiol ; 33(12): 8426-8435, 2023 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-37466710

RESUMEN

PURPOSE: To compare the oncological and perioperative outcomes of robot-assisted partial nephrectomy (RPN) and percutaneous thermal ablation (PTA) for treatment of T1 renal cell cancer (RCC) in patients older than 75 years. MATERIALS AND METHODS: Retrospective national multicenter study included all patients older than 75 years treated for a T1 RCC by RPN or PTA between January 2010 and January 2021. Patients' characteristics, tumor data, and perioperative and oncological outcomes were compared. RESULTS: A total of 205 patients for 209 procedures (143 RPN and 66 PTA) were included. In the PTA group, patients were older (80.4 ± 3.7 vs. 79 ± 3.7 years (p = 0.01)); frailer (ASA score (2.43 ± 0.6 vs. 2.17 ± 0.6 (p < 0.01)); and more frequently had a history of kidney surgery (16.7% [11/66] vs. 5.6% [8/143] (p = 0.01)) than in the RPN group. Tumors were larger in the RPN group (2.7 ± 0.7 vs. 3.2 ± 0.9 cm (p < 0.01)). Operation time, length of hospital stay, and increase of creatinine serum level were higher in RPN (respectively 92.1 ± 42.7 vs. 150.7 ± 61.3 min (p < 0.01); 1.7 ± 1.4 vs. 4.2 ± 3.4 days (p < 0.01); 1.9 ± 19.3% vs. 10.1 ± 23.7 (p = 0.03)). Disease-free survival and time to progression were similar (respectively, HR 2.2; 95% CI 0.88-5.5; p = 0.09; HR 2.1; 95% CI 0.86-5.2; p = 0.1). Overall survival was shorter for PTA that disappeared after Cox adjusting model (HR 3.3; 95% CI 0.87-12.72; p = 0.08). CONCLUSION: Similar oncological outcomes are observed after PTA and RPN for T1 RCC in elderly patients. CLINICAL RELEVANCE STATEMENT: Robot-assisted partial nephrectomy and percutaneous thermal ablation have similar oncological outcomes for T1a kidney cancer in patients over 75 years; however, operative time, decrease in renal function, and length of hospital stay were lower with ablation. KEY POINTS: • After adjusting model for age and ASA score, similar oncological outcomes are observed after percutaneous thermal ablation and robot-assisted partial nephrectomy for T1 renal cell cancer in elderly patients. • Operation time, length of hospital stay, and increase of creatinine serum level were higher in the robot-assisted partial nephrectomy group.


Asunto(s)
Carcinoma de Células Renales , Ablación por Catéter , Neoplasias Renales , Procedimientos Quirúrgicos Robotizados , Robótica , Humanos , Anciano , Carcinoma de Células Renales/cirugía , Carcinoma de Células Renales/patología , Estudios Retrospectivos , Creatinina , Resultado del Tratamiento , Neoplasias Renales/cirugía , Neoplasias Renales/patología , Nefrectomía/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Nefronas/patología , Nefronas/cirugía , Ablación por Catéter/métodos
12.
Lancet Oncol ; 23(5): 612-624, 2022 05.
Artículo en Inglés | MEDLINE | ID: mdl-35390339

RESUMEN

BACKGROUND: We previously reported a 35-gene expression classifier identifying four clear-cell renal cell carcinoma groups (ccrcc1 to ccrcc4) with different tumour microenvironments and sensitivities to sunitinib in metastatic clear-cell renal cell carcinoma. Efficacy profiles might differ with nivolumab and nivolumab-ipilimumab. We therefore aimed to evaluate treatment efficacy and tolerability of nivolumab, nivolumab-ipilimumab, and VEGFR-tyrosine kinase inhibitors (VEGFR-TKIs) in patients according to tumour molecular groups. METHODS: This biomarker-driven, open-label, non-comparative, randomised, phase 2 trial included patients from 15 university hospitals or expert cancer centres in France. Eligible patients were aged 18 years or older, had an Eastern Cooperative Oncology Group performance status of 0-2, and had previously untreated metastatic clear-cell renal cell carcinoma. Patients were randomly assigned (1:1) using permuted blocks of varying sizes to receive either nivolumab or nivolumab-ipilimumab (ccrcc1 and ccrcc4 groups), or either a VEGFR-TKI or nivolumab-ipilimumab (ccrcc2 and ccrcc3 groups). Patients assigned to nivolumab-ipilimumab received intravenous nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses followed by intravenous nivolumab 240 mg every 2 weeks. Patients assigned to nivolumab received intravenous nivolumab 240 mg every 2 weeks. Patients assigned to VEGFR-TKIs received oral sunitinib (50 mg/day for 4 weeks every 6 weeks) or oral pazopanib (800 mg daily continuously). The primary endpoint was the objective response rate by investigator assessment per Response Evaluation Criteria in Solid Tumors version 1.1. The primary endpoint and safety were assessed in the population who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, NCT02960906, and with the EU Clinical Trials Register, EudraCT 2016-003099-28, and is closed to enrolment. FINDINGS: Between June 28, 2017, and July 18, 2019, 303 patients were screened for eligibility, 202 of whom were randomly assigned to treatment (61 to nivolumab, 101 to nivolumab-ipilimumab, 40 to a VEGFR-TKI). In the nivolumab group, two patients were excluded due to a serious adverse event before the first study dose and one patient was excluded from analyses due to incorrect diagnosis. Median follow-up was 18·0 months (IQR 17·6-18·4). In the ccrcc1 group, objective responses were seen in 12 (29%; 95% CI 16-45) of 42 patients with nivolumab and 16 (39%; 24-55) of 41 patients with nivolumab-ipilimumab (odds ratio [OR] 0·63 [95% CI 0·25-1·56]). In the ccrcc4 group, objective responses were seen in seven (44%; 95% CI 20-70) of 16 patients with nivolumab and nine (50% 26-74) of 18 patients with nivolumab-ipilimumab (OR 0·78 [95% CI 0·20-3·01]). In the ccrcc2 group, objective responses were seen in 18 (50%; 95% CI 33-67) of 36 patients with a VEGFR-TKI and 19 (51%; 34-68) of 37 patients with nivolumab-ipilimumab (OR 0·95 [95% CI 0·38-2·37]). In the ccrcc3 group, no objective responses were seen in the four patients who received a VEGFR-TKI, and in one (20%; 95% CI 1-72) of five patients who received nivolumab-ipilimumab. The most common treatment-related grade 3-4 adverse events were hepatic failure and lipase increase (two [3%] of 58 for both) with nivolumab, lipase increase and hepatobiliary disorders (six [6%] of 101 for both) with nivolumab-ipilimumab, and hypertension (six [15%] of 40) with a VEGFR-TKI. Serious treatment-related adverse events occurred in two (3%) patients in the nivolumab group, 38 (38%) in the nivolumab-ipilimumab group, and ten (25%) patients in the VEGFR-TKI group. Three deaths were treatment-related: one due to fulminant hepatitis with nivolumab-ipilimumab, one death from heart failure with sunitinib, and one due to thrombotic microangiopathy with sunitinib. INTERPRETATION: We demonstrate the feasibility and positive effect of a prospective patient selection based on tumour molecular phenotype to choose the most efficacious treatment between nivolumab with or without ipilimumab and a VEGFR-TKI in the first-line treatment of metastatic clear-cell renal cell carcinoma. FUNDING: Bristol Myers Squibb, ARTIC.


Asunto(s)
Carcinoma de Células Renales , Nivolumab , Inhibidores de la Angiogénesis/efectos adversos , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Biomarcadores , Carcinoma de Células Renales/tratamiento farmacológico , Femenino , Humanos , Ipilimumab , Lipasa , Masculino , Estadificación de Neoplasias , Nivolumab/efectos adversos , Estudios Prospectivos , Inhibidores de Proteínas Quinasas/efectos adversos , Sunitinib , Microambiente Tumoral
13.
Ann Surg Oncol ; 29(11): 7218-7228, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-35780452

RESUMEN

BACKGROUND: The prognostic impact of renal cell carcinoma (RCC) morphotype remains unclear in patients who undergo partial nephrectomy (PN). Our objective was to determine the risk factors for recurrence after PN, including RCC morphotype. METHODS: Patients with RCC who had undergone PN were extracted from the prospective, national French database, UroCCR. Patients with genetic predisposition, bilateral or multiple tumours, and those who had undergone secondary totalization were excluded. Primary endpoint was 5-year, recurrence-free survival (RFS), and secondary endpoint was overall survival (OS). Risk factors for recurrence were assessed by multivariable Cox regression analysis. RESULTS: Overall, 2,767 patients were included (70% male; median age: 61 years [interquartile range (IQR) 51-69]). Most (71.5%) of the PN procedures were robot-assisted. Overall, 2,573 (93.0%) patients were recurrence free, and 74 died (2.7%). Five-year RFS was 84.9% (IQR 82.4-87.4). A significant difference in RFS was observed between RCC morphotypes (p < 0.001). Surgical margins (hazard ratio [HR] = 2.0 [95% confidence interval (CI): 1.3-3.2], p < 0.01), pT stage >1 (HR = 2.6 [95% CI: 1.8-3.7], p < 0.01]) and Fuhrmann grade >2 (HR = 1.9 [95% CI: 1.4-2.6], p < 0.001) were risk factors for recurrence, whereas chromophobe subtype was a protective factor (HR = 0.08 [95% CI: 0.01-0.6], p = 0.02). Five-year OS was 94.0% [92.4-95.7], and there were no significant differences between RCC subgroups (p = 0.06). The main study limitation was its design (multicentre national database), which may be responsible for declarative bias. CONCLUSIONS: Chromophobe morphotype was significantly associated with better RFS in RCC patients who underwent PN. Conversely, pT stage, Fuhrman group and positive surgical margins were risk factors for recurrence.


Asunto(s)
Carcinoma de Células Renales , Neoplasias Renales , Carcinoma de Células Renales/patología , Femenino , Humanos , Neoplasias Renales/patología , Masculino , Márgenes de Escisión , Persona de Mediana Edad , Nefrectomía , Pronóstico , Estudios Prospectivos
14.
World J Urol ; 40(2): 459-465, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-34779883

RESUMEN

BACKGROUND: Data evaluating the impact of positive vascular margins (PVMs) following surgical resection of non-metastatic renal cell carcinoma (RCC) with inferior vena cava (IVC) tumor thrombus are lacking. OBJECTIVE: To analyze the oncological impact of positive vascular margins following surgical resection of RCC with IVC tumor thrombus. METHODS: Patients who underwent radical nephrectomy with the removal of IVC tumour thrombus for RCC between 2000 and 2019 were included. PVMs were identified from pathology reports defined as microscopically identified tumour present in the IVC wall at the site of resection or in case of thrombus was not completely removed. To achieve balance in baseline characteristics between patients with PVMs versus negative vascular margins, we used inverse probability of treatment weighting (IPTW) based on the propensity score. Local recurrence, distant metastasis and overall mortality were evaluated between groups using Cox proportional hazards regression models. RESULTS: 209 patients were analyzed. Among them, 49 (23%) patients with PVMs were identified. Median follow-up was 55 months. After adjustment, excellent balance was achieved for most propensity score variables. In IPTW analysis, PVMs was associated with a higher risk of local recurrence (HR = 3.66; p < 0.001) without any impact on systemic recurrence (HR = 1.15; p = 0.47) or overall mortality (HR = 1.23; p = 0.48). Limitations include the sample size and unmeasured confounding. CONCLUSION: Our results suggest that a PVMs in patients with RCC after nephrectomy with thrombectomy is associated with a higher risk of local recurrence, however, it did not appear to influence the risk of distant metastasis or death.


Asunto(s)
Carcinoma de Células Renales , Neoplasias Renales , Trombosis , Carcinoma de Células Renales/patología , Humanos , Neoplasias Renales/patología , Nefrectomía/métodos , Puntaje de Propensión , Estudios Retrospectivos , Trombectomía/métodos , Trombosis/etiología , Trombosis/cirugía , Vena Cava Inferior/patología , Vena Cava Inferior/cirugía
15.
BJU Int ; 127(2): 222-228, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-32770633

RESUMEN

OBJECTIVE: To report the results of the robot-assisted kidney transplantation (RAKT) experience performed in 10 European centres by members of the European Robotic Urology Section (ERUS)-RAKT group. PATIENTS AND METHODS: This is a multicentre prospective observational study of RAKT. Descriptive analysis of recipients and donor characteristics, surgical data, intraoperative outcomes, complications rate and functional results were collected and analysed. RESULTS: Between July 2015 and September 2019, 291 living-donor RAKTs were performed. Recipients were mostly male (189 [65%]), the mean Standard deviation (sd) age was 45.2 (13.35) years, the mean (sd) body mass index was 27.13 (19.28) kg/m2 , and RAKT was pre-emptive in 155 (53.8%) cases. Right and multiple arteries kidneys were used in 15.4%. The mean (sd) total surgical and re-warming time was 244 (70.5) min and 53.16 (15.27) min, respectively. In all, 17 patients presented with postoperative bleeding (5.7%). Five kidneys had delayed graft function; five (2%) were lost due to thrombosis and one due to acute rejection. Two patients had arterial stenosis, three had incisional hernias, six had ureteric stenosis, and nine had lymphoceles. Neither surgical nor re-warming times were correlated with postoperative serum creatinine levels (P > 0.05). Comparison of surgical data between the first 120 cases and the following 171 cases showed a significantly shorter total surgical time in the second group (265 vs 230 min, P = 0.005). CONCLUSIONS: This is the largest European multicentre study of RAKT with good surgical and functional results competitive with open kidney transplant series, with a relatively short learning curve when performed in centres with a wide experience in open kidney transplantation and robotic surgery.


Asunto(s)
Fallo Renal Crónico/cirugía , Trasplante de Riñón/métodos , Complicaciones Posoperatorias/epidemiología , Sistema de Registros , Procedimientos Quirúrgicos Robotizados/métodos , Sociedades Médicas , Urología , Europa (Continente)/epidemiología , Femenino , Humanos , Incidencia , Donadores Vivos/provisión & distribución , Masculino , Persona de Mediana Edad , Tempo Operativo , Estudios Prospectivos , Tasa de Supervivencia/tendencias , Resultado del Tratamiento
16.
World J Urol ; 39(4): 1287-1298, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32562044

RESUMEN

PURPOSE: The main objective was to compare minor (Clavien I-II) and major (Clavien ≥ III) intra- and postoperative complications of living donor robotic assisted kidney transplantation (RAKT) in obese (≥ 30 kg/m2 BMI), overweight (< 30/ ≥ 25 kg/m2 BMI) and non-overweight recipients (< 25 kg/m2 BMI). METHODS: For the present retrospective study, we reviewed the multi-institutional ERUS-RAKT database to select consecutive living donor RAKT recipients. Functional outcomes, intra- and postoperative complications were compared between obese, overweight and non-overweight recipients. RESULTS: 169 living donor RAKTs were performed, by 10 surgeons, from July 2015 to September 2018 in the 8 European centers. 32 (18.9%) recipients were obese, 66 (39.1%) were overweight and 71 (42.0%) were non-overweight. Mean follow-up was 1.2 years. There were no major intra-operative complications in either study group. Conversion to open surgery occurred in 1 obese recipient, in 2 overweight recipients and no conversion occurred in non-overweight recipients (p = 0.3). Minor and major postoperative complications rates were similar in the 3 groups. At one-year of follow-up, median eGFR was similar in all groups [54 (45-60) versus 57 (46-70) versus 63 (49-78) ml/min/1.73 m2 in obese, overweight and non-overweight recipient groups, respectively, p = 0.5]. Delayed graft function rate was similar in the 3 groups. Only the number of arteries was an independent predictive factor of suboptimal renal function at post-operative day 30 in the multivariate analysis. CONCLUSION: RAKT in obese recipients is safe, compared to non-overweight recipients and yields very good function, when it performed at high-volume referral centers by highly trained transplant teams.


Asunto(s)
Trasplante de Riñón/métodos , Obesidad/complicaciones , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Procedimientos Quirúrgicos Robotizados , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos
17.
Int J Clin Oncol ; 26(4): 636-646, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-33502646

RESUMEN

To investigate the association of adherent perinephric fat (APF) with perioperative outcomes, we conducted a systematic review and meta-analysis of the literature to clarify the impact of APF in patients undergoing partial nephrectomy. A systematic literature search using the Medline, Scopus, and Cochrane databases was performed in April 2019 and updated in November 2019 to identify studies investigating the effect of APF on perioperative outcomes in patients treated with partial nephrectomy with the aim of evaluating its impact on intraoperative, postoperative and oncological outcomes. The Newcastle-Ottawa Scale (NOS) was used to assess the quality of the included studies. A total of 1534 patients in nine nonrandomized, observational studies met our inclusion criteria. Patients with APF were significantly older (p = 0.0001), had a higher BMI (p = 0.0001) and were predominately male (p = 0.003). APF was associated with a higher operative time (p = 0.001) and higher blood loss (p = 0.002). No significant impact of APF was found in terms of postoperative complications, positive margins or length of stay. APF was also found to be associated with malignant renal histology of RCC on final pathology (p = 0.005). APF was associated with some adverse perioperative outcomes, especially a prolonged operating time and higher blood loss. In addition, APF was also associated with underlying renal malignancy, but the precise causal mechanism requires further exploration.


Asunto(s)
Neoplasias Renales , Procedimientos Quirúrgicos Robotizados , Tejido Adiposo , Índice de Masa Corporal , Humanos , Riñón , Neoplasias Renales/cirugía , Masculino , Nefrectomía , Complicaciones Posoperatorias , Resultado del Tratamiento
18.
Clin Transplant ; 33(12): e13745, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31665808

RESUMEN

The main objective of this preliminary study was to evaluate the feasibility and safety of 3-D laparoscopic living donor left nephrectomy (LDLN). The secondary objective was to compare intraoperative and postoperative outcomes between 3-D and 2-D laparoscopic LDLN. All patients who underwent a laparoscopic LDLN from January 2015 to April 2018 in a university center were included. All surgeries were performed by three experienced surgeons. Seventy three patients were included the following: 16 underwent a 3-D laparoscopic LDLN (3-D group), and 57 underwent a 2-D laparoscopic LDLN (2-D group). Operative time and warm ischemia time (WIT) were significantly lower in the 3-D group (operative time: 80.9 ± 10.2 vs 114.1 ± 32.3 minutes in the 3-D and 2-D groups, P = .0002) (WIT: 1.7 ± 0.6 vs 2.3 ± 0.9 minutes in the 3-D and 2-D groups, P = .02). No conversion to open surgery occurred in both groups. Length of hospital stay was significantly shorter in the 3-D group. No major postoperative complications (Clavien ≥ III) occurred. One-year postoperative GFR was similar to 3-D and 2-D groups. Our preliminary study demonstrates that 3-D laparoscopic LDLN is a feasible and safe surgical procedure. Intraoperative and postoperative outcomes were similar in both 2-D and 3-D vision systems, but 3-D vision systems allow reduction in WIT and operative time.


Asunto(s)
Trasplante de Riñón/métodos , Laparoscopía/instrumentación , Laparoscopía/métodos , Donadores Vivos/provisión & distribución , Nefrectomía/métodos , Recolección de Tejidos y Órganos/métodos , Femenino , Estudios de Seguimiento , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Pronóstico , Estudios Retrospectivos , Isquemia Tibia
20.
BJU Int ; 122(2): 255-262, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-29645355

RESUMEN

OBJECTIVES: To evaluate functional results, graft survival and late complications in patients who underwent robot-assisted kidney transplantation (RAKT) and who had a minimum of 1 year of follow-up data, and to analyse the correlations between surgical data and functional results at a minimum of 1-year postoperatively and between renal function in the immediate postoperative period and after 1 year. MATERIALS AND METHODS: A common prospectively collected RAKT database was created by the European Robotic Urological Section (ERUS) RAKT working group, which included eight different European centres. In each centre RAKTs were performed with kidneys from living donors. Data on demographic variables, surgical results, graft survival, functional outcomes (creatinine and estimated glomerular filtration rate [eGFR]) on postoperative days 7 and 30 and at 1 year, and late complications were extracted from the common database. RESULTS: A total of 147 RAKTs were performed by the ERUS RAKT working group. Of the 147 patients, 83 had at least 1-year follow-up (mean [range] 21 [13-27] months). Of these 83 patients, 30 were women. The patients' median (range) age was 43 (30-75) years, body mass index was 25.3 (20-40) kg/m2 , pre-transplantation serum creatinine was 517 (198-1 414) µmol/L and estimated GFR (eGFR) was 10 (3-29) mL/min per 1.73 m2 . Of the 83 cases, 46 were pre-emptive. The median (range) overall ischaemia time was 116 (53-377) min. The median (range) rewarming time was 60 (35-110) min. At 1-year follow-up, the median (range) serum creatinine was 131 (66-244) µmol/L, with a median (range) eGFR of 57.4 (28-97) mL/min per 1.73 m2 . There was no statistically significant difference between functional data at postoperative day 30 and those at 1 year for creatinine (P = 0.78) or eGFR (P = 0.91). Regarding the correlation between the surgical data and the functional outcomes, the data showed that overall operating time and rewarming time did not affect the graft function at 1 year. Three cases of graft loss occurred as a result of massive arterial thrombosis within the first postoperative week. Late complications comprised one case of ureteric stenosis and one case of graft pyelonephritis. No late vascular complications or cases of incisional hernia were recorded. CONCLUSION: Findings at 1-year follow-up indicate RAKT from a living donor to be a safe procedure in a properly selected group of recipients. RAKT was associated with a low complication rate and there was maintenance of excellent graft survival and function. This is the first and largest study to report functional results after RAKT from a living donor with a minimum follow-up of 1 year.


Asunto(s)
Fallo Renal Crónico/cirugía , Trasplante de Riñón/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Adulto , Anciano , Creatinina/metabolismo , Europa (Continente) , Femenino , Tasa de Filtración Glomerular/fisiología , Supervivencia de Injerto/fisiología , Humanos , Fallo Renal Crónico/fisiopatología , Trasplante de Riñón/estadística & datos numéricos , Donadores Vivos , Masculino , Persona de Mediana Edad , Tempo Operativo , Estudios Prospectivos , Recalentamiento , Procedimientos Quirúrgicos Robotizados/estadística & datos numéricos , Resultado del Tratamiento
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