Publications by authors named "Maria Carmen Mir"

32 Publications

Collaborative Review: Factors Influencing Treatment Decisions for Patients with a Localized Solid Renal Mass.

Eur Urol 2021 Feb 5. Epub 2021 Feb 5.

Division of Urologic Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.

Context: With the addition of active surveillance and thermal ablation (TA) to the urologist's established repertoire of partial (PN) and radical nephrectomy (RN) as first-line management options for localized renal cell carcinoma (RCC), appropriate treatment decision-making has become increasingly nuanced.

Objective: To critically review the treatment options for localized, nonrecurrent RCC; to highlight the patient, renal function, tumor, and provider factors that influence treatment decisions; and to provide a framework to conceptualize that decision-making process.

Evidence Acquisition: A collaborative critical review of the medical literature was conducted.

Evidence Synthesis: We identify three key decision points when managing localized RCC: (1) decision for surveillance versus treatment, (2) decision regarding treatment modality (TA, PN, or RN), and (3) decision on surgical approach (open vs minimally invasive). In evaluating factors that influence these treatment decisions, we elaborate on patient, renal function, tumor, and provider factors that either directly or indirectly impact each decision point. As current nomograms, based on preselected patient datasets, perform poorly in prospective settings, these tools should be used with caution. Patient decision aids are an underutilized tool in decision-making.

Conclusions: Localized RCC requires highly nuanced treatment decision-making, balancing patient- and tumor-specific clinical variables against indirect structural influences to provide optimal patient care.

Patient Summary: With expanding treatment options for localized kidney cancer, treatment decision is highly nuanced and requires shared decision-making. Patient decision aids may be helpful in the treatment discussion.
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http://dx.doi.org/10.1016/j.eururo.2021.01.021DOI Listing
February 2021

Clinical, surgical, pathological and follow-up features of kidney cancer patients with Von Hippel-Lindau syndrome: novel insights from a large consortium.

World J Urol 2021 Jan 8. Epub 2021 Jan 8.

Unit of Urology, University Vita-Salute, IRCCS San Raffaele Scientific Institute, Via Olgettina 60, 20132, Milan, Italy.

Purpose: To investigate the natural history and follow-up after kidney tumor treatment of Von Hippel-Lindau (VHL) patients.

Materials And Methods: A multi-institutional European consortium of patients with VHL syndrome included 96 non-metastatic patients treated at 9 urological departments (1987-2018). Descriptive and survival analyses were performed.

Results And Limitations: Median age at VHL diagnosis was 34 years (IQR 25-43). Two patients (2.1%) showed only renal manifestations at VHL diagnosis. Concomitant involvement of Central Nervous System (CNS) vs. pancreas vs. eyes vs. adrenal gland vs. others were present in 60.4 vs. 68.7 vs. 30.2 vs. 15.6 vs. 15.6% of patients, respectively. 45% of patients had both CNS and pancreatic diseases alongside kidney. The median interval between VHL diagnosis and renal cancer treatment resulted 79 months (IQR 0-132), and median index tumor size leading to treatment was 35.5 mm (IQR 28-60). Of resected malignant tumours, 73% were low grade. Of high-grade tumors, 61.1% were large > 4 cm. With a median follow-up of 8 years, clinical renal progression rate was 11.7% and 29.3% at 5 and 10 years, respectively. Overall mortality was 4% and 7.5% at 5 and 10 years, respectively. During the follow-up, 50% of patients did not receive a second active renal treatment. Finally, 25.3% of patients had CKD at last follow-up.

Conclusions: Mean period between VHL diagnosis and renal cancer detection is roughly three years, with significant variability. Although, most renal tumors are small low-grade, clinical progression and mortality are not negligible. Moreover, kidney function represents a key issue in VHL patients.
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http://dx.doi.org/10.1007/s00345-020-03574-5DOI Listing
January 2021

Development of a Novel Risk Score to Select the Optimal Candidate for Cytoreductive Nephrectomy Among Patients with Metastatic Renal Cell Carcinoma. Results from a Multi-institutional Registry (REMARCC).

Eur Urol Oncol 2021 Apr 29;4(2):256-263. Epub 2020 Dec 29.

Department of Urology, Fundacion Instituto Valenciano Oncologia, Valencia, Spain. Electronic address:

Background: Selection of patients for upfront cytoreductive nephrectomy (CN) in metastatic renal cell carcinoma (mRCC) has to be improved.

Objective: To evaluate a new scoring system for the prediction of overall mortality (OM) in mRCC patients undergoing CN.

Design, Setting, And Participants: We identified a total of 519 patients with synchronous mRCC undergoing CN between 2005 and 2019 from a multi-institutional registry (Registry for Metastatic RCC [REMARCC]).

Outcome Measurements And Statistical Analysis: Cox proportional hazard regression was used to test the main predictors of OM. Restricted mean survival time was estimated as a measure of the average overall survival time up to 36 mo of follow-up. The concordance index (C-index) was used to determine the model's discrimination. Decision curve analyses were used to compare the net benefit from the REMARCC model with International mRCC Database Consortium (IMDC) or Memorial Sloan Kettering Cancer Center (MSKCC) risk scores.

Results And Limitations: The median follow-up period was 18 mo (interquartile range: 5.9-39.7). Our models showed lower mortality rates in obese patients (p = 0.007). Higher OM rates were recorded in those with bone (p = 0.010), liver (p = 0.002), and lung metastases (p < 0.001). Those with poor performance status (<80%) and those with more than three metastases had also higher OM rates (p = 0.026 and 0.040, respectively). The C-index of the REMARCC model was higher than that of the MSKCC and IMDC models (66.4% vs 60.4% vs 60.3%). After stratification, 113 (22.0%) patients were classified to have a favorable (no risk factors), 202 (39.5%) an intermediate (one or two risk factors), and 197 (38.5%) a poor (more than two risk factors) prognosis. Moreover, 72 (17.2%) and 51 (13.9%) patients classified as having an intermediate and a poor prognosis according to MSKCC and IMDC categories, respectively, would be reclassified as having a good prognosis according to the REMARCC score.

Conclusions: Our findings confirm the relevance of tumor and patient features for the risk stratification of mRCC patients and clinical decision-making regarding CN. Further prospective external validations are required for the scoring system proposed herein.

Patient Summary: Current stratification systems for selecting patients for kidney removal when metastatic disease is shown are controversial. We suggest a system that includes tumor and patient features besides the systems already in use, which are based on blood tests.
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http://dx.doi.org/10.1016/j.euo.2020.12.010DOI Listing
April 2021

Gelatin sponge (Spongostan®) and N-butyl-2-cyanoacrylate: Utility on percutaneous treatment of persistent urinary leakage after partial nephrectomy. Case report and review of the literature.

Arch Ital Urol Androl 2020 Oct 1;92(3). Epub 2020 Oct 1.

Department of Urology, San Bassiano Hospital, Bassano del Grappa.

Introduction: Percutaneous treatment of persistent urinary fistula after partial nephrectomy using N-butyl-2-cyanoacrylate and gelatin sponge (Spongostan®) is an effective and relatively non-invasive procedure that should be considered when a conservative approach fails. Three successful cases of percutaneous embolization by using N-butyl-2-cyanoacrylate have been reported in the literature. To our knowledge, the use of Spongostan for the treatment of urinary fistula after partial nephrectomy has not been previously described.

Case Report: We present the case of an 82-year old man who underwent percutaneous closure of a urinary fistula following partial nephrectomy by using gelatin sponge (Spongostan®) and N-butyl-2-cyanoacrylate.

Conclusions: We encourage the use of this technique in selected cases. Collaboration amongst urologists and skilled interventional radiologist is strongly recommended.
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http://dx.doi.org/10.4081/aiua.2020.3.200DOI Listing
October 2020

Active surveillance for small renal masses in elderly patients does not increase overall mortality rates compared to primary intervention: a propensity score weighted analysis.

Minerva Urol Nefrol 2020 Sep 29. Epub 2020 Sep 29.

Department of Urology, Instituto Valenciano de Oncología (IVO), Valencia, Spain -

Background: To test the effect of active surveillance (AS) versus primary intervention (PI) on overall mortality (OM) in elderly patients diagnosed with SRM.

Methods: Elderly patients (75 years or older) diagnosed with SRMs (< 4cm) and treated with either PI [i.e. partial nephrectomy or kidney ablation] or AS between 2009 and 2018 were abstracted from the REnal SURGery in the Elderly (RESURGE) and Delayed Intervention and Surveillance for Small Renal Masses (DISSRM) datasets, respectively. OM rates were estimated among groups with Kaplan Meier method and Cox proportional hazards regression models after applying inverse probability of treatment weighting (IPTW). Multivariable logistic regression model was used to estimate IPTW. Covariates of interest were those unbalanced and/or significantly correlated with the treatment choice or with OM.

Results: A total of 483 patients were included; 121 (25.1%) underwent AS. 60 patients (12.4%) died. Overall, 6.7% of all deaths were related to cancer. IPTW-Kaplan Meier curves showed a 5-year overall survival rates of 70.0 ± 3.5% and 73.2 ± 4.8% in AS and PI groups, respectively (IPTW-Log-rank p-value=0.308). IPTW-Cox regression model did not show meaningfully increased OM rates in AS group (HR=1.31, 95% CI: 0.69-2.49).

Conclusions: AS represents an appealing treatment option for very elderly patients presenting with SRM, as it avoids the risks of a PI while not compromising the survival outcomes of these patients.
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http://dx.doi.org/10.23736/S0393-2249.20.03785-6DOI Listing
September 2020

Nomogram Predicting Bladder Cancer-specific Mortality After Neoadjuvant Chemotherapy and Radical Cystectomy for Muscle-invasive Bladder Cancer: Results of an International Consortium.

Eur Urol Focus 2020 Aug 5. Epub 2020 Aug 5.

Department of Urologic Sciences, University of British Columbia, Vancouver, Canada.

Background: Cisplatin-based neoadjuvant chemotherapy (NAC) for muscle-invasive bladder cancer (MIBC) is associated with improved overall and cancer-specific survival. The post-NAC pathological stage has previously been reported to be a major determinant of outcome.

Objective: To develop a postoperative nomogram for survival based on pathological and clinical parameters from an international consortium.

Design, Setting, And Participants: Between 2000 and 2015, 1866 patients with MIBC were treated at 19 institutions in the USA, Canada, and Europe. Analysis was limited to 640 patients with adequate follow-up who had received three or more cycles of NAC.

Outcome Measurements And Statistical Analysis: A nomogram for bladder cancer-specific mortality (BCSM) was developed by multivariable Cox regression analysis. Decision curve analysis was used to assess the model's clinical utility.

Results And Limitations: A total of 640 patients were identified. Downstaging to non-MIBC (ypT1, ypTa, and ypTis) occurred in 271 patients (42 %), and 113 (17 %) achieved a complete response (ypT0N0). The 5-yr BCSM was 47.2 % (95 % confidence interval [CI]: 41.2-52.6 %). On multivariable analysis, covariates with a statistically significant association with BCSM were lymph node metastasis (hazard ratio [HR] 1.90 [95% CI: 1.4-2.6]; p < 0.001), positive surgical margins (HR 2.01 [95 % CI: 1.3-2.9]; p < 0.001), and pathological stage (with ypT0/Tis/Ta/T1 as reference: ypT2 [HR 2.77 {95 % CI: 1.7-4.6}; p < 0.001] and ypT3-4 [HR 5.9 {95 % CI: 3.8-9.3}; p < 0.001]). The area under the curve of the model predicting 5-yr BCSM after cross validation with 300 bootstraps was 75.4 % (95 % CI: 68.1-82.6 %). Decision curve analyses showed a modest net benefit for the use of the BCSM nomogram in the current cohort compared with the use of American Joint Committee on Cancer staging alone. Limitations include the retrospective study design and the lack of central pathology.

Conclusions: We have developed and internally validated a nomogram predicting BCSM after NAC and radical cystectomy for MIBC. The nomogram will be useful for patient counseling and in the identification of patients at high risk for BCSM suitable for enrollment in clinical trials of adjuvant therapy.

Patient Summary: In this report, we looked at the outcomes of patients with muscle-invasive bladder cancer in a large multi-institutional population. We found that we can accurately predict death after radical surgical treatment in patients treated with chemotherapy before surgery. We conclude that the pathological report provides key factors for determining survival probability.
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http://dx.doi.org/10.1016/j.euf.2020.07.002DOI Listing
August 2020

Chronic Kidney Disease After Partial Nephrectomy in Patients With Preoperative Inconspicuous Renal Function - Curiosity or Relevant Issue?

Clin Genitourin Cancer 2020 Dec 20;18(6):e754-e761. Epub 2020 May 20.

Department of Urology, University Medical Centre Mannheim, University of Heidelberg, Mannheim, Germany.

Background: Chronic kidney disease (CKD) is a severe long-term complication after partial nephrectomy (PN). Clinical and scientific focus lies on patients with impaired renal function at the time of surgery. Little data is available on patients with normal preoperative renal function (NPRF).

Patients And Methods: Patients who underwent PN with a preoperative estimated glomular filtration rate > 60 mL/min/1.73m were retrospectively examined at 8 European urologic centers. The occurrence of new onset CKD ≥ stage III after surgery (sCKD) was defined as the primary endpoint. Group comparisons and risk correlations were determined. Based on this data, a risk stratification model for sCKD was developed.

Results: Of the 1315 patients with NPRF included, 249 (18.9%) developed sCKD after a median follow-up of 44 months (range, 6-255 months). Pair analysis and univariable regression revealed age, arterial hypertension, American Society of Anesthesiologists score, tumor stage, surgical approach, intraoperative blood loss, perioperative blood transfusions and preoperative CKD stage as predictors for sCKD development. Multivariate analysis confirmed perioperative blood transfusion (hazard ratio [HR], 2.96; P ≤ .0001), age (≥ 55 years; HR, 2.60; P = .0002), tumor stage (> pT1; HR, 2.15; P = .025), and preoperative CKD stage (stage II vs. I; HR, 3.85; P ≤ .0001) as independent risk factors. A model that stratified patient risk for new onset CKD was highly significant (P < .0001).

Conclusion: Every fifth patient with NPRF developed sCKD following PN. Elderly patients with higher tumor stage and who require blood transfusion appear to be at increased risk. Based on our risk stratification, patients with ≥ 2 risk factors are candidates for an early, nephrologic follow-up.
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http://dx.doi.org/10.1016/j.clgc.2020.05.007DOI Listing
December 2020

Management of Metastatic Nonclear Renal Cell Carcinoma: What Are the Options and Challenges?

Eur Urol Oncol 2020 Jun 15. Epub 2020 Jun 15.

Predictive onco-uro, APHP, Urology, Pitié-Salpêtrière Hospital, Sorbonne University, Paris, France.

This case presents a 68-yr-old female patient with primary metastatic nonclear renal cell carcinoma (RCC) with multiple bone lesions. The patient underwent a single resection of skull bone lesion (diagnostic for poorly differentiated carcinoma of unknown origin) and cytoreductive nephrectomy. The pathology of the kidney specimen demonstrated an oncocytic papillary RCC. Within 3 mo, she developed skeletal progressive disease and was started on systemic therapy (sunitinib). After initial stabilization, bone metastasis progressed during the third cycle of sunitinib and required second-line therapy (cabozantinib). One of the major unmet needs in non-clear cell RCC is the lack of specific systemic therapy. Data on immunotherapy are still limited. Inclusion of these patients in clinical trials is strongly recommended. PATIENT SUMMARY: Patients with metastatic kidney cancer who present with the less common histological subtype (non-clear cell) have poor survival. In this case, the patient responded to second-line therapy. Very few therapies provide response to treatment. Patients should be offered participation in clinical trials testing combinations with immunotherapy.
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http://dx.doi.org/10.1016/j.euo.2020.05.010DOI Listing
June 2020

Renal surgery for the older population: time for a paradigm shift? Data from the RESURGE project.

Aging Clin Exp Res 2020 Jan 10;32(1):173-178. Epub 2019 Oct 10.

Urology Unit, ASST Spedali Civili Hospital, Department of Medical and Surgical Specialties, Radiological Science, and Public Health, University of Brescia, Brescia, Italy.

Aim: To provide a comprehensive analysis of the outcomes of partial nephrectomy (PN) and radical nephrectomy (RN) for renal cell carcinoma (RCC) in older patients.

Methods: The RESURGE project is a multi-institutional dataset including 24 institutions worldwide collecting data of patients older than 75 years old who underwent RN or PN.

Results: Among three already published studies, RN patients were older (p < 0.001), and presented a higher RENAL score (p < 0.001). PN showed shorter operative time (p = 0.020), as well as lower eGFR postoperative decline (p < 0.001). No statistically significant difference was found in terms of major complications between PN and RN. PN was shown to be protective factor with respect to de novo chronic kidney disease (CKD) (p < 0.001). RN was related to a higher rate of recurrence (p < 0.001), whereas PN demonstrated lower risk of cancer-specific mortality (CSM) (p = 0.05).

Conclusions: Data from the RESURGE project suggest that kidney cancer surgery could be feasible and safe in well-selected older patients. When surgery is indicated, PN should be preferred to RN as it offers better functional preservation. Otherwise, less invasive or non-interventional management options should be considered.
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http://dx.doi.org/10.1007/s40520-019-01366-5DOI Listing
January 2020

Systematic Review and Pooled Analysis of the Impact of Renorrhaphy Techniques on Renal Functional Outcome After Partial Nephrectomy.

Eur Urol Oncol 2019 09 9;2(5):572-575. Epub 2018 Dec 9.

Department of Urology, San Raffaele Scientific Institute, Milan, Italy; Division of Experimental Oncology/Unit of Urology, URI, IRCCS San Raffaele Hospital, Milan, Italy.

Despite the important relationship between renorrhaphy and functional outcomes of partial nephrectomy, the urological guidelines do not provide recommendations about the optimal renorrhaphy technique. We carried out the first pooled literature analysis of the impact of suture technique on ultimate renal function after partial nephrectomy. Three studies comparing interrupted versus running suture including data on glomerular filtration rate (GFR) were included, for a total of 124 versus 269 patients. No significant differences were found between pre- and postoperative GFR in either patients who received an interrupted suture (weighted mean difference, -4.88ml/min, 95% confidence interval [CI] -11.38; 1.63, p=0.14) or those who received a running suture (-3.42ml/min, 95% CI -9.96; 3.12, p=0.31). Three studies comparing single- versus double-layer renorrhaphy included data on GFR (321 vs 199 patients). A benefit in functional outcomes favored single-layer technique (-3.19ml/min, 95% CI -8.09; 1.70, p=0.2 vs -6.07ml/min, 95% CI -10.75; -1.39, p=0.01). In conclusion, our quantitative synthesis suggests a renal functional benefit of the single-layer closure during partial nephrectomy. PATIENT SUMMARY: The available studies on renal functional data included in the present review suggest that "less is more" for renorrhaphy after partial nephrectomy. The single-layer renorrhaphy technique showed advantages in renal functional outcomes compared with the double-layer technique.
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http://dx.doi.org/10.1016/j.euo.2018.11.008DOI Listing
September 2019

Role of Active Surveillance for Localized Small Renal Masses.

Eur Urol Oncol 2018 08 26;1(3):177-187. Epub 2018 May 26.

James Buchanan Brady Urological Institute and Department of Urology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.

Context: Stage migration of organ-confined renal masses is occurring as a result of incidental diagnosis, especially in the elderly. Active surveillance (AS) is gaining clinical traction as a treatment alternative to surgery and focal therapy.

Objective: To assess contemporary data and evaluate AS risk trade-offs in the treatment of organ-confined kidney cancer.

Evidence Acquisition: A comprehensive search of the Embase, Medline and Cochrane databases was carried out. A systematic review of the role of AS for organ-confined renal masses was performed. A total of 28 studies were included in the systematic review.

Evidence Synthesis: The median linear tumor growth rate for clinically localized renal masses (CLRMs) was 0.37cm/yr (interquartile range 0.15-0.7), with 0.22cm/yr in the cT1a subgroup and 0.45cm/yr in the cT1b--2 subgroup. The metastatic progression rate was 1-6% and was similar for cT1a (1-6%) and cT1b (0-5%); other-cause mortality for patients with CLRMs was 0-45% (1-25% for cT1a vs 11-13% for cT1b-2); cancer-specific mortality ranged between 0% and 18%. According to the 2011 Oxford scale, AS as a treatment option for CLRMs remains supported by level 3 evidence.

Conclusions: Although no randomized clinical data are available, current data support oncologic safety for AS in the management of CLRMs, particularly for small renal masses and among elderly and/or comorbid patients.

Patient Summary: In this review we looked at the outcomes for patients with small kidney masses managed with surveillance. We found that surveillance is a safe initial option for tumors of less than 2cm, especially in elderly and sick patients.
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http://dx.doi.org/10.1016/j.euo.2018.05.001DOI Listing
August 2018

Trifecta Outcomes of Partial Nephrectomy in Patients Over 75 Years Old: Analysis of the REnal SURGery in Elderly (RESURGE) Group.

Eur Urol Focus 2020 09 22;6(5):982-990. Epub 2019 Feb 22.

Department ofUrology, University of California San Diego School of Medicine, La Jolla, CA, USA. Electronic address:

Background: Partial nephrectomy (PN) in elderly patients is underutilized with concerns regarding risk of complications and potential for poor outcomes.

Objective: To evaluate quality and functional outcomes of PN in patients >75 yr using trifecta as a composite outcome of surgical quality.

Design, Setting, And Participants: Multicenter retrospective analysis of 653 patients aged >75 yr who underwent PN (REnal SURGery in Elderly [RESURGE] Group).

Intervention: PN.

Outcome Measurements And Statistical Analysis: Primary outcome was achievement of trifecta (negative margin, no major [Clavien ≥3] urological complications, and ≥90% estimated glomerular filtration rate [eGFR] recovery). Secondary outcomes included chronic kidney disease (CKD) stage III and CKD upstaging. Multivariable analysis (MVA) was used to assess variables for achieving trifecta and functional outcomes. Kaplan-Meier survival analysis (KMA) was used to calculate renal functional outcomes.

Results And Limitations: We analyzed 653 patients (mean age 78.4 yr, median follow-up 33 mo; 382 open, 157 laparoscopic, and 114 robotic). Trifecta rate was 40.4% (n=264). Trifecta patients had less transfusion (p<0.001), lower intraoperative (5.3% vs 27%, p<0.001) and postoperative (25.4% vs 37.8%, p=0.001) complications, shorter hospital stay (p=0.045), and lower ΔeGFR (p <0.001). MVA for predictive factors for trifecta revealed decreasing RENAL nephrometry score (odds ratio [OR] 1.26, 95% confidence interval 1.07-1.51, p=0.007) as being associated with increased likelihood to achieve trifecta. Achievement of trifecta was associated with decreased risk of CKD upstaging (OR 0.47, 95% confidence interval 0.32-0.62, p<0.001). KMA showed that trifecta patients had improved 5-yr freedom from CKD stage 3 (93.5% vs 57.7%, p<0.001) and CKD upstaging (84.3% vs 8.2%, p<0.001). Limitations include retrospective design.

Conclusions: PN in elderly patients can be performed with acceptable quality outcomes. Trifecta was associated with decreased tumor complexity and improved functional preservation.

Patient Summary: We looked at quality outcomes after partial nephrectomy in elderly patients. Acceptable quality outcomes were achieved, measured by a composite outcome called trifecta, whose achievement was associated with improved kidney functional preservation.
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http://dx.doi.org/10.1016/j.euf.2019.02.010DOI Listing
September 2020

Live Surgery for Laparoscopic Radical Prostatectomy-Does it Worsen the Outcomes? A Single-center Experience.

Urology 2019 01 9;123:133-139. Epub 2018 Oct 9.

Department of Urology, Fundación IVO, Valencia, Spain.

Objective: To compare outcomes of laparoscopic radical prostatectomy (LRP) performed in live surgery versus daily routine LRP.

Methods: From January 2014 to June 2017, data from LRP performed at our Institution in live broadcasting by 3 experienced laparoscopic surgeons during educational events were collected. A 1:2 matching (according to BMI, comorbidities, NCCN risk groups, and operating surgeon) was performed with the routine LRP patients collected in our prospectively-maintained database. Chosen procedures were performed within the same time span by the same surgeons. Data of interest were compared.

Results: Twenty-three live surgery LRPs were analyzed (Group A). Forty-six matched patients were the controls (Group B). Groups were comparable at baseline. No differences were found in perioperative data (operative time, blood loss, and intraoperative complications, 4.3% in both Groups) and postoperative complications. Particularly, 10 (43.5%) and 22 patients (47.8%) did not report complications (Group A vs B, respectively, P = .54). The majority of complications were Clavien 1-2, with 2 patients per Group requiring blood transfusion. Overall positive surgical margins rate was 26.1%. It was significantly higher in Group A (43.5% vs 17.4%; P = .02), but no differences were found in the number of patients who relapsed, who needed radiotherapy or androgen deprivation therapy within a median follow-up of 25 months in both Groups. No differences were found regarding functional data. Limitations include a low sample size and limited follow-up.

Conclusion: LRP has similar perioperative outcomes when performed in either live surgery or daily routine setting. We underline the higher positive surgical margins rate after live surgeries that should increase the awareness before embarking on it.
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http://dx.doi.org/10.1016/j.urology.2018.10.001DOI Listing
January 2019

Suture techniques during laparoscopic and robot-assisted partial nephrectomy: a systematic review and quantitative synthesis of peri-operative outcomes.

BJU Int 2019 06 19;123(6):923-946. Epub 2018 Nov 19.

Division of Urology, Washington University School of Medicine, St Louis, MO, USA.

Objective: To summarize the available evidence on renorrhaphy techniques and to assess their impact on peri-operative outcomes after minimally invasive partial nephrectomy (MIPN).

Materials And Methods: A systematic review of the literature was performed in January 2018 without time restrictions, using MEDLINE, Cochrane and Web of Science databases according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement recommendations. Studies providing sufficient details on renorrhaphy techniques during laparoscopic or robot-assisted partial nephrectomy and comparative studies focused on peri-operative outcomes were included in qualitative and quantitative analyses, respectively.

Results: Overall, 67 and 19 studies were included in the qualitative and quantitative analyses, respectively. The overall quality of evidence was low. Specific tumour features (i.e. size, hilar location, anatomical complexity, nearness to renal sinus and/or urinary collecting system), surgeon's experience, robot-assisted technology, as well as the aim of reducing warm ischaemia time and the amount of devascularized renal parenchyma preserved represented the key factors driving the evolution of the renorrhaphy techniques during MIPN over the past decade. Quantitative synthesis showed that running suture was associated with shorter operating and ischaemia time, and lower postoperative complication and transfusion rates than interrupted suture. Barbed suture had lower operating and ischaemia time and less blood loss than non-barbed suture. The single-layer suture technique was associated with shorter operating and ischaemia time than the double-layer technique. No comparisons were possible concerning renal functional outcomes because of non-homogeneous data reporting.

Conclusions: Renorrhaphy techniques significantly evolved over the years, improving outcomes. Running suture, particularly using barbed wires, shortened the operating and ischaemia times. A further advantage could derive from avoiding a double-layer suture.
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http://dx.doi.org/10.1111/bju.14537DOI Listing
June 2019

Does the Unexpected Presence of Non-organ-confined Disease at Final Pathology Undermine Cancer Control in Patients with Clinical T1N0M0 Renal Cell Carcinoma Who Underwent Partial Nephrectomy?

Eur Urol Focus 2018 12 21;4(6):972-977. Epub 2017 Mar 21.

Department of Urology, Ludwig-Maximilians University Munich, Campus Grosshadern, Munich, Germany; Janssen Pharma Research and Development, Los Angeles, CA, USA.

Background: A non-negligible proportion of individuals diagnosed with cT1 renal cell carcinoma (RCC) are upstaged to pT3a at final pathology. Few data on oncological outcomes for these patients are available to determine whether partial nephrectomy (PN) might jeopardise cancer control.

Objective: To assess, within an international multi-institutional collaboration, whether PN might undermine cancer control relative to radical nephrectomy (RN) in RCC patients with unexpected pT3a disease.

Design, Setting, And Participants: International multi-institutional collaboration including patients with cT1abN0M0-pT3a RCC.

Intervention: PN or RN.

Outcome Measurements And Statistical Analysis: We used Kaplan-Meier analyses, before and after propensity-score matching, to evaluate differences in metastatic progression (MP) and cancer-specific mortality (CSM) rates during follow-up. Univariable and multivariable Cox regression analyses were used to assess predictors of MP and CSM.

Results And Limitations: Overall, 309 patients with cT1abN0M0 RCC (cT1aN0M0, n=107, 34.6%; cT1bN0M0, n=202, 65.4%) had pT3a disease according to final pathology. Patients were treated with either PN (n=71, 23%) or RN (n=238, 77%). MP at 1, 2, and 5 yr was detected in 9.1%, 13.3%, and 24.1% of patients, respectively. CSM was 3.5%, 10.7%, and 18.4% at 1, 2, and 5 yr, respectively. After matching, no difference in terms of MP or CSM was observed between the PN and RN cohorts (both p>0.3). On multivariable analysis, type of surgery (PN vs RN) was not an independent predictor of either MP (p=0.3) or CSM (p=0.4). Limitations include the retrospective design.

Conclusions: In patients with unexpected pT3a RCC at final pathology, PN does not appear to jeopardise cancer control with regard to MP and CSM.

Patient Summary: Cancer control is similar between patients treated with removal of the entire kidney and those with only partial removal, even if the final histology examination demonstrates a tumour that is unexpectedly not confined within the kidney.
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http://dx.doi.org/10.1016/j.euf.2017.02.020DOI Listing
December 2018

Partial Nephrectomy Versus Radical Nephrectomy for Clinical T1b and T2 Renal Tumors: A Systematic Review and Meta-analysis of Comparative Studies.

Eur Urol 2017 04 7;71(4):606-617. Epub 2016 Sep 7.

Urology Institute, University Hospitals, Case Western Reserve University, Cleveland, OH, USA. Electronic address:

Background: Partial nephrectomy (PN) is the reference standard of management for a cT1a renal mass. However, its role in the management of larger tumors (cT1b and cT2) is still under scrutiny.

Objective: To conduct a meta-analysis assessing functional, oncologic, and perioperative outcomes of PN and radical nephrectomy (RN) in the specific case of larger renal tumors (≥cT1b). The primary endpoint was an overall analysis of cT1b and cT2 masses. The secondary endpoint was a sensitivity analysis for cT2 only.

Evidence Acquisition: A systematic literature review was performed up to December 2015 using multiple search engines to identify eligible comparative studies. A formal meta-analysis was performed for studies comparing PN to RN for both cT1b and cT2 tumors. In addition, a sensitivity analysis including the subgroup of studies comparing PN to RN for cT2 only was conducted. Pooled estimates were calculated using a fixed-effects model if no significant heterogeneity was identified; alternatively, a random-effects model was used when significant heterogeneity was detected. For continuous outcomes, the weighted mean difference (WMD) was used as summary measure. For binary variables, the odds ratio (OR) or risk ratio (RR) was calculated with 95% confidence interval (CI). Statistical analyses were performed using Review Manager 5 (Cochrane Collaboration, Oxford, UK).

Evidence Synthesis: Overall, 21 case-control studies including 11204 patients (RN 8620; PN 2584) were deemed eligible and included in the analysis. Patients undergoing PN were younger (WMD -2.3 yr; p<0.001) and had smaller masses (WMD -0.65cm; p<0.001). Lower estimated blood loss was found for RN (WMD 102.6ml; p<0.001). There was a higher likelihood of postoperative complications for PN (RR 1.74, 95% CI 1.34-2.2; p<0.001). Pathology revealed a higher rate of malignant histology for the RN group (RR 0.97; p=0.02). PN was associated with better postoperative renal function, as shown by higher postoperative estimated glomerular filtration rate (eGFR; WMD 12.4ml/min; p<0.001), lower likelihood of postoperative onset of chronic kidney disease (RR 0.36; p<0.001), and lower decline in eGFR (WMD -8.6ml/min; p<0.001). The PN group had a lower likelihood of tumor recurrence (OR 0.6; p<0.001), cancer-specific mortality (OR 0.58; p=0.001), and all-cause mortality (OR 0.67; p=0.005). Four studies compared PN (n=212) to RN (n=1792) in the specific case of T2 tumors (>7cm). In this subset of patients, the estimated blood loss was higher for PN (WMD 107.6ml; p<0.001), as was the likelihood of complications (RR 2.0; p<0.001). Both the recurrence rate (RR 0.61; p=0.004) and cancer-specific mortality (RR 0.65; p=0.03) were lower for PN.

Conclusions: PN is a viable treatment option for larger renal tumors, as it offers acceptable surgical morbidity, equivalent cancer control, and better preservation of renal function, with potential for better long-term survival. For T2 tumors, PN use should be more selective, and specific patient and tumor factors should be considered. Further investigation, ideally in a prospective randomized fashion, is warranted to better define the role of PN in this challenging clinical scenario.

Patient Summary: We performed a cumulative analysis of the literature to determine the best treatment option in cases of localized kidney tumor of higher clinical stage (T1b and T2, as based on preoperative imaging). Our findings suggest that removing only the tumor and saving the kidney might be an effective treatment modality in terms of cancer control, with the advantage of preserving the kidney function. However, a higher risk of perioperative complications should be taken into account when facing larger tumors (clinical stage T2) with kidney-sparing surgery.
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http://dx.doi.org/10.1016/j.eururo.2016.08.060DOI Listing
April 2017

Re: renal ischemia and function after partial nephrectomy: a collaborative review of the literature.

Eur Urol 2015 Sep;68(3):539

Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA.

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http://dx.doi.org/10.1016/j.eururo.2015.05.029DOI Listing
September 2015

Editorial comment.

Urology 2014 Aug 6;84(2):334. Epub 2014 Jun 6.

Center for Urologic Oncology, Glickman Urologic and Kidney Institute, Cleveland Clinic.

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http://dx.doi.org/10.1016/j.urology.2014.02.060DOI Listing
August 2014

Editorial comment.

Urology 2014 Aug 6;84(2):332-3. Epub 2014 Jun 6.

Center for Urologic Oncology, Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH.

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http://dx.doi.org/10.1016/j.urology.2014.02.046DOI Listing
August 2014

Robot-assisted laparoscopic adrenalectomy: step-by-step technique and comparative outcomes.

Eur Urol 2014 Nov 13;66(5):898-905. Epub 2014 May 13.

Glickman Urological and Kidney Institute, Cleveland Clinic, Cleveland, OH, USA. Electronic address:

Background: Recent evidence supports the use of robotic surgery for the minimally invasive surgical management of adrenal masses.

Objective: To describe a contemporary step-by-step technique of robotic adrenalectomy (RA), to provide tips and tricks to help ensure a safe and effective implementation of the procedure, and to compare its outcomes with those of laparoscopic adrenalectomy (LA).

Design, Setting, And Participants: We retrospectively reviewed the medical charts of consecutive patients who underwent RA performed by a single surgeon between April 2010 and October 2013. LA cases performed by the same surgeon between January 2004 and May 2010 were considered the control group.

Surgical Procedure: The main steps of our current surgical technique for RA are described in this video tutorial: patient positioning, port placement, and robot docking; exposure of the adrenal gland; identification and control of the adrenal vein; circumferential dissection of the adrenal gland; and specimen retrieval and closure.

Outcome Measurements And Statistical Analysis: Demographic parameters and main surgical outcomes were assessed.

Results And Limitations: A total of 76 cases (RA: 30; LA: 46) were included in the analysis. Median tumor size on computed tomography (CT) was significantly larger in the LA group (3cm [interquartile range (IQR): 3] vs 4cm [IQR: 3]; p=0.002). A significantly lower median estimated blood loss was recorded for the robotic group (50ml [IQR: 50] vs 100ml [IQR: 288]; p=0.02). The RA group presented five minor complications (16.7%) and one major (Clavien 3b) complication (3.3%), whereas four minor complications (8.7%) and one major (Clavien 3b) complication (2.3%) were observed in the LA group. No significant difference was noted between groups in terms of malignant histology (p=0.66) and positive margin rate (p=0.60). Distribution of pheochromocytomas in the LA group was significantly higher than in the RA group (43.5% vs 16.7%; p=0.02).

Conclusions: The standardization of each surgical step optimizes the RA procedure. The robotic approach can be applied for a wide range of adrenal indications, recapitulating the safety and effectiveness of open surgery and potentially improving the outcomes of standard laparoscopy.

Patient Summary: In this report we detail our surgical technique for robotic removal of adrenal masses. This procedure has been standardized and can be offered to patients, with excellent outcomes.
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http://dx.doi.org/10.1016/j.eururo.2014.04.003DOI Listing
November 2014

Robot assisted laparoscopic retroperitoneal lymph node dissection in testicular tumor.

Urol Ann 2014 Jan;6(1):99

Clevel and Clinic, Glickman Urological and Kidney Institute, Cleveland, OH 44195, USA.

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http://dx.doi.org/10.4103/0974-7796.127037DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3963358PMC
January 2014

Reply: To PMID 24468513.

Urology 2014 Feb;83(2):399

Department of Urology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.

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http://dx.doi.org/10.1016/j.urology.2013.10.041DOI Listing
February 2014

Robot-assisted laparoscopic retroperitoneal lymph node dissection for left clinical stage I non-seminomatous germ cell testicular cancer: focus on port placement and surgical technique.

Int J Urol 2014 Feb 30;21(2):212-4. Epub 2013 Sep 30.

Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, Ohio, USA.

The aim of our report was to describe the feasibility of robotic retroperitoneal lymph node dissection in the contemporary era. We suggest the linear port location and 90° robotic docking as the main key to minimizing instrument clashing and improving the range of surgical accessibility.
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http://dx.doi.org/10.1111/iju.12249DOI Listing
February 2014

Words of wisdom: Re: Precise segmental renal artery clamping under the guidance of dual-source computed tomography angiography during laparoscopic partial nephrectomy.

Eur Urol 2013 May;63(5):964-5

Center for Urologic Oncology, Glickman Urologic and Kidney Institute, Cleveland Clinic, Cleveland, OH 44195, USA.

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http://dx.doi.org/10.1016/j.eururo.2013.02.019DOI Listing
May 2013

The role of lymph node fine-needle aspiration in penile cancer in the sentinel node era.

Adv Urol 2011 30;2011:383571. Epub 2011 Mar 30.

Urology Unit, Department of Surgery, University of Melbourne, Austin Health, Australia.

Penile squamous cell carcinoma (SCC) is an uncommon condition in Western countries. Inguinal lymph nodes dissection can be curative in 20%-60% of node positive patients. However, there is a high complication rates from the dissection, thus accurate diagnosis of inguinal lymph nodes metastasis is required. Current non invasive methods to detect lymph nodes metastasis are unreliable. Dynamic Sentinel Node Biopsy (DNSB), ultrasonography (US), and fine needle aspiration (FNA) cytology were proposed to in an attempt to detect sentinel lymph node (SLN). Despite the initial high rate of false negative results, recent DSNB showed improved survival compared to wait and see policy as well as reduced mortality compared to prophylactic inguinal lymphadenectomy. In addition, the US guided FNA shown 100% of specificity in detecting clinically occult lymph nodes metastasis. We proposed an algorithm for management of lymph nodes in penile cancer and suggest that FNA with US guidance should be performed in all high risk patients and that therapeutic dissection should be performed if findings are positive.
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http://dx.doi.org/10.1155/2011/383571DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3095425PMC
July 2011

A three-gene panel on urine increases PSA specificity in the detection of prostate cancer.

Prostate 2011 Dec 25;71(16):1736-45. Epub 2011 Apr 25.

Research Unit in Biomedicine and Translational and Pediatric Oncology, Vall d'Hebron Research Institute, Barcelona, Spain.

Background: Several studies have demonstrated the usefulness of monitoring an RNA transcript, such as PCA3, in post-prostate massage (PM) urine for increasing the specificity of prostate-specific antigen (PSA) in the detection of prostate cancer (PCa). However, a single marker may not necessarily reflect the multifactorial nature of PCa.

Methods: We analyzed post-PM urine samples from 154 consecutive patients, who presented for prostate biopsies because of elevated serum PSA (>4 ng/ml) and/or abnormal digital rectal exam. We tested whether the putative PCa biomarkers PSMA, PSGR, and PCA3 could be detected by quantitative real-time PCR in post-PM urine sediment. We combined these findings to test if a combination of these biomarkers could improve the specificity of actual diagnosis. Afterwards, we specifically tested our model for clinical usefulness in the PSA diagnostic "gray zone" (4-10 ng/ml) on a target subset of 82 men with no prior biopsy.

Results: By univariate analysis, we found that the PSMA, PSGR, and PCA3 scores were significant predictors of PCa. Using a multiplex model, the area under the multi receiver-operating characteristic curve was 0.74 versus 0.82 in the diagnostic "gray zone." Fixing the sensitivity at 96%, we obtained a specificity of 34% and 50% in the gray zone.

Conclusions: Taken together, these results provide a strategy for the development of a more accurate model for PCa diagnosis. In the future, a multiplexed, urine-based diagnostic test for PCa with a higher specificity, but the same sensitivity as the serum-PSA test, could be used to determine better which patients should undergo biopsy.
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http://dx.doi.org/10.1002/pros.21390DOI Listing
December 2011

33% radius evaluation to assess bone mineral density in prostate cancer patients.

World J Urol 2011 Dec 30;29(6):815-9. Epub 2010 Dec 30.

Department of Urology, Vall d´Hebron Hospital, Autónoma University Medical School of Barcelona, Po Vall d'Hebron, 119-129, 08035, Barcelona, Spain.

Purpose: Dual-energy X-ray absorptiometry (DXA) is the standard method to assess bone mineral density (BMD). The International Society for Clinical Densitometry recommends the measurement of BMD at lumbar spine, total hip and femoral neck, but in certain circumstances the 33% radius may be the recommended area to measure BMD. The aim of this study has been to analyze whether 33% radius should be considered the recommended area to assess BMD in prostate cancer patients.

Methods: This is a retrospective study where BMD was assessed by DXA at 33% radius, lumbar spine, total hip, and femoral neck (cDXA) in 141 prostate cancer patients. Twenty-eight patients were hormone naïve while 113 were subjected to androgen suppression (AS) during the mean period of 29 months. Osteoporosis was diagnosed when T-score was lower than -2.5 and osteopenia when it ranged between -1 and -2.5.

Results: The osteoporosis rate was 29.8% at 33% radius, 23.4% at femoral neck, 19.9% at lumbar spine, and 12.8% at total hip. The overall osteoporosis rate at cDXA was 29.1%. Osteoporosis was detected in 52.2% at 33% radius and 36.2% at cDXA. Normal BMD was found in 17.7% at 33% radius and 34.8% at cDXA. The 33% radius was the only site where a significant increase in the osteoporosis rate was detected in patients subjected to AS compared to those hormone naïve (33 and 13.8%).

Conclusions: The 33% radius seems more sensible than the central skeleton areas to detect bone mass loss in patients with prostate cancer.
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http://dx.doi.org/10.1007/s00345-010-0630-7DOI Listing
December 2011

Altered transcription factor E3 expression in unclassified adult renal cell carcinoma indicates adverse pathological features and poor outcome.

BJU Int 2011 Jul 10;108(2 Pt 2):E71-6. Epub 2010 Nov 10.

Vall d'Hebron Hospital-Urology Department, Barcelona, Spain.

Objectives: To evaluate the clinical and pathologic features and the prognostic relevance of unclassified RCC with -TFE3 over-expression in our adult series. Recent studies suggest that renal cell carcinomas (RCCs) associated with the newly recognized Xp11.2 translocation (transcription factor E3 [TFE3] gene fusions) can be found among adults with RCC showing a very aggressive disease-course.

Material And Methods: We evaluated tumour specimens from 25 patients with unclassified RCC morphology out of 298 RCCs in the last 12 years in a tertiary academic centre. Immunohistochemistry was performed using monoclonal antibody for TFE3 C-terminal section, taking nuclear label into consideration. RT-PCR technique was performed for ASPL-TFE3 gene fusion on two tumours with available frozen tissue.

Results: Of the 25 cases analyzed, 8 (32%) showed positivity for TFE3 and 17 were negative for TFE3 staining. Two tumors with ASPL-TFE3 gene fusion also showed TFE3 over-expression. Fifty percent of the positive patients had lymph node metastatic disease, whereas only one TFE3-negative patient (5.8%) showed evidence of lymph node spread and cava thrombus at diagnosis. Of the TFE3-positive patients, three had a vena cava thrombus (37.5%). Seven of the eight positive cases (87.5%) were diagnosed with a high Fuhrman grade (III/IV). In comparison, five of 17 (29.4%) TFE3-negative patients had a high Fuhrman grade. Five of eight TFE3-positive patients relapsed rapidly at 3 month follow-up; conversely none of the negative cases relapsed. At 36-month mean follow-up, 5-year cancer-specific survival was 15.6% for TFE3-positive patients and 87.5% for TFE3-negative patients (P < 0.001).

Conclusion: Patients with unclassified RCC and TFE3 positivity have a grim prognosis due to their advanced stage at presentation and aggressive biologic features compared with the TFE3-negative unclassified RCC cases.
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http://dx.doi.org/10.1111/j.1464-410X.2010.09818.xDOI Listing
July 2011