Publications by authors named "Mariaconsiglia Ferriero"

45 Publications

Toxicity at 1 year after Stereotactic Body Radiotherapy in 3 Fractions for Localized Prostate Cancer.

Int J Radiat Oncol Biol Phys 2021 Mar 18. Epub 2021 Mar 18.

Radiation Oncology, IRCCS Regina Elena National Cancer Institute, Rome, Italy. Electronic address:

Purpose: To assess the toxicity profile of prostate cancer stereotactic radiotherapy (SBRT) in 3 fractions.

Methods And Materials: This is a prospective, multicenter phase II toxicity study enrolling patients with low to favorable intermediate risk prostate cancer. Before simulation 3-4 fiducial markers along with a rectal spacer were placed. The target (prostate only) was prescribed 40 Gy, while the maximum dose to the urethra was limited to 33 Gy with the highest priority at planning; less stringent objectives were placed on the bladder whose filling was controlled via a Foley catheter. Treatment was delivered every other day. Toxicity was prospectively scored with CTCAE and several PROs collected. The maximum allowed prevalence rate of grade 2+ GU toxicity at 1 year was set at 15% and the study was sized accordingly.

Results: Between November 2015 to May 2019, 59 patients were enrolled by 3 participating Institutions. Acute gastrointestinal (GI) toxicity was occasional and mild, while 11.9% and 1.7% developed acute GR2 and GR3 GU toxicity, respectively. No patient had persistent treatment-related GR2+ GU toxicity at 12 months after SBRT, and thus the null hypothesis is rejected. We observed a clinically relevant worsening of both IPSS and ICIQ-SF scores at 12 months compared to baseline. Moreover, we found a strong association between all selected bladder dose/volume metrics at planning and ICIQ-SF worsening at 12 months, while for IPSS, the correlation with bladder dose metrics was marginal.

Conclusions: At 12 months, the toxicity profile of SBRT in 3 fractions is acceptable.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ijrobp.2021.03.027DOI Listing
March 2021

Comparison of Patient-reported Health-related Quality of Life Between Open Radical Cystectomy and Robot-assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Interim Analysis of a Randomised Controlled Trial.

Eur Urol Focus 2021 Mar 9. Epub 2021 Mar 9.

Department of Urology, IRCCS Regina Elena National Cancer Institute, Rome, Italy.

Background: Open radical cystectomy (ORC) is still considered the reference approach for RC, although robot-assisted RC (RARC) has recently gained in popularity. There are literature reports on perioperative and oncologic outcomes of RARC, but functional outcomes and aspects related to health-related quality of life (HRQoL) remain unexplored.

Objective: To report an interim analysis of 1-yr HRQoL outcomes from an ongoing randomised controlled trial comparing ORC and RARC with totally intracorporeal urinary diversion (iUD) (ClinicalTrials.gov NCT03434132).

Design, Setting, And Participants: Patients with cT2-4N0M0 non-muscle-invasive bladder cancer or bacillus Calmette-Guérin failure who were candidates for cystectomy with curative intent without absolute contraindications to robotic surgery were included. A covariate adaptive randomisation based on the following variables was used: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin level, cT stage, type of UD, and neoadjuvant chemotherapy.

Intervention: ORC or RARC with iUD.

Outcome Measurements And Statistical Analysis: Data from patient-reported European Organization for Research and Treatment of Cancer QoL questionnaires (QLQ-C30 and QLQ-BLM30) were collected at baseline and 1 yr. Continuous variables were compared using the Student t test.

Results And Limitations: At interim analysis, 51 patients (24 RARC, 27 ORC) were analysed. Overall, both groups reported significant worsening of body image and physical and sexual functions (all p ≤ 0.012). Patients receiving ORC were more likely to report significant 1-yr impairment of role functioning, symptoms scales and bowel symptoms (all p ≤ 0.048). Patients receiving RARC reported significant impairment of urinary symptoms and problems (p = 0.018).

Conclusions: This study suggests equivalence between RARC-iUD and ORC for most HRQoL domains. Notwithstanding, after 1 yr patients receiving ORC were more likely to experience a decline in role functioning and higher symptoms scale, while RARC-iUD patients were more likely to report significant increases in urinary symptoms and problems.

Patient Summary: We analysed 1-year data for health-related quality of life from an ongoing trial comparing open and robotic surgery for removal of the bladder in patients with bladder cancer. Robotic surgery seems to provide benefits for most quality-of-life items on patient-reported questionnaires. This trial is registered at ClinicalTrial.gov as NCT03434132.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.euf.2021.03.002DOI Listing
March 2021

Fusion US/MRI prostate biopsy using a Computer Aided Diagnostic (CAD) system.

Minerva Urol Nefrol 2020 Nov 12. Epub 2020 Nov 12.

Department of Urology, Regina Elena National Cancer Institute, Rome, Italy.

Background: To investigate the impact of Computer Aided Diagnostic (CAD) system on the detection rate of prostate cancer (PCa) in a series of fusion prostate biopsy (FPB).

Methods: Two prospective transperineal FPB series (with or without CAD assistance) were analyzed and PCa detection rates compared with per patient and per target analyses. Chi-Square and Mann-Whitney test were used to compare categorical and continuous variables, respectively. Univariable and multivariable regression analyses were applied to identify predictors of any and clinically-significant (cs) PCa detection. Subgroup analyses were performed after stratifying for PIRADS Score and lesion location.

Results: Out of 183 FPB, 89 were performed with CAD assistance. At per patient analysis the detection rate of any PCa and of cs PCa were 56.3% and 30.6%, respectively; the aid of CAD was negligible for either any PCa or csPCa detection rates (p=0.45 and p=0.99, respectively). Conversely in a per target analysis, CAD-assisted biopsy had significantly higher positive predictive value (PPV) for any PCa versus MRI-only group (58%vs37.8%, p=0.001). PI-RADS Score was the only independent predictor of any and csPCa, either in per patient or per target multivariable regression analysis (all p<0.029). In a subgroup per patient analysis of anterior/transitional zone lesions, csPCa detection rate was significantly higher in the CAD cohort (54.5%vs11.1%, respectively; p=0.028), and CAD assistance was the only predictor of csPCa detection (p=0.013).

Conclusions: CAD assistance for FPB seems to improve detection of csPCa located in anterior/transitional zone. Enhanced identification and improved contouring of lesions may justify higher diagnostic performance.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.23736/S0393-2249.20.04008-4DOI Listing
November 2020

Robot-assisted radical cystectomy with intracorporeal neobladder: impact of learning curve and long-term assessment of functional outcomes.

Minerva Urol Nefrol 2020 Oct 5. Epub 2020 Oct 5.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Background: There is paucity of data about functional outcomes of Robot-assisted Radical Cystectomy (RARC) with intracorporeal orhotopic neobladder (ICON), and the impact of learning curve (LC) on those outcomes remains to be addressed. We aimed to report long-term functional outcomes of our single center series of RARC with ICON, assessing the role of LC in their achievement.

Methods: Patients treated with Robot assisted radical cystectomy with intracorporeal orthotopic neobladder in our center between January 2012 an August 2019 were retrospectively analysed. Preoperative, clinical, perioperative, pathologic and functional data were reported. The first cases were divided in tertiles, for assessing the impact of learning curve on the outcomes evaluated. Long-term functional outcomes of the whole cohort were evaluated.

Results: Overall, 167 patients were included. Concerning tertiles analysis, operative time (p<0.001), incidence of low (p=0.002) and high grade (p=0.001) complications and hospital stay (p=0.04) decreased significantly over time. Day-time continence recovery probability was significantly lower in the initial case series (1-yr rate 68.4%, 87% and 89.8 for I, II and III tertile, respectively; p=0.04;). Accordingly, Trifecta achievement was significantly higher in II and III tertiles (p=0.01). At a median follow- up of 34 months, the incidence of significant renal function deterioration of the whole cohort was 16.7%. Overall, 12, 24 and 60-mo day-time continence rates were 74.8 %, 82.7 % and 82.7 %.

Conclusions: Patients treated at the beginning of the learning curve show worse perioperative and functional results. Once standardized the procedure, complications rates, hospital stay and daytime continence recovery experienced a significant improvement. At a long-term analysis of functional outcomes of our patients, renal function preservation and continence recovery results are encouraging.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.23736/S0393-2249.20.03948-XDOI Listing
October 2020

Assessing the Impact of the Absence of Detrusor Muscle in Ta Low-grade Urothelial Carcinoma of the Bladder on Recurrence-free Survival.

Eur Urol Focus 2020 Sep 6. Epub 2020 Sep 6.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Background: Obtaining detrusor muscle (DM) in transurethral resection of bladder tumor (TURBt) specimen is considered a surrogate marker of resection quality. However, evidence was principally investigated in high-risk tumors. Therefore, DM sampling for low-grade (LG) urothelial carcinoma (UC) remains poorly investigated and certainly requires further investigation.

Objective: To assess whether the absence of DM in TURBt specimen has a negative impact on recurrence-free survival (RFS) in patients with a Ta LG UC.

Design, Setting, And Participants: A multicenter TURBt database was queried for "LG, Ta, UC of the bladder." All patients treated between 1996 and 2018 with tumor grade assessed according to both 1973 World Health Organization and 2004 WHO/International Society of Urological Pathology grading classifications and with a minimum follow-up of 1 yr were included. Patients with a previous history of high-grade UC, upper urinary tract UC, or bladder tumor differentiations other than UC were excluded.

Intervention: TURBt.

Outcome Measurements And Statistical Analysis: Baseline demographic, clinical, and pathologic data were analyzed. The European Organization for Research and Treatment of Cancer (EORTC) risk group was recorded. Kaplan-Meier analysis was performed to assess the predictive role of clinical and pathologic data for RFS. Univariable and multivariable Cox regression analyses were performed to identify the predictors of recurrence.

Results And Limitations: Overall, 521 patients were included. At Kaplan-Meier analysis, the low-risk cohort displayed significantly higher RFS than the intermediate-risk cohort (1-yr RFS 87% vs 79%; log-rank p = 0.007). At univariable Cox regression analysis, only gender, multiple tumors, tumor diameter ≥3 cm, and EORTC risk group were significant predictors of recurrence. Absence of DM had no impact on RFS. Multivariable Cox regression analysis confirmed gender and EORTC risk group as independent predictors of recurrence.

Conclusions: Absence of DM in TURBt specimen has negligible role in RFS of patients with Ta LG tumors of the bladder.

Patient Summary: In this study, we assessed the role that detrusor muscle (DM) in transurethral resection of bladder tumor specimen has in recurrence-free survival, in patients with a Ta low-grade urothelial carcinoma of the bladder. Absence of DM has no impact on tumor recurrence; therefore, it does not require additional attention.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.euf.2020.08.007DOI Listing
September 2020

Enzalutamide in patients with castration-resistant prostate cancer: retrospective, multicenter, real life study.

Minerva Urol Nefrol 2020 Aug 4. Epub 2020 Aug 4.

Department of Urology, ASL Abruzzo2, Chieti, Italy -

Background: Metastatic castration-resistant prostate cancer (mCRPC) is the final stage of pCa history and represents a clinically relevant phenotype with an elevated burden of mortality. The aim of the present study is to evaluate the efficacy and safety of enzalutamide in a "real-life" setting in mCRPC patients.

Methods: Data about all mCRPC patients treated with enzalutamide from September 2017 to September 2018 were collected. Demographics, comorbidities, clinical parameters, outcomes, toxicity, overall survival and progression free survival were analyzed.

Results: Overall 158 patients were enrolled. Mean age was 75.8 (±8.7) years with a baseline median PSA of 16.5 (IQR 7.4-47.8) ng/mL. The median follow-up lasted 7.7 (IQR 4-14.1) months. Of all the 10.1% of patients reported grade 3-4 adverse events. 43.7% of patients experienced a progression. Overall the 6 and 12 months PFS rates were 69.5% (95% CI: 61.7-78.3%) and the 45.6% (95% CI: 36.5-57.1%); a median baseline PSA >16 ng/mL (HR:2.0, 95% CI: 1.2-3.3, p=0.005), the use of opioid (HR:3.1, 95% CI 1.9-5.0, p<0.001), a previous treatment (abiraterone, docetaxel or abiraterone + docetaxel) were significantly associated with higher rates of cancer progression. Conversely, a brief pain questionnaire of 0-1 (HR: 0.4, 95% CI: 0.2-0.7, p<0.001), a 12 weeks 50% PSA reduction (HR: 0.4, 95% CI: 0.2-0.8, p=0.006) and a longer time to mCRPC (HR: 0.4, 95% CI: 0.3-0.7, p=0.002) were related to lower cancer progression rates.

Conclusions: Our data shows an effective and safe profile of enzalutamide in a "realworld" perspective in patients with mcRPC.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.23736/S0393-2249.20.03723-6DOI Listing
August 2020

Perioperative and 1-year patient-reported outcomes of Freyer versus Millin versus Madigan robot-assisted simple prostatectomy.

World J Urol 2020 Jul 29. Epub 2020 Jul 29.

Department of Urology, IRCCS "Regina Elena" National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Purpose: Robotic-assisted simple prostatectomy (RASP) is an established surgical procedure for the management of obstructive symptoms caused by large adenomas. Traditionally, this is performed according to the trans-vescical (Freyer) or trans-capsular (Millin) technique. We recently described a novel urethra-sparing (Madigan) robotic technique which showed promising preliminary results. In this study, we compared the above techniques for perioperative and 1-year patient-reported outcomes.

Methods: We retrospectively collected data from patients who underwent RASP across the three techniques, performed by two experienced surgeons in our center. We assessed patient self-reported pre-operative and post-operative functional outcomes with validated questionnaires: IPSS, IIEF short form, ICIQ short form, MSHQ Short Form. Continuous and categorical variables were compared between groups using the Mood's median test and the Chi-square tests, respectively.

Results: Millin, Madigan and Freyer procedures were performed in 23 (51%), 14 (31%) and 8 (18%) cases, respectively. No significant differences were observed for baseline ASA score, BMI, prostate volume, IPSS, IIEF, ICIQ and MSHQ scores (all p ≥ 0.2), as well as post-operative obstructive symptoms relief (IPSS: p = 0.25), continence (ICIQ: p = 0.54), complication rates (p = 0.32) and hospital stay (p = 0.23). Operative time was longer for Madigan procedures (p = 0.05). The 1-year MSHQ and IIEF scores were significantly higher in the Madigan cohort (p = 0.008 and p = 0.04, respectively).

Conclusion: RASP proved to be a safe surgical approach, providing an effective and durable relief of obstructive symptoms at mid-term follow-up regardless of the technique used. The Madigan technique provided significant benefits in terms of self-assessed quality of sexual function.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00345-020-03391-wDOI Listing
July 2020

Adjuvant chemotherapy is ineffective in patients with bladder cancer and variant histology treated with radical cystectomy with curative intent.

World J Urol 2020 Jul 25. Epub 2020 Jul 25.

Klinik für Urologie, Luzerner Kantonsspital, Lucerne, Switzerland.

Objectives: Adjuvant chemotherapy (ACT) is recommended for non-organ-confined bladder cancer (BCa) after radical cystectomy (RC) and pelvic lymph node dissection (PLND), but there are sparse data regarding its specific efficacy in patients with histological variants. The aim of our study was to evaluate the role of ACT on survival outcomes in patients with variant histology in a large multicenter cohort.

Materials And Methods: We retrospectively evaluated data of 3963 patients with BCa treated with RC and bilateral PLND with curative intent at several institutions between 1999 and 2018. The histological type was classified into six groups: pure urothelial carcinoma (PUC) or squamous, sarcomatoid, micropapillary, glandular and neuroendocrine differentiation. Multivariable competing risk analysis was applied to assess the role of ACT on recurrence and cancer-specific mortality (CSM) in each histological subtype.

Results: Of the 3963 patients included in the study, 23% had variant histology at RC specimen and 723 (18%) patients received ACT. ACT was found to be significantly associated with reduced risk of recurrence (sub-hazard ratio [SHR]: 0.55, confidence interval [CI] 0.42-0.71, p < 0.001) and CSM (SHR: 0.58, CI 0.44-0.78, p < 0.001) in the PUC only, while no histological subtype received a significant benefit on survival outcomes (all p > 0.05) from administration of ACT. The limitation of the study includes the retrospective design, the lack of a central pathology review and the number of ACT cycles.

Conclusion: In our study, the administration of ACT was associated with improved survival outcomes in PUC only. No histological subtype found a benefit in overall recurrence and CSM from ACT.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00345-020-03362-1DOI Listing
July 2020

Urinary expression of let-7c cluster as non-invasive tool to assess the risk of disease progression in patients with high grade non-muscle invasive bladder Cancer: a pilot study.

J Exp Clin Cancer Res 2020 Apr 17;39(1):68. Epub 2020 Apr 17.

Department of Research, Advanced Diagnostics and Technological Innovation, Genomic and Epigenetic Unit, Translational Research Area, IRCCS Regina Elena National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Background: High grade non-muscle-invasive bladder cancer (HG-NMIBC) is a heterogeneous disease with variable risk of progression. Urinary microRNAs are promising biomarkers for BC detection and surveillance. Let-7c-5p miRNA, clustered with miR-99a-5p and -125b-5p, is deregulated in cancer, including BC. The aim of this study is to evaluate urinary let-7c cluster expression in Ta/T1 HG-NMIBC patients and its impact on progression-free survival (PFS).

Methods: Quantitative Real-Time-Polymerase-Chain-Reaction (qRT-PCR) was used to analyze the let-7c cluster expression in 57 urine and 49 neoplastic paired tissue samples prospectively collected from transurethral resection (TUR) HG-NMIBC patients. Twenty urine and 10 bladder tissue samples were collected and analyzed as normal controls. QRT-PCR was also used to detect intra-/extra-cellular let-7c cluster in BC cells. Receiver Operating Characteristic (ROC) curves were used to identify urinary miRNAs cut-off values predicting T-stage and PFS. Uni/multivariable Cox regression was performed to identify predictors of PFS. A nomogram predicting progression risk and a decision curve analysis (DCA) were performed.

Results: Urinary let-7c was significantly up-regulated in patients compared with controls, while the whole cluster was down-regulated in tumor tissues. Supporting these findings, in vitro comparison of extra-/intra-cellular ratios of cluster levels between BC cells, showed a higher ratio for let-7c in HG-NMIBC versus low-grade cells. Urinary let-7c cluster expression was increased in higher T-stage and was an independent predictor of progression. Lower EORTC-score and downregulation of urinary cluster were predictors of higher PFS on univariable Cox regression, while on multivariable analysis only cluster expression was an independent progression predictor. On DCA, a benefit was evident for patients with a PFS probability > 20%.

Conclusions: Urinary let-7c cluster evaluation may improve prognosis, identifying patients at risk of progression and addressing early radical treatment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s13046-020-01550-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7164295PMC
April 2020

Comprehensive long-term assessment of outcomes following robot-assisted partial nephrectomy for renal cell carcinoma: the ROMe's achievement and its predicting nomogram.

Minerva Urol Nefrol 2020 Aug 16;72(4):482-489. Epub 2020 Apr 16.

Department of Urology, IRCCS "Regina Elena" National Cancer Institute, Rome, Italy.

Background: We proposed a new tool (named ROMe's) to summarize long-term outcomes after partial nephrectomy (PN), identified its predictors and generated a predicting nomogram.

Methods: A retrospective analysis of a multicenter dataset of patients with non-metastatic pT1-3a renal cell carcinoma was performed. Baseline demographic, clinical, pathologic and perioperative data were collected. ROMe's was defined as the concomitant lack of cancer-recurrences, death and newly onset Chronic Kidney Disease (CKD), at long term follow-up. Kaplan-Meier method investigated the predictive role of Trifecta on ROMe's achievement. Univariable and multivariable Cox regression analyses identified its predictors. A nomogram was generated and its accuracy was quantified using concordance index (CI). A calibration plot was obtained with 200 bootstraps resampling to explore nomogram performance at 5 years and decision curve analyses (DCA) assessed the net benefit of the model at 12, 36 and 60 months.

Results: We included 927 patients. The rates of ROMe's were 82%, 72% and 56% at 1, 3 and 5 years follow-up. At Kaplan-Meier analysis, patients who achieved Trifecta displayed a significantly higher probability of ROMe's (log rank P<0.001). Young age (OR=0.982; P=0.001), low RENAL score (OR=0.86; P=0.037), high preoperative filtration rate (OR=1.02; P<0.001) and Trifecta achievement (OR=2.03; P=0.015), were independent predictors of ROMe's. The nomogram showed a CI of 0.76 at 60 months. The 5-years calibration plot confirmed a good discrimination accuracy (0.74); on DCA, the net benefit of using the model was evident for probabilities >30%.

Conclusions: We conceived a triad to summarize the main long-term oncologic and functional outcomes after PN and generated a predicting nomogram.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.23736/S0393-2249.20.03813-8DOI Listing
August 2020

Impact of learning curve on perioperative outcomes of off-clamp minimally invasive partial nephrectomy: propensity score matched comparison of outcomes between training versus expert series.

Minerva Urol Nefrol 2020 Mar 16. Epub 2020 Mar 16.

"Regina Elena" National Cancer Institute, Roma, Italy.

Background: Off-Clamp Robotic partial nephrectomy (Off C-RPN) is a challenging technique, hard to teach since bleeding control is not easily reproducible in training settings. We compared preoperative outcomes of two propensity score matched (PSM) cohorts of patients undergone Off C-RPN by either a training or an expert surgeon in the same Institution.

Methods: The prospectively maintained "renal cancer" database was queried for "off-clamp", "robotic", "partial nephrectomy" performed between January 2017 and June 2018. Achievement of main outcomes along the learning curve of training surgeon was assessed with logistic regression and Lowess analysis. A 1:1 PSM analysis generated two populations homogeneous for demographics, ASA score, tumor size, nephrometry score, baseline hemoglobin and estimated glomerular filtration rate (eGFR). Multiple tumors, and imperative indications were excluded. Categorical and continuous variables were compared by Chi square and t test.

Results: Overall, 111 were treated by the expert, 51 by the training surgeon, respectively. Training surgeon experienced a significant decrease of console time (p=0.01). Patients treated by the expert surgeon had significantly larger tumors, higher PADUA and ASA scores (all p≤0.04). After applying the PSM, two cohorts of 29 patients, homogeneous for all baseline demographic and clinical variables (all p≥0.34) were selected. Hilar clamping was never necessary. Hospital stay, hemoglobin and eGFR at discharge, complication and positive surgical margins rates were comparable between the two cohorts (all p≥0.15).

Conclusions: Our results proved that the impact of learning curve on outcomes of Off C-RPN is negligible after completion of a proper training in minimally invasive surgery.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.23736/S0393-2249.20.03673-5DOI Listing
March 2020

Sex-Sparing Robot-Assisted Radical Cystectomy with Intracorporeal Padua Ileal Neobladder in Female: Surgical Technique, Perioperative, Oncologic and Functional Outcomes.

J Clin Med 2020 Feb 20;9(2). Epub 2020 Feb 20.

"Regina Elena" National Cancer Institute, Department of Urology, 00100 Rome, Italy.

Our aim was to illustrate our technique of sex-sparing (SS)-robot-assisted radical cystectomy (RARC) in female patients receiving an intracorporeal neobladder (iN). From January 2013 to June 2018, 11 female patients underwent SS-RARC-iN at a single tertiary referral center. Inclusion criteria were a cT ≤ 2 N0 M0 bladder tumor at baseline imaging (CT or MRI) and an absence of tumors in the bladder neck, trigone and urethra at TURB. Baseline, perioperative, and outcomes at one year were reported. The median operative time was 255 min and the median hospital stay was seven days. Low-grade Clavien complications occurred in four patients (36.3%), while high-grade complications were not observed in any. Seven patients (63.7%) had an organ-confined disease at the pathologic specimen; nodal involvement and positive surgical margins were not detected in any of the cases. At a median follow-up of 28 months (IQR 14-51), no patients developed new onset of chronic kidney disease stage 3b. After one year, daytime and nighttime continence rates were 90.9% and 86.4% respectively. Quality of life as well as physical and emotional functioning improved significantly over time (all ≤ 0.04), while urinary symptoms and sexual function worsened at three months with a significant recovery taking place at one year (all ≤ 0.04). Overall, 8 out of 11 patients (72.7%) were sexually active at the 12-month evaluation. In select female patients, SS-RARC-iN is an oncologically sound procedure associated with favorable perioperative and functional outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.3390/jcm9020577DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7073846PMC
February 2020

Surgical quality, cancer control and functional preservation: introducing a novel trifecta for robot-assisted partial nephrectomy.

Minerva Urol Nefrol 2020 Feb 12;72(1):82-90. Epub 2019 Dec 12.

Department of Urology, Regina Elena National Cancer Institute, Rome, Italy.

Background: In order to improve standard reporting of outcomes after partial nephrectomy, different "trifecta" systems have been conceived. The subjective assessment of the included parameters and the unreliability for off-clamp procedures limited their reproducibility; their role in predicting functional and oncologic outcomes has never been assessed. We propose a new trifecta, based on standardized parameters, that summarizes PN outcomes regardless the clamping technique used and predicts main clinical outcomes.

Methods: A retrospective analysis of a multicenter, multi-national dataset of patients with non-metastatic cT1-2 renal masses undergoing Robot-assisted partial nephrectomy was performed. Baseline demographic, clinical, pathologic and perioperative data were collected. Trifecta was defined as the coexistence of negative margins, no Clavien-Dindo ≥3 complications and ≤30% postoperative estimated glomerular filtration rate reduction. Univariable and multivariable regression analyses identified predictors of trifecta achievement. Kaplan-Meier method assessed differences in oncological outcomes between patients achieving trifecta or not. Univariable and multivariable Cox regression analysis identified predictors of newly onset chronic kidney disease stage ≥IIIa, recurrence-free and overall survival.

Results: Overall, 1492 patients achieved trifecta. This cohort displayed significantly lower incidence of newly onset IIIa-V chronic kidney disease stages (all P<0.001), higher recurrence-free (P=0.009) and overall (P=0.014) survival probabilities. Patients achieving trifecta had a 65% reduced risk of developing newly onset stage IIIb-V Chronic Kidney Disease and a 55% reduced risk of overall mortality. Heterogeneity of surgical technique is a limitation.

Conclusions: This novel reproducible trifecta is based on standardized parameters and is an independent predictor of severe chronic kidney disease development and mortality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.23736/S0393-2249.19.03570-7DOI Listing
February 2020

Combined reporting of surgical quality, cancer control and functional outcomes of robot-assisted radical cystectomy with intracorporeal orthotopic neobladder into a novel trifecta.

Minerva Urol Nefrol 2019 Dec 10;71(6):590-596. Epub 2019 Oct 10.

Department of Urology, Regina Elena National Cancer Institute, Rome, Italy.

Background: To optimize outcomes reporting after robot-assisted radical cystectomy (RARC) with intracorporeal orthotopic neobladder (iON), we propose a novel trifecta, aimed to overcome the available pentafectas that neglect functional outcomes.

Methods: A retrospective analysis of prospectively maintained RARC-iON dataset was performed. Baseline demographic, clinical, pathologic, perioperative and follow-up data were collected. Trifecta was defined as the coexistence of daytime urinary continence, Clavien-Dindo ≥3 complication-free and recurrence-free status, all assessed at 1 year. Kaplan-Meier method assessed the role of trifecta achievement in predicting overall survival (OS) probabilities. Univariable and multivariable regression analyses identified predictors of trifecta achievement. The predictive accuracy of trifecta and other pentafectas on 3-year OS probability was plotted with receiver operating characteristic (ROC) analyses.

Results: The trifecta rate was 53% while 62% and 47% of patients achieved the University of Southern California (USC-P) and PROMETRICS group (PROM-P) pentafectas, respectively. On tertile analysis, both trifecta (P=0.011) and USC-P (P=0.043) rates significantly increased with surgical experience, while PROM-P did not (P=0.204). On ROC analysis, trifecta was the only significant predictor of 3-year OS probability (AUC=0.69, 95% CI:0.55-0.82; P=0.018). On Kaplan-Meier analysis, patients achieving trifecta displayed significantly higher OS probability (P=0.032); adjusted for covariates, each incremental case was associated with a 2% increased probability (OR: 1.02) of achieving trifecta on multivariable regression model.

Conclusions: Learning curve in RARC-iON has a significant impact on achievement of trifecta. This tool combines accurate measurement of surgical proficiency with an independent predictive value in assessing 3-year OS probabilities.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.23736/S0393-2249.19.03566-5DOI Listing
December 2019

Managing lines of therapy in castration-resistant prostate cancer: real-life snapshot from a multicenter cohort.

World J Urol 2020 Jul 12;38(7):1757-1764. Epub 2019 Oct 12.

Department of Urology, "Regina Elena" National Cancer Institute of Rome, Via Elio Chianesi 53, 00154, Rome, Italy.

Purpose: To provide a snapshot of toxicities and oncologic outcomes of Abiraterone (AA) and Enzalutamide (EZ) in a chemo-naïve metastatic castration-resistant prostate cancer (mCPRC) population from a longitudinal real-life multicenter cohort.

Methods: We prospectively collected data on chemo-naïve mCRPC patients treated with AA or EZ. Primary outcomes were PSA response, oncologic outcomes and toxicity profile. The Kaplan-Meier method was used to compare differences in terms of progression-free survival (PFS) between AA vs EZ and high- vs low-volume disease cohorts. Univariable and multivariable Cox regression analyses were performed to identify predictors of PFS. Toxicity, PSA response rates and oncologic outcomes on second line were compared with those observed on first line.

Results: Out of 137 patients, 88 received AA, and 49 EZ. On first line, patients receiving EZ had significantly higher PSA response compared with AA (95.9% vs 67%, p < 0.001), comparable toxicity rate (10.2% vs 16.3%, p = 0.437) and PFS probabilities (p = 0.145). Baseline PSA and high-volume disease were predictors of lower PFS probabilities at univariable analysis (p = 0.027 and p = 0.007, respectively). Overall, 28 patients shifted to a second-line therapy (EZ or radiometabolic therapy). Toxicity and PSA response rates on second line were comparable to those observed on first line (11.1% vs 12.4%, p = 0.77; 73.1% vs 77.4%, p = 0.62, respectively); 2-year PFS, cancer-specific and overall survival probabilities were comparable to those displayed in first-line cohort (12.1% vs 16.2%, p = 0.07; 85.7% vs 86.4%, p = 0.98; 71% vs 80.3%, p = 0.66, respectively).

Conclusions: Toxicity profile, PSA response rate and oncological outcomes were comparable between first-line and second-line courses in patients treated with either AA or EZ for mCRPC. Our findings showed the tolerability and oncological effectiveness, when feasible, of two lines of therapy other than chemotherapy.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00345-019-02974-6DOI Listing
July 2020

Transnephrostomic Indocyanine Green-Guided Robotic Ureteral Reimplantation for Benign Ureteroileal Strictures After Robotic Cystectomy and Intracorporeal Neobladder: Step-By-Step Surgical Technique, Perioperative and Functional Outcomes.

J Endourol 2019 10 26;33(10):823-828. Epub 2019 Sep 26.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

To describe our surgical technique of robotic ureteroileal reimplantation (RUIR) for ureteroileal anastomosis strictures with the use of near-infrared fluorescence imaging (NIFI) after transnephrostomic antegrade injection of indocyanine green in patients previously treated with robot-assisted radical cystectomy and intracorporeal orthotopic neobladder. From March 2015 to December 2017, 10 consecutive patients underwent RUIR in our tertiary referral center. All patients previously underwent percutaneous nephrostomy and at least one antegrade stenting and stricture dilatation attempt. Clinical data were prospectively collected into our institutional dataset. Both perioperative and functional outcomes were assessed. Median time from robotic cystectomy to ureteroileal anastomosis strictures diagnosis was 5 months (interquartile range [IQR] 2-6). Median stricture length was 1.5 cm (IQR 1-2). Median operative time was 140 minutes (IQR 81-155), and median length of stay was 5 days (IQR 3-9). Two patients experienced Clavien grade 2 complications (urinary tract infection requiring antibiotics and blood transfusion, respectively). One patient underwent ileum resection and anastomosis due to bowel perforation (Clavien IIIb). At a median follow-up of 19 months (IQR 14-39), one patient developed a stricture recurrence. No patient developed worsening of renal function (newly onset chronic kidney disease stage 3b-4). Robotic reimplantation for ureteroileal anastomosis strictures is a safe and highly effective procedure, with a high success rate and excellent perioperative and functional outcomes. NIFI provides an easy guide to identify and progressively dissect the ureter.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1089/end.2019.0376DOI Listing
October 2019

On-clamp versus off-clamp partial nephrectomy: Propensity score-matched comparison of long-term functional outcomes.

Int J Urol 2019 10 24;26(10):985-991. Epub 2019 Jul 24.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Objectives: To compare long-term functional outcomes of off-clamp or on-clamp partial nephrectomy patients of two high-volume centers with cT1-2/N0 M0 renal tumors and baseline estimated glomerular filtration rate >60 mL/min.

Methods: A 3:1 propensity score-matched analysis was used to select two homogeneous cohorts to compare off-clamp versus on-clamp partial nephrectomy. Joinpoint regression analysis was used to compare the 2-8-year probabilities of estimated glomerular filtration rate modifications in both selected cohorts. The Kaplan-Meier method assessed the risk of developing a stage ≥3b chronic kidney disease during follow up. Multivariable analyses aimed to identify predictors of renal function deterioration. Perioperative complications and oncological outcomes were compared.

Results: Overall, 1073 patients were included (588 on-clamp and 485 off-clamp). After applying the propensity score-matched analysis, the two cohorts of 157 on-clamp and 472 off-clamp patients did not differ for all covariates, except for warm ischemia time and last estimated glomerular filtration rate. At joinpoint analysis, the off-clamp group showed higher probabilities of maintaining an unmodified estimated glomerular filtration rate (P = 0.02). The probability of developing a stage ≥3b chronic kidney disease was significantly higher (P < 0.001) in the on-clamp cohort. At multivariable analysis, estimated glomerular filtration rate at discharge and off-clamp approach were independent predictors of improved functional outcomes. Perioperative complications were comparable among the two cohorts (P = 0.67). There were not any statistically significant differences in terms of cancer-specific survival (P = 0.26) and overall survival (P = 0.18).

Conclusions: Off-clamp partial nephrectomy seems to offer a higher probability of maintaining 100% estimated glomerular filtration rate after surgery. In our cohort, patients undergoing on-clamp partial nephrectomy presented a 7.3-fold increased risk of developing a severe chronic kidney disease during follow up.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/iju.14079DOI Listing
October 2019

Long-term oncologic outcomes of robot-assisted radical cystectomy (RARC) with totally intracorporeal urinary diversion (ICUD): a multi-center study.

World J Urol 2020 Apr 12;38(4):837-843. Epub 2019 Jun 12.

Department of Urology, IRCCS "Regina Elena" National Cancer Institute, Rome, Italy.

Purpose: To report survival outcomes after robot-assisted radical cystectomy (RARC) with intracorporeal urinary diversion (ICUD) for recurrent/muscle-invasive non-metastatic bladder cancer.

Methods: Prospectively maintained databases were queried for "robotic cystectomy AND ICUD". Patients treated after October 2013 and those treated without curative intent were excluded. Kaplan-Meier method was used to plot stage-specific survival outcomes, computed at 1, 2, and 5 years after surgery. Univariable and multivariable Cox analyses assessed predictors of recurrence-free (RFS), cancer-specific (CSS) and overall (OS) survival.

Results: 113 consecutive patients were included, mostly men (82%). Neoadjuvant chemotherapy was performed in 23% of cases, median lymph node (LN) yield was 36 (IQR 28-45) and the rate of positive surgical margins (PSM) was 8%. Orthotopic ileal neobladder was the preferred ICUD type (57%). An organ-confined disease was observed in 51% of cases and 21% were pT0 on final histology. Overall, 5-year RFS, CSS and OS probabilities were 58 ± 5%, 61 ± 5% and 54 ± 5%, respectively. At Kaplan-Meier method, tumor stage group was a significant predictor of survival probabilities (all p < 0.001) and this was confirmed at multivariable Cox regression analysis (RFS-OR 2.29; 95% CI 1.58-3.32; p < 0.001) (CSS-OR 1.82; 95% CI 1.3-2.53; p < 0.001) (OS-OR 2.14; 95% CI 1.46-3.14; p < 0.001). PSM status was associated to CSS (OR 2.54; 95% CI 1.13-5.69; p = 0.024) and OS (OR 2.82; 95% CI 1.17-6.77; p = 0.021), but did not predict RFS (p = 0.062).

Conclusions: Long-term oncologic outcomes after RARC with ICUD appear similar to recent robotic series with extracorporeal diversion and historical open experiences.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00345-019-02842-3DOI Listing
April 2020

Urethra and Ejaculation Preserving Robot-assisted Simple Prostatectomy: Near-infrared Fluorescence Imaging-guided Madigan Technique.

Eur Urol 2019 03 12;75(3):492-497. Epub 2018 Dec 12.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Background: With the increasing adoption of novel technologies and anatomical techniques, surgical management of benign prostatic hyperplasia (BPH) provides significant benefits in terms of obstruction relief, early urethral catheter removal, and faster return to daily activities. However, the main pitfall of BPH surgery in sexually active men remains ejaculatory dysfunction (EjD), which permanently affects quality of life.

Objective: To detail a novel technique for marking the intraprostatic urethra through a retrograde injection of indocyanine green to enhance selective dissection of prostatic lobes during urethra-sparing robot-assisted simple prostatectomy (US-RASP) with the use of near-infrared fluorescence imaging (NIFI).

Design, Setting, And Participants: Between January and September 2017, 12 consecutive male patients, who had BPH, were sexually active, and were motivated to preserve ejaculatory function, underwent US-RASP.

Surgical Procedure: US-RASP with NIFI to enhance the identification and preservation of the prostatic urethra.

Measurements: Clinical data were prospectively collected in our institutional RASP dataset. Perioperative and functional outcomes of US-RASP were both graded, and assessed according to Clavien grading system and validated questionnaires postoperatively (International Prostate Symptom Score [IPSS]; Male Sexual Health Questionnaire on EjD [MSHQ-EjD] Short Form) at 3 and 12mo.

Results And Limitations: Median preoperative prostate size was 102cc (interquartile range [IQR] 88-115). Median operative time was 150min (IQR 145-170). Median estimated blood loss was 250 (IQR 200-350). Continuous bladder irrigation was avoided in 83.4% of patients. Median time to catheter removal was 7d (IQR 7-7) with a median hospital stay of 3d (IQR 2-3). At 1-yr follow-up, median IPSS score, International Index of Erectile Function score, and MSHQ-EjD Short Form score were 5 (IQR 4-8), 26 (IQR 26-28), and 12 (IQR 1-14), respectively. Satisfactory anterograde ejaculation was reported in eight patients (66%).

Conclusions: We described a novel NIFI-guided technique to perform US-RASP. This technique showed promising early functional results, suggesting a significant role of intraprostatic urethral integrity for the preservation of ejaculatory function.

Patient Summary: We developed a novel robotic technique to perform simple prostatectomy with integral preservation of the prostatic urethra. This technique provided a high rate of ejaculatory function preservation.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.eururo.2018.11.051DOI Listing
March 2019

"Ride the Green Light": Indocyanine Green-marked Off-clamp Robotic Partial Nephrectomy for Totally Endophytic Renal Masses.

Eur Urol 2019 06 24;75(6):1008-1014. Epub 2018 Sep 24.

Department of Urology, IRCCS "Regina Elena" National Cancer Institute, Rome, Italy.

Background: Complexity of robot-assisted partial nephrectomy (RAPN) mostly depends on tumor size and location. Totally endophytic renal masses represent a surgical challenge in terms of both intraoperative identification and anatomical dissection.

Objective: To detail a novel technique for marking preoperatively endophytic renal tumors with transarterial superselective intrarenal mass delivery of indocyanine green (ICG)-lipiodol mixture, in order to enhance surgical margins control during purely off-clamp (OC) RAPN with the use of near-infrared fluorescence imaging.

Design, Setting, And Participants: Between June and July 2017, 10 consecutive patients with totally endophytic renal masses underwent preoperative ICG tumor marking immediately followed by RAPN.

Surgical Procedure: Preoperative superselective transarterial delivery of a lipiodol-ICG mixture (1:2 volume ratio) into tertiary-order arterial branches feeding the renal mass prior to transperitoneal OC-RAPN.

Measurements: Clinical data were prospectively collected in our institutional RAPN dataset. Perioperative, pathological, and functional outcomes of RAPN were assessed.

Results And Limitations: Median tumor size was 3cm (interquartile range 2.3-3.8). The median PADUA score was 10 (9-11). Angiographic procedure was successful in all patients. Median operative time was 75min (65-85); median estimated blood loss was 250ml (200-350). No conversion to on-clamp PN or radical nephrectomy was needed. All patients had uneventful perioperative course; median hospital stay was 3 d (2-3). At discharge, median hemoglobin (Hgb) and percent estimated glomerular filtration rate (eGFR) drop were 3.3g/dl (2.1-3.3) and 11% (10-20%), respectively. Surgical margins were negative in all cases. One-year median ipsilateral renal volume and 1-yr eGFR percent decreases were 11.7% (6-20.9%) and 12.2% (5.3-13.7%), respectively.

Conclusions: We described a novel technique to simplify challenging RAPN based on ICG superselective transarterial tumor marking. Key benefits include quick intraoperative identification of the mass with improved visualization and real-time control of resection margins.

Patient Summary: Robot-assisted partial nephrectomy (RAPN) for totally endophytic renal masses is a technically demanding surgical procedure, sometimes requiring radical nephrectomy. This novel technique significantly simplified surgical complexity in our Institution. Further studies with larger cohorts are warranted to confirm whether this technique provides relevant intraoperative and functional advantages.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.eururo.2018.09.015DOI Listing
June 2019

Accuracy of elastic fusion biopsy in daily practice: Results of a multicenter study of 2115 patients.

Int J Urol 2018 12 5;25(12):990-997. Epub 2018 Sep 5.

Department of Surgical Sciences - Urology, University of Turin, Turin, Italy.

Objectives: To assess the accuracy of Koelis fusion biopsy for the detection of prostate cancer and clinically significant prostate cancer in the everyday practice.

Methods: We retrospectively enrolled 2115 patients from 15 institutions in four European countries undergoing transrectal Koelis fusion biopsy from 2010 to 2017. A variable number of target (usually 2-4) and random cores (usually 10-14) were carried out, depending on the clinical case and institution habits. The overall and clinically significant prostate cancer detection rates were assessed, evaluating the diagnostic role of additional random biopsies. The cancer detection rate was correlated to multiparametric magnetic resonance imaging features and clinical variables.

Results: The mean number of targeted and random cores taken were 3.9 (standard deviation 2.1) and 10.5 (standard deviation 5.0), respectively. The cancer detection rate of Koelis biopsies was 58% for all cancers and 43% for clinically significant prostate cancer. The performance of additional, random cores improved the cancer detection rate of 13% for all cancers (P < 0.001) and 9% for clinically significant prostate cancer (P < 0.001). Prostate cancer was detected in 31%, 66% and 89% of patients with lesions scored as Prostate Imaging Reporting and Data System 3, 4 and 5, respectively. Clinical stage and Prostate Imaging Reporting and Data System score were predictors of prostate cancer detection in multivariate analyses. Prostate-specific antigen was associated with prostate cancer detection only for clinically significant prostate cancer.

Conclusions: Koelis fusion biopsy offers a good cancer detection rate, which is increased in patients with a high Prostate Imaging Reporting and Data System score and clinical stage. The performance of additional, random cores seems unavoidable for correct sampling. In our experience, the Prostate Imaging Reporting and Data System score and clinical stage are predictors of prostate cancer and clinically significant prostate cancer detection; prostate-specific antigen is associated only with clinically significant prostate cancer detection, and a higher number of biopsy cores are not associated with a higher cancer detection rate.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/iju.13796DOI Listing
December 2018

Robot-assisted Partial Adrenalectomy for the Treatment of Conn's Syndrome: Surgical Technique, and Perioperative and Functional Outcomes.

Eur Urol 2019 05 1;75(5):811-816. Epub 2018 Aug 1.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Background: In the era of minimally invasive surgery, partial adrenalectomy has certainly been underused. We aimed to report surgical technique and perioperative, pathologic, and early functional outcomes of a two-center robot-assisted partial adrenalectomy (RAPA) series.

Objective: To detail surgical technique of RAPA for unilateral aldosterone-producing adenoma (UAPA), and to report perioperative and 1-yr functional outcomes.

Design, Setting, And Participants: Data of 10 consecutive patients who underwent RAPA for UAPA at two centers from June 2014 to April 2017 were prospectively collected and reported.

Surgical Procedure: RAPA was performed using a standardized technique with the da Vinci Si in a three-arm configuration.

Measurements: Baseline and perioperative data were reported. One-year functional outcomes were assessed according to primary aldosteronism surgery outcome guidelines. A descriptive statistical analysis was performed.

Results And Limitations: All cases were completed robotically. Median nodule size was 18mm (interquartile range [IQR] 16-20). Intraoperative blood loss was negligible. A single (10%) postoperative Clavien grade 2 complication occurred. Median hospital stay was 3 d (IQR 2-3). Patients became normotensive immediately after surgery (median pre- and postoperative blood pressure: 150/90 and 120/70mmHg, respectively). At both 3-mo and 1-yr functional evaluation, all patients achieved biochemical success (aldosterone level, plasmatic renin activity, and aldosterone-renin ratio within normal range). Complete clinical success was achieved in nine patients, but one required low-dose amlodipine at 6-mo evaluation. At a median follow-up of 30.5 mo (IQR 19-42), neither symptoms nor imaging recurrence was observed.

Conclusions: We demonstrated feasibility and safety of RAPA for UAPA; this technique had very low risk of complications and excellent functional results. Increased availability of robotic platform and increasing robotic skills among urologists make RAPA a treatment option with potential for widespread use in urologic community.

Patient Summary: Robot-assisted partial adrenalectomy is a safe, feasible, and minimally invasive surgical approach. Promising perioperative and functional outcomes suggest an increasing adoption of this technique in the near future.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.eururo.2018.07.030DOI Listing
May 2019

Perioperative and mid-term oncologic outcomes of robotic assisted radical cystectomy with totally intracorporeal neobladder: Results of a propensity score matched comparison with open cohort from a single-centre series.

Eur J Surg Oncol 2018 09 17;44(9):1432-1438. Epub 2018 Apr 17.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Aim: In this study, we compared perioperative and oncologic outcomes of patients treated with either open or robot-assisted radical cystectomy and intracorporeal neobladder at a tertiary care center.

Methods: The institutional prospective bladder cancer database was queried for "cystectomy with curative intent" and "neobladder". All patients underwent robot-assisted radical cystectomy and intracorporeal neobladder or open radical cystectomy and orthotopic neobladder for high-grade non-muscle invasive bladder cancer or muscle invasive bladder cancer with a follow-up length ≥2 years were included. A 1:1 propensity score matching analysis was used. Kaplan-Meier method was performed to compare oncologic outcomes of selected cohorts. Survival rates were computed at 1,2,3 and 4 years after surgery and the log rank test was applied to assess statistical significance between the matched groups.

Results: Overall, 363 patients (299 open and 64 robotic) were included. Open radical cystectomy patients were more frequently male (p = 0.08), with higher pT stages (p = 0.003), lower incidence of urothelial histologies (p = 0.05) and lesser adoption of neoadjuvant chemotherapy (<0.001). After applying the propensity score matching, 64 robot-assisted radical cystectomy patients were matched with 46 open radical cystectomy cases (all p ≥ 0.22). Open cohort showed a higher rate of perioperative overall complications (91.3% vs 42.2%, p 0.001). At Kaplan-Meier analysis robotic and open cohorts displayed comparable disease-free survival (log-rank p = 0.746), cancer-specific survival (p = 0.753) and overall-survival rates (p = 0.909).

Conclusions: Robot-assisted radical cystectomy and intracorporeal neobladder provides comparable oncologic outcomes of open radical cystectomy and orthotopic neobladder at intermediate term survival analysis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejso.2018.04.006DOI Listing
September 2018

Purely off-clamp robotic partial nephrectomy: Preliminary 3-year oncological and functional outcomes.

Int J Urol 2018 06 16;25(6):606-614. Epub 2018 Apr 16.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Objectives: To describe our surgical technique and to report perioperative, 3-year oncological and functional outcomes of a single-center series of purely off-clamp robotic partial nephrectomy.

Methods: A prospective renal cancer institutional database was queried, and data of consecutive patients treated with purely off-clamp robotic partial nephrectomy between 2010 and 2015 in a high-volume center were collected. Perioperative complications, and 3-year oncological and functional outcomes were assessed. Univariable and multivariable analyses were carried out to identify independent predictors of renal function deterioration.

Results: Out of 308 patients treated, 41 (13.3%) experienced perioperative complications, 2.9% of which were Clavien grade ≥3. The 3-year local recurrence-free survival and renal cell carcinoma-specific survival rates were 99.5% and 97.9%, respectively. No patient with preoperative chronic kidney disease stage ≤3B developed severe renal function deterioration (chronic kidney disease stage 4) at 1-year follow up. At multivariable analysis, preoperative estimated glomerular filtration rate (P = 0.005) was the only independent predictor of a new-onset chronic kidney disease stage ≥3 in patients with preoperative chronic kidney disease stages 1 or 2.

Conclusions: Off-clamp robotic partial nephrectomy is a safe surgical approach in tertiary referral centers, with adequate oncological outcomes and negligible impact on renal function.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/iju.13580DOI Listing
June 2018

Editorial Comment.

Urology 2017 09 3;107:237-238. Epub 2017 Jul 3.

"Regina Elena" National Cancer Institute, Department of Urology, Rome, Italy.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.urology.2017.03.067DOI Listing
September 2017

Robotic Intracorporeal Continent Cutaneous Diversion.

J Urol 2017 08 21;198(2):436-444. Epub 2017 Mar 21.

Section of Robotic Surgery, University of Southern California Institute of Urology, Catherine and Joseph Aresty Department of Urology, University of Southern California, Los Angeles, California; Department of Urology, Regina Elena National Cancer Institute (GS, MF, SG, FM, MG), Rome, Italy.

Purpose: Robotic intracorporeal urinary diversion has mostly been done for ileal conduit or orthotopic neobladder diversion. We present what is to our knowledge the initial series, detailed technique and outcomes of the robotic intracorporeal Indiana pouch with a minimum 1-year followup.

Materials And Methods: Ten patients underwent robotic radical cystectomy, pelvic lymphadenectomy and intracorporeal Indiana pouch urinary diversion for cancer in 9 and benign disease in 1. Data were collected prospectively. Baseline demographics, pathology data, and 1-year complication rates and functional outcomes were assessed.

Results: All 10 cases were successfully completed intracorporeally without open conversion. Median total operative time was 6 hours, including 3.5 hours for pouch creation. Median blood loss was 200 cc and median hospital stay was 10 days. Four Clavien grade 1-2 and 3 Clavien 3-5 complications occurred. None of the patients had a bowel leak. One noncompliant patient requested undiversion to an ileal conduit. The remaining 9 patients successfully catheterized the ileal channel and were completely continent at the last followup at a median of 13.7 months (range 12.3 to 15.2). Study limitations include small sample size and short followup.

Conclusions: We present what is to our knowledge the initial series of robotic completely intracorporeal Indiana pouch diversion. Early perioperative data indicate acceptable operative efficiency and complication rates. Longer followup is required to assess the functional outcomes of this less commonly performed diversion.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.juro.2017.01.091DOI Listing
August 2017

Robotic Intracorporeal Padua Ileal Bladder: Surgical Technique, Perioperative, Oncologic and Functional Outcomes.

Eur Urol 2018 06 22;73(6):934-940. Epub 2016 Oct 22.

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

Background: Robot-assisted radical cystectomy (RARC) with intracorporeal neobladder reconstruction is a challenging procedure. The need for surgical skills and the long operative times have led to concern about its reproducibility.

Objective: To illustrate our technique for RARC and totally intracorporeal orthotopic Padua ileal bladder.

Design, Setting, And Participants: From August 2012 to February 2014, 45 patients underwent this technique at a single tertiary referral centre.

Surgical Procedure: RARC, extended pelvic lymph node dissection, and intracorporeal partly stapled neobladder. Surgical steps are demonstrated in the accompanying video.

Measurements: Demographics, clinical, and pathological data were collected. Perioperative, 2-yr oncologic and 2-yr functional outcomes were reported.

Results And Limitations: Intraoperative transfusion or conversion to open surgery was not necessary in any case and intracorporeal neobladder was successfully performed in all 45 patients. Median operative time was 305min (interquartile range [IQR]: 282-345). Median estimated blood loss was 210ml (IQR: 50-250). Median hospital stay was 9 d (IQR: 7-12). The overall incidence of perioperative, 30-d and 180-d complications were 44.4%, 57.8%, and 77.8%, respectively, while severe complications occurred in17.8%, 17.8%, and 35.5%, respectively. Two-yr daytime and night-time continence rates were 73.3% and 55.5%, respectively. Two-yr disease free survival, cancer specific survival, and overall survival rates were 72.5%, 82.3%, and 82.4%, respectively. The small sample size and high caseload of the centre might affect the reproducibility of these results.

Conclusions: Our experience supports the feasibility of totally intracorporeal neobladder following RARC. Operative times and perioperative complication rates are likely to be reduced with increasing experience.

Patient Summary: We report the outcomes of our first 45 consecutive patients who underwent robot-assisted radical cystectomy with intracorporeal neobladders. Perioperative, oncologic, and functional outcomes support this technique as a feasible and safe surgical option in tertiary referral centres.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.eururo.2016.10.018DOI Listing
June 2018

Robot-assisted Level II-III Inferior Vena Cava Tumor Thrombectomy: Step-by-Step Technique and 1-Year Outcomes.

Eur Urol 2017 08 20;72(2):267-274. Epub 2016 Sep 20.

USC Institute of Urology, Departments of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA. Electronic address:

Background: Level II-III inferior vena cava (IVC) tumor thrombectomy for renal cell carcinoma is among the most challenging urologic oncologic surgeries. In 2015, we reported the initial series of robot-assisted level III caval thrombectomy.

Objective: To describe our University of Southern California technique in a step-by-step fashion for robot-assisted IVC level II-III tumor thrombectomy.

Design, Setting, And Participants: Twenty-five selected patients with renal neoplasm and level II-III IVC tumor thrombus underwent robot-assisted surgery with a minimum 1-yr follow-up (July 2011 to March 2015).

Surgical Procedure: Our standardized anatomic-based "IVC-first, kidney-last" technique for robot-assisted IVC thrombectomy focuses on minimizing the chances of an intraoperative tumor thromboembolism and major hemorrhage.

Outcome Measurements And Statistical Analysis: Baseline demographics, pathology data, 90-d and 1-yr complications, and oncologic outcomes at last follow-up were assessed.

Results And Limitations: Robot-assisted IVC thrombectomy was successful in 24 patients (96%) (level III: n=11; level II: n=13); one patient was electively converted to open surgery for failure to progress. Median data included operative time of 4.5h, estimated blood loss was 240ml, hospital stay 4 d; five patients (21%) received intraoperative blood transfusion. All surgical margins were negative. Complications occurred in four patients (17%): two were Clavien 2, one was Clavien 3a, and one was Clavien 3b. All patients were alive at a 16-mo median follow-up (range: 12-39 mo).

Conclusions: Robotic IVC tumor thrombectomy is feasible for level II-III thrombi. To maximize intraoperative safety and chances of success, a thorough understanding of applied anatomy and altered vascular collateral flow channels, careful patient selection, meticulous cross-sectional imaging, and a highly experienced robotic team are essential.

Patient Summary: We present the detailed operative steps of a new minimally invasive robot-assisted surgical approach to treat patients with advanced kidney cancer. This type of surgery can be performed safely with low blood loss and excellent outcomes. Even patients with advanced kidney cancer could now benefit from robotic surgery with a quicker recovery.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.eururo.2016.08.066DOI Listing
August 2017

Oncological outcomes of minimally invasive partial versus minimally invasive radical nephrectomy for cT1-2/N0/M0 clear cell renal cell carcinoma: a propensity score-matched analysis.

World J Urol 2017 May 30;35(5):789-794. Epub 2016 Aug 30.

Department of Urology, "Regina Elena" National Cancer Institute, Via Elio Chianesi 53, 00144, Rome, Italy.

Purpose: To compare the oncologic outcomes of partial nephrectomy (PN) and radical nephrectomy (RN) for cT1-2/N0 renal tumors and pathologically confirmed pT1-pT3a-pNx clear cell (cc)-renal cell carcinoma (RCC). Few studies compared the oncologic outcomes of PN and RN for renal tumors >7 cm.

Methods: A prospective "renal cancer" database was queried for cT<3-cN0-cM0 and pT1a-pT3a-pNx cc-RCC. Out of 1650 cases treated between 2001 and 2013, 921 were cc-RCC and 666 met inclusion criteria, 232 of which treated with minimally invasive RN and 434 with MIPN. A 1:1 propensity score-matched (PSM) analysis was employed to minimize the selection bias of non-random assignment of patients to PN as opposed to RN. Kaplan-Meier method was used to compare the oncologic outcomes of the PSM cohorts. Survival rates were computed at 2, 5, and 10 years after surgery, and the log-rank test was applied to assess statistical significance between the two PSM groups.

Results: RN tumors were significantly larger (p < 0.001), with higher pT stages (p < 0.001), higher Fuhrman grades (p = 0.002) and a more frequent sarcomatoid differentiation (p = 0.04). After applying the PSM analysis, the two cohorts of 155 RN and 155 PN cases did not differ for all clinical and pathologic covariates (all p ≥ 0.32). PN and RN cohorts displayed comparable 5-year metastasis-free survival (88.9 vs 89.9 %, p = 0.811), local recurrence-free survival (94.2 vs 95.9 %, p = 0.283), overall survival (94.5 vs 96.8 %, p = 0.419) and cancer-specific survival (96 vs 98.6 %, p = 0.907) rates.

Conclusions: PN and RN for patients with cc-RCC larger than 7 cm provided equivalent oncologic outcomes. Safety and reproducibility of our findings should be further investigated in larger multicentric cohorts.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00345-016-1923-2DOI Listing
May 2017

Editorial Comment.

Urology 2015 Jul;86(1):106-7

Department of Urology, "Regina Elena" National Cancer Institute, Rome, Italy.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.urology.2015.02.062DOI Listing
July 2015