Publications by authors named "Giuseppe Basile"

52 Publications

Pancreatic metastases after surgery for renal cell carcinoma: survival and pathways of progression.

World J Urol 2022 Jul 29. Epub 2022 Jul 29.

Department of Urology, Urological Research Institute (URI), IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.

Purpose: Metastatic ccRCC has peculiar tropism in the pancreas. We describe the characteristics and pathways of progression of patients with PM in a large multi-institutional consortium and compare them to patients with metastases from ccRCC at other sites.

Methods: Detailed clinical and histopathological data were collected. To account for differences in baseline characteristics between the two groups, IPTW was used to compare the two groups in terms of PFS and OS.

Results: Of the 182 patients, 33 (18%) had pancreatic, 94 (52%) pulmonary, 30 (16%) bone, 13 (7%) hepatic, and 12 (7%) brain metastases. Patients with PM had less aggressive ccRCC at baseline compared to those with progression at other sites in terms of tumour stage and grade. Median time from ccRCC surgery to PM was 8 (95%CI 5-10) vs. 1 year (95%CI 1-2) for progression to other sites (p < 0.001). Median IPTW-weighted time to second progression was 4.3 years (95%CI 2.4-not reached) for patients with PM vs 1.1 year (95%CI 0.8-2.3) for those with progression in other sites (p < 0.001). The most frequent second progression sites were pancreas (24%) and liver (15%) in patients with PM, while progression to the pancreas was rare (4%) in those with a different first progression site. Surgery alone (55%) or in combination with medical therapy (30%) was more frequent in the PM group than in other sites (p < 0.001). Median IPTW-OS time was longer for patients with PM [8.8 years (95%CI 6.5-not reached)] compared to those with first progression in other sites [2.8 years (95%CI 1.9-4.3), p < 0.001].

Conclusion: Pancreatic tropism is typical of ccRCC tumours with more indolent behaviour than those progressing to other sites. A long follow-up period is necessary to distinguish PM from ccRCC.
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http://dx.doi.org/10.1007/s00345-022-04106-zDOI Listing
July 2022

Advanced Squamous Cell Carcinomas of the Pelvic and Perineal Region: A Comprehensive Genomic Profiling Study.

Oncologist 2022 Jul 26. Epub 2022 Jul 26.

Foundation Medicine, Inc., Cambridge, MA, USA.

Background: Advanced pelvic squamous cell carcinoma (pSCC) is a broad category of cancers affecting different pelvic organs and usually featuring unfavorable clinical outcomes. Thus, we aimed to assess genomic differences among pSCC cases and learn whether pSCC could potentially benefit from targeted therapies and/or immunotherapy.

Materials And Methods: A total of 1917 advanced pSCCs, including penile (penSCC), male urethral (murthSCC), male anal (manSCC), female urethral (furthSCC), vulvar (vulSCC), cervical (crvSCC), female anal (fanSCC), and vaginal (vagSCC), underwent comprehensive genomic profiling (CGP). We used hybrid capture-based CGP to evaluate recurrent genomic alterations (GAs). Tumor mutational burden (TMB) was determined on up to 1.1 Mb of sequenced DNA and microsatellite instability (MSI) was determined on up to 95 loci. Programmed cell-death-ligand-1 (PD-L1) expression was determined by immunohistochemistry (IHC; Dako 22C3).

Results: PIK3CA was the most frequently identified potentially "actionable" GA (22%-43%), followed by mTOR pathway [PTEN (0%-18%), FBXW7 (7%-29%)], and cell-cycle GAs. DNA-damage response (DDR) GAs and receptor-tyrosine kinase (RTK) targeted options were uncommon. NOTCH1 GAs were present in >15% of penSCC and vulvSCC. TMB ≥10 mut/Mb was >15% in manSCC, fanSCC, crvSCC, and vagSCC. PD-L1 high expression was >18% in all pSCC except urthSCC, manSCC, and vagSCC. HPV-16/18 detection was highest in manSCC, fanSCC, and crvSCC.

Conclusion: Despite similar histology, pSCCs can differ in GAs and HPV status. Overall, PIK3CA is the most frequent potentially "targetable" GA followed by mTOR and cell cycle pathway. RTK and DDR GAs are rare in pSCC. Immunotherapy could be considered for pSCC management based on TMB and PD-L1 expression.
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http://dx.doi.org/10.1093/oncolo/oyac144DOI Listing
July 2022

Accuracy of the CUETO, EORTC 2016 and EAU 2021 scoring models and risk stratification tables to predict outcomes in high-grade non-muscle-invasive urothelial bladder cancer.

Urol Oncol 2022 Jul 15. Epub 2022 Jul 15.

Department of Minimally Invasive Robotic Urology Center of Excellence in Urology, Wrocław Medical University, Wrocław, Poland.

Purpose: Non-muscle-invasive bladder cancers (NMIBC) constitute 3-quarters of all primary diagnosed bladder tumors. For risk-adapted management of patients with NMIBC, different risk group systems and predictive models have been developed. This study aimed to externally validate EORTC2016, CUETO and novel EAU2021 risk scoring models in a multi-institutional retrospective cohort of patients with high-grade NMIBC who were treated with an adequate BCG immunotherapy.

Methods: The Kaplan-Meier estimates for recurrence-free survival and progression-free survival were performed, predictive abilities were assessed using the concordance index (C-index) and area under the curve (AUC).

Results: A total of 1690 patients were included and the median follow-up was 51 months. For the overall cohort, the estimates recurrence-free survival and progression-free survival rates at 5-years were 57.1% and 82.3%, respectively. The CUETO scoring model had poor discrimination for disease recurrence (C-index/AUC for G2 and G3 grade tumors: 0.570/0.493 and 0.559/0.492) and both CUETO (C-index/AUC for G2 and G3 grade tumors: 0.634/0.521 and 0.622/0.525) EAU2021 (c-index/AUC: 0.644/0.522) had poor discrimination for disease progression.

Conclusion: Both the CUETO and EAU2021 scoring systems were able to successfully stratify risks in our population, but presented poor discriminative value in predicting clinical events. Due to the lack of data, model validation was not possible for EORTC2016. The CUETO and EAU2021 systems overestimated the risk, especially in highest-risk patients. The risk of progression according to EORTC2016 was slightly lower when compared with our population analysis.
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http://dx.doi.org/10.1016/j.urolonc.2022.06.008DOI Listing
July 2022

Octogenarians Are the New Sexagenarians: Cruciate-Retaining Total Knee Arthroplasty Is Not Inferior to Posterior-Stabilized Arthroplasty in Octogenarian Patients.

J Clin Med 2022 Jun 30;11(13). Epub 2022 Jun 30.

Department of Orthopaedic Surgery, Faculty of Medicine, University Hospital of Larissa, University of Thessalia, 41110 Larissa, Greece.

Purpose: The primary goal of this study was to compare survivorship and functional results in individuals aged 80 and over who underwent total knee arthroplasty (TKA) with cruciate-retaining (CR) or posterior-stabilized (PS) implants.

Methods: We prospectively analyzed the clinical records of two consecutive cohorts for a total of 96 implants in patients aged 80 years or over. The first cohort consisted of 59 consecutive cemented PS cases, while the second cohort comprised 37 consecutive cemented CR cases. The decision to either perform a PS or CR arthroplasty was taken based on preoperative magnetic resonance imaging and intraoperative findings. The clinical evaluation entailed evaluating each patient's visual analogue scale for pain (VAS), range of motion (flexion and extension), Knee Society Score (KSS), and Oxford Knee Score (OKS). Each patient was clinically evaluated the day before surgery (T) and at two consecutive follow-ups at least 1 (T) and 2 (T) years after surgery. Implant survival was calculated using the Kaplan-Meier method.

Results: Both groups showed statistically significant improvements at each follow-up compared with the preoperative values ( < 0.05). The CR group showed a higher flexion degree at T than the PS group (116.14 ± 5.57° versus 113.16 ± 7.66°; = 0.048). No differences were found between the two groups regarding survival rate (chi-squared test -value = 0.789). Three failures were noted in the CR group, while there were four in the PS group.

Conclusions: This prospective clinical study demonstrates that CR and PS TKA had similar clinical outcomes in octogenarians with regard to knee function, postoperative knee pain, and other complications. Prosthesis survivorship for CR and PS TKA were both satisfactory, and in selected octogenarian patients, CR TKA should always be considered because of the reduced surgical time.
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http://dx.doi.org/10.3390/jcm11133795DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9267517PMC
June 2022

Traumatology: Adoption of the [email protected] Application for the Remote Evaluation of Patients and Possible Medico-Legal Implications.

J Clin Med 2022 Jun 23;11(13). Epub 2022 Jun 23.

IRCCS Galeazzi Orthopedics Institute, 20161 Milano, Italy.

Telemedicine is the combination of technologies and activities that offer new remote ways of medical care. The [email protected] application project is a remote assistance service that follows patients affected by lower limb fractures surgically treated at Galeazzi Orthopedic Institute (Milan, Italy). The [email protected] application aims to evaluate the clinical conditions of patients treated for lower limb fracture after discharge from hospital using remote follow-up (FU). The project is not a substitute for traditional clinical consultations but an additional tool for a more complete and prolonged view over time. The [email protected] application is installed on patients' smartphones and is used daily to communicate with healthcare personnel. In the first protocol, patients had to complete different tasks for 30 days, such as monitoring the load progression on the affected limb, the number of steps during the day, and body temperature and completing a questionnaire. A simplified protocol was proposed due to the pandemic and logistical issues. The revised protocol enrolled patients after more than 30 days of their operation, prioritized the rehabilitation phase, and required patients to use the app for fewer days. After an initial phase of correct use, a reduction in patient compliance was gradually reported in the first protocol. However, patient compliance in the second protocol remained high (96.25%) in the recording of all the required parameters. The [email protected] application has proven to be a valuable tool for following patients remotely, especially during the pandemic. Telemedicine has the same value as traditional clinical evaluations, and it enables patients to be followed over long distances and over time, minimizing any discomfort.
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http://dx.doi.org/10.3390/jcm11133644DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9267866PMC
June 2022

Atrophic pseudarthrosis of humeral diaphyseal fractures: medico-legal implications and methodological analysis of the evaluation.

Acta Biomed 2022 Jul 1;93(3):e2022176. Epub 2022 Jul 1.

Trauma Unit and Emergency Department, IRCCS Galeazzi Orthopedics Institute, Milano, Italy.

Humeral shaft fractures account for 1- 3% of all fractures and about 20-27% of those involving the humerus. In the past they were often conservatively treated, with an acceptable consolidation rate. Open reduction and internal fixation (ORIF) is the best choice in polytrauma patients, in complex or pathological fractures and in those associated with vascular injuries. Regardless the type of fixation used, these fractures can evolve into delayed union or pseudarthrosis (PSA). It should be noted that the humeral shaft itself has a high intrinsic healing potential, due to the blood supply provided by the surrounding muscles. The aim of this work is to evaluate whether the causes that led to the development of atrophic pseudarthrosis in a humeral diaphyseal fracture are attributable to inadequate management of this fearful complication and to highlight the possible medico-legal repercussions. We will try to verify whether the currently used forensic evaluation parameters of permanent disability are appropriate and adequate in relation to the complexity of such injuries. This complexity also includes the repercussions on the ergonomic efficiency of the entire limb, the relative possible postural alterations, the inevitable extension of the period of traumatic illness and the relative repercussions on the overall compromised structure of the subject.
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http://dx.doi.org/10.23750/abm.v93i3.12733DOI Listing
July 2022

Magnetic resonance arthrography in patients with multidirectional instability: could inferior capsulsar width be considered the cornerstone in the diagnosis of non-traumatic shoulder instability?

Skeletal Radiol 2022 Jun 30. Epub 2022 Jun 30.

Insubria University, Varese, 21100, Italy.

Objectives: To provide quantitative anatomical parameters in patients with and without non-traumatic multidirectional instability using MR arthrography (MR-a).

Materials And Methods: One hundred and seventy-six MR-a performed from January 2020 to March 2021 were retrospectively evaluated. Patients were divided according to the presence of clinically diagnosed multidirectional shoulder instability (MDI). Each MR-a was performed immediately after intra-articular injection of 20 ml of gadolinium using the anterior approach. The width of the axillary recess, the width of the rotator interval, and the circumference of the glenoid were measured by three independent radiologists, choosing the average value of the measurements. The difference between the mean values of each of the three parameters between the two study groups was then assessed.

Results: Thirty-seven patients were included in the study (20 in the MDI group, 17 in the control group). The mean axillary recess width in the MDI group was significantly greater than in the control group (t(33) = 3.15, p = .003); rotator interval width and glenoid circumference measurements were not significantly different (t(35) = 1.75, p = .08 and t(30) = 0,51, p = .6, respectively).

Conclusions: Inferior capsular redundancy may be an important predisposing factor in MDI, while glenoid circumference is not related to MDI. The relationship between the width of the rotator interval and shoulder instability remains debated.
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http://dx.doi.org/10.1007/s00256-022-04090-wDOI Listing
June 2022

A case of infection and severe soft tissue loss of the elbow. Planning surgical treatment in compliance with good clinical-care practices and medico-legal implications.

Acta Biomed 2022 Jun 30;93(S1):e2022106. Epub 2022 Jun 30.

Trauma Unit and Emergency Department, IRCCS Galeazzi Orthopedics Institute, Milano, Italy.

Soft tissue loss around  the elbow, with tendons, nerves and bone exposure,  represents a challenging condition, often requiring a complex and accurate surgical reconstruction. Inadequate repair of soft tissue defects may in fact compromise further reconstructive orthopedic procedures, including  osteosynthesis and joint replacement. A correct reparative sequence of these lesions usually starts with an appropriate debridement and removal of all non-viable and infected tissues, followed by soft tissues management through plastic and reconstructive techniques. Here we present a case report, showing a successful surgical solution, using a local muscular flap. The results are discussed in light of their functional and medico-legal implications, considering the frequent occurrence of partial functional recovery, the disabling impact on social and work activities and the aesthetic sequelae of these lesions, even in spite of a successful treatment.
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http://dx.doi.org/10.23750/abm.v93iS1.12389DOI Listing
June 2022

Spinal cord ischemia complicating treatment of abdominal aortic aneurysms: a legal overview.

Acta Biomed 2022 Jun 29;93(S1):e2022181. Epub 2022 Jun 29.

Vascular Surgery, Department of Clinical-Surgical, Diagnostic and Pediatric Sciences, University of Pavia; Director of Vascular Surgery Department, Gruppo Policlinico di Monza, Monza, Italy..

Background And Aim: Spinal cord ischemia following open or endovascular aneurysm repair of the abdominal aorta is rare but highly disabling complication. The aim of this work is to report on its occurrence and its legal consequences.

Methods: We report a case of spinal cord ischemia complicating an endovascular aortic repair, its management and sequalae, comparing it with the existing literature and we examine its legal consequences resulting in a malpractice lawsuit and the final decision of the judge.

Results: Although the causal relation between SCI and the neurological deficits reported were assessed by the Court, no element of responsibility imputable to the Hospital or the Medical Staff were found, since the defendant had made every effort to prevent it in the preoperatory setting, and to treat it once it established in the post-operative phase.

Conclusions: predictable but unpreventable complications of necessary interventions rule out medical malpractice, as long as the patient is fully informed about the risks and benefits of the treatment, and provided that in the perioperative setting all due measures are taken in order to prevent it and treat it.
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http://dx.doi.org/10.23750/abm.v93iS1.12763DOI Listing
June 2022

Which Are the Commonest Sites and Characteristics of Post-Transurethral Prostate Surgery Strictures in a High-Volume Reconstructive Center?

J Endourol 2022 Aug 4. Epub 2022 Aug 4.

Kulkarni Reconstructive Urology Center, Department of Urology, Pune, India.

Urethral stricture is a well-known complication after transurethral prostate surgery (TPS) and it is usually considered an easy-to-treat condition. We aimed to examine characteristics of post-TPS urethral stricture cases that were referred for urethroplasty at our tertiary center. We identified 201 patients with TPS-induced stricture treated with urethroplasty at our institution from 2017 to 2021. First, stricture length and location were evaluated during preoperative assessment. Second, multiple sets of multivariable logistic regression (MLR) analyses were run to assess whether clinical variables were associated with the location of the stricture. Median stricture length was 5 cm (4-7). One hundred forty-one (70.1%) patients received previous no-invasive treatments (dilatation and/or direct visual internal urethrotomy). Proximal bulbar urethra was the commonest site for stricture, whereas panurethral stricture (≥10 cm) was diagnosed in 41 (20.4%) patients. Lichen sclerosus was more common in patients with penile stricture location, compared with patients with other involved segments (26% 19%,  = 0.03), and it was the only predictor of penile and midbulbar urethra location at MLR. Surgical approaches were augmented urethroplasty in 94% of patients, especially for patients with previous treatment including urethroplasty (95.8% 82.5% for naive,  = 0.004). Dorsal onlay was the preferred approach for bulbar (53.4%) and penile urethra (90.7%), whereas ventral onlay (38.2%) and double face augmentation (20.6%) were the preferred approaches in membranous strictures. Most patients who were referred for TPS-induced stricture attempted previous noninvasive managements. Referred TPS-induced urethral strictures were long and frequently involving multiple segments of urethra. Augmentation urethroplasty was our preferred surgical approach because of the characteristics and complexity of these strictures. The presence of lichen may increase the risk of post-TPS stricture in a specific segment of urethra, namely the penile and midbulbar urethra.
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http://dx.doi.org/10.1089/end.2022.0130DOI Listing
August 2022

Clinical, pathological and long-term oncologic outcomes of papillary type I vs. type II renal cell carcinoma.

Urol Oncol 2022 Aug 31;40(8):384.e15-384.e21. Epub 2022 May 31.

Department of Urology and Division of Experimental Oncology, URI, Urological Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.

Background: Despite papillary renal cell carcinoma (pRCC) subtype represents the second most common histological renal tumor, controversial findings have been shown regarding its prognosis. Thus, we investigated the natural history of patients harbouring pRCC, focusing on its clinicopathological characteristics and long-term oncologic outcomes among pRCC subtypes.

Materials And Methods: We identified 447 patients treated with either partial (PN) or radical nephrectomy (RN) for pRCC at a single tertiary centre, between 1994 and 2019. First, we explored differences in baseline and clinicopathological characteristics. Second, Kaplan-Meier plots investigated progression-free survival (PFS) and cancer-specific survival (CSS) differences among pRCC subtypes. Third, multivariable Cox-regression analyses (MVA) were used to assess predictors of clinical progression (CP) and cancer-specific mortality (CSM).

Results: Overall, 120 (27%) patients had symptoms at time of diagnosis. 263 (58.8%) vs. 184 (41.2%) patients underwent PN vs. RN. At histopathological evaluation, 243 (54.4%) harboured pRCC type I vs. 204 (45.6%) type II. pRCC type II more frequently showed higher tumor grade, tumor necrosis or lymphovascular invasion (all P<0.001). After a median follow-up of 51 months, 2.5% and 11% of patients had local relapse and CP, respectively. Kaplan-Meier plots revealed 93 vs. 83% 5-year PFS (P<0.001) and 96 vs. 89% 5-year CSS (P=0.01) for non-metastatic pRCC type I vs. II, respectively. At MVA, pRCC type II predicted higher risk of CP (Hazard ratio [HR]: 3.03, 95%CI 1.42-6.44; P=0.01), as well as of CSM (HR: 2.60, 95%CI 1.05-6.29; P=0.02), relative to pRCC type I.

Conclusions: PRCC type II harbour more unfavorable tumor characteristics, such as higher tumor grade, more frequent tumor necrosis or lymphvascular invasion, which translates into worse long-term oncologic outcomes, compared with pRCC type I. Thus, patients harbouring pRCC type II may benefit from stricter follow-up, as well as earlier risk-based adjuvant therapies, based on potential worse oncologic outcomes in this patient population.
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http://dx.doi.org/10.1016/j.urolonc.2022.05.012DOI Listing
August 2022

In Vitro Study Evaluating the Effect of Different Immunosuppressive Agents on Human Polyomavirus BK Replication.

Transplant Proc 2022 Jun 2. Epub 2022 Jun 2.

Department of Biomedical, Surgical, and Dental Sciences, University of Milan, Milan, Italy.

Background: Human polyomavirus BK (BKPyV) is the etiologic agent of polyomavirus-associated nephropathy, a leading cause of kidney transplant dysfunction. Because of the lack of antiviral therapies, immunosuppression minimization is the recommended treatment. This strategy offers suboptimal outcomes and entails a significant risk of rejection. Our aim was to evaluate the effect of different immunosuppressive drugs (leflunomide, tacrolimus, mycophenolic acid, sirolimus, and everolimus) and their combinations in an in vitro model of BKPyV infection.

Methods: Human renal tubular epithelial cells were infected with BKPyV and treated with leflunomide, tacrolimus, mycophenolic acid, sirolimus, and everolimus, administered alone or in some combination thereof. Viral replication was assessed every 24 hours (up to 72 hours) by BKPyV-specific quantitative real-time polymerized chain reaction for the VIRAL PROTEIN 1 sequence in cell supernatants and by western blot analysis targeting the viral protein 1 and the glyceraldehyde 3-phosphate dehydrogenase on total protein lysates. Results were described as viral copies/mL and compared between treatments at any prespecified time point of the study.

Results: The highest inhibitory effects were observed using leflunomide or everolimus plus mycophenolic acid (mean BKPyV replication log reduction 0.28). The antiviral effect of everolimus persisted when it was used in combination with tacrolimus (mean BKPyV replication log reduction 0.27).

Conclusions: Our experience confirms that everolimus has anti-BKPyV properties and prompts future research to investigate possible mechanisms of action. It also provides a rational basis for targeted clinical trials evaluating alternative immunosuppressive modification strategies.
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http://dx.doi.org/10.1016/j.transproceed.2022.04.017DOI Listing
June 2022

Ultra-high-performance liquid chromatography-tandem mass spectrometry assay for quantifying THC, CBD and their metabolites in hair. Application to patients treated with medical cannabis.

J Pharm Biomed Anal 2022 Aug 20;217:114841. Epub 2022 May 20.

Marche Polytechnic University, Department of Excellence of Biomedical Sciences and Public Health, Section of Legal Medicine, Unit of Forensic Toxicology, Via Tronto 10/a, 60126 Ancona, Italy. Electronic address:

Recently, several countries approved the use of cannabis flowering tops with standardized amount of ∆9-tetrahydrocannabinol (THC), cannabidiol (CBD) to treat several diseases. Therapeutic monitoring of medical cannabis products administered to patients for the established pathologies is rarely carried out. Previous few investigations have been developed in conventional matrices like blood and urine. This is the first study involving hair analysis of THC, CBD and their metabolites in patients treated with medical cannabis. An ultra-high-performance liquid chromatography-tandem mass spectrometry method to quantify THC, CBD, and metabolites, i.e., 11-nor-9-carboxy-THC (THC-COOH), 11-hydroxy-THC (11-OH-THC) cannabidiol-7-oic acid (7-COOH-CBD), 7-hydroxycannabidiol (7-OH-CBD), 6-α-hydroxycannabidiol (6-α-OH-CBD) and 6-β-hydroxycannabidiol (6-β-OH-CBD) in hair samples was developed and fully validated. The validation results indicated that the method was accurate (average inter/intra-day error, <10%), precise (inter/intra-day imprecision, <10%), and fast (10 min run time). Average hair concentrations in four patients treated with different formulations of medical cannabis were 2.75 ng/mg THC, 2.87 ng/mg 11-OH-THC, and 0.32 ng/mg THC-COOH (n = 3); 1.65 ng/mg CBD, 2.73 ng/mg 7-OH-CBD, 1.29 ng/mg 7-COOH-CBD, 0.35 ng/mg 6-α-OH-CBD, and 0.03 ng/mg 6-β-OH-CBD. The proposed method proved suitable for a fast and sensitive determination of all target compounds allowing high throughput testing in individuals monitored for medical cannabis treatments.
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http://dx.doi.org/10.1016/j.jpba.2022.114841DOI Listing
August 2022

The Impact of Surgical Volume on Perioperative Safety After Urethroplasty: a population-based study.

Minerva Urol Nephrol 2022 May 27. Epub 2022 May 27.

Unit of Urology, Urological Research Institute (URI), IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele, University, Milan, Italy.

Background: To assess whether the risk of perioperative complications after urethroplasty is affected by hospital annual surgical volume (ASV).

Methods: In the Nationwide Inpatient Sample, we searched for patients who underwent urethroplasty between 2001 and 2015. Hospitals were categorized into empirically determined tertiles, according to ASV of performed urethroplasties and divided into low (< 3) (LVC), intermediate (3-19) (IVC) and high (> 20) volume centers (HVC). Multivariable logistic regression (MLR) analyses examined the effect of ASV on perioperative complications and on four specific sub-types of post-operative complications.

Results: A weighted estimate of 39 912 patients underwent urethroplasty in the US. 34.9% were operated in HVC, while the rate of performed urethroplasties increased in LVC and decreased in HVC. Overall, 1.1%, 18.8% and 2.1% patients respectively experienced intraoperative, post-operative, and transfusions complications. At MLR, IVC and LVC were associated with higher risk of both intraoperative (IVC: OR 2.65, p=0.0008; LVC: OR 4.98, p<0.0001), postoperative (IVC: OR 1.14, p=0.01; LVC: OR 1.26, p=0.001) and transfusions complications (IVC: OR 1.85, p<0.001; LVC: OR 3.03, p=0.01). LVC was also associated with higher risk of hematuria (OR 3.77), urinary infections (OR 1.60) and sepsis (OR 2.83) complications.

Conclusions: Approximately 65% of patients were operated in IVC and LVC, and patients treated in IVC or LVC had higher risk of developing both intra and post-operative complications. These data provide important indicators for policy makers to categorize institution based on urethroplasty outcomes.
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http://dx.doi.org/10.23736/S2724-6051.22.04893-5DOI Listing
May 2022

New Psychoactive Substances and receding COVID-19 pandemic: really going back to "normal"?

Acta Biomed 2022 05 11;93(2):e2022186. Epub 2022 May 11.

Department of Anatomical, Histological, Forensic and Orthopedic Sciences, "Sapienza", University of Rome, Rome, Italy.

To the Editor, The ongoing rise of New Psychoactive Substances (NPS), i.e. psychotropic molecules devised and synthesized to replicate the effects of traditional drugs of abuse in order to circumvent banned substances schedules, has been posing a challenge of enormous magnitude to substance detection systems and law enforcement worldwide. Still, it would be remiss to ignore the role played by the unprecedented public health emergency relating to the COVID-19 pandemic in the exacerbation of the NPS crisis. The diversion of resources has in fact hindered conventional approaches to drug monitoring, surveillance, control, and public health responses. The dangerous path ahead in our struggle against NPS abuse is best exemplified by the rather recent emergence of isotonitazene, an analogue of a benzimidazole class of analgesic compounds, powerful synthetic opioid and full mu-opioid receptor agonist belonging to the 2-benzylbenzimidazole group of compounds, which comprises the structurally different clonitazene, metonitazene and etonitazene (1). Isonitazene has reportedly been detected on European markets in at least five different forms and could even supplant fentanyl derivatives (2). Currently available data on isonitazene-related abuse and fatalities seem to be emblematic of the volatile, elusive nature of NPS: deaths in which isotonitazene was involved in fact presented substantial differences from casualties arising from synthetic opioids abuse. Case reports have highlighted how flualprazolam was detected in most fatalities associated with isotonitazene whereas flualprazolam was involved in only 8% of other synthetic opioid overdose deaths (3). Rather than rising background use, such a finding seems to suggest likely co-use or co-distribution of flualprazolam and isotonitazene. The key element of polysubstance involvement is rife in synthetic opioid overdose deaths. That being said, significantly more substances were implicated in isotonitazene-related deaths than fatalities linked to other synthetic opioid overdose (4, 5). Such dynamics and mortality patterns further stress the urgency of expanding health services for those suffering from opioid addiction disorders. Fine-tuned and standardized detection mechanisms relying on specialized assays based on sensitive instrumentation are essential for the timely and accurate characterization of such novel synthetic opioids (6-8). Isotonitazene in fact cannot be detected by common fentanyl testing strips (9). Hence, the essential nature of clinical and toxicological cannot be overstated, if we are to effectively deal with the public health risks arising from new substances or classes, along with the healthcare and social costs thereof (10). As new substances appear on illicit markets and are detected, their distinctive traits can only be identified by user experience, in the early stages (11-13). Nonetheless, the pandemic scenario has brought about a profound alteration of substance abuse patterns, and opened up new avenues of supply and demand for which our surveillance/detection systems may not be fully prepared or well-suited. As the pandemic appears to recede and hopefully turn into an endemic context based on coexistence with the SARS-CoV-2 and its less harmful variants, it would be a mistake to take for granted that drug abuse/trafficking dynamics will also get back to where they were before the pandemic. Putting in place policies aimed at monitoring web-based platforms and social media can potentially constitute a valuable tool in terms of keeping in check emerging substances, given how during the COVID-19 pandemic many interactions between traffickers and buyers have moved online (14). After all, social media have been playing an increasingly relevant role as interacting platforms, which users and drug dealers can take advantage of in order to discuss drug prices, substance purity, distinctive traits of the "high" (i.e. desired drug effects) they are seeking, ways of taking the substances, dosages, and characteristics of any new NPS becoming available on such back-alley marketing channels (15). Softwares designed and specifically programmed to sift through and analyze all detectable online information in that regard may prove valuable to figure out evolving dynamics of trafficking, purchases and use. Probing social media users has proven effective tool for public health concerns, e.g. drug checking services which have been harnessed due to their harm reduction potential in places estimated to be at risk, with large crowds gathering (concerts, clubs and the like). Nonetheless, research efforts need to be directed towards the new realm of criminality, the "Dark Web", in which all sorts of illegal exchanges and interactions are known to take place. A 2020 study has highlighted the appalling risks for drug users who choose to pursue that option in order to buy drugs (16). Three dealers were selected on a specific "Dark Web" marketplace, and NPS were ordered through such a channel. All these exchanges were thoroughly documented, and an analysis was undertaken of all the substances thus bought, totaling nine samples, by NMR, HRMS, LC-UV, and two also by x-ray diffraction. It was ultimately concluded that four out of five substances bought had been labeled with NPS names that did not match the actual substance, and two out of three samples of substances sold as new (i.e. unscheduled) NPS were instead found to be already documented substances, mislabeled and peddled under false pretenses. Drug dealers were therefore either deceiving their clients or were unaware as to the actual substances which they were selling. In light of such extremely worrisome findings, it is not hard to understand the implications and the major public health risks that such new trends of trafficking and abuse may entail. It is therefore incumbent upon the scientific community and law enforcement agencies to adapt and strive to meet the new challenges brought by the new criminal ecosystems in terms of drug enforcement, first and foremost the impervious environment known as "Dark Web" relying on untraceable cryptocurrencies for illegal transactions.
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http://dx.doi.org/10.23750/abm.v93i2.13008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9171884PMC
May 2022

Editorial Comment.

J Urol 2022 08 10;208(2):357-358. Epub 2022 May 10.

Department of Urology and Division of Experimental Oncology, URI, Urological Research Institute, IRCCS San Raffaele Scientific Institute, Milan, Italy.

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http://dx.doi.org/10.1097/JU.0000000000002688.01DOI Listing
August 2022

MR arthrography: correlation between anatomic intraarticular variants of the long head of the biceps tendon (long head biceps tendon) and superior labral anterior to posterior (SLAP) lesions.

J Orthop Traumatol 2022 Mar 8;23(1):13. Epub 2022 Mar 8.

Department of Diagnostic and Interventional Radiology, University of Insubria, Varese, Italy.

Background: The purpose of this work is to characterize the anatomy of the intraarticular portion of the long head of the biceps tendon (long head biceps tendon) using magnetic resonance (MR) arthrography by investigating whether anatomical variants may facilitate the onset of a supraequatorial lesion (superior labral anterior to posterior, SLAP).

Materials And Methods: In 482 shoulder MR arthrographies, we considered the anatomical variants of the intraarticular portion of the long head of the biceps tendon classified according to Dierickx's arthroscopic classification; lesions of supraequatorial structures were considered in the data analysis. For each anatomical variant, correlation with SLAP and the odd ratio were statistically evaluated, using Fisher's exact (or chi-squared) test and logistic regression analysis, respectively.

Results: In the mesotenon-type variant, the SLAP frequency was higher than expected [χ (df = 4) = 14.9, p = 0.005] with a higher risk of developing a type I SLAP (p = 0.0003). In the adherent-type variant, the type II SLAP frequency was higher than expected [χ (df = 3) = 18.1, p = 0.0004] with a higher risk of developing type II SLAP (p = 0.0001). Two cases of "split" (SPL) long head biceps tendon had III and type IV SLAP, respectively. These patients have a higher risk for type IV SLAP [odds ratio (OR) 19.562, 95% confidence interval (CI) 1.604-238.541, p = 0.001]. An increased risk of developing SLAP type II was calculated for male subjects (OR 3.479, 95% CI 1.013-11.951, p = 0.019).

Conclusions: It is possible that adherence of the long head biceps tendon to the supraspinatus more often predisposes to a lesion of the superior glenoid labrum (SLAP), in view of the close relationships between the fibrocartilage and the bicipital anchor, probably related to the limited excursion of the intraarticular long head biceps tendon.
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http://dx.doi.org/10.1186/s10195-022-00631-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8904654PMC
March 2022

A global approach to improving penile cancer care.

Nat Rev Urol 2022 04 22;19(4):231-239. Epub 2021 Dec 22.

Moffitt Cancer Center and Research Institute, Tampa, FL, USA.

Rare tumours such as penile carcinoma have been largely neglected by the urology scientific community in favour of more common - and, therefore, more easily fundable - diseases. Nevertheless, penile cancer represents a rising burden for health-care systems around the world, because a lack of widespread expertise, ineffective centralization of care and absence of research funds have hampered our ability to improve the global care of these patients. Moreover, a dichotomy has arisen in the field of penile cancer, further impeding care: the countries that are mainly supporting research on this topic through the development of epidemiological studies and design of clinical trials are not the countries that have the highest prevalence of the disease. This situation means that randomized controlled trials in developed countries often do not meet the minimum accrual and are intended to close before reaching their end points, whereas trials are almost completely absent in those areas with the highest disease prevalence and probability of successful recruitment, such as Africa, South America and South Asia. The scientific and organizational inaction that arises owing to this mismatch translates into a burdensome cost for our patients. A global effort to gather experts and pull together scientific data from around the world may be the best way to boost clinical research, to change clinical practice and, ultimately, to improve care for patients and their families.
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http://dx.doi.org/10.1038/s41585-021-00557-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8693593PMC
April 2022

Pelvic ring and acetabular fracture: Concepts of traumatological forensic interest.

Injury 2022 Feb 26;53(2):475-480. Epub 2021 Nov 26.

Department of Reconstructive and Prosthetic Revision-Surgery- and Sepsis, San Gaudenzio Clinic - High Speciality Institute, Novara, Italy.

Fractures of the pelvic ring and acetabulum generally result after high energy trauma. Pelvic fractures, especially, are considered complex injuries from a therapeutic point of view, in relation to the frequent coexistence of skeletal and / or parenchymal lesions affecting other areas, and the abundant bleeding invariably associated with the latter. The systematic study of these injuries, starting from the 1950s, has led to a significant prognostic improvement, while generally remaining a non-negligible degree of disability. The knowledge of the characteristics of the lesions and of the classification systems, as well as an accurate assessment of the anatomo-functional repercussions, represent therefore the fundamental prerequisites for the correct assessment of physical damage. Herein, we aim to examine whether the medico-legal assessment parameters of physical damage being used in Italy and Europe are appropriate and consistent with the complexity of similar injuries.
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http://dx.doi.org/10.1016/j.injury.2021.11.063DOI Listing
February 2022

Bladder-sparing combination treatments for muscle-invasive bladder cancer: A plea for standardized assessment and definition of clinical trials endpoints.

Urol Oncol 2022 02 25;40(2):37-44. Epub 2021 Nov 25.

Department of Medical Oncology, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy.

Radical cystectomy is the standard of care for muscle invasive bladder cancer, although it represents a surgical procedure with high complication and mortality burden. Thus, more and more emphasis has been placed in favor of alternative treatments especially for patients who are unfit for or aim to avoid radical cystectomy. In this context, preclinical studies highlighted that chemoradiation therapy (CRT) may have immunomodulatory properties on tumor microenvironment with a consequent increase in immune biomarkers. Thus, following the encouraging results reached by immune checkpoint inhibitors (ICIs) in both metastatic and localized disease, CRT and ICIs combination treatment gained momentum as bladder-sparing option and several clinical trials were recently launched both as concurrent and sequential treatments. A narrative review of the literature was performed to summarize the rationale and clinical outcomes of trials testing CRT and ICIs combination. Promising results were recently released mainly from phase II trials reporting clinal complete response rates from 48% to 83%. Moreover, combination treatment, both as concurrent and sequential schedules, appeared to be quite tolerable. However, interpretation of preliminary findings is made difficult due to the heterogeneity of clinical endpoints among trials, patient population included and different measurement of response to treatment. Novel bladder-sparing strategies are finally gaining momentum in bladder cancer treatment. Despite preliminary findings are encouraging, harmonization of terminology and definition of clinical endpoints among trials will be mandatory to correctly assess the potential role of CRT and immunotherapy combination as bladder-sparing solution in routine clinical practice.
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http://dx.doi.org/10.1016/j.urolonc.2021.10.012DOI Listing
February 2022

Prosthetic joint infections and legal disputes: a threat to the future of prosthetic orthopedics.

J Orthop Traumatol 2021 Nov 9;22(1):44. Epub 2021 Nov 9.

Department of Reconstructive and Prothesic Revision-Surgery and Sepsis, San Gaudenzio Clinic-High Speciality Institute, Novara, Italy.

Prosthetic joint infections (PJI) represent one of the major problems in orthopedic prosthetic surgery. The incidence of PJIs varies according to the site of intervention, and different published case studies report occurrence at 0.5 to 3.0% in the event of first implants, with a significant greater risk in the case of prosthesis revisions. The diagnosis of prosthetic infections is seldom simple, needing a multi-specialist approach, which includes the accurate collection of patient anamnesis, its clinical evaluation, the evaluation of inflammation biomarkers, and the use of imaging techniques. It is essential to identify the bacteria responsible for the infection not only for an accurate diagnosis, but also to select the correct antibiotic treatment. Failure to identify the bacteria involved makes it impossible to establish targeted systemic antibiotic therapy. In developed countries such as Italy, the right to health is guaranteed by the Constitution, where the institutions that provide health services must be staffed by a team of medical professionals that can guarantee the safest possible health pathways. Risk management represents the set of actions aimed at improving the quality of the care provided, the adherence to guidelines and good care practices with the final objective of guaranteeing patients' safety. All hospitals, including the ones where prosthetic orthopedic surgery is performed, must adopt clinical risk management procedures which, through prospective tools aimed at preventing errors and complications and by retrospective methods, permit the identification of critical points in the different phases of the process and propose actions for improvement. The constant increase in litigation for malpractice in Western countries, especially in Italy, calls for special attention to the problem of PJIs and the in-depth assessment of medico-legal problems, also considering the new legislative initiatives in the field of medical malpractice. Hospitals need to tackle the onset of PJIs in a transparent and linear fashion by constantly informing the patient on their progress.
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http://dx.doi.org/10.1186/s10195-021-00607-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8578522PMC
November 2021

Nerve lesions during arthroscopic procedure: a literature overview.

Orthop Rev (Pavia) 2021 29;13(2):24441. Epub 2021 May 29.

University of Piemonte Orientale.

Arthroscopy is more and more popular. Although minimally-invasive, it's not completely free of complications as nerves lesions which can be invalidating for the patient and frustrating for the surgeon with significant economic, psychological and medico-legal implications. The purpose was to review the literature about nerve injuries related to arthroscopy. A scientific literature review was performed in PubMed/Medline, including articles dealing with cases of iatrogen lesions of the peripheral nerves occurred during arthroscopic procedures. These lesions are mainly due to direct damage by nerve section while cutting for making the portals or during surgical maneuvers, or indirect damage due to traction or pressure mechanisms especially for errors in patient positioning. Also the tourniquet can lead to compression and ischemic nerve injury. Arthroscopy can cause both transient and permanent neurological lesions manifested with dysesthesia up to paralysis according to Seddon's classification in neuroapraxia, axonotmesis and neurotmesis. Incidence of complications in general and of nerve injuries during arthroscopy are reported by joint. A rigorous respect for surgical technique and all perioperative precautions, particularly in relation to the positioning of the patient, greatly reduce the risk of nerve injury. The suggested waiting time before surgical nerve revision is 6 months. In the meanwhile the patient should perform physiotherapy constantly and improvements should be evaluated with clinical examination and electromyography 15-20 days after the lesion, and thereafter at 3 and 6 months.
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http://dx.doi.org/10.52965/001c.24441DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8567779PMC
May 2021

The epidemiology of proximal femur fractures during COVID-19 emergency in Italy: a multicentric study.

Acta Biomed 2021 11 5;92(5):e2021398. Epub 2021 Nov 5.

School of Medicine, AOU Consorziale Policlinico, Department of Basic Medical Sciences, Neuroscience and Sense Organs, Orthopaedic & Trauma Unit, University of  Bari Aldo Moro, Bari, Italy.

Background And Aim: After the first Italian case of Covid-19, the Government imposed the complete closure of all areas involved by the spread of the virus to contain transmissions. There was a massive reorganization of Hospitals, a stop of all elective activities and a convertion of many hospitals in "Covid Centers''. AITOG (Associazione Italiana Traumatologia e Ortopedia Geriatrica) conducted a retrospective study on all proximal femur fractures surgeries that occurred in this period, to find out whether the pandemic and the correlated lockdown somehow changed the incidence of these events.  Methods: 10 Italian orthopedic centers were involved in the study. Considering the geographic location, three groups were created (North, Centre and South). The considered period is the Italian "Phase 1" (February 23rd - May 3rd 2020).

Results: the cohort is composed of 412 patients, 116 male and 296 female (mean age 81.1 ± 9.1 years). The same period of 2019 has been used as control group, with 558 patients, 156 male and 402 female (mean age 84.2 ± 8.0 years). In 2020 we counted 323 (78.4%) fractures occurred at home, 61 (14.8%) in retirement houses and 28 (6.8%) in different locations. We mainly treated fractures with intramedullary nails (n.237 57.5%). Among all patients we had 46 (11.1%) Covid-19 positive. The mortality rate within 30 days was of 51 patients (12.4%); 23 of these died because of complications related to Covid-19 while 31 of  these were in treatment with anticoagulant/antiaggregant.

Conclusions: AITOG analysis demonstrates a decrease in surgical interventions for proximal femur fractures from 2019 to 2020, a reduction in patients mean age and an increase in trauma occurred in domestic environment. We also registered a consistent difference between the North, Center and South of the Country.
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http://dx.doi.org/10.23750/abm.v92i5.11925DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8689341PMC
November 2021

Femoral neck fractures: Key points to consider for fixation or replacement a narrative review of recent literature.

Injury 2021 Sep 25. Epub 2021 Sep 25.

Orthopaedics and Traumatology, University of Milan, Milan, Italy; Orthopaedic Surgery Department, Hadassah Hebrew University Medical School, Ein Kerem, Jerusalem, Israel.

Introduction: Femoral neck fractures (FNF) are frequent injuries and not rarely complicated by non-union, implant failure, and avascular necrosis. Some of these fractures represent a dilemma for trauma surgeons. Which fracture should be fixed? Which replaced with a prosthesis? How? The aim of this narrative review is to investigate the literature in order to provide the most updated and evidence-based knowledge about FNF' treatment.

Materials And Methods: A literature research has been performed to find the essential key points to consider when dealing with FNF and their treatment. The most representative papers and the new meta-analysis were matched with authors' experience to give a concise but comprehensive view of the problem. Timing, age, comorbidities, vascularization of the femoral head, displacement, instability, comminution of the fracture, bone quality, and surgeon experience seem to be the major topics to consider in the decision making. We then focus on the optimal fixation or replacement as suggested by the literature.

Results: Age is the main independent factor to consider. Timing seems essential in the elderly population to reduce mortality and important in the younger patients to reduce complications. Vascular supply should be always considered. Displacement, instability, and comminution of the fracture are negative prognostic factors for fixation as well as, theoretically, bone quality. In the elderly hip replacement is mostly indicated. A stable and solid fixation is mandatory to allow early mobilization. Sliding Hip Screws (SHS) seem preferable to cannulated screws for displaced/unstable (Pauwels II-III, posterior comminution) and basicervical fracture patterns or in smokers. There is a tendency toward Total Hip Arthroplasty (THA) also in the elderly if the patient is an indipendent ambulator without severe comorbidities. Dual mobility cups are gaining popularity in THA for FNF.

Conclusions: FNF are frequent injuries and represent, in some cases, a dilemma for the trauma surgeon. Age, timing, comorbidities, bone quality, femoral head vascularization, fracture displacement, intrinsic instability, and comminution as surgeon experience should be carefully evaluated before surgery. A case-to-case analysis of the patient-related factors helps the surgeon to make the right choice and reduce the well-known complications.
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http://dx.doi.org/10.1016/j.injury.2021.09.024DOI Listing
September 2021

A feasibility study of preoperative pembrolizumab before radical nephroureterectomy in patients with high-risk, upper tract urothelial carcinoma: PURE-02.

Urol Oncol 2022 01 17;40(1):10.e1-10.e6. Epub 2021 Jun 17.

Vita-Salute San Raffaele University; Department of Urology, IRCCS San Raffaele Hospital and Scientific Institute, Milan, Italy.

Introduction: Advances in neoadjuvant therapy for patients with localized, nonmetastatic, upper tract urothelial carcinoma (UTUC) is needed.

Patients And Methods: PURE-02 was a feasibility study enrolling individuals with UTUC, at clinical stage N0M0, with high-risk features according to the modified European Association of Urology definition, based on the presence of either: high-grade disease, multifocality, tumor size ≥2 cm, and/or hydronephrosis. The treatment consisted of 3 courses of 200 mg pembrolizumab, intravenously, every 3 weeks, followed by radical nephroureterectomy (RNU). The endpoints were to assess the safety, pathological responses, and biomarkers.

Results: Ten patients were enrolled between August 2018 and November 2020, 9 (90%) completed the neoadjuvant course. One treatment-related death occurred as a complication of severe myocarditis, myasthenia gravis, hepatitis and myositis. One (14.3%) patient achieved a clinical complete response and refused to undergo RNU. Two (20%) had disease progression and received subsequent chemotherapy, prior to RNU. Overall, 7 patients underwent RNU: one (14.3%) achieved an ypT1N0 response, although this patient was reported to have a cT1 tumor at baseline imaging. The remaining patients were nonresponders. Circulating tumor DNA assay did not identify patients likely to achieve a complete pathologic response.

Conclusion: Single-agent neoadjuvant pembrolizumab did not appear to be a promising treatment strategy for patients with biomarker-unselected, high-risk localized UTUC.
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http://dx.doi.org/10.1016/j.urolonc.2021.05.014DOI Listing
January 2022

Is There a Detrimental Effect of Antibiotic Therapy in Patients with Muscle-invasive Bladder Cancer Treated with Neoadjuvant Pembrolizumab?

Eur Urol 2021 09 27;80(3):319-322. Epub 2021 May 27.

Unit of Urology, Urological Research Institute, IRCCS Ospedale San Raffaele, Vita-Salute San Raffaele University, Milan, Italy; Department of Medical Oncology, IRCCS Ospedale San Raffaele, Milan, Italy. Electronic address:

In locally advanced and metastatic malignancies, antibiotic (ATB) therapy has a negative effect on immunotherapy efficacy. Therefore, we aimed to evaluate whether ATB therapy and use of specific ATB classes with concomitant neoadjuvant pembrolizumab affected pathologic complete response (ypT0N0) and relapse-free survival (RFS) for patients with clinical T2-4N0M0 bladder cancer enrolled in the PURE-01 study. Of the 149 patients evaluated, 48 (32%) received any concomitant ATB therapy. The ATB class most commonly administered was fluoroquinolones (16 patients; 33%). In the ATB cohort, seven patients (15%) achieved ypT0N0 status, compared to 50 (50%; p < 0.001) in the untreated group. Moreover, ATB use was negatively associated with ypT0N0 status (odds ratio 0.18, 95% confidence interval [CI] 0.05-0.48; p = 0.001). The 24-mo RFS rate was 63% (95% CI 48-83%) in the ATB group versus 90% (95% CI 83-97) in the untreated group. We found that ATB use was associated with a higher recurrence rate (hazard ratio [HR] 2.64, 95% CI 1.08-6.50; p = 0.03). Exploratory analyses showed that fluoroquinolone use was associated with a higher recurrence rate (HR 3.28, 95% CI 1.12-9.60; p = 0.03). Our study revealed an association between ATB use and neoadjuvant immunotherapy efficacy in an intention-to-cure population, highlighting the need for future studies to better investigate this relationship. PATIENT SUMMARY: The efficacy of immunotherapy for cancer is influenced by several patient and tumor factors, including the use of antibiotics. We found that antibiotics taken at the same time as immunotherapy drugs were associated with lower rates of complete response and of recurrence-free survival among patients with muscle-invasive bladder cancer. These findings need to be confirmed in future studies.
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http://dx.doi.org/10.1016/j.eururo.2021.05.018DOI Listing
September 2021

A seven week observational analysis of clinical activities in a North Italian orthopaedic hospital during the second wave of SARS-CoV-2 pandemic: far from usual volumes, but different from the first wave.

Int Orthop 2021 10 13;45(10):2473-2482. Epub 2021 May 13.

Laboratory of Experimental Biochemistry and Molecular Biology, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.

Purpose: We previously described the radical changes occurred in an orthopaedic hospital in Milan (Italy) during the first SARS-CoV-2 pandemic outbreak. Currently, during the second wave, the situation is still far from normality. Here we describe the changes that took place, and are still ongoing, in the clinical practice.

Methods: Number and type of admissions, outpatients activity, ER and urgent procedures in SARS-CoV-2 negative and positive patients have been analyzed over seven weeks (October 26th-December 13th, 2020) and compared with the correspondent period in 2019 and the same timeframe during the first wave (February 24th-April 10th).

Results: 2019 vs. 2020: Overall admissions decreased by 39.8%; however, while admissions for elective surgery dropped by 42.0%, urgent surgeries increased by 117.0%. Rehabilitation admissions declined by 85.2%. White and green priority ER consultations declined by 41.6% and 52.0%, respectively; yellow and red increased by 766.7% and 400.0%, respectively. Second vs. first wave: Overall admissions increased by 58.6% with a smoother decrement in weekly admissions than during the first wave. Disparity of acute admissions vs. rehabilitation expanded: Acute cases increased by 63.6% while rehabilitation cases decreased by 8.7%. Admissions to triage procedures increased by 72.3%.

Conclusions: Activity levels are far from normality during the second COVID-19 wave. Elective surgery and outpatients-related activities are still strongly limited compared to 2019 while the number of urgent cases treated increased consistently. SARS-CoV-2 positive emergencies are slightly higher than during the first wave. These important changes are expected to impact on health service and hospital budget for long.
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http://dx.doi.org/10.1007/s00264-021-05064-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8116436PMC
October 2021

Assessing in-hospital morbidity after urethroplasty using the European Association of Urology Quality Criteria for standardized reporting.

World J Urol 2021 Oct 15;39(10):3921-3930. Epub 2021 Apr 15.

Department of Urology, Humanitas Clinical and Research Center, IRCCS, Rozzano, Milan, Italy.

Purpose: To conduct a rigorous assessment of in-hospital morbidity after urethroplasty according with the European Association of Urology (EAU) guidelines for complication reporting.

Methods: We retrospectively (2015-2019) identified 469 consecutive patients receiving urethroplasty (e.g. bulbar urethroplasty with grafts, penile urethroplasty with/without grafts/flaps, Johanson, de novo or revision perineostomy, end-to-end anastomosis, meatoplasty and/or meatotomy) at our tertiary care institution. Complications were graded with Clavien-Dindo score and Comprehensive Complication Index (CCI). Complications were classified in: bleeding no gastrointestinal, cardiac, gastrointestinal, genitourinary, infectious, neurological, oral, wound, miscellaneous, and pulmonary. Logistic regression tested for predictors of in-hospital complications and prolonged hospitalization (> 75th percentile). Kaplan-Meier and Cox regression investigated the effect of complications on failure after urethroplasty.

Results: Overall, 161 (34.3%) patients experienced at least one complication. Of those, 47 (10%) experienced two or more complications and 59 (12.6%) experienced at least one Clavien-Dindo ≥ II complication. Only two patients had Clavien-Dindo III complications. Infectious was the most frequent complication, and de novo or revision perineostomy was associated with the highest rate of complications. The occurrence of any complications, as well as complication with Clavien-Dindo ≥ II were associated with prolonged hospitalizations, but not with higher rates of post-urethroplasty failure.

Conclusions: Complications after urethroplasty were common events, but rarely with severe sequelae. Infectious were the most common complications and perineostomy was the type of urethroplasty with the highest rate of complications. The application of the EAU recommendations allowed the identifications of a higher number of complications after urethroplasty if compared with previous reports based on unsupervised chart review.
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http://dx.doi.org/10.1007/s00345-021-03692-8DOI Listing
October 2021
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