Surgical approach affecting long-term urinary continence status after robot-assisted laparoscopic prostatectomy prospectively evaluated using self-reported functional status (Expanded Prostate Cancer Index Composite, EPIC-26).

Purpose: The aim of the study was to examine the influence of the surgical approach for robot-assisted laparoscopic prostatectomy (RALP) on long-term urinary continence status in the era of self-reported functional status measures using the Expanded Prostate Cancer Index Composite 26. Materials and methods: This is a prospective evaluation of 232 patients undergoing RALP between September, 2019 and September, 2020. Urinary continence status and postoperative incontinence (pad usage) were evaluated 12 months after RALP using Expanded Prostate Cancer Index Composite 26 questionnaires. Patients were categorized according to their surgical approach and outcome into the following groups: successful nerve sparing (NS), primarily without nerve sparing (prim. NNS), and no nerve sparing by secondary resection (NNS by SR). The median levels of their questionnaire outcomes were evaluated and compared using the Wilcoxon rank sum test with continuity correction. Results: Urinary continence status 12 months after RALP differed significantly between the NS and prim. NNS (p = 0.0071) and the NS and NNS by SR (p = 0.0076) groups. There was no significant difference between the prim. NNS and NNS by SR (p = 0.53) groups. Pad usage 12 months after RALP had no significant difference with regard to SR of the neurovascular bundle (p = 0.14). Conclusions: Patient-reported outcomes of long-term urinary continence status seem to show no difference in postoperative continence, regardless of whether a non-nerve-sparing result was planned or reached through SR. Instead, preservation of neurovascular bundle seems to lead to better long-term continence rates.

Personalized Treatment Strategy in "Low-Risk Prostate Cancer Active Surveillance Candidates" Using Irreversible Electroporation: Prospective Evaluation of Feasibility, Morbidity, Functional and Oncological Outcomes.

PURPOSE: To evaluate the morbidity, functional and oncological outcome of irreversible electroporation (IRE) as a focal therapy for prostate cancer (PCa) when used in "active surveillance (AS)" candidates refusing standard treatment options. MATERIALS AND METHODS: IRE was performed under general anaesthesia, and the transurethral catheter was removed one day after intervention in all patients. Pre- and post-interventional voiding parameters (measured by International Prostate Symptom Score Questionnaire [IPSS], uroflowmetry and post-void residue) were compared. Follow-up (FU) was observed over a minimum of six months, including oncological outcome (controlled by multiparametric magnetic resonance imaging, rebiopsy, prostate-specific antigen dynamic as well as the need and type of secondary treatment) and general functional outcome (International Index of Erectile Function Questionnaire, satisfaction of the procedure). RESULTS: Twenty-four patients refusing AS or standard treatment with a median FU of 18.7 months were included. IPSS showed nine patients with mild, 12 with moderate and two with severe obstructive voiding symptoms pre-intervention (focal IRE). Median IPSS pre-IRE was 9 points, 8.5 (p=0.341) at six months and 10 (p=0.392) after 12 months, respectively. Pre-IRE maximum urinary flow (Qmax) (median: 16.1±8.0 mL/sec) and Qmax after catheter removal (16.2±7.6 mL/sec) did not differ significantly (p=0.904). Thirteen PCa recurrences occurred (54.2%). Out-of-lesion-PCa was found in 12/13 patients (92.3%), while 4/13 patients showed in-lesion-PCa recurrence simultaneously (30.8%). In one patient, there was an in-lesion-PCa recurrence only (7.7%). Six out of 24 patients (25.0%) received a secondary treatment. All patients were satisfied with the IRE procedure. CONCLUSIONS: Focal IRE underperforms regarding the overall oncological outcome and should not be offered as an equivalent therapy to established curative treatment strategies. Nevertheless, under a strict FU regimen, its lack of significant additional morbidity compared to an active surveillance strategy makes IRE a feasible alternative for low-risk PCa in highly selected patients as a personalised approach.

Sunitinib for Metastatic Renal Cell Carcinoma: Real-World Data from the STAR-TOR Registry and Detailed Literature Review.

INTRODUCTION: We evaluated the effectiveness and safety profile of the tyrosine kinase inhibitor sunitinib in patients with advanced or metastatic renal cell carcinoma (a/mRCC) in a real-world setting. METHODS: We analyzed data of adult a/mRCC patients treated with sunitinib. Data were derived from the German non-interventional post-approval multicenter STAR-TOR registry (NCT00700258). Progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were evaluated using descriptive statistics and survival analyses for the entire cohort and patient subgroups. RESULTS: A total of 116 study sites recruited 702 patients treated with sunitinib (73.1% male; median age 68.0 years; median Karnofsky index 90%) between November 2010 and May 2020. The most frequent histological subtype was clear cell RCC (81.6%). Sunitinib was administered as first-line treatment in 83.5%, as second line in 11.7%, and as third line or beyond in 4.8% of the patients. Drug-related AEs and serious AEs were reported in 66.3% and 13.9% of the patients, respectively (most common AE: gastrointestinal disorders; 39.7% of all patients). CONCLUSIONS: This study adds further real-world evidence of the persisting relevance of sunitinib for patients with a/mRCC who cannot receive or tolerate immune checkpoint inhibitors. The study population includes a high proportion of patients with unfavorable MSKCC poor-risk score, but shows still good PFS and OS results, while the drug demonstrates a favorable safety profile. The STAR-TOR registry is also registered in the database of US library of medicine (NCT00700258).

Prospective evaluation of an intraoperative urodynamic stress test predicting urinary incontinence after robot-assisted laparoscopic radical prostatectomy.

Introduction: Multiple factors influence postprostatectomy incontinence (PPI). This study evaluates the association between an intraoperative urodynamic stress test (IST) with PPI. Materials and Methods: This is an observational, single-center, prospective evaluation of 109 robot-assisted laparoscopic radical prostatectomies (RALPs) performed between July 2020 and March 2021. All patients underwent an intraoperative urodynamic stress test (IST) in which the bladder is filled up to an intravesical pressure of 40 cm H2O to evaluate whether the rhabdomyosphincter is capable of withstanding the pressure and ensure continence. Early PPI was evaluated using a standardized 1-h pad test performed the day after removal of the urinary catheter. The association of IST and PPI was evaluated using univariate and multivariable logistic regression models. Results: Nearly 76.6% of the patients showed no urine loss during the IST ("sufficient" population group). There was no significant correlation between this group and PPI after catheter removal (P = 0.5). Subgroup analyses of the "sufficient" patient population showed a 3.1 higher risk of PPI when no nerve sparing was performed (95% confidence interval: 1.05-9.70, P = 0.045). Conclusion: A sufficient IST, as a surrogate variable for a fully obtained rhabdomyosphincter, has no significant predictive value on its own but seems to be the optimal prerequisite for continence, since the data shows that the lack of neurovascular supply required for a functioning sphincter leads up to a 3.1 times higher risk for PPI.

Optimizing the structure of interdisciplinary tumor boards for effective cancer care.

Introduction: Multi-professional interdisciplinary tumor boards (ITB) are essential institutions to discuss all newly diagnosed, relapsed or complex cancer patients in a team of specialists to find an optimal cancer care plan for each individual patient with regard to national and international clinical practice guidelines, patient´s preference and comorbidities. In a high-volume cancer center, entity-specific ITBs take place at least once a week discussing a large number of patients. To a high level of expertise and dedication, this also requires an enormous amount of time for physicians, cancer specialists and administrative support colleagues, especially for radiologists, pathologists, medical oncologists and radiation oncologists, who must attend all cancer-specific boards according to certification requirements. Methods: In this 15-month prospective German single-center analysis, we examined the established structures of 12 different cancer-specific ITBs at the certified Oncology Center and demonstrate tools helping to optimize processes before, during and after the boards for optimal, time-saving procedures. Results: By changing pathways, introducing revised registration protocols and new digital supports we could show that the workload of preparation by radiologists and pathologists could be reduced significantly by 22.9% (p=<0.0001) and 52.7% (p=<0.0001), respectively. Furthermore, two questions were added to all registration forms about the patient´s need for specialized palliative care support that should lead to more awareness and early integration of specialized help. Discussion: There are several ways to reduce the workload of all ITB team members while maintaining high quality recommendations and adherence to national and international guidelines.

Study protocol: a prospective single-center study for non-invasive biomonitoring of renal complications in cancer patients treated with immune checkpoint inhibitors.

Background: The advent of immune checkpoint inhibitors (ICIs) has powerfully broadened the scope of treatment options for malignancies with an ongoing increase of indications, but immune-related adverse events (irAEs) represent a serious threat to treatment success. Agents directed against programmed cell death protein 1 (PD-1) or its ligand 1 (PD-L1) are known to cause renal complications with an incidence of 3%. In contrast, subclinical renal involvement is estimated to be much higher, up to 29%. We recently reported about urinary flow cytometry-based detection of urinary PD-L1-positive (PD-L1+) kidney cells correlating with tubular PD-L1-positivity that reflected susceptibility to develop ICI-related nephrotoxicity as an irAE attending ICI treatment. Therefore, we designed a study protocol to evaluate urinary detection of PD-L1+ kidney cells as a tool for non-invasive biomonitoring of renal complications in cancer patients treated with ICIs. Methods: A prospective, controlled, non-interventional, longitudinal, single-center observational study will be conducted at the Department of Nephrology and Rheumatology of the University Medical Center Göttingen, Germany. We intend to enroll approximately 200 patients treated with immunotherapy from the Departments of Urology, Dermatology, and Hematology and Medical Oncology of the University Medical Center Göttingen, Germany. First, we will assess clinical, laboratory, histopathological, and urinary parameters in addition to urinary cell collection. Then, we will perform a correlative analysis between urinary flow cytometry of different PD-L1+ cell of renal origin with the onset of ICI-related nephrotoxicity. Discussion: Because of growing ICI-treatment applicability with an expectable incidence of renal complications, providing cost-efficient and easily performable diagnostic tools for treatment-attendant and non-invasive biomonitoring becomes vital to improve both renal and overall survival rates in cancer patients receiving immunotherapy. Trial registration: https://www.drks.de, DRKS-ID DRKS00030999.

[A noteworthy case: An atypically located urachal cyst after continent urinary diversion using a MAINZ pouch with an appendix stoma]. / Ein bemerkenswerter Fall: Eine atypisch gelegene Urachuszyste nach kontinenter Harnableitung mittels MAINZ-Pouch mit Appendixstoma.

This case presents a 29-year-old man, with a urinary diversion via MAINZ Pouch I after cystectomy due to trauma in early childhood with a history of multiple previous surgeries. The reason for the presentation was a non-specific paraumbilical swelling on the right, which was disturbing for him. Despite further diagnostics by means of magnetic resonance imaging, a clear diagnosis of the subcutaneous tissue could not be made. After surgical removal of the complete cyst and after histological work-up, the diagnosis of an urachus-cyst could be made.

[Use of men's support underwear after elective scrotal surgery-a prospective, randomized assessment of postoperative complication rates and health-related quality of life : A prospective, randomized assessment of postoperative complication rates and health-related quality of life]. / Einsatz einer stützenden Herrenunterhose bei elektiven skrotalen Eingriffen : Eine prospektive, randomisierte Bewertung hinsichtlich postoperativer Komplikationsraten und gesundheitsbezogener Lebensqualität.

BACKGROUND: Elective scrotal surgery is associated with a high rate of postoperative complications. There is no specific recommendation for postoperative care. AIM: We investigated whether support underwear has an impact on postoperative complications and quality of life. MATERIALS AND METHODS: From July 2020 to November 2021, patients with prior elective scrotal surgery were randomized into the intervention group "support underwear" or the control group. In addition to patient characteristics, intraoperative and postoperative findings were documented. The primary endpoint comprised postoperative complications. Secondary endpoints were prolonged length of hospital stay, emergency visits, unplanned readmissions, increased use of analgesics, and quality of life, which was recorded using the EQ5D (European Quality of Life 5 Dimensions) questionnaire preoperatively, on day 1 and 4 weeks postoperatively. RESULTS: Data from 50 patients were analyzed. The mean age was 46.7 years (standard deviation [SD] 18.6). Inguinal surgery with/without orchiectomy (52%), hydrocele resection (22%), or ligation of varicocele (14%) were performed most frequently. The mean operating time was 62.8 min (SD 35.2); length hospital stay was 2.6 days (SD 1.2). In all, 20% of the patients suffered a postoperative complication. Type of surgery was significantly associated with postoperative complications (p = 0.01) and unplanned readmission (p = 0.04). Regarding biometric and perioperative data, there were no significant differences between the interventional group (n = 27) and control group (n = 23). CONCLUSION: A nonnegligible number of complications occurs after elective scrotal surgery. Complications affects quality of life up to 4 weeks after the surgery. Postoperative care with support underwear does not appear to affect the postoperative complication rate, but it positively influences the quality of life in patients with scrotal access.

Understanding long-term continence rates after robot-assisted laparoscopic prostatectomy - one-year follow-up on "Cognitive ability as a non-modifiable risk factor for post-prostatectomy urinary incontinence".

Purpose: To evaluate long-term continence rates (12 months) in patients after robot-assisted laparoscopic prostatectomy (RALP) in relation to their cognitive ability (CoAb), which proved to be a predictor for early post-prostatectomy incontinence. Material & Methods: This is the 12-month follow-up evaluation of our previously published observational single-center, prospective evaluation of 84 patients who underwent RALP as treatment of their localized prostate cancer between 07/2020 and 03/2021. Post-prostatectomy incontinence (PPI) was measured by asking patients about their 24 h pad usage, whereby 0 pads were considered continent and ≥1 pad was considered incontinent. CoAb was evaluated by performing the Mini-Mental State Examination prior to surgery. Possible predictors for PPI were evaluated using univariate and multivariable logistic regression models. Results: Multivariable logistic regression analyses identified early incontinence status and nerve sparing (NS) as independent predictors for PPI after 12 months, resulting in a 5.69 times higher risk for PPI when the loss of urine was between 10 and 50 ml during the early performed pad test (one day after catheter removal) compared to 0-1 ml loss of urine [95% confidence interval (CI): 1.33-28.30, p = 0.024] and a 6.77 times higher risk for PPI, respectively, when only unilateral NS was performed compared to bilateral NS (95% CI: 1.79-30.89, p = 0.007). CoAb lost its predictive value for long-term PPI (p = 0.44). Conclusion: The results of this study suggest that PPI is a dynamic, rather than a static condition with a dynamically changing pathophysiology within the first 12 months after RALP. Coping methods and therapies should adapt to this circumstance.

The Role of PSMA PET/CT in the Primary Diagnosis and Follow-Up of Prostate Cancer-A Practical Clinical Review.

The importance of PSMA PET/CT in both primary diagnostics and prostate cancer recurrence has grown steadily since its introduction more than a decade ago. Over the past years, a vast amount of data have been published on the diagnostic accuracy and the impact of PSMA PET/CT on patient management. Nevertheless, a large heterogeneity between studies has made reaching a consensus difficult; this review aims to provide a comprehensive clinical review of the available scientific literature, covering the currently known data on physiological and pathological PSMA expression, influencing factors, the differences and pitfalls of various tracers, as well as the clinical implications in initial TNM-staging and in the situation of biochemical recurrence. This review has the objective of providing a practical clinical overview of the advantages and disadvantages of the examination in various clinical situations and the body of knowledge available, as well as open questions still requiring further research.

Comparison of First-Line Anti-PD-1-Based Combination Therapies in Metastatic Renal-Cell Carcinoma: Real-World Experiences from a Retrospective, Multi-Institutional Cohort.

INTRODUCTION: The aim of this study was to test for differences in overall (OS) and progression-free survival (PFS) rates and toxicity in first-line immune checkpoint inhibition (IO) combination therapy in metastatic renal-cell carcinoma (mRCC) patients. METHODS: Between November 2017 and April 2021, 104 patients with histologically confirmed mRCC from 6 tertiary referral centers with either IO + IO (nivolumab + ipilimumab, n = 68) or IO + tyrosine kinase inhibitor (TKI) (pembrolizumab + axitinib, n = 36) were included. Kaplan-Meier and Cox regression analyses tested for OS and PFS differences. RESULTS: Of 104 mRCC patients, 68 received IO + IO (65.4%) and 36 IO + TKI (34.6%) therapy, respectively. Median age was 67 years (interquartile range: 57-70.3). Patients receiving IO + TKI were less likely to be poor risk according to the International Metastatic Renal-Cell Carcinoma Database Consortium score (16.7 vs. 30.9%) and presented with lower T-stage, compared to IO + IO treated patients. Median PFS was 9.8 months (CI: 5.3-17.6) versus 12.3 months (CI: 7.7 - not reached) for IO + IO versus IO + TKI treatment, respectively (p = 0.22). Median OS was not reached, survival rates at 12 months being 73.9 versus 90.0% for IO + IO versus IO + TKI patients (p = 0.089). In subgroup analyses of elderly patients (≥70 years, n = 38), IO + TKI treatment resulted in better OS rates at 12 months compared to IO + IO (91.0 vs. 57.0%; p = 0.042). CONCLUSION: IO + IO and IO + TKI as first-line therapies in mRCC patients were both comparable as for the oncological outcome and toxicity.

A Prospectivly Randomized Phase-II Trial of Axitinib versus Everolimus as Second-Line Therapy in Metastatic Renal Cell Carcinoma (BERAT Study).

INTRODUCTION: Inhibition of neo-angiogenesis is a cornerstone of medical treatment in metastatic renal cell carcinoma (mRCC). While 1st line therapies were previously dominated by inhibitors of the vascular endothelial growth factor axis, 2nd line options were less clearly defined. We investigated the role of everolimus (EVE) or a tyrosine kinase inhibitor (TKI) in 2nd line treatment of mRCC patients. METHODS: Key inclusion criteria were measurable mRCC, ECOG 0-1, IMDC risk: good or intermediate and adequate organ function. Patients who progressed on or were intolerant to bevacizumab + interferon were subject for randomization between TKI and EVE treatment. Cross-over occurred at time of progression during 2nd line treatment. Improvement of 2nd line progression-free survival (PFS) rate (PFR) at 6 months from 50% to 65% was the primary endpoint. Secondary endpoints were PFS, total PFS, objective response rate (ORR), overall survival (OS), safety, and patient reported outcomes. RESULTS: In 2012-2015, a total of 22 patients were included. The study was stopped for poor accrual. Ten patients (46%) were randomized to receive 2nd line treatment with EVE (n = 5) or axitinib (n = 4)/sunitinib (n = 1). ECOG 0 was recorded in 20% (EVE) and 60% (TKI). Severe adverse events occurred in approx. 60% in each arm. ORR was 1/5 (20%) for TKI and 0/5 (0%) for EVE. PFR at 6 months was 20% in each arm. Median PFS was 3.7 months (EVE) and 2.2 months (TKI) (hazard ratio [HR] 1.0 [95% confidence interval [CI]: 0.26-3.85]). The OS was comparable between arms HR 1.12 (95% CI: 0.27-4.61). CONCLUSION: The rapid change of the treatment landscape, the limited use of bevacizumab and interferon in 1st line and the duration of 1st line treatment jeopardized BERAT trial recruitment. The small number of patients is a major limitation of our trial. Our observation indicated the poor prognosis in progressive patients and the limited efficacy of TKI or mTOR inhibitors in 2nd line treatment.

C-reactive protein flare-response predicts long-term efficacy to first-line anti-PD-1-based combination therapy in metastatic renal cell carcinoma.

OBJECTIVES: Immune checkpoint blockade (IO) has revolutionised the treatment of metastatic renal cell carcinoma (mRCC). Early C-reactive protein (CRP) kinetics, especially the recently introduced CRP flare-response phenomenon, has shown promising results to predict IO efficacy in mRCC, but has only been studied in second line or later. Here, we aimed to validate the predictive value of early CRP kinetics for 1st-line treatment of mRCC with αPD-1 plus either αCTLA-4 (IO+IO) or tyrosine kinase inhibitor (IO+TKI). METHODS: In this multicentre retrospective study, we investigated the predictive potential of early CRP kinetics during 1st-line IO therapy. Ninety-five patients with mRCC from six tertiary referral centres with either IO+IO (N = 59) or IO+TKI (N = 36) were included. Patients were classified as CRP flare-responders, CRP responders or non-CRP responders as previously described, and their oncological outcome was compared. RESULTS: Our data validate the predictive potential of early CRP kinetics in 1st-line immunotherapy in mRCC. CRP responders, especially CRP flare-responders, had significantly prolonged progression-free survival (PFS) compared with non-CRP responders (median PFS: CRP flare-responder: 19.2 months vs. responders: 16.2 vs. non-CRP responders: 5.6, P < 0.001). In both the IO+IO and IO+TKI subgroups, early CRP kinetics remained significantly associated with improved PFS. CRP flare-response was also associated with long-term response ≥ 12 months. CONCLUSIONS: Early CRP kinetics appears to be a low-cost and easy-to-implement on-treatment biomarker to predict response to 1st-line IO combination therapy. It has potential to optimise therapy monitoring and might represent a new standard of care biomarker for immunotherapy in mRCC.

Liver Enzyme Elevation After 177Lu-PSMA Radioligand Therapy for Metastasized Castration-Resistant Prostate Cancer.

177Lu-PSMA radioligand therapy is a promising new option for patients with metastasized castration-resistant prostate cancer, and the spectrum of adverse events with this treatment has to be evaluated. Here, we describe the case of a patient with M1c disease (metastasis to the mediastinum, lungs, bones, and liver) who presented with elevated liver enzyme levels after receiving 177Lu-PSMA radioligand therapy for castration-resistant prostate cancer. Pretreatment 68Ga-PSMA PET/CT showed at least 4 liver lesions with low uptake. Overall, the liver uptake was inhomogeneous. Liver biopsy was performed subsequently.

Real-world outcomes in patients with metastatic renal cell carcinoma according to risk factors: the STAR-TOR registry.

Aim: Examine outcomes in sunitinib-treated patients by International Metastatic RCC Database Consortium (IMDC) or Memorial Sloan-Kettering Cancer Center (MSKCC) risk factors. Patients & methods: Patients enrolled in STAR-TOR registry (n = 327). End points included overall survival, progression-free survival and objective response rate. Results: Overall survival was similar for IMDC 0 versus 1 (p = 0.238) or 2 versus ≥3 (p = 0.156), but different for MSKCC (0 vs 1, p = 0.037; 2 vs ≥3, p = 0.001). Progression-free survival was similar for IMDC 2 versus 3 (p = 0.306), but different for MSKCC (p = 0.009). Objective response rate was different for IMDC 1 (41.9%) and 2 (29.5%) and similar for MSKCC 1 (34.4%) and 2 (31.0%). Conclusion: Outcome data varied according to IMDC or MSKCC. MSKCC model accurately stratify patients into risk groups. Clinical trial registration: NCT00700258 (ClinicalTrials.gov).

Mesorectal Lymph Node Metastases as Index Lesion in 68Ga-PSMA-PET/CT Imaging for Recurrent Prostate Cancer.

Purpose: Several studies have demonstrated an advantage of 68Ga-PSMA-PET/CT as staging modality for detection of prostate cancer (PCa) metastases. Data concerning metastatic manifestation and impact on PCa development of mesorectal lymph nodes (MLN) is limited. Our investigation describes MLN metastases as index lesion in 68Ga-PSMA PET/CT imaging for recurrent PCa. Methods: Twelve PCa patients with biochemical recurrence (BCR) after primary therapy who prospectively underwent a baseline 68Ga-PSMA-PET/CT initially showed MLN metastases. Eight of these patients received a follow-up 68Ga-PSMA-PET/CT to evaluate treatment response and further evolution. Prostate-specific antigen (PSA)-levels, changes in PSMA-uptake of MLN metastases and further 68Ga-PSMA PET/CT findings were recorded. Results: Median PSA at the first 68Ga-PSMA-PET/CT was 5.39 ng/ml. In all patients therapeutic management changed after the first 68Ga-PSMA-PET/CT. Androgen deprivation therapy (ADT) was initiated in seven of eight patients, one patient restarted initial ADT. Three patients additionally received salvage radiation therapy (sRT) including the prostatic lodge and docetaxel chemotherapy was started in one case. At follow-up, a decrease of PSA-level was detected in all patients (median 2.05 ng/ml) after median 10 months. In six of eight patients we observed a decrease or complete regress of PSMA-uptake in MLN in the follow-up 68Ga-PSMA-PET/CT. Conclusion: MLN metastases detected by 68Ga-PSMA-PET/CT seem to be a relevant localization of tumor manifestation and may serve as index lesion in the treatment of recurrent PCa. Besides the known oncological benefits of ADT and sRT, in case of sole MLN metastases individualized therapy like salvage lymphadenectomy or RT with a defined radiation field could be options for these patients.

Toxicities of axitinib, sunitinib and temsirolimus: implications for progression-free and overall survival in metastatic renal cell cancer.

The aim of this study was to evaluate the association between axitinib, sunitinib and temsirolimus toxicities and patient survival in metastatic renal cell cancer patients. Overall survival (OS) and progression-free survival (PFS) of metastatic renal cell cancer patients from the prospective multicenter STAR-TOR study were assessed using multivariable Cox models. A total of 1195 patients were included (n = 149 axitinib; n = 546 sunitinib; n = 500 temsirolimus). The following toxicities significantly predicted outcomes: hand-foot skin reaction (hazard ratio [HR] = 0.29) for PFS with axitinib; stomatitis (HR = 0.62) and pneumonitis (HR = 0.23) for PFS with temsirolimus; stomatitis (HR = 0.52) and thrombocytopenia (HR = 0.6) for OS with temsirolimus; fatigue (HR = 0.71) for PFS with sunitinib; hand-foot skin reaction (HR = 0.56) and fatigue (HR = 0.58) for OS with sunitinib. In conclusion, in metastatic renal cell cancer, axitinib, sunitinib and temsirolimus demonstrate specific toxicities that are protective OS/PFS predictors.

Effect of comorbidities/comedications on sunitinib outcomes for metastatic renal cell carcinoma: the STAR-TOR registry.

Aim: Examine the effects of baseline hypertension (HTN) and statin or proton pump inhibitor (PPI) use on sunitinib treatment outcomes in STAR-TOR, a real-world registry. Materials & methods: Presence or absence of HTN and use or nonuse of statins or PPIs were determined at registry entry. End points included overall survival (OS) and progression-free survival (PFS). Results: Data were from 557 patients. Presence or absence of HTN did not affect OS or PFS. PFS (median [95% CI]) was longer in statin users (9.4 [6.5-13.6] months) versus nonusers (6.9 [5.7-8.2] months) (p = 0.0442). OS was shorter in PPI users (20.2 [14.9-28.3] months) versus nonusers (25.7 [22.7-33.0] months) (p = 0.0212). Conclusion: Comorbidities and comedications may affect real-world sunitinib treatment outcomes. Clinical Trial Registration: NCT00700258 (ClinicalTrials.gov).

Surgical approaches for treatment of ureteropelvic junction obstruction - a systematic review and network meta-analysis.

BACKGROUND: Multiple surgical treatment options are available for the treatment of ureteropelvic junction obstruction (UPJO). The aim of this study is to compare the most frequently used technics in a comprehensive network approach. METHODS: A systematic literature search of the EMBASE, MEDLINE and COCHRANE libraries was conducted in January 2018. Publications were included that evaluated at least two of the following surgical techniques: open pyeloplasty (OP), endopyelotomy (EP), laparoscopic (LP) and robot assisted pyeloplasty (RP). Main outcomes were operative success, complications, urinary leakage, re-operation, transfusion rate, operating time, and length of stay. Network meta-analyses with random effects models simultaneously assessed effectiveness of all surgical techniques. RESULTS: A total of 26 studies including 3143 patients were analyzed. Compared with RP, EP and LP showed lower operative success rates (EP: OR = 0.09, 95%CI:0.05-0.19; p < 0.001; LP: OR = 0.51, 95%CI:0.31-0.84; p = 0.008). Compared with OP, LP and RP had lower risk for complications (LP: OR = 0.62; 95%CI:0.41-0.95; p = 0.027; RP: OR = 0.41; 95%CI:0.22-0.79; p = 0.007). Compared with RP, no significant differences were detected for urinary leakage or re-operation, transfusion rates. Compared with EP, RP yielded longer operating time (mean = 102.87 min, 95%CI:41.79 min-163.95 min, p = < 0.001). Further significant differences in operating times were detected when comparing LP to EP (mean = 115.13 min, 95%CI:65.63 min-164.63 min, p = < 0.001) and OP to EP (mean = 91.96 min, 95%CI:32.33 min-151.58 min, p = 0.003). CONCLUSIONS: Multiple surgical techniques are available for treatment of UPJO. RP has the highest rates of operative success and as well as LP lower complication rates than OP. Although surgical outcomes are worse for EP, its operating time is shorter than OP, RP, and LP. Surgeons should consider these findings when selecting the optimal treatment method for individual patients.