Publications by authors named "Susanne Krege"

48 Publications

Late toxicities and recurrences in patients with clinical stage I non-seminomatous germ cell tumours after 1 cycle of adjuvant bleomycin, etoposide and cisplatin versus primary retroperitoneal lymph node dissection - A 13-year follow-up analysis of a phase III trial cohort.

Eur J Cancer 2021 Sep 6;155:64-72. Epub 2021 Aug 6.

Department of Urology, Medical Faculty, University of Duesseldorf, Germany.

Background: One cycle of adjuvant chemotherapy with bleomycin, etoposide and cisplatin (BEP) has shown superiority in recurrence-free survival over retroperitoneal lymph node dissection (RPLND) in patients with clinical stage (CS) I non-seminomatous germ cell tumours (NSGCTs) of the testis in the setting of a phase III trial. We report the recurrences and late toxicities of this study after 13 years of follow-up.

Methods: Questionnaires from 382 patients with CS I NSGCT treated with 1 cycle of adjuvant BEP (arm A) or RPLND + two cycles of adjuvant BEP in cases of pathological stage II disease (arm B) were evaluated regarding recurrences and late toxicity. Overall, information on recurrence status was available in 337 patients, and 170 questionnaires were evaluable for toxicity (arm A: 95; arm B: 75).

Results: With a median follow-up of 13.8 years (0-22), 3 patients (1.6%) in arm A and 16 patients (8.4%) in arm B experienced recurrence. The 15-year PFS in arm A/B was 99% (CI 96-100%)/92% (CI 89-99%) (p = 0.0049). The 15-year OS in arm A/B was 93% (CI 87-97%)/93% (CI 86-97%) (p = 0.83). Eight patients (4.2%) in arm A and four patients (2.1%) in arm B showed metachronous secondary testicular cancer (p = 0.26). Five patients (2.6%) in arm A and four patients (2.1%) in arm B developed other malignancies. Toxicities were not significantly different apart from retrograde ejaculation, which occurred more frequently after RPLND (10% versus 24%, p = 0.01).

Conclusions: With long-term observation, one cycle of BEP remains superior to RPLND in preventing recurrence and was tolerated without any clinically relevant long-term toxicities.
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http://dx.doi.org/10.1016/j.ejca.2021.06.022DOI Listing
September 2021

[Testicular and penile cancer].

Urologe A 2021 07 13;60(7):845-846. Epub 2021 Jul 13.

Klinik für Urologie, Helios Kliniken Schwerin GmbH, Wismarsche Straße 393-397, 19049, Schwerin, Deutschland.

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http://dx.doi.org/10.1007/s00120-021-01577-7DOI Listing
July 2021

Management of Germ Cell Tumours of the Testes in Adult Patients: German Clinical Practice Guideline, PART II - Recommendations for the Treatment of Advanced, Recurrent, and Refractory Disease and Extragonadal and Sex Cord/Stromal Tumours and for the Management of Follow-Up, Toxicity, Quality of Life, Palliative Care, and Supportive Therapy.

Urol Int 2021 22;105(3-4):181-191. Epub 2021 Jan 22.

II. Medical Clinic and Polyclinic, University Hospital Hamburg-Eppendorf, Hamburg, Germany.

Objectives: We developed the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up of germ cell tumours (GCT) of the testes in adult patients. We present the guideline content in 2 separate publications. The present second part summarizes therecommendations for the treatment of advanced disease stages and for the management of follow-up and late effects.

Materials And Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search in March 2018), were provided. Thirty-one experts, who were entitled to vote, rated the final clinical recommendations and statements.

Results: Here we present the treatment recommendations separately for patients with metastatic seminoma and non-seminomatous GCT (stages IIA/B and IIC/III), for restaging and treatment of residual masses, and for relapsed and refractory disease stages. The recommendations also cover extragonadal and sex cord/stromal tumours, the management of follow-up and toxicity, quality-of-life aspects, palliative care, and supportive therapy.

Conclusion: Physicians and other medical service providers who are involved in the diagnostics, treatment, and follow-up of GCT (all stages, outpatient and inpatient care as well as rehabilitation) are the users of the present guideline. The guideline also comprises quality indicators for measuring the implementation of the guideline recommendations in routine clinical care; these data will be presented in a future publication.
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http://dx.doi.org/10.1159/000511245DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006578PMC
July 2021

Management of Germ Cell Tumours of the Testis in Adult Patients. German Clinical Practice Guideline Part I: Epidemiology, Classification, Diagnosis, Prognosis, Fertility Preservation, and Treatment Recommendations for Localized Stages.

Urol Int 2021 7;105(3-4):169-180. Epub 2021 Jan 7.

II. Medical Clinic and Polyclinic, University Hospital Hamburg-Eppendorf, Hamburg, Germany.

Introduction: This is the first German evidence- and consensus-based clinical guideline on diagnosis, treatment, and follow-up on germ cell tumours (GCTs) of the testis in adult patients. We present the guideline content in two publications. Part I covers the topic's background, methods, epidemiology, classification systems, diagnostics, prognosis, and treatment recommendations for the localized stages.

Methods: An interdisciplinary panel of 42 experts including 1 patient representative developed the guideline content. Clinical recommendations and statements were based on scientific evidence and expert consensus. For this purpose, evidence tables for several review questions, which were based on systematic literature searches (last search was in March 2018) were provided. Thirty-one experts entitled to vote, rated the final clinical recommendations and statements.

Results: We provide 161 clinical recommendations and statements. We present information on the quality of cancer care and epidemiology and give recommendations for staging and classification as well as for diagnostic procedures. The diagnostic recommendations encompass measures for assessing the primary tumour as well as procedures for the detection of metastases. One chapter addresses prognostic factors. In part I, we separately present the treatment recommendations for germ cell neoplasia in situ, and the organ-confined stages (clinical stage I) of both seminoma and nonseminoma.

Conclusion: Although GCT is a rare tumour entity with excellent survival rates for the localized stages, its management requires an interdisciplinary approach, including several clinical experts. Quality of care is highly related to institutional expertise and can be reassured by established online-based second-opinion boards. There are very few studies on diagnostics with good level of evidence. Treatment of metastatic GCTs must be tailored to the risk according to the International Germ Cell Cancer Collaboration Group classification after careful diagnostic evaluation. An interdisciplinary approach as well as the referral of selected patients to centres with proven experience can help achieve favourable clinical outcomes.
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http://dx.doi.org/10.1159/000510407DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006579PMC
July 2021

Self- and proxy-reported outcomes after surgery in people with disorders/differences of sex development (DSD) in Europe (dsd-LIFE).

J Pediatr Urol 2021 06 13;17(3):353-365. Epub 2020 Dec 13.

Department of Women's and Children's Health and Centre for Molecular Medicine, Karolinska Institutet, Stockholm, Sweden; Pediatric Surgery, Astrid Lindgren Children Hospital, Karolinska University Hospital, Stockholm, Sweden. Electronic address:

Background: Surgery is performed in many individuals with disorders/differences of sex development (DSD). Irreversibility of some surgical procedures, lack of information about the procedures, and lack of follow-up care for physical and psychological outcomes, lead to wish for more knowledge from both surgeons and patients. After the consensus conference in 2006, multidisciplinary care is provided to a higher degree with psychological support and more restricted surgical procedures. Outcome studies after genital surgery often lack of patient's perspective.

Objective: To describe surgical procedures in relation to diagnosis, to evaluate the outcomes of surgery through genital examination, and through patient's and observer's satisfaction with the anatomical and functional result after genital surgery.

Study Design: In a cross-sectional clinical study performed in six European countries in 2014/15, we have included 500 participants where surgery was performed, from a total of 1040 adolescents (≥16years) and adults with a DSD. Diagnoses included Turner syndrome (n = 301), mixed gonadal dysgenesis (45,XO/46,XY; n = 45), Klinefelter syndrome (n = 218), XYY (n = 1), 46, XY DSD (n = 222) and 46, XX DSD (n = 253). Study protocol included clinical report files, an optional gynecological or urological examination, patient reported outcomes including received surgical interventions, satisfaction with appearance and function after surgery, and impact of the surgical procedure on life.

Results: Five hundred participants had received genital or breast surgery, with the highest rate in 46, XY DSD and the lowest in Turner syndrome. Altogether; 240 participants had feminizing surgery, 112 had masculinizing surgery, and 217 underwent gonadectomy. Physicians evaluated anatomical appearance at genital examination as poor in less than 10%. Dissatisfaction with anatomical appearance was reported by 22% of the participants, dissatisfaction with function by 20%. Being (very) dissatisfied with anatomical appearance and function was reported by 13% of the study participants. Most participants reported no impact, or positive impact, of the surgical procedures on their lives, but 29% experienced a negative effect of gonadectomy on their life.

Discussion: There might be a selection bias and/or a recall bias for participating in our studies. Due to poor data quality about surgical procedures performed in the past, we also relied on participants memory about surgical procedures in their past. Ideally, patient reported outcomes should be evaluated both before and after surgical procedures.

Conclusion: A vast majority are satisfied with appearance and function, but still genital or breast surgery have a long-lasting effect on patient's life. Self-reported satisfaction is usually lower than the observer's evaluation regarding both appearance and function.
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http://dx.doi.org/10.1016/j.jpurol.2020.12.007DOI Listing
June 2021

[Urology (m/f/d) seeking: … answers].

Urologe A 2020 11;59(11):1311

Klinik und Poliklinik für Urologie, Kinderurologie und Uroonkologie, Universitätsklinikum Essen (AöR), Hufelandstraße 55, 45147, Essen, Deutschland.

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http://dx.doi.org/10.1007/s00120-020-01364-wDOI Listing
November 2020

Consensus paper: current state of first- and second-line therapy in advanced clear-cell renal cell carcinoma.

Future Oncol 2020 Oct 23;16(29):2307-2328. Epub 2020 Sep 23.

Interdisciplinary GU Oncology, Clinic for Medical Oncology & Clinic for Urology, University Hospital Essen, D-45147, Essen, Germany.

The therapy of advanced (clear-cell) renal cell carcinoma (RCC) has recently experienced tremendous changes. Several new treatments have been developed, with PD-1 immune-checkpoint inhibition being the backbone of therapy. Diverse immunotherapy combinations change current first-line standards. These changes also require new approaches in subsequent lines of therapy. In an expert panel, we discussed the new treatment options and how they change clinical practice. While first-line immunotherapies introduce a new level of response rates, data on second-line therapies remains poor. This scenario poses a challenge for clinicians as guideline recommendations are based on historical patient cohorts and agents may lack the appropriate label for their in guidelines recommended use. Here, we summarize relevant clinical data and consider appropriate treatment strategies.
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http://dx.doi.org/10.2217/fon-2020-0403DOI Listing
October 2020

[What is the pratical relevance of guidelines?]

Urologe A 2020 May;59(5):531-532

Universitätsklinik für Urologie und Urochirurgie, Universitätsmedizin Mannheim, Universität Heidelberg, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Deutschland.

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http://dx.doi.org/10.1007/s00120-020-01196-8DOI Listing
May 2020

Erratum zu: Warum haben Tyrosinkinaseinhibitoren in der adjuvanten Situation versagt bzw. können Checkpoint-Inhibitoren eher Sinn machen?

Authors:
Susanne Krege

Urologe A 2020 Apr;59(4):488

Klinik für Urologie, Kinderurologie und urologische Onkologie, Ev. Kliniken Essen Mitte, Huyssens Stiftung, Henricistr. 92, 45136, Essen, Deutschland.

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http://dx.doi.org/10.1007/s00120-020-01172-2DOI Listing
April 2020

Erratum zu: Nierenzellkarzinom.

Urologe A 2020 Apr;59(4):487

Klinik für Urologie, Kinderurologie und urologische Onkologie, Kliniken Essen-Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Henricistr. 92, 45136, Essen, Deutschland.

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http://dx.doi.org/10.1007/s00120-020-01171-3DOI Listing
April 2020

[Why have tyrosine kinase inhibitors failed in the adjuvant situation and do checkpoint inhibitors make more sense?]

Authors:
Susanne Krege

Urologe A 2020 Feb;59(2):149-154

Klinik für Urologie, Kinderurologie und urologische Onkologie, Ev. Kliniken Essen Mitte, Huyssens Stiftung, Henricistr. 92, 45136, Essen, Deutschland.

In view of a considerable risk of recurrence especially in patients with a high-risk profile after organ-sparing surgery or nephrectomy, adjuvant treatment seems to make sense in renal cell carcinoma. After the failed attempts using older immunotherapeutics or vaccination therapies, new hope was put in the panel of targeted VEGF/R inhibitors. But the results from these studies published so far are also disappointing. In this context the instruments for selecting the best suitable patients for adjuvant trials have to be discussed. It remains to be seen whether using the same selection criteria as in ongoing trials with checkpoint inhibitors will show better results.
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http://dx.doi.org/10.1007/s00120-020-01142-8DOI Listing
February 2020

[Renal cell carcinoma].

Urologe A 2020 Feb;59(2):133-134

Klinik für Urologie, Kinderurologie und urologische Onkologie, Kliniken Essen-Mitte, Evang. Huyssens Stiftung/Knappschaft GmbH, Henricistr. 92, 45136, Essen, Deutschland.

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http://dx.doi.org/10.1007/s00120-020-01130-yDOI Listing
February 2020

EAU-ESMO Consensus Statements on the Management of Advanced and Variant Bladder Cancer-An International Collaborative Multistakeholder Effort: Under the Auspices of the EAU-ESMO Guidelines Committees.

Eur Urol 2020 02 19;77(2):223-250. Epub 2019 Nov 19.

Department of Biomedical Sciences, Humanitas University, Milan, Italy; Humanitas Research Hospital, Milan, Italy.

Background: Although guidelines exist for advanced and variant bladder cancer management, evidence is limited/conflicting in some areas and the optimal approach remains controversial.

Objective: To bring together a large multidisciplinary group of experts to develop consensus statements on controversial topics in bladder cancer management.

Design: A steering committee compiled proposed statements regarding advanced and variant bladder cancer management which were assessed by 113 experts in a Delphi survey. Statements not reaching consensus were reviewed; those prioritised were revised by a panel of 45 experts prior to voting during a consensus conference.

Setting: Online Delphi survey and consensus conference.

Participants: The European Association of Urology (EAU), the European Society for Medical Oncology (ESMO), experts in bladder cancer management.

Outcome Measurements And Statistical Analysis: Statements were ranked by experts according to their level of agreement: 1-3 (disagree), 4-6 (equivocal), and 7-9 (agree). A priori (level 1) consensus was defined as ≥70% agreement and ≤15% disagreement, or vice versa. In the Delphi survey, a second analysis was restricted to stakeholder group(s) considered to have adequate expertise relating to each statement (to achieve level 2 consensus).

Results And Limitations: Overall, 116 statements were included in the Delphi survey. Of these statements, 33 (28%) achieved level 1 consensus and 49 (42%) achieved level 1 or 2 consensus. At the consensus conference, 22 of 27 (81%) statements achieved consensus. These consensus statements provide further guidance across a broad range of topics, including the management of variant histologies, the role/limitations of prognostic biomarkers in clinical decision making, bladder preservation strategies, modern radiotherapy techniques, the management of oligometastatic disease, and the evolving role of checkpoint inhibitor therapy in metastatic disease.

Conclusions: These consensus statements provide further guidance on controversial topics in advanced and variant bladder cancer management until a time when further evidence is available to guide our approach.

Patient Summary: This report summarises findings from an international, multistakeholder project organised by the EAU and ESMO. In this project, a steering committee identified areas of bladder cancer management where there is currently no good-quality evidence to guide treatment decisions. From this, they developed a series of proposed statements, 71 of which achieved consensus by a large group of experts in the field of bladder cancer. It is anticipated that these statements will provide further guidance to health care professionals and could help improve patient outcomes until a time when good-quality evidence is available.
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http://dx.doi.org/10.1016/j.eururo.2019.09.035DOI Listing
February 2020

Validation of survivin and HMGA2 as biomarkers for cisplatin resistance in bladder cancer.

Urol Oncol 2019 11 30;37(11):810.e7-810.e15. Epub 2019 Apr 30.

Department of Urology, West German Cancer Center, University of Duisburg-Essen, University Hospital Essen, Essen, Germany; Department of Urology, Semmelweis University, Budapest, Hungary. Electronic address:

Objectives: Cisplatin-based chemotherapy represents the gold standard in the treatment of advanced bladder cancer (BC) both in the neoadjuvant and adjuvant setting. Since novel immunooncologic agents are available for cisplatin-resistant or ineligible patients, biological markers for the prediction of cisplatin resistance become more important in treatment decisions. Therefore, we aimed to assess the therapy predictive value of 8 promising tissue biomarkers with regard to cisplatin therapy.

Methods: Emmprin, survivin, HMGA2, MTA1, RhoGDI, PEG10, TGM2, and TLN1 expressions were analyzed in paraffin-embedded bladder cancer tissue samples of 106 patients who underwent adjuvant or salvage cisplatin-based chemotherapy by using immunohistochemistry. Results were correlated with the clinicopathological and follow-up data by performing both univariable and multivariable survival analyses.

Results: Higher HMGA2 nuclear staining intensity and positive survivin nuclear staining were associated with worse overall survival (OS) (P = 0.045 and P = 0.002, respectively). In accordance, survivin nuclear staining also significantly correlated with shorter progression free survival (PFS, P = 0.024), while HMGA2 nuclear positivity tended to correlate with shorter PFS (P = 0.069) after at least 2 cycles of chemotherapy. In the multivariable analyses only survivin remained as an independent predictor of both OS and PFS (P = 0.008 and P = 0.025). None of the other markers proved to be significant predictors of adjuvant or salvage cisplatin-based chemotherapy.

Conclusions: Our results demonstrate that survivin represents a promising marker for the prediction of cisplatin resistance in BC. In addition the therapy predictive role of HMGA2 should be further investigated. Immunohistochemical analysis of BC samples provides a feasible way for the prediction of cisplatin-resistance and may therefore provide a valuable tool for optimizing treatment decisions in advanced BC.
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http://dx.doi.org/10.1016/j.urolonc.2019.04.015DOI Listing
November 2019

Serum Levels of MicroRNA-371a-3p (M371 Test) as a New Biomarker of Testicular Germ Cell Tumors: Results of a Prospective Multicentric Study.

J Clin Oncol 2019 06 15;37(16):1412-1423. Epub 2019 Mar 15.

27 Kantonsspital Graubünden, Chur, Switzerland.

Purpose: Previous studies suggested that serum levels of microRNA (miR)-371a-3p (so-called M371 test) have a much higher sensitivity and specificity than the classic markers of testicular germ cell tumors (GCTs) and are applicable toward both seminoma and nonseminoma. We sought to confirm the usefulness of this test as a novel biomarker for GCT.

Patients And Methods: In a prospective, multicentric study, serum samples of 616 patients with testicular GCTs and 258 male controls were examined for serum levels of miRNA-371a-3p (miR levels) by quantitative polymerase chain reaction. The GCT population encompassed 359 patients with seminoma and 257 with nonseminoma; 371 had clinical stage I disease, 201 had systemic disease, and 46 had relapses. Paired measurements before and after orchiectomy were performed in 424 patients; 118 with systemic disease had serial measurements during treatment. miR levels were compared with those of β-human chorionic gonadotropin, α-fetoprotein, and lactate dehydrogenase.

Results: For the primary diagnosis of GCT, the M371 test showed a sensitivity of 90.1%, a specificity of 94.0%, an area under the curve of 0.966 upon receiver operating characteristic analysis, and a positive predictive value of 97.2%. α-Fetoprotein, β-human chorionic gonadotropin, and lactate dehydrogenase had sensitivities of less than 50% in seminoma and slightly higher sensitivities in nonseminomas. miR levels were significantly associated with clinical stage, primary tumor size, and response to treatment. Relapses had elevated miR levels that subsequently dropped to normal upon remission. Teratoma did not express miR-371a-3p.

Conclusion: The M371 test outperforms the classic markers of GCT with both a sensitivity and a specificity greater than 90%. All histologic subgroups, except teratoma, express this marker. The test could be considered for clinical implementation after further validation.
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http://dx.doi.org/10.1200/JCO.18.01480DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6544462PMC
June 2019

[Practice Pattern of Systemic Therapy for Urothelial Cancer in Germany - A Survey of the German Cancer Society].

Aktuelle Urol 2018 Aug 7;49(4):346-354. Epub 2018 Aug 7.

Klinik für Urologie, Kinderurologie und Urologische Onkologie, Kliniken Essen-Mitte, Evang. Huyssens-Stiftung/Knappschaft GmbH, Essen.

Background:  In 2016, the first German guideline for bladder cancer was introduced. This survey evaluates current management of bladder cancer in Germany, focusing on systemic therapies and compares this to the guidelines.

Material And Methods:  More than 4000 urologists and oncologists in Germany received a questionnaire assessing surgical and systemic therapeutic management of bladder cancer. We received 278 evaluable responses.

Results:  This is the largest nationwide survey evaluating current bladder cancer management in Germany. Management can be optimised of non-muscle invasive bladder cancer including intravesical instillation therapies, as well as of muscle invasive bladder cancer including (neo)adjuvant chemotherapies, particularly with respect to the numbers of chemotherapy courses. Management of metastasised bladder cancer is predominantly performed according to the guidelines.

Conclusions:  Adherence to bladder cancer guidelines in Germany can be optimised and could possibly decrease cancer-specific mortality, supported by the development of novel diagnostic and therapeutic options.
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http://dx.doi.org/10.1055/a-0645-1076DOI Listing
August 2018

Experience with One-Stage Repair of Urethral Strictures Using the Augmented Anastomotic Repair Technique.

Urol Int 2018 2;100(4):386-396. Epub 2018 May 2.

Section of Reconstructive Urologic Surgery, Kliniken Essen-Mitte, Essen, Germany.

Introduction: We report the results of augmented anastomotic repair (AAR) in the treatment of anterior urethral strictures.

Material And Methods: In this retrospective study, we evaluated 71 consecutive patients who had undergone AAR between June 2004 and June 2013. Medical records were reviewed to identify early postoperative complications based on the Clavien-Dindo classification (CDC). Self-developed standardized questionnaires sent to the patients and referring urologists were used to collect data on late complications (>90) days. Stricture recurrence (SR) was defined as any postoperative endoscopic or open surgical intervention on the urethra. The influence of patient demographics, stricture characteristics, and operative procedure performed on the occurrence of SR was analyzed.

Results: Early postoperative complications were rare events (11.3%) with only one severe CDC complication. Late complications were reported in 46.5% cases. At a median follow-up of 17 months (range 3-114 months), however, 64 patients had no evidence of SR and required no further intervention, giving an overall success rate of 90.1%. Seven patients with SR had a higher body mass index, were older, and had been operated on by less experienced surgeon(s). Most SRs occurred within the first year after surgery.

Conclusions: AAR was an effective and safe operative technique that allowed one-stage repair in our patients with anterior urethral strictures who needed resection of the scarred urethra and otherwise were not suitable for primary anastomosis or simple substitution urethroplasty.
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http://dx.doi.org/10.1159/000481267DOI Listing
January 2019

Ileal vaginoplasty as vaginal reconstruction in transgender women and patients with disorders of sex development: an international, multicentre, retrospective study on surgical characteristics and outcomes.

BJU Int 2018 06 4;121(6):952-958. Epub 2018 Mar 4.

Department of Plastic, Reconstructive and Hand Surgery, VU University Medical Center, Amsterdam, The Netherlands.

Objective: To describe the surgical outcomes of ileal vaginoplasty in transgender women and patients with disorders of sex development (DSD).

Patients And Methods: Transgender women and patients with DSD, who underwent ileal vaginoplasty at the VU University Medical Center Amsterdam, University Hospital Trieste, University Hospital Essen, and Belgrade University Hospital, were retrospectively identified. A chart review was performed, recording surgical technique, intraoperative characteristics, complications, and re-operations.

Results: We identified a total of 32 patients (27 transgender and five non-transgender), with a median (range) age of 35 (6-63) years. Ileal vaginoplasty was performed as the primary procedure in three and as a revision procedure in the remaining 29. The mean (sd) operative time was 288 (103) min. The procedure was performed laparoscopically (seven patients) or open (25). An ileal 'U-pouch' was created in five patients and a single lumen in 27. Intraoperative complications occurred in two patients (one iatrogenic bladder damage and one intraoperative blood loss necessitating transfusion). The median (range) hospitalisation was 12 (6-30) days. Successful neovaginal reconstruction was achieved in all. The mean (sd) achieved neovaginal depth was 13.2 (3.1) cm. The median (range) clinical follow-up was 35 (3-159) months. In one patient a recto-neovaginal fistula occurred, which lead to temporary ileostomy. Introital stenosis occurred in four patients (12.5%).

Conclusion: Ileal vaginoplasty can be performed with few intra- and postoperative complications. It appears to have similar complication rates when compared to sigmoid vaginoplasty. It now seems to be used predominantly for revision procedures.
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http://dx.doi.org/10.1111/bju.14155DOI Listing
June 2018

[Diagnosis, treatment and follow-up of testicular cancer].

Authors:
Susanne Krege

Urologe A 2017 Dec;56(12):1623-1636

Klinik für Urologie, Kinderurologie und urologische Onkologie, Kliniken Essen Mitte, Hyussens-Stiftung, Henricistraße 92, 45136, Essen, Deutschland.

Background: Testicular cancer is a disease of young adult men, and it is curable in most cases. Even in advanced disease, cure rates reach 80 % nowadays. This was achieved by consistently performing studies concerning the different stages of disease.

Treatment And Follow-up Care: The concept of treatment is interdisciplinary. After removal of the affected testis, histology and stage determine further therapy, which can be active surveillance, polychemotherapy, radiotherapy, surgery, or a combination of these. Curability also has consequences for the long-term follow-up. We speak about long-term survivorship. Besides looking for recurrences, it is also necessary to observe and treat long-term toxicities caused by the different therapeutic procedures.

Conclusion: Because testicular cancer is rare with about 4500 cases annually, treatment-especially for advanced disease-should be performed at centers. In addition, it is possible to obtain a second opinion using the Interdisciplinary German Testicular Study Group website.
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http://dx.doi.org/10.1007/s00120-017-0543-9DOI Listing
December 2017

Robot-assisted laparoscopic Y-V plasty in 12 patients with refractory bladder neck contracture.

J Robot Surg 2018 Mar 27;12(1):139-145. Epub 2017 Apr 27.

Department of Urology, Paediatric Urology and Urologic Oncology, Kliniken Essen-Mitte, Henricistrasse 92, 45136, Essen, Germany.

We present preliminary results of a case series on refractory bladder neck contracture (BNC) treated with robot-assisted laparoscopic Y-V plasty (RAYV). Between 01/2013 and 02/2016, 12 consecutive adult male patients underwent RAYV in our hospital. BNC developed after transurethral procedures (n = 9), simple prostatectomy (n = 2) and HIFU therapy of the prostate (n = 1). Each patient had had multiple unsuccessful previous endoscopic treatments. All RAYV procedures were performed using a transperitoneal six-port approach (four-arm robotic setting). There were no intraoperative or major postoperative complications. During a median follow-up of 23.2 months two cases of refractory BNC were observed. In both cases a postoperative International Prostate Symptom Score (IPSS) of 20 and 25 was reported, respectively. In contrast, amongst the patients without evidence of refractory BNC the median IPSS was 6.5 reflecting an only mildly impaired voiding function in most cases, thus, suggesting a treatment success in 83.3% of patients. To the best of our knowledge, this is the first report on RAYV for refractory BNC. In our series RAYV was feasible in all patients, and only two cases of refractory BNC were reported during a median follow-up of almost 2 years. At the same time, no intraoperative or major postoperative complications were observed. More clinical data with a longer follow-up are needed in this promising field to reveal the actual efficacy and relevance of RAYV.
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http://dx.doi.org/10.1007/s11701-017-0708-yDOI Listing
March 2018

The Diagnosis, Treatment, and Follow-up of Renal Cell Carcinoma.

Dtsch Arztebl Int 2016 Sep;113(35-36):590-6

Urologikum Lübeck, Department of Hematology, Hemostaseology, Oncology and Stem Cell Transplantation, Hannover Medical School, Department of Urology, HELIOS Klinikum Erfurt GmbH, German Guideline Program in Oncology/German Cancer Society, MeckEvidence, Schwarz, Department of Urology, Urologic Onkology and Pediatric Urology, Kliniken Essen-Mitte/Evangelische Huyssens-Stiftung.

Background: In 2014, 15 500 persons in Germany were given the diagnosis of renal cell carcinoma. This disease is the third most common cancer of the urogenital system. The mean age at diagnosis is 68 years in men and 71 in men.

Methods: Pertinent publications up to 2014 were retrieved by a systematic literature search and reviewed in a moderated, formalized consensus process. Key questions were generated and answered by the adaptation of existing international guidelines, on the basis of an independent literature review, and by expert consensus. Representatives of 30 medical specialty societies, patient self-help groups, and other organizations participated in the process.

Results: The search for guidelines yielded 80 hits, 23 of which were judged by DELBI to be potentially relevant; 7 were chosen for adaptation. Smoking, obesity, and hypertension increase the risk of renal cell carcinoma. Its 5-year survival rate is 75% for men and 77% for women. Renal cell carcinoma accounts for 2.6% of all deaths from cancer in men and 2.1% in women. Nephrectomy and partial nephrectomy are the standard treatments. Locally confined tumors in clinical stage T1 should be treated with kidney-preserving surgery. Minimally invasive surgery is often possible as long as the surgeon has the requisite experience. For patients with metastases, overall and progression-free survival can be prolonged with VEGF and mTOR inhibitors. The resection or irradiation of metastases can be a useful palliative treatment for patients with brain metastases or osseous metastases that are painful or increase the risk of fracture.

Conclusion: Minimally invasive surgery and new systemic drugs have expanded the therapeutic options for patients with renal cell carcinoma. The search for new predictive and prognostic markers is now in progress.
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http://dx.doi.org/10.3238/arztebl.2016.0590DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5963492PMC
September 2016

[Testicular tumors - results of primary retroperitoneal lymphadenectomy].

Authors:
Susanne Krege

Aktuelle Urol 2014 May 16;45(3):169-70. Epub 2014 Jun 16.

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http://dx.doi.org/10.1055/s-0034-1383476DOI Listing
May 2014

German second-opinion network for testicular cancer: sealing the leaky pipe between evidence and clinical practice.

Oncol Rep 2014 Jun 24;31(6):2477-81. Epub 2014 Apr 24.

Department of Urology, University Hospital of Ulm, Ulm, Germany.

In 2006, the German Testicular Cancer Study Group initiated an extensive evidence-based national second-opinion network to improve the care of testicular cancer patients. The primary aims were to reflect the current state of testicular cancer treatment in Germany and to analyze the project's effect on the quality of care delivered to testicular cancer patients. A freely available internet-based platform was developed for the exchange of data between the urologists seeking advice and the 31 second-opinion givers. After providing all data relevant to the primary treatment decision, urologists received a second opinion on their therapy plan within <48 h. Endpoints were congruence between the first and second opinion, conformity of applied therapy with the corresponding recommendation and progression-free survival rate of the introduced patients. Significance was determined by two-sided Pearson's χ2 test. A total of 1,284 second-opinion requests were submitted from November 2006 to October 2011, and 926 of these cases were eligible for further analysis. A discrepancy was found between first and second opinion in 39.5% of the cases. Discrepant second opinions led to less extensive treatment in 28.1% and to more extensive treatment in 15.6%. Patients treated within the framework of the second-opinion project had an overall 2-year progression-free survival rate of 90.4%. Approximately every 6th second opinion led to a relevant change in therapy. Despite the lack of financial incentives, data from every 8th testicular cancer patient in Germany were submitted to second-opinion centers. Second-opinion centers can help to improve the implementation of evidence into clinical practice.
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http://dx.doi.org/10.3892/or.2014.3153DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4055348PMC
June 2014

Prospective randomized double-blind multicentre phase II study comparing gemcitabine and cisplatin plus sorafenib chemotherapy with gemcitabine and cisplatin plus placebo in locally advanced and/or metastasized urothelial cancer: SUSE (AUO-AB 31/05).

BJU Int 2014 Mar;113(3):429-36

Department of Urology, Alexianer Hospital Maria Hilf GmbH, Krefeld, Germany.

Objective: To evaluate the efficacy and safety of gemcitabine and cisplatin in combination with sorafenib, a tyrosine-kinase inhibitor, compared with chemotherapy alone as first-line treatment in advanced urothelial cancer.

Patients And Methods: The study was a randomized phase II trial. Its primary aim was to show an improvement in progression-free survival (PFS) of 4.5 months by adding sorafenib to conventional chemotherapy. Secondary objectives were objective response rate (ORR), overall survival (OS) and toxicity. The patients included in the trial had histologically confirmed locally advanced and/or metastatic urothelial cancer of the bladder or upper urinary tract. Chemotherapy with gemcitabine (1250 mg/qm on days 1 and 8) and cisplatin (70 mg/qm on day 1) repeated every 21 days, was administered to all patients in a double-blind randomization of additional sorafenib (400 mg twice daily) vs placebo (two tablets twice daily) on days 3-21. Treatment continued until progression or unacceptable toxicity, the maximum number of cycles was limited to eight. The response assessment was repeated after every two cycles.

Results: Between October 2006 and October 2010, 98 of 132 planned patients were recruited. Nine patients were ineligible. The final analysis included 40 patients in the sorafenib and 49 patients in the placebo arm. There were no significant differences between the two arms concerning ORR (sorafenib: complete response [CR] 12.5%, partial response [PR] 40%; placebo: CR 12%, PR 35%), median PFS (sorafenib: 6.3 months, placebo: 6.1 months) or OS (sorafenib: 11.3 months, placebo: 10.6 months). Toxicity was moderately higher in the sorafenib arm. Diarrrhoea occurred significantly more often in the sorafenib arm and hand-foot syndrome occurred only in the sorafenib arm. The study was closed prematurely because of slow recruitment.

Conclusion: Although the addition of sorafenib to standard chemotherapy showed acceptable toxicity, the trial failed to show a 4.5 months improvement in PFS.
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http://dx.doi.org/10.1111/bju.12437DOI Listing
March 2014

The contemporary role of chemotherapy for advanced testis cancer: a systematic review of the literature.

Eur Urol 2012 Jun 24;61(6):1212-21. Epub 2012 Mar 24.

Department of Medical Oncology, San Camillo Forlanini Hospital, Rome, Italy.

Context: Germ cell tumours (GCTs) of the testis are the most common cancer in young men; they are also one of the most curable cancers. Standard treatment of metastatic GCTs has evolved on the basis of randomised trials and prognostic factors.

Objective: This review summarises the evolving role of chemotherapy in the treatment of previously treated and untreated patients with metastatic GCTs and outlines the current standard treatment.

Evidence Acquisition: Randomised and nonrandomised trials of first-line, salvage, and palliative therapy were reviewed.

Evidence Synthesis: Three cycles of standard bleomycin, etoposide, and platinum (BEP) can be considered the gold-standard treatment in good-risk patients, and four cycles of the same combination can result in cure in approximately 80% of intermediate-risk and 50% of poor-risk patients. The routine use of high-dose chemotherapy in patients with intermediate- or poor-prognosis GCT has not improved treatment outcome, but the role of tumour marker decline during the first cycles may provide useful prognostic information. Prognostic variables in patients who experience treatment failure after cisplatin-based chemotherapy can be used to guide salvage strategies, and many new drugs or combinations have shown activity in this setting. Patients and physicians should be aware of the risk of short- and long-term toxicity of treatments, and guidelines for screening and prevention of this risk should be established.

Conclusions: A risk-based strategy offers the best chance of cure, even in patients with refractory GCT.
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http://dx.doi.org/10.1016/j.eururo.2012.03.038DOI Listing
June 2012

Time trends in prostate cancer surgery: data from an Internet-based multicentre database.

BJU Int 2012 Feb 24;109(3):355-9. Epub 2011 Aug 24.

Charité, Universitätsmedizin Berlin, Urologische Klinik und Hochschulambulanz, Berlin, Germany.

Objectives: To report our experience with an Internet-based multicentre database that enables tumour documentation, as well as the collection of quality-related parameters and follow-up data, in surgically treated patients with prostate cancer. The system was used to assess the quality of prostate cancer surgery and to analyze possible time-dependent trends in the quality of care.

Patients And Methods: An Internet-based database system enabled a standardized collection of treatment data and clinical findings from the participating urological centres for the years 2005-2009. An analysis was performed aiming to evaluate relevant patient characteristics (age, pathological tumour stage, preoperative International Index of Erectile Function-5 score), intra-operative parameters (operating time, percentage of nerve-sparing operations, complication rate, transfusion rate, number of resected lymph nodes) and postoperative parameters (hospitalization time, re-operation rate, catheter indwelling time). Mean values were calculated and compared for each annual cohort from 2005 to 2008. The overall survival rate was also calculated for a subgroup of the Berlin patients.

Results: A total of 914, 1120, 1434 and 1750 patients submitted to radical prostatectomy in 2005, 2006, 2007 and 2008 were documented in the database. The mean age at the time of surgery remained constant (66 years) during the study period. More than half the patients already had erectile dysfunction before surgery (median International Index of Erectile Function-5 score of 19-20). During the observation period, there was a decrease in the percentage of pT2 tumours (1% in 2005; 64% in 2008) and a slight increase in the percentage of patients with lymph node metastases (8% in 2005; 10% in 2008). No time trend was found for the operating time (142-155 min) or the percentage of nerve-sparing operations (72-78% in patients without erectile dysfunction). A decreasing frequency was observed for the parameters: blood transfusions (1.9% in 2005; 0.5% in 2008), postoperative bleeding (2.6%; 1.2%) and re-operations (4.5%; 2.8%). The mean hospitalization time decreased accordingly (10 days in 2005; 8 days in 2008). The examined subcohort had an overall mortality of 1.5% (median follow-up of 3 years).

Conclusions: An Internet-based database system for tumour documentation in patients with prostate cancer enables the collection and assessment of important parameters for the quality of care and outcomes. The participating centres show an improvement in the quality of surgical management, including a reduction of the complication rate.
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http://dx.doi.org/10.1111/j.1464-410X.2011.10356.xDOI Listing
February 2012

Interdisciplinary evidence-based recommendations for the follow-up of early stage seminomatous testicular germ cell cancer patients.

Strahlenther Onkol 2011 Mar 21;187(3):158-66. Epub 2011 Feb 21.

Department of Radiation Oncology, University Hospital, Tübingen, Germany.

Purpose: To provide guidance regarding follow-up procedures after initial treatment of early stage testicular seminoma (clinical stages (CS) I-II A/B) based on current published evidence complemented by expert opinion.

Methods And Material: An interdisciplinary, multinational working group consisting of urologists, medical oncologists, and radiation oncologists analyzed the published evidence regarding follow-up procedures in various stages of seminomatous and nonseminomatous testicular cancers. Focusing on radiooncological aspects, the recommendations contained herein are restricted to early stage seminoma (with radiotherapy being a standard treatment option). In particular, extent, frequency, and duration of imaging at follow-up were analyzed concerning relapse patterns, risk factors, and mode of relapse detection.

Results: Active surveillance, adjuvant carboplatin or radiotherapy are equally accepted options for CS I seminoma but they result in different relapse rates and patterns. Usually relapses occur within the first 2(-6) years. Routinely performed follow-up using computerized tomography (CT) after adjuvant treatment yield only low detection rates of recurrences. Therefore, there is no evidence to maintain routine examinations every 3-4 months. After treatment of stage IIA/B, detection rates of relapses or progression identified solely by routinely performed CT during follow-up are low.

Conclusion: Considering lifelong cure rates of up to 99% for patients treated for seminoma CS I-IIA/B, the negative impact of unnecessary ionizing radiation exposure has to be considered. The presented recommendations for various follow-up scenarios for early stage seminoma strongly promote the restrictive use of imaging procedures that utilize ionizing radiation (especially CT), due to its potential to induce secondary malignancies.
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http://dx.doi.org/10.1007/s00066-010-2227-xDOI Listing
March 2011

Interdisciplinary evidence-based recommendations for the follow-up of testicular germ cell cancer patients.

Onkologie 2011 17;34(1-2):59-64. Epub 2011 Jan 17.

Medical Oncology, Kantonsspital Graubünden, Chur, Switzerland.

Over the last years, clear treatment recommendations for patients with testicular cancer have been published. This has led to significant improvements in outcome and survival. Moreover, active surveillance has become a cornerstone in the management of clinical stage I seminomatous and non-seminomatous germ cell tumors. On the other hand, the existing recommendations for the follow-up of testis cancer patients are unclear and differ widely. Follow-up recommendations in this young patient population have to be as evidence based as possible, feasible in order to ensure adherence, and must not be harmful. Therefore, attention has to be paid to the negative impact of unnecessary radiation exposure. Recently, new evidence became available regarding the relapse pattern of different disease stages of testicular cancer, the use of imaging at follow-up, and the risks of excessive radiation due to imaging, and in particular that of computed tomography (CT) scans. This article summarizes the recommendations for follow-up of testicular cancer patients of an interdisciplinary multinational working group consisting of urologists, medical oncologists, and radiation oncologists.
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http://dx.doi.org/10.1159/000323346DOI Listing
July 2011

Imaging studies in metastatic urogenital cancer patients undergoing systemic therapy: recommendations of a multidisciplinary consensus meeting of the Association of Urological Oncology of the German Cancer Society.

Urol Int 2010 26;85(1):1-10. Epub 2010 Jul 26.

Department of Urology, RWTH University, Aachen, Germany. aheidenreich @ ukaachen.de

Introduction: Imaging studies are an integral and important diagnostic modality to stage, to monitor and follow-up patients with metastatic urogenital cancer. The currently available guidelines on diagnosis and treatment of urogenital cancer do not provide the clinician with evidence-based recommendations for daily practice.

Objectives: To develop scientifically valid recommendations with regard to the most appropriate imaging technique and the most useful time interval in metastatic urogenital cancer patients undergoing systemic therapy.

Methods: A systematic literature review was performed searching MedLine, Embase and Web of Science databases using the terms prostate, renal cell, bladder and testis cancer in combination with the variables lymph node, lung, liver, bone metastases, chemotherapy and molecular therapy, and the search terms computed tomography, magnetic resonance imaging and positron emission tomography were applied. A total of 11,834 records were retrieved from all databases. The panel reviewed the records to identify articles with the highest level of evidence using the recommendation of the US Agency for Health Care Policy and Research.

Conclusions: Contrast-enhanced computed tomography remains the standard imaging technique for monitoring of pulmonary, hepatic and lymph node metastases. Bone scintigraphy is still the most widely used imaging technique for the detection and follow-up of osseous lesions. For clinical trials it might be replaced by either PET-CT or MRI of the skeletal axis. Response assessment for patients treated with cytotoxic regime is best performed by the RECIST/WHO criteria; treatment response to molecular triggered therapy is best assessed by CT evaluating decrease in tumor size and density. Cross-sectional imaging studies for response assessment might be obtained after each 2 cycles of systemic therapy to early stratify responders from non-responders.
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http://dx.doi.org/10.1159/000318985DOI Listing
December 2010
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