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PURPOSE: To investigate functional, oncological and complication outcomes in women undergoing robot-assisted cystectomy (RARC) with intracorporeal orthotopic neobladder. METHODS: From a multi-institutional database, we identified females with bladder cancer treated with RARC and intracorporeal orthotopic neobladder. We evaluated the continence rate, short-term oncological outcomes, and complication rates. Analyses were repeated and stratified by the status of preserving gynecological organs. RESULTS: The study involved 146 patients with the median age 60 years (IQR, 51-66 years). Pelvic organ-preserving procedure (POP) was performed in 77 patients (53%). Overall daytime and nighttime continence rates were 54% and 53%, respectively. For POP, the continence rate was 58% for both daytime and nighttime continence. In the non-POP cohort, the continence rate was 50% for daytime and 49% for nighttime continence. Both groups had balanced positive surgical margin rates (5,3% for POP and 4,7% for non-POP). In the whole cohort, high-grade (Clavien-Dindo ≥3) early and late complication rate was 7,5% and 7,5%, respectively. CONCLUSIONS: Robot-assisted radical cystectomy with intracorporeal orthotopic neobladder in females demonstrate excellent functional and complication outcomes. Pelvic organ-preserving cystectomy enhances urinary continence rates without adversely affecting surgical margins. Orthotopic neobladder in selected women with bladder cancer, along with pelvic organ-preserving cystectomy may be used for improved functional outcomes without compromising oncological results.
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Cistectomía , Procedimientos Quirúrgicos Robotizados , Neoplasias de la Vejiga Urinaria , Humanos , Femenino , Cistectomía/métodos , Persona de Mediana Edad , Procedimientos Quirúrgicos Robotizados/métodos , Anciano , Neoplasias de la Vejiga Urinaria/cirugía , Resultado del Tratamiento , Estudios Retrospectivos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Reservorios Urinarios Continentes , Derivación Urinaria/métodosRESUMEN
BACKGROUND: Previous studies have shown that men with HIV and germ cell cancer (HIV-GCC) have inferior overall survival (OS) in comparison with their HIV-negative counterparts. However, little information is available on treatments and outcomes of HIV-GCC in the era of combination antiretroviral therapy (cART). METHODS: This study examined men living with HIV who were 18 years old or older and had a diagnosis of histologically proven germ cell cancer (GCC). The primary outcomes were OS and progression-free survival (PFS). RESULTS: Data for 89 men with a total of 92 HIV-GCCs (2 synchronous GCCs and 1 metachronous bilateral GCC) were analyzed; among them were 64 seminomas (70%) and 28 nonseminomas (30%). The median age was 36 years, the median CD4 T-cell count at GCC diagnosis was 420 cells/µL, and 77% of the patients on cART had an HIV RNA load < 500 copies/mL. Stage I disease was found in 44 of 79 gonadal GCCs (56%). Among 45 cases with primary disseminated GCC, 78%, 18%, and 4% were assigned to the good-, intermediate-, and poor-prognosis groups, respectively, of the International Germ Cell Cancer Collaborative Group. Relapses occurred in 14 patients. Overall, 12 of 89 patients (13%) died. The causes of death were refractory GCC (n = 5), an AIDS-defining illness (n = 3), and other causes (n = 4). After a median follow-up of 6.5 years, the 5- and 10-year PFS rates were 81% and 73%, respectively, and the 5- and 10-year OS rates were 91% and 85%, respectively. CONCLUSIONS: The 5- and 10-year PFS and OS rates of men with HIV-GCC were similar to those reported for men with HIV-negative GCC. Patients with HIV-GCC should be managed identically to HIV-negative patients. LAY SUMMARY: Men living with HIV are at increased risk for germ cell cancer (GCC). Previous studies have shown that the survival of men with HIV-associated germ cell cancer (HIV-GCC) is poorer than the survival of their HIV-negative counterparts. This study examined the characteristics, treatments, and outcomes of 89 men with HIV-GCC in the era of effective combination antiretroviral therapies. The long-term outcomes of men with HIV-GCC were similar to those reported for men with HIV-negative GCC. Patients with HIV-GCC should be managed identically to HIV-negative patients.
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Infecciones por VIH , Neoplasias de Células Germinales y Embrionarias , Seminoma , Neoplasias Testiculares , Adolescente , Adulto , Infecciones por VIH/complicaciones , Infecciones por VIH/tratamiento farmacológico , Humanos , Masculino , Recurrencia Local de Neoplasia , Seminoma/patología , Neoplasias Testiculares/patologíaRESUMEN
Chronic lymphocytic leukaemia (CLL) is characterised by malignant mature-like B cells. Supportive to CLL cell survival is chronic B-cell receptor (BCR) signalling; however, emerging evidence demonstrates CLL cells proliferate in response to T-helper (Th) cells in a CD40L-dependent manner. We showed provision of Th stimulation via CD40L upregulated CD45 phosphatase activity and BCR signalling in non-malignant B cells. Consequently, we hypothesised Th cell upregulation of CLL cell CD45 activity may be an important regulator of CLL BCR signalling and proliferation. Using patient-derived CLL cells in a culture system with activated autologous Th cells, results revealed increases in both Th and CLL cell CD45 activity, which correlated with enhanced downstream antigen receptor signalling and proliferation. Concomitantly increased was the surface expression of Galectin-1, a CD45 ligand, and CD43, a CLL immunophenotypic marker. Galectin-1/CD43 double expression defined a proliferative CLL cell population with enhanced CD45 activity. Targeting either Galectin-1 or CD43 using silencing, pharmacology, or monoclonal antibody strategies dampened CD45 activity and CLL cell proliferation. These results highlight a mechanism where activated Th cells drive CLL cell BCR signalling and proliferation via Galectin-1 and CD43-mediated regulation of CD45 activity, identifying modulation of CD45 phosphatase activity as a potential therapeutic target in CLL.
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Leucemia Linfocítica Crónica de Células B , Ligando de CD40 , Proliferación Celular , Galectina 1 , Humanos , Leucemia Linfocítica Crónica de Células B/patología , Linfocitos T Colaboradores-InductoresRESUMEN
PURPOSE: Follow-up protocols for patients with testicular cancer (TC) have significantly reduced the number of cross-sectional imaging studies to reduce radiation exposure. At present, it is unclear whether magnetic resonance imaging (MRI) could replace conventional computerized tomography (CT) imaging. The objective of this study is to summarize the scientific evidence on this topic and to review guideline recommendations with regard to the use of MRI. METHODS: A systematic literature review was performed searching Medline and Cochrane databases for prospective studies on patients with TC in the follow-up care (last search in February 2021). Additionally, guideline recommendations for TC were screened. Data extraction and quality assessment of included studies were performed and used for a descriptive presentation of results. RESULTS: A total of four studies including two ongoing trials were identified. Overall, the scientific evidence of prospective comparative studies is based on 102 patients. Data suggest that abdominal imaging with MRI can replace conventional CT for detection of lymph node metastasis of the retroperitoneum to spare radiation exposure and contrast media application. However, experienced radiologists are needed. Clinical guidelines are aware of the risk of diagnosis-induced secondary malignancy due to CT imaging and some have adapted their recommendations accordingly. Results of the two ongoing trials on 738 patients are expected soon to provide more reliable results on this topic. CONCLUSIONS: There is growing evidence that abdominopelvic MRI imaging can replace CT imaging during follow-up of patients with TC in order to reduce radiation exposure and diagnosis-induced secondary malignancy.
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Neoplasias Testiculares , Masculino , Humanos , Neoplasias Testiculares/diagnóstico por imagen , Neoplasias Testiculares/patología , Estudios Prospectivos , Estudios de Seguimiento , Imagen por Resonancia MagnéticaRESUMEN
OBJECTIVE: To systematically evaluate evidence on prognostic factors for tumor recurrence in clinical stage I nonseminoma patients other than lymphovascular invasion (LVI). METHODS: We performed a systematic literature search in the biomedical databases Medline (via Ovid) and Cochrane Central Register of Controlled Trials (search period January 2010 to February 2021) for full text publications in English and German language, reporting on retro- or prospectively assessed prognostic factors for tumor recurrence in patients with stage I nonseminomatous germ cell tumors. RESULTS: Our literature search yielded eleven studies reporting on 20 potential prognostic factors. Results are based on cohort studies of mostly moderate to low quality. Five out of eight studies found a significant association of embryonal carcinoma (EC) in the primary tumor with relapse. Among the different risk definitions of embryonal carcinoma (presence, predominance, pure), presence of EC alone seems to be sufficient for prognostification. Interesting results were found for rete testis invasion, predominant yolk sac tumor, T-stage and history of cryptorchidism, but the sparse data situation does not justify their clinical use. CONCLUSIONS: No additional factors that meet the prognostic value of LVI, especially when determined by immunohistochemistry, could be identified through our systematic search. The presence of EC might serve as a second, subordinate prognostic factor for clinical use as the data situation is less abundant than the one of LVI. Further efforts are necessary to optimize the use of these two prognostic factors and to evaluate and validate further potential factors with promising preliminary data.
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Carcinoma Embrionario , Neoplasias Testiculares , Masculino , Humanos , Carcinoma Embrionario/patología , Pronóstico , Recurrencia Local de Neoplasia/patología , Estadificación de Neoplasias , Invasividad Neoplásica/patología , Neoplasias Testiculares/patologíaRESUMEN
PURPOSE: To present the current evidence and the development of studies in recent years on the management of extragonadal germ cell tumors (EGCT). METHODS: A systematic literature search was conducted in Medline and the Cochrane Library. Studies within the search period (January 2010 to February 2021) that addressed the classification, diagnosis, prognosis, treatment, and follow-up of extragonadal tumors were included. Risk of bias was assessed and relevant data were extracted in evidence tables. RESULTS: The systematic search identified nine studies. Germ cell tumors (GCT) arise predominantly from within the testis, but about 5% of the tumors are primarily located extragonadal. EGCT are localized primarily mediastinal or retroperitoneal in the midline of the body. EGCT patients are classified according to the IGCCCG classification. Consecutively, all mediastinal non-seminomatous EGCT patients belong to the "poor prognosis" group. In contrast mediastinal seminoma and both retroperitoneal seminoma and non-seminoma patients seem to have a similar prognosis as patients with gonadal GCTs and metastasis at theses respective sites. The standard chemotherapy regimen for patients with a EGCT consists of 3-4 cycles (good vs intermediate prognosis) of bleomycin, etoposid, cisplatin (BEP); however, due to their very poor prognosis patients with non-seminomatous mediastinal GCT should receive a dose-intensified or high-dose chemotherapy approach upfront on an individual basis and should thus be referred to expert centers Ifosfamide may be exchanged for bleomycin in cases of additional pulmonary metastasis due to subsequently planned resections. In general patients with non-seminomatous EGCT, residual tumor resection (RTR) should be performed after chemotherapy. CONCLUSION: In general, non-seminomatous EGCT have a poorer prognosis compared to testicular GCT, while seminomatous EGGCT seem to have a similar prognosis to patients with metastatic testicular seminoma. The current insights on EGCT are limited, since all data are mainly based on case series and studies with small patient numbers and non-comparative studies. In general, systemic treatment should be performed like in testicular metastatic GCTs but upfront dose intensification of chemotherapy should be considered for mediastinal non-seminoma patients. Thus, EGCT should be referred to interdisciplinary centers with utmost experience in the treatment of germ cell tumors.
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Neoplasias del Mediastino , Neoplasias de Células Germinales y Embrionarias , Neoplasias Primarias Secundarias , Seminoma , Neoplasias Testiculares , Masculino , Humanos , Estudios de Seguimiento , Neoplasias de Células Germinales y Embrionarias/terapia , Neoplasias de Células Germinales y Embrionarias/tratamiento farmacológico , Neoplasias Testiculares/terapia , Neoplasias Testiculares/tratamiento farmacológico , Seminoma/tratamiento farmacológico , Neoplasias del Mediastino/terapia , Neoplasias del Mediastino/tratamiento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Bleomicina/uso terapéuticoRESUMEN
PURPOSE: Testicular germ cell tumours (GCTs) represent the most common malignancy in young adult males with two thirds of all cases presenting with clinical stage I (CSI). Active surveillance is the management modality mostly favoured by current guidelines. This systematic review assesses the treatment results in CSI patients concerning recurrence rate and overall survival in non-seminoma (NS) and pure seminoma (SE) resulting from surveillance in comparison to adjuvant strategies. METHODS/SYSTEMATIC REVIEW: We performed a systematic literature review confining the search to most recent studies published 2010-2021 that reported direct comparisons of surveillance to adjuvant management. We searched Medline and the Cochrane Library with additional hand-searching of reference lists to identify relevant studies. Data extraction and quality assessment of included studies were performed with stratification for histology (NS vs. SE) and treatment modalities. The results were tabulated and evaluated with descriptive statistical methods. RESULTS: Thirty-four studies met the inclusion criteria. In NS patients relapse rates were 12 to 37%, 0 to 10%, and 0 to 11.8% for surveillance, chemotherapy and for retroperitoneal lymph node dissection (RPLND) while overall survival rates were 90.7-100%, 91.7-100%, and 97-99.1%, respectively. In SE CSI, relapse rates were 0-22.3%, 0-5%, and 0-12.5% for surveillance, radiotherapy, chemotherapy, while overall survival rates were 84.1-98.7%, 83.5-100%, and 92.3-100%, respectively. CONCLUSION: In both histologic subgroups, active surveillance offers almost identical overall survival as adjuvant management strategies, however, at the expense of higher relapse rates. Each of the management strategies in CSI GCT patients have specific merits and shared-decision-making is advised to tailor treatment.
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Neoplasias de Células Germinales y Embrionarias , Seminoma , Neoplasias Testiculares , Masculino , Adulto Joven , Humanos , Orquiectomía/métodos , Estadificación de Neoplasias , Recurrencia Local de Neoplasia/terapia , Recurrencia Local de Neoplasia/tratamiento farmacológico , Neoplasias Testiculares/patología , Neoplasias de Células Germinales y Embrionarias/patología , Seminoma/patología , Escisión del Ganglio Linfático/métodos , Quimioterapia Adyuvante/métodosRESUMEN
PURPOSE: In this review, we summarize and discuss contemporary treatment standards and possible selection criteria for decision making after failure of adjuvant or first-line cisplatin-based chemotherapy for primarily localized or metastatic germ cell tumors. METHODS: This work is based on a systematic literature search conducted for the elaboration of the first German clinical practice guideline to identify prospective clinical trials and retrospective comparative studies published between Jan 2010 and Feb 2021. Study end points of interest were progression-free (PFS) and overall survival (OS), relapse rate (RR), and/or safety. RESULTS: Relapses of clinical stage I (CS I) patients irrespective of prior adjuvant treatment after orchiectomy are treated stage adapted in accordance for primary metastatic patients. Surgical approaches for sole retroperitoneal relapses are investigated in ongoing clinical trials. The appropriate salvage chemotherapy for metastatic patients progressing or relapsing after first-line cisplatin-based chemotherapy is still a matter of controversy. Conventional cisplatin-based chemotherapy is the international guideline-endorsed standard of care, but based on retrospective data high-dose chemotherapy and subsequent autologous stem cell transplantation may offer a 10-15% survival benefit for all patients. Secondary complete surgical resection of all visible residual masses irrespective of size is paramount for treatment success. CONCLUSIONS: Patients relapsing after definite treatment of locoregional disease are to be treated by stage-adapted first-line standard therapy for metastatic disease. Patients with primary advanced/metastatic disease failing one line of cisplatin-based combination chemotherapy should be referred to GCT expert centers. Dose intensity is a matter of ongoing debate, but sequential high-dose chemotherapy seems to improve patients' survival.
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Trasplante de Células Madre Hematopoyéticas , Neoplasias de Células Germinales y Embrionarias , Neoplasias Testiculares , Masculino , Humanos , Neoplasias Testiculares/patología , Terapia Recuperativa , Cisplatino/uso terapéutico , Estudios Retrospectivos , Estudios Prospectivos , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Recurrencia Local de Neoplasia/tratamiento farmacológico , Trasplante Autólogo , Neoplasias de Células Germinales y Embrionarias/tratamiento farmacológicoRESUMEN
PURPOSE: The optimal treatment for clinical stage (CS) IIA/IIB seminomas is still controversial. We evaluated current treatment options. METHODS: A systematic review was performed. Only randomized clinical trials and comparative studies published from January 2010 until February 2021 were included. Search items included: seminoma, CS IIA, CS IIB and therapy. Outcome parameters were relapse rate (RR), relapse-free (RFS), overall and cancer-specific survival (OS, CSS). Additionally, acute and long-term side effects including secondary malignancies (SMs) were analyzed. RESULTS: Seven comparative studies (one prospective and six retrospective) were identified with a total of 5049 patients (CS IIA: 2840, CS IIB: 2209). The applied treatment modalities were radiotherapy (RT) (n = 3049; CS IIA: 1888, CSIIB: 1006, unknown: 155) and chemotherapy (CT) or no RT (n = 2000; CS IIA: 797, CS IIB: 1074, unknown: 129). In CS IIA, RRs ranged from 0% to 4.8% for RT and 0% for CT. Concerning CS IIB RRs of 9.5%-21.1% for RT and of 0%-14.2% for CT have been reported. 5-year OS ranged from 90 to 100%. Only two studies reported on treatment-related toxicities. CONCLUSIONS: RT and CT are the most commonly applied treatments in CS IIA/B seminoma. In CS IIA seminomas, RRs after RT and CT are similar. However, in CS IIB, CT seems to be more effective. Survival rates of CS IIA/B seminomas are excellent. Consequently, long-term toxicities and SMs are important survivorship issues. Alternative treatment approaches, e.g., retroperitoneal lymph node dissection (RPLND) or dose-reduced sequential CT/RT are currently under prospective investigation.
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Neoplasias Primarias Secundarias , Seminoma , Neoplasias Testiculares , Masculino , Humanos , Seminoma/radioterapia , Seminoma/tratamiento farmacológico , Estudios Retrospectivos , Estudios Prospectivos , Estadificación de Neoplasias , Recurrencia Local de Neoplasia/patología , Neoplasias Testiculares/radioterapia , Neoplasias Testiculares/tratamiento farmacológico , Neoplasias Primarias Secundarias/patologíaRESUMEN
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.
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Carcinoma de Células Renales , Neoplasias Renales , Humanos , Anciano , Carcinoma de Células Renales/patología , Neoplasias Renales/tratamiento farmacológico , Estudios Retrospectivos , Inhibidores de Proteínas Quinasas/uso terapéutico , Supervivencia sin ProgresiónRESUMEN
PURPOSE: Salvage lymph node dissection is a rescue treatment for patients with nodal recurrence after radical prostatectomy. Very limited data are available on robotic salvage lymph node dissection. Our purpose was to investigate perioperative and oncological outcomes of robotic salvage lymph node dissection in a large monocentric series. MATERIALS AND METHODS: Perioperative data, complications within 30 days after surgery and oncological outcomes as assessed by histology, prostate specific antigen changes, prostate specific antigen nadir after salvage lymph node dissection, and time to further therapy were analyzed. To identify predictive factors for oncological outcome, Kaplan-Meier and Cox-regression analyses were performed. For cases with a mismatch between preoperative positron emission tomography/computed tomography and the number of histologically positive lymph nodes, prostate specific membrane antigen immunohistochemistry was performed on removed lymph nodes. RESULTS: A total of 68 patients underwent robotic salvage lymph node dissection with a median operation time of 126 minutes, a blood loss of 50 ml, and a length of stay of 4 days. No major complications (>Clavien 3) occurred. Median followup was 12.1 months. Median time to further therapy was 12.4 months, 37% of patients experienced complete biochemical response (prostate specific antigen <0.2 ng/ml) and 11% reached an undetectable prostate specific antigen, which was maintained for >1 year in 3 cases. Lower preoperative prostate specific antigen, longer time between radical prostatectomy and salvage lymph node dissection, preoperative prostate specific membrane antigen positron emission tomography/computed tomography and complete biochemical response after salvage lymph node dissection were significant predictors of longer therapy-free survival (all p <0.005). Prostate specific membrane antigen immunohistochemistry revealed that prostate specific membrane antigen positron emission tomography/computed tomography tends to miss small lymph node metastases <5 mm. CONCLUSIONS: Robotic salvage lymph node dissection is a feasible approach with low perioperative morbidity and delays further systemic therapy in most patients. Prostate specific membrane antigen positron emission tomography/computed tomography detection is mostly limited to tumor foci >5 mm.
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Escisión del Ganglio Linfático/métodos , Recurrencia Local de Neoplasia/cirugía , Prostatectomía/métodos , Neoplasias de la Próstata/cirugía , Procedimientos Quirúrgicos Robotizados , Terapia Recuperativa/métodos , Anciano , Anciano de 80 o más Años , Predicción , Humanos , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia/diagnóstico por imagen , Tomografía Computarizada por Tomografía de Emisión de Positrones , Neoplasias de la Próstata/diagnóstico por imagen , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
PURPOSE: The prognostic significance of lactate dehydrogenase (LDH) in patients with metastatic seminoma is not defined. We investigated the prognostic impact of LDH levels prior to first-line systemic treatment and other clinical characteristics in this subset of patients. METHODS: Files from two registry studies and one single-institution database were analyzed retrospectively. Uni- and multivariate analyses were conducted to identify patient characteristics associated with recurrence free survival (RFS), overall survival (OS), and complete response rate (CRR). RESULTS: The dataset included 351 metastatic seminoma patients with a median follow-up of 5.36 years. Five-year RFS, OS and CRR were 82%, 89% and 52%, respectively. Explorative analysis revealed a cut-off LDH level of < 2.5 upper limit of normal (ULN) (n = 228) vs. ≥ 2.5 ULN (n = 123) to be associated with a significant difference concerning OS associated with 5-years OS rates of 93% vs. 83% (p = 0.001) which was confirmed in multivariate analysis (HR 2.87; p = 0.004). Furthermore, the cut-off LDH < 2.5 ULN vs. ≥ 2.5 ULN correlated with RFS and CRR associated with a 5-years RFS rate and CRR of 76% vs. 86% (p = 0.012) and 32% vs. 59% (p ≤ 0.001), respectively. CONCLUSIONS: LDH levels correlate with treatment response and survival in metastatic seminoma patients and should be considered for their prognostic stratification.
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L-Lactato Deshidrogenasa/sangre , Seminoma/sangre , Seminoma/mortalidad , Neoplasias Testiculares/sangre , Neoplasias Testiculares/mortalidad , Adolescente , Adulto , Anciano , Humanos , Masculino , Persona de Mediana Edad , Estadificación de Neoplasias , Pronóstico , Estudios Retrospectivos , Seminoma/patología , Tasa de Supervivencia , Neoplasias Testiculares/patología , Adulto JovenRESUMEN
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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Neoplasias de Células Germinales y Embrionarias , Neoplasias Testiculares , Adulto , Preservación de la Fertilidad , Humanos , Masculino , Estadificación de Neoplasias , Neoplasias de Células Germinales y Embrionarias/clasificación , Neoplasias de Células Germinales y Embrionarias/diagnóstico , Neoplasias de Células Germinales y Embrionarias/epidemiología , Neoplasias de Células Germinales y Embrionarias/terapia , Guías de Práctica Clínica como Asunto , Pronóstico , Neoplasias Testiculares/clasificación , Neoplasias Testiculares/diagnóstico , Neoplasias Testiculares/epidemiología , Neoplasias Testiculares/terapiaRESUMEN
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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Neoplasias de Células Germinales y Embrionarias/terapia , Tumores de los Cordones Sexuales y Estroma de las Gónadas/terapia , Neoplasias Testiculares/terapia , Adulto , Cuidados Posteriores , Humanos , Masculino , Metástasis de la Neoplasia , Recurrencia Local de Neoplasia/terapia , Estadificación de Neoplasias , Neoplasias de Células Germinales y Embrionarias/patología , Cuidados Paliativos , Guías de Práctica Clínica como Asunto , Calidad de Vida , Neoplasias Testiculares/patologíaRESUMEN
Human papilloma virus (HPV) infections are one of the most common sexually transmitted diseases. We present the case of a 77-year-old Caucasian male with enormous genital warts of the penis, scrotum, groins and anus. Lesions were excised by electrosurgery. The histological examination revealed Condylomata gigantea as well as an invasive perianal squamous cell carcinoma. Mucosal "low-risk" HPV type 6 was detected. The patient had a history of an immunosuppressing disease. During the 4-year follow-up, multiple relapses occurred. Thus, particularly in immunosuppressed patients, early prophylactic HPV vaccination seems to be indicated for use in the prevention of HPV-associated mutilating and life-threatening disease. Vaccination should also protect from "low-risk" HPV.
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Neoplasias del Ano/virología , Tumor de Buschke-Lowenstein/virología , Carcinoma de Células Escamosas/virología , Papillomavirus Humano 6/patogenicidad , Huésped Inmunocomprometido , Infecciones Oportunistas/virología , Neoplasias del Pene/virología , Anciano , Neoplasias del Ano/diagnóstico , Neoplasias del Ano/inmunología , Neoplasias del Ano/terapia , Biopsia , Tumor de Buschke-Lowenstein/diagnóstico , Tumor de Buschke-Lowenstein/inmunología , Tumor de Buschke-Lowenstein/terapia , Carcinoma de Células Escamosas/diagnóstico , Carcinoma de Células Escamosas/inmunología , Carcinoma de Células Escamosas/terapia , Pruebas de ADN del Papillomavirus Humano , Papillomavirus Humano 6/inmunología , Humanos , Masculino , Infecciones Oportunistas/diagnóstico , Infecciones Oportunistas/inmunología , Infecciones Oportunistas/terapia , Neoplasias del Pene/diagnóstico , Neoplasias del Pene/inmunología , Neoplasias del Pene/terapia , Resultado del TratamientoRESUMEN
OBJECTIVE: The study aimed to calculate direct medical costs (DMC) during the first year of diagnosis and to evaluate the impact of guideline changes on treatment costs in clinical stage (CS) I testicular germ cell tumor (TGCT) patients in a German healthcare system. MATERIALS AND METHODS: Healthcare expenditures as DMC during the first year of diagnosis for 307 TGCT patients in CS I treated at our institution from 1987 to 2013 were calculated from the statutory health insurance perspective using patient level data. Three periods were defined referring to the first European Association of Urology (EAU) guideline in 2001 as well as to subsequent major guideline changes in 2005 and 2010. Data source for cost calculations were the German Diagnosis Related Groups system for inpatient stays (version 2014) and the German system for reimbursement of outpatient care (EBM - Einheitlicher Bewertungsmaßstab, edition 2014). RESULTS: During our 25 years of study period, mean DMC in the first year after diagnosis for the entire cohort of TGCT patients in CS I almost halved from EUR 13.000 to EUR 6.900 (p < 0.001). From 1987 to 2001, DMC for CS I seminomatous germ cell tumor (SGCT) patients were EUR 13.790 ± 4.700. From 2002 to 2010, mean costs were EUR 10.900 ± 5.990, and from 2011 to 2013, mean costs were EUR 5.190 ± 3.700. For CS I non-seminomatous germ cell tumor (NSGCT) patients, from 1987 to 2001, mean DMC were EUR 11.650 ± 5.690. From 2002 to 2010, mean costs were EUR 11.230 ± 5.990, and from 2011 to 2013, mean costs were EUR 11.170 ± 7.390. Follow-up examinations became less frequent over time, which caused a significant cost reduction for NSGCT (p = 0.042) while costs remained stable for SGCT. When adding costs of relapse treatment, active surveillance (AS) was the most cost-effective adjuvant treatment option in CS I NSGCT whereas one course carboplatin or AS caused similar expenditures in SGCT patients. CONCLUSION: The introduction of the EAU guidelines in 2001 caused a decrease in DMC in CS I seminoma patients. This cost reduction mainly took place due to the declining importance of radiation therapy. No substantial changes were seen in patients with CS I NSGCT. Costs for follow-up care also diminished, but to a lesser degree. Even when considering expenditures for relapse treatment, AS remained cost-effective in CS I TCGT patients. Our data show that evidence-based medicine in TGCT can reduce DMC in the first year after diagnosis.
Asunto(s)
Neoplasias de Células Germinales y Embrionarias/economía , Neoplasias de Células Germinales y Embrionarias/terapia , Neoplasias Testiculares/economía , Neoplasias Testiculares/terapia , Urología/métodos , Urología/normas , Adolescente , Adulto , Anciano , Carboplatino/uso terapéutico , Estudios de Cohortes , Análisis Costo-Beneficio , Economía Médica , Europa (Continente) , Estudios de Seguimiento , Costos de la Atención en Salud , Humanos , Seguro de Salud , Masculino , Persona de Mediana Edad , Recurrencia Local de Neoplasia , Pacientes Ambulatorios , Guías de Práctica Clínica como Asunto , Recurrencia , Seminoma , Sociedades Médicas , Resultado del Tratamiento , Adulto JovenRESUMEN
The incidence of segmental testicular infarction (STI) is very low. Such a disorder most often affects young men. The most common symptom is sudden testicular pain. We report 6 cases of men diagnosed with STI. Clinical examination, blood test, urine analysis, and ultrasound examination with colour Doppler were performed. Furthermore, tissue sonoelastography or MRI was performed in selected patients. All men underwent surgical exploration. In all but one man, the affected testis was preserved. Although STI is a rare condition, it should be taken into account if testicular pain prior to suspicious ultrasound imaging occurs. To be aware of this benign testicular pathology and its clinical and imaging features is important to avoid unnecessary orchiectomies in young patients.
Asunto(s)
Infarto/diagnóstico por imagen , Enfermedades Testiculares/diagnóstico por imagen , Testículo/diagnóstico por imagen , Dolor Agudo , Adulto , Diagnóstico por Imagen de Elasticidad , Humanos , Imagen por Resonancia Magnética , Masculino , Orquiectomía , Testículo/cirugía , Ultrasonografía Doppler , Urinálisis , Enfermedades Vasculares , Adulto JovenRESUMEN
OBJECTIVE: Despite the low local toxicity of the used agents, Cisplatin-based chemotherapy (CBP) for patients with testicular germ cell tumors (TGCT) is mostly delivered via a central venous access (CVA). Since 2008, CBP is given peripherally in our hospital. METHODS: Medical reports of TGCT patients who received CBP between September 1991 and August 2014 were evaluated. Complications regarding the way of administration (CVA vs. peripheral venous catheter [PVC]) were classified according to the Common Terminology Criteria of Adverse Events. The complication rates were compared using chi square test and propensity score matching. RESULTS: During 288 cycles in 109 patients, 85 complications (29.5%) were observed with similar rates for overall (PVC 31.3%, CVA 29.9%; p = 0.820) and grade I complications (21.3%, 25.4%; p = 0.470). More grade II complications were observed in the PVC group (10.0 vs. 1.5%; p < 0.001). Grade III complications requiring invasive treatment were found only in the CVA group (3.0%; p = 0.120). Using propensity score matching, no differences in overall (p = 0.950), grade I (p = 0.540) and grades II/III (p = 0.590) complications were seen. CONCLUSION: The peripheral and central administration of CBP has similar overall complication rates. Despite more grade II complications, the peripheral administration of CBP is a safe alternative for TGCT patients. Additionally, no severe grade III complications occurred.
Asunto(s)
Protocolos de Quimioterapia Combinada Antineoplásica/administración & dosificación , Cateterismo Venoso Central , Cateterismo Periférico , Cisplatino/administración & dosificación , Neoplasias de Células Germinales y Embrionarias/tratamiento farmacológico , Neoplasias Testiculares/tratamiento farmacológico , Administración Intravenosa , Adolescente , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/efectos adversos , Cateterismo Venoso Central/efectos adversos , Cateterismo Periférico/efectos adversos , Distribución de Chi-Cuadrado , Cisplatino/efectos adversos , Humanos , Modelos Logísticos , Masculino , Persona de Mediana Edad , Análisis Multivariante , Neoplasias de Células Germinales y Embrionarias/patología , Puntaje de Propensión , Estudios Retrospectivos , Factores de Riesgo , Neoplasias Testiculares/patología , Factores de Tiempo , Resultado del Tratamiento , Adulto JovenRESUMEN
INTRODUCTION: International guidelines are ambivalent regarding the recommendations for the management of clinical stage 1 (CS1) seminoma. PATIENTS AND METHODS: During 2008-2013, 1,050 patients with seminoma CS1 were prospectively registered with regard to assessing management modality (radiotherapy, carboplatin, surveillance). Associations with tumor size, rete testis invasion, age, year of diagnosis, type of institution, and geographic location were assessed. RESULTS: Of the total number of patients, 49.3% received carboplatin 1 course, 8.5% carboplatin 2 courses, 35.9% surveillance, and 6.3% radiotherapy. In 2013, surveillance increased significantly to 57.9%. Treatment decisions were significantly associated with rete testis invasion and tumor size. Carboplatin was applied significantly more in office clinics than elsewhere. There is some regional variation regarding treatment preferences. CONCLUSIONS: The rising acceptance of surveillance mirrors international trends. The associations with prognostic factors demonstrate care givers to be compliant with contemporary guidelines. The association with the type of institution suggests non-oncological factors to be also relevant in decision making.