Hormonal Symptoms Research Articles

Ovarian Steroid Cell Tumor, Not Otherwise Specified: a case series

Case series of Ovarian Steroid Cell Tumor Not Otherwise Specified is being reported in a child and two post-menopausal females. Hormonal symptoms were present in all of them. Two of three had malignant potential. The clinical presentation and histopathologic features and treatment of this extremely rare variety of sex cord stromal tumor has been discussed.

Standardising the Assessment of Patient-reported Outcome Measures in Localised Prostate Cancer. A Systematic Review

ContextProstate cancer (PCa) is the second most common cancer among men worldwide. Urinary, bowel, and sexual function, as well as hormonal symptoms and health-related quality of life (HRQoL), were prioritised by patients and professionals as part of a core outcome set for localised PCa regardless of treatment type. ObjectiveTo systematically review the measurement properties of patient-reported outcome measures (PROMs) used in localised PCa and recommend PROMs for use in routine practice and research settings. Evidence acquisitionThe psychometric properties of PROMs measuring functional and HRQoL domains used in randomised controlled trials including patients with localised PCa were assessed according to the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) methodology. MEDLINE and Embase were searched to identify publications evaluating psychometric properties of the PROMs. The characteristics and methodological quality of the studies included were extracted, tabulated, and assessed according to the COSMIN criteria. Evidence synthesisOverall, 27 studies evaluating psychometric properties of the Expanded Prostate Cancer Index Composite (EPIC), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), European Organisation for Research and Treatment of Cancer (EORTC) quality of life core 30 (QLQ-C30) and prostate cancer 25 (QLQ-PR25) modules, International Index of Erectile Function (IIEF), and the 36-item (SF-36) and 12-item Short-Form health survey (SF-12) PROMs were identified and included in the systematic review. EPIC and EORTC QLQ-C30, a general module that assesses patients’ physical, psychological, and social functions, were characterised by high internal consistency (Cronbach’s α 0.46–0.96 and 0.68–0.94 respectively) but low content validity. EORTC QLQ-PR25, which is primarily designed to assess PCa-specific HRQoL, had moderate content validity and internal consistency (Cronbach’s α 0.39–0.87). UCLA-PCI was characterised by moderate content validity and high internal consistency (Cronbach’s α 0.21–0.94). However, it does not directly assess hormonal symptoms, whereas EORTC QLQ-PR25 does. ConclusionThe tools with the best evidence for psychometric properties and feasibility for use in routine practice and research settings to assess PROMs in patients with localised PCa were EORTC QLQ-C30 and QLQ-PR25. Since EORTC QLQ-C30 is a general module that does not directly assess PCa-specific issues, it should be adopted in conjunction with the QLQ-PR25 module. Patient summaryWe reviewed and appraised the measurement properties of patient-reported outcome measure questionnaires used for patients with localised prostate cancer. We found good evidence to suggest that two questionnaires (EORTC QLQ-C30 and QLQ-PR25) can be used to measure urinary, bowel, and sexual functions and health-related quality of life.

Type of treatment, symptoms and patient satisfaction play an important role in primary care contact during prostate cancer follow-up: results from the population-based PROFILES registry

BackgroundWith the increasing attention for the role of General Practitioners (GPs) after cancer treatment, it is important to better understand the involvement of GPs following prostate cancer treatment. This study investigates factors associated with GP contact during follow-up of prostate cancer survivors, such as patient, treatment and symptom variables, and satisfaction with, trust in, and appraised knowledge of GPs.MethodsOf 787 prostate cancer survivors diagnosed between 2007 and 2013, and selected from the Netherlands Cancer Registry, 557 (71%) responded to the invitation to complete a questionnaire. Multivariable logistic regression analyses were performed to investigate which variables were associated with GP contact during follow- up.ResultsIn total, 200 (42%) prostate cancer survivors had contact with their GP during follow-up, and 76 (16%) survivors preferred more contact. Survivors who had an intermediate versus low educational level (OR = 2.0) were more likely to have had contact with their GP during follow-up. Survivors treated with surgery (OR = 2.8) or hormonal therapy (OR = 3.5) were also more likely to seek follow-up care from their GP compared to survivors who were treated with active surveillance. Patient reported bowel symptoms (OR = 1.4), hormonal symptoms (OR = 1.4), use of incontinence aids (OR = 1.6), and being satisfied with their GP (OR = 9.5) were also significantly associated with GP contact during follow-up.ConclusionsEducation, treatment, symptoms and patient satisfaction were associated with GP contact during prostate cancer follow-up. These findings highlight the potential for adverse side-effects to be managed in primary care. In light of future changes in cancer care, evaluating prostate cancer follow-up in primary care remains important.

Patients’ perspective on the quality of prostate cancer follow-up care.

175 Background: Information about prostate cancer patients’ perspective on the quality of their follow-up care in the hospital is important to optimize survivorship care. This study assessed the quality of prostate cancer follow-up care as experienced by cancer patients and its association with patients’ sociodemographic and clinical characteristics, and treatment-related symptom burden. Methods: We surveyed 385 (response rate, 100%) patients with localized prostate cancer participating in a randomized controlled trial comparing the (cost)effectiveness of specialist- versus primary care-based prostate cancer follow-up. For this study, we used baseline data that were collected during patients’ first follow-up visit at the hospital (2-34 weeks) after primary treatment (radical prostatectomy or radiotherapy) prior to randomization. We assessed patients’ ratings of the quality of follow-up care using the Assessment of Patient Experiences of Cancer Care survey. This survey consists of thirteen scales: getting needed care, timeliness of care, waiting time in physician’s office, information exchange, physician’s affective behavior, physicians’ knowledge about patients’ life, interaction with nurses, interaction with office staff, symptom management, symptom information provision, health promotion, coordination of care, and overall rating of care. Logistic regression analysis was used to identify factors associated with perceived quality of follow-up care. Results: Patients reported positive experiences with follow-up care for 10 of 13 scales, with mean scores ranging from 72 to 97 (on a 0-100 response scale). The three scales where patients reported suboptimal follow-up care were symptom management (mean score of 43), health promotion (mean score of 45), and physicians’ knowledge about patients’ life (mean score of 66). Overall, patients’ report of suboptimal quality of follow-up care was associated significantly with being more highly educated, not having a partner, being older, having multiple comorbidities, and experiencing symptoms (urinary, bowel, and hormonal symptoms). Conclusions: Prostate cancer patients were generally positive about their initial, hospital-based follow-up care after primary surgery or radiation. However, physicians’ knowledge about patients’ lives, symptom management, and health promotion was rated as suboptimal. The findings point to areas where prostate cancer survivorship care can be improved.

Malignancies Associated with Extraovarian Endometriosis: A Literature Review

Endometriosis-associated ovarian malignancies have been well documented. Although these malignancies also occur as extraovarian lesions, little is known about them. Thus, this literature review aimed to further explore these rarely experienced tumors. A total of 257 published cases between April 1990 and April 2020 were found using PubMed, and 212 cases were included in the analysis considering Sampson’s criteria and the history of endometriosis. We classified these cases as follows: intestine, abdominal scar, vagina and vulva, peritoneum and deep endometriosis, urinary tract, uterine cervix, and others. Age of patients, history of endometriosis, types of past hormonal therapy, symptoms, histological types, and treatment were identified. The most common tumor site was the intestine. Endometrioid carcinoma was the dominant histological type. Contrary to the ovary, clear cell carcinoma was rare in extraovarian sites. On the other hand, clear cell carcinoma represented the largest number of abdominal scars. This difference may help us to understand the development of endometriosis-related malignancies. Hormonal treatment was mentioned in 67 cases and estrogen replacement therapy in 33 cases. Although risks of estrogen therapy are still controversial, the highly differentiated histological types and hormone-dependent characteristics of endometriosis-associated malignancy should be considered. Physicians should be careful about estrogen monotherapy after hysterectomy and long-term hormone replacement therapy in patients with a history of endometriosis.

Tamoxifen for Five Years?

Tamoxifen is an effective anti-cancer drug in breast cancer treatment. However, very few women could do the complete 5-year treatment due to the side effects of the medication. The irregular bleeding, osteoporosis, and hormonal imbalance symptoms always cut the time short. Since every woman is different in body weight, genetic compose, reproductive history, and personal habits, the treatment with tamoxifen should also be different. Moreover, since estrogen has the similar positive effects as Vitamin K2 in bone formation; tamoxifen, as a estrogen blocker, should be used with proper vitamin K2 supplement, to which, current medical world has not paid enough attention.

The association between nocturia, hormonal symptoms and bladder parameters in women: anobservational study.

Postmenopausal nocturia is poorly understood. This study aimed to identify hormonal and lifestyle factors associated with nocturia and to understand the relative contribution of altered urine production and bladder storage dysfunction in women. Women ≥40 years presenting to public continence services were enrolled in a cross-sectional study. A total of 153 participants completed a hormone status questionnaire, a validated nocturia causality screening tool and a 3-day bladder diary. Descriptive statistics and logistic regression models for nocturia severity and bladder diary parameters were computed. Overall, 91.5% reported nocturia, 55% ≥2 /night. There was a difference of 167.5 ml (P < 0.001) in nocturnal urine volume between women with nocturia ≥2 (median 736 ml) versus less often (517 ml). Significant predictors of self-reported disruptive nocturia were age (odds ratio [OR] 1.04, 95% CI 1.002-1.073) and vitamin D supplementation (OR 2.33, 95% CI 1.11-4.91). Nocturnal polyuria was significantly more common with nocturia ≥2 compared with less frequent nocturia (P < 0.002). Exercise for 150 minutes a week was protective for nocturnal polyuria (OR 0.22, P = 0.001). Nocturia index >1.3 was significantly predicted by age (OR 1.07, P < 0.001), regular exercise (OR 0.41, P = 0.036), day flushes (OR 4.00, P = 0.013) and use of vitamin D (OR 2.34, P = 0.043). Maximum voidedvolumes were significantly lower with nocturia ≥2 versus less often (night: 268 ml versus 350 ml; day: 200 ml versus 290 ml). Bothersome nocturia in postmenopausal women is associated with changes to both nocturnal diuresis and bladder storage. Regular physical activity, prolapse reduction and oestrogen replacement may be adjunctive in managing bothersome nocturia in women.

Cardiovascular Toxicities Secondary to Biotherapy and Molecular Targeted Therapies in Neuroendocrine Neoplasms: A Systematic Review and Meta-Analysis of Randomized Placebo-Controlled Trials.

Simple SummaryRecent innovations in molecular pathogenesis of neuroendocrine neoplasms (NEN) and improvements in their multidisciplinary management, including the introduction of novel targeted therapies have contributed to favorable patient outcomes. Compared with traditional chemotherapy, targeted therapies have fewer toxicities and a more distinct safety profile. However, treatment-induced cardiovascular toxicities are occasionally critical issues in NEN management. Herein, we present a comprehensive summary of high quality randomized evidence with the methodology of a systematic review and quantitative meta-analysis on the safety profile of biotherapy and molecular targeted therapies in advanced and/or metastatic NEN with a special focus on cardiovascular toxicities in order to promote a patient-tailored approach and assist clinicians involved in the management of NEN patients.A broad spectrum of novel targeted therapies with prime antitumor activity and/or ample control of hormonal symptoms together with an overall acceptable safety profile have emerged for patients with metastatic neuroendocrine neoplasms (NENs). In this systematic review and quantitative meta-analysis, the PubMed, EMBASE, Cochrane Central Register of Controlled Trials and clinicaltrials.gov databases were searched to assess and compare the safety profile of NEN treatments with special focus on the cardiovascular adverse effects of biotherapy and molecular targeted therapies (MTTs). Quality/risk of bias were assessed using GRADE criteria. Placebo-controlled randomized clinical trials (RCTs) in patients with metastatic NENs, including medullary thyroid cancer (MTC) were included. A total of 3695 articles and 122 clinical trials registered in clinicaltrials.gov were screened. We included sixteen relevant RCTs comprising 3408 unique patients assigned to different treatments compared with placebo. All the included studies had a low risk of bias. We identified four drug therapies for NENs with eligible placebo-controlled RCTs: somatostatin analogs (SSAs), tryptophan hydroxylase (TPH) inhibitors, mTOR inhibitors and tyrosine kinase inhibitors (TKI). Grade 3 and 4 adverse effects (AE) were more often encountered in patients treated with mTOR inhibitors and TKI (odds ratio [OR]: 2.42, 95% CI: 1.87–3.12 and OR: 3.41, 95% CI: 1.46–7.96, respectively) as compared to SSAs (OR:0.77, 95% CI: 0.47–1.27) and TPH inhibitors (OR:0.77, 95% CI: 0.35–1.69). MTOR inhibitors had the highest risk for serious cardiac AE (OR:3.28, 95% CI: 1.66–6.48) followed by TKIs (OR:1.51, 95% CI: 0.59–3.83). Serious vascular AE were more often encountered in NEN patients treated with mTOR inhibitors (OR: 1.72, 95% CI: 0.64–4.64) and TKIs (OR:1.64, 95% CI: 0.35–7.78). Finally, patients on TKIs were at higher risk for new-onset or exacerbation of pre-existing hypertension (OR:3.31, 95% CI: 1.87–5.86). In conclusion, SSAs and TPH inhibitors appear to be safer as compared to mTOR inhibitors and TKIs with regards to their overall toxicity profile, and cardiovascular toxicities in particular. Special consideration should be given to a patient-tailored approach with anticipated toxicities of targeted NEN treatments together with assessment of cardiovascular comorbidities, assisting clinicians in treatment selection and early recognition/management of cardiovascular toxicities. This approach could improve patient compliance and preserve cardiovascular health and overall quality of life.

Abstract No. 495 Microwave ablation for metastatic neuroendocrine tumors: a case series

Neuroendocrine tumors (NET) typically originate in the gastrointestinal tract or pancreas and present with quality-of-life limiting symptoms after hepatic metastases. Percutaneous microwave ablation (MWA) is a minimally invasive procedure proven to be effective for treating hepatocellular carcinoma and metastatic colorectal cancer in the liver. We retrospectively reviewed our single-institutional experience in treating NETs with MWA and aim to investigate its safety and efficacy in controlling hormonal symptoms.

Decision regret, adverse outcomes, and treatment choice in men with localized prostate cancer: Results from a multi-site randomized trial

IntroductionMen diagnosed with localized prostate cancer must navigate a highly preference-sensitive decision between treatment options with varying adverse outcome profiles. We evaluated whether use of a decision support tool previously shown to decrease decisional conflict also impacted the secondary outcome of post-treatment decision regret. MethodsParticipants were randomized to receive personalized decision support via the Personal Patient Profile-Prostate or usual care prior to a final treatment decision. Symptoms were measured just before randomization and 6 months later; decision regret was measured at 6 months along with records review to ascertain treatment choices. Regression modeling explored associations between baseline variables including race and D`Amico risk, study group, and 6-month variables regret, choice, and symptoms. ResultsAt 6 months, 287 of 392 (73%) men returned questionnaires of which 257 (89%) had made a treatment choice. Of that group, 201 of 257 (78%) completely answered the regret scale. Regret was not significantly different between participants randomized to the P3P intervention compared to the control group (P = 0.360). In univariate analyses, we found that Black men, men with hormonal symptoms, and men with bowel symptoms reported significantly higher decision regret (all P < 0.01). Significant interactions were detected between race and study group (intervention vs. usual care) in the multivariable model; use of the Personal Patient Profile-Prostate was associated with significantly decreased decisional regret among Black men (P = 0.037). Interactions between regret, symptoms and treatment revealed that (1) men choosing definitive treatment and reporting no hormonal symptoms reported lower regret compared to all others; and (2) men choosing active surveillance and reporting bowel symptoms had higher regret compared to all others. ConclusionThe Personal Patient Profile-Prostate decision support tool may be most beneficial in minimizing decisional regret for Black men considering treatment options for newly-diagnosed prostate cancer. Trial RegistrationNCT01844999

Currently available treatment options for neuroendocrine liver metastases.

Neuroendocrine neoplasms (NEN) are frequently characterized by a high propensity for metastasis to the liver, which appears to be a dominant site of distant-stage disease, affecting quality of life and overall survival. Liver surgery with the intention to cure is the treatment of choice for resectable neuroendocrine liver metastases (NELM), aiming to potentially prolong survival and ameliorate hormonal symptoms refractory to medical control. Surgical resection is indicated for patients with NELM from well-differentiated NEN, while its feasibility and complexity are largely dictated by the degree of liver involvement. As a result of advances in surgical techniques over the past decades, complex 1- and 2-stage, or repeat liver resections are performed safely and effectively by experienced surgeons. Furthermore, liver transplantation for the treatment of NELM should be anchored in a multimodal and multidisciplinary therapeutic strategy and restricted only to highly selected individual cases. A broad spectrum of interventional radiology treatments for NELM have recently been available, with expanding indications that are more applicable, as they are less limited by patient- and tumor-related parameters, being therefore important adjuncts or alternatives to surgery. Overall, liver-targeted treatment modalities may precede the administration of systemic molecular targeted agents and chemotherapy for patients with liver-dominant metastatic disease; these appear to be a crucial component of multimodal management of patients with NEN. In the present review, we discuss surgical and non-surgical liver-targeted treatment approaches for NELM, each complementing the other, with a view to assisting physicians in optimizing multimodal NEN patient care.

Оцінка якості життя після гістеректомії з приводу міоми матки

Hysterectomy, performed in reproductive age, undoubtedly causes a decrease in all parameters of quality of life and contributes to the development of imbalance of hormonal homeostasis, psycho-emotional, vegetative-neurotic symptoms, increasing sexual and urogenital dysfunction, impeding psycho-social adaptation in the family,the professional and intellectual spheres of a woman’s life. This aspect is often overlooked by surgeons when evaluating the effectiveness of treatment, although it has a significant impact on recovery from surgery. The article presents data on experimental psychological research, evaluation of the severity of urogenital dysfunction using a standardized POP-Q system, characteristics of quality of life parameters both at the stage of preoperative observation and within 1, 3 and 5 years after surgery in 80 women of reproductive age with uterine fibroids who have undergone vaginal hysterectomy. The comparison group included 60 patients with hysterectomy performed by abdominal access. According to the results of this study, in women of reproductive age after radical surgery for fibroids, it was determined that the leading violations of quality of life after hysterectomy are general somatic symptoms, psycho-emotional disorders, genitourinary and sexual disorders. Radical operations for uterine fibroids cause an increase in the proportion of urogenital disorders, among which the most important are urinary incontinence and prolapse, the clinical manifestations of which have a negative impact on, including the psychosocial sphere, while reducing quality of life. Today there is no consensus on the degree of impact of radical surgery for uterine fibroids on the versatility of metabolic and hormonal homeostasis, the formation of psychovegetative symptom complex, and as a consequence, the impact on quality of life, which necessitates a validated method of quality of life optimization of the rehabilitation program with personalized consideration of the leading factors of status comorbidity when planning surgical treatment. Keywords: uterine fibroids, hysterectomy, quality of life parameters.

Endocrine manifestations of central nervous system germ cell tumors in children

IntroductionCentral nervous system germ cell tumors need to be adequately diagnosed because their treatment is usually effective and they do not always require surgery. The study objectives are to describe the endocrine manifestations of these tumors and to compare the time of their onset to that of the occurrence of neurological and visual changes. Patients and methodsThe medical histories of patients under 14 years of age seen at a pediatric endocrinology unit between 2000 and 2018 were reviewed. Wilcoxon and Fisher statistical tests were performed. ResultsWe found 12 patients (10 females) with an age at diagnosis of 9.4±1.7 years and a follow-up time of 5.5±3.0 years, 10 with tumors in the sellar region, and each one with a pineal gland and a bifocal tumor. Clinical changes leading to diagnosis were neurological and/or visual in nine patients and hormonal in three. Seven patients diagnosed on the basis of neurological or visual symptoms had previously reported hormonal changes, giving us a total of 10 children at diagnosis (the most common diagnosis was central diabetes insipidus, found in 8). Endocrine symptoms had been present before diagnosis for 25.0±26.2 months, considerably longer than neuro-ophthalmological complaints (2.0±2.1 months, p=0.012). ConclusionsAlmost all intracranial germ cell tumors have associated endocrine manifestations at diagnosis, with central diabetes insipidus the most common. Hormonal symptoms usually appear long before neuro-ophthalmological manifestations. Adequate clinical and endocrinological assessment may allow for an earlier diagnosis of these tumors.

Use of octreotide long acting repeatable (LAR) as second-line therapy in advanced neuroendocrine tumors in different clinical settings: an Italian Delphi survey

ABSTRACT Background Somatostatin receptor ligands including octreotide LAR are first-line therapy in locally advanced or metastatic NETs that are nonresectable and well differentiated and are recommended as first-line therapy in functioning and in G1/low G2 nonfunctioning NETs. However, several questions remain that are not adequately addressed in current guidelines regarding its use in clinical scenarios in which the tumor progresses. These include use of nonconventional doses or schedules of octreotide LAR in tumors with hormonal symptoms or showing clinical-radiological progression, administration in combination with everolimus, peptide receptor radionuclide therapy, and chemotherapy, following first-line treatment with octreotide LAR. Methods An expert panel was gathered to obtain consensus using Delphi methodology on a series of statements regarding further administration of octreotide LAR after its use in first-line therapy in these settings in patients who experience disease progression. Results Consensus was reached for 8 of the 10 statements proposed in the above clinical scenarios; consensus was not achieved for two statements. Conclusions The present statements aim to fill current gaps in treatment guidelines by providing recommendations based on expert consensus in clinical settings in which patients progress following first-line therapy with octreotide LAR.

How does thyroidectomy for benign thyroid disease impact upon quality of life? A prospective study.

Choosing which patients to recommend surgery for benign thyroid conditions can be difficult due to the subjective nature of compressive thyroid and hormonal symptoms. The aim of this prospective study was to analyse changes in quality of life (QOL) following thyroid surgery using a validated disease-specific assessment tool, the thyroid-related patient-reported outcome (ThyPRO) questionnaire. Participants undergoing elective thyroid surgery for benign conditions were recruited. Patient demographics and clinical data were collected. ThyPRO consists of 85 questions grouped into 13 physical, mental and social symptom domains. Patients completed a ThyPRO questionnaire pre-operatively and at 6 weeks and 6 months post-operatively. ThyPRO items were scored according to protocol to produce 13 subscales. Repeated measures linear models with no random effects were performed using data for each outcome. Results were available for a total of 72 patients. The sample was predominately female (n = 63, 88%) with average age 49.8 years. The majority of patients underwent surgery for multi-nodular goitre. At 6 weeks post-operatively, significant improvement was demonstrated in the goitre, hypothyroid, hyperthyroid and anxiety symptom domains. At 6 months post-operatively, significant improvement was demonstrated in all but four domains. No domains demonstrated significant increase in impairment post-operatively. Patients had significant improvement in nine of 13 symptom domains following surgery. Patients did not experience a negative impact on QOL following surgery. Further studies with larger patient cohorts may be able to identify potential pre-operative predictive factors for a post-operative improvement in QOL for benign thyroid disease.

Feasibility of Utilizing EPIC-CP to Guide Symptom Management for Clinically Localized Prostate Cancer Patients Undergoing Hypofractionated Radiotherapy

Utilization of patient-reported outcome measures (PROMs) to guide symptom management during radiation therapy has shown to be more sensitive to changes in health status and might detect the exact onset of the toxic effects of radiotherapy more accurately than clinician-reported outcomes. The Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) is a validated 16-item, diseasespecific PROM that targets the unique needs of men with prostate cancer (PCa) and evaluates the five HRQOL domains of urinary incontinence, urinary irritation/obstruction, bowel related symptoms, sexual dysfunction and hormonal symptoms.

Management and outcome of metastatic pheochromocytomas/paragangliomas: an overview.

Metastatic pheochromocytomas and paragangliomas (PPGLs) occur in about 5-26% of cases and are characterized by a heterogeneous prognosis. Metastases can be synchronous at the initial diagnosis, but they can occur also many years after surgery for the primary tumor. To date, the treatment of patients affected by metastatic PPGLs represents a clinical challenge because of the lack of guidelines. The aim of this article is to review the available management options and their impact on the outcomes of patients with metastatic PPGLs. Generally, treatments are not curative. Surgery, when possible, can be used to reduce hormonal symptoms and cardiovascular morbidity. Chemotherapy plays a role in patients with high burden tumor and rapid disease progression. Tyrosine kinases inhibitors (TKIs) might be considered for their ability to block the angiogenesis and cell growth. Radiation therapy and interventional radiology techniques can help in the management of local metastases to control symptoms and avoid tumor progression. On the other hand, peptide receptor radionuclide therapy (PRRT), using 90Y or 177Lu-DOTATATE, could be a promising therapy. In addition, high specific 131I-MIBG was approved by the Food and Drug Administration (FDA) in the US for the treatment of patients affected by metastatic and unresectable 131I-MIBG positive PPGLs. Considering the different pathways involved in the pathogenesis of PPGLs, several target therapies have been proposed and are under evaluation in clinical trials. The choice of the appropriate treatment should be based on multidisciplinary and personalized approach taking into account the rarity and the variability of these tumors.

MP23-19 DECISION REGRET, ADVERSE OUTCOMES AND TREATMENT CHOICE IN MEN WITH LOCALIZED PROSTATE CANCER: RESULTS FROM A MULTI-SITE RANDOMIZED TRIAL

You have accessJournal of UrologyProstate Cancer: Localized: Active Surveillance I (MP23)1 Apr 2020MP23-19 DECISION REGRET, ADVERSE OUTCOMES AND TREATMENT CHOICE IN MEN WITH LOCALIZED PROSTATE CANCER: RESULTS FROM A MULTI-SITE RANDOMIZED TRIAL Donna L. Berry*, Fangxin Hong, Traci Blonquist, Barbara Halpenny, Niya Xiong, Christopher P Filson, Viraj A Master, Martin G Sanda, Peter Chang, Gary Chien, Randy Jones, Tracey Krupski, Seth Wolpin, Leslie Wilson, Julia Hayes, Quoc-Dien Trinh, and Mitch Sokoloff Donna L. Berry*Donna L. Berry* More articles by this author , Fangxin HongFangxin Hong More articles by this author , Traci BlonquistTraci Blonquist More articles by this author , Barbara HalpennyBarbara Halpenny More articles by this author , Niya XiongNiya Xiong More articles by this author , Christopher P FilsonChristopher P Filson More articles by this author , Viraj A MasterViraj A Master More articles by this author , Martin G SandaMartin G Sanda More articles by this author , Peter ChangPeter Chang More articles by this author , Gary ChienGary Chien More articles by this author , Randy JonesRandy Jones More articles by this author , Tracey KrupskiTracey Krupski More articles by this author , Seth WolpinSeth Wolpin More articles by this author , Leslie WilsonLeslie Wilson More articles by this author , Julia HayesJulia Hayes More articles by this author , Quoc-Dien TrinhQuoc-Dien Trinh More articles by this author , and Mitch SokoloffMitch Sokoloff More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000856.019AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Men diagnosed with localized prostate cancer must navigate a highly preference-sensitive decision between treatment options with varying adverse outcome profiles. Decisional regret has been documented in men after treatment. We evaluated whether use of a decision support tool previously shown to decrease decisional conflict also impacted post-treatment decisional regret. METHODS: Participants at 10 urology or radiation oncology clinics across the United States were randomized to receive personalized decision support via the Personal Patient Profile-Prostate or usual care. Symptoms were measured at baseline and 6 months after enrollment; decision regret was measured at 6 months along with medical records review to ascertain treatment choices. Regression modeling explored associations between regret, 6-month symptoms and baseline variables including race, study group, choice, D`Amico risk, and symptoms. RESULTS: At 6 months, 287 of 392 (73%) men returned questionnaires of which 257 (89%) had made a treatment choice. Of that group, 201/257 (78%) completely answered the regret scale. While there was no significant difference between study groups (p=0.360), univariate analyses revealed Black men (p=0.019), men with any hormonal symptoms (p=0.009), and men with any bowel symptoms (p=0.032) reported higher regret. Significant interactions between treatment choice, regret and symptoms were detected. Men receiving definitive treatment and reporting no hormonal symptoms reported lower regret compared to all others (p=0.002). Men choosing active surveillance and reporting bowel symptoms had higher regret compared to all others (p=0.002). Significant interactions were detected between race and study group (intervention vs usual care) in the multivariable model; use of Personal Patient Profile-Prostate was associated with significantly decreased decisional regret among Black men (p=0.037). CONCLUSIONS: Decisional regret was associated with active surveillance and adverse symptom outcomes for men of various races. The Personal Patient Profile-Prostate decision support tool may be most beneficial in minimizing decisional regret for Black men considering treatment options for newly-diagnosed prostate cancer. Source of Funding: NIH R01NR009692 © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e345-e346 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Donna L. Berry* More articles by this author Fangxin Hong More articles by this author Traci Blonquist More articles by this author Barbara Halpenny More articles by this author Niya Xiong More articles by this author Christopher P Filson More articles by this author Viraj A Master More articles by this author Martin G Sanda More articles by this author Peter Chang More articles by this author Gary Chien More articles by this author Randy Jones More articles by this author Tracey Krupski More articles by this author Seth Wolpin More articles by this author Leslie Wilson More articles by this author Julia Hayes More articles by this author Quoc-Dien Trinh More articles by this author Mitch Sokoloff More articles by this author Expand All Advertisement PDF downloadLoading ...

Manifestaciones endocrinas de los tumores germinales del sistema nervioso central en niños

IntroductionCentral nervous system germ cell tumors need to be adequately diagnosed because their treatment is usually effective and they do not always require surgery. The study objectives are to describe the endocrine manifestations of these tumors and to compare the time of their onset to that of the occurrence of neurological and visual changes. Patients and methodsThe medical histories of patients under 14 years of age seen at a pediatric endocrinology unit between 2000 and 2018 were reviewed. Wilcoxon and Fisher statistical tests were performed. ResultsWe found 12patients (10 females) with an age at diagnosis of 9.4±1.7 years and a follow-up time of 5.5±3.0 years, 10with tumors in the sellar region, and each one with a pineal gland and a bifocal tumor. Clinical changes leading to diagnosis were neurological and/or visual in 9patients and hormonal in three. Seven patients diagnosed on the basis of neurological or visual symptoms had previously reported hormonal changes, giving us a total of 10 children at diagnosis (the most common diagnosis was central diabetes insipidus, found in 8). Endocrine symptoms had been present before diagnosis for 25.0±26.2 months, considerably longer than neuro-ophthalmological complaints (2.0±2.1 months, p=0.012). ConclusionsAlmost all intracranial germ cell tumors have associated endocrine manifestations at diagnosis, with central diabetes insipidus the most common. Hormonal symptoms usually appear long before neuro-ophthalmological manifestations. Adequate clinical and endocrinological assessment may allow for an earlier diagnosis of these tumors.

Phase II Trial of Enzalutamide and Androgen Deprivation Therapy with Salvage Radiation in Men with High-risk Prostate-specific Antigen Recurrent Prostate Cancer: The STREAM Trial

BackgroundSalvage external beam radiotherapy (RT) with androgen deprivation therapy (ADT) improves survival over RT in men with prostate cancer (PC) and rising prostate-specific antigen (PSA) levels after radical prostatectomy (RP). ObjectiveTo investigate the safety and efficacy of enzalutamide concurrent with salvage RT and ADT. Design, setting, and participantsThis was a three-center prospective phase 2 single-arm trial (NCT02057939) of men with Gleason 7–10 PC and PSA recurrence within 4 yr of RP ranging from 0.2 to 4.0 ng/dl, no prior hormonal therapy, and no radiographic evidence of metastases. We enrolled 38 men; 37 completed therapy and were evaluable with testosterone recovery at 2 yr. InterventionSix months of ADT with 160 mg/d enzalutamide and 66 Gy RT to the prostate bed. Outcome measurements and statistical analysisThe primary endpoint was improved 2-yr progression-free survival (PFS) over historical controls. Secondary objectives included 3-yr PFS, safety, and patient-reported quality of life (QOL). Results and limitationsThe primary endpoint of 2-yr PFS was 65% (95% confidence interval [CI]: 47, 78) versus 51% (95% CI: 33, 67) in a trial of men with similar eligibility treated with salvage RT and adjuvant docetaxel. The 3-yr PFS was 53%. Eleven (29%) men experienced G3 toxicities, and there were no G4–5 or unexpected toxicities. QOL data suggest modest worsening of bowel, bladder, and hormonal symptoms at 3 mo, with recovery by 24 mo in most men. ConclusionsSalvage RT with enzalutamide and ADT following RP for men with PSA recurrent high-risk PC is safe and demonstrates encouraging efficacy, warranting prospective controlled phase 3 trials of ADT with or without potent androgen receptor inhibition in this curative-intent setting. Patient summaryAddition of 6 mo of oral daily enzalutamide to standard salvage radiation and hormone therapy is safe and may improve prostate cancer remission rates at 2 and 3 yr.