An ionising radiation-induced specific transcriptional signature of inflammation-associated genes in whole blood from radiotherapy patients: a pilot study.

BACKGROUND: This communication reports the identification of a new panel of transcriptional changes in inflammation-associated genes observed in response to ionising radiation received by radiotherapy patients. METHODS: Peripheral blood samples were taken with ethical approval and informed consent from a total of 20 patients undergoing external beam radiotherapy for breast, lung, gastrointestinal or genitourinary tumours. Nanostring nCounter analysis of transcriptional changes was carried out in samples prior and 24 h post-delivery of the 1st radiotherapy fraction, just prior to the 5th or 6th fraction, and just before the last fraction. RESULTS: Statistical analysis with BRB-ArrayTools, GLM MANOVA and nSolver, revealed a radiation responsive panel of genes which varied by patient group (type of cancer) and with time since exposure (as an analogue for dose received), which may be useful as a biomarker of radiation response. CONCLUSION: Further validation in a wider group of patients is ongoing, together with work towards a full understanding of patient specific responses in support of personalised approaches to radiation medicine.

LATE RADIATION TOXICITY AFTER RADICAL RADIOTHERAPY FOR GENITAL CANCER. / PIZNIa PROMENEVA TOKSYChNIST' PISLIa RADYKAL'NOÏ RADIOTERAPIÏ RAKU GENITALII.

Radiation therapy for malignant tumors of the female genital area, even with the use of modern radiotherapy equipment and dosimetric planning, causes the development of local radiation changes. An approach involving methodsof general and local exposure is used in their treatment. One of the most promising directions is the creation of optimal combinations of medicines (in the form of ointments, gels, aerosols, suppositories, etc.), which have a therapeutic effect on the inflammatory process. The article reflects the clinical course and stage of occurrence of late radiation reactions of the skin, vaginal/cervix mucosa, bladder, and intestines, as well as the features of their treatment.Literary data and own practical experience in the treatment of radiation complications are presented. Whenreviewing the topic under study, it could be concluded that the leading cause of the development of local radiationdamage is the errors in the planning and implementation of radiation therapy, when high absorbed doses thatexceed the tolerance of healthy tissues are used. Another reason for this is the poor accounting for dose distribution of ionizing radiation in tissues, the presence of concomitant diseases in patients, and the underestimation ofthe long-term effects of radiation.

Temporal Trends of Resident Experience in External Beam Radiation Therapy Cases: Analysis of ACGME Case Logs from 2007 to 2018.

PURPOSE: We sought to characterize temporal trends of radiation oncology resident-reported external beam radiation therapy (EBRT) case experience with respect to various disease sites, including trends in stereotactic radiosurgery and stereotactic body radiation therapy cases. METHODS AND MATERIALS: Summarized, deidentified case logs for graduating radiation oncology residents between 2007 and 2018 were obtained from the Accreditation Council for Graduate Medical Education national summary data report. Mean number of cumulative cases and standard deviations per graduating resident by year were evaluated. Cases were subdivided into 12 disease-site categories using the Accreditation Council for Graduate Medical Education classification. Analysis of variance was used to determine significant differences, and strength of association was evaluated using Pearson correlation. RESULTS: The number of graduating residents per year increased by 66% from 114 in 2007 to 189 in 2018 (P < .001, r = 0.88). The overall mean number of EBRT cases per graduating resident decreased by 13.2% from 521.9 in 2007 to 478.5 in 2018, with a decrease in the ratio of nonmetastatic to metastatic cases per graduating resident. There was significant variation among the disease categories analyzed; however, the largest proportionate decreases were seen in hematologic, lung, and genitourinary malignancies. Stereotactic radiosurgery volume per graduating resident increased from an average of 27.9 cases in 2007 to 50.3 in 2018 (P < .001, r = 0.96). Stereotactic body radiation therapy volume per graduating resident increased as well, from a mean of 6 cases in 2007 to 55.6 cases in 2018 (P < .001, r = 0.99). CONCLUSIONS: We report a longitudinal summary of resident-reported experience in EBRT cases. These findings have implications for future efforts to optimize residency training programs and requirements.

Combining Immunotherapy with Radiotherapy for the Treatment of Genitourinary Malignancies.

CONTEXT: Immunotherapy drugs, particularly checkpoint inhibitors, have recently been approved by the Food and Drug Administration for various malignancies. Preclinical and early clinical data show that combining these agents with radiotherapy may produce an even more potent antitumor effect in the treatment of cancer. OBJECTIVE: To describe the rationale, available data, and emerging data on the use of combined immunotherapy and radiation therapy in the setting of genitourinary (GU) malignancies. EVIDENCE ACQUISITION: We performed a search of primary studies from PubMed/Medline that included combinations of the search terms "radiation therapy," "radiotherapy," "abscopal effect," "immunotherapy," "combined," and "combination." EVIDENCE SYNTHESIS: Preclinical and clinical data support both immune-stimulating and immune-suppressing effects of radiotherapy. Preclinical and clinical studies investigating the combination of radiotherapy with immunotherapy, primarily in the setting of non-GU malignancies, have suggested efficacy and tolerability. Early randomized trials combining radiotherapy and immunotherapy have demonstrated success in lung cancer. Although a trial investigating combined immunotherapy and radiotherapy use for prostate cancer did not clearly improve survival, trials are ongoing in multiple GU malignancies to identify synergy between immunotherapy and radiotherapy. Several practical and technical questions remain about the optimal combination of radiotherapy and immunotherapy. CONCLUSIONS: Preclinical and clinical trials show that the combination of the immunotherapy and radiation therapy has the potential to provide a synergistic effect in treating cancer, including GU malignancies, although more work is needed to uncover the mechanism and determine the optimal delivery of this treatment. PATIENT SUMMARY: This paper reviews evidence that immunotherapy drugs can be given together with radiation therapy to improve outcomes in cancers of the genitourinary tract. We find promising initial results and raise important questions that need to be answered before this type of treatment can be utilized successfully.

Dicentric Dose Estimates for Patients Undergoing Radiotherapy in the RTGene Study to Assess Blood Dosimetric Models and the New Bayesian Method for Gradient Exposure.

The RTGene study was focused on the development and validation of new transcriptional biomarkers for prediction of individual radiotherapy patient responses to ionizing radiation. In parallel, for validation purposes, this study incorporated conventional biomarkers of radiation exposure, including the dicentric assay. Peripheral blood samples were taken with ethical approval and informed consent from a total of 20 patients undergoing external beam radiotherapy for breast, lung, gastrointestinal or genitourinary tumors. For the dicentric assay, two samples were taken from each patient: prior to radiotherapy and before the final fraction. Blood samples were set up using standard methods for the dicentric assay. All the baseline samples had dicentric frequencies consistent with the expected background for the normal population. For blood taken before the final fraction, all the samples displayed distributions of aberrations, which are indicative of partial-body exposures. Whole-body and partial-body cytogenetic doses were calculated with reference to a 250-kVp X-ray calibration curve and then compared to the dose to blood derived using two newly developed blood dosimetric models. Initial comparisons indicated that the relationship between these measures of dose appear very promising, with a correlation of 0.88 (P = 0.001). A new Bayesian zero-inflated Poisson finite mixture method was applied to the dicentric data, and partial-body dose estimates showed no significant difference (P > 0.999) from those calculated by the contaminated Poisson technique. The next step will be further development and validation in a larger patient group.

Interstitial brachytherapy for pediatric soft tissue sarcoma: Evolving practice over three decades and long-term outcomes.

PURPOSE: Evaluate long-term clinical outcomes, adverse effects, and evolving practice of interstitial brachytherapy (BT) for pediatric soft tissue sarcomas (STS). METHODS: From September 1984 to December 2014, 105 children (median age 10 years) were included. There were 60 males and 45 females. The majority (74%) had primary lesions. Synovial sarcoma (22%) was the most frequent histology. Treatment included wide local excision and BT with or without external beam radiotherapy (EBRT). Eighty-five (81%) received BT alone. RESULTS: After a median follow-up of 65 months, local control (LC), disease-free survival (DFS), and overall survival (OS) at 10 years were 83, 66, and 73%, respectively. On univariate analysis, LC was superior with tumors <5 cm versus >5 cm (93% vs. 75%, P = 0.10), Grade I/II versus Grade III tumors (97% vs. 73%, P = 0.01), nonround cell versus round cell histology (89% vs. 72%, P = 0.03), and trunk/extremity versus head and neck/genitourinary sites (87% vs. 57%, P = 0.0001). On multivariate analysis tumor size (P = 0.03) and location (P = 0.002) retained significance. Children receiving BT alone had comparable LC to those receiving BT and EBRT (84% vs. 80%, P = 0.43). There was no difference in LC between LDR versus HDR BT (86% vs. 83%, P = 0.30). Wound complications were seen in 6%. Subcutaneous fibrosis (25%), limb edema (6%), skeletal abnormalities (3%), and neuropathy (1%) were the late complications. One child (0.9%) developed a second malignancy after 7 years. CONCLUSION: Interstitial BT with or without EBRT results in excellent outcomes. Radical BT alone, when used judiciously, results in excellent local control and function with minimal treatment-related morbidity.

[Mucosal malignant melanomas in the gastrointestinal tract and urogenital organs].

The aim of this article is to investigate the latest knowledge of the aetiology, pathogenesis and treatment of mucosal malignant melanomas (MMM) in the gastrointestinal tract (GIT) and urogenital organs. MMM constitute 1.4% of all melanomas with an incidence rate in USA of 2.2 per million a year. MMM in the GIT occur mostly in the anal canal and rectum, but can also occur in the small intestine, gallbladder and the large intestine, though very rarely. Melanomas can occur in almost any part of the urinary tract. The aetiology and pathogenesis are unknown. Surgery appears to be the most effective treatment.

Quantitative analysis of treatment process time and throughput capacity for spot scanning proton therapy.

PURPOSE: To determine the patient throughput and the overall efficiency of the spot scanning system by analyzing treatment time, equipment availability, and maximum daily capacity for the current spot scanning port at Proton Therapy Center Houston and to assess the daily throughput capacity for a hypothetical spot scanning proton therapy center. METHODS: At their proton therapy center, the authors have been recording in an electronic medical record system all treatment data, including disease site, number of fields, number of fractions, delivered dose, energy, range, number of spots, and number of layers for every treatment field. The authors analyzed delivery system downtimes that had been recorded for every equipment failure and associated incidents. These data were used to evaluate the patient census, patient distribution as a function of the number of fields and total target volume, and equipment clinical availability. The duration of each treatment session from patient walk-in to patient walk-out of the spot scanning treatment room was measured for 64 patients with head and neck, central nervous system, thoracic, and genitourinary cancers. The authors retrieved data for total target volume and the numbers of layers and spots for all fields from treatment plans for a total of 271 patients (including the above 64 patients). A sensitivity analysis of daily throughput capacity was performed by varying seven parameters in a throughput capacity model. RESULTS: The mean monthly equipment clinical availability for the spot scanning port in April 2012-March 2015 was 98.5%. Approximately 1500 patients had received spot scanning proton therapy as of March 2015. The major disease sites treated in September 2012-August 2014 were the genitourinary system (34%), head and neck (30%), central nervous system (21%), and thorax (14%), with other sites accounting for the remaining 1%. Spot scanning beam delivery time increased with total target volume and accounted for approximately 30%-40% of total treatment time for the total target volumes exceeding 200 cm(3), which was the case for more than 80% of the patients in this study. When total treatment time was modeled as a function of the number of fields and total target volume, the model overestimated total treatment time by 12% on average, with a standard deviation of 32%. A sensitivity analysis of throughput capacity for a hypothetical four-room spot scanning proton therapy center identified several priority items for improvements in throughput capacity, including operation time, beam delivery time, and patient immobilization and setup time. CONCLUSIONS: The spot scanning port at our proton therapy center has operated at a high performance level and has been used to treat a large number of complex cases. Further improvements in efficiency may be feasible in the areas of facility operation, beam delivery, patient immobilization and setup, and optimization of treatment scheduling.

TOLERABILITY AND TUMOR RESPONSE OF A NOVEL LOW-DOSE PALLIATIVE RADIATION THERAPY PROTOCOL IN DOGS WITH TRANSITIONAL CELL CARCINOMA OF THE BLADDER AND URETHRA.

Previously reported radiation protocols for transitional cell carcinoma of the canine lower urinary tract have been ineffective or associated with increased side effects. Objectives of this retrospective, cross-sectional study were to describe safety of and tumor responses for a novel palliative radiation protocol for transitional cell carcinoma in dogs. Included dogs had cytologically or histologically confirmed transitional cell carcinoma of the bladder or urethra, and were treated with 10 once-daily fractions (Monday-Friday) of 2.7 Gy. Thirteen dogs were sampled, with six treated using radiation as first-line (induction) therapy and seven treated using radiation as rescue therapy after failing previous chemotherapy. Within 6 weeks of radiation, 7.6% (1/13) dogs had a complete response, 53.8% (7/13) partial response, 38.5% (5/13) stable disease, and none had progressive disease. Three patients presenting with urethral obstruction had spontaneous micturition restored during the treatment protocol. A single patient with unilateral ureteral obstruction was patent at recheck examination. Median survival time from time of initial diagnosis was 179 days. Median survival time from start of radiation was 150 days. Acute radiation side effects occurred in 31% (4/13) patients and were classified as grade 1 or 2. No significant late side radiation side effects were reported. No variables examined were identified as prognostic factors. Findings indicated that the reported radiation protocol was safe in this sample of dogs with bladder and urethral transitional cell carcinoma. Future prospective studies are needed to determine utility of this treatment as a rescue therapy in patients with complete urinary tract obstruction.

A Quantitative Analysis of the Relationship Between Radiation Therapy Use and Travel Time.

PURPOSE: To model and quantify the relationship between radiation therapy (RT) use and travel time to RT services. METHODS AND MATERIALS: Population-based registries and databases were used to identify both incident cancer patient and patients receiving RT within 1 year of diagnosis (RT1y) in British Columbia, Canada, between 1992 and 2011. The effects of age, gender, diagnosis year, income, prevailing wait time, and travel duration for RT on RT1y were assessed. Significant factors from univariate analyses were included in a multivariable logistic regression model. The shape of the travel time-RT1y curve was represented by generalized additive and segmented regression models. Analyses were conducted for breast, lung, and genitourinary cancer separately and for all cancer sites combined. RESULTS: After adjustment for age, gender, diagnosis year, income, and prevailing wait times, increasing travel time to the closest RT facility had a negative impact RT1y. The shape of the travel time-RT1y curve varied with cancer type. For breast cancer, the odds of RT1y were constant for the first 2 driving hours and decreased at 17% per hour thereafter. For lung cancer, the odds of RT1y decreased by 16% after 20 minutes and then decreased at 6% per hour. Genitourinary cancer RT1y was relatively independent of travel time. For all cancer sites combined, the odds of RT1y were constant within the first 2 driving hours and decreased at 7% per hour thereafter. CONCLUSIONS: Travel time to receive RT has a different impact on RT1y for different tumor sites. The results provide evidence-based insights for the configuration of catchment areas for new and existing cancer centers providing RT.

A qualitative study of cancer survivors' responses to information on the long-term and late effects of pelvic radiotherapy 1-11 years post treatment.

As more patients survive cancer for longer term, the long-term and late effects of treatments become increasingly important issues for cancer survivors and providing information to enable survivors to recognise and manage them becomes an increasingly pressing challenge for health care professionals. The aim of this study was to explore the experiences of cancer survivors regarding information given on potential long-term and late effects of pelvic radiotherapy. Semi-structured interviews were conducted with 28 cancer survivors who had had radiotherapy to the pelvic area for a range of cancers 1-11 years previously. Participants were recruited using maximum variation sampling from a larger questionnaire survey of patients treated at one hospital. Interviews were recorded, transcribed and analysed using Framework. Participants recognised the value of information to reassure and to inform action but also its potentially undesirable effects to frighten or raise anxieties about future problems and its inherent limitations in meeting their wider needs. They identified the timing, amount of information and context in which it was given as of particular importance. Information based on personal experience was also valued. These findings highlight the importance of appropriate, individualised information during treatment, at hospital discharge and subsequently in primary care.

Modern radiation therapy for extranodal lymphomas: field and dose guidelines from the International Lymphoma Radiation Oncology Group.

Extranodal lymphomas (ENLs) comprise about a third of all non-Hodgkin lymphomas (NHL). Radiation therapy (RT) is frequently used as either primary therapy (particularly for indolent ENL), consolidation after systemic therapy, salvage treatment, or palliation. The wide range of presentations of ENL, involving any organ in the body and the spectrum of histological sub-types, poses a challenge both for routine clinical care and for the conduct of prospective and retrospective studies. This has led to uncertainty and lack of consistency in RT approaches between centers and clinicians. Thus far there is a lack of guidelines for the use of RT in the management of ENL. This report presents an effort by the International Lymphoma Radiation Oncology Group (ILROG) to harmonize and standardize the principles of treatment of ENL, and to address the technical challenges of simulation, volume definition and treatment planning for the most frequently involved organs. Specifically, detailed recommendations for RT volumes are provided. We have applied the same modern principles of involved site radiation therapy as previously developed and published as guidelines for Hodgkin lymphoma and nodal NHL. We have adopted RT volume definitions based on the International Commission on Radiation Units and Measurements (ICRU), as has been widely adopted by the field of radiation oncology for solid tumors. Organ-specific recommendations take into account histological subtype, anatomy, the treatment intent, and other treatment modalities that may be have been used before RT.

Radiation enteritis leading to intestinal failure: 1994 patient-years of experience in a national referral centre.

BACKGROUND/OBJECTIVES: Chronic radiation enteritis (RE) has been reported in up to 20% of patients receiving pelvic radiotherapy and can lead to intestinal failure (IF), accounting for 3.9% of new registrants for home parenteral nutrition (HPN) in the UK annually. Our aim is to report nutritional and survival outcomes for patients with RE referred to a national IF unit. SUBJECTS/METHODS: A retrospective study of all new admissions over a 13-year period at the Intestinal Failure Centre, Manchester, UK. Data are presented as median (range). RESULTS: Twenty-three (3.8%) of 611 patients were admitted with IF secondary to RE. The primary site of malignancy was genitourinary in 17 (74%) patients. Radiotherapy was administered 9.5 (1-42) years previously. Patients underwent 2 (1-5) laparotomies prior to intestinal failure unit (IFU) admission. Twelve (52%) patients were admitted with intestinal obstruction and 11 (48%) with intractable weight loss and/or high output fistulae/stomas. Additional conditions contributing to IF were noted in 11 (48%) patients. Twenty-two (96%) patients had 2 (1-5) laparotomies prior to IFU referral. At discharge, 5 (22%) patients resumed oral diet without the need for artificial nutrition support, 3 (13%) required enteral feeding and 13 (56%) commenced HPN. The 10-year survival of the patient cohort was 48.2%. CONCLUSIONS: Surgical intervention is infrequently required, whereas the majority of patients with IF secondary to RE require long-term HPN. The judicious use of surgery in selected patients, coupled with an aggressive medical strategy to detect and treat contributing factors, and optimal enteral feeding may allow a modest proportion of patients with IF secondary to RE to achieve independence from PN.

Radiation therapy for extramammary Paget's disease: treatment outcomes and prognostic factors.

BACKGROUND: Extramammary Paget's disease (EMPD) is a relatively rare malignancy, and there are few reports related to radiation therapy. In the present study, we investigated the outcome of radiation therapy for EMPD. PATIENTS AND METHODS: Forty-one patients with EMPD in the genitalia underwent radiation therapy with curative intent. Fifteen patients had regional lymph node metastases before radiation therapy, but none had distant metastasis. Total doses of 45-80.2 Gy (median, 60 Gy) were delivered to tumor sites in 23-43 fractions (median, 33 fractions). RESULTS: At a median follow-up period of 41 months, 16 patients had developed recurrences, including 5 with local progression within the radiation field and 12 with lymph node or/and distant metastases outside the radiation field. The local progression-free and disease-free rates were 88% and 55% at 3 years, and 82% and 46% at 5 years, respectively. Nine patients died at 6-73 months after irradiation; the causes of death were tumor progression in five patients, infectious pneumonia in two, renal failure in one and old age in one. The overall and cause-specific survival rates were 93% and 96% at 3 years, and 68% and 84% at 5 years, respectively. Tumor invasion into the dermis and regional lymph node metastasis were significant prognostic factors for both distant metastasis and survival. No therapy-related toxicities of grade ≥3 were observed. CONCLUSIONS: Radiation therapy is safe and effective for patients with EMPD. It appeared to contribute to prolonged survival owing to good tumor control, and to be a promising curative treatment option.

[Why is PET/CT essential in urooncology?]. / Miért kell a PET/CT az uroonkológiában?

The wide use of molecular positron emission tomography/computed tomography (PET/CT) imaging in the tumor diagnostics has been playing an important role recently. The clinical role of hybrid imaging (PET/CT, single photon ECT/CT (SPECT/CT)) is growing continuously due to the simultaneous imaging of anatomy and function. Regarding oncology the role of (18)F-fluorodeoxyglucose ((18)F-FDG) PET is proved in several clinical questions, including urooncology. Urologic cancers are associated with low or slightly significant uptake of FDG, due to their more benign behaviour. However, alternative PET tracers have been developed which show promising clinical results and hopefully, in the near future the combination of different tracers are awaited. Additionally, in the future the use of multiparametric measurements, multitracer techniques, and the multimodal PET/magnetic resonance imaging (PET/MRI) technology is going to have a crucial clinical role.

Ovarian transposition in prepubescent and adolescent girls with cancer.

Ovarian transposition was the first procedure proposed to preserve fertility in girls with cancer and is indicated for patients with tumours requiring pelvic radiation at doses of 42·0-58·4 Gy, much higher doses than those that can induce loss of ovarian function (4-20 Gy). Ovarian transposition is usually done after neoadjuvant chemotherapy and is completed by minimally invasive surgery or open surgery in case of concomitant resection of the abdominal tumour. According to the type of tumour, the ovaries are moved and placed in the paracolic gutters when the radiation field reaches the midline (for medulloblastoma or urogenital rhabdomyosarcoma), contralaterally to the tumour (for pelvic sarcomas), or in line with the iliac crests (for Hodgkin's lymphoma). However, in 10-14% of cases the procedure can fail to protect the ovaries. Although few long-term results in adults are available, normal hormonal function and pregnancies have been reported in a few long-term follow-up studies. In view of the continued development of fertility preservation techniques, ovarian transposition should be discussed at a multidisciplinary meeting at the time of cancer diagnosis.

Evaluación urodinámica en pacientes sometidos a braquiterapia por rabdomiosarcomas genitourinarios / Urodynamic evaluation in patients undergoing brachytherapy for genitourinary rhabdomyosarcoma

Introducción: El rabdomiosarcoma (RMS) es uno de los tumores sólidos pediátricos más frecuentes. Se ha descrito que la braquiterapia es una herramienta prometedora para tratar esta patología, presentando menos secuelas en los tejidos vecinos. Este estudio tiene como propósito objetivar las secuelas de la dinámica vesical, a través de evaluación con estudios urodinámicos (EUD) a pacientes pediátricos sometidos a cirugía conservadora más braquiterapia por RMS de origen uroginecológico.P acientes y Métodos: Revisión de casos de RMS uroginecológicos desde 2004 a 2011, manejados con braquiterapia pre y/o post operatoria, más quimioterapia preoperatoria. Se realiza estudio urodinámico invasivo y/o no invasivo para evaluar secuelas en función miccional. Resultados: Serie de 4 casos de pacientes con RMS genitourinarios sometidos a braquiterapia sola o asociada a cirugía resectiva: 2 de próstata, 1 vaginal y 1 vesical. Los estudios urodinámicos muestran una capacidad vesical disminuida en 1 paciente, mínima disminución en otro y 2 presentan capacidad normal para la edad. La acomodación del detrusor es adecuada en los 4 pacientes y no hay alteraciones en la función esfinteriana. Clínicamente todos los pacientes son continentes y no presentan sintomatología de disfunción miccional. Conclusiones: El RMS genitourinario es un tumor altamente invasivo y secuelante. La braquiterapia ha logrado un nivel de radiación óptimo que se enfoca en el área tumoral sin afectar mayormente tejidos vecinos. Esto implicaría menos probabilidades de producir efectos secundarios en la dinámica vesical. Hemos demostrado en esta serie, con evaluación urodinámica, que estos pacientes con RMS presentan mínimas alteraciones en la evaluación urodinámica y no tienen repercusión clínica post tratamiento. Trabajos futuros están orientados a evaluación urodinámica pre y post braquiterapia.

Introduction: Rhabdomyosarcoma (RMS) is one of the most common pediatric solid tumors. It has been described that brachytherapy is a promising tool to treat this pathology, presenting less sequelae in neighboring tissues. This study aims to objectify alterations in bladder function through evaluation with urodynamic studies (UDS) in pediatric patients undergoing conservative surgery plus brachytherapy due to urogynecological RMS. Patients and Methods: A review of cases of RMS urogynecological from 2004-2011, managed with pre and / or post-operative brachytherapy, and preoperative chemotherapy. Invasive and / or noninvasive Urodynamic Studies are performed to assess sequelae in voiding function. Results: A series of 4 cases of genitourinary RMS patients undergoing brachytherapy alone or combined with resection surgery: 2 prostate cases, 1 vaginal and 1 bladder case. Urodynamic studies show a decreased bladder in 1 patient, minimal decrease in another and 2 show normal capacity for the patients age. Detrusor compliance is adequate in the 4 patients and there are no alterations in sphincter function. Clinically all patients are continent and show no symptoms of voiding dysfunction. Conclusions: Genitourinary RMS are a highly invasive and invalidating tumor. Brachytherapy achieves optimal radiation level that focuses on the tumor area without greatly affecting neighboring tissues.This could imply less likelyhood to cause side effects in bladder dynamics. We have shown in this series, with urodynamic evaluation, that these patients with RMS have minimal alterations in urodynamic Studies and have no post-treatment clinical impact. Future work is aimed at evaluating urodynamics before and after brachytherapy.

Applicability of randomized trials in radiation oncology to standard clinical practice.

BACKGROUND: Randomized controlled trials (RCTs) are commonly used to inform clinical practice; however, it is unclear how generalizable RCT data are to patients in routine clinical practice. The authors of this report assessed the availability and applicability of randomized evidence guiding medical decisions in a cohort of patients who were evaluated for consideration of definitive management in a radiation oncology clinic. METHODS: The medical records of consecutive, new patient consultations between January and March 2007 were reviewed. Patient medical decisions were classified as those with (Group 1) or without (Group 2) available, relevant level I evidence (phase 3 RCT) supporting recommended treatments. Group 1 medical decisions were further divided into 3 groups based on the extent of fulfilling eligibility criteria for each RCT: Group 1A included decisions that fulfilled all eligibility criteria; Group 1B, decisions that did not fulfill at least 1 minor eligibility criteria; or Group 1C, decisions that did not fulfill at least 1 major eligibility criteria. Patient and clinical characteristics were tested for correlations with the availability of evidence. RESULTS: Of the 393 evaluable patients, malignancies of the breast (30%), head and neck (18%), and genitourinary system (14%) were the most common presenting primary disease sites. Forty-seven percent of all medical decisions (n = 451) were made without available (36%) or applicable (11%) randomized evidence to inform clinical decision making. Primary tumor diagnosis was significantly associated with the availability of evidence (P < .0001). CONCLUSIONS: A significant proportion of medical decisions in an academic radiation oncology clinic were made without available or applicable level I evidence, underscoring the limitations of relying solely on RCTs for the development of evidence-based health care.