Stability of Multi-Parametric Prostate MRI Radiomic Features to Variations in Segmentation.

Stability analysis remains a fundamental step in developing a successful imaging biomarker to personalize oncological strategies. This study proposes an in silico contour generation method for simulating segmentation variations to identify stable radiomic features. Ground-truth annotation provided for the whole prostate gland on the multi-parametric MRI sequences (T2w, ADC, and SUB-DCE) were perturbed to mimic segmentation differences observed among human annotators. In total, we generated 15 synthetic contours for a given image-segmentation pair. One thousand two hundred twenty-four unfiltered/filtered radiomic features were extracted applying Pyradiomics, followed by stability assessment using ICC(1,1). Stable features identified in the internal population were then compared with an external population to discover and report robust features. Finally, we also investigated the impact of a wide range of filtering strategies on the stability of features. The percentage of unfiltered (filtered) features that remained robust subjected to segmentation variations were T2w-36% (81%), ADC-36% (94%), and SUB-43% (93%). Our findings suggest that segmentation variations can significantly impact radiomic feature stability but can be mitigated by including pre-filtering strategies as part of the feature extraction pipeline.

Impact of Microscopically Positive (≤1 mm) Distal Margins on Disease Recurrence in Rectal Cancer Treated by Neoadjuvant Chemoradiotherapy.

BACKGROUND: The adequate distal resection margin is still controversial in rectal cancer treated by neoadjuvant chemoradiotherapy (nCRT). The aim of this study was to assess the impact of a distal margin of ≤1 mm on locoregional recurrence-free survival (LRRFS). METHODS: Among 255 patients treated with nCRT and surgery at the National Cancer Institute of Milan, 83 (32.5%) had a distal margin of ≤1 mm and 172 (67.5%) had a distal margin of >1 mm. Survival analyses were performed to assess the impact of distal margin on 5-year LRRFS, as well as Cox survival analysis. The role of distal margin on survival was analyzed according to different tumor regression grades (TRGs). RESULTS: The overall 5-year LRRFS rate was 77.6% with a distal margin of ≤1 mm vs. 88.3% with a distal margin of >1 mm (Log-rank p = 0.09). Only stage ypT4 was an independent predictor of worse LRRFS (HR 15.14, p = 0.026). The 5-year LRRFS was significantly lower in TRG3-5 patients with a distal margin of ≤1 mm compared to those with a distal margin of >1 mm (68.5% vs. 84.2%, p = 0.027), while no difference was observed in case of TRG1-2 (p = 0.77). CONCLUSIONS: Low-responder rectal cancers after nCRT still require a distal margin of >1 mm to reduce the high likelihood of local relapse.

Radiotherapy after testis-sparing surgery for seminoma in monorchid patients: safety and efficacy.

PURPOSE: To evaluate local control and longitudinal endocrine data in monorchid patients treated with testicular-sparing surgery and adjuvant radiotherapy (RT) for seminomatous germ-cell tumors. METHODS: We searched our database established in 2009 for patients with seminoma who received testis irradiation following partial orchiectomy up to 2018. Eleven patients were identified. All had associated germ cell neoplasia in situ (GCNIS) in surrounding parenchyma. Analysis focused on local control and testosterone levels preservation after RT. We considered age, baseline (pre-RT) testosterone and luteinizing hormone (LH) levels, residual testicular volume, tumor size, and testosterone and LH levels trend over time in order to identify any association with endocrine impairment leading to hormonal replacement need. RESULTS: After a median follow-up of 21 months, no local or distant relapses were observed and hormonal function was maintained in 54.5% of patients (6/11). No significant interactions were observed for the investigated covariates. Notably, we observed an association between higher baseline testosterone levels and a decreased risk of exogenous androgen replacement (hazard ratio [HR] 0.409, 95% confidence interval [CI] 0.161-1.039, p = 0.060), whereas tumor size was associated with an increased risk of exogenous androgen replacement (HR 1.847, 95% CI 0.940-3.627, p = 0.075). CONCLUSIONS: Radiotherapy after testicular sparing surgery is effective in preventing local disease relapse in presence of GCNIS in the medium term. This strategy allows a preservation of adequate endocrine function in about half of patients. More patients and longer follow-up are needed to confirm these findings.

Glans Preservation in Surgical Treatment of Distal Urethral Strictures With Dorsal Buccal Mucosa Graft Onlay by Subcoronal Approach.

OBJECTIVE: To describe dorsal onlay buccal mucosa graft urethroplasty technique by subcoronal approach and glans preservation in distal penile urethral strictures with fossa navicularis involvement and to report safety, effectiveness, and cosmetic outcomes. METHODS: Retrospective review of a prospective database of patients treated at Hospital Italiano de Buenos Aires between January 2011 and December 2019. Main surgical steps: ventral subcoronal incision, dorsal dissection of glandelar urethra until piercing the tip of the glans, dorsal urethrotomy, and graft transposition. Low urinary tract symptoms, uroflowmetry, and urinalysis were assessed at follow-up. Simplified International Index Erectile Function and Hypospadias Objective Scoring Evaluation were applied 1 year after surgery. RESULTS: Sixteen patients with a median age of 56.5 years (IQR 35.7-66.7) were included. Median stricture length was 5.5 cm (IQR 4-8.7). In 3 patients, Clavien-Dindo grade I-II complications were reported. At 1 year, median peak flow was 18 mL/seg (IQR 12.7-27.4) and median mean flow 7.8 mL/seg (IQR 6.1-9.9). At 41.5 months follow-up (IQR 13.2-74), all patients were stricture free and had no changes in erectile function. Hypospadias Objective Scoring Evaluation score ≥14 points was achieved by 14 patients (87.5%). CONCLUSION: For treatment of distal penile urethral strictures with fossa navicularis involvement, dorsal onlay buccal mucosa graft by subcoronal approach and glans preservation is a feasible technique with excellent functional outcomes, minimal complications, and substantial cosmetic results.

How to implement the requirements of a quality assurance system for prostate cancer.

PURPOSE: In 2003, the German Cancer Society (Deutsche Krebsgesellschaft, DKG) launched a certification program aimed at improving the quality of cancer care. The purpose of this article is to describe the experience of the Prostate Cancer Unit (PCU) at Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, in the process towards DKG certification. METHODS: In 2018, PCU decided to apply for certification by adopting DKG catalogue of requirements (CoR) and quality indicators. A multiprofessional working group was established with the aim of acting the necessary steps to meet DKG standards. RESULTS: Our organizational setting (procedures, personnel) and activities were accurately analyzed, thus outlining strengths and weaknesses, and modified to comply with DKG CoR and indicators. As examples, (1) a quality management plan was developed; (2) measures were taken to strengthen the surgical expertise; (3) cases evaluated in weekly tumor boards were expanded to include surgical cases with pathological risk factors, metastatic, relapsed and castration-resistant patients; (4) a survey was added to the patient-dedicated initiatives already scheduled; (5) the TuDoc software became the tool to register all new cases of prostate cancer patients referred to PCU. CONCLUSIONS: The process of certification requires many efforts but represents a unique opportunity of improving quality of care of prostate cancer patients, making it comparable on an international scale.

Bulbomembranous Urethral Strictures Repair After Surgical Treatment of Benign Prostatic Hyperplasia. Experience From a Latin American Referral Centre.

OBJECTIVE: To evaluate stricture recurrence and urinary incontinence (UI) rates in patients who underwent bulbomembranous anastomosis for management of short (≤ 2cm) bulbomembranous urethral stricture (BMS) after benign prostatic hyperplasia (BPH) surgical treatment. In addition, we studied if there was any relation between post urethroplasty UI and the method employed for BPH surgical treatment. MATERIALS AND METHODS: A retrospective study was conducted between January 2011 and October 2019. We included all patients who developed BMS after undergoing Transurethral Resection of the Prostate, Holmium Laser Enucleation of the Prostate or Open Simple Prostatectomy (OSP). We excluded patients with UI after BPH surgical treatment as well as patients who underwent a dorsal or ventral onlay oral graft urethroplasty for longer proximal bulbar strictures, and also patients with associated bladder neck contracture or other strictures locations. We defined failure as the need for any intervention to restore the urethral caliber. RESULTS: Overall, 77 patients were included in the study with mean age 70 years (sd 8). Median BMS length was 1.5 cm (IQR 1-2). Median follow-up was 53 months (IQR 24 to 82). Of the patients, 74/77 (96.1%) were classified as success and 3/77 (3.9%), as failure. Out of the 6/77 (7.8%) patients who had postoperative UI, 5 of them had been treated for their BPH with OSP (p 0.001). CONCLUSIONS: Bulbomembranous anastomosis is a suitable reconstructive option for short proximal bulbar urethral strictures after BPH surgical treatment. OSP was associated with postoperative UI more frequently than endoscopic treatments modalities.

Neoadjuvant (re)chemoradiation for locally recurrent rectal cancer: Impact of anatomical site of pelvic recurrence on long-term results.

BACKGROUND: Selection criteria to propose neoadjuvant (re)chemoradiation (CHRT) in locally recurrent rectal cancer (LRRC) are required, since re-irradiation is sometimes associated to severe adverse effects. Aim of the present study was to compare chances of R0 surgery and disease-free survival (DFS) in LRRC patients (pts) treated by neoadjuvant (re)CHRT followed by surgery vs. upfront surgery, stratifying pts by each localization of LRRC. METHODS: LRRC pts treated at the National Cancer Institute of Milan (Italy) were retrospectively divided into two groups: neoadjuvant (re)CHRT vs. upfront surgery. According to our Milan classification, LRRC were categorized as S1, if located centrally (S1a-b) or anteriorly (S1c) within the pelvis; S2, in case of sacral involvement; S3, in case of lateral pelvic wall infiltration. RESULTS: 152 pts were candidate for multimodal treatment: 49 (32.2%) by neoadjuvant (re)CHRT and surgery, including 33 re-irradiations, vs. 103 (67.8%) by upfront surgery. No difference was observed in R0 resection rates (respectively 47.6% vs. 51.0%). However, neoadjuvant (re)CHRT followed by surgery improved the DFS (p = 0.028), also in R1 procedures (p = 0.013), compared with upfront surgery. At multivariate analysis, the R+ surgery (p < 0.0001) strongly predicted unfavorable DFS, while neoadjuvant (re)CHRT followed by surgery was independently associated to better DFS (p = 0.0197). Stratifying by LRRC localization, the combined approach significantly improved DFS in the S1c (p = 0.029) and S2 (p = 0.004) subgroups compared to upfront surgery, but not in S1a-b and S3 pts. CONCLUSION: Anterior (S1c) and sacral-invasive (S2) pelvic recurrences significantly benefit in terms of DFS by combination of neoadjuvant (re)CHRT and radical surgery, also after R1 resection.

Immunohistochemical, histomorphometric, and gingival crevicular fluid analysis of residual and shallow periodontal pockets in patients with periodontitis Stages III and IV.

BACKGROUND: To study the differences between shallow and residual periodontal pockets in patients with periodontitis (Stages III and IV) after non-surgical periodontal treatment. METHODS: Twenty patients diagnosed of periodontitis who were scheduled for periodontal surgery were included. In each patient, a palatal shallow site (≤3 mm) and a residual site (≥5 mm) were selected and GCF samples were processed by Luminex® analysis to determine the concentrations of interleukins (IL-1ß, IL-6, IL-10, and IL-17a). During the periodontal surgery gingival biopsies were collected and processed for histo-morphometric and immunohistochemical evaluation to determine the extent of connective tissue inflammatory infiltrate (CTII) using the following markers (CD4, CD5, CD8, CD14, CD19, Elastase, and Syndecan). Mean differences between shallow and residual pockets samples, as well as correlations between GCF cytokine concentrations, area of CTII, and cellularity of the CTII were calculated. RESULTS: A total of 15 patients were finally included, with analysis of 30 histological specimens and 30 GCF samples. Residual pockets presented significantly higher mean GCF volume, higher mean area of CTII and higher concentrations of IL-1ß and IL-6 in GCF than shallow pockets. A significant correlation was detected between IL-10 levels and the CTII area, IL-10 and the percentage of Syndecan, and the area of CTII and the percentages of CD14 and Syndecan. CONCLUSIONS: The concentration of GCF cytokines did not correlate with the area of CTII measured histologically. A residual CTII and elevated concentrations of proinflammatory cytokines and cells were present in all sites 2 months after non-surgical treatment. The lack of healthy controls does not allow to establish differences between both groups.

Ethnonursing: cultural care in a mapuche community in Puerto Aguirre, Aysén, Chile / Etnoenfermagem: cuidados culturais em uma comunidade mapuche em Puerto Aguirre, Aysén, Chile / Etnoenfermería: cuidados culturales en una comunidad mapuche en Puerto Aguirre, región de Aysén-Chile

ABSTRACT Objectives: to understand the beliefs, expressions, and practices of generic care used by the Mapuche community in Puerto Aguirre and acknowledge the professional care offered to promote health. Method: a qualitative research based on ethnonursing carried out during seven trips to Puerto Aguirre between July 2018 and January 2019. A total of seven key informants and seven general informants were interviewed. Information was collected through observations, field notes, conversations, and interviews. Results: the scientific property of ethnonursing was verified. Three themes that structure the cultural care practices in the studied community emerged: Mapuche identity as the main value to preserve cultural care; The essesntial presence of women to carry out meaningful experiences and care practices among the Mapuche; and Mapuche value and use of cultural and professional care practices to promote health. Conclusion: the research recognizes the full validity of the Cultural Care Theory. Nursing and, in general, the different health professions tend to become popular, and professional knowledge is complemented, thus learning and improving cultural care in the community.

RESUMO Objetivos: compreender as crenças, expressões e práticas genéricas de cuidado utilizadas pela comunidade mapuche em Puerto Aguirre e reconhecer o cuidado profissional oferecido à promoção da saúde. Método: pesquisa qualitativa baseada na etnoenfermagem, realizada durante sete viagens a Puerto Aguirre, realizadas entre julho de 2018 e janeiro de 2019. Foram entrevistados sete informantes-chave e sete informantes gerais. As informações foram compiladas por meio de observações, anotações de campo, conversas e entrevistas. Resultados: confirmou-se a propriedade científica da etnoenfermagem, identificando três temas que estruturam as práticas de cuidado cultural na comunidade estudada: A identidade mapuche como principal valor para preservar o cuidado cultural; A presença de mulheres é essencial para realizar experiências e práticas de cuidado significativas entre os mapuches; e Os mapuches valorizam e usam práticas de cuidado cultural e profissional para promover a saúde. Conclusão: a pesquisa reconhece a validade plena da Teoria do Cuidado Cultural, uma vez que a enfermagem e, em geral, as diferentes profissões da saúde, tendem a se popularizar e o conhecimento profissional é complementado, aprendendo e aprimorando o cuidado cultural na comunidade.

RESUMEN Objetivos: comprender las creencias, expresiones y prácticas de cuidados genéricos utilizados por la comunidad mapuche en Puerto Aguirre y reconocer la atención profesional ofrecida a la Promoción de la Salud. Método: investigación cualitativa basada en la Etnoenfermería, llevada a cabo durante siete viajes a Puerto Aguirre realizado entre julio de 2018 y enero de 2019. Se entrevistó a un total de siete informantes claves y siete informantes generales. Las informaciones fueron recopiladas por intermedio de observaciones, notas de campo, conversaciones y entrevistas. Resultados: se constató la propiedad científica de la Etnoenfermería, identificándose tres temas que estructuran las prácticas de cuidado cultural en la comunidad estudiada: La identidad mapuche como principal valor para preservar el cuidado cultural; La presencia de mujeres es esencial para la realización de experiencias y prácticas de atención significativas entre los mapuches; y Los mapuches valoran y utilizan las prácticas de cuidado cultural y profesionales para promover la salud. Conclusión: la investigación reconoce la plena vigencia de la Teoría del Cuidado Cultural, pues la enfermería y, en general, las diferentes profesiones de la salud, tienden a popularizarse y el conocimiento profesional se complementa, aprendiéndose y mejorando así el cuidado cultural en la comunidad.

Evaluation of Mediators Associated with the Inflammatory Response in Prostate Cancer Patients Undergoing Radiotherapy.

A recent "hot topic" in prostate cancer radiotherapy is the observed association between acute/late rectal toxicity and the presence of abdominal surgery before radiotherapy. The exact mechanism is unclear. Our working hypothesis was that a previous surgery may influence plasma level of inflammatory molecules and this might result in enhanced radiosensitivity. We here present results on the feasibility of monitoring the expression of inflammatory molecules during radiotherapy. Plasma levels of a panel of soluble mediators associated with the inflammatory response were measured in prostate cancer patients undergoing radical radiotherapy. We measured 3 cytokines (IL-1b, IL-6, and TNF alpha), 2 chemokines (CCL2 and CXCL8), and the long pentraxin PTX3. 20 patients were enrolled in this feasibility evaluation. All patients were treated with IMRT at 78 Gy. 3/20 patients reported grade 2 acute rectal toxicity, while 4/20 were scored as grade 2 late toxicity. CCL2 was the most interesting marker showing significant increase during and after radiotherapy. CCL2 levels at radiotherapy end could be modelled using linear regression including basal CCL2, age, surgery, hypertension, and use of anticoagulants. The 4 patients with late toxicity had CCL2 values at radiotherapy end above the median value. This trial is registered with ISRCTN64979094.

Safety and performance of a novel collagenated xenogeneic bone block for lateral alveolar crest augmentation for staged implant placement.

OBJECTIVES: To evaluate the performance and safety of placing a collagenated xenogeneic bone block (CXBB) graft for the lateral bone augmentation of the alveolar crest prior to implant placement. MATERIAL & METHODS: In patients with single or multiple tooth gaps and a severe horizontal collapse of the alveolar ridge, a ridge augmentation procedure was performed using CXBB fixated with osteosynthesis screws to the atrophic bone crest and complemented with deproteinized bovine bone mineral particles (DBBM) and a native bilayer collagen membrane (NBCM). Patients were examined with CBCT prior to and 24 weeks after the augmentation. Twenty-six weeks postoperatively, a re-entry procedure was performed to evaluate the bone width and availability for adequate implant placement. RESULTS: Fifteen patients received 28 CXBB, and in 13 patients, a re-entry procedure was performed. Eleven patients (84.6%) gained enough bone volume for implant insertion without additional contouring or secondary bone augmentation. The mean crest width at baseline was 2.83 mm (SD 0.57), and the mean crest width at re-entry was 6.90 mm (SD 1.22), with a mean ridge width increase of 4.12 mm (SD 1.32). Soft tissue dehiscence occurred during the follow-up in 5 of 14 patients (35.7%) at various time points. In addition, there was a high incidence of early implant loss (30.8% [patient-based]). CONCLUSIONS: CXBB achieved significant horizontal crestal width gains allowing a secondary implant placement in the majority of the patients. However, the occurrence of soft tissue dehiscence may notably affect the outcome of the subsequent implant therapy.

Physicists' views on hadrontherapy: a survey of members of the Italian Association of Medical Physics (AIFM).

BACKGROUND: This study was based on a survey to investigate perceptions of hadrontherapy of the members of the Italian Association of Medical Physics (AIFM). The survey was digitally submitted to the 991 members between the end of January and the beginning of April 2016. METHODS: A 19-item questionnaire was designed focusing on advantages and disadvantages of hadrontherapy, current status and possible future improvements, and need and opportunities for future investments in Italy and abroad. Information about professional qualifications, main fields of clinical involvement and specific competencies of the respondents was also collected. RESULTS: The survey was completed by 121 AIFM members (response rate 12.2%). In the answers collected, it was shown that medical physicists expressed interest in hadrontherapy mainly for reasons of personal interest rather than for professional needs (90% ± 2.5% vs. 52% ± 4.3% of the respondents, respectively), with a good knowledge of the related basic aspects as well as of the pros and cons of its application. However, poor knowledge of the current status of hadrontherapy was observed among the medical physicists not directly involved at a professional level, who were less than 3% of the physicists working in radiotherapy. CONCLUSIONS: In light of these results, the implementation of new training and education initiatives should be devised to promote a deeper and global knowledge of hadrontherapy-related issues, not only from a theoretical point of view but also in practical terms. Moreover, a close collaboration between highly specialized medical physicists employed in hadrontherapy centers and others in oncology hospitals should be -encouraged.

Eleven-year management of prostate cancer patients on active surveillance: what have we learned?

PURPOSE: To evaluate the outcomes of active surveillance (AS) on patients with low-risk prostate cancer (PCa) and to identify predictors of disease reclassification. METHODS: In 2005, we defined an institutional AS protocol (Sorveglianza Attiva Istituto Nazionale Tumori [SAINT]), and we joined the Prostate Cancer Research International: Active Surveillance (PRIAS) study in 2007. Eligibility criteria included clinical stage ≤T2a, initial prostate-specific antigen (PSA) <10 ng/mL, and Gleason Pattern Score (GPS) ≤3 + 3 (both protocols); ≤25% positive cores with a maximum core length containing cancer ≤50% (SAINT); and ≤2 positive cores and PSA density <0.2 ng/mL/cm3 (PRIAS). Switching to active treatment was advised for a worsening of GPS, increased positive cores, or PSA doubling time <3 years. Active treatment-free survival (ATFS) was assessed using the Kaplan-Meier method. Factors associated with ATFS were evaluated with a multivariate Cox proportional hazards model. RESULTS: A total of 818 patients were included: 200 in SAINT, 530 in PRIAS, and 88 in personalized AS monitoring. Active treatment-free survival was 50% after a median follow-up of 60 months. A total of 404/818 patients (49.4%) discontinued AS: 274 for biopsy-related reclassification, 121/404 (30%) for off-protocol reasons, 9/404 (2.2%) because of anxiety. Biopsy reclassification was associated with PSA density (hazard ratio [HR] 1.8), maximum percentage of core involvement (HR 1.5), positive cores at diagnostic biopsy (HR 1.6), older age (HR 1.5), and prostate volume (HR 0.6) (all p<0.01). Patients from SAINT were significantly more likely to discontinue AS than were the patients from PRIAS (HR 1.65, p<0.0001). CONCLUSIONS: Five years after diagnosis, 50% of patients with early PCa were spared from active treatment. Wide inclusion criteria are associated with lower ATFS. However, at preliminary analysis, this does not seem to affect the probability of unfavorable pathology.

Histomorphometric and immunohistochemical evaluation of collagen containing xenogeneic bone blocks used for lateral bone augmentation in staged implant placement.

BACKGROUND: The osteoconductive properties of collagen containing xenogeneic bone blocks (CCXBB) remain unclear. The aim of this prospective single-arm clinical study was to assess the histological outcomes of CCXBB blocks used as bone replacement grafts for lateral bone augmentation procedures. METHODS: In 15 patients with severe horizontal alveolar ridge resorption, lateral augmentation procedures were performed using CCXBB as bone replacement grafts. Twenty-six weeks postoperatively, a re-entry procedure was performed to evaluate the bone width for adequate implant placement and two histological specimens were retrieved from each patient, one being processed for ground sectioning and the other for decalcified paraffin-included sections. In non-decalcified sections, the relative proportions occupied by bone, biomaterials, and connective tissue present in the biopsies were identified. In de-calcified sections, structures and cells positive for osteopontin (OPN), tartrate-resistant acid phosphatase activity (TRAP), osteocalcin (OSC), and alkaline phosphatase (ALP) were assessed. RESULTS: Soft tissue dehiscence occurred during the follow-up in 5 out of 15 patients (33.3%). The mean crest width at baseline was 2.78 mm (SD 0.57) and the mean crest width at re-entry was 6.90 mm (SD 1.22), with a mean ridge width increase of 4.12 mm (SD 1.32). Twenty-six bone biopsies were obtained from 13 patients. Histomorphometric analysis showed a mean of 26.90% (SD 12.21) of mineralized vital bone (MVB), 21.37% (SD 7.36) of residual CCXBB, 47.13% (SD 19.15) of non-mineralized tissue, and 0.92% of DBBM. The immunohistochemical analysis revealed a large number of OPN-positive cells 8.12% (SD 4.73), a lower proportion of TRAP positive multinuclear cells 5.09% (SD 4.91), OSC-positive cells 4.09% (SD 4.34), and a limited amount of ALP positive cells 1.63% (SD 2). CONCLUSIONS: CCXBB achieved significant horizontal crestal width allowing for staged implant placement in most of the patients. In light of the histological outcomes and implant failures, special attention must be placed to prevent soft tissue dehiscence when CCXBB is used in severe atrophic alveolar crests.

Aspectos críticos contextuales de un hospital de alta complejidad / Critical contextual aspects of a highly complex hospital / Aspectos críticos contextuais de um hospital de alta complexidade

Este artículo presenta los resultados parciales de un análisis FODA realizado en el Instituto Nacional del Tórax, con el fin de generar información sobre los aspectos críticos que afectan la gestión estratégica de un hospital público de alta complejidad, y abrir una reflexión ética sobre tales procesos. Para su determinación se usaron focus group, entrevistas en profundidad, propuestas por el equipo Directivo del Hospital y discusiones en torno al ámbito contextual. Las entrevistas individuales y grupales tuvieron una duración de una hora y veinte minutos aproximadamente y se realizaron en dependencias del hospital. La conceptualización de los datos, se hizo desde la Teoría Fundamentada. El estudio muestra, de acuerdo con la percepción de los entrevistados, que hay aspectos contextuales, tales como reglas del juego, stakeholders y cultura país, cuya tensión ética con la organización, afectan el quehacer del Instituto Nacional del Tórax, en cuanto hospital público de alta complejidad.

This article presents the partial results of a SWOT analysis at the National Chest Institute, in order to generate information on critical issues affecting the strategic management of a public hospital of high complexity, and open an ethical reflection on such processes. For their determination were used: focus groups, interviews, proposed by the management team of the Hospital and discussions on the contextual level. The Individual and group interviews lasted about an hour and twenty minutes and were performed at hospital units. The conceptualization of the data was made from Grounded Theory. The study shows, according to the perception of the interviewees, their contextual issues such as rules, stakeholders and cultural country, whose ethical tension with the organization, affect the work of the National Chest Institute as a high complexity public hospital.

objetivo: Este artigo apresenta resultados parciais de uma análise FOFA realizada no Instituto Nacional de Tórax do Chile, com a finalidade de gerar informações sobre os aspectos críticos que afetam a gestão estratégica de um hospital público de alta complexidade, e gerar uma reflexão ética sobre tais processos. Método: para sua determinação fora utilizado o focus group, entrevistas em profundidade propostas pela equipe de gestão do hospital e discussões acerca do escopo contextual. A conceitualização dos dados, foi feita a partir da Teoria Fundamentada. Conclusões: o estudo demonstra que, de acordo com a percepção dos entrevistados, há aspectos contextuais, tais como as regras do jogo, stakeholders e a cultura do país, cuja tensão ética com a organização afetam o trabalho do Instituto Nacional do tórax, enquanto hospital público de alta complexidade.

An accurate method to quantify breathing-induced prostate motion for patients implanted with electromagnetic transponders.

PURPOSE: To validate and apply a method for the quantification of breathing-induced prostate motion (BIPM) for patients treated with radiotherapy and implanted with electromagnetic transponders for prostate localization and tracking. METHODS: For the analysis of electromagnetic transponder signal, dedicated software was developed and validated with a programmable breathing simulator phantom. The software was then applied to 1,132 radiotherapy fractions of 30 patients treated in supine position, and to a further 61 fractions of 2 patients treated in prone position. RESULTS: Application of the software in phantom demonstrated reliability of the developed method in determining simulated breathing frequencies and amplitudes. For supine patients, the in vivo analysis of BIPM resulted in median (maximum) amplitudes of 0.10 mm (0.35 mm), 0.24 mm (0.66 mm), and 0.17 mm (0.61 mm) in the left-right (LR), cranio-caudal (CC), and anterior-posterior (AP) directions, respectively. Breathing frequency ranged between 7.73 and 29.43 breaths per minute. For prone patients, the ranges of the BIPM amplitudes were 0.1-0.5 mm, 0.5-1.3 mm, and 0.7-1.7 mm in the LR, CC, and AP directions, respectively. CONCLUSIONS: The developed method was able to detect the BIPM with sub-millimeter accuracy. While for patients treated in supine position the BIPM represents a reduced source of treatment uncertainty, for patients treated in prone position, it can be higher than 3 mm.

Phase II multi-institutional clinical trial on a new mixed beam RT scheme of IMRT on pelvis combined with a carbon ion boost for high-risk prostate cancer patients.

PURPOSE: Definition of the optimal treatment schedule for high-risk prostate cancer is under debate. A combination of photon intensity modulated radiotherapy (IMRT) on pelvis with a carbon ion boost might be the optimal treatment scheme to escalate the dose on prostate and deliver curative dose with respect to normal tissue and quality of dose distributions. In fact, carbon ion beams offer the advantage to deliver hypofractionated radiotherapy (RT) using a significantly smaller number of fractions compared to conventional RT without increasing risks of late effects. METHODS: This study is a prospective phase II clinical trial exploring safety and feasibility of a mixed beam scheme of carbon ion prostate boost followed by photon IMRT on pelvis. The study is designed to enroll 65 patients with localized high-risk prostate cancer at 3 different oncologic hospitals: Istituto Europeo di Oncologia, Fondazione IRCCS Istituto Nazionale dei Tumori, and Centro Nazionale di Adroterapia Oncologica. The primary endpoint is the evaluation of safety and feasibility with acute toxicity scored up to 1 month after the end of RT. Secondary endpoints are treatment early (3 months after the end of RT) and long-term tolerability, quality of life, and efficacy. RESULTS: The study is not yet recruiting; in silico studies are ongoing and we expect to start recruitment by 2017. CONCLUSIONS: The present clinical trial aims at improving the current treatment for high-risk prostate cancer, evaluating safety and feasibility of a new RT mixed-beam scheme including photons and carbon ions. Encouraging results are coming from carbon ion facilities worldwide on the treatment of different tumors including prostate cancers. Carbon ions combine physical properties allowing for high dose conformity and advantageous radiobiological characteristics. The proposed mixed beam treatment has the advantage to combine a photon high conformity standard of care IMRT phase with a hypofractionated carbon ion RT boost delivered in a short overall treatment time.

"What if ": decisional regret in patients who discontinued active surveillance.

PURPOSE: To investigate the presence of regret in patients about having followed an active surveillance (AS) protocol. The secondary aim was to identify variables that influence regret. METHODS: From February 2006 to May 2014, 204 patients discontinued the AS protocols and were invited to enter the study. Sociodemographic variables were collected at AS enrollment, together with health-related quality of life (Functional Assessment of Cancer Therapy-Prostate version [FACT-P]) and coping (Mini-Mental Adjustment to Cancer). Patients were asked to complete a Treatment Regret Scale as well as the FACT-P questionnaire. Clinical data were gathered, as well as time of stay within the AS protocol, reason for discontinuing AS, kind of post-AS treatment, and time elapsed since AS discontinuation. Questionnaires were completed by 105 patients (51.5% of those who had been invited to enter the study). RESULTS: Most of the patients had a low or null degree of regret on the Treatment Regret Scale from 0 to 100 (82/105 patients [78.1%] obtained a score <30, and about 30% of the sample had a score equal to zero). Only 5 patients (4.7%) scored 60 or more, indicating some degree of regret. None of the statistical tests between regret scores and a number of analyzed variables reached significance. CONCLUSIONS: These results show that the degree of regret about following an AS protocol and after its discontinuation because of entering active treatment was very low. The regret after AS was not related to sociodemographic or clinical factors.

Predictors of health-related quality of life and adjustment to prostate cancer during active surveillance.

BACKGROUND: Active surveillance (AS) is emerging as an alternative approach to limit the risk of overtreatment and impairment of quality of life (QoL) in patients with low-risk localised prostate cancer. Although most patients report high levels of QoL, some men may be distressed by the idea of living with untreated cancer. OBJECTIVE: To identify factors associated with poor QoL during AS. DESIGN, SETTING, AND PARTICIPANTS: Between September 2007 and March 2012, 103 patients participated in the Prostate Cancer Research International Active Surveillance (PRIAS) QoL study. Mental health (Symptom Checklist-90), demographic, clinical, and decisional data were assessed at entrance in AS. Health-related QoL (HRQoL) Functional Assessment of Cancer Therapy-Prostate version and Mini-Mental Adjustment to Cancer outcomes were assessed after 10 mo of AS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Multivariate logistic regression models were used to identify predictors of low (<25th percentile) HRQoL, adjustment to cancer, and a global QoL index at 10 mo after enrollment. RESULTS AND LIMITATIONS: The mean age of the study patients was 67 yr (standard deviation: ±7 yr). Lack of partner (odds ratio [OR]: 0.08; p=0.009) and impaired mental health (OR: 1.2, p=0.1) were associated with low HRQoL (p=0.006; area under the curve [AUC]: 0.72). The maladaptive adjustment to cancer (p=0.047; AUC: 0.60) could be predicted by recent diagnosis (OR: 3.3; p=0.072). Poor global QoL (overall p=0.02; AUC: 0.85) was predicted by impaired mental health (OR: 1.16; p=0.070) and time from diagnosis to enrollment in AS <5 mo (OR: 5.52; p=0.009). Influence of different physicians on the choice of AS (OR: 0.17; p=0.044), presence of a partner (OR: 0.22; p=0.065), and diagnostic biopsy with >18 core specimens (OR: 0.89; p=0.029) were predictors of better QoL. Limitations of this study were the small sample size and the lack of a control group. CONCLUSIONS: Factors predicting poor QoL were lack of a partner, impaired mental health, recent diagnosis, influence of clinicians and lower number of core samples taken at diagnostic biopsy. Educational support from physicians and emotional/social support should be promoted in some cases to prevent poor QoL.