Psychometric validation of the Spanish version of the Expanded Prostate Cancer Index Composite-26.

PURPOSE: To assess the validity, reliability, and responsiveness of the Spanish version of the Expanded Prostate cancer Index Composite (EPIC) with 26 items. METHODS: Multicentric longitudinal study of patients diagnosed with localized or locally advanced prostate cancer (any T, any N, M0) treated with active surveillance, surgery, external radiotherapy, or brachytherapy. The EPIC-50 was administered initially to the cohort (n = 324 patients), until it was replaced in November 2019 by the EPIC-26 (n = 543), in both groups before treatment and 12 months after. We assessed confirmatory factor analysis (CFA), reliability with Cronbach's alpha coefficient, criterion validity with the intraclass correlation coefficient (ICC), and responsiveness by testing a priori hypotheses on deterioration effect size (ES). RESULTS: The CFA confirmed the five-domain structure of the EPIC-26 proposed by the original instrument (comparative fit index = 0.95). The agreement between EPIC-50 (gold standard) and EPIC-26 domains was excellent (ICC > 0.90). Cronbach's alpha was > 0.7 in almost all domains, and the floor effect was near zero, although ceiling effect was higher than 50% in urinary incontinence and bowel domains. Hypothesized changes between before and 12 months after treatment were confirmed: ES > 0.8 in both urinary incontinence and sexual domains among patients who underwent surgery; and ES ranging 0.44-0.48 for bowel and sexual domains in patients treated with external radiotherapy. CONCLUSION: The Spanish version of the EPIC-26 has demonstrated adequate metric properties, similar to those of the original version, with acceptable goodness-of-fit indices, good criterion validity, reliability, and responsiveness to detect changes after radical prostatectomy or external radiotherapy.

Management of high-risk and post-operative non-metastatic prostate cancer in Catalonia: an expert Delphi consensus.

BACKGROUND: To reach a consensus on recommendations for the management of high-risk and post-operative non-metastatic prostate cancer by a group of Radiation Oncologists in Catalonia dedicated to prostate cancer. METHODS: A modified Delphi approach was employed to reach consensus on controversial topics in Radiation Oncology on high-risk non-metastatic (eight questions) and post-operative (eight questions) prostate cancer. An agreement of at least 75% was considered as consensus. The survey was electronically sent 6 weeks before an expert meeting where topics were reviewed and discussed. A second-round survey for the controversial questions only was sent and answered by participants after the meeting. RESULTS: After the first round of the survey, 19 experienced Radiation Oncologists attended the meeting and 74% fulfilled the second-round online questionnaire. An agreement of 9 of the 16 questions was accounted for the first round. After the meeting, an additional agreement was reached in 3 questions leading to a final consensus on 12 of the 16 questions. There are still controversial topics like the use of PET for staging of high-risk and post-operative non-metastatic prostate cancer and the optimal dose to the prostate bed in the salvage setting. CONCLUSION: This consensus contributes to establish recommendations and a framework to help in prostate cancer radiation therapy and pharmacological management in daily clinical practice of high-risk and post-operative non-metastatic prostate cancer.

Abiraterone plus prednisone added to androgen deprivation therapy and docetaxel in de novo metastatic castration-sensitive prostate cancer (PEACE-1): a multicentre, open-label, randomised, phase 3 study with a 2 × 2 factorial design.

BACKGROUND: Current standard of care for metastatic castration-sensitive prostate cancer supplements androgen deprivation therapy with either docetaxel, second-generation hormonal therapy, or radiotherapy. We aimed to evaluate the efficacy and safety of abiraterone plus prednisone, with or without radiotherapy, in addition to standard of care. METHODS: We conducted an open-label, randomised, phase 3 study with a 2 × 2 factorial design (PEACE-1) at 77 hospitals across Belgium, France, Ireland, Italy, Romania, Spain, and Switzerland. Eligible patients were male, aged 18 years or older, with histologically confirmed or cytologically confirmed de novo metastatic prostate adenocarcinoma, and an Eastern Cooperative Oncology Group performance status of 0-1 (or 2 due to bone pain). Participants were randomly assigned (1:1:1:1) to standard of care (androgen deprivation therapy alone or with intravenous docetaxel 75 mg/m2 once every 3 weeks), standard of care plus radiotherapy, standard of care plus abiraterone (oral 1000 mg abiraterone once daily plus oral 5 mg prednisone twice daily), or standard of care plus radiotherapy plus abiraterone. Neither the investigators nor the patients were masked to treatment allocation. The coprimary endpoints were radiographic progression-free survival and overall survival. Abiraterone efficacy was first assessed in the overall population and then in the population who received androgen deprivation therapy with docetaxel as standard of care (population of interest). This study is ongoing and is registered with ClinicalTrials.gov, NCT01957436. FINDINGS: Between Nov 27, 2013, and Dec 20, 2018, 1173 patients were enrolled (one patient subsequently withdrew consent for analysis of his data) and assigned to receive standard of care (n=296), standard of care plus radiotherapy (n=293), standard of care plus abiraterone (n=292), or standard of care plus radiotherapy plus abiraterone (n=291). Median follow-up was 3·5 years (IQR 2·8-4·6) for radiographic progression-free survival and 4·4 years (3·5-5·4) for overall survival. Adjusted Cox regression modelling revealed no interaction between abiraterone and radiotherapy, enabling the pooled analysis of abiraterone efficacy. In the overall population, patients assigned to receive abiraterone (n=583) had longer radiographic progression-free survival (hazard ratio [HR] 0·54, 99·9% CI 0·41-0·71; p<0·0001) and overall survival (0·82, 95·1% CI 0·69-0·98; p=0·030) than patients who did not receive abiraterone (n=589). In the androgen deprivation therapy with docetaxel population (n=355 in both with abiraterone and without abiraterone groups), the HRs were consistent (radiographic progression-free survival 0·50, 99·9% CI 0·34-0·71; p<0·0001; overall survival 0·75, 95·1% CI 0·59-0·95; p=0·017). In the androgen deprivation therapy with docetaxel population, grade 3 or worse adverse events occurred in 217 (63%) of 347 patients who received abiraterone and 181 (52%) of 350 who did not; hypertension had the largest difference in occurrence (76 [22%] patients and 45 [13%], respectively). Addition of abiraterone to androgen deprivation therapy plus docetaxel did not increase the rates of neutropenia, febrile neutropenia, fatigue, or neuropathy compared with androgen deprivation therapy plus docetaxel alone. INTERPRETATION: Combining androgen deprivation therapy, docetaxel, and abiraterone in de novo metastatic castration-sensitive prostate cancer improved overall survival and radiographic progression-free survival with a modest increase in toxicity, mostly hypertension. This triplet therapy could become a standard of care for these patients. FUNDING: Janssen-Cilag, Ipsen, Sanofi, and the French Government.

Results of the IROCA international clinical audit in prostate cancer radiotherapy at six comprehensive cancer centres.

To assess adherence to standard clinical practice for the diagnosis and treatment of patients undergoing prostate cancer (PCa) radiotherapy in four European countries using clinical audits as part of the international IROCA project. Multi-institutional, retrospective cohort study of 240 randomly-selected patients treated for PCa (n = 40/centre) in the year 2015 at six European hospitals. Clinical indicators applicable to general and PCa-specific radiotherapy processes were evaluated. All data were obtained directly from medical records. The audits were performed in the year 2017. Adherence to clinical protocols and practices was satisfactory, but with substantial inter-centre variability in numerous variables, as follows: staging MRI (range 27.5-87.5% of cases); presentation to multidisciplinary tumour board (2.5-100%); time elapsed between initial visit to the radiation oncology department and treatment initiation (42-102.5 days); number of treatment interruptions ≥ 1 day (7.5-97.5%). The most common deviation from standard clinical practice was inconsistent data registration, mainly failure to report data related to diagnosis, treatment, and/or adverse events. This clinical audit detected substantial inter-centre variability in adherence to standard clinical practice, most notably inconsistent record keeping. These findings confirm the value of performing clinical audits to detect deviations from standard clinical practices and procedures.

Corticotomy in orthodontic treatment: systematic review.

OBJECTIVE: The aim of this study is to evaluate corticotomies effects to accelerate or facilitate dental movements in different kind of orthodontic treatments. DATA: This report followed the PRISMA Statement. A total of 9 articles were included in review. SOURCES: Two reviewers performed a literature search up to December 2018 in four databases: PubMed, Web of Science, Scopus and SciELO. STUDY SELECTION: Controlled clinical trials and randomized controlled clinical trials conducted in human patients and published during the last 10 years in English were eligible to be selected. The articles should give detailed information about the results and treatment parameters. There were no limitations established in terms of the type of malocclusion to be corrected or the type of orthodontic treatment performed. RESULTS: The methodological quality and evidence of the selected studies was low. Most of the studies observed a statistically significant increase in the rate of dental movement, when performing alveolar corticotomies as coadjuvants of orthodontic treatment; either with the conventional technique or with piezocision. The effect of combining corticotomy with bone grafts was assessed. CONCLUSIONS: High heterogeneity among studies made it difficult to draw clear conclusions. However, within the limitations of this review, the corticotomy procedures were able to statistically and clinically produce significant temporary decrease in orthodontic tooth movement rate. This technique does not seem to involve major complications compared to conventional orthodontic treatments. CLINICAL RELEVANCE: The use of this technique can reduce treatment time and therefore the undesirable effects associated with prolonged treatments.

Hyperprogression after first dose of immunotherapy in a patient with radioresistant metastasis from nonsmall cell lung cancer.

Immune checkpoint inhibitors (ICIs) represent a new standard of care for patients with advanced nonsmall cell lung cancer, improving overall survival compared with standard chemotherapy. However, a new pattern of response to ICIs characterized by accelerated tumor growth has been recently described, termed hyperprogressive disease (HPD). We report the case of a 73-year-old patient with advanced lung adenocarcinoma who developed HPD following treatment with a unique dose of atezolizumab for a skin metastasis that was refractory to chemotherapy and radiotherapy. Potential clinical biomarkers related to HPD to ICIs are reviewed.

Manejo quirúrgico-endodóncico de una reabsorción cervical invasiva clase III empleando composite / Endo-surgical management of a class III invasive cervical resorption using composite

La reabsorción cervical invasiva (RCI) es un tipo de reabsorción radicular insidiosa y agresiva que se origina en la superficie radicular externa. Típicamente, suele pasar inadvertida puesto que en la mayoría de los casos es asintomática. El uso de la tomografía computarizada con haz cónico (CBCT) mejora el diagnóstico y la planificación y la utilización dental mejora la realización del tratamiento. El objetivo principal de un tratamiento óptimo de ICR es la eliminación e inactivación del proceso de reabsorción y la reconstrucción del defecto. Entre los materiales empleados en la literatura para el sellado del defecto, el composite parece ser una opción válida. En el presente caso clínico se describe el tratamiento combinado quirúrgico-endodóncico de una reabsorción cervical invasiva clase III de Heithersay sellada con composite. Después de un año de seguimiento, el paciente se mostraba asintomático y la rarefacción ósea peri radicular ha disminuido significativamente no existiendo recidiva de la reabsorción

Invasive cervical resorption (ICR) is an aggressive type of radicular resorption that originates in the external radicular surface. It can typically go unnoticed since it is often asymptomatic. The use of cone beam computed tomography (CBCT) increases in a greater diagnostic and planning and a dental microscope increases the proper execution of the treatment. The main objective of an optimal treatment of ICR is the elimination and inactivation of the resorptive process, and the reconstruction of the defect. Among the dental material used in the literature for sealing the defect, composite seems to be a valid option. The present case-report describes a combined surgical and endodontic treatment of a Heithersay class III invasive cervical resorption sealed with dental composite. A one-year follow-up shows the patient to be asymptomatic, and the bone rarefaction to have decreased significantly, with no evidence of a resorption recurrence