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.

[Targeted biopsies using magnetic resonance imaging/ultrasonograpgy fusion compared with sistematic biopsies prostate cancer detection. Initial experience.] / Comparación entre la biopsia prostática con fusión de imagen ecografía/resonáncia magnética y la biopsia sistemática para la detección de cáncer de próstata. Experiencia inicial.

OBJECTIVE: To describe the initial experiencein our center on targeted prostate biopsies (TB) using Magnetic Resonance imaging/ultrasonography (MRI/US) fusion and to compare PCa detection with systematic biopsies (SB). PATIENTS AND ME THODS: A retrospective, descriptive and comparative study was conducted on the first 94 men who underwent TB using MRU/US fusion in our center since February 2017 to March 2018. All patients underwent a protocol of 6-12 cores of systematic biopsies (SB) (except 9) and 2-6 targeted coreson the MRI index lesion. The Hitachi/HiVision Preirus equipment was used with RVS software (Real-time virtual sonography) and a biplane transducer for the fusion imaging procedure. Clinically significant PCa (csPCa) was defined as: at least one core with a Gleason score of 3+4. RESULTS: The proportion of patients diagnosed with PCa was higher in TB compared with SB (p=0.035) and the mean of core performed for diagnosis was lower in TB compared with SB (p<0.001). A trend towards an improved detection of csPCa in TB compared to SB was observed (p=0.063). CONCLUSIONS: The MRI/US fusion targeted biopsies (TB) showed a higher detection rate of PCa, with less cores taken for diagnosis and a tendency to better identification of csCaP compared to SB.

OBJETIVO: El objetivo de este estudio es describir la experiencia inicial en nuestro centro de las primeras 94 Biopsias de Próstata dirigidas (BD) con fusión de imagen ecografía/Resonancia magnética (US/RMmp) y comparar la tasa de detección de CaP con las biopsias sistemáticas.MATERIAL Y MÉTODOS: Se realizó un estudio retrospectivo, descriptivo y comparativo de los primeros 94 pacientes sometidos a BD por fusión de imagen US/RMmp en nuestro centro desde febrero de 2017 hasta marzo de 2018. Todos los pacientes fueron sometidos a un protocolo de 6-12 cilindros de biopsias sistemáticas (BS) (menos 9) y de 2-6 cilindros dirigidos a las lesiones diana visualizadas en la RMmp. Se utilizó el equipo Hitachi/HiVision Preirus con software RVS (Real-time virtual sonography) y un transductor biplanar para la fusión de imagen. Se definió como CaP clínicamente significativo un GS ≥ 3+4 en, al menos, 1 de los cilindros realizados. RESULTADOS: La proporción de detección de CaP fue mayor en las BD que en las BS (p=0,035) y el número de cilindros realizados para su diagnóstico fue menor en las BD comparado con las BS (p<0,001). Se observó  una clara tendencia a una mayor identificación de CaP clínicamente significativo (CaPcs) en las BD comparado con las BS (p=0,063). CONCLUSIONES: Comparado con las BS, las BD por fusión de imagen US/RMmp presentaron una mayor tasa de detección de CaP y una tendencia a una mayor identificación de CaPcS con una necesidad menor de cilindros realizados.

Comparación entre la biopsia prostática con fusión de imagen ecografía/resonáncia magnética y la biopsia sistemática para la detección de cáncer de próstata. Experiencia inicial / Targeted biopsies using magnetic resonance imaging/ultrasonograpgy fusion compared with sistematic biopsies prostate cancer detection. Initial experience

OBJETIVO: El objetivo de este estudio es describir la experiencia inicial en nuestro centro de las primeras 94 Biopsias de Próstata dirigidas (BD) con fusión de imagen ecografía/Resonancia magnética (US/RMmp) y comparar la tasa de detección de CaP con las biopsias sistemáticas. MATERIAL Y MÉTODOS: Se realizó un estudio retrospectivo, descriptivo y comparativo de los primeros 94 pacientes sometidos a BD por fusión de imagen US/RMmp en nuestro centro desde febrero de 2017 hasta marzo de 2018. Todos los pacientes fueron sometidos a un protocolo de 6-12 cilindros de biopsias sistemáticas (BS) (menos 9) y de 2-6 cilindros dirigidos a las lesiones diana visualizadas en la RMmp. Se utilizó el equipo Hitachi/HiVision Preirus con software RVS (Real-time virtual sonography) y un transductor biplanar para la fusión de imagen. Se definió como CaP clínicamente significativo un GS ≥ 3 + 4 en, al menos, 1 de los cilindros realizados. RESULTADOS: La proporción de detección de CaP fue mayor en las BD que en las BS (p = 0,035) y el número de cilindros realizados para su diagnóstico fue menor en las BD comparado con las BS (p < 0,001). Se observó una clara tendencia a una mayor identificación de CaP clínicamente significativo (CaPcs) en las BD comparado con las BS (p = 0,063). CONCLUSIONES: Comparado con las BS, las BD por fusión de imagen US/RMmp presentaron una mayor tasa de detección de CaP y una tendencia a una mayor identificación de CaPcS con una necesidad menor de cilindros realizados

OBJECTIVE: To describe the initial experience in our center on targeted prostate biopsies (TB) using Magnetic Resonance imaging/ultrasonography (MRI/US) fusion and to compare PCa detection with systematic biopsies (SB). PATIENTS AND METHODS: A retrospective, descriptive and comparative study was conducted on the first 94 men who underwent TB using MRU/US fusion in our center since February 2017 to March 2018. All patients underwent a protocol of 6-12 cores of systematic biopsies (SB) (except 9) and 2-6 targeted cores on the MRI index lesion. The Hitachi/HiVision Preirus equipment was used with RVS software (Real-time virtual sonography) and a biplane transducer for the fusión imaging procedure. Clinically significant PCa (csPCa) was defined as: at least one core with a Gleason score of 3+4. RESULTS: The proportion of patients diagnosed with PCa was higher in TB compared with SB (p = 0.035) and the mean of core performed for diagnosis was lower in TB compared with SB (p < 0.001). A trend towards an improved detection of csPCa in TB compared to SB was observed (p = 0.063). CONCLUSIONS: The MRI/US fusion targeted biopsies (TB) showed a higher detection rate of PCa, with les cores taken for diagnosis and a tendency to better identification of csCaP compared to SB

Association between EBRT dose volume histograms and quality of life in prostate cancer patients.

AIM: To evaluate the association between dose-volume histogram (DVH) values in organs at risk (OAR) and patient-reported HRQoL outcomes. BACKGROUND: Data on the association between DVHs and health-related quality of life (HRQoL) in prostate cancer (PCa) patients are limited. MATERIALS AND METHODS: Five-year follow-up study of 154 patients with organ-confined (stage T1/T2) PCa treated with EBRT between January 2003 and November 2005. HRQoL was evaluated with the Expanded Prostate Cancer Index (EPIC). DVH for OARs (penile bulb, rectum and bladder) were created for all patients for whom data were available (119/154; 77%). The functional data analysis (FDA) statistical method was used. HRQoL data was collected prospectively and data analysis was performed retrospectively. RESULTS: Worsening of urinary incontinence and obstructive symptoms correlated with higher DVH dose distributions at 24 months. Increased rectal bleeding at months 24 and 60 correlated with higher DVH dose distributions in the 40-70 Gy range. Patients with deterioration in rectal incontinence presented a higher DVH distribution range than patients without rectal incontinence. Penile bulb DVH values and erectile dysfunction were not significantly associated. CONCLUSIONS: DVH parameters and post-radiotherapy HRQoL appear to be closely correlated, underscoring the importance of assessing DVH values prior to initiating EBRT to determine the risk of developing HRQoL related adverse effects. Advanced treatment modalities may be appropriate in high risk cases to minimize treatment-related toxicity and to improve treatment outcomes and HRQoL. Future studies are needed to better elucidate the association between pre-treatment DVH parameters in organs at risk and subsequent HRQoL.

Clinical relevance of histologic subtypes in locally advanced esophageal carcinoma treated with pre-operative chemoradiotherapy: Experience of a monographic oncologic centre.

BACKGROUND: Locally advanced esophageal carcinoma (LAEC) represents less than 30% of all diagnosed esophageal carcinoma worldwide. The standard of care for resectable tumours consists of preoperative chemoradiotherapy (CRT) followed by surgery. Despite the curative intent, the prognosis is still poor mainly due to relapse. A multidisciplinary approach is required in order to optimize the therapeutic strategy and follow-up. Differences in outcomes between the two main histological subtypes, adenocarcinoma (ADC) and squamous cell carcinoma (SCC), have been reported. Nevertheless, the heterogeneity in trials design and data available have hampered the achievement of clear conclusions. The purpose of this study is to report the outcomes from a cohort of patients with LAEC treated with a multidisciplinary approach and to remark the differences observed between the two main histologic subtypes and their clinical implications. METHODS: We retrospectively reviewed 100 patients diagnosed with LAEC that were treated with preoperative CRT at our institution and integrated centres. Histopathological characteristics and toxicities during treatment were recorded. Patterns of recurrence at the first relapse were analysed. Survival curves were plotted using the Kaplan Meier method and multivariate Cox proportional hazards models were used. RESULTS: Among the patients who received preoperative CRT, 83% underwent surgery. The median overall survival (mOS) was 31.7 months, 26.9 months for ADC and 45.5 for SCC (p-value = 0.33). In the multivariate Cox regression analysis, ypN+ was the only factor that negatively influenced in OS (OR = 4.1, p-value = 0.022). Patterns of recurrence differed according to histologic subtype. Distant relapse was more frequent in ADC (62%), whereas locoregional relapse was higher in SCC (50%) (p-value = 0.027). Second line therapeutic strategies could be offered to 50% of those patients who relapsed. CONCLUSIONS: Differences in outcomes and recurrence pattern could be observed between the two main histologic subtypes of LAEC. A better molecular characterization, adapted therapeutic regimens and follow up strategies should be adopted in order to improve survival of these patients.

Improving radiation oncology through clinical audits: Introducing the IROCA project.

As radiotherapy practice and processes become more complex, the need to assure quality control becomes ever greater. At present, no international consensus exists with regards to the optimal quality control indicators for radiotherapy; moreover, few clinical audits have been conducted in the field of radiotherapy. The present article describes the aims and current status of the international IROCA "Improving Radiation Oncology Through Clinical Audits" project. The project has several important aims, including the selection of key quality indicators, the design and implementation of an international audit, and the harmonization of key aspects of radiotherapy processes among participating institutions. The primary aim is to improve the processes that directly impact clinical outcomes for patients. The experience gained from this initiative may serve as the basis for an internationally accepted clinical audit model for radiotherapy.

Localized prostate cancer treated with external beam radiation therapy: Long-term outcomes at a European comprehensive cancer centre.

AIMS AND BACKGROUND: To present survival and toxicity outcomes in patients with clinically localized, non-metastatic prostate cancer (PCa) treated with external beam radiotherapy (EBRT) combined with androgen deprivation therapy (ADT). MATERIALS AND METHODS: Retrospective study of 849 PCa patients (pts) treated from 1996 to 2005. Until August 2000, all patients (281) were treated with conventional dose EBRT (<76 Gy); subsequent pts received ≥76 Gy (565 pts). Median age was 70 years (range, 39-82). Most pts were intermediate (353; 42.8%) or high-risk (344; 41.7%). Mean PSA was 10.1 ng/ml. Median dose to the prostate was 75 Gy. Complete ADT was administered to 525 pts (61.8%). RESULTS: Median follow-up was 109.6 months (range, 68.3-193.4). Overall survival (OS) was 92.5% and 81.1% at 5 and 10 years; by risk group (low, intermediate, high), 5- and 10-year OS rates were 94.3% and 85.9%, 92.3% and 79.2%, and 91.9% and 80.2% (p = 0.728). Five- and 10-year BRFS was 94.1% and 80.6% (low risk), 86.4% and 70.9% (intermediate), and 85.2% and 71.4% (high) (p = 0.0666). Toxicity included rectitis: grade 1 (G1) (277 pts; 32.6%), G2 (108; 12.7%), and G3 (20; 2.6%) and urethritis: G1 (294; 34.6%); G2 (223; 26.2%), and G3 (11; 1.3%). By dose rate (<76 Gy vs. ≥76 Gy), 5 and 10-year BRFS rates were 83.1% and 68.3% vs. 88.4% and 74.8% (p = 0.038). CONCLUSIONS: Our results are comparable to other published series in terms of disease control and toxicity. These findings confirm the need for dose escalation to achieve better biochemical control and the benefits of ADT in high-risk PCa patients.

Three linked nomograms for predicting biochemical failure in prostate cancer treated with radiotherapy plus androgen deprivation therapy.

BACKGROUND: Nomograms were established to predict biochemical recurrence (BCR) after radiotherapy (RT) with a low weight of the characteristic variables of RT and androgen deprivation therapy (ADT). Our aim is to provide a new stratified tool for predicting BCR at 4 and 7 years in patients treated using RT with radical intent. MATERIALS AND METHODS: A retrospective, nonrandomized analysis was performed on 5044 prostate cancer (PCa) patients with median age 70 years, who received RT-with or without ADT-between November 1992 and May 2007. Median follow-up was 5.5 years. BCR was defined as a rise in serum prostate-specific antigen (PSA) of 2 ng/ml over the post-treatment PSA nadir. Univariate association between predictor variables and BCR was assessed by the log-rank test, and three linked nomograms were created for multivariate prognosis of BCR-free survival. Each nomogram corresponds to a category of the Gleason score-either 6,7, or 8-10-and all of them were created from a single proportional hazards regression model stratified also by months of ADT (0, 1-6, 7-12, 13-24, 25-36, 36-60). The performance of this model was analyzed by calibration, discrimination, and clinical utility. RESULTS: Initial PSA, clinical stage, and RT dose were significant variables (p < 0.01). The model showed a good calibration. The concordance probability was 0.779, improving those obtained with other nomograms (0.587, 0.571, 0.554) in the database. Survival curves showed best clinical utility in a comparison with National Comprehensive Cancer Network (NCCN) risk groups. CONCLUSION: For each Gleason score category, the nomogram provides information on the benefit of adding ADT to a specific RT dose.