BACKGROUND:Image-guided radiation therapy (IGRT) has changed clinical practice. We proposed a survey to radiotherapy centers in Lombardy to picture the current clinical practice of its use.RESEARCH DESIGN AND METHODS:The survey consisted of 32 multiple-choice questions, divided into five topics: type of hospital, patients treated in 2019, number of LINACs; presence of protocols and staff involved in IGRT; IGRT in stereotaxis; IGRT in non-stereotactic treatments; availability of medical and technical staff.RESULTS:Twenty-seven directors answered (77%). Most centers (74%) have produced protocols to ensure uniformity in the IGRT process. The most widely used IGRT modality (92%) is cone-beam CT. Daily IGRT control is favored for prostate (100%), head and neck (87%), and lung (78%) neoplasms. The resident doctors can always perform supervised IGRT matching in only six centers. Radiation therapists perform IGRT controls only for some sites in 12 cases (44%) and always in 9 cases (33%). Radiation oncologists are present in real time, in most cases.CONCLUSIONS:Today, IGRT can be considered standard practice but at the price of more time-consuming procedures. A balance between a fully physician-controlled process and an increased role for specifically trained RTTs is actively being sought.

Besides promoting the cultural and organizational change to multidisciplinarity, PerSTEP supported by the Italian Society for Urologic Oncology (SIUrO) and the Board of Medical Oncology Directors (CIPOMO) wanted to make a picture of the multidisciplinary activities performed by the 23 participating centers and start a discussion on the efficacy of the interdisciplinary collaboration in the management of prostate cancer (PC) patients. The centers were invited to collect the data of 3 months' activity. Nineteen joined the call and gathered information on:-patients with genito-urinary cancers managed with a multidisciplinary approach-patients to whom the Multidisciplinary Team changed the stage-patients to whom the Multidisciplinary Team changed the therapeutic and observational options-patients who had received partial or incorrect information in previous consultations-patients who required psychological support The patients with genito-urinary cancers managed with a multidisciplinary approach were 1420. PC patients were 920. Fourteen centers reported the multidisciplinary evaluation to be effective in better definning the stage (80 cases, 8.7%). Fifteen centers reported that the multidisciplinary approach led to changing the therapeutic and observational options that patients had received before (153 cases, 12.5%). Sixteen centers reported that patients had received partial or incorrect information in previous consultations (197 cases, 21.4%). Ten centers reported that patients asked for psychological support (86 cases, 0.9%). Despite the limitations of this data collection, PerSTEP centers wanted to see if the interaction of urologists, radiation oncologists and medical oncologists, supported by other specialists such as pathologists, psychologists and imaging specialists, could prove effective in the management of PC patients and confirm the theoretical assumption of the advantages of multidisciplinary working. Further data on the way the centers work are needed to make a more detailed picture and to support these preliminary interesting results. Further effort will be necessary to promote the cultural and organizational change towards a multidisciplinary management of PC patients and overcome the barriers towards multiprofessional team working effective for health professionals and patients. A special thank to SANOFI for supporting the communication plan of PerSTEP

The multidisciplinary management is acknowledged as the best approach to cancer patients. The multiprofessional interaction enables to offer prostate cancer (PC) patients objective information, reduce the number of consultations and favour individualized proposals. PerSTEP is an educational project which promotes the cultural and organizational change to multidisciplinarity supported by the Italian Society for Urologic Oncology (SIUrO) and the Board of Medical Oncology Directors (CIPOMO). PerSTEP Activities:1.collection of information on 23 participating centers2.meetings of the centers3.communication (newsletters, press releases). The information enabled to have a picture of the working models. Some centers were organized according to formalized multidisciplinary models, others enjoyed good collaboration among specialists, others worked in monodisciplinary setting and requested specialistic consultations occasionally. Some centers organized multidisciplinarily improved their organizational models and centers working in a monodisciplinary setting started the reorganizational process. The centers shared information, discussed experiences in the literature and identified minimal requirements favouring the organizational change: 1.support from Admins and Directors of the specialties2.creation of a multidisciplinary team and identification of a leader3.adoption of evidence-based guidelines and paths of care4.decision on multidisciplinary activities (i.e. clinics, case discussions)5.activation of regular case discussions The meetings were the occasion to discuss on problems:1.resistance towards working multidisciplinarily2.not univocal interpretation of guidelines3.no formalized collaboration to overcome the unavailability of a specialty4.unavailability of contractual time to attend multidisciplinary activities The communication plan favoured sensibilization actions on the importance of the multidisciplinary approach. Last updated March 2015, PerSTEP produced marvelous results such as: 1.good interaction among centers2.formalization and update of 6 PC Units3.constitution of 7 new multidisciplinary teams4.activation of 10 tumor boards Further effort is needed to support the change towards the multidisciplinary management of PC patients. Thanks to SANOFI for supporting the communication plan

Aims and Background Bladder preservation is a treatment option in muscle-invasive bladder carcinoma. The most investigated approach is a trimodality schedule including maximum transurethral resection of bladder tumor (TURBT) followed by chemoradiotherapy. Our aim was to evaluate the use of bladder preservation by radiation oncologists of the Lombardy region in Italy. Methods and Study Design A survey with 13 items regarding data of 2012 was sent to all 32 radiotherapy centers within the collaboration between the Lombardy Oncological Network and the Lombardy Section of the Italian Society of Oncological Radiotherapy. Results Thirteen centers (41%) answered the survey; the presented data come from 11 active centers. In these centers, 11,748 patients were treated with external-beam radiotherapy in 2012, 100 of whom having bladder cancer (0.9%). 74/100 patients received radiotherapy as palliative treatment for T, N or M lesions. A further 9 and 5 patients received radiotherapy for oligometastatic disease (ablative doses to small volumes) and postoperatively, respectively. Bladder preservation was performed in 12 cases and included trimodality and other strategies (mainly TURBT followed by radiotherapy). A multidisciplinary urology tumor board met regularly in 5 of 11 centers. All responders declared their interest in the Lombardy multicenter collaboration on bladder preservation. Conclusions Our survey showed that bladder preservation is rarely used in Lombardy despite the availability of the latest radiotherapy technologies and the presence of an urology tumor board in half of the centers. The initiative of multicenter and multidisciplinary collaboration was undertaken to prepare the platform for bladder preservation as a treatment option in selected patients.

Aims and Background In 2002, a survey including 1759 patients treated from 1980 to 1998 established a “benchmark” Italian data source for prostate cancer radiotherapy. This report updates the previous one. Methods Data on clinical management and outcomes of 3001 patients treated in 15 centers from 1999 through 2003 were analyzed and compared with those of the previous survey. Results Significant differences in clinical management (-10% had abdominal magnetic resonance imaging; +26% received ≥70 Gy, +48% conformal radiotherapy, −20% pelvic radiotherapy) and in G3–4 toxicity rates (-3.8%) were recorded. Actuarial 5-year overall, disease-specific, clinical relapse-free, and biochemical relapse-free survival rates were 88%, 96%, 96% and 88%, respectively. At multivariate analysis, D'Amico risk categories significantly impacted on all the outcomes; higher radiotherapy doses were significantly related with better overall survival rates, and a similar trend was evident for disease-specific and biochemical relapse-free survival; cumulative probability of 5-year late G1–4 toxicity was 24.8% and was significantly related to higher radiotherapy doses (P <0.001). Conclusions The changing patterns of practice described seem related to an improvement in efficacy and safety of radiotherapy for prostate cancer. However, the impact of the new radiotherapy techniques should be prospectively evaluated.

PurposeTo prospectively evaluate long-term late rectal bleeding (lrb) and faecal incontinence (linc) after high-dose radiotherapy (RT) for prostate cancer in the AIROPROS 0102 population, and to assess clinical/dosimetric risk factors.Materials and methodsQuestionnaires of 515 patients with G0 baseline incontinence and bleeding scores (follow-up ⩾6years) were analysed. Correlations between lrb/linc and many clinical and dosimetric parameters were investigated by univariate and multivariate logistic analyses. The correlation between lrb/linc and symptoms during the first 3years after RT was also investigated.ResultsOf 515 patients lrb G1, G2 and G3 was found in 32 (6.1%), 2 (0.4%) and 3 (0.6%) patients while linc G1, G2 and G3 was detected in 50 (9.7%), 3 (0.6%) and 3 (0.6%), respectively. The prevalence of G2–G3 lrb events was significantly reduced compared to the first 3-years (1% vs 2.7%, p=0.016) ⩾G1 lrb was significantly associated with V75Gy (OR=1.07). In multivariate analysis, ⩾G1 linc was associated with V40Gy (OR=1.015), use of antihypertensive medication (OR=0.38), abdominal surgery before RT (OR=4.7), haemorrhoids (OR=2.6), and G2–G3 acute faecal incontinence (OR=4.4), a nomogram to predict the risk of long-term ⩾G1 linc was proposed.Importantly, the prevalence of ⩾G1 linc was significantly correlated with the mean incontinence score during the first 3years after RT (OR=16.3).ConclusionsLong-term (median: 7years) rectal symptoms are prevalently mild and strongly correlated with moderate/severe events occurring in the first 3years after RT. Linc was associated with several risk factors.

To present an innovative approach based on the methods of Artificial Intelligence to better predict N status in low risk prostate cancer pts, integrating some important clinical and herapeutic parameters (Gleason Score/sum, age, initial PSA, neoadjuvant or neoadjuvant/concomitant hormonal therapy vs no hormonal therapy), known before radiotherapy (RT).

71 Background: To evaluate the incidence of late fecal incontinence (linc) after high-dose radiotherapy (RT) in prostate cancer patients (pts) accrued in AIROPROS 0102 trial (RT doses: 70-80Gy, 1.8-2Gy/fr) and to model the relationship between linc and clinical/dosimetric factors. Methods: Self-reported questionnaires of 515 pts with a minimum follow up of 6 yrs were analyzed with respect to linc. G1 linc was scored if unintentional stool discharge was “sometimes” experienced, G2 linc if unintentional stool discharge was “often” experienced or if pts sporadically used sanitary pads; G3 if pts reported daily unintentional stool discharge or use of sanitary pad >2 times/week. Correlation between pre-treatment morbidities, hormonal therapy, drug prescription, presence of diabetes or hypertension, abdominal surgery prior to RT (SURG), presence of G2-G3 acute fecal incontinence (ACUINC), pelvic nodes and seminal vesicles irradiation, mean rectal dose, dose-volume histograms constraints (from V20Gy to V75Gy) and linc was investigated by uni- and multivariate (MVA) logistic analyses. 347/515 pts had at least 3 toxicity questionnaires in the first 36 mos after the end of RT. Correlation between the mean score of fecal incontinence in the first 36 mos and linc at 6 yrs was also investigated. Results: 50/515 G1, 3/515 G2 and 3/515 G3 linc were reported. In MVA, V40Gy (continuous variable, p=0.09, OR=1.015), use of antihypertensives (protective factors, p=0.005, OR=0.38), SURG (p=0.004, OR=4.7), presence of haemorrhoids (p=0.008, OR=2.6) and ACUINC (p=0.007, OR=4.4) resulted to be correlated to linc. Based on MVA results, a nomogram was developed. Linc at 6 yrs was also correlated to the mean incontinence scores in the first 36 mos (p<0.0001): pts without linc at 6 yrs had a mean score of 0.1 during the first 36 mos, while pts with G1 and with G2-G3 linc at 6 yrs had a mean score of 0.5 and 0.78 during the first 36 mos, respectively. Conclusions: Mean score for incontinence during the first 36 mos after RT can be used as a surrogate endpoint for late (>6yrs) fecal incontinence. Linc is correlated to clinical and dosimetric risk factors and individualised toxicity prediction can be performed through a nomogram.

PURPOSE:To evaluate and discuss the role of specific types of abdominal surgery (SURG) before radical radiation therapy as a risk factor for late rectal toxicity in prostate cancer patients. METHODS:Results concerning questionnaire-based scored late bleeding and faecal incontinence in 718 patients with a complete follow-up of 36 months were analysed, focusing on the impact of specific pre-radiotherapy abdominal/pelvic surgery procedures. Patients were accrued in the prospective study AIROPROS 0102. Different types of surgery (rectum-sigma resection, kidney resection, cholecystectomy or appendectomy) were considered as covariates together with a number of different parameters previously found to be predictive of late toxicity and including clinical as well as dosimetric parameters. Univariate (UVA) and multivariate (MVA) logistic analyses were carried out. RESULTS:In total 69/718 patients were previously submitted to one or more surgical procedures, mostly cholecystectomy (n=21) and appendectomy (n=27). Actuarial incidences of G2-G3 and G3 bleeding were 52 (7.2%) and 24 (3.3%) respectively; 19 (2.6%) chronic incontinence events were registered. Cholecystectomy was found to be highly correlated with late rectal bleeding at UVA: OR=4.3 and p=0.006 for G2-G3 and OR=5.4 and p=0.01 for G3. Considering MVA (including dosimetric and clinical factors), G2-G3 bleeding was significantly correlated to cholecystectomy (OR=6.5, p=0.002), V75 Gy (OR=1.074, p=0.003) and secondarily with appendectomy (OR=2.7, p=0.10), presence of acute radioinduced rectal bleeding (OR=1.70, p=0.21) and androgen deprivation (OR=0.67, p=0.25). Appendectomy (OR=5.9, p=0.004) and cholecystectomy (OR=5.5, p=0.016) were very strong predictors of G3 bleeding with V75 Gy playing a less significant role (OR=1.037, p=0.26). Conversely, no specific surgery was correlated with actuarial or chronic incontinence. CONCLUSIONS:This analysis highlights previous SURG as the best predictor of late rectal bleeding. Among the different types of abdominal surgery, cholecystectomy and appendectomy play the major role, especially for severe late bleeding.

Purpose: To model late fecal incontinence after high-dose prostate cancer radiotherapy (RT) in patients accrued in the AIROPROS (prostate working group of the Italian Association of Radiation Oncology) 0102 trial using different endpoint definitions.Methods and Materials: The self-reported questionnaires (before RT, 1 month after RT, and every 6 months for <= 3 years after RT) of 586 patients were available. The peak incontinence (P_INC) and two longitudinal definitions (chronic incontinence [C_INC], defined as the persistence of Grade 1 or greater incontinence after any Grade 2-3 event; and mean incontinence score [M_INC], defined as the average score during the 3-year period after RT) were considered. The correlation between the clinical/dosimetric parameters (including rectal dose-volume histograms) and P_INC (Grade 2 or greater), C_INC, and M_INC of >= 1 were investigated using multivariate logistic analyses. Receiver operating characteristic curves and the area under the curve were used to assess the predictive value of the different multivariate models.Results: Of the 586 patients, 36 with a Grade 1 or greater incontinence score before RT were not included in the present analysis. Of the 550 included patients, 197 (35.8%) had at least one control with a Grade 1 or greater incontinence score (M_INC >0). Of these 197 patients, 37 (6.7%), 22 (4.0%), and 17 (3.1%) were scored as having P_INC, M_INC >= 1, and C_INC, respectively. On multivariate analysis, Grade 2 or greater acute incontinence was the only predictor of P_INC (odds ratio [OR], 5.9; p = .0009). Grade 3 acute incontinence was predictive of C_INC (OR, 9.4; p = .02), and percentage of the rectal volume receiving >40 Gy of >= 80% was predictive of a M_INC of >= 1 (OR, 3.8; p = .008) and of C_INC (OR, 3.6; p = .03). Previous bowel disease, previous abdominal/pelvic surgery, and the use of antihypertensive (protective factor) correlated highly with both C_INC and M_INC >= 1. The predictive values of the models for C_INC (area under the curve, 0.83) and M_INC >= 1 (area under the curve, 0.73) were greater than the ones for P_INC (area under the curve, 0.62) and more reliable (p = .0001-.0003 against p = .02). Nomograms for the two longitudinal definitions were derived.Conclusions: The longitudinal definitions of fecal incontinence (C_INC and M_INC >= 1) were helpful in accounting for both the persistence and the severity of the incontinence. A significant fraction of peak events was consequential to acute incontinence, and a longer duration of symptoms mainly depended on the rectal dose bath (percentage of rectal volume receiving >40 Gy), and pretreatment clinical factors. (C) 2012 Elsevier Inc.

Purpose Assessing the predictors of late rectal toxicity after high-dose conformal radiotherapy for prostate cancer. Methods One thousand one hundred thirty-two patients entered a prospective observational multicentric study; late rectal toxicity was evaluated by a self-reported questionnaire. Results concerning bleeding and faecal incontinence of 718/1132 patients with a complete follow-up at 36 months were analysed. The correlation between a number of clinical–dosimetric parameters and moderate/severe toxicity was investigated by univariate and multivariate logistic analyses. Results Fifty-two (7.2%) and 57/718 (7.9%) patients were scored as moderate/severe bleeders and faecal incontinents, respectively; 19/57 incontinent patients showed persistent incontinence at 36 months. Bleeding was mainly correlated with V75 Gy while severe bleeding was mainly correlated with the previous abdominal/pelvic surgery; a different rectal dose–volume relationship in the two groups of patients (with/without surgery) was found. Moderate/severe acute toxicity was weakly correlated to late bleeding. The best predictor of faecal incontinence was acute toxicity (OR = 4 and 7 for chronic and actuarial incontinence, respectively). Conclusion The application of rectal dose–volume constraints limited the incidence of rectal bleeding. The risk of bleeding may be further reduced by limiting V75 Gy < 5% and, in the case of patients previously submitted to abdominal/pelvic surgery, V70 Gy < 15–20%. Faecal incontinence seems to be mainly a consequential effect after acute toxicity.

Purpose: To predict acute Radiation Therapy Oncology Group (RTOG)/European Organization for Research and Treatment of Cancer (EORTC) and Subjective Objective Signs Management and Analysis/Late Effect of Normal Tissue (SOMA/LENT) toxicities of the lower gastrointestinal (LGI) syndrome in patients with prostate cancer undergoing three-dimensional conformal radiotherapy using a tool (nomogram) that takes into account clinical and dosimetric variables that proved to be significant in the Italian Association for Radiation Oncology (AIRO) Group on Prostate Cancer (AIROPROS) 0102 trial.Methods and Materials: Acute rectal toxicity was scored in 1,132 patients by using both the RTOG/EORTC scoring system and a 10-item self-assessed questionnaire. Correlation between clinical variables/dose-volume histogram constraints and rectal toxicity was investigated by means of multivariate logistic analyses. Multivariate logistic analyses results were used to create nomograms predicting the symptoms of acute LGI syndrome.Results: Mean rectal dose was a strong predictor of Grade 2-3 RTOG/EORTC acute LGI toxicity (p = 0.0004; odds ratio (OR) = 1.035), together with hemorrhoids (p = 0.02; OR = 1.51), use of anticoagulants/antiaggregants (P = 0.02; OR = 0.63), and androgen deprivation (AD) (p = 0.04; OR = 0.65). Diabetes (p = 0.34; OR = 1.28) and pelvic node irradiation (p = 0.11; OR = 1.56) were significant variables to adjust toxicity prediction. Bleeding was related to hemorrhoids (p = 0.02; OR = 173), AD (p = 0.17; OR = 0.67), and mean rectal dose (p = 0.009; OR = 1.024). Stool frequency was related to seminal vesicle irradiation (p = 0.07; OR = 6.46), AD administered for more than 3 months (p = 0.002; OR = 0.32), and the percent volume of rectum receiving more than 60 Gy (V60Gy) V60 (p = 0.02; OR = 1.02). Severe fecal incontinence depended on seminal vesicle irradiation (p = 0.14; OR = 4.5) and V70 (p = 0.033; OR = 1.029).Conclusions: To the best of our knowledge, this work presents the first set of nomograms available in the literature specific to symptoms of LGI syndrome and provides clinicians with a tailored probability of the specific outcome. Validation of the tool is in progress. (C) 2008 Elsevier Inc.

Purpose: To find predictors for rectal and intestinal acute toxicity in patients with prostate cancer treated with >= 70 Gy conformal radiotherapy.Methods and Materials: Between July 2002 and March 2004, 1,132 patients were entered into a cooperative study (AIROPROS01-02). Toxicity was scored using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scale and by considering the changes (before and after treatment) of the scores of a self-administered questionnaire on rectal/intestinal toxicity. The correlation with a number of parameters was assessed by univariate and multivariate analyses. Concerning the questionnaire, only moderate/ severe complications were considered.Results: Of 1,132 patients, 1,123 were evaluable. Of these patients, 375, 265, and 28 had Grade 1, 2, and 3 Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer toxicity, respectively. The mean rectal dose was the most predictive parameter (p = 0.0004; odds ratio, 1.035) for Grade 2 or worse toxicity, and the use of anticoagulants/antiaggregants (p = 0.02; odds ratio, 0.63) and hormonal therapy (p = 0.04, odds ratio, 0.65) were protective. The questionnaire-based scoring revealed that a greater mean rectal dose was associated with a greater risk of bleeding; larger irradiated volumes were associated with frequency, tenesmus, incontinence, and bleeding; hormonal therapy was protective against frequency and tenesmus; hemorrhoids were associated with a greater risk of tenesmus and bleeding; and diabetes associated highly with diarrhea.Conclusion: The mean rectal dose correlated with acute rectal/intestinal toxicity in three-dimensional conformal radiotherapy for prostate cancer, and hormonal therapy and the use of anticoagulants/antiaggregants were protective. According to the moderate/severe injury scores on the self-assessed questionnaire, several clinical and dose-volume parameters were independently predictive for particular symptoms. (c) 2007 Elsevier Inc.