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To analyze the prevalence of cardiovascular disease (CVD) and osteoporosis in patients treated with androgen deprivation therapy (ADT) for prostate cancer (PCa) but not adherent to European Association of Urology (EAU) guidelines.The CHOosIng Treatment for Prostate CanCEr (CHOICE) study was an Italian multicenter, cross-sectional study conducted from December 2010 to January 2012. A total of 1386 patients treated with ADT for PCa (first prescription or renewal of ADT) were selected. According to EAU guidelines, the cohort was categorized in discordant ADT (Group A) and concordant ADT (Group B). The prevalence of CVD and osteoporosis after ADT was recorded.The final cohort included 1075 patients. According to EAU guidelines adherence, 285 (26.51%) and 790 (73.49%) were considered discordant and concordant, respectively. The proportion of men with Charlson Comorbidity Index >2 at baseline was statistically similar in Group A (81.8%) compared to Group B (80.8%) (P=.96). The number of complications reported at enrollment was as follows: cardiovascular in 351 (32.7%), endocrine in 166 (15.4%), sexual in 498 (46.3%), osteoporosis in 181 (16.8%), and gynecomastia in 274 (25.5%) subjects. At the multivariate logistic regression analysis adjusted for confounding factors, discordant ADT was associated with greater risk of cardiovascular complications (odds ratio: 2.07; P<.01) and osteoporosis (odds ratio: 1.75; P=.04).About one-third of patients with PCa received inappropriate ADT and showed a greater risk of CVD and osteoporosis. These results could be useful for setting better policy strategies to limit the inappropriateness of ADT prescription.

PubMed | S.O. Oncologia Radioterapica, Centro Uro Andrologico La CURA, Urology, University of Turin and 22 more.
Type: Journal Article | Journal: BJU international | Year: 2016

To evaluate both the patterns of prescription of androgen deprivation therapy (ADT) in patients with prostate cancer (PCa) and the adherence to European Association of Urology (EAU) guidelines for ADT prescription.The Choosing Treatment for Prostate Cancer (CHOICE) study was an Italian multicentre cross-sectional study conducted between December 2010 and January 2012. A total of 1 386 patients, treated with ADT for PCa (first prescription or renewal of ADT), were selected. With regard to the EAU guidelines on ADT, the cohort was categorized into discordant ADT (Group A) and concordant ADT (Group B).The final cohort included 1 075 patients with a geographical distribution including North Italy (n = 627, 58.3%), Central Italy (n = 233, 21.7%) and South Italy (n = 215, 20.0%). In the category of patients treated with primary ADT, a total of 125 patients (56.3%) were classified as low risk according to DAmico classification. With regard to the EAU guidelines, 285 (26.51%) and 790 patients (73.49%) were classified as discordant (Group A) and concordant (Group B), respectively. In Group A, patients were more likely to receive primary ADT (57.5%, 164/285 patients) than radical prostatectomy (RP; 30.9%, 88/285 patients), radiation therapy (RT; 6.7%, 19/285 patients) or RP + RT (17.7%, 14/285 patients; P < 0.01). Multivariate logistic regression analysis, adjusted for clinical and pathological variables, showed that patients from Central Italy (odds ratio [OR] 2.86; P < 0.05) and South Italy (OR 2.65; P < 0.05) were more likely to receive discordant ADT.EAU guideline adherence for ADT was low in Italy and was influenced by geographic area. Healthcare providers and urologists should consider these results in order to quantify the inadequate use of ADT and to set policy strategies to overcome this risk.

Rancati T.,Fondazione IRCCS Instituto Nazionale Dei Tumori | Fiorino C.,San Raffaele Scientific Institute | Fellin G.,Radiotherapy | Vavassori V.,Radiotherapy | And 8 more authors.
Radiotherapy and Oncology | Year: 2011

Background and purpose: To fit an NTCP model including clinical risk factors to late rectal toxicities after radiotherapy for prostate cancer. Methods and materials: Data of 669 patients were considered. The probability of late toxicity within 36 months (bleeding and incontinence) was fitted with the original and a modified Logit-EUD model, including clinical factors by fitting a subset specific TD 50s: the ratio of TD 50s with and without including the clinical variable was the dose-modifying factor (D mod). Results: Abdominal surgery (surg) was a risk factor for G2-G3 bleeding, reflecting in a TD 50 = 82.7 Gy and 88.4 Gy for patients with and without surg (D mod = 0.94; 0.90 for G3 bleeding); acute toxicity was also an important risk factor for G2-G3 bleeding (D mod = 0.93). Concerning incontinence, surg and previous diseases of the colon were the clinical co-factors. D mod(surg) and D mod(colon) were 0.50 and 0.42, respectively for chronic incontinence and 0.73 and 0.64, respectively for mean incontinence score ≥1. Best-fit n values were 0.03-0.05 and 1 for bleeding and incontinence, respectively. The inclusion of clinical factors always improved the predictive value of the models. Conclusions: The inclusion of predisposing clinical factors improves NTCP estimation; the assessment of other clinical and genetic factors will be useful to reduce parameter uncertainties. © 2011 Elsevier Ltd. All rights reserved.

Santini D.,Biomedical University of Rome | Virzi V.,Biomedical University of Rome | Fratto M.E.,Biomedical University of Rome | Bertoldo F.,University of Verona | And 5 more authors.
Current Cancer Drug Targets | Year: 2010

New emerging data suggest that bisphosphonates may exert antitumor properties. Preclinical studies have demonstrated that zoledronic acid (ZA) can induce direct and indirect antitumor activities such as inhibition of angiogenesis, invasion and adhesion of tumor cells, and overall tumor progression, stimulation of adoptive and innate immunity and emerging evidence suggests that the use of these agents may prevent the development of skeletal and extra skeletal metastases. This review will critically describe the new growing evidence of antitumor activity exerted by bisphosphonates in cancer patients, both in metastatic disease and in the adjuvant setting. The effects of bisphosphonates on survival in metastatic cancer patients will be described and evidence from retrospective analyses and prospective studies will be critically reported. The early evidence from prospective analyses of survival impact by ZA in the adjuvant setting in breast cancer will be discussed together with the recently published results of the ABCSG-12 study. A new "era" for bisphosphonates in the oncological setting is opening. The clinical data that will be reported in this review represent the first step in a path that will conduct us to explore new horizons in the field of adjuvant and metastatic cancer therapies. © 2010 Bentham Science Publishers Ltd.

PubMed | Radiotherapy, San Raffaele Scientific Institute, Instituto Nazionale dei Tumori IRCCS, Medical Physics, Inc. and Medical Software Solutions GmbH
Type: Journal Article | Journal: Physica medica : PM : an international journal devoted to the applications of physics to medicine and biology : official journal of the Italian Association of Biomedical Physics (AIFB) | Year: 2016

The purpose of this study was to quantify the impact of inter-fraction modifications of bladder during RT of prostate cancer on bladder dose surface maps (DSM). Eighteen patients treated with daily image-guided Tomotherapy and moderate hypofractionation (70-72.8Gy at 2.5-2.6Gy/fr in 28 fractions and full bladder) were considered. Bladder contours were delineated on co-registered daily Megavoltage CT (MVCT) by a single observer and copied on the planning CT to generate dose-volume/surface histograms (DVH/DSH) and bladder DSMs. Discrepancies between planned and daily absorbed doses were analyzed through the average of individual systematic errors, the population systematic errors and the population random errors for the DVH/DSHs and DSMs. In total, 477 DVH/DSH and 472 DSM were available. DSH and DVH showed small population systematic errors of absolute surfaces (<3.4cm(2)) and volumes (<8.4cm(3)) at the highest doses. The dose to the posterior bladder base assessed on DSMs showed a mean systematic error below 1Gy, with population systematic and random errors within 4 and 3Gy, respectively. The region surrounding this area shows higher mean systematic errors (1-3Gy), population systematic (8-11Gy) and random (5-7Gy) errors. In conclusion, DVH/DSH and DSMs are quite stable with respect to inter-fraction variations in the high-dose region, within about 2cm from bladder base. Larger systematic variations occur in the anterior portion and cranially 2.5-3.5cm from the base. Results suggest that dose predictors related to the high dose area (including the trigone dose) are likely to be sufficiently reliable with respect to the expected variations due to variable bladder filling.

PubMed | Radiotherapy, San Raffaele Scientific Institute, Fondazione IRCCS Instituto Nazionale dei Tumori, Medical Physics, Inc. and Instituto Of Candiolo Fondazione Del Piemonte Per Loncologia Irccs
Type: Clinical Trial | Journal: Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology | Year: 2016

Prospectively assessing clinical/dosimetry factors affecting the acute worsening of urinary functionality after radiotherapy for prostate cancer.DUE01 population was considered, including patients treated with conventional or moderate hypo-fractionation (2.2-2.7 Gy/fr). Relevant clinical factors were collected, urinary symptoms were self-reported through the International Prostate Symptom Score (IPSS) before and at the end of radiotherapy; while absolute weekly dose-surface histograms (DSHw) were chosen as dosimetry descriptors. An IPSS increase of at least 10 and 15 points (IPSS 10 and IPSS 15) were chosen as endpoints. Patients with baseline IPSS>20 were excluded. Relevant factors were chosen through a bootstrap-based in silico methodology.Complete information was available for 380 patients: 77/380 (20%) and 28/380 (7%) with IPSS 10 and IPSS 15, respectively. Neoadjuvant hormone was protective (OR=0.49 and 0.69). DSHw at 8.5 Gy/week and 12 Gy/week were risk factors, with additional risk for patients who use cardiovascular drugs and anti-hypercholesterolemia drugs. In the hypo-fractionated subgroup (n=209) the role of cardiovascular drugs (OR=2.16) for IPSS 10 and anti-hypercholesterolemia drugs (OR=2.80) for IPSS15, together with DSHw (10 Gy/week and 12.5 Gy/week, respectively), was confirmed.Current study shows a dose-surface/volume effect for acute large worsening of urinary functionality; several clinical variables largely impact the risk and especially all the factors related with vascular diseases.

PubMed | Radiotherapy, San Raffaele Scientific Institute and Fondazione IRCCS Instituto Nazionale dei Tumori
Type: Journal Article | Journal: Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] | Year: 2016

To assess the predictors of the onset of impotence 1year after radiotherapy for prostate cancer.In a multi-centric prospective study, the International Index of Erectile Function (IIEF) questionnaire-based potency of 91 hormone-nave and potent patients (IIEF1-5 >11 before radiotherapy) was assessed. At the time of this analysis, information on potency 1year after treatment was available for 62 of 91patients (42 treated with hypofractionation: 2.35-2.65Gy/fr, 70-74.2Gy; 20 with conventional fractionation: 74-78Gy). Prospectively collected individual information and Dmax/Dmean to the penile bulb were available; the corresponding 2Gy-equivalent values (EQD2_max/EQD2_mean) were also considered. Predictors of 1year impotency were assessed through uni- and multi-variable backward logistic regression: The best cut-off values discriminating between potent and impotent patients were assessed by ROC analyses. The discriminative power of the models and goodness-of-fit were measured by AUC analysis and the Hosmer-Lemeshow (H&L) test.At 1year follow-up, 26 of 62patients (42%) became impotent. The only predictive variables were baseline IIEF1-5 values (best cut-off baseline IIEF1-5 19), Dmax 68.5Gy and EQD2_max 74.2Gy. The risk of 1year impotence may be predicted by a two-variable model including baseline IIEF1-5 (OR: 0.80, p= 0.003) and EQD2_max 74.2Gy (OR: 4.1, p= 0.022). The AUC of the model was 0.77 (95% CI: 0.64-0.87, p= 0.0007, H&L: p= 0.62). The 1year risk of impotency after high-dose radiotherapy in potent men depends on the EQD2_max to the penile bulb and on baseline IIEF1-5 values.Asignificant reduction in the risk may be expected mainly when sparing the bulb in patients with no/mild baseline impotency (IIEF1-5 >17).

Guzzo M.,Fondazione IRCCS Instituto Nazionale dei Tumori | Locati L.D.,Fondazione IRCCS Instituto Nazionale dei Tumori | Prott F.J.,Radiotherapy | Gatta G.,Fondazione IRCCS Instituto Nazionale dei Tumori | And 2 more authors.
Critical Reviews in Oncology/Hematology | Year: 2010

Malignant salivary gland tumors are rare. The most common tumor site is the parotid. Aetiologic factors are not clear. Nutrition may be a risk factor, as well as irradiation or a long-standing histologically benign tumor that occurs at youth. Painless swelling of a salivary gland should always be considered as suspicious, especially if no sign of inflammation is present. Signs and symptoms related to major salivary gland tumors differ from those concerning minor salivary gland tumors, as they depend on the different location of the salivary gland. Surgical excision represents the standard option in the treatment of resectable tumors of both major and minor salivary glands. Neutron, heavy ions or proton radiotherapy may be a treatment option for inoperable locoregional disease. Surgery, irradiation or re-irradiation are treatment options for local relapse, whereas radical neck dissection is indicated for regional relapses. Metastatic disease may be either treated with radiotherapy or palliative chemotherapy, depending on the site of metastases. For highly selected patients the employment of anti-androgen therapy is indicated. © 2009 Elsevier Ireland Ltd.

Hatt M.,French Institute of Health and Medical Research | Tixier F.,French Institute of Health and Medical Research | Cheze Le Rest C.,Nuclear Medicine | Pradier O.,Radiotherapy | Visvikis D.,French Institute of Health and Medical Research
European Journal of Nuclear Medicine and Molecular Imaging | Year: 2013

Purpose: Intratumour uptake heterogeneity in PET quantified in terms of textural features for response to therapy has been investigated in several studies, including assessment of their robustness for reconstruction and physiological reproducibility. However, there has been no thorough assessment of the potential impact of preprocessing steps on the resulting quantification and its predictive value. The goal of this work was to assess the robustness of PET heterogeneity in textural features for delineation of functional volumes and partial volume correction (PVC). Methods: This retrospective analysis included 50 patients with oesophageal cancer. PVC of each PET image was performed. Tumour volumes were determined using fixed and adaptive thresholding, and the fuzzy locally adaptive Bayesian algorithm, and heterogeneity was quantified using local and regional textural features. Differences in the absolute values of the image-derived parameters considered were assessed using Bland-Altman analysis. The impact on their predictive value for the identification of patient nonresponders was assessed by comparing areas under the receiver operating characteristic curves. Results: Heterogeneity parameters were more dependent on delineation than on PVC. The parameters most sensitive to delineation and PVC were regional ones (intensity variability and size zone variability), whereas local parameters such as entropy and homogeneity were the most robust. Despite the large differences in absolute values obtained from different delineation methods or after PVC, these differences did not necessarily translate into a significant impact on their predictive value. Conclusion: Parameters such as entropy, homogeneity, dissimilarity (for local heterogeneity characterization) and zone percentage (for regional characterization) should be preferred. This selection is based on a demonstrated high differentiation power in terms of predicting response, as well as a significant robustness with respect to the delineation method used and the partial volume effects. © 2013 Springer-Verlag Berlin Heidelberg.

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