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Gronchi A.,Fondazione Istituto Nazionale Dei Tumori | De Paoli A.,Centro Of Riferimento Oncologico | Dani C.,Biostatistics and Clinical Trials | Merlo D.F.,Biostatistics and Clinical Trials | And 14 more authors.
European Journal of Cancer

Background To study feasibility, safety and activity of the combination of high-dose long-infusion ifosfamide (HLI) and radiotherapy (RT) as preoperative treatment for resectable localised retroperitoneal sarcoma (RPS). Methods Patients received three cycles of HLI (14 g/m2). RT was started in combination with second cycle and administered up to a total dose of 50.4 Gy. Surgery was scheduled 4-6 weeks after the end of RT. Primary end-point was 3-year relapse free survival (RFS). The trial is registered with ITASARC-â̂ - II-2004-003. Findings Between December 2003 and 2010, 83 patients were recruited. Main histological subtypes were well differentiated liposarcoma (19/83, 23%), dedifferentiated liposarcoma (26/83, 31%), leiomyosarcoma (14/83, 17%). Median tumour size was 120 mm (interquartile (IQ) range = 82-160). The overall preoperative treatment was completed in 60 patients. Chemotherapy (CT) was completed in 65, while RT in 73. Four patients progressed before surgery and were not operated. 79 patients underwent surgery. At a median follow-up of 4.8 years (IQ range = 3-6.1), 23 and 15 patients developed local recurrence (LR) and distant metastases (DM); 30 patients died of disease. 3 and 5-year RFS and overall survival were 0.56 (90% confidence interval (CI): 0.45, 0.65) and 0.44 (90% CI: 0.27, 0.48), and 0.74 (90% CI: 0.62, 0.81) and 0.59 (90% CI: 0.33, 0.58). Crude cumulative incidence of LR and DM at 5 years were 0.37 (standard error (SE): 0.06) and 0.26 (SE: 0.06). Interpretation The combination of preoperative HLI and RT was feasible in two thirds of patients, while preoperative RT could be completed in most (73/83). Although a systemic coverage can be added to RT when this is felt to be appropriate, the ongoing international phase III trial is exploring the role of RT alone. Funding This is a pure academic trial. No funding sources contributed to it. © 2013 Elsevier Ltd. All rights reserved. Source

Conteduca V.,Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori | Caffo O.,Santa Chiara Hospital | Derosa L.,Santa Chiara Hospital | Veccia A.,Santa Chiara Hospital | And 8 more authors.

BACKGROUND Metabolic syndrome (MS) has not yet been studied in castration-resistant prostate cancer (CRPC) men treated with novel hormonal therapies. The study aims to assess the impact of MS on outcome from time starting abiraterone. PATIENTS AND METHODS We retrospectively evaluated a consecutive series of metastatic CRPC patients treated with abiraterone after docetaxel failure. MS, as defined by modified Adult Treatment Panel (ATP) III criteria, was assessed at the time of initiation of abiraterone, during treatment and follow-up. RESULTS Sixty-seven of 178 patients evaluated (37.6%) met MS criteria at baseline, before abiraterone initiation, whereas for 11 (9.9%) without MS before treatment with abiraterone this occurred during treatment. Median PFS was equal to 4.7 months for patients with MS versus 9 months for those without MS. Patients with MS had an increased risk of 71% of progression or death for all causes than patients without MS (HR = 1.7, 95% CI [1.2-2.4], P = 0.03). Median OS was 14.7 months and 22.3 months in patients with and without MS, respectively. After adjusting for covariates, MS resulted not significantly associated to OS (HR = 1.42, 95% CI [0.91-2.22], P = 0.073). CONCLUSIONS The presence of MS is a significant risk factor for shorter PFS in CRPC patients treated with abiraterone, even if it does not show a significant impact on OS. A prospective evaluation is warranted. Prostate 75:1329-1338, 2015. © 2015 Wiley Periodicals, Inc. © 2015 Wiley Periodicals, Inc. Source

Naselli A.,Azienda Ospedaliera Universitaria San Martino | Introini C.,Azienda Ospedaliera Universitaria San Martino | Timossi L.,Azienda Ospedaliera Universitaria San Martino | Spina B.,Azienda Ospedaliera Universitaria San Martino | And 5 more authors.
European Urology

Background: Narrow band imaging (NBI) is an optical enhancement technology that filters white light into two bandwidths of illumination centered on 415 nm (blue) and 540 nm (green). NBI cystoscopy can increase bladder cancer (BCa) visualization and detection at the time of transurethral resection (TUR). NBI may therefore reduce subsequent relapse following TUR. Objective: Assess the impact of NBI modality on 1-yr non-muscle-invasive BCa (NMIBC) recurrence risk. Design, setting, and participants: Consecutive patients with overt or suspected BCa were included in a prospective study powered to test a 10% difference in 1-yr recurrence risk in favor of cases submitted to NBI TUR. Excluding patients with muscle-invasive BCa, negative pathologic examination, or without follow-up, the study population was composed of 148 subjects randomized from August 2009 to September 2010 to NBI TUR (76 cases) or white light (WL) TUR (72 cases). Intervention: TUR was performed in NBI or standard WL modality. Measurements: The 1-yr recurrence risks in NBI or WL TUR groups were compared using odds ratio (OR) point and interval estimates derived from logistic regression modeling. Results and limitations: The 1-yr recurrence-risk was 25 of 76 patients (32.9%) in the NBI and 37 of 72 patients (51.4%) in the WL group (OR = 0.62; p = 0.0141). Simple and multiple logistic regression analyses provided similar OR points and interval estimates. Conclusions: TUR performed in the NBI modality reduces the recurrence risk of NMIBC by at least 10% at 1 yr. © 2012 European Association of Urology. Source

Tucker J.D.,Wayne State University | Vadapalli M.,Wayne State University | Joiner M.C.,Wayne State University | Ceppi M.,Biostatistics and Clinical Trials | And 2 more authors.
Radiation Research

The frequency of binucleated cells containing one or more micronuclei (MNBN cells) in cytokinesis-blocked peripheral blood lymphocytes can be used to determine whether a person has received an overexposure to ionizing radiation. However, the absence of a pre-exposure sample can preclude precise dosimetry. Here we use a database of MNBN cell frequencies in peripheral blood lymphocytes from 3,104 apparently healthy, unexposed, control subjects aged birth to 88 years, contributed by laboratories participating in the HUMN project. To determine whether a putatively exposed person has actually received a measurable dose, that person's peripheral blood lymphocyte MNBN frequency is compared to values from age and gender-matched controls in the database. If the subject's frequency is significantly higher than the controls, then a cobalt-60 dose-response curve obtained with the cytokinesis-block micronucleus (CBMN) assay in human peripheral blood lymphocytes is used to estimate the minimum dose of low-LET radiation that could have caused the increase. The response curve was generated with 11 acutely administered doses ranging from 0-4 Gy; the majority of doses were in the low end of this range to provide an accurate estimate of the linear portion of the response. The minimum detectable acute whole-body dose at the 95% prediction level and their corresponding 95% confidence intervals are 0.18 Gy (0.15-0.22) and 0.20 (0.17-0.24) Gy for 20-year-old males and females, respectively. Corresponding values for 50 year olds are 0.23 Gy (0.19-0.26) and 0.25 (0.21-0.29) Gy, and for 70 year olds are 0.24 (0.21-0.28) Gy and 0.26 (0.22-0.31) Gy. The minimum detectable chronic doses are approximately fivefold higher for both genders. These types of analyses, including knowledge of assay variability, will improve our understanding of the requirements and limitations for biodosimetry when a pre-exposure micronucleus value is unavailable and reliance on historical baseline micronucleus values is required. © 2013 by Radiation Research Society. Source

Burgio S.L.,Medical Oncology | Conteduca V.,Medical Oncology | Menna C.,Medical Oncology | Carretta E.,Biostatistics and Clinical Trials | And 6 more authors.
Endocrine-Related Cancer

In this retrospective study, we evaluated the chromogranin A (CgA) baseline value as a predictor of clinical outcome in patients with metastatic castration-resistant prostate cancer (CRPC) treated with abiraterone 1000 mg per day, whose disease progressed after docetaxel chemotherapy. In the 48 evaluable patients, serum CgA level was normal when <120 ng/ml (group A, n=16), within three times the upper normal value (UNV) when between 120 and 360 (group B, n=16), more than three times the UNV when ≥360 ng/ml (group C, n=16). Decline in PSA level ≥50% or more (PSA RR) was observed in 26 of 48 (54%) patients. PSA response rate did not correlate with the CgA groups. CgA levels more than three times the UNV predicted an early radiological progressive disease in eight of 11 cases (73%). The median progression-free survival (PFS) among the CgA groups A, B, and C was 9.2, 9.2, and 4.8 months respectively, P=0.0459. The median overall survival (OS) among the CgA groups was 19.0, 18.8, and 10.8 months respectively, P=0.2092. In the multivariate analysis, PSA RR (nonresponsive vs responsive) and CgA levels (group 3 vs groups 1+2) were predictors of PFS (P=0.0002 and P=0.0047 respectively), whereas PSA RR only was significantly associated with OS (P=0.0024), while CgA levels remained of borderline significance (P=0.0919). A serum CGA level more than three times the UNV predicted PFS and showed a trend vs OS prediction, independently from PSA response, in CRPC patients treated with abiraterone. © 2014 Society for Endocrinology. Source

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