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Moonen A.,Catholic University of Leuven | Annese V.,AOU Careggi | Belmans A.,Interuniversity Center for Biostatistics and Statistical Bioinformatics | Varannes S.B.D.,University of Nantes | And 7 more authors.
Gut | Year: 2016

Objective: Achalasia is a chronic motility disorder of the oesophagus for which laparoscopic Heller myotomy (LHM) and endoscopic pneumodilation (PD) are the most commonly used treatments. However, prospective data comparing their long-term efficacy is lacking. Design:201 newly diagnosed patients with Achalasia were randomly assigned to PD (n=96) or LHM (n=105). Before randomisation, symptoms were assessed using the Eckardt score, functional test were performed and quality of life was assessed. The primary outcome was therapeutic success (presence of Eckardt score =3) at the yearly follow-up assessment. The secondary outcomes included the need for re-treatment, lower oesophageal sphincter pressure, oesophageal emptying and the rate of complications. Results: In the full analysis set, there was no significant difference in success rate between the two treatments with 84% and 82% success after 5 years for LHM and PD, respectively (p=0.92, log-rank test). Similar results were obtained in the per-protocol analysis (5-year success rates: 82% for LHM vs 91% for PD, p=0.08, log-rank test). After 5 years, no differences in secondary outcome parameter were observed. Redilation was performed in 24 (25%) of PD patients. Five oesophageal perforations occurred during PD (5%) while 12 mucosal tears (11%) occurred during LHM. Conclusions: After at least 5 years of follow-up, PD and LHM have a comparable success rate with no differences in oesophageal function and emptying. However, 25% of PD patients require redilation during follow-up. Based on these data, we conclude that either treatment can be proposed as initial treatment for Achalasia. Trial registration numbers Netherlands trial register (NTR37) and Current Controlled Trials registry (ISRCTN56304564). Source

Puntoni M.,Clinical Trial Unit | Petrera M.,Medical Oncology Unit | Campora S.,Medical Oncology Unit | Garrone E.,Liguria Region Mortality Registry | And 7 more authors.
Cancer Prevention Research | Year: 2016

Non-muscle-invasive bladder cancer (NMIBC) may progress to muscle-invasive disease, but no effective preventive treatments are available. In addition, no reliable prognostic biomarkers have been identified. We assessed the long-term effect of the oral retinoid fenretinide and the prognostic value of circulating VEGF levels. We updated through the Tumor Registry the vital status of 99 patients with resected Ta/T1 bladder tumors who were recruited in a randomized trial of 2 years of fenretinide or no treatment in 1993-1994. Serum VEGF levels measured at baseline and 12 months were available in a subgroup of 62 patients. After a median of 20.5 years, 54 subjects died, 35 of any cancer and 14 of bladder cancer. Neither overall survival (OS), nor cancer survival (CS) or bladder cancer survival (BCS) was affected by fenretinide (log-rank P ≥ 0.2). DNA aneuploidy in bladder washing was associated with shorter OS (P =0.02), CS (P =0.05), and BCS (P = 0.09). Subjects with baseline VEGF levels in the top quintile (≥350 pg/mL) had a significantly shorter OS (P =0.01), CS (P = 0.02), and BCS (P= 0.008). The trend across quintiles of VEGF was significant for BCS (P =0.007). Multivariate analyses showed that, in addition to smoking status, VEGF level in the top quintile was an independent prognostic factor for OS (HR =2.7; 95% CI, 1.1-6.5), CS (HR = 3.3; 95% CI, 1.1-9.4) and BCS (HR =8.9; 95% CI,1.3-61). Fenretinide did not affect the long-term outcome of patients with NMIBC. High serum VEGF level was a significant predictor of overall and cancer death and may help to identify high-risk subjects who may benefit from a preventive therapy. Cancer Prev Res; 9(6); 437-44. © 2016 American Association for Cancer Research. Source

Clemente S.,Centro Of Riferimento Oncologico Della Basilicata | Nigro R.,Azienda Sanitaria Locale Rieti | Oliviero C.,Centro Of Riferimento Oncologico Della Basilicata | Marchioni C.,Azienda Sanitaria Locale Rieti | And 9 more authors.
International Journal of Radiation Oncology Biology Physics | Year: 2015

The increasing use of moderate (<35 fractions) and extreme (<5 fractions) hypofractionated radiation therapy in prostate cancer is yielding favorable results, both in terms of maintained biochemical response and toxicity. Several hypofractionation (HF) schemes for the treatment of prostate cancer are available, although there is considerable variability in the techniques used to manage intra-/interfraction motion and deliver radiation doses. We performed a review of the published studies on HF regimens as a topic of interest for the Stereotactic Ablative Radiotherapy working group, which is part of the Italian Association of Medical Physics. Aspects of organ motion management (imaging for contouring, target volume definition, and rectum/bladder preparation) and treatment delivery (prostate localization, image guided radiation therapy strategy and frequency) were evaluated and categorized to assess outcome relative to disease control and toxicity. Despite the heterogeneity of the data, some interesting trends that emerged from the review might be useful in identifying an optimum HF strategy. © 2015 Elsevier Inc. Source

Canovi M.,Istituto di Ricerche Farmacologiche Mario Negri | Lucchetti J.,Istituto di Ricerche Farmacologiche Mario Negri | Stravalaci M.,Istituto di Ricerche Farmacologiche Mario Negri | Valentino S.,Humanitas Clinical and Research Hospital | And 4 more authors.
Sensors (Switzerland) | Year: 2014

A new immunoassay based on surface plasmon resonance (SPR) for the rapid, reproducible and sensitive determination of pentraxin-3 (PTX3) levels in human plasma has been developed and characterized. The method involves a 3-min flow of plasma over a sensor chip pre-coated with a monoclonal anti-PTX3 antibody (MNB4), followed by a 3-min flow of a polyclonal anti-PTX3 antibody (pAb), required for specific recognition of captured PTX3. The SPR signal generated with this secondary antibody linearly correlates with the plasma PTX3 concentration, in the range of 5-1500 ng/mL, with a lowest limit of detection of 5 ng/mL. The PTX3 concentrations determined with the SPR-based immunoassay in the plasma of 21 patients with sepsis, ranging 15-1600 ng/mL, were superimposable to those found in a classic ELISA immunoassay. Since the PTX3 concentration in the plasma of healthy subjects is <2 ng/mL, but markedly rises in certain medical conditions, the method is useful to quantify pathological levels of this important biomarker, with important diagnostic applications. In comparison with the classic ELISA, the SPR-based approach is much faster (30 min versus 4-5 h) and could be exploited for the development of new cost-effective SPR devices for point-of-care diagnosis. © 2014 by the authors; licensee MDPI, Basel, Switzerland. Source

Mancosu P.,Humanitas Clinical and Research Hospital | Clemente S.,University of Naples Federico II | Landoni V.,Istituto Nazionale Tumori Regina Elena | Ruggieri R.,Ospedale Sacro Cuore Don Calabria | And 4 more authors.
Physica Medica | Year: 2016

Emerging data are showing the safety and the efficacy of Stereotactic Body Radiation Therapy (SBRT) in prostate cancer management. In this context, the medical physicists are regularly involved to review the appropriateness of the adopted technology and to proactively study new solutions. From the physics point of view there are two major challenges in prostate SBRT: (1) mitigation of geometrical uncertainty and (2) generation of highly conformal dose distributions that maximally spare the OARs. Geometrical uncertainties have to be limited as much as possible in order to avoid the use of large PTV margins. Furthermore, advanced planning and delivery techniques are needed to generate maximally conformal dose distributions. In this non-systematic review the technology and the physics aspects of SBRT for prostate cancer were analyzed. In details, the aims were: (i) to describe the rationale of reducing the number of fractions (i.e. increasing the dose per fraction), (ii) to analyze the features to be accounted for performing an extreme hypo-fractionation scheme (>6-7 Gy), and (iii) to describe technological solutions for treating in a safe way. The analysis of outcomes, toxicities, and other clinical aspects are not object of the present evaluation. © 2016 Associazione Italiana di Fisica Medica. Source

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