29 results on '"F. Bianciardi"'
Search Results
2. PD-0495 Stereotactic MR-guided Adaptive RT for rectal cancer: toxicity, radiological & pathological response
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A. Castelluccia, D. Marchesano, G. Grimaldi, I. Annessi, F. Bianciardi, C. Borrazzo, A. Di Palma, R. El Gawhary, M. Masi, M. Rago, M. Valentino, L. Verna, and P. Gentile
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Oncology ,Radiology, Nuclear Medicine and imaging ,Hematology - Published
- 2022
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3. MR-guided adaptive versus CT-guided stereotactic radiotherapy for prostate cancer: Where is the best cost-benefit balance?
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A. Castelluccia, D. Marchesano, G. Grimaldi, I. Annessi, F. Bianciardi, A. Di Palma, M. Valentino, L. Verna, V. Confaloni, F. Rea, B. Tolu, C. Borrazzo, M. Rago, M. Masi, R. El Gawhary, and P.C. Gentile
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Urology - Published
- 2022
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4. Case report: online adaptive magnetic resonance-guided radiation therapy for patient with pacemaker
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R. El Gawhary, C. Borrrazzo, C. D’Ambrosio, M. Rago, I. Annessi, F. Bianciardi, A. Castelluccia, A.M. Di Palma, D. Marchesano, M. Valentino, L. Verna, L. Zuccaro, and P. Gentile
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Biophysics ,General Physics and Astronomy ,Radiology, Nuclear Medicine and imaging ,General Medicine - Published
- 2021
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5. Telemedicine in pediatric wound care
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M F, Bianciardi Valassina, S, Bella, F, Murgia, A, Carestia, and E, Prosseda
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Male ,Wound Healing ,Adolescent ,Quality Assurance, Health Care ,Remote Consultation ,Infant ,Pediatrics ,Telemedicine ,Italy ,Patient Satisfaction ,Child, Preschool ,Photography ,Humans ,Wounds and Injuries ,Female ,Child - Abstract
Telemedical wound care is one of the possible applications of teledermatology. The treatment of pediatric wounds needs frequent and periodic assessments of their local status and adjustment of dressings choice.We present our experience using telemedicine in the successful assessment and treatment of 19 pediatric patients at the OPBG, Rome . Photographs with a digital camera were taken and sent weekly by mail to a wound care specialist in Rome. This allowed the expert to diagnose and evaluate the wounds periodically.In the shown cases, telemedicine allowed us to have an immediate evaluation and therapy adjustment. The quality of the images was good enough that the physician could regularly evaluate the status of the wound and immediately give his feedback to the parents. Of these 19, 13 patients (68%) experienced a wound resolution during the remote monitoring period. The satisfaction of the parents detected at 3, 6 and 12 months was found to be respectively 57%, 71%, 84%.Reducing transportation to the hospital to obtain a specialist advice, wound teleconsultation lowers health care costs and improve the quality of life for pediatric patients and their family, while still maintaining a high quality of pediatric wound care.
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- 2016
6. Telemedicine Home Program in Patients with Cystic Fibrosis: Results after 10 Years
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F, Murgia, F, Bianciardi, T, Solvoll, I, Tagliente, F, Bella, A, Carestia, and S, Bella
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Male ,Treatment Outcome ,Cystic Fibrosis ,Spirometry ,Forced Expiratory Volume ,Feasibility Studies ,Humans ,Female ,Telemedicine ,Follow-Up Studies - Abstract
We studied the effect of Telehomecare (THC) in a group of cystic fibrosis (CF) patients.Forced Expiratory Volume in the first second (FEV1) was monitored at home, with the aim of an early recognition of the relapses of pulmonary infections. FEV1 was monitored for 4.5 years, using THC as a tool, in addition to the standard therapeutic protocol. 16 CF patients were followed by doctors experts in the treatment of CF, over a period of 4.5 years. We compared a control group among patients seen in the past for an identical period, matching for number, age, sex, respiratory function, bacterial colonization, O2 dependency, and complications. 16 CF patients with similar characteristics of age, degree of pulmonary involvement, bacterial colonization and O2 dependency. We calculated the annual mean values of FEV1 in both groups.Spirometry data showed a significant improvement in annual Fev1 mean values for the THC patients as compared to the control group.The data are encouraging for a possible role of Telemedicine as a tool for domestic assistance of patients affected by chronic diseases, such as CF. However, reliable data on the long-term effectiveness of the use of THC in the treatment of CF patients is still lacking. The time has come to obtain reliable data through a multicenter collaboration study, also in order to standardize the international Telemedicine protocols.
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- 2016
7. The application of telemedicine in the follow-up of lung transplantation in a patient with cystic fibrosis
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F, Murgia, B, Corona, F, Bianciardi, P, Romano, I, Tagliente, and S, Bella
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Adolescent ,Cystic Fibrosis ,Italy ,Chronic Disease ,Cystic Fibrosis Transmembrane Conductance Regulator ,Humans ,Female ,Telemedicine ,Follow-Up Studies ,Lung Transplantation - Abstract
The Cystic Fibrosis (CF) Unit of Children's Hospital Bambino Gesù in Rome (Italy) has more than 25 years of experience in diagnosis and treatment of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) related diseases. The CF Unit actively collaborates with the Transplantation Division for the follow-up of patients with CF who undergo lung transplantation, performed in our Unit since 1991. We present the case of a 19 year-old girl with CF, with severe respiratory failure for which it was subjected to two lung transplant. During the follow-up the remote monitoring has allowed the identification of an early episode of pulmonary relapse and graft-versus-host reaction even before the onset of symptoms, allowing an effective intervention and a complete recovery of lung function.
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- 2014
8. Mesentery-like steri-strip: a scarless drain fixation
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Valerio, Finocchi, Maria F, Bianciardi Valassina, Gianluigi, Longobardi, Angelo, Trivisonno, and Damiano, Tambasco
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Wound Closure Techniques ,Drainage ,Humans ,Mesentery ,Tissue Adhesives ,Letters to the Editor ,Bandages - Published
- 2014
9. Target spectrum matrix definition for multiple-input- multiple-output control strategies applied on direct-field- acoustic-excitation tests
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M. Alvarez Blanco, Karl Janssens, and F Bianciardi
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0209 industrial biotechnology ,History ,Engineering ,Field (physics) ,business.industry ,MIMO ,0211 other engineering and technologies ,02 engineering and technology ,Computer Science Applications ,Education ,Matrix (mathematics) ,020901 industrial engineering & automation ,Component (UML) ,021105 building & construction ,Electronic engineering ,Initial value problem ,Sound pressure ,business ,Excitation ,Energy (signal processing) - Abstract
During the last two decades there have been several improvements on environmental acoustic qualification testing for launch and space vehicles. Direct field excitation (DFAX) tests using Multiple-Input-Multiple-Output (MIMO) control strategies seems to become the most cost-efficient way for component and subsystem acoustic testing. However there are still some concerns about the uniformity and diffusivity of the acoustic field produced by direct field testing. Lately, much of the documented progresses aimed to solve the non-uniformity of the field by altering the sound pressure level requirement, limiting responses and adding or modifying control microphones positions. However, the first two solutions imply modifying the qualification criteria, which could lead to under-testing, potentially risking the mission. Furthermore, adding or moving control microphones prematurely changes the system configuration, even if it is an optimal geometric layout in terms of wave interference patterns control. This research investigates the target definition as an initial condition for the acoustic MIMO control. Through experiments it is shown that for a given system configuration the performance of a DFAX test strongly depends on the target definition procedure. As output of this research a set of descriptors are presented describing a phenomenon defined as "Energy- sink".
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- 2016
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10. Papillary carcinoma on a thyroglossal duct cyst: diagnostic problems and therapeutic dilemma. A case report
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G, Proia, M F, Bianciardi Valassina, G, Palmieri, and M, Zama
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Head and Neck Neoplasms ,Sistrunk operation ,Humans ,Female ,Case Report ,Papillary carcinoma ,Middle Aged ,Carcinoma, Papillary ,Thyroglossal Cyst ,Thyroglossal duct cysts - Abstract
Thyroglossal duct cysts are one of the most common congenital abnormalities of the cervical region. Complications of these swellings are rare, and among these, appearance of a carcinoma has also been noted. We present a case of papillary carcinoma arising in a thyroglossal duct cyst in 20-year-old woman with a swelling of about 4 cm, located at the middle region of the neck over the hyoid bone. Our patient was treated using a modified Sistrunk operation, in which thyroidectomy proved crucial for the correct diagnosis and continuation of appropriate treatment. Our case confirms the difficulty in distinguishing a primitive thyroglossal duct carcinoma from a synchronous metastatic papillary carcinoma of the thyroid. This dilemma often remains unresolved.Le cisti del dotto tireoglosso sono fra le più comuni anomalie congenite della regione cervicale. Le complicanze di queste tumefazioni sono rare e, fra queste, è stata descritta la comparsa di un carcinoma. Presentiamo un nuovo caso di carcinoma papillare insorto in una cisti del dotto tireoglosso in una giovane donna di 20 anni portatrice di una tumefazione di circa 4 cm, localizzata nella regione media del collo al di sopra dell'osso joide. La nostra paziente è stata trattata mediante l'operazione di Sistrunk, nella quale la tiroidectomia ha rappresentato uno step avanzato risultato cruciale per il raggiungimento di una corretta diagnosi e la continuazione di un appropriato protocollo terapeutico. Il nostro caso conferma la difficoltà nel distinguere un carcinoma del dotto tireoglosso primitivo da una metastasi sincrona di carcinoma papillare della tiroide. Questo dilemma spesso rimane irrisolto.
- Published
- 2011
11. A quantification of the electron return effect using Monte Carlo simulations and experimental measurements for the MRI-linac.
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Tortorelli F, Borrazzo C, Masi M, Rago M, El Gawhary R, Properzi C, Marchesano D, Grimaldi G, Bianciardi F, Annessi I, Di Palma A, Valentino M, Verna L, Chiarello G, Wolfango P, and Gentile P
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- Humans, Radiotherapy Planning, Computer-Assisted methods, Radiotherapy, Image-Guided methods, Lung diagnostic imaging, Lung radiation effects, Monte Carlo Method, Magnetic Resonance Imaging methods, Particle Accelerators, Phantoms, Imaging, Electrons, Radiotherapy Dosage, Computer Simulation
- Abstract
The integration of magnetic resonance (MR) imaging and linear accelerators into hybrid treatment systems has made MR-guided radiation therapy a clinical reality. This work aims to evaluate the influence of the Electron Return Effect (ERE) on the dose distributions. This study was conducted using MRIdian (ViewRay, Cleveland, Ohio) system. Monte-Carlo simulations (MCs) and experimental measurements with EBT3 Gafchromic films were performed to investigate the dose distribution in a slab water phantom with and without a 2-cm air gap. Plus, MCs took into account different field sizes and a lung gap. A gamma analysis compared calculated versus measured dose distributions. The MCs have shown an increase of the ERE with the radiation field size both in Percent Depth Dose (PDD) and crossline direction. As concerns to the PDD direction, the smallest field for which there was a significant dose accumulation was 4.15 × 4.15 cm
2 both for air-gap (13.5%) and lung-gap (3.3%). The largest field for which there was a significant dose accumulation was 24.07 × 24.07 cm2 both for air-gap (39.7%) and lung-gap (4.9%). Instead for the crossline direction, the smallest field for which there was a significant dose accumulation was 2.49 × 2.49 cm2 both for air-gap (8.6% ) and lung-gap (0.5%). The largest field for which there was a significant dose accumulation was 24.07 × 24.07 cm2 both for air-gap (46.2%) and lung-gap (4.2%). PDD and crossline profiles showed good agreement with a gamma-passing rate higher than 91.15% for 2%/2 mm. The ERE can be adequately calculated by MC dose calculation platform available in the MRIdian Treatment Planning System. The MCs show an increase of the ERE directly proportional with the radiation field size. Good agreement was observed between the experimental measurements and calculated dose distributions., (© 2024 IOP Publishing Ltd. All rights, including for text and data mining, AI training, and similar technologies, are reserved.)- Published
- 2024
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12. Fabrication of hydrogel mini-capsules as carrier systems.
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Roberti E, Petrucci G, Bianciardi F, and Palagi S
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Conventional drug administration often results in systemic action, thus needing high dosages and leading to potentially pronounced side effects. Targeted delivery, employing carriers like nanoparticles, aims to release drugs at a target site, but only a small fraction of nanoparticles actually reaches it. Microrobots have been proposed to overcome this issue since they can be guided to hard-to-reach sites and locally deliver payloads. To enhance their functionality, we propose microrobots made as deformable capsules with hydrogel shells and aqueous cores, having the potential added advantages of biocompatibility, permeability, and stimulus-responsiveness. Endowing microrobots with deformability could allow them to navigate inside capillaries and cross barriers to finally reach the target site. In this study, we present a cost-effective method for fabricating core-shell structures without the use of organic solvents, surfactants, or extreme pH conditions unlike other techniques (e.g. Layer by Layer). The process begins with the dripping of a mixture of hydrogels, agarose and alginate, into a solution to gelate the drops into beads. After they are loaded with calcium ions at different concentrations, they are immersed in an alginate solution to form the shell. Finally, the beads are heated to let the agarose melt and diffuse out, leaving a liquid core. By varying the concentration of calcium ions, we obtain shells of different thicknesses. To estimate it, we have developed a method using the colour intensity from microscope images. This allowed us to observe that lowering the calcium ions concentration below a threshold does not lead to the formation of continuous shells. For higher concentrations, although the core may remain partially gelled, continuous shells successfully form. Therefore, our fabrication process could find applications in drug delivery, encapsulation systems, and microrobotics., Competing Interests: No competing interests were disclosed., (Copyright: © 2024 Roberti E et al.)
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- 2024
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13. Stereotactic MR-guided adaptive radiotherapy (SMART) for primary rectal cancer: evaluation of early toxicity and pathological response.
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Castelluccia A, Marchesano D, Grimaldi G, Annessi I, Bianciardi F, Borrazzo C, Dipalma A, El Gawhary R, Masi M, Rago M, Valentino M, Verna L, Portaluri M, and Gentile P
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Background: The purpose of this study is to measure the effects of stereotactic MR-guided adaptive radiotherapy (SMART) for rectal cancer patients in terms of early toxicity and pathological response., Materials and Methods: For this prospective pilot study, patients diagnosed with locally advanced rectal cancer (LARC) with positive lymph node clinical staging underwent SMART on rectal lesion and mesorectum using hybrid MR-Linac (MRIdian ViewRay). Dose prescription at 80% isodose for the rectal lesion and mesorectum was 40 Gy (8 Gy/fr) and 25 Gy (5 Gy/fr), respectively, delivered on 5 days (3 fr/week). Response assessment by MRI was performed 3 weeks after SMART, then patients fit for surgery underwent total mesorectal excision. Primary endpoint was evaluation of adverse effect of radiotherapy. Secondary endpoint was pathological complete response rate. Early toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0)., Results: From October 2020 to January 2022, twenty patients underwent rectal SMART. No grade 3-5 toxicity was recorded. Twelve patients were eligible for total mesorectal excision (TME). Mean interval between the completion of SMART and surgery was 4 weeks. Pathological downstaging occurred in all patients; rate of pathological complete response (pCR) was 17%. pCR occurred with a prolonged time to surgery (> 7 weeks)., Conclusion: To our knowledge, this is the first study to use stereotactic radiotherapy for primary rectal cancer. SMART for rectal cancer is well tolerated and effective in terms of tumor regression, especially if followed by delayed surgery., Competing Interests: Conflict of interest None declared., (© 2023 Greater Poland Cancer Centre.)
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- 2023
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14. Stereotactic or conventional radiotherapy for macroscopic prostate bed recurrence: a propensity score analysis.
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Francolini G, Jereczek-Fossa BA, Di Cataldo V, Simontacchi G, Marvaso G, Gandini S, Corso F, Ciccone LP, Zerella MA, Gentile P, Bianciardi F, Allegretta S, Detti B, Desideri I, D'Angelillo RM, Masi L, Ingrosso G, Di Staso M, Mazzeo E, Trippa F, Lohr F, Bruni A, and Livi L
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- Humans, Male, Neoplasm Recurrence, Local radiotherapy, Neoplasm Recurrence, Local surgery, Propensity Score, Prostate-Specific Antigen, Prostatectomy adverse effects, Retrospective Studies, Salvage Therapy, Prostate surgery, Prostatic Neoplasms radiotherapy, Prostatic Neoplasms surgery
- Abstract
Purpose: To assess outcomes between salvage radiation therapy (SRT) with curative intent and stereotactic radiotherapy for macroscopic prostate recurrence (SSRT) after radical prostatectomy (RP). In order to compare these two different options, we compared their outcomes with a propensity score-based matched analysis., Methods: Data from 185 patients in seven Italian centres treated for macroscopic prostate bed recurrence after RP were retrospectively collected. To make a comparison between the two treatment groups, propensity matching was applied to create comparable cohorts., Results: After matching, 90 patients in the SRT and SSRT groups were selected (45 in each arm). Kaplan-Meier analysis did not show any significant differences in terms of BRFS and PFS between matched populations (p = 0.08 and p = 0.8, respectively). Multivariate models show that treatment was not associated with BRFS, neither in the whole or matched cohort, with HR of 2.15 (95%CI 0.63-7.25, p = 0.21) and 2.65 (95%CI 0.59-11.97, p = 0.21), respectively. In the matched cohort, lower rate of toxicity was confirmed for patients undergoing SSRT, with acute GI and GU adverse events reported in 4.4 versus 44.4% (p < 0.001) and 28.9 versus 46.7% (p = 0.08) of patients, and late GI and GU adverse events reported in 0 versus 13.3% (p = 0.04) and 6.7 versus 22.2% (p = 0.03) of patients, respectively., Conclusion: Considering the favourable therapeutic ratio of this approach and the lower number of fractions needed, SSRT should be considered as an attractive alternative to conventional SRT in this setting., (© 2022. Italian Society of Medical Radiology.)
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- 2022
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15. Leptomeningeal disease and brain control after postoperative stereotactic radiosurgery with or without immunotherapy for resected brain metastases.
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Minniti G, Lanzetta G, Capone L, Giraffa M, Russo I, Cicone F, Bozzao A, Alongi F, Nicosia L, Fineschi G, Marchetti L, Tufo T, Bianciardi F, Esposito V, Gentile P, and Paolini S
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- Adult, Aged, Brain Neoplasms mortality, Brain Neoplasms pathology, Female, Humans, Male, Middle Aged, Postoperative Period, Survival Analysis, Treatment Outcome, Brain Neoplasms secondary, Immunotherapy methods, Meningeal Neoplasms complications, Meningeal Neoplasms radiotherapy, Radiosurgery methods
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Purpose: Immunotherapy has shown activity in patients with brain metastases (BM) and leptomeningeal disease (LMD). We have evaluated LMD and intraparenchymal control rates for patients with resected BM receiving postoperative stereotactic radiosurgery (SRS) and immunotherapy or postoperative SRS alone. We hypothesize that postoperative SRS and immunotherapy will result in a lower rate of LMD with acceptable toxicity compared with postoperative SRS., Patients and Methods: One hundred and twenty-nine patients with non-small-cell lung cancer (NSCLC) and melanoma BM who received postoperative fractionated SRS (fSRS; 3×9 Gy) in combination with immunotherapy or postoperative fSRS alone for completely resected BM were retrospectively evaluated. The primary endpoint of the study was the rate of LMD after treatments. The secondary endpoints were local failure, distant brain parenchymal failure (DBF), overall survival (OS), and treatment-related toxicity., Results: Sixty-three patients received postoperative SRS and immunotherapy, either nivolumab or pembrolizumab, and 66 patients received postoperative SRS alone to the resection cavity. With a median follow-up of 15 months, LMD occurred in 19 patients: fSRS group, 14; fSRS and immunotherapy, 5. The 12-month LMD cumulative rates were 22% (95% CI 14% to 37%) in the fSRS group and 6% (95% CI 2% to 17%) in the combined treatment group (p=0.007). Resection cavity control was similar between the groups, whereas DBF and OS were significantly different; the 1-year DBF rates were 31% (95% CI 20% to 46%) in the fSRS and immunotherapy group and 52% (95% CI 39% to 68%) in the fSRS group; respective OS rates were 78% (95% CI 67% to 88%) and 58.7% (95% CI 47% to 70%). Twenty-two patients undergoing postoperative fSRS and immunotherapy and nine subjected to postoperative fSRS experienced treatment-related imaging changes suggestive of radiation-induced brain necrosis (p=0.02)., Conclusions: Postoperative fSRS in combination with immunotherapy decreases the incidence of LMD and DBF in patients with resected BM from NSCLC and melanoma as compared with fSRS alone, reducing the rate of neurological death and prolonging survival., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
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- 2021
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16. Initial Experience With Single-Isocenter Radiosurgery to Target Multiple Brain Metastases Using an Automated Treatment Planning Software: Clinical Outcomes and Optimal Target Volume Margins Strategy.
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Minniti G, Capone L, Alongi F, Figlia V, Nardiello B, El Gawhary R, Scaringi C, Bianciardi F, Tolu B, Gentile P, and Paolini S
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Purpose: Our purpose was to assess the clinical outcomes and target positioning accuracy of frameless linear accelerator single-isocenter multiple-target (SIMT) dynamic conformal arc (DCA) stereotactic radiosurgery (SRS) for multiple brain metastases (BM)., Methods and Materials: Between October 2016 and September 2018, 31 consecutive patients ≥18 years old with 204 BM <3 cm in maximum size receiving SIMT DCA SRS were retrospectively evaluated. All plans were created using a dedicated automated treatment planning software (Brainlab, Munich, Germany), and treatments were performed with a Truebeam STx or a Novalis Tx (Brainlab and Varian Medical Systems, CA). The accuracy of setup and interfraction patient repositioning was assessed by Brainlab ExacTrac radiograph 6-dimensional image system and the risk of compromised target dose coverage evaluated. Brain control and overall survival were estimated by Kaplan-Meier method calculated from the time of SRS., Results: Fourteen patients were treated for 4 to 6 and 17 patients for 7 to 10 BM. The mean gross tumor volume (GTV) was 0.65 cm
3 and the mean planning target volume (PTV) was 0.89 cm3 . Mean V95 (the volume of the PTV covered by 95% of the prescription dose) and D95 (the prescription dose covering 95% of the PTV) were 99.5% and 21.1 Gy, respectively. With a median clinical follow-up of 11 months (range, 4-26 months), the 1-year survival was 68% and local control was 89%. As a consequence of plan isocenter residual errors, a loss of target coverage, defined as V95 < 95%, occurred in 28 PTVs (10 patients); using a 1 mm GTV-to-PTV margin, adequate dose coverage was maintained for all lesions., Conclusions: SIMT DCA SRS represents a fast and effective approach for patients with up to 10 BM. The dosimetric effects of residual set-up and intrafraction positioning errors are modest, although a GTV-to-PTV margin of 1 mm is recommended., (© 2020 The Author(s).)- Published
- 2020
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17. A new standardized data collection system for brain stereotactic external radiotherapy: the PRE.M.I.S.E project.
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Chiesa S, Tolu B, Longo S, Nardiello B, Capocchiano ND, Rea F, Capone L, Stimato G, Gatta R, Pacchiarotti A, Massaccesi M, Minniti G, Cellini F, Damiani A, Balducci M, Gentile P, Valentini V, and Bianciardi F
- Abstract
Background: In recent years, novel radiation therapy techniques have moved clinical practice toward tailored medicine. An essential role is played by the decision support system, which requires a standardization of data collection. The Aim of the Prediction Models In Stereotactic External radiotherapy (PRE.M.I.S.E.) project is the implementation of systems that analyze heterogeneous datasets. This article presents the project design, focusing on brain stereotactic radiotherapy (SRT)., Materials & Methods: First, raw ontology was defined by exploiting semiformal languages (block and entity relationship diagrams) and the natural language; then, it was transposed in a Case Report Form, creating a storage system., Results: More than 130 brain SRT's variables were selected. The dedicated software Beyond Ontology Awareness (BOA-Web) was set and data collection is ongoing., Conclusion: The PRE.M.I.S.E. project provides standardized data collection for a specific radiation therapy technique, such as SRT. Future aims are: including other centers and validating an extracranial SRT ontology., Competing Interests: Financial & competing interests disclosure The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in, or financial conflict, with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending or royalties. No writing assistance was utilized in the production of this manuscript., (© 2020 Silvia Longo.)
- Published
- 2020
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18. Neurological outcome and memory performance in patients with 10 or more brain metastases treated with frameless linear accelerator (LINAC)-based stereotactic radiosurgery.
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Minniti G, Capone L, Nardiello B, El Gawhary R, Raza G, Scaringi C, Bianciardi F, Gentile P, and Paolini S
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- Adult, Aged, Female, Humans, Kaplan-Meier Estimate, Male, Middle Aged, Neuropsychological Tests, Radiosurgery instrumentation, Treatment Outcome, Brain Neoplasms psychology, Brain Neoplasms radiotherapy, Memory, Radiosurgery methods
- Abstract
Purpose: To assess the neurocognitive function and neurological toxicity of frameless linear accelerator (LINAC)-based stereotactic radiosurgery (SRS) in patients with 10 or more brain metastases (BM)., Patients and Methods: Forty consecutive adult patients who received SRS for ten or more 10 BM < 3 cm in maximum size were evaluated. All plans were generated using a single-isocenter multiple-target (SIMT) SRS technique with doses of 22 Gy for lesions < 2 cm and 16-18 Gy for those ≥ 2 cm in size. Survival analyses were estimated by Kaplan-Meier method from the date of SRS. Neurocognitive function using the Hopkins verbal learning test-revised (HVLT-R) and activity of daily living scale (ADLS) were collected prospectively at baseline and at 3,6 and 12-month follow-up. Toxicity was assessed by the National Cancer Institute Common Toxicity Criteria for Adverse Events (Version 5.0)., Results: With a median follow-up of 10.8 months, 1-year survival and local control rates were 65% and 86%, respectively. Grade 2 or 3 toxicity occurred in eleven patients, being associated with radiological changes suggestive of radiation necrosis in seven patients. Three months after SRS, the mean relative decline was 14.2% for HVLT-R delayed recall, 12.3% for HVLT-R recognition, and 9.8% for HVLT-R total recall. A significant deterioration of HVLT-R scores ranged from 5.5 to 18.7% of patients at different time points. ADLS scores declined over time, but changes were not significant., Conclusions: SRS is an effective and safe approach for patients with 10 or more BM able to maintain the pretreatment neurocognitive function in the majority of patients.
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- 2020
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19. Stereotactic radiotherapy for prostate bed recurrence after prostatectomy, a multicentric series.
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Francolini G, Jereczek-Fossa BA, Di Cataldo V, Simontacchi G, Marvaso G, Zerella MA, Gentile P, Bianciardi F, Allegretta S, Detti B, Masi L, Lo Russo M, and Livi L
- Subjects
- Aged, Humans, Male, Retrospective Studies, Salvage Therapy, Treatment Outcome, Neoplasm Recurrence, Local radiotherapy, Prostatectomy, Prostatic Neoplasms radiotherapy, Prostatic Neoplasms surgery, Radiosurgery adverse effects
- Abstract
Objective: To assess the safety and effectiveness of stereotactic salvage radiotherapy (SSRT) in RT-naïve patients affected by macroscopic prostate bed recurrence., Patients and Methods: Consecutive patients treated for prostate bed macroscopic recurrence in three different Italian institutes were reviewed. Patients were treated with SSRT, with a total dose of 30-40 Gy in five fractions, the mean pre-SSRT PSA level was 2.3 ng/mL. Two different PSA thresholds were defined and biochemical recurrence-free survival (BCRFS) was reported, in order to better express outcome: BCRFS1 (a PSA level increase of >10% compared to the pre-SSRT value) and BCRFS2 (a PSA level increase of >0.2 ng/mL for patients with a PSA nadir of <0.2 ng/mL or two consecutive PSA level increases of >25% compared to nadir in patients with a PSA nadir of <0.2 ng/mL)., Results: In all, 90 patients were treated, with a mean (range) follow-up of 21.2 (2-64) months, and 17 of these patients (19%) had concomitant androgen-deprivation therapy (ADT) during SSRT. Complete biochemical response, defined as a PSA nadir of <0.2 ng/mL, was obtained in 39 of the 90 patients (43.3%). Considering BCRFS1, 25 patients (27.8%) had BCR, with an actuarial median BCRFS1 time of 36.4 months. For BCRFS2, BCR was reported in 32 patients (35.5%), with an actuarial median BCRFS2 time of 24.3 months. There was no Grade >2 toxicity., Conclusions: SSRT was found to yield significant biochemical control and allowed ADT delay despite adverse features., (© 2019 The Authors BJU International © 2019 BJU International Published by John Wiley & Sons Ltd.)
- Published
- 2020
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20. Can thoracic nodes oligometastases be safely treated with image guided hypofractionated radiation therapy?
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Franceschini D, Bianciardi F, Mazzola R, De Rose F, Gentile P, Alongi F, and Scorsetti M
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- Aged, Breast Neoplasms mortality, Disease Progression, Disease-Free Survival, Dose-Response Relationship, Radiation, Feasibility Studies, Female, Humans, Intestinal Neoplasms mortality, Kidney Neoplasms mortality, Lung Neoplasms mortality, Lymphatic Metastasis, Male, Mediastinal Neoplasms diagnostic imaging, Mediastinal Neoplasms mortality, Middle Aged, Radiation Dose Hypofractionation, Radiotherapy, Image-Guided methods, Retrospective Studies, Thoracic Neoplasms diagnostic imaging, Thoracic Neoplasms mortality, Tomography, X-Ray Computed methods, Mediastinal Neoplasms radiotherapy, Thoracic Neoplasms radiotherapy
- Abstract
Objective: To evaluate safety and efficacy of image guided-hypofractionated radiation therapy (IG-HRT) in patients with thoracic nodes oligometastases., Methods: The present study is a multicenter analysis. Oligometastatic patients, affected by a maximum of five active lesions in three or less different organs, treated with IG-HRT to thoracic nodes metastases between 2012 and 2017 were included in the analysis. Primary end point was local control (LC), secondary end points were overall survival (OS), progression-free survival, acute and late toxicity. Univariate and multivariate analysis were performed to identify possible prognostic factors for the survival end points., Results: 76 patients were included in the analysis. Different RT dose and fractionation schedules were prescribed according to site, number, size of the lymph node(s) and to respect dose constraints for relevant organs at risk. Median biologically effective dose delivered was 75 Gy (interquartile range: 59-86 Gy). Treatment was optimal; one G1 acute toxicity and seven G1 late toxicities of any grade were recorded. Median follow-up time was 23.16 months. 16 patients (21.05%) had a local progression, while 52 patients progressed in distant sites (68.42 %).Median local relapse free survival was not reached, LC at 6, 12 and 24 months was 96.05% [confidence interval (CI) 88.26 - 98.71%], 86.68% (CI 75.86 - 92.87) and 68.21% (CI 51.89 - 80.00%), respectively. Median OS was 28.3 months (interquartile range 16.1 - 47.2). Median progression-freesurvival was 9.2 months (interquartile range 4.1 - 17.93).At multivariate analysis, RT dose, colorectal histology, systemic therapies were correlated with LC. Performance status and the presence of metastatic sites other than the thoracic nodes were correlated with OS. Local response was a predictor of OS., Conclusion: IG-HRT for thoracic nodes was safe and feasible. Higher RT doses were correlated to better LC and should be taken in consideration at least in patients with isolated nodal metastases and colorectal histology., Advances in Knowledge: Radiotherapy is safe and effective treatment for thoracic nodes metastases, higher radiotherapy doses are correlated to better LC. Oligometastatic patients can receive IG-HRT also for thoracic nodes metastases.
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- 2019
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21. Comparative effectiveness of multi-fraction stereotactic radiosurgery for surgically resected or intact large brain metastases from non-small-cell lung cancer (NSCLC).
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Minniti G, Scaringi C, Lanzetta G, Anzellini D, Bianciardi F, Tolu B, Morace R, Romano A, Osti M, Gentile P, and Paolini S
- Subjects
- Adult, Aged, Aged, 80 and over, Brain surgery, Brain Neoplasms secondary, Carcinoma, Non-Small-Cell Lung secondary, Dose Fractionation, Radiation, Female, Follow-Up Studies, Humans, Lung Neoplasms mortality, Lung Neoplasms pathology, Male, Meningeal Carcinomatosis, Middle Aged, Neurosurgical Procedures, Retrospective Studies, Risk, Survival Analysis, Treatment Outcome, Brain pathology, Brain Neoplasms therapy, Carcinoma, Non-Small-Cell Lung therapy, Lung Neoplasms therapy, Radiosurgery methods
- Abstract
Purpose: to investigate clinical outcomes in patients with large brain metastases from non-small-cell lung cancer (NSCLC) who received surgical resection and postoperative stereotactic radiosurgery or SRS alone., Patients and Methods: Two hundred and twenty-two patients with 241 large brain metastases (2-4 cm in size) who received surgery and multi-fraction SRS (mfSRS) to the resection cavity or mfSRS alone were analyzed. For all lesions the delivered dose was 3 x 9 Gy over three consecutive days. Primary endpoint of the study was local control (LC). Secondary endpoints included early improvement of neurological deficits, changes in performance status, treatment-related toxicity, radiation-induced brain necrosis (RN), distant brain failure (DBF), and overall survival (OS). Kaplan-Meier analysis and cumulative incidence function were used for comparing the probability of failure., Results: At a median follow-up of 13 months, median OS times and 1-year survival rates were comparable: 13.5 months and 59% for patients receiving surgery and postoperative mfSRS to the resection cavity and 15.2 months and 68% for those treated with mfSRS alone (p = 0.2). Median DBF did not differ significantly between groups (surgery and mfSRS,12 months; mfSRS,14 months). Eighteen patients receiving surgery and mfSRS and 17 patients treated with mfSRS alone recurred locally (p = 0.2); respective 6-month and 12-month LC rates were 87% and 83% and 96% and 91% (p = 0.15). The 1-year cumulative incidence rates of RN were 15% and 7% after postoperative mfSRS and mfSRS alone (p = 0.03), respectively., Conclusions: In conclusion, mfSRS is an effective treatment for patients with large brain metastases from NSCLC resulting in equivalent LC and lower RN and risk of leptomeningeal spread compared to surgery and mf-SRS to the resection cavity. Surgery is an effective treatment option for patients with large symptomatic brain metastases who require rapid relief of neurological symptoms caused by tumor mass effect., (Copyright © 2019 Elsevier B.V. All rights reserved.)
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- 2019
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22. Stereotactic radiosurgery combined with nivolumab or Ipilimumab for patients with melanoma brain metastases: evaluation of brain control and toxicity.
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Minniti G, Anzellini D, Reverberi C, Cappellini GCA, Marchetti L, Bianciardi F, Bozzao A, Osti M, Gentile PC, and Esposito V
- Subjects
- Administration, Intravenous, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological adverse effects, Brain drug effects, Brain pathology, Brain radiation effects, Brain Neoplasms mortality, Brain Neoplasms secondary, Chemoradiotherapy adverse effects, Drug Administration Schedule, Female, Humans, Ipilimumab administration & dosage, Ipilimumab adverse effects, Male, Melanoma mortality, Melanoma secondary, Middle Aged, Neurotoxicity Syndromes diagnosis, Neurotoxicity Syndromes etiology, Nivolumab administration & dosage, Nivolumab adverse effects, Progression-Free Survival, Radiosurgery adverse effects, Retrospective Studies, Severity of Illness Index, Skin Neoplasms mortality, Skin Neoplasms therapy, Young Adult, Antineoplastic Agents, Immunological administration & dosage, Brain Neoplasms therapy, Chemoradiotherapy methods, Melanoma therapy, Neurotoxicity Syndromes epidemiology, Radiosurgery methods, Skin Neoplasms pathology
- Abstract
Purpose: To investigate the efficacy and safety of concurrent stereotactic radiosurgery (SRS) and ipilimumab or nivolumab in patients with untreated melanoma brain metastases., Patients and Methods: Eighty consecutive patients with 326 melanoma brain metastases receiving SRS in combination with ipilimumab or nivolumab were identified from an institutional database and retrospectively evaluated. Patients started systemic treatment with intravenous nivolumab or ipilimumab within one week of receiving SRS. Nivolumab was given at doses of 3 mg/kg every two weeks. Ipilimumab was administered up to four doses of 10 mg/kg, one every 3 weeks, then patients had a maintenance dose of 10 mg/kg every 12 weeks, until disease progression or inacceptable toxicity. Primary endpoint of the study was intracranial progression-free survival (PFS). Secondary endpoints were extracranial PFS, overall survival (OS), and neurological toxicity., Results: Eighty patients were analyzed. Forty-five patients received SRS and ipilimumab, and 35 patients received SRS and nivolumab. With a median follow-up of 15 months, the 6-month and 12-month intracranial PFS rates were 69% (95%CI,54-87%) and 42% (95%CI,24-65%) for patients receiving SRS and nivolumab and 48% (95%CI,34-64%) and 17% (95%CI,5-31%) for those treated with SRS and ipilimumab (p = 0.02), respectively. Extracranial PFS and OS were 37 and 78% in SRS and nivolumab group, respectively, and 17 and 68% in SRS and ipilimumab group, respectively, at 12 months. Sub-group analysis showed significantly better intracranial PFS for patients receiving multi-fraction SRS (3 × 9 Gy) compared to single-fraction SRS (70% versus 46% at 6 months, p = 0.01), especially in combination with nivolumab. Grade 3 treatment-related adverse events occurred in 11 (24%) patients treated with SRS and ipilimumab and 6 (17%) patients who received SRS and nivolumab. Radiation-induced brain necrosis (RN) occurred in 15% of patients., Conclusions: Concurrent SRS and ipilimumab or nivolumab show meaningful intracranial activity in patients with either asymptomatic and symptomatic melanoma brain metastases, although a subset of patients may develop symptomatic RN. The combination of nivolumab with SRS is associated with better intracranial control.
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- 2019
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23. Metastases to extraocular muscles from breast cancer: case report and up-to-date review of the literature.
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Framarino-Dei-Malatesta M, Chiarito A, Bianciardi F, Fiorelli M, Ligato A, Naso G, and Pecorella I
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- Adult, Breast Neoplasms diagnostic imaging, Breast Neoplasms drug therapy, Breast Neoplasms pathology, Female, Humans, Magnetic Resonance Imaging, Muscle Neoplasms diagnostic imaging, Muscle Neoplasms pathology, Muscle Neoplasms secondary, Neoplasm Metastasis, Piperazines therapeutic use, Pyridines therapeutic use, Breast Neoplasms diagnosis, Muscle Neoplasms diagnosis
- Abstract
Background: Unilateral or bilateral metastases to extraocular muscles are very rare in breast cancer., Case Presentation: We describe a case of inferior rectus extraocular muscle involved by ductal luminal B/Her-2 neu negative breast cancer, observed in a cohort of 580 patients. Our patient had received chemotherapy and hormonal therapy (tamoxifen for 3 years and letrozole in the following 3 years) for her primary cancer and developed an orbital metastasis while she was under aromatase inhibitor-based therapy. Diagnosis was confirmed by MRI and biopsy. Orbital radiotherapy, combined with fulvestrant, resulted in shrinking of the secondary mass. A third line hormonal therapy using palbociclib was then started. Twelve-months later, MRI showed no residual tumor mass. Currently, the patient is alive and in good general conditions after 20 months., Conclusions: Literature review yielded 57 patients with extraocular muscle metastases from breast cancer, mostly due to the invasive lobular subtype of carcinoma. In addition to the present case, only 4 other extraocular muscles metastases from invasive ductal carcinoma has been reported, pointing out to the rarity of ductal type spread to the orbit in the natural history of breast cancer. Surgery may be used as a single treatment, despite no improvement of symptoms. Radiotherapy alone or combined with chemotherapy, or with chemotherapy plus hormonal therapy are available options. Results are, however, missing or poor. The present case is the first one with complete and stable response after 20 months to radiotherapy, antiestrogen drug fulvestrant and selective inhibitor of CDK4 /CDK6 palbociclib. In this subset of patients, with unusual metastatic sites and frequent multi-organ metastatic impairment, a multidisciplinary approach is indicated in order to achieve the best therapeutic management and long-term surveillance.
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- 2019
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24. Stereotactic ablative radiation therapy as a potential curative treatment in duodenal adenocarcinoma: a case report.
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Aquilanti FM, Barba MC, Bianciardi F, Tolu B, Nardiello B, Hamid Raza G, El Gawhary R, D'Ambrosio C, and Gentile P
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- Adenocarcinoma pathology, Aged, 80 and over, Duodenal Neoplasms pathology, Humans, Male, Treatment Outcome, Adenocarcinoma surgery, Duodenal Neoplasms surgery, Radiosurgery methods
- Abstract
Purpose: One of the rarest gastrointestinal neoplasm is small bowel cancer. Experience with its treatment modalities is limited. Stereotactic ablative radiation therapy (SABR) has improved, with image-guided radiation therapy becoming a curative option in many tumors. Especially when surgery cannot be performed due to comorbidities, SABR provides a good toxicity profile and an excellent tumor control rate owing to its specific schedule: high dose on a limited and well-defined area., Methods: An 83-year-old man had arterial hypertension and congestive cardiomyopathy, with recent history of upper abdominal pain, weight loss over 10 kg, and progressive severe fatigue. The patient underwent endoscopy that showed a large mass partially obstructing the second part of the duodenum; a biopsy revealed a moderately differentiated adenocarcinoma. A staging CT scan confirmed localized disease. Due to the patient's age and comorbidities, a SABR was proposed as the preferred treatment. In order to localize the tumor during radiotherapy sessions, surgical clips were placed endoscopically next to the lesion as fiducial markers. The patient received 25 Gy in 5 fractions on alternate days., Results: Resolution of duodenal obstruction and bleeding lasted for 14 months. The patient died of myocardial infarction., Conclusions: This case suggests that SABR could have a role in the palliative treatment of small bowel cancers, with good toxicity profile, particularly in patients for whom surgical treatment is not a viable option.
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- 2017
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25. Telemedicine Home Program in Patients with Cystic Fibrosis: Results after 10 Years.
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Murgia F, Bianciardi F, Solvoll T, Tagliente I, Bella F, Carestia A, and Bella S
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- Cystic Fibrosis diagnosis, Feasibility Studies, Female, Follow-Up Studies, Forced Expiratory Volume, Humans, Male, Spirometry, Treatment Outcome, Cystic Fibrosis therapy, Telemedicine
- Abstract
Objectives: We studied the effect of Telehomecare (THC) in a group of cystic fibrosis (CF) patients., Materials and Methods: Forced Expiratory Volume in the first second (FEV1) was monitored at home, with the aim of an early recognition of the relapses of pulmonary infections. FEV1 was monitored for 4.5 years, using THC as a tool, in addition to the standard therapeutic protocol. 16 CF patients were followed by doctors experts in the treatment of CF, over a period of 4.5 years. We compared a control group among patients seen in the past for an identical period, matching for number, age, sex, respiratory function, bacterial colonization, O2 dependency, and complications. 16 CF patients with similar characteristics of age, degree of pulmonary involvement, bacterial colonization and O2 dependency. We calculated the annual mean values of FEV1 in both groups., Results: Spirometry data showed a significant improvement in annual Fev1 mean values for the THC patients as compared to the control group., Discussion: The data are encouraging for a possible role of Telemedicine as a tool for domestic assistance of patients affected by chronic diseases, such as CF. However, reliable data on the long-term effectiveness of the use of THC in the treatment of CF patients is still lacking. The time has come to obtain reliable data through a multicenter collaboration study, also in order to standardize the international Telemedicine protocols.
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- 2015
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26. The application of telemedicine in the follow-up of lung transplantation in a patient with cystic fibrosis.
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Murgia F, Corona B, Bianciardi F, Romano P, Tagliente I, and Bella S
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- Adolescent, Chronic Disease, Cystic Fibrosis Transmembrane Conductance Regulator, Female, Follow-Up Studies, Humans, Italy, Cystic Fibrosis rehabilitation, Lung Transplantation rehabilitation, Telemedicine methods
- Abstract
The Cystic Fibrosis (CF) Unit of Children's Hospital Bambino Gesù in Rome (Italy) has more than 25 years of experience in diagnosis and treatment of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) related diseases. The CF Unit actively collaborates with the Transplantation Division for the follow-up of patients with CF who undergo lung transplantation, performed in our Unit since 1991. We present the case of a 19 year-old girl with CF, with severe respiratory failure for which it was subjected to two lung transplant. During the follow-up the remote monitoring has allowed the identification of an early episode of pulmonary relapse and graft-versus-host reaction even before the onset of symptoms, allowing an effective intervention and a complete recovery of lung function.
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- 2014
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27. Prevalence and influence of malnutrition on quality of life and performance status in patients with locally advanced head and neck cancer before treatment.
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Capuano G, Gentile PC, Bianciardi F, Tosti M, Palladino A, and Di Palma M
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- Adolescent, Adult, Aged, Anorexia etiology, Fatigue etiology, Female, Humans, Male, Malnutrition epidemiology, Malnutrition etiology, Middle Aged, Multivariate Analysis, Nausea etiology, Neoplasm Staging, Prevalence, Severity of Illness Index, Vomiting etiology, Young Adult, Head and Neck Neoplasms complications, Malnutrition complications, Nutritional Support methods, Quality of Life
- Abstract
Goals of Work: The aim of this study was to evaluate the prevalence and influence of malnutrition (unintentional weight loss >or=5% in the last 3 months) on quality of life (QoL) and performance status (PS) in head and neck cancer patients (HNC) before treatment., Patients and Methods: Sixty-one consecutive outpatients affected by locally advanced HNC (III-IVA stage) were enrolled. In all patients, nutritional intake (by diet history), nutritional status (Patient Generated Subjective Global Assessment), unintentional weight loss (UWL), serum prealbumin, hemoglobin level (Hb), C-reactive protein, QoL (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30 v. 3.0), and PS (Eastern Cooperative Oncology Group (ECOG) PS) were assessed before radio or concomitant chemoradiotherapy., Main Results: Thirty-six percent of HNC were malnourished before treatment. The median ECOG PS in malnourished patients was 1 (0-2), whereas in nonmalnourished was 0 (0-2; p = 0.018). Physical (p = 0.043), role (p = 0.047), and social functions (p = 0.024) scores were significantly worse in malnourished than in nonmalnourished HNC. Fatigue (p < 0.001), appetite loss (p < 0.001), and nausea and vomiting (p = 0.002) scores were worse in malnourished patients than in nonmalnourished. In the multivariate analysis, UWL and Hb level independently influenced physical (p = 0.002; p = 0.005), role (p = 0.004; p = 0.001), and social functions (p = 0.024; p = 0.009)., Conclusion: Our data suggest that an early and intensive nutritional support might reduce weight loss before, during, and after treatment completion, improving outcome, QoL, and PS.
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- 2010
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28. Influence of weight loss on outcomes in patients with head and neck cancer undergoing concomitant chemoradiotherapy.
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Capuano G, Grosso A, Gentile PC, Battista M, Bianciardi F, Di Palma A, Pavese I, Satta F, Tosti M, Palladino A, Coiro G, and Di Palma M
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- Adolescent, Adult, Aged, Bacterial Infections complications, Candidiasis complications, Counseling, Female, Head and Neck Neoplasms mortality, Humans, Male, Middle Aged, Nutritional Requirements, Nutritional Support, Patient Readmission statistics & numerical data, Prealbumin analysis, Survival Analysis, Head and Neck Neoplasms therapy, Nutritional Status, Outcome Assessment, Health Care, Patient Compliance, Weight Loss
- Abstract
Background: The purpose of this study was to determine the influence of weight loss on outcome in patients with head and neck cancer undergoing concomitant chemoradiotherapy (CCRT): treatment interruption, infections, mortality, and hospital readmission rate., Methods: Forty patients with head and neck cancer were enrolled. All patients were counseled to follow a nutritional program during CCRT. Body weight was evaluated at baseline, at the end, and 30 days after radiochemotherapy., Results: Ninety percent of compliant patients with nutritional program maintained body weight (mean, 1 +/- 2.4 kg) and 100% of noncompliant patients continued to lose weight (mean, -9 +/- 4 kg; p < .001). A reduction greater than 20% of prediagnosis weight significantly correlated with treatment interruption (p = .003), infections (p = .002), early mortality (p = .011), hospital readmission rate (p = .001), and survival (log-rank test: z = -2.722, p = .006)., Conclusion: In patients with head and neck cancer undergoing CCRT, the early nutritional management reduces weight loss and improve outcome.
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- 2008
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29. Concomitant radiotherapy with protracted 5-fluorouracil infusion in locally advanced carcinoma of the pancreas: a phase II study.
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Osti MF, Costa AM, Bianciardi F, De Nicolò M, Donato V, Silecchia G, and Enrici RM
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- Adenocarcinoma pathology, Adult, Aged, Antimetabolites, Antineoplastic administration & dosage, Antimetabolites, Antineoplastic adverse effects, Chemotherapy, Adjuvant, Drug Administration Schedule, Female, Fluorouracil administration & dosage, Fluorouracil adverse effects, Humans, Infusions, Intravenous, Male, Middle Aged, Pancreatic Neoplasms pathology, Radiotherapy Dosage, Radiotherapy, Adjuvant, Survival Analysis, Treatment Outcome, Adenocarcinoma drug therapy, Adenocarcinoma radiotherapy, Antimetabolites, Antineoplastic therapeutic use, Fluorouracil therapeutic use, Pancreatic Neoplasms drug therapy, Pancreatic Neoplasms radiotherapy
- Abstract
Aims and Background: To evaluate the efficacy of combined radiation therapy and continuous infusion of 5-fluorouracil in patients with locally advanced carcinoma of the pancreas., Methods: Between January 1992 and June 1999, 31 patients with locally advanced adenocarcinoma of the pancreas were treated in our Institute. In 20 patients, the tumor (65%) was located in the head of the pancreas and in 11 (35%) in the body or tail; 13 cases also showed involved nodes. Radiation therapy consisted in a median dose of 63 Gy in 33-36 fractions applied to the tumor and regional lymph nodes. Chemotherapy with 5-fluorouracil in continuous infusion, 250 mg/m2 daily, was administered in the first and fifth week of the radiation therapy. Thereafter, 22 patients received 3-10 cycles of adjuvant chemotherapy with same doses. Median follow-up of the series was 20 months. The toxicity of the treatment was scored according to WHO criteria. All patients underwent nutritional assessment at the time of radiochemotherapy., Results: The median overall survival was 15.2 months (range, 4-42). At restaging, 17 cases (55%) showed no change and 14 (45%) a partial remission. At the end of radiochemotherapy in 8 (26%) of the cases there was indication for pancreatectomy, which was executed in 4 patients. At the time of the study, 2 patients (6.4%) were surgically proven disease free. Eleven of the 13 cases (85%) presenting involved nodes showed that the enlarged lymph nodes had disappeared. Nineteen patients (61%) are alive with clinical evidence of disease anti 2 cases are alive with liver metastases; 8 patients (26%) died for disease. In 74% of cases there was complete pain control. Tolerance to the regimen was good. Nutritional assistance was evaluated and was found to be correlated to survival., Conclusions: The results of the series confirm a good tolerance with low acute toxicity. Tumor down-staging and resectability rates were high, together with prolonged survival and a good quality of life.
- Published
- 2001
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