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Griffo R.,Direzione Scientifica Instituto Cardiovascolare Camogli GE | Ambrosetti M.,UO Cardiologia e Angiologia Riabilitativa | Furgi G.,Instituto Of Telese Terme | Carlon R.,Presidio | And 10 more authors.
Monaldi Archives for Chest Disease - Cardiac Series | Year: 2012

Despite major improvements in diagnostics and interventional therapies, cardiovascular diseases remain a major health care and socio-economic problem in Italy. Costs and resources required are increasing in close correlation to both the improved quality of care and to the population ageing. There is an overwhelming evidence of the efficacy of cardiac rehabilitation (CR) in terms of reduction in morbidity and mortality after acute cardiac events. CR services are by definition multi-factorial and comprehensive. Furthermore, systematic analysis and monitoring of the process of delivery and outcomes is of paramount importance. The aim of this position paper promoted by the Italian Association for Cardiovascular Prevention and Rehabilitation (GICR-IACPR) is to provide specific recommendations to assist CR staff in the design, evaluation and development of their care delivery organization. The position paper should also assist health care providers, insurers, policy makers and consumers in the recognition of the quality of care requirements, standards and outcome measure, quality and performance indicators, and professional competence involved in such organization and programs. The position paper i) include comprehensive CR definition and indications, ii) describes priority criteria based on the clinical risk for admission to both inpatient or outpatient CR, and iii) defines components and technological, structural and organizing requirements for inpatient or outpatient CR services, with specific indicators and standards, performance measures and required professional skills. A specific chapter is dedicated to the requirements for highly specialized CR services for patients with more advanced cardiovascular diseases.


Brignole M.,Arrhythmologic Center | Occhetta E.,Ospedale Maggiore della Carita | Bongiorni M.G.,Ospedale Cisanello | Proclemer A.,Ospedale Santa Maria della Misericordia | And 15 more authors.
Journal of the American College of Cardiology | Year: 2012

Objectives: The purpose of this study is to assess the effectiveness of defibrillation testing (DT) in patients undergoing implantable cardioverter-defibrillator (ICD) insertion. Background: Although DT is considered a standard procedure during ICD implantation, its usefulness has not been definitively proven. Methods: The SAFE-ICD (Safety of Two Strategies of ICD Management at Implantation) study is a prospective observational study designed to evaluate the outcome of 2 strategies: performing defibrillation testing (DT+) versus not performing defibrillation testing (DT-) during de novo ICD implants. No deviation from the centers' current practice was introduced. In all, 2,120 consecutive patients (836 DT+ and 1,284 DT-) age <18 years were enrolled at 41 Italian centers from April 2008 to May 2009 and followed up for 24 months until June 2011. The primary endpoint was a composite of severe complications at ICD implant and sudden cardiac death or resuscitation at 2 years. Results: The primary endpoint occurred in 34 patients: 12 intraoperative complications (8 in DT+ group; 4 in DT- group) and 22 during follow-up (10 in DT+ group; 12 in DT- group). Overall, the estimated yearly incidence (95% confidence interval) was DT+ 1.15% (0.73 to 1.83) and DT- 0.68% (0.42 to 1.12). The difference between the 2 groups was negligible: 0.47% per year (-0.15 to 1.10). Mortality from any cause was similar at 2 years (adjusted hazard ratio: 0.97 [0.76 to 1.23], p = 0.80). Conclusions: In this large cohort of new ICD implants, event rates were similar and extremely low in both groups. These data indicate a limited clinical relevance for DT testing, thus supporting a strategy of omitting DT during an ICD implant. (Safety of Two Strategies of ICD Management at Implantation [SAFE-ICD]; NCT00661037) © 2012 American College of Cardiology Foundation.


PubMed | Ospedale Sacro Cuore don Calabria, Medical Oncology, Medical Oncology Unit, Unit of Oncology and 13 more.
Type: Journal Article | Journal: PloS one | Year: 2015

The management of pT1a-b pN0 HER2-positive breast cancer is controversial and no data about the efficacy of trastuzumab in this setting are available from randomized clinical trials. The aims of this retrospective study were to assess how patients are managed in clinical practice in Italy, which clinical or biological characteristics influenced the choice of adjuvant systemic therapy and the outcome of patients.Data of consecutive patients who underwent surgery from January 2007 to December 2012 for HER2-positive, pT1a-b pN0 M0 breast cancer were retrospectively collected from 28 Italian centres. Analysis of contingency tables and multivariate generalized logit models were used to investigate the association between the baseline clinical and biological features and the treatment strategy adopted.Among 303 enrolled patients, 204 received adjuvant systemic therapy with trastuzumab, 65 adjuvant systemic therapy without trastuzumab and 34 did not receive adjuvant systemic therapy. At the multivariate analysis age, tumor size, proliferation index and hormone receptor status were significantly associated with the treatment choice. Five-year disease-free survival (DFS) probability was 95%, 94.3% and 69.6% for patients treated with adjuvant systemic therapy and trastuzumab, with adjuvant systemic therapy without trastuzumab and for patients who did not receive adjuvant systemic therapy, respectively (p<0.001).The majority of patients (66%) with pT1a-b pN0 HER2-positive breast cancer enrolled in this retrospective study received adjuvant systemic therapy with trastuzumab, whereas only 11% patients did not receive any adjuvant systemic therapy. It should be emphasized, however, that in the adjuvant systemic therapy without trastuzumab group 94% of tumors were hormone receptor positive and 89% of patients were treated with endocrine therapy only [corrected]. The 5-year DFS probability was significantly higher for patients receiving adjuvant systemic therapy with trastuzumab compared with patients not receiving adjuvant systemic therapy or receiving adjuvant systemic therapy without trastuzumab.


Celio L.,Fondazione IRCCS Instituto Nazionale Dei Tumori | Frustaci S.,Centro Of Riferimento Oncologico | Denaro A.,Fondazione IRCCS Instituto Nazionale Dei Tumori | Buonadonna A.,Centro Of Riferimento Oncologico | And 9 more authors.
Supportive Care in Cancer | Year: 2011

Purpose: A phase III trial assessed the efficacy of palonosetron plus dexamethasone given once in preventing acute and delayed chemotherapy-induced nausea and vomiting (CINV) following a broad range of moderately emetogenic chemotherapy (MEC) regimens. Methods: This multicentre, randomized, open-label, non-inferiority trial evaluated two different treatment groups. One group received palonosetron (0.25 mg intravenously) and dexamethasone (8 mg intravenously) before chemotherapy, while the other was administered the same regimen on day 1 followed by dexamethasone 8 mg orally on days 2 and 3. The primary endpoint was complete response (CR; defined as no emetic episodes and no rescue medication) during the overall phase (days 1-5 after chemotherapy initiation). The non-inferiority margin was predefined as a 15% difference between groups in the primary endpoint. Results: Of 332 chemotherapy-naïve patients included in the intention-to-treat analysis, 65.1% were female, and 35.2% received anthracycline plus cyclophosphamide (AC)-based regimens. Overall CR rates were 67.5% for those administered dexamethasone only on day 1 (n=166), and 71.1% for those also administered dexamethasone on days 2 and 3 (n=166; difference -3.6% (95% confidence interval, -13.5 to 6.3)). CR rates were not significantly different between groups during the acute (0-24 h post-chemotherapy; 88.6% versus 84.3%; P=0.262) and delayed phases (days 2-5; 68.7% versus 77.7%; P=0.116). Conclusions: Palonosetron plus single-dose dexamethasone administered before common MEC regimens provide protection against acute and delayed CINV which is non-inferior to that of palonosetron plus dexamethasone for 3 days. However, the major benefit of the single-day regimen occurs in patients receiving non-AC MEC regimens. © 2010 The Author(s).


Santoro A.,Humanitas Cancer Center | Comandone A.,Gradenigo Hospital | Basso U.,Instituto Oncologico Veneto IOV IRCCS | Soto Parra H.,Azienda Ospedaliera Universitaria Policlinico Vittorio Emanuele | And 7 more authors.
Annals of Oncology | Year: 2013

Introduction: We investigated the activity and safety of sorafenib, a multitargeted tyrosine-kinase inhibitor, in patients with advanced soft tissue sarcomas (STS). Patients and methods: An open-label nonrandomised multicentre phase II study was conducted in advanced STS patients pre-treated with anthracycline-based chemotherapy. Patients received sorafenib 400 mg twice daily for 28 days. The primary end point was the progression-free survival (PFS) rate at 6 months. Toxicity was assessed. Clinical outcomes were evaluated in all histologies and in leiomyosarcoma (L) and angiovascular sarcomas (A). Results: Between November 2006 and January 2010, 101 patients (36 L, 19 A, and 46 others) were enrolled; 76 patients per-protocol (PP) and 100 per intention-to-treat (ITT) were assessable for the primary end point. In the PP analysis, 11 (14.5) achieved partial response and 25 (32.9) stable disease; 6-month PFS rates were all histologies, 34.5; L, 38.4; and A, 56.3. In the ITT analysis, 6-month PFS results were 27.1, 35, and 35.5 in all histologies, L, and A, respectively. When stratified by histology, we observed a better PFS favouring leiomyosarcoma versus other histologies (P 0.033). Treatment was well tolerated. Conclusions: Sorafenib appears to be a promising option in leiomyosarcoma patients. This finding warrants further evaluation in histology-driven trials. © The Author 2012.


Cavanna L.,Ospedale Guglielmo da Saliceto | Bodini F.C.,Ospedale Guglielmo da Saliceto | Stroppa E.M.,Ospedale Guglielmo da Saliceto | Banchini F.,Ospedale Guglielmo da Saliceto | And 4 more authors.
Chemotherapy | Year: 2014

Background: At diagnosis, about 35% of patients with gastric cancer present with distant metastases, and most patients with gastric cancer and liver metastases are excluded from curative surgery. Case: We report a case of human epidermal growth factor receptor-2 (HER2)-negative gastric cancer with metastases to the liver and perigastric lymph nodes. The patient (a 60-year-old man) was considered unresectable at diagnosis and was treated with palliative chemotherapy (docetaxel plus cisplatin and 5-fluorouracil by continuous intravenous infusion over 5 days every 3 weeks). However, after 6 courses of chemotherapy, a computed tomography scan showed a reduction of the liver metastasis and the disappearance of the enlarged perigastric lymph nodes. The patient then underwent a curative gastrectomy, lymphadenectomy and liver resection. After surgery, the patient was treated with 6 courses of FOLFOX-4 regimen as adjuvant chemotherapy. With a follow-up of 26 months after surgery, the patient is alive and disease free. Conclusion: In patients with metastatic gastric cancer, the prognosis is poor with a median overall survival of 11 months since curative treatments are excluded; however, this case illustrated that a personalized treatment with chemotherapy and surgery can allow a curative strategy in selected patients with HER2-negative advanced gastric cancer. © 2015 S. Karger AG, Basel.


Fois P.,University of Parma | Giannuzzi A.L.,Gruppo Otologico | Paties C.T.,Ospedale Guglielmo da Saliceto | Falcioni M.,Gruppo Otologico
Ear, Nose and Throat Journal | Year: 2014

Choristoma of the middle ear is a rare condition characterized by the presence of normal salivary gland tissue in the middle ear space. Salivary gland choristomas are benign lesions that are frequently associated with ossicular chain and facial nerve anomalies. Total surgical excision is indicated when there is no risk of damaging the facial nerve. We describe a new case of salivary gland choristoma of the middle ear, and we discuss the etiology, histologic features, and management of such lesions. Our patient was a 22-year-old woman in whom we surgically removed a whitish retrotympanic mass. Intraoperatively, we also detected an ossicular chain malformation. Histologic examination of the choristoma revealed the presence of salivary gland tissue. Furthermore, the lesion contained an extensive and previously undescribed component: a well-defined pseudostratified respiratory-type epithelium, similar to that of a normal eustachian tube. Ten months after removal of the choristoma, we surgically repaired the ossicular chain anomalies. No recurrence was noted on follow-up. © 2015 Vendome Group, LLC.


Orlandi E.,Ospedale Guglielmo da Saliceto | Mordenti P.,Ospedale Guglielmo da Saliceto | Zangrandi A.,Ospedale Guglielmo da Saliceto | Cavanna L.,Ospedale Guglielmo da Saliceto
Chemotherapy | Year: 2014

BACKGROUND: Malignant pleural effusion (MPE) is an extremely common problem affecting cancer patients with advanced disease. The current therapy for MPE is local treatment, such as thoracentesis, chemical pleurodesis, intracavitary administration of anticancer drugs and systemic therapy. However, the management of MPE is still unsatisfactory.CASE: We report a case of MPE secondary to human epidermal growth factor receptor 2 (HER2)-positive gastric cancer that was successfully treated with intrapleural trastuzumab. A 52-year-old male with metastatic HER2-positive gastric cancer received chemotherapy (FOLFOX4 regimen) plus trastuzumab; after 11 courses of chemotherapy, he developed right MPE refractory to systemic treatment and pleurodesis. A pleural biopsy performed during thoracoscopy showed pleural metastasis from HER2-positive gastric cancer. The patient received 2 courses of intrapleuric trastuzumab. After the second course, the MPE disappeared, and he continued systemic therapy with trastuzumab and docetaxel.CONCLUSION: The safety was good, no local or systemic complications occurred, and the dyspnea secondary to MPE improved and subsequently disappeared. To our knowledge, this case is the first report on intrapleuric trastuzumab use to treat refractory MPE secondary to metastasis from HER2-positive gastric cancer. The treatment was well-tolerated and efficacious. © 2015 S. Karger AG, Basel.


PubMed | Ospedale Guglielmo da Saliceto
Type: Case Reports | Journal: Chemotherapy | Year: 2015

Malignant pleural effusion (MPE) is an extremely common problem affecting cancer patients with advanced disease. The current therapy for MPE is local treatment, such as thoracentesis, chemical pleurodesis, intracavitary administration of anticancer drugs and systemic therapy. However, the management of MPE is still unsatisfactory.We report a case of MPE secondary to human epidermal growth factor receptor 2 (HER2)-positive gastric cancer that was successfully treated with intrapleural trastuzumab. A 52-year-old male with metastatic HER2-positive gastric cancer received chemotherapy (FOLFOX4 regimen) plus trastuzumab; after 11 courses of chemotherapy, he developed right MPE refractory to systemic treatment and pleurodesis. A pleural biopsy performed during thoracoscopy showed pleural metastasis from HER2-positive gastric cancer. The patient received 2 courses of intrapleuric trastuzumab. After the second course, the MPE disappeared, and he continued systemic therapy with trastuzumab and docetaxel.The safety was good, no local or systemic complications occurred, and the dyspnea secondary to MPE improved and subsequently disappeared. To our knowledge, this case is the first report on intrapleuric trastuzumab use to treat refractory MPE secondary to metastasis from HER2-positive gastric cancer. The treatment was well-tolerated and efficacious.


At diagnosis, about 35% of patients with gastric cancer present with distant metastases, and most patients with gastric cancer and liver metastases are excluded from curative surgery.We report a case of human epidermal growth factor receptor-2 (HER2)-negative gastric cancer with metastases to the liver and perigastric lymph nodes. The patient (a 60-year-old man) was considered unresectable at diagnosis and was treated with palliative chemotherapy (docetaxel plus cisplatin and 5-fluorouracil by continuous intravenous infusion over 5 days every 3 weeks). However, after 6 courses of chemotherapy, a computed tomography scan showed a reduction of the liver metastasis and the disappearance of the enlarged perigastric lymph nodes. The patient then underwent a curative gastrectomy, lymphadenectomy and liver resection. After surgery, the patient was treated with 6 courses of FOLFOX-4 regimen as adjuvant chemotherapy. With a follow-up of 26 months after surgery, the patient is alive and disease free.In patients with metastatic gastric cancer, the prognosis is poor with a median overall survival of 11 months since curative treatments are excluded; however, this case illustrated that a personalized treatment with chemotherapy and surgery can allow a curative strategy in selected patients with HER2-negative advanced gastric cancer.

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