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Bartucci M.,Oncology and Molecular Medicine | Dattilo R.,Oncology and Molecular Medicine | Martinetti D.,Istituto Oncologico del Mediterraneo | Todaro M.,University of Palermo | And 5 more authors.
Clinical Cancer Research | Year: 2011

Purpose: Chemotherapy-induced apoptosis of immature hematopoietic cells is a major cause of anemia and thrombocytopenia in cancer patients. Although hematopoietic growth factors such as erythropoietin and colony-stimulating factors cannot prevent the occurrence of drug-induced myelosuppression, stem cell factor (SCF) has been previously shown to protect immature erythroid and megakaryocytic cells in vitro from drug-induced apoptosis. However, the effect of SCF in vivo as a single myeloprotective agent has never been elucidated. Experimental Design: The ability of SCF to prevent the occurrence of chemotherapy-induced anemia and thrombocytopenia was tested in a mouse model of cisplatin-induced myelosuppression. To highlight the importance of maintaining a continuous antiapoptotic signal in immature hematopoietic cells, we compared two treatment schedules: in the first schedule, SCF administration was interrupted during chemotherapy treatment and resumed thereafter, whereas in the second schedule, SCF was administered without interruption for 7 days, including the day of chemotherapy treatment. Results: The administration of SCF to cisplatin-treated mice could preserve bone marrow integrity, inhibit apoptosis of erythroid and megakaryocytic precursors, prevent chemotherapy-induced anemia, and rapidly restore normal platelet production. Treatment with SCF increased the frequency of Bcl-2/Bcl-XL-positive bone marrow erythroid cells and sustained Akt activation in megakaryocytes. Myeloprotection was observed only when SCF was administered concomitantly with cisplatin and kept constantly present during the days following chemotherapy treatment. Conclusions: SCF treatment can prevent the occurrence of chemotherapy-induced anemia and thrombocytopenia in mice, indicating a potential use of this cytokine in the supportive therapy of cancer patients. ©2011 AACR.

Campiglio M.,Molecular Targeting Unit | Bufalino R.,Molecular Targeting Unit | Sasso M.,Molecular Targeting Unit | Ferri E.,Molecular Targeting Unit | And 15 more authors.
Breast Cancer Research and Treatment | Year: 2013

Clinical trials have shown the efficacy of trastuzumab-based adjuvant therapy in HER2-positive breast cancers, but routine clinical use awaits evaluation of compliance, safety, and effectiveness. Adjuvant trastuzumab-based therapy in routine clinical use was evaluated in the retrospective study GHEA, recording 1,002 patients treated according to the HERA protocol between March 2005 and December 2009 in 42 Italian oncology departments; 874 (87.23 %) patients completed 1-year trastuzumab treatment. In 128 patients (12.77 %), trastuzumab was withdrawn due to cardiac or non-cardiac toxicity (28 and 29 patients, respectively), disease progression (5 patients) or the clinician's decision (66 patients). In addition, 156 patients experienced minor non-cardiac toxicities; 10 and 44 patients showed CHF and decreased LVEF, respectively, at the end of treatment. Compliance and safety of adjuvant trastuzumab-based therapy in Italian hospitals were high and close to those reported in the HERA trial. With a median follow-up of 32 months, 107 breast cancer relapses were recorded (overall frequency, 10.67 %), and lymph node involvement, estrogen receptor negativity, lymphoid infiltration, and vascular invasion were identified as independent prognostic factors for tumor recurrence, indicating that relapses were associated with advanced tumor stage. Analysis of site and frequency of distant metastases showed that bone metastases were significantly more frequent during or immediately after trastuzumab (<18 months from the start of treatment) compared to recurrences in bone after the end of treatment and wash-out of the drug (>18 months from the start of treatment) (35.89 vs. 14.28 %, p = 0.0240); no significant differences were observed in recurrences in the other recorded body sites, raising the possibility that the protection exerted by trastuzumab is lower in bone metastases. © 2013 The Author(s).

Zinzani P.L.,University of Bologna | Pellegrini C.,University of Bologna | Cerciello G.,University of Naples Federico II | Monaco F.,A.O. SS Antonio E Biagio E Cesare Arrigo | And 18 more authors.
Leukemia and Lymphoma | Year: 2016

Clinical trial results indicate that romidepsin, a histone deacetylase inhibitor, is a promising treatment in relapsed/refractory T-cell lymphomas (TCLs). This retrospective multicenter study was conducted in patients with relapsed/refractory TCL treated with romidepsin monotherapy through a Named Patient Program (NPP) in Italy. Principal endpoints were overall response rate (ORR), safety, and overall survival (OS). The ORR in 33 evaluable patients was 24.2% with an ORR in the cutaneous TCL of 35.7%. Global OS was 39.3% at 30 months. There were not any specific differences on hematological and extrahematological adverse events. Data from patients treated with romidepsin outside a controlled clinical trial give additional information about the clinical use, efficacy, and toxicity of the drug given to relapsed or refractory TCL patients in a real life context as TCLs are rare diseases and more information is needed. These findings suggest that romidepsin is effective and safe for heavily pretreated TCL patients. © 2016 Taylor & Francis

Caronia F.P.,Istituto Oncologico del Mediterraneo | Fiorelli A.,The Second University of Naples | Ruffini E.,University of Turin | Nicolosi M.,Chirurgia Toracica | And 2 more authors.
Interactive Cardiovascular and Thoracic Surgery | Year: 2014

OBJECTIVES: The aim of the present paper was to conduct a comparative analysis of outcomes after thoracoscopic resection versus standard thoracotomy approach in the treatment of Pancoast tumours. METHODS: All consecutive patients with Pancoast tumours undergoing surgical treatment from March 2000 to November 2012 were enrolled. Patients were divided into 2 groups according to whether a thoracoscopic or standard thoracotomy approach was adopted. In addition to morbidity and mortality, (i) intensity of pain; (ii) respiratory function focusing on the postoperative value and its variation with respect to the predicted value (Delta); (iii) analgesic consumption at different times during the postoperative course; and (iiii) survival rate were recorded in both groups and the inter-group differences were statistically compared. RESULTS: Of the 45 enrolled patients, 34 (75%) were included in the final analysis (18 in the thoracoscopic group and 16 in the standard group). Eleven (25%) patients were excluded because they (i) were unfit for surgery after induction therapy (n = 4); (ii) refused the operation (n = 1) or (iii) had unexpected pleural involvement (n = 6). Compared with the standard group, in the thoracoscopic group we observed less pain (P = 0.01), better recovery of forced vital capacity (P = 0.01) and forced expiratory value in 1 s (P < 0.001), and a reduction in opioid (P = 0.01) and analgesic consumption (P = 0.02). The median survival for all patients was 15 months. Patients with N0/N1 disease had better median survival than N2 patients (47 vs 9 months; P = 0.009). One local recurrence in the standard group was observed 1 year after operation, whereas 2 local recurrences, 1 in the thoracoscopic group and another in the standard group, were registered 2 years after the operation (P = 1.0). Finally, 4 (22%) extrathoracic metastases in the thoracoscopic group and 5 (31%) in the standard group (P = 0.8) were found over the 2 years following the procedure. CONCLUSIONS: In the management of Pancoast tumours, a thoracoscopic approach is safe and may be an effective adjunct to standard surgical resection in selected cases. Such an approach enabled surgeons to explore the pleural cavity and avoid exploratory thoracotomy in cases of unexpected pleural involvement. © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Adamo V.,Messina University | Ricciardi G.R.R.,Messina University | De Placido S.,University of Naples Federico II | Colucci G.,Ospedale Oncologico Istituto Tumori Giovanni Paolo | And 7 more authors.
European Journal of Cancer | Year: 2012

Aims: Triple-negative breast cancers (TNBCs) lack expression of oestrogen, progesterone, and Human Epidermal Growth Factor 2 receptors. The NEMESI study described current Italian treatment practices in patients with operable, early-stage breast cancer (EBC). Patients and methods: Retrospective, observational study involving 63 Italian oncology centres. Eligible patients were aged ≥18 years with EBC (stage I-II) who had undergone surgery, received ≥1 cycle of adjuvant chemotherapy and/or adjuvant hormonal therapy and attended an oncology centre between 1 January 2008 and 30 June 2008. This subanalysis focused on patients with TNBC. Variables evaluated included: demographic data/clinical characteristics; tumour characteristics; adjuvant therapy; compliance to chemotherapy. Continuous variables were summarised using descriptive statistics. Results: Of 1894 patients in the NEMESI study, 185 patients (9.8%) had TNBC. At diagnosis, 98 patients were aged 50-70 years and 114 were post-menopausal. Tumours were subcategorised as pT1mic/pT1a/pT1b/pT1c in 108 patients and pT2/pT3/pT4b in 77 patients. Mean tumour size was 2.1 cm, tumours were highly undifferentiated in 144 patients and 128 patients were pNO. 179 patients received adjuvant chemotherapy; anthracyclines with or without taxanes were commonly used. 145 patients received radiotherapy. Conclusions: Adherence of Italian clinical practice to International Guidelines in the management of early-stage TNBC is satisfactory. © 2011 Elsevier Ltd. All rights reserved.

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