National Tumour Institute

Napoli, Italy

National Tumour Institute

Napoli, Italy
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Comella P.,National Tumour Institute | Casaretti R.,National Tumour Institute | Manzo R.,National Tumour Institute | Sandomenico C.,National Tumour Institute | And 22 more authors.
Acta Oncologica | Year: 2010

Background. No differences in response rate (RR), progression-free survival (PFS), overall survival (OS) and quality of life (QoL) were seen in patients randomly treated with biweekly oxaliplatin plus either fluorouracil/folinic acid or capecitabine. Methods. We investigated the independent effect of baseline clinical characteristics and physical functioning (PF) domain on RR, PFS, and OS in 310 patients who completed the EORTC QLQ-C30 questionnaire. Multivariate analyses stratified by treatment were performed. An exploratory analysis was done by grouping patients with a PF score superior or equal to the highest quartile (n = 111), included between the highest and the lowest quartiles (n = 99), or inferior to the lowest quartile (n = 100). The relationship between these three groups and the ECOG PS was then analysed. Results. At multivariate analysis, OS was negatively affected by the number of metastatic sites, the serum alkaline phosphatase, and the ECOG PS, while it was positively affected by the previous surgical resection of the primary tumour. Adding the baseline PF score, the number of disease sites (p < 0.0001), the serum alkaline phosphatase (p = 0.0057), and the PF (p = 0.0007) retained an independent significance, while the ECOG PS and the previous surgery were no longer significant. PF did not significantly affect PFS or RR. A good but not totally overlapping correlation was found between PF grouping and ECOG PS score. Conclusions. Baseline self-reported PF independently predicted the OS of patients. Assessment of QoL should be incorporated in randomised trials evaluating the management of patients with MCRC.


Comella P.,National Tumour Institute | Chiuri V.E.,Vito Fazi Hospital | De Cataldis G.,Da Procida Hospital | Filippelli G.,San Francesco Of Paola Hospital | And 10 more authors.
Lung Cancer | Year: 2010

Purpose: To estimate the safety, activity, and impact on quality of life of a combination of gemcitabine and pemetrexed in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in the context of a randomized two-stage phase II study. Patients and methods: Patients in stage IIIB or IV NSCLC were randomly allocated to receive either gemcitabine 1250 mg/m2 on day 1, and pemetrexed (Alimta) 500 mg/m2 followed by gemcitabine 1250 mg/m2 on day 8 of a 3-weekly cycle (GA arm), or paclitaxel 120 mg/m2 followed by gemcitabine 1000 mg/m2, both given on days 1 and 8 of a 3-weekly cycle (PG arm). Results: 105 (GA arm, 51; PG arm, 54) eligible patients (stage IV, 32 and 30, respectively) were enrolled into this study; thereafter, accrual was stopped due to first-stage analysis. The response rate was 20% (95% confidence interval [CI], 10-33%) in the GA arm, and 32% (95% CI, 20-46%) in the PG arm. Median progression-free survival was 5.1 (95% CI, 3.7-6.5) months in the GA arm, and 8.3 (95% CI, 5.9-10.7) months in the PG arm, while median overall survival was 10.5 (95% CI 7.1-13.9), and 13.3 (95% CI 11.7-14.9) months, respectively. Severe neutropenia (36% vs 22%), and febrile neutropenia (14% vs 7%) were more common with the GA regimen, while hair loss (52% vs 16%) and any grade peripheral neuropathy (31% vs 2%) occurred more frequently with PG regimen. Other severe side effects of GA regimen were diarrhoea (10%), liver enzyme derangement (10%), and fatigue (8%). Conclusion: The GA regimen was tolerated and moderately active in advanced or metastatic NSCLC. However, this combination did not yield any advantage in comparison with the PG regimen, and does not deserve further evaluation. © 2009 Elsevier Ireland Ltd. All rights reserved.


Bisogno G.,University of Padua | Cecchetto G.,University of Padua | Ferrari A.,National Tumour Institute
European Oncology and Haematology | Year: 2012

Very rare tumours (VRTs) in paediatric age are a heterogeneous group of cancers very rarely encountered in daily practice, even in large paediatric oncology centres. Some of them are typical of paediatric age, such as pleuropulmonary blastoma or pancreatoblastoma; others are typically found in adulthood, such as carcinomas and melanoma. With the objective of improving the research on, and management of, paediatric VRTs, a national study group was founded and the Tumori Rari in Età Pediatrica (Rare Tumours in Paediatric Age [TREP]) project was launched in Italy in 2000. For the purposes of this project, VRTs have been defined as "any solid malignancy characterized by an annual incidence of <2 cases/million children and not considered in other clinical trials". From January 2000 to December 2011, 652 patients <18 years of age were registered in the TREP database. This article presents the experience gathered so far and underlines the need to develop international collaborations dedicated to paediatric VRTs. With this aim, national groups from Italy, Germany, France, Poland and the UK have created, in June 2008, a new collaborative group named European Cooperative Study Group for Paediatric Rare Tumours (EXPeRT). © TOUCH BRIEFINGS 2012.


Panza E.,University of Naples Federico II | Panza E.,University of Palermo | Tersigni M.,University of Naples Federico II | Iorizzi M.,University of Molise | And 7 more authors.
Journal of Natural Products | Year: 2011

Malignant melanoma is a highly aggressive tumor that frequently resists chemotherapy, so the search for new agents for its treatment is of great importance. In the present study, the antiproliferative propensity against human melanoma cell lines of lauroside B (1), a megastigmane glycoside isolated from Laurus nobilis (bay laurel) leaves, was investigated. This compound suppressed the proliferation of three human melanoma cell lines, namely, A375, WM115, and SK-Mel-28. The 1-induced inhibition of human melanoma cell proliferation was due to the induction of apoptosis, as demonstrated by FACS analysis with annexin V/PI staining and confirmed by activation of caspase-3 and by the cleavage of poly(ADP-ribose) polymerase (PARP). Growing evidence implicates NF-κB as an important contributor to metastasis and increased chemoresistance of melanoma. Thus, it was hypothesized that 1-induced apoptosis could be associated with suppression of NF-κB activation. The results showed that exposure of human melanoma cells to 1 inhibited IκB-α degradation and constitutive NF-κB DNA-binding activity as well as the expression, regulated by NF-κB, of two antiapoptotic genes, XIAP and c-FLIP. Induction of apoptosis by 1 in human aggressive melanoma cell lines has a potential high biological value. © 2010 The American Chemical Society and American Society of Pharmacognosy.


Squadrelli-Saraceno M.,National Tumour Institute | Compan A.,Guillermo Grant Benavente Hospital | Bimbi G.,National Tumour Institute | Gatto L.,University of Palermo | And 2 more authors.
Acta Otorhinolaryngologica Italica | Year: 2010

Usually, harvesting free flap in the limbs creates an inevitable sequence of aesthetic damage not only in the donor site but also in the area of the graft used to repair the free flap donor site. Aim of the study was to standardize a simple method, defined Autonomous Reparative Unit, that allows closing of the donor site defects with a skin graft from the adjacent cutaneous area, avoiding further aesthetic damage in a third area. We define the "Autonomous Reparative Unit" the rectangular shaped skin area of the flap and the dermoepidermic skin graft designed as an isoscele triangle with the base adjacent to the smaller side of the flap defect. From 2003 to 2008, at the Fondazione IRCCS Istituto Nationale Tumori of Milan, 143 free radial forearm flaps and 42 free osteofasciocutaneus fibula flaps have been performed for head and neck cancer. The autonomous reparative unit has been applicable in 177 cases (92.1%). The autonomous reparative unit method allows a "standard" primary reconstructive unit to be created which can be used in a single or in multiple ways thus avoiding an additional surgical scar and a subsequent additional aesthetic impairment.


Comella P.,National Tumour Institute | Casaretti R.,National Tumour Institute | Avallone A.,National Tumour Institute | Franco L.,National Tumour Institute
Critical Reviews in Oncology/Hematology | Year: 2010

The prognosis of patients with metastatic colorectal cancer has significantly improved in the last few years, with the introduction into the clinical practice of new cytotoxic treatments, the availability of non-cross resistant agents after the front-line treatment failure, and the combination of targeted agents (i.e., the inhibitors of the epidermal growth factor and vascular endothelial growth factor pathways) with conventional drugs. All these options must be incorporated into a complex strategy of management, in which a customized management according to the disease status, with an intensified induction approach followed by maintenance (and reinduction), should be investigated. © 2009 Elsevier Ireland Ltd.


No differences in response rate (RR), progression-free survival (PFS), overall survival (OS) and quality of life (QoL) were seen in patients randomly treated with biweekly oxaliplatin plus either fluorouracil/folinic acid or capecitabine.We investigated the independent effect of baseline clinical characteristics and physical functioning (PF) domain on RR, PFS, and OS in 310 patients who completed the EORTC QLQ-C30 questionnaire. Multivariate analyses stratified by treatment were performed. An exploratory analysis was done by grouping patients with a PF score superior or equal to the highest quartile (n = 111), included between the highest and the lowest quartiles (n = 99), or inferior to the lowest quartile (n = 100). The relationship between these three groups and the ECOG PS was then analysed.At multivariate analysis, OS was negatively affected by the number of metastatic sites, the serum alkaline phosphatase, and the ECOG PS, while it was positively affected by the previous surgical resection of the primary tumour. Adding the baseline PF score, the number of disease sites (p < 0.0001), the serum alkaline phosphatase (p = 0.0057), and the PF (p = 0.0007) retained an independent significance, while the ECOG PS and the previous surgery were no longer significant. PF did not significantly affect PFS or RR. A good but not totally overlapping correlation was found between PF grouping and ECOG PS score.Baseline self-reported PF independently predicted the OS of patients. Assessment of QoL should be incorporated in randomised trials evaluating the management of patients with MCRC.

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