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202. Chemoradioimmunotherapy in locally advanced pancreatic and biliary tree adenocarcinoma: A multicenter phase II study

Author

Recchia, Francesco, Sica, Gigliola, Candeloro, Giampiero, Bisegna, Roberta, Bratta, Massimo, Bonfili, Pierluigi, Necozione, Stefano, Tombolini, Vincenzo, Rea, Silvio, Sica, Gigliola (ORCID:0000-0002-7231-9139), Recchia, Francesco, Sica, Gigliola, Candeloro, Giampiero, Bisegna, Roberta, Bratta, Massimo, Bonfili, Pierluigi, Necozione, Stefano, Tombolini, Vincenzo, Rea, Silvio, and Sica, Gigliola (ORCID:0000-0002-7231-9139)

Abstract

OBJECTIVES: The antitumor activity and toxicity of a multi-step treatment were evaluated in patients with locally advanced, inoperable, or incompletely resected pancreatic (Pa) and biliary tree (Bt) adenocarcinomas (ADKs). METHODS: Fifty-four patients, 63% with Pa and 37% with Bt ADK, received 3 courses of cisplatin-gemcitabine induction chemotherapy. Progression-free (PF) patients were given consolidation radiotherapy with concurrent capecitabine. PF patients had, as maintenance immunotherapy (MI), interleukin 2 (1.8x10 IU) and 13-cis-retinoic acid (5 mg/kg). RESULTS: Thirty-eight patients, 27 with Pa and 11 with Bt ADKs, PF after cisplatin/gemcitabine, were treated with consolidation radiotherapy with concurrent capecitabine. Fourteen PF patients, 7 with Pa and 7 with Bt ADK, received MI. Median PF and overall survivals (OS) for all 54 patients were 6.8 and 12.1 months, respectively. Patients treated with MI had a median PF survival of 16.2 months, whereas median OS had not been reached yet, after a median follow-up of 27.5 months. Toxicity: Grades 3 and 4 hematological and gastrointestinal in 30% and 37% of patients, respectively; grades 1 and 2 autoimmune reactions in 28% of patients. CONCLUSIONS: These results support the efficacy and safety of a multi-step sequential treatment in patients with locally advanced, inoperable or incompletely resected Pa and Bt ADKs.

Published
2009

203. Beta-interferon, retinoids and tamoxifen in metastatic breast cancer: Long-term follow-up of a phase II study

Author

Recchia, Francesco, Sica, Gigliola, Candeloro, Giampiero, Necozione, Stefano, Bisegna, Roberta, Bratta, Massimo, Rea, Silvio, Sica, Gigliola (ORCID:0000-0002-7231-9139), Recchia, Francesco, Sica, Gigliola, Candeloro, Giampiero, Necozione, Stefano, Bisegna, Roberta, Bratta, Massimo, Rea, Silvio, and Sica, Gigliola (ORCID:0000-0002-7231-9139)

Abstract

Based on a series of in vitro data, including the additive and/or synergistic antiproliferative effect of interferon and tamoxifen on breast cancer cell lines, and on clinical reports, we designed a pilot phase II study to test the activity and toxicity of simultaneous administration of beta-interferon (beta-IFN), retinoids (R) and tamoxifen (TAM) as a salvage therapy in a group of patients with metastatic breast cancer (MBC). Herein we describe the outcome of this cohort of patients after a median follow-up of 150 months. Sixty-five stage IV breast cancer patients, 13 pre-treated with hormones, 38 with chemotherapy and 15 with both, received, as a salvage therapy, TAM, beta-IFN and R. Among 65 evaluable patients, 36 achieved a clinical response (55.5%) (95% c.i. 42-67.7%). Toxicity was moderate and mainly hepatic. Median progression-free and overall survival, which did not show any statistically significant difference in patients with different estrogen and progesterone receptor content, were 43 months and 47.9 months, respectively. In conclusion, the study shows that long-term treatment with TAM, beta-IFN and R in MBC is feasible, has moderate toxicity and seems to give a long-term benefit, irrespective of the receptorial status.

Published
2009

204. Tadalafil treatment had a modest effect on endothelial cell damage and repair ability markers in men with erectile dysfunction and vascular risk

Author

Francavilla, Sandro, primary, Pelliccione, Fiore, additional, D'Angeli, Anatolia, additional, D'Andrea, Settimio, additional, Barbonetti, Arcangelo, additional, Pezzella, Alfonso, additional, Necozione, Stefano, additional, Falone, Stefano, additional, Amicarelli, Fernanda, additional, and Francavilla, Felice, additional

Published
2014
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205. Maintenance immunotherapy in metastatic breast cancer

Author

Recchia, Francesco, Sica, Gigliola, Candeloro, Giampiero, Necozione, Stefano, Bisegna, Roberta, Bratta, Massimo, Rea, Silvio, Sica, Gigliola (ORCID:0000-0002-7231-9139), Recchia, Francesco, Sica, Gigliola, Candeloro, Giampiero, Necozione, Stefano, Bisegna, Roberta, Bratta, Massimo, Rea, Silvio, and Sica, Gigliola (ORCID:0000-0002-7231-9139)

Abstract

Maintenance chemotherapy provides only a modest survival advantage in metastatic breast cancer (MBC). We have previously shown that a maintenance immunotherapy (MI) regimen based on low-dose interleukin-2 (IL-2) and 13-cis retinoic acid (RA) improved the lymphocyte and natural killer cell (NK) counts, and CD4+/CD8+ ratio in patients with a clinical benefit from chemotherapy. With the aim of improving progression-free survival (PFS), 100 consecutive MBC patients with a clinical benefit from chemotherapy were treated with an MI. Patients with MBC were eligible if they had no evidence of progression after 6-8 courses of epirubicin-paclitaxel induction chemotherapy. Treatment consisted of low-dose IL-2 and oral RA given until progression. The primary endpoint was progression-free survival (PFS); secondary endpoints were toxicity, overall survival (OS), and changes in immunological parameters. From 04/1997 to 04/2002, 100 patients with MBC were enrolled. After a median follow-up of 49 months, median PFS and OS were 37.1 and 57.5 months, respectively. No WHO grade 3 or 4 toxicity was observed; grade 2 cutaneous toxicity and autoimmune reactions occurred in 19 and 16% of patients, respectively. A sustained improvement in lymphocytes, NKs, and in the CD4+/CD8+ ratio was observed, with respect to baseline values. In conclusion, MI with IL-2 and RA in MBC patients who do not progress after 6-8 courses of chemotherapy is well-tolerated, improves lymphocyte, NK, CD4+/CD8+ ratio, and appears to delay disease recurrence. A randomized trial is warranted.

Published
2008

215. Benefits in Cognitive Function, Blood Pressure, and Insulin Resistance Through Cocoa Flavanol Consumption in Elderly Subjects With Mild Cognitive Impairment

Author

Desideri, Giovambattista, primary, Kwik-Uribe, Catherine, additional, Grassi, Davide, additional, Necozione, Stefano, additional, Ghiadoni, Lorenzo, additional, Mastroiacovo, Daniela, additional, Raffaele, Angelo, additional, Ferri, Livia, additional, Bocale, Raffaella, additional, Lechiara, Maria Carmela, additional, Marini, Carmine, additional, and Ferri, Claudio, additional

Published
2012
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226. Abstract 3722: Ovarian suppression with gonadotropin-releasing hormone analogues (Gn-RH) in high risk premenopausal breast cancer patients (PM-HR-BC): decrease of T regulatory cells (T-regs) and of vascular endothelial growth factor (VEGF)

Author

Recchia, Francesco, primary, Candeloro, Giampiero, additional, Necozione, Stefano, additional, Desideri, Giovambattista, additional, D'Andrea, Maurizio S., additional, Recchia, Cornelia O.C., additional, and Rea, Silvio, additional

Published
2010
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233. Enhanced soluble CD40 ligand and Alzheimer's disease: Evidence of a possible pathogenetic role

Author

Desideri, Giovambattista, primary, Cipollone, Francesco, additional, Necozione, Stefano, additional, Marini, Carmine, additional, Lechiara, Maria Carmela, additional, Taglieri, Guglielmo, additional, Zuliani, Giovanni, additional, Fellin, Renato, additional, Mezzetti, Andrea, additional, di Orio, Ferdinando, additional, and Ferri, Claudio, additional

Published
2008
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235. Inhibition of phosphodiesterase type 5 with tadalafil is associated to an improved activity of circulating angiogenic cells in men with cardiovascular risk factors and erectile dysfunction

Author

Bocchio, Massimo, primary, Pelliccione, Fiore, additional, Passaquale, Gabriella, additional, Mihalca, Radu, additional, Necozione, Stefano, additional, Desideri, Giovambattista, additional, Francavilla, Felice, additional, Ferri, Claudio, additional, and Francavilla, Sandro, additional

Published
2008
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236. Different Effects of Angiotensin Converting Enzyme Inhibitors on Endothelin-1 and Nitric Oxide Balance in Human Vascular Endothelial Cells: Evidence of an Oxidant-Sensitive Pathway

Author

Desideri, Giovambattista, primary, Grassi, Davide, additional, Croce, Giuseppe, additional, Bocale, Raffaella, additional, Tiberti, Sergio, additional, Evangelista, Stefano, additional, Necozione, Stefano, additional, Di Orio, Ferdinando, additional, and Ferri, Claudio, additional

Published
2008
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246. Cocoa flavanol consumption improves cognitive function, blood pressure control, and metabolic profile in elderly subjects: the Cocoa, Cognition, and Aging (CoCoA) Study -- a randomized controlled trial.

Author

Mastroiacovo, Daniela, Kwik-Uribe, Catherine, Grassi, Davide, Necozione, Stefano, Raffaele, Angelo, Pistacchio, Luana, Righetti, Roberta, Bocale, Raffaella, Lechiara, Maria Carmela, Marini, Carmine, Ferri, Claudio, and Desideri, Giovambattista

Subjects
FLAVONOIDS, CACAO, ANALYSIS of variance, BLOOD pressure, BLOOD sugar, CEREBRAL circulation, CHI-squared test, COGNITION, INSULIN, INSULIN resistance, NEUROPSYCHOLOGICAL tests, LIPID peroxidation (Biology), HEALTH outcome assessment, PROBABILITY theory, PSYCHOLOGICAL tests, QUESTIONNAIRES, REGRESSION analysis, RESEARCH funding, STATISTICAL hypothesis testing, STATISTICS, DATA analysis, MULTIPLE regression analysis, EFFECT sizes (Statistics), RANDOMIZED controlled trials, REPEATED measures design, BLIND experiment, GERIATRIC Depression Scale, THERAPEUTICS
Abstract

Background: Recent evidence has indicated that flavanol consumption may have many health benefits in humans, including improved cognitive activities. Objective: The aim was to evaluate the effect of flavanol consumption on cognitive performance in cognitively intact elderly subjects. Design: This was a double-blind, controlled, parallel-arm study conducted in 90 elderly individuals without clinical evidence of cognitive dysfunction who were randomly assigned to consume daily for 8 wk a drink containing 993 mg [high flavanol (HF)], 520 mg [intermediate flavanol (IF)], or 48 mg [low flavanol (LF)] cocoa flavanols (CFs). Cognitive function was assessed at baseline and after 8 wk by using the Mini-Mental State Examination (MMSE), the Trail Making Test (TMT) A and B, and the Verbal Fluency Test (VFT). Results: The changes in MMSE score in response to the 3 different treatments were not different. In contrast, there was a positive impact of the intervention on specific aspects of cognitive function. Mean changes (±SEs) in the time required to complete the TMT A and B after consumption of the HF (28.6 ± 0.4 and 216.5 ± 0.8 s, respectively) and IF (26.7 ± 0.5 and 214.2 ± 0.5 s, respectively) drinks significantly (P < 0.0001) differed from that after consumption of the LF drinks (20.8 ± 1.6 and 21.1 ± 0.7 s, respectively). Similarly, VFT scores significantly improved among all treatment groups, but the magnitude of improvement in the VFT score was significantly (P < 0.0001) greater in the HF group (7.7 ± 1.1 words/60 s) than in the IF (3.6 ± 1.2 words/60 s) and LF (1.3 ± 0.5 words/60 s) groups. Significantly different improvements in insulin resistance (P < 0.0001), blood pressure (P, 0.0001), and lipid peroxidation (P = 0.001) were also observed for the HF and IF groups in comparison with the LF group. Changes in insulin resistance explained ~ 17% of changes in composite z score (partial r² = 0.1703, P < 0.0001). Conclusions: This dietary intervention study provides evidence that regular CF consumption can reduce some measures of age-related cognitive dysfunction, possibly through an improvement in insulin sensitivity. These data suggest that the habitual intake of flavanols can support healthy cognitive function with age. This trial was registered at www.controlled-trials.com as ISRCTN68970511. [ABSTRACT FROM AUTHOR]

Published
2015
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248. Phase II study of interleukin-2 and 13-cis-retinoic acid as maintenance therapy in metastatic colorectal cancer

Author

Recchia, Francesco, primary, Saggio, Gaetano, additional, Cesta, Alisia, additional, Candeloro, Giampiero, additional, Di Blasio, Anna, additional, Amiconi, Giovanna, additional, Lombardo, Marco, additional, Nuzzo, Antonio, additional, Lalli, Angelo, additional, Alesse, Edoardo, additional, Necozione, Stefano, additional, and Rea, Silvio, additional

Published
2006
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