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1. National, longitudinal NASCITA birth cohort study: prevalence of overweight at 12 months of age in children born healthy

Author

Antonio Clavenna, Massimo Cartabia, Maurizio Bonati, Federico Marchetti, Giorgio Tamburlini, Antonio Addis, Michele Valente, Rita Campi, Stefania Manetti, Valeria Carraro, Sergio Conti Nibali, Renato Sansone, Patrizia Rogari, Annalisa Campomori, Luca De Fiore, Renata Bortolus, Sergio Cattani, Cristiana Piloni, Valeria Renzetti, Rosario Cavallo, Gherardo Rapisardi, Giacomo Toffol, Vicenza Briscioli, Carla Cafaro, Cristoforo Cocchiara, Isodiana Crupi, Patrizia Del Balzo, Laura Dell’edera, Chiara Di Francesco, Alberto Ferrando, Francesca Grassa, Chiara Guidoni, Claudio Mangialavori, Stefano Marinoni, Francesca Marongiu, Fausta Matera, Paolo Moretti, Laura Olimpi, Angela Pasinato, Ilaria Porro, Ippolita Roncoroni, Raffaella Schiro’, Patrizia Seppia, Federica Zanetto, Anna Aloisio, Elisabetta Anedda, Giuliana Apuzzo, Giovanna Argo, Anna Armenio, Emanuela Ballerini, Monica Benedetti, Daniela Bertoli, Stefano Bollettini, Chiara Bottalico, Aurora Bottiglieri, Vincenza Briscioli, Antonella Bruno, Laura Brusadin, Mariantonietta Caiazzo, Patrizia Calamita, Miriana Callegari, Rosaria Cambria, Maria Cristina Cantù, Domenico Capomolla, Anna Caracciolo, Maria Concetta Carbone, Gaetano Carrassi, Maria Laura Cartiglia, Sara Casagranda, Ornella Castiglione, Rosario Salvatore Cavallo, Teresa Cazzato, Maria Angela Cazzuffi, Jennifer Chiarolanza, Rosaria China, Nicoletta Cimadamore, Roberto Cionini, Cristina Ciuffo, Damiano Colazzo, Anna Maria Costantini, Claudio Cravidi, Marialuisa Criscione, Rita D’Agostino, Daniela Danieli, Luigi De Carlo, Marina De Sanctis, Giuseppina De Santes, Gian Piero Del Bono, Maria Elisabetta Di Pietro, Maria Chiara Dini, Paolo Fiammengo, Micaela Foco, Maria Teresa Fonte, Maria Frigeri, Andrea Galvagno, Matteo Gaudino, Stefania Genoni, Silvia Girotto, Gianluca Gornati, Marta Gozzi, Enrica Heritier, Antonella Lavagetto, Raffaele Limauro, Alessandra Magnelli, Maria Gabriella Maiolino, Monica Malventano, Silvia Marchi, Natale Maresca, Federico Marolla, Agata Martinelli, Chiara Martinez, Nicoletta Mascarello, Carla Matiotti, Elisabetta Mazzucchi, Donatella Moggia, Manuela Musetti, Paolo Nardini, Alberto Neri, Patrizia Neri, Flavia Nicoloso, Laura Maria Olimpi, Giancarlo Ottonello, Giacinta Padula, Paolo Maria Paganuzzi, Rosanna Palazzi, Alessandra Palmero, Maria Chiara Parisini, Giovannina Pastorelli, Marilena Pavoni, Lucia Peccarisi, Antonella Pellacani, Cristina Perrera, Michela Picciotti, Ivo Picotto, Tiziana Piunti, Francesca Preziosi, Giuseppe Primavera, Miriam Prodi, Maria Letizia Rabbone, Innocenza Rafele, Laura Reali, Franziska Stefanie Rempp, Ada Riundi, Paolo Rosas, Annarita Russo, Mariagrazia Saccà, Elisabetta Sala, Francesca Sala, Francesca Santus, Vittoria Sarno, Alessandra Savino, Raffaella Schirò, Giuseppa Scornavacca, Maria Francesca Siracusano, Adelisa Spalla, Gloria Sturaro, Maria Grazia Toma, Ettore Tomagra, Maria Tortorella, Fausta Trentadue, Marina Trevisan, Silvia Tulisso, Roberta Usella, Anna Valente, Mariangela Valera, Edda Vernile, Valeria Vicario, Lucia Vignutelli, Paolo Vinci, Lucia Vizziello, Rosette Zand, Marco Zanette, Graziano Zucchi, Maria Luisa Zuccolo, Eleonora Morabito, Chiara Liz Pandolfini, Chiara Segre’, Rossella Claudia Cannavo’, Melania Maria Cera, Emma Maria Giugnini, and Giovanni Giuliano Semprini

Subjects
Pediatrics, RJ1-570
Abstract

Objective To estimate the prevalence of overweight at 12 months in an Italian birth cohort and to identify factors related to an increased likelihood of being overweight.Methods The Italian NASCITA birth cohort was analysed. Infants were classified as underweight (

Published
2023
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2. Postpartum depression screening in mothers and fathers at well-child visits: a feasibility study within the NASCITA cohort

Author

Antonio Clavenna, Massimo Cartabia, Maurizio Bonati, Federico Marchetti, Giorgio Tamburlini, Antonio Addis, Michele Valente, Stefania Manetti, Valeria Carraro, Renato Sansone, Patrizia Rogari, Annalisa Campomori, Renata Bortolus, Sergio Cattani, Cristiana Piloni, Valeria Renzetti, Chiara Segré, Rosario Cavallo, Gherardo Rapisardi, Giacomo Toffol, Vicenza Briscioli, Carla Cafaro, Cristoforo Cocchiara, Isodiana Crupi, Laura Dell’edera, Alberto Ferrando, Francesca Grassa, Chiara Guidoni, Claudio Mangialavori, Stefano Marinoni, Francesca Marongiu, Fausta Matera, Paolo Moretti, Laura Olimpi, Angela Pasinato, Ilaria Porro, Ippolita Roncoroni, Raffaella Schiro’, Patrizia Seppia, Federica Zanetto, Anna Aloisio, Elisabetta Anedda, Giuliana Apuzzo, Giovanna Argo, Anna Armenio, Emanuela Ballerini, Monica Benedetti, Daniela Bertoli, Stefano Bollettini, Chiara Bottalico, Aurora Bottiglieri, Vincenza Briscioli, Antonella Bruno, Laura Brusadin, Mariantonietta Caiazzo, Patrizia Calamita, Miriana Callegari, Rosaria Cambria, Domenico Capomolla, Anna Caracciolo, Gaetano Carrassi, Sara Casagranda, Ornella Castiglione, Teresa Cazzato, Jennifer Chiarolanza, Rosaria China, Nicoletta Cimadamore, Roberto Cionini, Cristina Ciuffo, Damiano Colazzo, Claudio Cravidi, Marialuisa Criscione, Rita D’Agostino, Daniela Danieli, Paolo Fiammengo, Micaela Foco, Maria Frigeri, Andrea Galvagno, Matteo Gaudino, Stefania Genoni, Silvia Girotto, Gianluca Gornati, Marta Gozzi, Enrica Heritier, Antonella Lavagetto, Raffaele Limauro, Alessandra Magnelli, Monica Malventano, Silvia Marchi, Natale Maresca, Federico Marolla, Agata Martinelli, Chiara Martinez, Nicoletta Mascarello, Carla Matiotti, Elisabetta Mazzucchi, Donatella Moggia, Manuela Musetti, Paolo Nardini, Alberto Neri, Patrizia Neri, Flavia Nicoloso, Giancarlo Ottonello, Giacinta Padula, Rosanna Palazzi, Alessandra Palmero, Giovannina Pastorelli, Marilena Pavoni, Lucia Peccarisi, Antonella Pellacani, Cristina Perrera, Michela Picciotti, Ivo Picotto, Tiziana Piunti, Francesca Preziosi, Giuseppe Primavera, Miriam Prodi, Maria Letizia Rabbone, Innocenza Rafele, Laura Reali, Ada Riundi, Paolo Rosas, Annarita Russo, Mariagrazia Saccà, Elisabetta Sala, Francesca Sala, Francesca Santus, Vittoria Sarno, Alessandra Savino, Raffaella Schirò, Giuseppa Scornavacca, Giovanni GiulianoSemprini, Adelisa Spalla, Gloria Sturaro, Ettore Tomagra, Maria Tortorella, Fausta Trentadue, Marina Trevisan, Silvia Tulisso, Roberta Usella, Anna Valente, Mariangela Valera, Edda Vernile, Valeria Vicario, Lucia Vignutelli, Paolo Vinci, Lucia Vizziello, Rosette Zand, Marco Zanette, Graziano Zucchi, Giulia Segre, Luca DeFiore, Sergio ContiNibali, Patrizia DelBalzo, Chiara DiFrancesco, Rossella ClaudiaCannavò, Maria CristinaCantù, Maria ConcettaCarbone, Maria LauraCartiglia, Rosario SalvatoreCavallo, Maria AngelaCazzuffi, MelaniaMaria GiuseppinaCera, Anna MariaCostantini, Luigi DeCarlo, Marina DeSanctis, Giuseppina DeSantes, GianPiero DelBono, MariaElisabetta DiPietro, Maria ChiaraDini, Maria TeresaFonte, EmmaMaria LetiziaGiugnini, Maria GabriellaMaiolino, Laura MariaOlimpi, Paolo MariaPaganuzzi, Maria ChiaraParisini, Franziska StefanieRempp, Maria FrancescaSiracusano, Maria GraziaToma, and Maria LuisaZuccolo

Subjects
Medicine
Abstract

Objective To assess the feasibility of the family paediatrician’s (FP) role in identifying the signs of postpartum depression in parents in time to guarantee child well-being.Design, setting and participants Data for this observational prospective study were collected within the NASCITA (NAscere e creSCere in ITAlia) cohort. During the first visit, paediatricians collected sociodemographic data regarding the parents and information about their health status, the pregnancy and the delivery. Whooley questions were administered during the first and second visits (scheduled 60–90 days after childbirth). Moreover, on the third visit (5–7 months after childbirth) the FP was asked to answer ‘yes’ or ‘no’ to a question on the parental postpartum depression, based on his knowledge and on the acquired information.Results In 2203 couples who completed the assessment, 529 mothers (19.9%), 141 fathers (6.3%) and 110 (5%) couples reported any depressive symptomatology. Of these, 141 mothers (5.3% of the total sample) and 18 fathers (0.8% of the total sample) were classified as ‘likely depressed’. An association was found between maternal postnatal depressive symptoms and having a diagnosed psychiatric disorder during pregnancy (OR 9.49, 95% CI: 3.20 to 28.17), not exclusively breastfeeding at hospital discharge (OR 1.76, 95% CI: 1.19 to 2.61) and the presence of child sleeping disorders at 3 (OR 2.46, 95% CI: 1.41 to 4.28) and 6 months (OR 2.18, 95% CI: 1.37 to 3.47). Another significant predictor of postpartum depression was being primiparous (OR 1.99, 95% CI: 1.31 to 3.02). Concerning the fathers, a significant association was reported only between likely depressed fathers and child sleeping disorders at 3 months (OR 7.64, 95% CI: 2.92 to 19.97). Moreover, having a likely depressed partner was strongly associated with depressive symptoms in fathers (OR 85.53, 95% CI 26.83 to 272.69).Conclusions The findings of this study support the feasibility of an active screening programme for parental postnatal depression during well-child visits as an integral part of postpartum care.Trial registration number NCT03894566; Pre-results.

Published
2023
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3. National, longitudinal NASCITA birth cohort study to investigate the health of Italian children and potential influencing factors

Author

Antonio Clavenna, Massimo Cartabia, Maurizio Bonati, Federico Marchetti, Giorgio Tamburlini, Antonio Addis, Michele Valente, Rita Campi, Stefania Manetti, Valeria Carraro, Chiara Pandolfini, Sergio Conti Nibali, Renato Sansone, Patrizia Rogari, Annalisa Campomori, Luca De Fiore, Renata Bortolus, Sergio Cattani, Cristiana Piloni, Valeria Renzetti, Chiara Segré, Rosario Cavallo, Gherardo Rapisardi, Giacomo Toffol, Vicenza Briscioli, Carla Cafaro, Cristoforo Cocchiara, Isodiana Crupi, Patrizia Del Balzo, Laura Dell’edera, Chiara Di Francesco, Alberto Ferrando, Francesca Grassa, Chiara Guidoni, Claudio Mangialavori, Stefano Marinoni, Francesca Marongiu, Fausta Matera, Paolo Moretti, Laura Olimpi, Angela Pasinato, Ilaria Porro, Ippolita Roncoroni, Raffaella Schiro’, Patrizia Seppia, Federica Zanetto, Anna Aloisio, Elisabetta Anedda, Giuliana Apuzzo, Giovanna Argo, Anna Armenio, Emanuela Ballerini, Monica Benedetti, Daniela Bertoli, Stefano Bollettini, Chiara Bottalico, Aurora Bottiglieri, Vincenza Briscioli, Antonella Bruno, Laura Brusadin, Mariantonietta Caiazzo, Patrizia Calamita, Miriana Callegari, Rosaria Cambria, Rossella Claudia Cannavò, Maria Cristina Cantù, Domenico Capomolla, Anna Caracciolo, Maria Concetta Carbone, Gaetano Carrassi, Maria Laura Cartiglia, Sara Casagranda, Ornella Castiglione, Rosario Salvatore Cavallo, Teresa Cazzato, Maria Angela Cazzuffi, Melania MariaGiuseppina Cera, Jennifer Chiarolanza, Rosaria China, Nicoletta Cimadamore, Roberto Cionini, Cristina Ciuffo, Damiano Colazzo, Anna Maria Costantini, Claudio Cravidi, Marialuisa Criscione, Rita D’Agostino, Daniela Danieli, Luigi De Carlo, Marina De Sanctis, Giuseppina De Santes, Gian Piero Del Bono, Maria Elisabetta Di Pietro, Maria Chiara Dini, Paolo Fiammengo, Micaela Foco, Maria Teresa Fonte, Maria Frigeri, Andrea Galvagno, Matteo Gaudino, Stefania Genoni, Silvia Girotto, Emma MariaLetizia Giugnini, Gianluca Gornati, Marta Gozzi, Enrica Heritier, Antonella Lavagetto, Raffaele Limauro, Alessandra Magnelli, Maria Gabriella Maiolino, Monica Malventano, Silvia Marchi, Natale Maresca, Federico Marolla, Agata Martinelli, Chiara Martinez, Nicoletta Mascarello, Carla Matiotti, Elisabetta Mazzucchi, Donatella Moggia, Manuela Musetti, Paolo Nardini, Alberto Neri, Patrizia Neri, Flavia Nicoloso, Laura Maria Olimpi, Giancarlo Ottonello, Giacinta Padula, Paolo Maria Paganuzzi, Rosanna Palazzi, Alessandra Palmero, Maria Chiara Parisini, Giovannina Pastorelli, Marilena Pavoni, Lucia Peccarisi, Antonella Pellacani, Cristina Perrera, Michela Picciotti, Ivo Picotto, Tiziana Piunti, Francesca Preziosi, Giuseppe Primavera, Miriam Prodi, Maria Letizia Rabbone, Innocenza Rafele, Laura Reali, Franziska Stefanie Rempp, Ada Riundi, Paolo Rosas, Annarita Russo, Mariagrazia Saccà, Elisabetta Sala, Francesca Sala, Francesca Santus, Vittoria Sarno, Alessandra Savino, Raffaella Schirò, Giuseppa Scornavacca, Giovanni GiulianoSemprini, Maria Francesca Siracusano, Adelisa Spalla, Gloria Sturaro, Maria Grazia Toma, Ettore Tomagra, Maria Tortorella, Fausta Trentadue, Marina Trevisan, Silvia Tulisso, Roberta Usella, Anna Valente, Mariangela Valera, Edda Vernile, Valeria Vicario, Lucia Vignutelli, Paolo Vinci, Lucia Vizziello, Rosette Zand, Marco Zanette, Graziano Zucchi, and Maria Luisa Zuccolo

Subjects
Medicine
Abstract

Purpose The NASCITA Study, a national-level, population-based, prospective cohort study, was set up to better understand the early health status of Italian children, comprising their physical, cognitive and psychological development, and how it is affected by social and health determinants, including nurturing care. NASCITA will also assess geographical differences and disparities in healthcare.Participants Participating family paediatricians from throughout Italy enrolled infants born during the enrolment period (April 2019–July 2020). The 5054 newborns seen by the 139 paediatricians for at least two visits, including the first well-child visit, and for whom parental consent was given, make up the baseline population.Findings to date Mothers had a mean age at delivery of 33.0 years and tended to have a high or medium level of education (42.5% university and 41.7% high school degrees) and to be employed (69.7%). One-third (36.1%) took folic acid supplementation appropriately, and 6.5% smoked or consumed alcohol (10.0%) during pregnancy. One-third (31.7%) of deliveries were caesarean deliveries. Concerning the newborns, 5.8% had a low birth weight and 6.2% were born prematurely. The majority (87.7%) slept in the supine position, and 63.6% were exclusively breast fed at 1 month, with a decreasing north to south prevalence (χ2t 52; p

Published
2022
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4. Randomized phase II study of valproic acid in combination with bevacizumab and oxaliplatin/fluoropyrimidine regimens in patients with -mutated metastatic colorectal cancer: the REVOLUTION study protocol

Author

Antonio Avallone, Maria Carmela Piccirillo, Elena Di Gennaro, Carmela Romano, Filomena Calabrese, Maria Serena Roca, Fabiana Tatangelo, Vincenza Granata, Antonio Cassata, Ernesta Cavalcanti, Nicola Maurea, Piera Maiolino, Lucrezia Silvestro, Alfonso De Stefano, Francesco Giuliani, Gerardo Rosati, Emiliano Tamburini, Pasquale Aprea, Valeria Vicario, Anna Nappi, Carlo Vitagliano, Rossana Casaretti, Alessandra Leone, Antonella Petrillo, Gerardo Botti, Paolo Delrio, Francesco Izzo, Francesco Perrone, and Alfredo Budillon

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: Despite effective treatments, metastatic colorectal cancer (mCRC) prognosis is still poor, mostly in RAS -mutated tumors, thus suggesting the need for novel combinatorial therapies. Epigenetic alterations play an important role in initiation and progression of cancers, including CRC. Histone-deacetylase inhibitors (HDACi) have shown activity in combination with chemotherapy in the treatment of solid tumors. Owing to its HDACi activity and its safe use for epileptic disorders, valproic acid (VPA) is a good candidate for anticancer therapy that we have largely explored preclinically translating our findings in currently ongoing clinical studies. We have shown in CRC models that HDACi, including VPA, induces synergistic antitumor effects in combination with fluoropyrimidines. Furthermore, unpublished results from our group demonstrated that VPA induces differentiation and sensitization of CRC stem cells to oxaliplatin. Moreover, preclinical and clinical data suggest that HDACi may prevent/reverse anti-angiogenic resistance. Methods/Design: A randomized, open-label, two-arm, multicenter phase-II study will be performed to explore whether the addition of VPA to first line bevacizumab/oxaliplatin/fluoropyrimidine regimens (mFOLFOX-6/mOXXEL) might improve progression-free survival (PFS) in RAS -mutated mCRC patients. A sample size of 200 patients was calculated under the hypothesis that the addition of VPA to chemotherapy/bevacizumab can improve PFS from 9 to 12 months, with one-sided alpha of 0.20 and a power of 0.80. Secondary endpoints are overall survival, objective response rate, metastases resection rate, toxicity, and quality of life. Moreover, the study will explore several prognostic and predictive biomarkers on blood samples, primary tumors, and on resected metastases. Discussion: The “Revolution” study aims to improve the treatment efficacy of RAS -mutated mCRC through an attractive strategy evaluating the combination of VPA with standard cancer treatment. Correlative studies could identify novel biomarkers and could add new insight in the mechanism of interaction between VPA, fluoropyrimidine, oxaliplatin, and bevacizumab. Trial Registration: EudraCT: 2018-001414-15; ClinicalTrials.gov identifier: NCT04310176

Published
2020
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5. Effect of Bevacizumab in Combination with Standard Oxaliplatin-Based Regimens in Patients with Metastatic Colorectal Cancer: A Randomized Clinical Trial

Author

Paolo Delrio, Domenico Bilancia, G. Rosati, Lucrezia Silvestro, Chiara Carlomagno, F. Perrone, Luigi Aloj, Gerardo Botti, Antonino Cassata, Anna Nappi, Guglielmo Nasti, Secondo Lastoria, Antonella Petrillo, Fabiana Tatangelo, A. Avallone, Alessandra Leone, Carmela Romano, Elena Di Gennaro, Laura Arenare, Vincenza Granata, Maria Carmela Piccirillo, Alfredo Budillon, Alfonso De Stefano, Valeria Vicario, Francesco Izzo, Ciro Gallo, Avallone, A., Piccirillo, M. C., Nasti, G., Rosati, G., Carlomagno, C., Di Gennaro, E., Romano, C., Tatangelo, F., Granata, V., Cassata, A., Silvestro, L., De Stefano, A., Aloj, L., Vicario, V., Nappi, A., Leone, A., Bilancia, D., Arenare, L., Petrillo, A., Lastoria, S., Gallo, C., Botti, G., Delrio, P., Izzo, F., Perrone, F., and Budillon, A.

Subjects
Adult, Diarrhea, Male, medicine.medical_specialty, Adolescent, Bevacizumab, Colorectal Neoplasm, law.invention, Young Adult, Randomized controlled trial, Interquartile range, law, Internal medicine, medicine, Clinical endpoint, Aged, Antineoplastic Combined Chemotherapy Protocol, business.industry, Hazard ratio, Nausea, General Medicine, Middle Aged, Chemotherapy regimen, Progression-Free Survival, Oxaliplatin, Neoplasm Metastasi, Treatment Outcome, Response Evaluation Criteria in Solid Tumors, Quality of Life, Female, Drug-Related Side Effects and Adverse Reaction, business, Angiogenesis Inhibitor, Human, medicine.drug
Abstract

Importance Although bevacizumab is a standard of care in combination treatments for metastatic colorectal cancer (mCRC), its clinical benefit has been limited. Objective To determine whether sequential scheduling of bevacizumab administration in combination with chemotherapy improves treatment efficacy in patients with mCRC, in keeping with the tumor vascular normalization hypothesis. Design, Setting, and Participants This open-label, randomized clinical phase 3 trial was conducted from May 8, 2012, to December 9, 2015, at 3 Italian centers. Patients aged 18 to 75 years with unresectable, previously untreated, or single line–treated mCRC were recruited. Follow-up was completed December 31, 2019, and data were analyzed from February 26 to July 24, 2020. Interventions Patients received 12 biweekly cycles of standard oxaliplatin-based regimens (modified FOLFOX-6 [levo–folinic acid, fluorouracil, and oxaliplatin]/modified CAPOX [capecitabine and oxaliplatin]) plus bevacizumab administered either on the same day as chemotherapy (standard arm) or 4 days before chemotherapy (experimental arm). Main Outcomes and Measures The primary end point was the objective response rate (ORR) measured with Response Evaluation Criteria in Solid Tumors, version 1.1. Secondary end points included progression-free survival, overall survival, safety, and quality of life (QOL). Results Overall, 230 patients (136 men [59.1%]; median age, 62.3 [interquartile range, 53.3-67.6] years) were randomly assigned to the standard arm (n = 115) or the experimental arm (n = 115). The median duration of follow-up was 68.3 (95% CI, 61.0-70.0) months. No difference in ORR (57.4% [95% CI, 47.8%-66.6%] in the standard arm and 56.5% [95% CI, 47.0-65.7] in the experimental arm;P = .89) or progression-free survival (10.5 [95% CI, 9.1-12.3] months in the standard arm and 11.7 [95% CI, 9.9-12.9] months in the experimental arm;P = .15) was observed. However, the median overall survival was 29.8 (95% CI, 22.5-41.1) months in the experimental arm compared with 24.1 (95% CI, 18.6-29.8) months in the standard arm (adjusted hazard ratio, 0.73; 95% CI, 0.54-0.99;P = .04). Moreover, the experimental arm was associated with a significant reduction in the rate of severe diarrhea (6 [5.3%] vs 19 [16.5%];P = .006) and nausea (2 [1.8%] vs 8 [7.0%];P = .05) and improved physical functioning (mean [SD] change from baseline, 0.65 [1.96] vs −7.41 [2.95] at 24 weeks;P= .02), and constipation scores (mean [SD] change from baseline, −17.2 [3.73] vs −0.62 [4.44];P= .003). Conclusions and Relevance In this randomized clinical trial, sequential administration of bevacizumab plus chemotherapy did not improve ORR, the primary end point. However, the overall survival advantage, fewer adverse effects, and better health-related QOL associated with sequential bevacizumab administration might provide the basis for exploring antiangiogenic combination treatments with innovative perspectives. Trial Registration EudraCT Identifier:2011-004997-27; ClinicalTrials.gov Identifier:NCT01718873

Published
2021

6. Randomized phase II study of valproic acid in combination with bevacizumab and oxaliplatin/fluoropyrimidine regimens in patients with

Author

María Roca, Emiliano Tamburini, Rossana Casaretti, Maria Carmela Piccirillo, Nicola Maurea, Antonella Petrillo, Paolo Delrio, Antonio Avallone, Lucrezia Silvestro, A. Cassata, Anna Nappi, Carmela Romano, Alfredo Budillon, Gerardo Botti, Carlo Vitagliano, Pasquale Aprea, Fabiana Tatangelo, Francesco Giuliani, Francesco Perrone, Alfonso De Stefano, Filomena Calabrese, Ernesta Cavalcanti, Piera Maiolino, Valeria Vicario, Francesco Izzo, Gerardo Rosati, Alessandra Leone, Vincenza Granata, and Elena Di Gennaro

Subjects
Oncology, Anti vegf, medicine.medical_specialty, Valproic Acid, Bevacizumab, epigenetics, business.industry, Colorectal cancer, Phases of clinical research, KRAS mutation, colorectal cancer, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, medicine.disease, lcsh:RC254-282, Oxaliplatin, Study Protocol, anti-VEGF, Internal medicine, Medicine, In patient, Epigenetics, business, predictive biomarker, medicine.drug
Abstract

Background:Despite effective treatments, metastatic colorectal cancer (mCRC) prognosis is still poor, mostly in RAS-mutated tumors, thus suggesting the need for novel combinatorial therapies. Epigenetic alterations play an important role in initiation and progression of cancers, including CRC. Histone-deacetylase inhibitors (HDACi) have shown activity in combination with chemotherapy in the treatment of solid tumors. Owing to its HDACi activity and its safe use for epileptic disorders, valproic acid (VPA) is a good candidate for anticancer therapy that we have largely explored preclinically translating our findings in currently ongoing clinical studies. We have shown in CRC models that HDACi, including VPA, induces synergistic antitumor effects in combination with fluoropyrimidines. Furthermore, unpublished results from our group demonstrated that VPA induces differentiation and sensitization of CRC stem cells to oxaliplatin. Moreover, preclinical and clinical data suggest that HDACi may prevent/reverse anti-angiogenic resistance.Methods/Design:A randomized, open-label, two-arm, multicenter phase-II study will be performed to explore whether the addition of VPA to first line bevacizumab/oxaliplatin/fluoropyrimidine regimens (mFOLFOX-6/mOXXEL) might improve progression-free survival (PFS) in RAS-mutated mCRC patients. A sample size of 200 patients was calculated under the hypothesis that the addition of VPA to chemotherapy/bevacizumab can improve PFS from 9 to 12 months, with one-sided alpha of 0.20 and a power of 0.80. Secondary endpoints are overall survival, objective response rate, metastases resection rate, toxicity, and quality of life. Moreover, the study will explore several prognostic and predictive biomarkers on blood samples, primary tumors, and on resected metastases.Discussion:The “Revolution” study aims to improve the treatment efficacy of RAS-mutated mCRC through an attractive strategy evaluating the combination of VPA with standard cancer treatment. Correlative studies could identify novel biomarkers and could add new insight in the mechanism of interaction between VPA, fluoropyrimidine, oxaliplatin, and bevacizumab.Trial Registration:EudraCT: 2018-001414-15; ClinicalTrials.gov identifier: NCT04310176

Published
2020

7. Integration of stereotactic radiotherapy in the treatment of metastatic colorectal cancer patients: a real practice study with long-term outcome and prognostic factors

Author

Valerio Scotti, Alessandro Ottaiano, Valeria Vicario, Lucrezia Silvestro, Alfonso De Stefano, Monica Capozzi, Chiara De Divitiis, Guglielmo Nasti, Anna Nappi, Antonino Cassata, Salvatore Tafuto, Carmen Romano, Rossana Casaretti, Massimiliano Berretta, and Antonio Avallone

Subjects
Oncology, medicine.medical_specialty, Colorectal cancer, medicine.medical_treatment, colorectal cancer, Standardized uptake value, Stereotactic radiation therapy, chemotherapy, medicine.disease_cause, radiation therapy, 03 medical and health sciences, 0302 clinical medicine, Internal medicine, medicine, Fluorodeoxyglucose, business.industry, metastatic colorectal cancer, medicine.disease, Primary tumor, Radiation therapy, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, 030211 gastroenterology & hepatology, KRAS, Clinical Research Paper, Chemotherapy, Metastatic colorectal cancer, business, medicine.drug
Abstract

// Alessandro Ottaiano 1, * , Valerio Scotti 2, * , Chiara De Divitiis 3 , Monica Capozzi 3 , Carmen Romano 3 , Antonino Cassata 3 , Rossana Casaretti 3 , Lucrezia Silvestro 3 , Anna Nappi 3 , Valeria Vicario 3 , Alfonso De Stefano 3 , Salvatore Tafuto 3 , Massimiliano Berretta 4 , Guglielmo Nasti 1 and Antonio Avallone 3 1 Department of Abdominal Oncology, SSD–Innovative Therapies for Abdominal Metastases, Istituto Nazionale Tumori di Napoli G. Pascale IRCCS, National Cancer Institute, 80131, Naples, Italy 2 San Rossore Clinic, Viale delle Cascine, 56122, Pisa, Italy 3 Department of Abdominal Oncology, Experimental Clinical Oncology, Istituto Nazionale Tumori di Napoli G. Pascale IRCCS, National Cancer Institute, 80131, Naples, Italy 4 Department of Medical Oncology, CRO Aviano, National Cancer Institute, 33081, Aviano, Italy * These authors have contributed equally to this work Correspondence to: Guglielmo Nasti, email: g.nasti@istitutotumori.na.it , ale.otto@libero.it Keywords: colorectal cancer; radiation therapy; chemotherapy; metastatic colorectal cancer Received: April 26, 2018 Accepted: June 23, 2018 Published: October 16, 2018 ABSTRACT Background: There are very few clinical or prognostic studies on the role of SRT (Stereotactic Radiation Therapy) in the continuum of care of metastatic colorectal cancer (mCRC) patients. Patients and methods: Patients affected by oligo-mCRC were treated with SRT before or after front-line standard treatments. SRT was delivered according to a risk-adapted protocol. Total body CT (Computed Tomography) scan was done before therapy and every three months thereafter. The radiologic responses to therapy were evaluated by RECIST (Response Evaluation Criteria In Solid Tumors). FDG-PET (FluoroDeoxyGlucose - Positron Emission Tomography) was done before and after SRT; metabolic responses were evaluated by using the EORTC (European Organization for Research and Treatment of Cancer) criteria. The Kaplan-Meier product limit method was applied to graph Overall Survival (OS) and Progression-Free Survival (PFS). Results: Forty-seven patients were included. Twenty-one patients had disease limited to lungs, 9 to lung and liver, 7 only to liver, 10 to multiple sites. The median prescription SRT dose was 60 Gy per organ in 3 fractions (median biological effective dose of 180 Gy). The reduction of delta SUVmax (maximum Standardized Uptake Value) correlated with the local control (p

Published
2018
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8. Update survival analysis from a multicenter, randomized phase 3 study on the optimization of the combination of bevacizumab with FOLFOX/OXXEL in patients with metastatic colorectal cancer (mCRC)

Author

Guglielmo Nasti, Antonella Petrillo, Valeria Vicario, Francesco Izzo, Paolo Delrio, Lucrezia Silvestro, Domenico Bilancia, Alfonso De Stefano, Ciro Gallo, Salvatore Tafuto, Chiara Carlomagno, Antonino Cassata, F. Bianco, Vincenza Granata, Secondo Lastoria, Alfredo Budillon, Antonio Avallone, Carmen Romano, Maria Carmela Piccirillo, and Gerardo Rosati

Subjects
Oncology, Cancer Research, medicine.medical_specialty, Chemotherapy, Bevacizumab, medicine.drug_class, Colorectal cancer, business.industry, medicine.medical_treatment, Growth factor, Phases of clinical research, Monoclonal antibody, medicine.disease, digestive system diseases, FOLFOX, Internal medicine, medicine, business, Survival analysis, medicine.drug
Abstract

3562Background: Bevacizumab is a humanized anti-vascular endothelial growth factor (VEGF) monoclonal antibody, approved in combination with chemotherapy in the treatment of mCRC. It has been hypoth...

Published
2018
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9. 96 Bevacizumab-Based Anti-Tumoral Therapy Does Not Increase the Risk of Bowel Perforation in Patients With Metastatic Obstructive Colorectal Cancer Palliated With Self-Expanding Metallic Stents. Results of a Prospective Study

Author

Giovanni Rossi, Paolo Delrio, Cristina Bucci, Daniela Rega, Guglielmo Nasti, Andrea Belli, Mario De Bellis, Elena Di Girolamo, F. Bianco, Leonardo Frazzoni, Valeria Vicario, Antonio Avallone, and Lorenzo Fuccio

Subjects
medicine.medical_specialty, Bevacizumab, Colorectal cancer, business.industry, Gastroenterology, Bowel perforation, medicine.disease, Surgery, medicine, Radiology, Nuclear Medicine and imaging, In patient, Prospective cohort study, business, medicine.drug
Published
2015
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