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1. Artificial intelligence: A new tool in the pathologist's armamentarium for the diagnosis of IBD

Author

Anna Lucia Cannarozzi, Luca Massimino, Anna Latiano, Tommaso Lorenzo Parigi, Francesco Giuliani, Fabrizio Bossa, Anna Laura Di Brina, Federica Ungaro, Giuseppe Biscaglia, Silvio Danese, Francesco Perri, and Orazio Palmieri

Subjects
IBD, CD, UC, Histological analysis, AI, Biotechnology, TP248.13-248.65
Abstract

Inflammatory bowel diseases (IBD) are classified into two entities, namely Crohn's disease (CD) and ulcerative colitis (UC), which differ in disease trajectories, genetics, epidemiological, clinical, endoscopic, and histopathological aspects. As no single golden standard modality for diagnosing IBD exists, the differential diagnosis among UC, CD, and non-IBD involves a multidisciplinary approach, considering professional groups that include gastroenterologists, endoscopists, radiologists, and pathologists. In this context, histological examination of endoscopic or surgical specimens plays a fundamental role. Nevertheless, in differentiating IBD from non-IBD colitis, the histopathological evaluation of the morphological lesions is limited by sampling and subjective human judgment, leading to potential diagnostic discrepancies. To overcome these limitations, artificial intelligence (AI) techniques are emerging to enable automated analysis of medical images with advantages in accuracy, precision, and speed of investigation, increasing interest in the histological analysis of gastrointestinal inflammation. This review aims to provide an overview of the most recent knowledge and advances in AI methods, summarizing its applications in the histopathological analysis of endoscopic biopsies from IBD patients, and discussing its strengths and limitations in daily clinical practice.

Published
2024
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2. Comprehensive genomic profiling by liquid biopsy captures tumor heterogeneity and identifies cancer vulnerabilities in patients with RAS/BRAFV600E wild-type metastatic colorectal cancer in the CAPRI 2-GOIM trial

Author

Ciardiello, Davide, Bielo, Luca Boscolo, Napolitano, Stefania, Martinelli, Erika, Troiani, Teresa, Nicastro, Antonella, Latiano, Tiziana Pia, Parente, Paola, Maiello, Evaristo, Avallone, Antonio, Normanno, Nicola, Pisconti, Salvatore, Nisi, Claudia, Bordonaro, Roberto, Russo, Alessia Erika, Tamburrini, Emiliano, Toma, Ilaria, Lotesoriere, Claudio, Vallarelli, Simona, Zampino, Maria Giulia, Fazio, Nicola, Curigliano, Giuseppe, Ciardiello, Fortunato, Martini, Giulia, Lonardi, Sara, Cremolini, Chiara, Garufi, Carlo, Tagliaferri, Pierosandro, Tortora, Giampaolo, Pietrantonio, Filippo, Febbraro, Antonio, Rosati, Gerardo, Leo, Silvana, Brunetti, Oronzo, Berardi, Rosanna, Cinieri, Saverio, Scartozzi, Mario, Zaniboni, Alberto, Paoletti, Giancarlo, Ciardiello, D., Boscolo Bielo, L., Napolitano, S., Martinelli, E., Troiani, T., Nicastro, A., Latiano, T.P., Parente, P., Maiello, E., Avallone, A., Normanno, N., Pisconti, S., Nisi, C., Bordonaro, R., Russo, A.E., Tamburini, E., Toma, I., Lotesoriere, C., Vallarelli, S., Zampino, M.G., Fazio, N., Curigliano, G., De Vita, F., Ciardiello, F., and Martini, G.

Published
2024
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3. A powerful machine learning approach to identify interactions of differentially abundant gut microbial subsets in patients with metastatic and non-metastatic pancreatic cancer

Author

Annacandida Villani, Andrea Fontana, Concetta Panebianco, Carmelapia Ferro, Massimiliano Copetti, Radmila Pavlovic, Denise Drago, Carla Fiorentini, Fulvia Terracciano, Francesca Bazzocchi, Giuseppe Canistro, Federica Pisati, Evaristo Maiello, Tiziana Pia Latiano, Francesco Perri, and Valerio Pazienza

Subjects
Microbiota, machine learning, pancreatic cancer, metastasis, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Pancreatic cancer has a dismal prognosis, as it is often diagnosed at stage IV of the disease and is characterized by metastatic spread. Gut microbiota and its metabolites have been suggested to influence the metastatic spread by modulating the host immune system or by promoting angiogenesis. To date, the gut microbial profiles of metastatic and non-metastatic patients need to be explored. Taking advantage of the 16S metagenomic sequencing and the PEnalized LOgistic Regression Analysis (PELORA) we identified clusters of bacteria with differential abundances between metastatic and non-metastatic patients. An overall increase in Gram-negative bacteria in metastatic patients compared to non-metastatic ones was identified using this method. Furthermore, to gain more insight into how gut microbes can predict metastases, a machine learning approach (iterative Random Forest) was performed. Iterative Random Forest analysis revealed which microorganisms were characterized by a different level of relative abundance between metastatic and non-metastatic patients and established a functional relationship between the relative abundance and the probability of having metastases. At the species level, the following bacteria were found to have the highest discriminatory power: Anaerostipes hadrus, Coprobacter secundus, Clostridium sp. 619, Roseburia inulinivorans, Porphyromonas and Odoribacter at the genus level, and Rhodospirillaceae, Clostridiaceae and Peptococcaceae at the family level. Finally, these data were intertwined with those from a metabolomics analysis on fecal samples of patients with or without metastasis to better understand the role of gut microbiota in the metastatic process. Artificial intelligence has been applied in different areas of the medical field. Translating its application in the field of gut microbiota analysis may help fully exploit the potential information contained in such a large amount of data aiming to open up new supportive areas of intervention in the management of cancer.

Published
2024
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4. Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line oxaliplatin-based chemotherapy in patients with advanced HER2-negative gastric or gastro-oesophageal junction cancer (ARMANI): a randomised, open-label, multicentre, phase 3 trial

Author

Randon, Giovanni, Lonardi, Sara, Fassan, Matteo, Palermo, Federica, Tamberi, Stefano, Giommoni, Elisa, Ceccon, Carlotta, Di Donato, Samantha, Fornaro, Lorenzo, Brunetti, Oronzo, De Vita, Ferdinando, Bittoni, Alessandro, Chini, Claudio, Spallanzani, Andrea, Nappo, Floriana, Bethaz, Valerie, Strippoli, Antonia, Latiano, Tiziana, Cardellino, Giovanni Gerardo, Giuliani, Francesco, Morano, Federica, Niger, Monica, Raimondi, Alessandra, Prisciandaro, Michele, Pircher, Chiara Carlotta, Sciortino, Carolina, Marchesi, Silvia, Garattini, Silvio Ken, Airò, Giulia, Miceli, Rosalba, Di Bartolomeo, Maria, and Pietrantonio, Filippo

Published
2024
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5. Survival analysis of the metastatic cohort of Italian Association of Medical Oncology (AIOM) GARIBALDI survey

Author

Reni, M., Giommoni, E., Bergamo, F., Cavanna, L., Simionato, F., Spada, M., Di Marco, M., Bernardini, I., Cordio, S.S., Latiano, T., Spallanzani, A., Silvestris, N., Cardellino, G.G., Bonomi, M., Milella, M., Luchena, G., Tamburini, E., Macchini, M., Orsi, G., Modesti, M., Procaccio, L., Santoni, A., De Simone, I., Caldirola, L., Galli, F., and Pinto, C.

Published
2024
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8. Deciphering Microbial Composition in Patients with Inflammatory Bowel Disease: Implications for Therapeutic Response to Biologic Agents

Author

Orazio Palmieri, Fabrizio Bossa, Stefano Castellana, Tiziana Latiano, Sonia Carparelli, Giuseppina Martino, Manuel Mangoni, Giuseppe Corritore, Marianna Nardella, Maria Guerra, Giuseppe Biscaglia, Francesco Perri, Tommaso Mazza, and Anna Latiano

Subjects
biologic drugs, CD, microbiome, UC, Biology (General), QH301-705.5
Abstract

Growing evidence suggests that alterations in the gut microbiome impact the development of inflammatory bowel diseases (IBDs), including Crohn’s disease (CD) and ulcerative colitis (UC). Although IBD often requires the use of immunosuppressant drugs and biologic therapies to facilitate clinical remission and mucosal healing, some patients do not benefit from these drugs, and the reasons for this remain poorly understood. Despite advancements, there is still a need to develop biomarkers to help predict prognosis and guide treatment decisions. The aim of this study was to investigate the gut microbiome of IBD patients using biologics to identify microbial signatures associated with responses, following standard accepted criteria. Microbiomes in 66 stool samples from 39 IBD patients, comprising 20 CD and 19 UC patients starting biologic therapies, and 29 samples from healthy controls (HCs) were prospectively analyzed via NGS and an ensemble of metagenomics analysis tools. At baseline, differences were observed in alpha and beta metrics among patients with CD, UC and HC, as well as between the CD and UC groups. The degree of dysbiosis was more pronounced in CD patients, and those with dysbiosis exhibited a limited response to biological drugs. Pairwise differential abundance analyses revealed an increasing trend in the abundance of an unannotated genus from the Clostridiales order, Gemmiger genus and an unannotated genus from the Rikenellaceae family, which were consistently identified in greater abundance in HC. The Clostridium genus was more abundant in CD patients. At baseline, a greater abundance of the Odoribacter and Ruminococcus genera was found in IBD patients who responded to biologics at 14 weeks, whereas a genus identified as SMB53 was more enriched at 52 weeks. The Collinsella genus showed a higher prevalence among non-responder IBD patients. Additionally, a greater abundance of an unclassified genus from the Barnesiellaceae family and one from Lachnospiraceae was observed in IBD patients responding to Vedolizumab at 14 weeks. Our analyses showed global microbial diversity, mainly in CD. This indicated the absence or depletion of key taxa responsible for producing short-chain fatty acids (SCFAs). We also identified an abundance of pathobiont microbes in IBD patients at baseline, particularly in non-responders to biologic therapies. Furthermore, specific bacteria-producing SCFAs were abundant in patients responding to biologics and in those responding to Vedolizumab.

Published
2024
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9. Exploring the Neandertal legacy of pancreatic ductal adenocarcinoma risk in Eurasians

Author

Margherita Piccardi, Manuel Gentiluomo, Stefania Bertoncini, Raffaele Pezzilli, Bálint Erőss, Stefania Bunduc, Faik G. Uzunoglu, Renata Talar-Wojnarowska, Tomas Vanagas, Cosimo Sperti, Martin Oliverius, Mateus Nóbrega Aoki, Stefano Ermini, Tamás Hussein, Ugo Boggi, Krzysztof Jamroziak, Evaristo Maiello, Luca Morelli, Ludmila Vodickova, Gregorio Di Franco, Stefano Landi, Andrea Szentesi, Martin Lovecek, Marta Puzzono, Francesca Tavano, Hanneke W. M. van Laarhoven, Alessandro Zerbi, Beatrice Mohelnikova-Duchonova, Hannah Stocker, Eithne Costello, Gabriele Capurso, Laura Ginocchi, Rita T. Lawlor, Giuseppe Vanella, Francesca Bazzocchi, Jakob R. Izbicki, Anna Latiano, Bas Bueno-de-Mesquita, Ruggero Ponz de Leon Pisani, Ben Schöttker, Pavel Soucek, Péter Hegyi, Maria Gazouli, Thilo Hackert, Juozas Kupcinskas, Lina Poskiene, Matteo Tacelli, Susanne Roth, Silvia Carrara, Francesco Perri, Viktor Hlavac, George E. Theodoropoulos, Olivier R. Busch, Andrea Mambrini, Casper H. J. van Eijck, Paolo Arcidiacono, Aldo Scarpa, Claudio Pasquali, Daniela Basso, Maurizio Lucchesi, Anna Caterina Milanetto, John P. Neoptolemos, Giulia Martina Cavestro, Dainius Janciauskas, Xuechen Chen, Roger Chammas, Mara Goetz, Hermann Brenner, Livia Archibugi, Michael Dannemann, Federico Canzian, Sergio Tofanelli, and Daniele Campa

Subjects
Neandertal, Pancreatic cancer, Association study, Introgression, Eurasians, Admixture, Biology (General), QH301-705.5
Abstract

Abstract Background The genomes of present-day non-Africans are composed of 1–3% of Neandertal-derived DNA as a consequence of admixture events between Neandertals and anatomically modern humans about 50–60 thousand years ago. Neandertal-introgressed single nucleotide polymorphisms (aSNPs) have been associated with modern human disease-related traits, which are risk factors for pancreatic ductal adenocarcinoma (PDAC), such as obesity, type 2 diabetes, and inflammation. In this study, we aimed at investigating the role of aSNPs in PDAC in three Eurasian populations. Results The high-coverage Vindija Neandertal genome was used to select aSNPs in non-African populations from 1000 Genomes project phase 3 data. Then, the association between aSNPs and PDAC risk was tested independently in Europeans and East Asians, using existing GWAS data on more than 200 000 individuals. We did not find any significant associations between aSNPs and PDAC in samples of European descent, whereas, in East Asians, we observed that the Chr10p12.1-rs117585753-T allele (MAF = 10%) increased the risk to develop PDAC (OR = 1.35, 95%CI 1.19–1.54, P = 3.59 × 10–6), with a P-value close to a threshold that takes into account multiple testing. Conclusions Our results show only a minimal contribution of Neandertal SNPs to PDAC risk.

Published
2023
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11. Trop-2 and Nectin-4 immunohistochemical expression in metastatic colorectal cancer: searching for the right population for drugs’ development

Author

Moretto, Roberto, Germani, Marco Maria, Giordano, Mirella, Conca, Veronica, Proietti, Agnese, Niccoli, Cristina, Pietrantonio, Filippo, Lonardi, Sara, Tamburini, Emiliano, Zaniboni, Alberto, Passardi, Alessandro, Latiano, Tiziana Pia, Fanotto, Valentina, Di Donato, Samantha, Prisciandaro, Michele, Bergamo, Francesca, Masi, Gianluca, Fontanini, Gabriella, Ugolini, Clara, and Cremolini, Chiara

Published
2023
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12. Genetic and non-genetic risk factors for early-onset pancreatic cancer

Author

Nodari, Ylenia, Gentiluomo, Manuel, Mohelnikova-Duchonova, Beatrice, Kreivenaite, Edita, Milanetto, Anna Caterina, Skieceviciene, Jurgita, Landi, Stefano, Lawlor, Rita T, Petrone, Maria Chiara, Arcidiacono, Paolo Giorgio, Lovecek, Martin, Gazouli, Maria, Bijlsma, Maarten F., Morelli, Luca, Kiudelis, Vytautas, Tacelli, Matteo, Zanette, Dalila Lucíola, Soucek, Pavel, Uzunoglu, Faik, Kaaks, Rudolf, Izbicki, Jakob, Boggi, Ugo, Pezzilli, Raffaele, Mambrini, Andrea, Pasquali, Claudio, van Laarhoven, Hanneke W., Katzke, Verena, Cavestro, Giulia Martina, Sperti, Cosimo, Loos, Martin, Latiano, Anna, Erőss, Bálint, Oliverius, Martin, Johnson, Theron, Basso, Daniela, Neoptolemos, John P., Aoki, Mateus Nóbrega, Greenhalf, William, Vodicka, Pavel, Archibugi, Livia, Vanella, Giuseppe, Lucchesi, Maurizio, Talar-Wojnarowska, Renata, Jamroziak, Krzysztof, Saeedi, Mohammed Al, van Eijck, Casper H.J., Kupcinskas, Juozas, Hussein, Tamás, Puzzono, Marta, Bunduc, Stefania, Götz, Mara, Carrara, Silvia, Szentesi, Andrea, Tavano, Francesca, Moz, Stefania, Hegyi, Péter, Luchini, Claudio, Capurso, Gabriele, Perri, Francesco, Ermini, Stefano, Theodoropoulos, George, Capretti, Giovanni, Palmieri, Orazio, Ginocchi, Laura, Furbetta, Niccolò, Canzian, Federico, and Campa, Daniele

Published
2023
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13. HLA-DP on Epithelial Cells Enables Tissue Damage by NKp44+ Natural Killer Cells in Ulcerative Colitis

Author

Akar, Alaa, Flemming, Cornelius, Felix, Flomm, Flosbach, Markus, Jäger, Julia, Jeromin, Niklas, Jung, Johannes, Ohms, Mareike, Reinshagen, Konrad, Rische, Johann, Sagebiel, Adrian, Sandfort, Deborah, Steinert, Fenja, Tomuschat, Christian, Wesche, Jasmin, Shifteh Abedian, Abraham, Clara, Achkar, Jean-Paul, Ahmad, Tariq, Alberts, Rudi, Alizadeh, Behrooz, Amininejad, Leila, Ananthakrishnan, Ashwin N., Andersen, Vibeke, Anderson, Carl A., Andrews, Jane M., Annese, Vito, Aumais, Guy, Baidoo, Leonard, Baldassano, Robert N., Bampton, Peter A., Barclay, Murray, Barrett, Jeffrey C., Bethge, Johannes, Bewshea, Claire, Bis, Joshua C., Bitton, Alain, BK, Thelma, Boucher, Gabrielle, Brain, Oliver, Brand, Stephan, Brant, Steven R., Cheon, Jae Hee, Chew, Angela, Cho, Judy H., Cleynen, Isabelle, Cohain, Ariella, Cooney, Rachel, Croft, Anthony, Daly, Mark J., D'Amato, Mauro, Danese, Silvio, Daryani, Naser Ebrahim, Datta, Lisa Wu, Degenhardt, Frauke, Denapiene, Goda, Denson, Lee A., Devaney, Kathy L., Dewit, Olivier, D'Inca, Renata, Drummond, Hazel E., Dubinsky, Marla, Duerr, Richard H., Edwards, Cathryn, Ellinghaus, David, Ellul, Pierre, Esaki, Motohiro, Essers, Jonah, Ferguson, Lynnette R., Festen, Eleonora A., Fleshner, Philip, Florin, Tim, Franchimont, Denis, Franke, Andre, Fuyuno, Yuta, Gearry, Richard, Georges, Michel, Gieger, Christian, Glas, Jürgen, Goyette, Philippe, Green, Todd, Griffiths, Anne M., Guthery, Stephen L., Hakonarson, Hakon, Halfvarson, Jonas, Hanigan, Katherine, Haritunians, Talin, Hart, Ailsa, Hawkey, Chris, Hayward, Nicholas K., Hedl, Matija, Henderson, Paul, Hold, Georgina L., Hong, Myhunghee, Hu, Xinli, Huang, Hailiang, Hugot, Jean-Pierre, Hui, Ken Y., Imielinski, Marcin, Jazayeri, Omid, Jonaitis, Laimas, Jostins, Luke, Juyal, Garima, Chandra Juyal, Ramesh, Kalla, Rahul, Karlsen, Tom H., Kennedy, Nicholas A., Khan, Mohammed Azam, Kim, Won Ho, Kitazono, Takanari, Kiudelis, Gediminas, Kubo, Michiaki, Kugathasan, Subra, Kupcinskas, Limas, Lamb, Christopher A., de Lange, Katrina M., Latiano, Anna, Laukens, Debby, Lawrance, Ian C., Lee, James C., Lees, Charlie W., Leja, Marcis, Lewis, Nina, Van Limbergen, Johan, Lionetti, Paolo, Liu, Jimmy Z., Louis, Edouard, Luo, Yang, Mahy, Gillian, Malekzadeh, Masoud Mohammad, Malekzadeh, Reza, Mansfield, John, Marriott, Suzie, Massey, Dunecan, Mathew, Christopher G., Matsui, Toshiyuki, McGovern, Dermot P.B., van der Meulen, Andrea, Midha, Vandana, Milgrom, Raquel, Mirzaei, Samaneh, Mitrovic, Mitja, Montgomery, Grant W., Mowat, Craig, Müller, Christoph, Newman, William G., Ng, Aylwin, Ng, Siew C., Evelyn Ng, Sok Meng, Nikolaus, Susanna, Ning, Kaida, Nöthen, Markus, Oikonomou, Ioannis, Okou, David, Orchard, Timothy R., Palmieri, Orazio, Parkes, Miles, Phillips, Anne, Ponsioen, Cyriel Y., Potocnik, Urõs, Poustchi, Hossein, Prescott, Natalie J., Proctor, Deborah D., Radford-Smith, Graham, Rahier, Jean- Francois, Regueiro, Miguel, Reinisch, Walter, Rieder, Florian, Rioux, John D., Roberts, Rebecca, Rogler, Gerhard, Russell, Richard K., Sanderson, Jeremy D., Sans, Miquel, Satsangi, Jack, Schadt, Eric E., Scharl, Michael, Schembri, John, Schreiber, Stefan, Schumm, L. Philip, Scott, Regan, Seielstad, Mark, Shah, Tejas, Sharma, Yashoda, Silverberg, Mark S., Simmons, Alison, Simms, Lisa A., Singh, Abhey, Skieceviciene, Jurgita, van Sommeren, Suzanne, Song, Kyuyoung, Sood, Ajit, Spain, Sarah L., Steinhart, A. Hillary, Stempak, Joanne M., Stronati, Laura, Sung, Joseph J.Y., Targan, Stephan R., Taylor, Kirstin M., Theatre, Emilie, Torkvist, Leif, Torres, Esther A., Tremelling, Mark, Uhlig, Holm H., Umeno, Junji, Vahedi, Homayon, Vasiliauskas, Eric, Velde, Anje ter, Ventham, Nicholas T., Vermeire, Severine, Verspaget, Hein W., De Vos, Martine, Walters, Thomas, Wang, Kai, Wang, Ming-Hsi, Weersma, Rinse K., Wei, Zhi, Whiteman, David, Wijmenga, Cisca, Wilson, David C., Winkelmann, Juliane, Wong, Sunny H., Xavier, Ramnik J., Yamazaki, Keiko, Yang, Suk-Kyun, Ye, Byong Duk, Zeissig, Sebastian, Zhang, Bin, Zhang, Clarence K., Zhang, Hu, Zhang, Wei, Zhao, Hongyu, Zhao, Zhen Z., Baumdick, Martin E., Niehrs, Annika, Schwerk, Maria, Hinrichs, Ole, Jordan-Paiz, Ana, Padoan, Benedetta, Wegner, Lucy H.M., Schloer, Sebastian, Zecher, Britta F., Malsy, Jakob, Joshi, Vinita R., Illig, Christin, Schröder-Schwarz, Jennifer, Möller, Kimberly J., Martin, Maureen P., Yuki, Yuko, Ozawa, Mikki, Sauter, Jürgen, Schmidt, Alexander H., Perez, Daniel, Giannou, Anastasios D., Carrington, Mary, Davis, Randall S., Schumacher, Udo, Sauter, Guido, Huber, Samuel, Puelles, Victor G., Melling, Nathaniel, Altfeld, Marcus, and Bunders, Madeleine J.

Published
2023
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14. Cetuximab as third‐line rechallenge plus either irinotecan or avelumab is an effective treatment in metastatic colorectal cancer patients with baseline plasma RAS/BRAF wild‐type circulating tumor DNA: Individual patient data pooled analysis of CRICKET and CAVE trials

Author

G. Martini, D. Ciardiello, V. Famiglietti, D. Rossini, C. Antoniotti, T. Troiani, S. Napolitano, L. Esposito, T. P. Latiano, E. Maiello, M. Del Re, S. Lonardi, G. Aprile, D. Santini, G. Masi, A. Avallone, N. Normanno, F. Pietrantonio, C. Pinto, F. Ciardiello, C. Cremolini, and E. Martinelli

Subjects
cetuximab, immunotherapy, metastatic colorectal cancer, rechallenge, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract The rechallenge strategy is based on the concept that a subset of patients with RAS wild‐type (WT) metastatic colorectal cancer (mCRC) could still benefit of epidermal growth factor receptor (EGFR) inhibition, after progression to an anti‐EGFR based‐therapy. We performed a pooled analysis of two‐phase II prospective trials to determine the role of rechallenge in third‐line mCRC patients with RAS/BRAF WT baseline circulating tumor DNA (ctDNA). Individual data of 33 and 13 patients from CAVE and CRICKET trials that received as third‐line therapy cetuximab rechallenge were collected. Overall survival (OS), Progression‐free survival (PFS), Overall response rate (ORR), Stable disease (SD) >6 months were calculated. Adverse events were reported. For the whole 46 patient population, median PFS (mPFS) was 3.9 months (95% Confidence Interval, CI 3.0–4.9) with median OS (mOS) of 16.9 months (95% CI 11.7–22.1). For CRICKET patients, mPFS was 3.9 months (95% CI 1.7–6.2); mOS was 13.1 months (95% CI 7.3–18.9) with OS rates at 12, 18, and 24 months of 62%, 23%, and 0%, respectively. For CAVE patients, mPFS was 4.1 months (95% CI 3.0–5.2); mOS was 18.6 months (95% CI 11.7–25.4) with OS rates at 12, 18, 24 months of 61%, 52%, 21%, respectively. Skin rash was more frequently reported in CAVE trial (87.9% vs. 30.8%; p = 0.001), whereas a increased incidence of hematological toxicities was observed in CRICKET trial (53.8%% vs. 12.1%; p = 0.003). Third‐line cetuximab rechallenge in combination with either irinotecan or avelumab in RAS/BRAF WT ctDNA mCRC patients represents a promising therapy.

Published
2023
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15. Dissecting the genetic heterogeneity of gastric cancer

Author

Hess, Timo, Maj, Carlo, Gehlen, Jan, Borisov, Oleg, Haas, Stephan L., Gockel, Ines, Vieth, Michael, Piessen, Guillaume, Alakus, Hakan, Vashist, Yogesh, Pereira, Carina, Knapp, Michael, Schüller, Vitalia, Quaas, Alexander, Grabsch, Heike I., Trautmann, Jessica, Malecka-Wojciesko, Ewa, Mokrowiecka, Anna, Speller, Jan, Mayr, Andreas, Schröder, Julia, Hillmer, Axel M., Heider, Dominik, Lordick, Florian, Pérez-Aísa, Ángeles, Campo, Rafael, Espinel, Jesús, Geijo, Fernando, Thomson, Concha, Bujanda, Luis, Sopeña, Federico, Lanas, Ángel, Pellisé, María, Pauligk, Claudia, Goetze, Thorsten Oliver, Zelck, Carolin, Reingruber, Julian, Hassanin, Emadeldin, Elbe, Peter, Alsabeah, Sandra, Lindblad, Mats, Nilsson, Magnus, Kreuser, Nicole, Thieme, René, Tavano, Francesca, Pastorino, Roberta, Arzani, Dario, Persiani, Roberto, Jung, Jin-On, Nienhüser, Henrik, Ott, Katja, Schumann, Ralf R., Kumpf, Oliver, Burock, Susen, Arndt, Volker, Jakubowska, Anna, Ławniczak, Małgorzta, Moreno, Victor, Martín, Vicente, Kogevinas, Manolis, Pollán, Marina, Dąbrowska, Justyna, Salas, Antonio, Cussenot, Olivier, Boland-Auge, Anne, Daian, Delphine, Deleuze, Jean-Francois, Salvi, Erika, Teder-Laving, Maris, Tomasello, Gianluca, Ratti, Margherita, Senti, Chiara, De Re, Valli, Steffan, Agostino, Hölscher, Arnulf H., Messerle, Katharina, Bruns, Christiane Josephine, Sīviņš, Armands, Bogdanova, Inga, Skieceviciene, Jurgita, Arstikyte, Justina, Moehler, Markus, Lang, Hauke, Grimminger, Peter P., Kruschewski, Martin, Vassos, Nikolaos, Schildberg, Claus, Lingohr, Philipp, Ridwelski, Karsten, Lippert, Hans, Fricker, Nadine, Krawitz, Peter, Hoffmann, Per, Nöthen, Markus M., Veits, Lothar, Izbicki, Jakob R., Mostowska, Adrianna, Martinón-Torres, Federico, Cusi, Daniele, Adolfsson, Rolf, Cancel-Tassin, Geraldine, Höblinger, Aksana, Rodermann, Ernst, Ludwig, Monika, Keller, Gisela, Metspalu, Andres, Brenner, Hermann, Heller, Joerg, Neef, Markus, Schepke, Michael, Dumoulin, Franz Ludwig, Hamann, Lutz, Cannizzaro, Renato, Ghidini, Michele, Plaßmann, Dominik, Geppert, Michael, Malfertheiner, Peter, Gehlen, Olivier, Skoczylas, Tomasz, Majewski, Marek, Lubiński, Jan, Palmieri, Orazio, Boccia, Stefania, Latiano, Anna, Aragones, Nuria, Schmidt, Thomas, Dinis-Ribeiro, Mário, Medeiros, Rui, Al-Batran, Salah-Eddin, Leja, Mārcis, Kupcinskas, Juozas, García-González, María A., Venerito, Marino, and Schumacher, Johannes

Published
2023
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16. The PANcreatic Disease ReseArch (PANDoRA) consortium: Ten years’ experience of association studies to understand the genetic architecture of pancreatic cancer

Author

Campa, Daniele, Gentiluomo, Manuel, Stein, Angelika, Aoki, Mateus Nóbrega, Oliverius, Martin, Vodičková, Ludmila, Jamroziak, Krzysztof, Theodoropoulos, George, Pasquali, Claudio, Greenhalf, William, Arcidiacono, Paolo Giorgio, Uzunoglu, Faik, Pezzilli, Raffaele, Luchini, Claudio, Puzzono, Marta, Loos, Martin, Giaccherini, Matteo, Katzke, Verena, Mambrini, Andrea, Kiudeliene, Edita, Federico, Kauffmann Emanuele, Johansen, Julia, Hussein, Tamás, Mohelnikova-Duchonova, Beatrice, van Eijck, Casper H.J., Brenner, Hermann, Farinella, Riccardo, Pérez, Juan Sainz, Lovecek, Martin, Büchler, Markus W., Hlavac, Viktor, Izbicki, Jakob R., Hackert, Thilo, Chammas, Roger, Zerbi, Alessandro, Lawlor, Rita, Felici, Alessio, Götz, Mara, Capurso, Gabriele, Ginocchi, Laura, Gazouli, Maria, Kupcinskas, Juozas, Cavestro, Giulia Martina, Vodicka, Pavel, Moz, Stefania, Neoptolemos, John P., Kunovsky, Lumir, Bojesen, Stig E., Carrara, Silvia, Gioffreda, Domenica, Morkunas, Egidijus, Abian, Olga, Bunduc, Stefania, Basso, Daniela, Boggi, Ugo, Wlodarczyk, Barbara, Szentesi, Andrea, Vanella, Giuseppe, Chen, Inna, Bijlsma, Maarten F., Kiudelis, Vytautas, Landi, Stefano, Schöttker, Ben, Corradi, Chiara, Giese, Nathalia, Kaaks, Rudolf, Peduzzi, Giulia, Hegyi, Péter, Morelli, Luca, Furbetta, Niccolò, Soucek, Pavel, Latiano, Anna, Talar-Wojnarowska, Renata, Lindgaard, Sidsel C., Dijk, Frederike, Milanetto, Anna Caterina, Tavano, Francesca, Cervena, Klara, Erőss, Bálint, Testoni, Sabrina G., Verhagen-Oldenampsen, Judith H.E., Małecka-Wojciesko, Ewa, Costello, Eithne, Salvia, Roberto, Maiello, Evaristo, Ermini, Stefano, Sperti, Cosimo, Holleczek, Bernd, Perri, Francesco, Skieceviciene, Jurgita, Archibugi, Livia, Lucchesi, Maurizio, Rizzato, Cosmeri, and Canzian, Federico

Published
2023
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17. Genome-Wide Methylation Profiling in 229 Patients With Crohn’s Disease Requiring Intestinal Resection: Epigenetic Analysis of the Trial of Prevention of Post-operative Crohn’s Disease (TOPPIC)Summary

Author

Nicholas T. Ventham, Nicholas A. Kennedy, Rahul Kalla, Alex T. Adams, Alexandra Noble, Holly Ennis, Craig Mowat, Malcolm G. Dunlop, Jack Satsangi, Ian Arnott, Aiden Cahill, Malcolm Smith, Tariq Ahmad, Sreedhar Subramanian, Simon Travis, John Morris, John Hamlin, Anjan Dhar, Chuka Nwokolo, Cathryn Edwards, Tom Creed, Stuart Bloom, Mohamed Yousif, Linzi Thomas, Simon Campbell, Stephen J. Lewis, Shaji Sebastian, Sandip Sen, Simon Lal, Chris Hawkey, Charles Murray, Fraser Cummings, Jason Goh, James O. Lindsay, Naila Arebi, Lindsay Potts, Aileen J. McKinley, John M. Thomson, John A. Todd, Mhairi Collie, Ashley Mowat, Daniel R. Gaya, Jack Winter, Graham D. Naismith, Catriona Keerie, Steff Lewis, Robin J. Prescott, Gordan Lauc, Harry Campbell, Dermot P.B. McGovern, Vito Annese, Vlatka Zoldoš, Iain K. Permberton, Manfred Wuhrer, Daniel Kolarich, Daryl L. Fernandes, Evropi Theorodorou, Victoria Merrick Daniel I. Spencer, Richard A. Gardner, Ray Doran, Archana Shubhakar, Ray Boyapati, Igor Rudan, Paolo Lionetti, Irena Trbojević Akmačić, Jasminka Krištić, Frano Vuč ković, Jerko Štambuk, Mislav Novokmet, Maja Pučić-Baković, Olga Gornik, Angelo Andriulli, Laura Cantoro, Giancarlo Sturniolo, Gionata Fiorino, Natalia Manetti, Anna Latiano, Anna Kohn, Renata D’Inca`, Silvio Danese, Ian D. Arnott, Colin L. Noble, Charlie W. Lees, Alan G. Shand, Gwo-Tzer Ho, Lee Murphy, Jude Gibson, Louise Evenden, Nicola Wrobel, Tamara Gilchrist, Angie Fawkes, Guinevere S.M. Kammeijer, Florent Clerc, Noortje de Haan, Aleksandar Vojta, Ivana Samaržija, Dora Markulin, Marija Klasić, Paula Dobrinić, Yurii Aulchenko, Tim van den Heuve, Daisy Jonkers, and Marieke Pierik

Subjects
Crohn's disease, Surgery, DNA methylation, Epigenetics, Inflammatory bowel disease, Aging, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Background & Aims: DNA methylation alterations may provide important insights into gene-environment interaction in cancer, aging, and complex diseases, such as inflammatory bowel disease (IBD). We aim first to determine whether the circulating DNA methylome in patients requiring surgery may predict Crohn’s disease (CD) recurrence following intestinal resection; and second to compare the circulating methylome seen in patients with established CD with that we had reported in a series of inception cohorts. Methods: TOPPIC was a placebo-controlled, randomized controlled trial of 6-mercaptopurine at 29 UK centers in patients with CD undergoing ileocolic resection between 2008 and 2012. Genomic DNA was extracted from whole blood samples from 229 of the 240 patients taken before intestinal surgery and analyzed using 450KHumanMethylation and Infinium Omni Express Exome arrays (Illumina, San Diego, CA). Coprimary objectives were to determine whether methylation alterations may predict clinical disease recurrence; and to assess whether the epigenetic alterations previously reported in newly diagnosed IBD were present in the patients with CD recruited into the TOPPIC study. Differential methylation and variance analysis was performed comparing patients with and without clinical evidence of recurrence. Secondary analyses included investigation of methylation associations with smoking, genotype (MeQTLs), and chronologic age. Validation of our previously published case-control observation of the methylome was performed using historical control data (CD, n = 123; Control, n = 198). Results: CD recurrence in patients following surgery is associated with 5 differentially methylated positions (Holm P < .05), including probes mapping to WHSC1 (P = 4.1 × 10-9, Holm P = .002) and EFNA3 (P = 4.9 × 10-8, Holm P = .02). Five differentially variable positions are demonstrated in the group of patients with evidence of disease recurrence including a probe mapping to MAD1L1 (P = 6.4 × 10-5). DNA methylation clock analyses demonstrated significant age acceleration in CD compared with control subjects (GrimAge + 2 years; 95% confidence interval, 1.2–2.7 years), with some evidence for accelerated aging in patients with CD with disease recurrence following surgery (GrimAge +1.04 years; 95% confidence interval, -0.04 to 2.22). Significant methylation differences between CD cases and control subjects were seen by comparing this cohort in conjunction with previously published control data, including validation of our previously described differentially methylated positions (RPS6KA2 P = 1.2 × 10-19, SBNO2 = 1.2 × 10-11) and regions (TXK [false discovery rate, P = 3.6 × 10-14], WRAP73 [false discovery rate, P = 1.9 × 10-9], VMP1 [false discovery rate, P = 1.7 × 10-7], and ITGB2 [false discovery rate, P = 1.4 × 10-7]). Conclusions: We demonstrate differential methylation and differentially variable methylation in patients developing clinical recurrence within 3 years of surgery. Moreover, we report replication of the CD-associated methylome, previously characterized only in adult and pediatric inception cohorts, in patients with medically refractory disease needing surgery.

Published
2023
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18. Guideline Application in Real world: multi-Institutional Based survey of Adjuvant and first-Line pancreatic Ductal adenocarcinoma treatment in Italy. Primary analysis of the GARIBALDI survey

Author

Reni, Michele, Macchini, Marina, Orsi, Giulia, Peretti, Umberto, Valente, Mariamaddalena, Giommoni, Elisa, Antonuzzo, Lorenzo, Di Costanzo, Francesco, Bergamo, Francesca, Zagonel, Vittorina, Lonardi, Sara, Buggin, Federica, Milella, Michele, Palmerio, Silvia, Cavanna, Luigi, Di Nunzio, Camilla, Di Marco, Maria Cristina, Grassi, Elisa, Spada, Massimiliano, Messina, Marco, Cordio, Stefano, Avola, Francesco, Aprile, Giuseppe, Pagano, Salvatore, Simionato, Francesca, Cardellino, Giovanni Gerardo, Majer, Federica, Maiello, Evaristo, Latiano, Tiziana Pia, Chiarazzo, Cinzia, Artioli, Fabrizio, Razzini, Giorgia, Pasqualini, Antonella, Ghidini, Michele, Binda, Elisa, Lazzarelli, Silvia, Bozzarelli, Silvia, Sala, Simona, Luppi, Gabriele, Pettorelli, Elisa, Spallanzani, Andrea, Vicario, Giovanni, Salmaso, Flavia, Basso, Marco, Silvestris, Nicola, Del Curatolo, Sabina, Zustovich, Fable, Bongiovanni, Francesca, Longobardi, Ciro, Sandi, Ilenia, Fontanella, Caterina, Montelatici, Silvia, Giordano, Monica, Luchena, Giovanna, Gilardoni, Micol, Tamburini, Emiliano, Rudnas, Britt, Venturini, Barbara, Merelli, Barbara, Negrini, Giorgia, Vici, Elio Maria, Marabese, Alessandra, Garetto, Cristina, Curcio, Paola, Cinieri, Saverio, Cinefra, Margherita, Ferrara, Pasqualinda, Cantore, Maurizio, Morselli, Patrizia, Fumi, Guglielmo, Isidori, Agnese, Ciccarese, Giovanni, Paolo Frassineti, Giovanni Luca, Pagan, Flavia, Vaccaro, Vanja, Spoto, Chiara, Ferrara, Marianna, Garufi, Carlo, Caporale, Marta, Vasile, Enrico, Salani, Francesca, Barone, Elisa, Berardi, Rossana, Onofri, Azzurra, Ballatore, Zelmira, Lucarelli, Alessandra, Barucca, Alessandra, Pancotti, Amedeo, Scipioni, Teresa, Bencardino, Katia, Marrapese, Giovanna, Idotta, Laura, Petrelli, Fausto, Lonati, Veronica, Ceribelli, Anna, Giuli, Angelo, Zannori, Cristina, Bassanelli, Maria, Mambrini, Andrea, Ginocchi, Laura, Orlandi, Massimo, Celio, Luigi, Niger, Monica, Biamonte, Lavinia, Tamberi, Stefano, Piancastelli, Alessandra, Papiani, Giorgio, Valli, Irene, Allione, Paolo, Boe, Maria Giovanna, Scartozzi, Mario, Lai, Eleonora, Pireddu, Annagrazia, Ziranu, Pina, Demurtas, Laura, Puzzoni, Marco, Mariani, Stefano, Pretta, Andrea, Liscia, Nicole, Savastano, Clementina, Malaspina, Valentina, Tonini, Giuseppe, Grassani, Teresa, Barco, Barbara, Pierosandro, Tagliaferri, Ciliberto, Domenico, Ierardi, Antonella, Calandruccio, Natale Daniele, Minotti, Vincenzo, Matocci, Roberta, Torri, Valter, Porcu, Luca, Rulli, Erica, De Simone, Irene, Carlucci, Luciano, Rulli, Eliana, Poli, Davide, Tonto, Paola, Scellato, Francesca, Pinto, Carmine, Reni, M., Giommoni, E., Bergamo, F., Milella, M., Cavanna, L., Di Marco, M.C., Spada, M., Cordio, S., Aprile, G., Cardellino, G.G., Maiello, E., Bernardini, I., Ghidini, M., Bozzarelli, S., Macchini, M., Orsi, G., De Simone, I., Rulli, Er., Porcu, L., Torri, V., and Pinto, C.

Published
2023
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19. Corrigendum to 'Dissecting the genetic heterogeneity of gastric cancer'

Author

Timo Hess, Carlo Maj, Jan Gehlen, Oleg Borisov, Stephan L. Haas, Ines Gockel, Michael Vieth, Guillaume Piessen, Hakan Alakus, Yogesh Vashist, Carina Pereira, Michael Knapp, Vitalia Schüller, Alexander Quaas, Heike I. Grabsch, Jessica Trautmann, Ewa Malecka-Wojciesko, Anna Mokrowiecka, Jan Speller, Andreas Mayr, Julia Schröder, Axel M. Hillmer, Dominik Heider, Florian Lordick, Ángeles Pérez-Aísa, Rafael Campo, Jesús Espinel, Fernando Geijo, Concha Thomson, Luis Bujanda, Federico Sopeña, Ángel Lanas, María Pellisé, Claudia Pauligk, Thorsten Oliver Goetze, Carolin Zelck, Julian Reingruber, Emadeldin Hassanin, Peter Elbe, Sandra Alsabeah, Mats Lindblad, Magnus Nilsson, Nicole Kreuser, René Thieme, Francesca Tavano, Roberta Pastorino, Dario Arzani, Roberto Persiani, Jin-On Jung, Henrik Nienhüser, Katja Ott, Ralf R. Schumann, Oliver Kumpf, Susen Burock, Volker Arndt, Anna Jakubowska, Małgorzta Ławniczak, Victor Moreno, Vicente Martín, Manolis Kogevinas, Marina Pollán, Justyna Dąbrowska, Antonio Salas, Olivier Cussenot, Anne Boland-Auge, Delphine Daian, Jean-Francois Deleuze, Erika Salvi, Maris Teder-Laving, Gianluca Tomasello, Margherita Ratti, Chiara Senti, Valli De Re, Agostino Steffan, Arnulf H. Hölscher, Katharina Messerle, Christiane Josephine Bruns, Armands Sīviņš, Inga Bogdanova, Jurgita Skieceviciene, Justina Arstikyte, Markus Moehler, Hauke Lang, Peter P. Grimminger, Martin Kruschewski, Nikolaos Vassos, Claus Schildberg, Philipp Lingohr, Karsten Ridwelski, Hans Lippert, Nadine Fricker, Peter Krawitz, Per Hoffmann, Markus M. Nöthen, Lothar Veits, Jakob R. Izbicki, Adrianna Mostowska, Federico Martinón-Torres, Daniele Cusi, Rolf Adolfsson, Geraldine Cancel-Tassin, Aksana Höblinger, Ernst Rodermann, Monika Ludwig, Gisela Keller, Andres Metspalu, Hermann Brenner, Joerg Heller, Markus Neef, Michael Schepke, Franz Ludwig Dumoulin, Lutz Hamann, Renato Cannizzaro, Michele Ghidini, Dominik Plaßmann, Michael Geppert, Peter Malfertheiner, Olivier Glehen, Tomasz Skoczylas, Marek Majewski, Jan Lubiński, Orazio Palmieri, Stefania Boccia, Anna Latiano, Nuria Aragones, Thomas Schmidt, Mário Dinis-Ribeiro, Rui Medeiros, Salah-Eddin Al-Batran, Mārcis Leja, Juozas Kupcinskas, María A. García-González, Marino Venerito, and Johannes Schumacher

Subjects
Medicine, Medicine (General), R5-920
Published
2023
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20. Impact of the COVID-19 outbreak and the serum prevalence of SARS-CoV-2 antibodies in patients with inflammatory bowel disease treated with biologic drugs

Author

Bossa, Fabrizio, Carparelli, Sonia, Latiano, Anna, Palmieri, Orazio, Tavano, Francesca, Panza, Anna, Pastore, Maria, Marseglia, Antonio, D'Altilia, Mario, Latiano, Tiziana, Corritore, Giuseppe, Martino, Giuseppina, Nardella, Marianna, Guerra, Maria, Terracciano, Fulvia, Sacco, Michele, Perri, Francesco, and Andriulli, Angelo

Published
2021
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22. Duodenal Fluid Analysis as a Rewarding Approach to Detect Low-Abundance Mutations in Biliopancreatic Cancers.

Author

Tavano, Francesca, Latiano, Anna, Palmieri, Orazio, Gioffreda, Domenica, Latiano, Tiziana, Gentile, Annamaria, Tardio, Matteo, Latiano, Tiziana Pia, Gentile, Marco, Terracciano, Fulvia, and Perri, Francesco

Subjects
*BIOMARKERS, *CELL-free DNA, *TUMOR markers, *NUCLEOTIDE sequencing, *PLASMA sources
Abstract

Diagnosis of biliopancreatic cancers by the available serum tumor markers, imaging, and histopathological tissue specimen examination remains a challenge. Circulating cell-free DNA derived from matched pairs of secretin-stimulated duodenal fluid (DF) and plasma from 10 patients with biliopancreatic diseases and 8 control subjects was analyzed using AmpliSeq™ HD technology for Ion Torrent Next-Generation Sequencing to evaluate the potential of liquid biopsy with DF in biliopancreatic cancers. The median cfDNA concentration was greater in DF-derived than in plasma-derived samples. A total of 13 variants were detected: 11 vs. 1 were exclusive for DF relative to the plasma source, and 1 was shared between the two body fluids. According to the four-tier systems, 10 clinical tier-I–II (76.9%), 1 tier–III (7.7%), and 2 tier–IV (15.4%) variants were identified. Notably, the 11 tier-I-III variants were exclusively found in DF-derived cfDNA from five patients with biliopancreatic cancers, and were detected in seven genes (KRAS, TP53, BRAF, CDKN2A, RNF43, GNAS, and PIK3CA); 82% of the tier-I-III variants had a low abundance, with a VAF < 6%. The mutational profiling of DF seems to be a reliable and promising tool for identifying cancer-associated alterations in malignant cancers of the biliopancreatic tract. [ABSTRACT FROM AUTHOR]

Published
2024
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23. New concept in urologic surgery: The total extended genital sparing radical cystectomy in women

Author

Antonio Cisternino, Lorenzo Capone, Antonio Rosati, Costanzo Latiano, Nicola Sebastio, Antonio Colella, and Giuseppe Cretì

Subjects
Muscle-invasive bladder cancer, High risk non-muscle invasive bladder cancer, Total extended genital sparing, Oncologic outcomes, Sexual life, Post-operative continence, Diseases of the genitourinary system. Urology, RC870-923
Abstract

Introduction and objectives: The aim of the study was to evaluate genital sparing radical cystectomy surgery in female patients from the point of view of both oncologic and functional outcomes (with emphasis on urinary and sexual outcomes) in a single high-volume center for the treatment of muscular invasive bladder cancer. Materials and methods: Between January 2014 and January 2018, 14 female patients underwent radical cystectomy with preservation of genital organs (the entire vagina, uterus, fallopian tubes, ovaries) and orthotopic urinary neobladder (Padua neobladder). Inclusion criteria were recurrent T1G3 tumors; refractory tumors after BCG therapy without associated carcinoma in situ (CIS); T2 or T3a tumors entirely resected at endoscopic transurethral resection of the bladder and not involving urethra/bladder trigone. Exclusion criteria were: T3b or higher bladder cancer, associated CIS and involvement of urethra or bladder trigone. Oncological and histopathological outcomes (Overall Survival - OS, Recurrence Free Survival - RFS), urinary outcomes (day and night incontinence, intermittent catheterization use, Sandvik Score) and sexual outcomes (Female Sexual Function Index 19 FSFI-19) were considered. The average follow-up time was 56 months. Results: Considering oncological outcomes, histologic examination reported urothelial carcinoma in 13/14 patients; 8/13 patients (61.5%) had high grade T1 stage, 3/13 patients (23%) had high grade T2 stage and finally 2/13 patients (15.5%) had high-grade T3 stage. One patient presented with embryonal rhabdomyosarcoma completely excised after surgery (PT2aN0M0). No patient developed local or metastatic recurrence (RFS 100%); OS was 100%. Considering urinary continence outcomes, 12/14 patients retained daytime and nighttime continence (85.5%); 2/14 (14.5%) complained of low stress urinary incontinence daily and nighttime urinary leakage. The Sandvik Score showed complete continence in 7/14 patients (50%); mild degree incontinence in 6/14 patients without use of incontinence devices (43%); moderate degree of incontinence in one patient (7%). The FSFI administered at 1 year from the surgery showed sexual desire in all patients (100%); subjective arousal, achievement of orgasm and sexual satisfaction in 12/14 patients (85.5%); sufficient lubrication in 11/14 patients (78.5%). Only one patient (7%) complained about dyspareunia during sexual intercourse. Conclusions: Our study aims to demonstrate that genital-sparing radical cystectomy is a safe surgery in terms of oncologic outcomes and, most importantly, that it is beneficial in terms of urinary and sexual function. Indeed, patients’ quality of life together with their psychological and emotional health should be put on the same level as oncological safety. However, it is a treatment reserved for selected patients who are strongly motivated to preserve fertility and sexual function and thoroughly informed about the benefits and complications of such a procedure.

Published
2023
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24. A PCR-based method for the diagnosis of Enterobius vermicularis in stool samples, specifically designed for clinical application

Author

Aldo Ummarino, Michele Caputo, Francesco Antonio Tucci, Gaetano Pezzicoli, Ada Piepoli, Annamaria Gentile, Tiziana Latiano, Anna Panza, Nicholas Calà, Antonio Pio Ceglia, Giovanni Pistoio, Vincenzo Troiano, Michela Pucatti, Anna Latiano, Angelo Andriulli, Antonio Tucci, and Orazio Palmieri

Subjects
Enterobiasis vermicularis, PCR, stool (DNA) test, pinworm infection, ribosomal DNA–rDNA, Microbiology, QR1-502
Abstract

BackgroundEnterobius vermicularis (E. vermicularis) is a nematode that infects up to 200 million people worldwide, despite effective medications being available. Conventional diagnostic tests are hindered by low sensitivity and poor patient compliance. Furthermore, no biomolecular techniques are available for clinical application. The aim of this study was to develop a procedure specifically designed for clinical application to detect E. vermicularis by means of PCR.Materials and methodsTwo subject groups were taken into account: a group of 27 infected patients and a control group of 27 healthy subjects. A nested-PCR was performed on fecal samples to detect E. vermicularis. Due to the intrinsic difficulties of the fecal matrix, several countermeasures were adopted to ensure the efficient performance of the method: (a) a large amount of feces for the extraction process (20 g instead of 200 mg); (b) a combination of chemical and physical treatments to grind the fecal matrix; (c) an additional purification process for the negative samples after the first nested-PCR; and (d) the selection of a very specific target region for the PCR.ResultsDue to the lack of overlap with other organisms, a sequence of the 5S ribosomal DNA (rDNA) spacer region including the tract SL1 was chosen to design appropriate external and internal primers. The first nested-PCR detected E.vermicularis in 19/27 samples from infected patients. After further purification, 5/8 of the negative samples resulted positive at the second PCR. Conversely, all the samples from healthy controls resulted negative to both PCRs. Sensitivity and specificity of the method were, respectively, 88.9% and 100%.ConclusionThe results prove the high diagnostic accuracy of the proposed method, addressing and overcoming the challenges posed by both conventional tests and PCR-based approaches. Therefore, the method can be proposed for clinical application.

Published
2022
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25. Clinical efficacy of sequential treatments in KRASG12C-mutant metastatic colorectal cancer: findings from a real-life multicenter Italian study (CRC-KR GOIM)

Author

Ciardiello, D., Chiarazzo, C., Famiglietti, V., Damato, A., Pinto, C., Zampino, M.G., Castellano, G., Gervaso, L., Zaniboni, A., Oneda, E., Rapisardi, S., Bordonaro, R., Zichi, C., De Vita, F., Di Maio, M., Parisi, A., Giampieri, R., Berardi, R., Lavacchi, D., Antonuzzo, L., Tamburini, E., Maiorano, B.A., Parrella, P., Latiano, T.P., Normanno, N., De Stefano, A., Avallone, A., Martini, G., Napolitano, S., Troiani, T., Martinelli, E., Ciardiello, F., and Maiello, E.

Published
2022
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29. Bevacizumab-induced hypertension as a predictor of clinical outcome in metastatic colorectal cancer: An individual patient data-based pooled analysis of two randomized studies and a systematic review of the literature

Author

Lombardi, Pasquale, Rossini, Daniele, Crespi, Veronica, Germani, Marco Maria, Bergamo, Francesca, Pietrantonio, Filippo, Santini, Daniele, Allegrini, Giacomo, Daniel, Francesca, Pagani, Filippo, Antoniotti, Carlotta, Zaniboni, Alberto, Conca, Veronica, Latiano, Tiziana Pia, Boccaccino, Alessandra, Passardi, Alessandro, Tamburini, Emiliano, Masi, Gianluca, Di Maio, Massimo, and Cremolini, Chiara

Published
2022
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30. Efficacy and safety of a biomarker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF wild type tumors at start of first line: The CAPRI 2 GOIM trial

Author

Giulia Martini, Davide Ciardiello, Stefania Napolitano, Erika Martinelli, Teresa Troiani, Tiziana Pia Latiano, Antonio Avallone, Nicola Normanno, Massimo Di Maio, Evaristo Maiello, and Fortunato Ciardiello

Subjects
colorectal cancer, EGFR, liquid biopsy, biomarker, cetuximab, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

BackgroundMonoclonal antibodies targeting EGFR such as cetuximab or panitumumab represent a major step forward in the treatment of RAS wild type (WT) metastatic colorectal cancer (mCRC). Unfortunately, primary and acquired resistance mechanisms occur, with a huge percentage of patients succumbing to the disease. In the last years, RAS mutation has been identified as the main molecular driver that determine resistance to anti-EGFR monoclonal antibodies. Liquid biopsy analysis allows to a dynamic and longitudinal assessment of mutational status during mCRC disease and has provided important information on the use of anti-EGFR drugs beyond progression or as rechallenge strategy in patients with RAS WT tumors.MethodsThe phase II CAPRI 2 GOIM trial investigates the efficacy and safety of a bio-marker-driven cetuximab-based treatment regimen over 3 treatment lines in mCRC patients with RAS/BRAF WT tumors at start of first line.DiscussionThe aim of the study is to identify patients with RAS/BRAF WT tumors defined as “addicted” to an-anti EGFR based treatment along three lines of therapy. Moreover, the trial will evaluate the activity of cetuximab re-introduction in combination with irinotecan as 3rd line therapy as rechallenge for patients that will be treated in second line with FOLFOX plus bevacizumab, having a RAS/BRAF mutant disease at progression after FOLFIRI plus cetuximab first line. A novel characteristic of this program is that the therapeutic algorithm will be defined at each treatment decision (first line, second line and third line) in a prospective fashion in each patient by a liquid biopsy assessment of RAS/BRAF status by a comprehensive 324 genes Foundation One Liquid assay (Foundation/Roche).Trial registrationEudraCT Number: 2020-003008-15, ClinicalTrials.gov identifier: NCT05312398.

Published
2023
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31. Female-Specific Association Between Variants on Chromosome 9 and Self-Reported Diagnosis of Irritable Bowel Syndrome

Author

Bonfiglio, Ferdinando, Zheng, Tenghao, Garcia-Etxebarria, Koldo, Hadizadeh, Fatemeh, Bujanda, Luis, Bresso, Francesca, Agreus, Lars, Andreasson, Anna, Dlugosz, Aldona, Lindberg, Greger, Schmidt, Peter T, Karling, Pontus, Ohlsson, Bodil, Simren, Magnus, Walter, Susanna, Nardone, Gerardo, Cuomo, Rosario, Usai-Satta, Paolo, Galeazzi, Francesca, Neri, Matteo, Portincasa, Piero, Bellini, Massimo, Barbara, Giovanni, Latiano, Anna, Hübenthal, Matthias, Thijs, Vincent, Netea, Mihai G, Jonkers, Daisy, Chang, Lin, Mayer, Emeran A, Wouters, Mira M, Boeckxstaens, Guy, Camilleri, Michael, Franke, Andre, Zhernakova, Alexandra, and D'Amato, Mauro

Subjects
Genetics, Prevention, Digestive Diseases, Pain Research, Human Genome, 2.1 Biological and endogenous factors, Aetiology, Adult, Aged, Chromosomes, Human, Pair 9, Constipation, Europe, Female, Genetic Predisposition to Disease, Genetic Variation, Genome-Wide Association Study, Genotype, Humans, Irritable Bowel Syndrome, Male, Menarche, Middle Aged, Polymorphism, Single Nucleotide, Self Report, Sex Factors, Sweden, United States, SNP, Biobank Research, Bowel Symptoms, Clinical Sciences, Neurosciences, Paediatrics and Reproductive Medicine, Gastroenterology & Hepatology
Abstract

Background & aimsGenetic factors are believed to affect risk for irritable bowel syndrome (IBS), but there have been no sufficiently powered and adequately sized studies. To identify DNA variants associated with IBS risk, we performed a genome-wide association study (GWAS) of the large UK Biobank population-based cohort, which includes genotype and health data from 500,000 participants.MethodsWe studied 7,287,191 high-quality single nucleotide polymorphisms in individuals who self-reported a doctor's diagnosis of IBS (cases; n = 9576) compared to the remainder of the cohort (controls; n = 336,499) (mean age of study subjects, 40-69 years). Genome-wide significant findings were further investigated in 2045 patients with IBS from tertiary centers and 7955 population controls from Europe and the United States, and a small general population sample from Sweden (n = 249). Functional annotation of GWAS results was carried out by integrating data from multiple biorepositories to obtain biological insights from the observed associations.ResultsWe identified a genome-wide significant association on chromosome 9q31.2 (single nucleotide polymorphism rs10512344; P = 3.57 × 10-8) in a region previously linked to age at menarche, and 13 additional loci of suggestive significance (P < 5.0×10-6). Sex-stratified analyses revealed that the variants at 9q31.2 affect risk of IBS in women only (P = 4.29 × 10-10 in UK Biobank) and also associate with constipation-predominant IBS in women (P = .015 in the tertiary cohort) and harder stools in women (P = .0012 in the population-based sample). Functional annotation of the 9q31.2 locus identified 8 candidate genes, including the elongator complex protein 1 gene (ELP1 or IKBKAP), which is mutated in patients with familial dysautonomia.ConclusionsIn a sufficiently powered GWAS of IBS, we associated variants at the locus 9q31.2 with risk of IBS in women. This observation may provide additional rationale for investigating the role of sex hormones and autonomic dysfunction in IBS.

Published
2018

32. Ramucirumab plus paclitaxel as switch maintenance versus continuation of oxaliplatin-based chemotherapy in patients (pts) with advanced HER2-negative gastric or gastroesophageal junction (GEJ) cancer: The ARMANI phase III trial.

Author

Pietrantonio, Filippo, primary, Randon, Giovanni, additional, Lonardi, Sara, additional, Garattini, Silvio Ken, additional, Tamberi, Stefano, additional, Giommoni, Elisa, additional, Di Donato, Samantha, additional, Fornaro, Lorenzo, additional, Brunetti, Oronzo, additional, De Vita, Ferdinando, additional, Frassineti, Giovanni Luca, additional, Chini, Claudio, additional, Spallanzani, Andrea, additional, Bethaz, Valerie, additional, Strippoli, Antonia, additional, Latiano, Tiziana Pia, additional, Cardellino, Giovanni Gerardo, additional, Palermo, Federica, additional, Miceli, Rosalba, additional, and Di Bartolomeo, Maria, additional

Published
2024
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33. Deciphering Microbial Composition in Patients with Inflammatory Bowel Disease: Implications for Therapeutic Response to Biologic Agents.

Author

Palmieri, Orazio, Bossa, Fabrizio, Castellana, Stefano, Latiano, Tiziana, Carparelli, Sonia, Martino, Giuseppina, Mangoni, Manuel, Corritore, Giuseppe, Nardella, Marianna, Guerra, Maria, Biscaglia, Giuseppe, Perri, Francesco, Mazza, Tommaso, and Latiano, Anna

Subjects
INFLAMMATORY bowel diseases, CROHN'S disease, SHORT-chain fatty acids, ULCERATIVE colitis, GUT microbiome
Abstract

Growing evidence suggests that alterations in the gut microbiome impact the development of inflammatory bowel diseases (IBDs), including Crohn's disease (CD) and ulcerative colitis (UC). Although IBD often requires the use of immunosuppressant drugs and biologic therapies to facilitate clinical remission and mucosal healing, some patients do not benefit from these drugs, and the reasons for this remain poorly understood. Despite advancements, there is still a need to develop biomarkers to help predict prognosis and guide treatment decisions. The aim of this study was to investigate the gut microbiome of IBD patients using biologics to identify microbial signatures associated with responses, following standard accepted criteria. Microbiomes in 66 stool samples from 39 IBD patients, comprising 20 CD and 19 UC patients starting biologic therapies, and 29 samples from healthy controls (HCs) were prospectively analyzed via NGS and an ensemble of metagenomics analysis tools. At baseline, differences were observed in alpha and beta metrics among patients with CD, UC and HC, as well as between the CD and UC groups. The degree of dysbiosis was more pronounced in CD patients, and those with dysbiosis exhibited a limited response to biological drugs. Pairwise differential abundance analyses revealed an increasing trend in the abundance of an unannotated genus from the Clostridiales order, Gemmiger genus and an unannotated genus from the Rikenellaceae family, which were consistently identified in greater abundance in HC. The Clostridium genus was more abundant in CD patients. At baseline, a greater abundance of the Odoribacter and Ruminococcus genera was found in IBD patients who responded to biologics at 14 weeks, whereas a genus identified as SMB53 was more enriched at 52 weeks. The Collinsella genus showed a higher prevalence among non-responder IBD patients. Additionally, a greater abundance of an unclassified genus from the Barnesiellaceae family and one from Lachnospiraceae was observed in IBD patients responding to Vedolizumab at 14 weeks. Our analyses showed global microbial diversity, mainly in CD. This indicated the absence or depletion of key taxa responsible for producing short-chain fatty acids (SCFAs). We also identified an abundance of pathobiont microbes in IBD patients at baseline, particularly in non-responders to biologic therapies. Furthermore, specific bacteria-producing SCFAs were abundant in patients responding to biologics and in those responding to Vedolizumab. [ABSTRACT FROM AUTHOR]

Published
2024
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34. Mucosal Microbiota from Colorectal Cancer, Adenoma and Normal Epithelium Reveals the Imprint of Fusobacterium nucleatum in Cancerogenesis

Author

Orazio Palmieri, Stefano Castellana, Anna Latiano, Tiziana Latiano, Annamaria Gentile, Anna Panza, Marianna Nardella, Davide Ciardiello, Tiziana Pia Latiano, Giuseppe Corritore, Tommaso Mazza, Francesco Perri, and Giuseppe Biscaglia

Subjects
colorectal cancer, adenomas, microbiota, Fusobacterium nucleatum, Biology (General), QH301-705.5
Abstract

An increasing amount of evidence suggests the emerging role of the gut microbiota in the development of colorectal cancer (CRC). This study aimed to elucidate the architecture of microbial communities within normal and neoplastic colonic mucosa. Methods: Microbiota were analyzed by NGS and by an ensemble of metagenomics analysis tools in a total of 69 tissues from 9 patients with synchronous colorectal neoplasia and adenomas (27 specimens: 9 from normal tissues, 9 adenomas, and 9 tumours), 16 patients with only colonic adenomas (32 specimens: 16 from normal tissues and 16 adenomas), and from healthy subjects (10 specimens of normal mucosa). Results: Weak differences were observed in alpha and beta metrics among the synchronous tissues from CRC and controls. Through pairwise differential abundance analyses of sample groups, an increasing trend of Rikenellaceae, Pseudomonas and Fusobacterium, and decreasing trends of Staphylococcus, Actinobacillus and Gemmiger were observed in CRC, while Staphylococcus and Bifidobacterium were decreased in patients with only adenomas. At RT-qPCR analysis, Fusobacterium nucleatum was significantly enriched in all the tissues of subjects with synchronous colorectal neoplasia. Conclusion: Our findings provide a comprehensive view of the human mucosa-associated gut microbiota, emphasizing global microbial diversity mostly in synchronous lesions and proving the constant presence of Fusobacterium nucleatum, with its ability to drive carcinogenesis.

Published
2023
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35. Inflammatory bowel disease genomics, transcriptomics, proteomics and metagenomics meet artificial intelligence

Author

Cannarozzi, Anna Lucia, Latiano, Anna, Massimino, Luca, Bossa, Fabrizio, Giuliani, Francesco, Riva, Matteo, Ungaro, Federica, Guerra, Maria, Brina, Anna Laura Di, Biscaglia, Giuseppe, Tavano, Francesca, Carparelli, Sonia, Fiorino, Gionata, Danese, Silvio, Perri, Francesco, and Palmieri, Orazio

Abstract

Various extrinsic and intrinsic factors such as drug exposures, antibiotic treatments, smoking, lifestyle, genetics, immune responses, and the gut microbiome characterize ulcerative colitis and Crohn's disease, collectively called inflammatory bowel disease (IBD). All these factors contribute to the complexity and heterogeneity of the disease etiology and pathogenesis leading to major challenges for the scientific community in improving management, medical treatments, genetic risk, and exposome impact. Understanding the interaction(s) among these factors and their effects on the immune system in IBD patients has prompted advances in multi‐omics research, the development of new tools as part of system biology, and more recently, artificial intelligence (AI) approaches. These innovative approaches, supported by the availability of big data and large volumes of digital medical datasets, hold promise in better understanding the natural histories, predictors of disease development, severity, complications and treatment outcomes in complex diseases, providing decision support to doctors, and promising to bring us closer to the realization of the “precision medicine” paradigm. This review aims to provide an overview of current IBD omics based on both individual (genomics, transcriptomics, proteomics, metagenomics) and multi‐omics levels, highlighting how AI can facilitate the integration of heterogeneous data to summarize our current understanding of the disease and to identify current gaps in knowledge to inform upcoming research in this field.

Published
2024
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36. The use of liquid biopsy comprehensive genomic profiling to identify the molecular landscape of patients with metastatic colorectal cancer who are candidates for anti-EGFR rechallange therapy: Findings from the CAVE-2 GOIM trial.

Author

Napolitano, Stefania, Boscolo Bielo, Luca, Martini, Giulia, Pietrantonio, Filippo, Pisconti, Salvatore, Sartore-Bianchi, Andrea, Blasi, Livio, Tortora, Giampaolo, Zaniboni, Alberto, Pinto, Carmine, Santabarbara, Giuseppe, Avallone, Antonio, Leo, Silvana, Lotesoriere, Claudio, Latiano, Tiziana, Zampino, M. Giulia, Martinelli, Erika, Troiani, Teresa, Ciardiello, Fortunato, and Ciardiello, Davide

Published
2025
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37. Activity and Safety of NAB-FOLFIRI and NAB-FOLFOX as First-Line Treatment for metastatic Pancreatic Cancer (NabucCO Study)

Author

Elisa Giommoni, Evaristo Maiello, Vanja Vaccaro, Ermanno Rondini, Caterina Vivaldi, Giampaolo Tortora, Laura Toppo, Guido Giordano, Tiziana Pia Latiano, Cinzia Lamperini, Serena Pillozzi, Luca Boni, Lorenzo Antonuzzo, and Francesco Di Costanzo

Subjects
metastatic pancreatic cancer, nab-paclitaxel, FOLFIRINOX, dose finding, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Background: Relevant improvement in first-line treatment of metastatic pancreatic cancer (mPC) was provided by FOLFIRINOX and by gemcitabine (gem) plus nab-paclitaxel (Nab-p) regimens. Regardless of the first-line treatment survival benefit, most patients survive less than 1 year. Aim: The objectives of this multicenter phase I/II study were to evaluate as first-line chemotherapy (CT) two modified regimens of FOLFIRINOX, replacing either oxaliplatin (Oxa) or irinotecan with Nab-p, in patients with mPC. Methods: The primary objectives of phase 1 were the definition of the dose limit binations, while for phase II they were the characterization of safety and activity of Nab-FOLFIRI and Nab-FOLFOX in mPC. Results: Sixty-three patients received Nab-FOLFIRI or Nab-FOLFOX in phase I. We defined MTD at 120 mg/m2 for Nab-p with FOLFIRI and 160 mg/m2 with FOLFOX. In phase II, we randomized 42 patients for each arm with the following results: (1) overall response rate (ORR) was 31% for both schedules; (2) a clinical benefit rate (CBR) of 69% and 71%; (3) 1-year survival was 41% and 50%; (4) progression free survival (PFS) was 6 months and 5.6 months; (5) median overall survival (OS) was 10.2 and 10.4 months for Nab-FOLFIRI and Nab-FOLFOX, respectively. (6) Neutropenia was the most common grade ≥3 adverse event in our regimens, significantly lower than that reported for the FOLFIRINOX triplet. Conclusion: Nab-FOLFIRI and Nab-FOLFOX might be hopeful first-line CT options for mPC patients, with promising activity and a good safety profile.

Published
2021
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38. Focus on Achalasia in the Omics Era.

Author

Di Brina, Anna Laura Pia, Palmieri, Orazio, Cannarozzi, Anna Lucia, Tavano, Francesca, Guerra, Maria, Bossa, Fabrizio, Gentile, Marco, Merla, Antonio, Biscaglia, Giuseppe, Cuttitta, Antonello, Perri, Francesco, and Latiano, Anna

Subjects
ESOPHAGOGASTRIC junction, ESOPHAGUS diseases, SCIENTIFIC literature, ESOPHAGEAL achalasia, TRANSCRIPTOMES
Abstract

Achalasia is a rare and complex esophageal disease of unknown etiology characterized by difficulty in swallowing due to the lack of opening of the lower esophageal sphincter and the absence of esophageal peristalsis. Recent advancements in technology for analyzing DNA, RNA and biomolecules in high-throughput techniques are offering new opportunities to better understand the etiology and the pathogenetic mechanisms underlying achalasia. Through this narrative review of the scientific literature, we aim to provide a comprehensive assessment of the state-of-the-art knowledge on omics of achalasia, with particular attention to those considered relevant to the pathogenesis of the disease. The notion and importance of the multi-omics approach, its limitations and future directions are also introduced, and it is highlighted how the integration of single omics data will lead to new insights into the development of achalasia and offer clinical tools which will allow early diagnosis and better patient management. [ABSTRACT FROM AUTHOR]

Published
2024
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39. Multicenter Single-Arm, Two-Stage Phase 2 Study of Panitumumab in Patients With Cetuximab-Refractory Metastatic Colorectal Cancer: The PACER Trial

Author

Piccirillo, Maria Carmela, Avallone, Antonio, Carlomagno, Chiara, Maiello, Evaristo, Rosati, Gerardo, Alabiso, Oscar, Nasti, Guglielmo, De Placido, Sabino, Latiano, Tizana Pia, Bilancia, Domenico, Ottaiano, Alessandro, De Stefano, Alfonso, Romano, Carmela, Silvestro, Lucrezia, Nappi, Anna, Cassata, Antonino, Giordano, Pasqualina, Iaffaioli, Rosario Vincenzo, Normanno, Nicola, Perrone, Francesco, and Daniele, Bruno

Published
2020
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40. Bevacizumab in Combination With Either FOLFOX-4 or XELOX-2 in First-line Treatment of Patients With Metastatic Colorectal Cancer: A Multicenter Randomized Phase II Trial of the Gruppo Oncologico dell’Italia Meridionale (GOIM 2802)

Author

Maiello, Evaristo, Di Maggio, Gabriele, Cordio, Stefano, Cinieri, Saverio, Giuliani, Francesco, Pisconti, Salvatore, Rinaldi, Antonio, Febbraro, Antonio, Latiano, Tiziana Pia, Aieta, Michele, Rossi, Antonio, Rizzi, Daniele, Di Maio, Massimo, Colucci, Giuseppe, and Bordonaro, Roberto

Published
2020
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41. Upfront FOLFOXIRI plus bevacizumab and reintroduction after progression versus mFOLFOX6 plus bevacizumab followed by FOLFIRI plus bevacizumab in the treatment of patients with metastatic colorectal cancer (TRIBE2): a multicentre, open-label, phase 3, randomised, controlled trial

Author

Falcone, Alfredo, Lonardi, Sara, De Braud, Filippo Guglielmo Maria, Bordonaro, Roberto, Maiello, Evaristo, Tamburini, Emiliano, Santini, Daniele, Frassineti, Giovanni Luca, Gamucci, Teresa, Aprile, Giuseppe, Zaniboni, Alberto, Granetto, Cristina, Buonadonna, Angela, Di Costanzo, Francesco, Tomasello, Gianluca, Gianni, Luca, Di Donato, Samantha, Carlomagno, Chiara, Clavarezza, Matteo, Racca, Patrizia, Mambrini, Andrea, Roselli, Mario, Allegrini, Giacomo, Sobrero, Alberto, Aglietta, Massimo, Corgna, Enrichetta, Cortesi, Enrico, Corsi, Domenico Cristiano, Ballestrero, Alberto, Bonetti, Andrea, Di Clemente, Francesco, Ruggeri, Enzo, Ciardiello, Fortunato, Benasso, Marco, Vitello, Stefano, Cinieri, Saverio, Mosconi, Stefania, Silvestris, Nicola, Frassoldati, Antonio, Cupini, Samantha, Bertolini, Alessandro, Tortora, Giampaolo, Bengala, Carmelo, Ferrari, Daris, Ardizzoia, Antonia, Milandri, Carlo, Chiara, Silvana, Romano, Gianpiero, Miraglia, Stefania, Scaltriti, Laura, Pucci, Francesca, Blasi, Livio, Brugnatelli, Silvia, Fioretto, Luisa, Ribecco, Angela Stefania, Longarini, Raffaella, Frisinghelli, Michela, Banzi, Maria, Cremolini, Chiara, Antoniotti, Carlotta, Rossini, Daniele, Loupakis, Fotios, Pietrantonio, Filippo, Latiano, Tiziana Pia, Passardi, Alessandro, Marmorino, Federica, Grande, Roberta, Murgioni, Sabina, Moretto, Roberto, Corallo, Salvatore, Cordio, Stefano, Antonuzzo, Lorenzo, Masi, Gianluca, Ronzoni, Monica, Ritorto, Giuliana, Cupini, Samanta, Mammoliti, Serafina, Fenocchio, Elisabetta, Zagonel, Vittorina, Fontanini, Gabriella, Ugolini, Clara, and Boni, Luca

Published
2020
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42. Fluorouracil, Leucovorin, and Irinotecan Plus Cetuximab Versus Cetuximab as Maintenance Therapy in First-Line Therapy for RAS and BRAF Wild-Type Metastatic Colorectal Cancer: Phase III ERMES Study

Author

Pinto, Carmine, primary, Orlandi, Armando, additional, Normanno, Nicola, additional, Maiello, Evaristo, additional, Calegari, Maria A., additional, Antonuzzo, Lorenzo, additional, Bordonaro, Roberto, additional, Zampino, Maria G., additional, Pini, Sara, additional, Bergamo, Francesca, additional, Tonini, Giuseppe, additional, Avallone, Antonio, additional, Latiano, Tiziana P., additional, Rosati, Gerardo, additional, Cogoni, Alessio Aligi, additional, Ballestrero, Alberto, additional, Zaniboni, Alberto, additional, Roselli, Mario, additional, Tamberi, Stefano, additional, and Barone, Carlo, additional

Published
2024
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43. BRAFV600E mutation impinges on gut microbial markers defining novel biomarkers for serrated colorectal cancer effective therapies

Author

Nadia Trivieri, Riccardo Pracella, Maria Grazia Cariglia, Concetta Panebianco, Paola Parrella, Alberto Visioli, Fabrizio Giani, Amata Amy Soriano, Chiara Barile, Giuseppe Canistro, Tiziana Pia Latiano, Lucia Dimitri, Francesca Bazzocchi, Dario Cassano, Angelo L. Vescovi, Valerio Pazienza, and Elena Binda

Subjects
Serrated human BRAF V600E colorectal carcinoma (CRC), Gut microbiota, CRC biology and biomarkers, BRAF V600E CRC non-invasive diagnosis, Anti-BRAF V600E CRC patient-tailored strategies, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background Colorectal cancer (CRC) harboring BRAF V600E mutation exhibits low response to conventional therapy and poorest prognosis. Due to the emerging correlation between gut microbiota and CRC carcinogenesis, we investigated in serrated BRAF V600E cases the existence of a peculiar fecal microbial fingerprint and specific bacterial markers, which might represent a tool for the development of more effective clinical strategies. Methods By injecting human CRC stem-like cells isolated from BRAF V600E patients in immunocompromised mice, we described a new xenogeneic model of this subtype of CRC. By performing bacterial 16S rRNA sequencing, the fecal microbiota profile was then investigated either in CRC-carrying mice or in a cohort of human CRC subjects. The microbial communities’ functional profile was also predicted. Data were compared with Mann-Whitney U, Welch’s t-test for unequal variances and Kruskal-Wallis test with Benjamini–Hochberg false discovery rate (FDR) correction, extracted as potential BRAF class biomarkers and selected as model features. The obtained mean test prediction scores were subjected to Receiver Operating characteristic (ROC) analysis. To discriminate the BRAF status, a Random Forest classifier (RF) was employed. Results A specific microbial signature distinctive for BRAF status emerged, being the BRAF-mutated cases closer to healthy controls than BRAF wild-type counterpart. In agreement, a considerable score of correlation was also pointed out between bacteria abundance from BRAF-mutated cases and the level of markers distinctive of BRAF V600E pathway, including those involved in inflammation, innate immune response and epithelial-mesenchymal transition. We provide evidence that two candidate bacterial markers, Prevotella enoeca and Ruthenibacterium lactatiformans, more abundant in BRAF V600E and BRAF wild-type subjects respectively, emerged as single factors with the best performance in distinguishing BRAF status (AUROC = 0.72 and 0.74, respectively, 95% confidence interval). Furthermore, the combination of the 10 differentially represented microorganisms between the two groups improved performance in discriminating serrated CRC driven by BRAF mutation from BRAF wild-type CRC cases (AUROC = 0.85, 95% confidence interval, 0.69–1.01). Conclusion Overall, our results suggest that BRAF V600E mutation itself drives a distinctive gut microbiota signature and provide predictive CRC-associated bacterial biomarkers able to discriminate BRAF status in CRC patients and, thus, useful to devise non-invasive patient-selective diagnostic strategies and patient-tailored optimized therapies.

Published
2020
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45. Treatments after progression to first-line FOLFOXIRI and bevacizumab in metastatic colorectal cancer: a pooled analysis of TRIBE and TRIBE2 studies by GONO

Author

Rossini, Daniele, Lonardi, Sara, Antoniotti, Carlotta, Santini, Daniele, Tomasello, Gianluca, Ermacora, Paola, Germani, Marco Maria, Bergamo, Francesca, Ricci, Vincenzo, Caponnetto, Salvatore, Moretto, Roberto, Zaniboni, Alberto, Pietrantonio, Filippo, Buonadonna, Angela, Ritorto, Giuliana, Masi, Gianluca, Latiano, Tiziana Pia, Rapisardi, Stefania, Falcone, Alfredo, and Cremolini, Chiara

Published
2021
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48. Impact of age and gender on the safety and efficacy of chemotherapy plus bevacizumab in metastatic colorectal cancer: a pooled analysis of TRIBE and TRIBE2 studies

Author

Marmorino, F., Rossini, D., Lonardi, S., Moretto, R., Zucchelli, G., Aprile, G., Dell’Aquila, E., Ratti, M., Bergamo, F., Masi, G., Urbano, F., Ronzoni, M., Libertini, M., Borelli, B., Randon, G., Buonadonna, A., Allegrini, G., Pella, N., Ricci, V., Boccaccino, A., Latiano, T.P., Cordio, S., Passardi, A., Tamburini, E., Boni, L., Falcone, A., and Cremolini, C.

Published
2019
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49. Stemness underpinning all steps of human colorectal cancer defines the core of effective therapeutic strategies

Author

Visioli, Alberto, Giani, Fabrizio, Trivieri, Nadia, Pracella, Riccardo, Miccinilli, Elide, Cariglia, Maria Grazia, Palumbo, Orazio, Arleo, Andrea, Dezi, Fabio, Copetti, Massimiliano, Cajola, Laura, Restelli, Silvia, Papa, Valerio, Sciuto, Antonio, Latiano, Tiziana Pia, Carella, Massimo, Amadori, Dino, Gallerani, Giulia, Ricci, Riccardo, Alfieri, Sergio, Pesole, Graziano, Vescovi, Angelo L., and Binda, Elena

Published
2019
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50. Association of Genetic Variants Affecting microRNAs and Pancreatic Cancer Risk

Author

Ye Lu, Chiara Corradi, Manuel Gentiluomo, Evangelina López de Maturana, George E. Theodoropoulos, Susanne Roth, Evaristo Maiello, Luca Morelli, Livia Archibugi, Jakob R. Izbicki, Patricia Sarlós, Vytautas Kiudelis, Martin Oliverius, Mateus Nóbrega Aoki, Yogesh Vashist, Casper H. J. van Eijck, Maria Gazouli, Renata Talar-Wojnarowska, Andrea Mambrini, Raffaele Pezzilli, Bas Bueno-de-Mesquita, Péter Hegyi, Pavel Souček, John P. Neoptolemos, Gregorio Di Franco, Cosimo Sperti, Emanuele F. Kauffmann, Viktor Hlaváč, Faik G. Uzunoğlu, Stefano Ermini, Ewa Małecka-Panas, Maurizio Lucchesi, Giuseppe Vanella, Frederike Dijk, Beatrice Mohelníková-Duchoňová, Franco Bambi, Maria Chiara Petrone, Krzysztof Jamroziak, Feng Guo, Katerina Kolarova, Giovanni Capretti, Anna Caterina Milanetto, Laura Ginocchi, Martin Loveček, Marta Puzzono, Hanneke W. M. van Laarhoven, Silvia Carrara, Audrius Ivanauskas, Konstantinos Papiris, Daniela Basso, Paolo G. Arcidiacono, Ferenc Izbéki, Roger Chammas, Pavel Vodicka, Thilo Hackert, Claudio Pasquali, Maria L. Piredda, Eithne Costello-Goldring, Giulia Martina Cavestro, Andrea Szentesi, Francesca Tavano, Barbara Włodarczyk, Hermann Brenner, Edita Kreivenaite, Xin Gao, Stefania Bunduc, Roel C. H. Vermeulen, Martin A. Schneider, Anna Latiano, Domenica Gioffreda, Sabrina G. G. Testoni, Juozas Kupcinskas, Rita T. Lawlor, Gabriele Capurso, Núria Malats, Daniele Campa, and Federico Canzian

Subjects
pancreatic cancer, miRNA, genetic polymorphisms, susceptibility, pancreatic ductal adenocarcinoma, Genetics, QH426-470
Abstract

Genetic factors play an important role in the susceptibility to pancreatic cancer (PC). However, established loci explain a small proportion of genetic heritability for PC; therefore, more progress is needed to find the missing ones. We aimed at identifying single nucleotide polymorphisms (SNPs) affecting PC risk through effects on micro-RNA (miRNA) function. We searched in silico the genome for SNPs in miRNA seed sequences or 3 prime untranslated regions (3'UTRs) of miRNA target genes. Genome-wide association data of PC cases and controls from the Pancreatic Cancer Cohort (PanScan) Consortium and the Pancreatic Cancer Case–Control (PanC4) Consortium were re-analyzed for discovery, and genotyping data from two additional consortia (PanGenEU and PANDoRA) were used for replication, for a total of 14,062 cases and 11,261 controls. None of the SNPs reached genome-wide significance in the meta-analysis, but for three of them the associations were in the same direction in all the study populations and showed lower value of p in the meta-analyses than in the discovery phase. Specifically, rs7985480 was consistently associated with PC risk (OR = 1.12, 95% CI 1.07–1.17, p = 3.03 × 10−6 in the meta-analysis). This SNP is in linkage disequilibrium (LD) with rs2274048, which modulates binding of various miRNAs to the 3'UTR of UCHL3, a gene involved in PC progression. In conclusion, our results expand the knowledge of the genetic PC risk through miRNA-related SNPs and show the usefulness of functional prioritization to identify genetic polymorphisms associated with PC risk.

Published
2021
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