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1. A phase II/III randomized clinical trial of CisPlatin plUs Gemcitabine and Nabpaclitaxel (GAP) as pReoperative chemotherapy versus immediate resection in patIents with resecTable BiliarY Tract Cancers (BTC) at high risk for recurrence: PURITY study

Author

Niger, Monica, Nichetti, Federico, Fornaro, Lorenzo, Pircher, Chiara, Morano, Federica, Palermo, Federica, Rimassa, Lorenza, Pressiani, Tiziana, Berardi, Rossana, Gardini, Andrea Casadei, Sperti, Elisa, Salvatore, Lisa, Melisi, Davide, Bergamo, Francesca, Siena, Salvatore, Mosconi, Stefania, Longarini, Raffaella, Arcangeli, Giuseppina, Corallo, Salvatore, Delliponti, Laura, Tamberi, Stefano, Fea, Elena, Brandi, Giovanni, Rapposelli, Ilario Giovanni, Salati, Massimiliano, Baili, Paolo, Miceli, Rosalba, Ljevar, Silva, Cavallo, Ilaria, Sottotetti, Elisa, Martinetti, Antonia, Busset, Michele Droz Dit, Sposito, Carlo, Di Bartolomeo, Maria, Pietrantonio, Filippo, de Braud, Filippo, and Mazzaferro, Vincenzo

Published
2024
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2. Pemigatinib for patients with previously treated, locally advanced or metastatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements: A joint analysis of the French PEMI-BIL and Italian PEMI-REAL cohort studies

Author

Parisi, Alessandro, Delaunay, Blandine, Pinterpe, Giada, Hollebecque, Antoine, Blanc, Jean Frederic, Bouattour, Mohamed, Assenat, Eric, Ben Abdelghani, Meher, Sarabi, Matthieu, Niger, Monica, Vivaldi, Caterina, Mandalà, Mario, Palloni, Andrea, Bensi, Maria, Garattini, Silvio Ken, Tougeron, David, Combe, Pierre, Salati, Massimiliano, Rimini, Margherita, Cella, Chiara Alessandra, Tucci, Marco, Diana, Anna, Mori, Elena, Longarini, Raffaella, Artru, Pascal, Roth, Gael, Evesque, Ludovic, Vienne, Agathe, Turpin, Anthony, Hiret, Sandrine, Bourgeois, Vincent, Herve, Camille, Paulon, Rodolphe, Stacoffe, Marion, Malka, David, Neuzillet, Cindy, Edeline, Julien, Lievre, Astrid, Guimbaud, Rosine, Chapda, Marie Christelle Pajiep, Rimassa, Lorenza, Giampieri, Riccardo, Valle, Juan, Berardi, Rossana, and Fares, Nadim

Published
2024
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3. Optimal treatment strategy after first-line induction therapy in advanced HER2-positive oeso-gastric adenocarcinoma—a retrospective, international, multicentric AGEO study

Author

Bergen, Elisabeth S., Pilla, Lorenzo, Auclin, Edouard, Ilhan-Mutlu, Aysegül, Prager, Gerald W., Pietrantonio, Filippo, Antista, Maria, Ghelardi, Filippo, Basile, Debora, Aprile, Giuseppe, Longarini, Raffaella, Hautefeuille, Vincent, Tougeron, David, Artru, Pascal, Mabro, May, Drouillard, Antoine, Roth, Gael, Ben Abdelghani, Meher, Clement, Inès, Toullec, Clemence, Mineur, Laurent, Guimbaud, Rosine, Taieb, Julien, and Zaanan, Aziz

Published
2023
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4. Codon-specific KRAS mutations predict survival benefit of trifluridine/tipiracil in metastatic colorectal cancer

Author

van de Haar, Joris, Ma, Xuhui, Ooft, Salo N., van der Helm, Pim W., Hoes, Louisa R., Mainardi, Sara, Pinato, David J., Sun, Kristi, Salvatore, Lisa, Tortora, Giampaolo, Zurlo, Ina Valeria, Leo, Silvana, Giampieri, Riccardo, Berardi, Rossana, Gelsomino, Fabio, Merz, Valeria, Mazzuca, Federica, Antonuzzo, Lorenzo, Rosati, Gerardo, Stavraka, Chara, Ross, Paul, Rodriquenz, Maria Grazia, Pavarana, Michele, Messina, Carlo, Iveson, Timothy, Zoratto, Federica, Thomas, Anne, Fenocchio, Elisabetta, Ratti, Margherita, Depetris, Ilaria, Cergnul, Massimiliano, Morelli, Cristina, Libertini, Michela, Parisi, Alessandro, De Tursi, Michele, Zanaletti, Nicoletta, Garrone, Ornella, Graham, Janet, Longarini, Raffaella, Gobba, Stefania Maria, Petrillo, Angelica, Tamburini, Emiliano, La Verde, Nicla, Petrelli, Fausto, Ricci, Vincenzo, Wessels, Lodewyk F. A., Ghidini, Michele, Cortellini, Alessio, Voest, Emile E., and Valeri, Nicola

Published
2023
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5. Prognostic Value of Body Mass Index in Stage II/III Colon Cancer: Posthoc Analysis From the TOSCA Trial

Author

Basile, Debora, Rosati, Gerardo, Bergamo, Francesca, Garattini, Silvio Ken, Banzi, Maria, Zampino, Maria, Bozzarelli, Silvia, Marchetti, Paolo, Galli, Fabio, Galli, Francesca, Longarini, Raffaella, Zaniboni, Alberto, Ferrari, Daris, De Placido, Sabino, Frassineti, Luca Giovanni, Nicolini, Mario, Cinieri, Saverio, Priscindiaro, Michele, Ziranu, Pina, Caccialanza, Riccardo, Pastorino, Alessandro, Mosconi, Stefania, and Aprile, Giuseppe

Published
2023
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7. Systemic doxycycline for pre-emptive treatment of anti-EGFR-related skin toxicity in patients with metastatic colorectal cancer receiving first-line panitumumab-based therapy: a post hoc analysis of the Valentino study

Author

Raimondi, Alessandra, Corallo, Salvatore, Lonardi, Sara, Antoniotti, Carlotta, Rimassa, Lorenza, Amatu, Alessio, Tampellini, Marco, Racca, Patrizia, Murialdo, Roberto, Clavarezza, Matteo, Zaniboni, Alberto, Toscano, Giuseppe, Tomasello, Gianluca, Petrelli, Fausto, Antonuzzo, Lorenzo, Giordano, Monica, Cinieri, Saverio, Longarini, Raffaella, Niger, Monica, Antista, Maria, Ambrosini, Margherita, Pagani, Filippo, Prisciandaro, Michele, Randon, Giovanni, de Braud, Filippo, Di Bartolomeo, Maria, Pietrantonio, Filippo, and Morano, Federica

Published
2021
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8. Health-related quality of life in patients with RAS wild-type metastatic colorectal cancer treated with panitumumab-based first-line treatment strategy: A pre-specified secondary analysis of the Valentino study

Author

Raimondi, Alessandra, Di Maio, Massimo, Morano, Federica, Corallo, Salvatore, Lonardi, Sara, Antoniotti, Carlotta, Rimassa, Lorenza, Sartore-Bianchi, Andrea, Tampellini, Marco, Ritorto, Giuliana, Murialdo, Roberto, Clavarezza, Matteo, Zaniboni, Alberto, Adamo, Vincenzo, Tomasello, Gianluca, Petrelli, Fausto, Antonuzzo, Lorenzo, Giordano, Monica, Cinieri, Saverio, Longarini, Raffaella, Bergamo, Francesca, Niger, Monica, Antista, Maria, Peverelli, Giorgia, de Braud, Filippo, Di Bartolomeo, Maria, and Pietrantonio, Filippo

Published
2020
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9. 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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10. Emerging Treatment Options for Neuroendocrine Neoplasms of Unknown Primary Origin: Current Evidence and Future Perspectives

Author

Corti, Francesca, primary, Rossi, Roberta Elisa, additional, Cafaro, Pietro, additional, Passarella, Gaia, additional, Turla, Antonella, additional, Pusceddu, Sara, additional, Coppa, Jorgelina, additional, Oldani, Simone, additional, Guidi, Alessandro, additional, Longarini, Raffaella, additional, and Cortinovis, Diego Luigi, additional

Published
2024
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11. Colorectal Cancer Pulmonary Metastasectomy: When, Why and How

Author

Petrella, Francesco, primary, Danuzzo, Federica, additional, Sibilia, Maria Chiara, additional, Vaquer, Sara, additional, Longarini, Raffaella, additional, Guidi, Alessandro, additional, Raveglia, Federico, additional, Libretti, Lidia, additional, Pirondini, Emanuele, additional, Cara, Andrea, additional, Cassina, Enrico Mario, additional, Tuoro, Antonio, additional, and Cortinovis, Diego, additional

Published
2024
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12. Ramucirumab as Second-Line Therapy in Metastatic Gastric Cancer: Real-World Data from the RAMoss Study

Author

Di Bartolomeo, Maria, Niger, Monica, Tirino, Giuseppe, Petrillo, Angelica, Berenato, Rosa, Laterza, Maria Maddalena, Pietrantonio, Filippo, Morano, Federica, Antista, Maria, Lonardi, Sara, Fornaro, Lorenzo, Tamberi, Stefano, Giommoni, Elisa, Zaniboni, Alberto, Rimassa, Lorenza, Tomasello, Gianluca, Sava, Teodoro, Spada, Massimiliano, Latiano, Tiziana, Bittoni, Alessandro, Bertolini, Alessandro, Proserpio, Ilaria, Bencardino, Katia Bruna, Graziano, Francesco, Beretta, Giordano, Galdy, Salvatore, Ventriglia, Jole, Scagnoli, Simone, Spallanzani, Andrea, Longarini, Raffaella, and De Vita, Ferdinando

Published
2018
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13. Assessment of Ramucirumab plus paclitaxel as switch maintenance versus continuation of first-line chemotherapy in patients with advanced HER-2 negative gastric or gastroesophageal junction cancers: the ARMANI phase III trial

Author

Di Bartolomeo, Maria, Niger, Monica, Morano, Federica, Corallo, Salvatore, Antista, Maria, Tamberi, Stefano, Lonardi, Sara, Di Donato, Samantha, Berardi, Rossana, Scartozzi, Mario, Cardellino, Giovanni Gerardo, Di Costanzo, Francesco, Rimassa, Lorenza, Luporini, Alberto Gianluigi, Longarini, Raffaella, Zaniboni, Alberto, Bertolini, Alessandro, Tomasello, Gianluca, Pinotti, Graziella, Scagliotti, Giorgio, Tortora, Giampaolo, Bonetti, Andrea, Spallanzani, Andrea, Frassineti, Giovanni Luca, Tassinari, Davide, Giuliani, Francesco, Cinieri, Saverio, Maiello, Evaristo, Verusio, Claudio, Bracarda, Sergio, Catalano, Vincenzo, Basso, Michele, Ciuffreda, Libero, De Vita, Ferdinando, Parra, Hector Soto, Fornaro, Lorenzo, Caporale, Marta, de Braud, Filippo, and Pietrantonio, Filippo

Published
2019
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14. Codon-specific KRAS mutations predict survival benefit of trifluridine/tipiracil in metastatic colorectal cancer

Author

van de Haar, Jori, Ma, Xuhui, Ooft, Salo N, van der Helm, Pim W, Hoes, Louisa R, Mainardi, Sara, Pinato, David J, Sun, Kristi, Salvatore, Lisa, Tortora, Giampaolo, Zurlo, Ina Valeria, Leo, Silvana, Giampieri, Riccardo, Berardi, Rossana, Gelsomino, Fabio, Merz, Valeria, Mazzuca, Federica, Antonuzzo, Lorenzo, Rosati, Gerardo, Stavraka, Chara, Ross, Paul, Rodriquenz, Maria Grazia, Pavarana, Michele, Messina, Carlo, Iveson, Timothy, Zoratto, Federica, Thomas, Anne, Fenocchio, Elisabetta, Ratti, Margherita, Depetris, Ilaria, Cergnul, Massimiliano, Morelli, Cristina, Libertini, Michela, Parisi, Alessandro, De Tursi, Michele, Zanaletti, Nicoletta, Garrone, Ornella, Graham, Janet, Longarini, Raffaella, Gobba, Stefania Maria, Petrillo, Angelica, Tamburini, Emiliano, La Verde, Nicla, Petrelli, Fausto, Ricci, Vincenzo, Wessels, Lodewyk F A, Ghidini, Michele, Cortellini, Alessio, Voest, Emile E, Valeri, Nicola, Tortora, Giampaolo (ORCID:0000-0002-1378-4962), van de Haar, Jori, Ma, Xuhui, Ooft, Salo N, van der Helm, Pim W, Hoes, Louisa R, Mainardi, Sara, Pinato, David J, Sun, Kristi, Salvatore, Lisa, Tortora, Giampaolo, Zurlo, Ina Valeria, Leo, Silvana, Giampieri, Riccardo, Berardi, Rossana, Gelsomino, Fabio, Merz, Valeria, Mazzuca, Federica, Antonuzzo, Lorenzo, Rosati, Gerardo, Stavraka, Chara, Ross, Paul, Rodriquenz, Maria Grazia, Pavarana, Michele, Messina, Carlo, Iveson, Timothy, Zoratto, Federica, Thomas, Anne, Fenocchio, Elisabetta, Ratti, Margherita, Depetris, Ilaria, Cergnul, Massimiliano, Morelli, Cristina, Libertini, Michela, Parisi, Alessandro, De Tursi, Michele, Zanaletti, Nicoletta, Garrone, Ornella, Graham, Janet, Longarini, Raffaella, Gobba, Stefania Maria, Petrillo, Angelica, Tamburini, Emiliano, La Verde, Nicla, Petrelli, Fausto, Ricci, Vincenzo, Wessels, Lodewyk F A, Ghidini, Michele, Cortellini, Alessio, Voest, Emile E, Valeri, Nicola, and Tortora, Giampaolo (ORCID:0000-0002-1378-4962)

Abstract

Genomics has greatly improved how patients with cancer are being treated; however, clinical-grade genomic biomarkers for chemotherapies are currently lacking. Using whole-genome analysis of 37 patients with metastatic colorectal cancer (mCRC) treated with the chemotherapy trifluridine/tipiracil (FTD/TPI), we identified KRAS codon G12 (KRAS(G12)) mutations as a potential biomarker of resistance. Next, we collected real-world data of 960 patients with mCRC receiving FTD/TPI and validated that KRAS(G12) mutations were significantly associated with poor survival, also in analyses restricted to the RAS/RAF mutant subgroup. We next analyzed the data of the global, double-blind, placebo-controlled, phase 3 RECOURSE trial (n = 800 patients) and found that KRAS(G12) mutations (n = 279) were predictive biomarkers for reduced overall survival (OS) benefit of FTD/TPI versus placebo (unadjusted interaction P = 0.0031, adjusted interaction P = 0.015). For patients with KRAS(G12) mutations in the RECOURSE trial, OS was not prolonged with FTD/TPI versus placebo (n = 279; hazard ratio (HR) = 0.97; 95% confidence interval (CI) = 0.73-1.20; P = 0.85). In contrast, patients with KRAS(G13) mutant tumors showed significantly improved OS with FTD/TPI versus placebo (n = 60; HR = 0.29; 95% CI = 0.15-0.55; P < 0.001). In isogenic cell lines and patient-derived organoids, KRAS(G12) mutations were associated with increased resistance to FTD-based genotoxicity. In conclusion, these data show that KRAS(G12) mutations are biomarkers for reduced OS benefit of FTD/TPI treatment, with potential implications for approximately 28% of patients with mCRC under consideration for treatment with FTD/TPI. Furthermore, our data suggest that genomics-based precision medicine may be possible for a subset of chemotherapies.A combination of real-world evidence and a reanalysis of phase 3 clinical trial data unveils KRAS codon G12 mutations as a biomarker of resistance to trifluridine/tipiracil in metastatic

Published
2023

15. Supplementary Figure S5 from Capecitabine and Temozolomide versus FOLFIRI in RAS-Mutated, MGMT-Methylated Metastatic Colorectal Cancer

Author

Pietrantonio, Filippo, primary, Lobefaro, Riccardo, primary, Antista, Maria, primary, Lonardi, Sara, primary, Raimondi, Alessandra, primary, Morano, Federica, primary, Mosconi, Stefania, primary, Rimassa, Lorenza, primary, Murgioni, Sabina, primary, Sartore-Bianchi, Andrea, primary, Tomasello, Gianluca, primary, Longarini, Raffaella, primary, Farina, Gabriella, primary, Petrelli, Fausto, primary, Gori, Stefania, primary, Randon, Giovanni, primary, Corallo, Salvatore, primary, Pagani, Filippo, primary, Guarini, Vincenzo, primary, Palermo, Federica, primary, Martinetti, Antonia, primary, Macagno, Marco, primary, Barault, Ludovic, primary, Perrone, Federica, primary, Tamborini, Elena, primary, Milione, Massimo, primary, Di Nicolantonio, Federica, primary, Di Maio, Massimo, primary, Fucà, Giovanni, primary, Di Bartolomeo, Maria, primary, and de Braud, Filippo, primary

Published
2023
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16. Supplementary Appendix from Capecitabine and Temozolomide versus FOLFIRI in RAS-Mutated, MGMT-Methylated Metastatic Colorectal Cancer

Author

Pietrantonio, Filippo, primary, Lobefaro, Riccardo, primary, Antista, Maria, primary, Lonardi, Sara, primary, Raimondi, Alessandra, primary, Morano, Federica, primary, Mosconi, Stefania, primary, Rimassa, Lorenza, primary, Murgioni, Sabina, primary, Sartore-Bianchi, Andrea, primary, Tomasello, Gianluca, primary, Longarini, Raffaella, primary, Farina, Gabriella, primary, Petrelli, Fausto, primary, Gori, Stefania, primary, Randon, Giovanni, primary, Corallo, Salvatore, primary, Pagani, Filippo, primary, Guarini, Vincenzo, primary, Palermo, Federica, primary, Martinetti, Antonia, primary, Macagno, Marco, primary, Barault, Ludovic, primary, Perrone, Federica, primary, Tamborini, Elena, primary, Milione, Massimo, primary, Di Nicolantonio, Federica, primary, Di Maio, Massimo, primary, Fucà, Giovanni, primary, Di Bartolomeo, Maria, primary, and de Braud, Filippo, primary

Published
2023
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17. Clinical treatment of cholangiocarcinoma: an updated comprehensive review

Author

Elvevi, A, Laffusa, A, Scaravaglio, M, Rossi, R, Longarini, R, Stagno, A, Cristoferi, L, Ciaccio, A, Cortinovis, D, Invernizzi, P, Massironi, S, Elvevi, Alessandra, Laffusa, Alice, Scaravaglio, Miki, Rossi, Roberta Elisa, Longarini, Raffaella, Stagno, Anna Maria, Cristoferi, Laura, Ciaccio, Antonio, Cortinovis, Diego Luigi, Invernizzi, Pietro, Massironi, Sara, Elvevi, A, Laffusa, A, Scaravaglio, M, Rossi, R, Longarini, R, Stagno, A, Cristoferi, L, Ciaccio, A, Cortinovis, D, Invernizzi, P, Massironi, S, Elvevi, Alessandra, Laffusa, Alice, Scaravaglio, Miki, Rossi, Roberta Elisa, Longarini, Raffaella, Stagno, Anna Maria, Cristoferi, Laura, Ciaccio, Antonio, Cortinovis, Diego Luigi, Invernizzi, Pietro, and Massironi, Sara

Abstract

Cholangiocarcinoma (CCA) is a heterogeneous group of neoplasms of the bile ducts and represents the second most common hepatic cancer after hepatocellular carcinoma; it is sub-classified as intrahepatic cholangiocarcinoma (iCCA) and extrahepatic cholangiocarcinoma (eCCA), the latter comprising both perihilar cholangiocarcinoma (pCCA or Klatskin tumor), and distal cholangiocarcinoma (dCCA). The global incidence of CCA has increased worldwide in recent decades. Chronic inflammation of biliary epithelium and bile stasis represent the main risk factors shared by all CCA sub-types. When feasible, liver resection is the treatment of choice for CCA, followed by systemic chemotherapy with capecitabine. Liver transplants represent a treatment option in patients with very early iCCA, in referral centers only. CCA diagnosis is often performed at an advanced stage when CCA is unresectable. In this setting, systemic chemotherapy with gemcitabine and cisplatin represents the first treatment option, but the prognosis remains poor. In order to ameliorate patients’ survival, new drugs have been studied in the last few years. Target therapies are directed against different molecules, which are altered in CCA cells. These therapies have been studied as second-line therapy, alone or in combination with chemotherapy. In the same setting, the immune checkpoints inhibitors targeting programmed death 1 (PD-1), programmed death-ligand 1 (PD-L1), cytotoxic T-lymphocyte antigen-4 (CTLA-4), have been proposed, as well as cancer vaccines and adoptive cell therapy (ACT). These experimental treatments showed promising results and have been proposed as second- or third-line treatment, alone or in combination with chemotherapy or target therapies.

Published
2022

18. Codon-specific KRASmutations predict survival benefit of trifluridine/tipiracil in metastatic colorectal cancer

Author

van de Haar, Joris, Ma, Xuhui, Ooft, Salo N., van der Helm, Pim W., Hoes, Louisa R., Mainardi, Sara, Pinato, David J., Sun, Kristi, Salvatore, Lisa, Tortora, Giampaolo, Zurlo, Ina Valeria, Leo, Silvana, Giampieri, Riccardo, Berardi, Rossana, Gelsomino, Fabio, Merz, Valeria, Mazzuca, Federica, Antonuzzo, Lorenzo, Rosati, Gerardo, Stavraka, Chara, Ross, Paul, Rodriquenz, Maria Grazia, Pavarana, Michele, Messina, Carlo, Iveson, Timothy, Zoratto, Federica, Thomas, Anne, Fenocchio, Elisabetta, Ratti, Margherita, Depetris, Ilaria, Cergnul, Massimiliano, Morelli, Cristina, Libertini, Michela, Parisi, Alessandro, De Tursi, Michele, Zanaletti, Nicoletta, Garrone, Ornella, Graham, Janet, Longarini, Raffaella, Gobba, Stefania Maria, Petrillo, Angelica, Tamburini, Emiliano, La Verde, Nicla, Petrelli, Fausto, Ricci, Vincenzo, Wessels, Lodewyk F. A., Ghidini, Michele, Cortellini, Alessio, Voest, Emile E., and Valeri, Nicola

Abstract

Genomics has greatly improved how patients with cancer are being treated; however, clinical-grade genomic biomarkers for chemotherapies are currently lacking. Using whole-genome analysis of 37 patients with metastatic colorectal cancer (mCRC) treated with the chemotherapy trifluridine/tipiracil (FTD/TPI), we identified KRAScodon G12 (KRASG12) mutations as a potential biomarker of resistance. Next, we collected real-world data of 960 patients with mCRC receiving FTD/TPI and validated that KRASG12mutations were significantly associated with poor survival, also in analyses restricted to the RAS/RAFmutant subgroup. We next analyzed the data of the global, double-blind, placebo-controlled, phase 3 RECOURSE trial (n= 800 patients) and found that KRASG12mutations (n= 279) were predictive biomarkers for reduced overall survival (OS) benefit of FTD/TPI versus placebo (unadjusted interaction P= 0.0031, adjusted interaction P= 0.015). For patients with KRASG12mutations in the RECOURSE trial, OS was not prolonged with FTD/TPI versus placebo (n= 279; hazard ratio (HR) = 0.97; 95% confidence interval (CI) = 0.73–1.20; P= 0.85). In contrast, patients with KRASG13mutant tumors showed significantly improved OS with FTD/TPI versus placebo (n= 60; HR = 0.29; 95% CI = 0.15–0.55; P< 0.001). In isogenic cell lines and patient-derived organoids, KRASG12mutations were associated with increased resistance to FTD-based genotoxicity. In conclusion, these data show that KRASG12mutations are biomarkers for reduced OS benefit of FTD/TPI treatment, with potential implications for approximately 28% of patients with mCRC under consideration for treatment with FTD/TPI. Furthermore, our data suggest that genomics-based precision medicine may be possible for a subset of chemotherapies.

Published
2023
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19. Validation of the Italian version of the full and abbreviated Trust in Oncologist Scale

Author

Bani, M, Rossi, E, Cortinovis, D, Russo, S, Gallina, F, Hillen, M, Canova, S, Cicchiello, F, Longarini, R, Cazzaniga, M, Bidoli, P, Valsecchi, M, Strepparava, M, Bani, Marco, Rossi, Emanuela, Cortinovis, Diego, Russo, Selena, Gallina, Francesca, Hillen, Marij A, Canova, Stefania, Cicchiello, Federica, Longarini, Raffaella, Cazzaniga, Marina Elena, Bidoli, Paolo, Valsecchi, Maria Grazia, Strepparava, Maria Grazia, Bani, M, Rossi, E, Cortinovis, D, Russo, S, Gallina, F, Hillen, M, Canova, S, Cicchiello, F, Longarini, R, Cazzaniga, M, Bidoli, P, Valsecchi, M, Strepparava, M, Bani, Marco, Rossi, Emanuela, Cortinovis, Diego, Russo, Selena, Gallina, Francesca, Hillen, Marij A, Canova, Stefania, Cicchiello, Federica, Longarini, Raffaella, Cazzaniga, Marina Elena, Bidoli, Paolo, Valsecchi, Maria Grazia, and Strepparava, Maria Grazia

Abstract

Introduction: The Trust in Oncologist Scale (TiOS) is an 18-item questionnaire aimed to assess the cancer patients' trust in their oncologist and has been validated in Dutch and English language. This study aims to validate the Italian version of the TiOS (IT-TiOS) and the TiOS-Short Form (IT-TiOS-SF). Methods: The IT-TiOS was administered to 194 patients recruited in an Italian oncology department from April to December 2018. Data collected included socio-demographic data, health and clinical information, satisfaction with the most recent oncology visit and trust in the regional healthcare system. Internal consistency, test–retest reliability, convergent and the structural validity of both the full and short form were tested. Results: Factor analyses indicated that neither four-factor nor one-factor models of the full scale were acceptable. However, confirmatory factor analysis supported the one-dimensionality of the IT-TiOS-SF, and internal consistency assessed with Cronbach's alpha was 0.88. Mean scores on the IT-TiOS-SF correlated with satisfaction with the oncologist (rs = 0.64) and willingness to recommend the oncologist to others (rs = 0.67), confirming good construct validity. Conclusion: The IT-TiOS-SF demonstrates good psychometric properties and can be used to assess trust for both clinical and research purposes.

Published
2021

20. Trust in Oncologist Scale--Short Form; Italian Version

Author

Bani, Marco, primary, Rossi, Emanuela, additional, Cortinovis, Diego, additional, Russo, Selena, additional, Gallina, Francesca, additional, Hillen, Marij A., additional, Canova, Stefania, additional, Cicchiello, Federica, additional, Longarini, Raffaella, additional, Cazzaniga, Marina Elena, additional, Bidoli, Paolo, additional, Valsecchi, Maria Grazia, additional, and Strepparava, Maria Grazia, additional

Published
2021
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21. Trust in Oncologist Scale--Italian Version

Author

Bani, Marco, primary, Rossi, Emanuela, additional, Cortinovis, Diego, additional, Russo, Selena, additional, Gallina, Francesca, additional, Hillen, Marij A., additional, Canova, Stefania, additional, Cicchiello, Federica, additional, Longarini, Raffaella, additional, Cazzaniga, Marina Elena, additional, Bidoli, Paolo, additional, Valsecchi, Maria Grazia, additional, and Strepparava, Maria Grazia, additional

Published
2021
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22. Validation of the Italian version of the full and abbreviated Trust in Oncologist Scale

Author

Bani, Marco, primary, Rossi, Emanuela, additional, Cortinovis, Diego, additional, Russo, Selena, additional, Gallina, Francesca, additional, Hillen, Marij A., additional, Canova, Stefania, additional, Cicchiello, Federica, additional, Longarini, Raffaella, additional, Cazzaniga, Marina Elena, additional, Bidoli, Paolo, additional, Valsecchi, Maria Grazia, additional, and Strepparava, Maria Grazia, additional

Published
2020
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23. 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

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

Published
2020
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25. Capecitabine and Temozolomide versus FOLFIRI in RAS-Mutated, MGMT-Methylated Metastatic Colorectal Cancer

Author

Pietrantonio, Filippo, primary, Lobefaro, Riccardo, additional, Antista, Maria, additional, Lonardi, Sara, additional, Raimondi, Alessandra, additional, Morano, Federica, additional, Mosconi, Stefania, additional, Rimassa, Lorenza, additional, Murgioni, Sabina, additional, Sartore-Bianchi, Andrea, additional, Tomasello, Gianluca, additional, Longarini, Raffaella, additional, Farina, Gabriella, additional, Petrelli, Fausto, additional, Gori, Stefania, additional, Randon, Giovanni, additional, Corallo, Salvatore, additional, Pagani, Filippo, additional, Guarini, Vincenzo, additional, Palermo, Federica, additional, Martinetti, Antonia, additional, Macagno, Marco, additional, Barault, Ludovic, additional, Perrone, Federica, additional, Tamborini, Elena, additional, Milione, Massimo, additional, Di Nicolantonio, Federica, additional, Di Maio, Massimo, additional, Fucà, Giovanni, additional, Di Bartolomeo, Maria, additional, and de Braud, Filippo, additional

Published
2020
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27. New and Emerging Systemic Therapeutic Options for Advanced Cholangiocarcinoma

Author

Massironi, S, Pilla, L, Elvevi, A, Longarini, R, Rossi, R, Bidoli, P, Invernizzi, P, Massironi, Sara, Pilla, Lorenzo, Elvevi, Alessandra, Longarini, Raffaella, Rossi, Roberta Elisa, Bidoli, Paolo, Invernizzi, Pietro, Massironi, S, Pilla, L, Elvevi, A, Longarini, R, Rossi, R, Bidoli, P, Invernizzi, P, Massironi, Sara, Pilla, Lorenzo, Elvevi, Alessandra, Longarini, Raffaella, Rossi, Roberta Elisa, Bidoli, Paolo, and Invernizzi, Pietro

Abstract

Cholangiocarcinoma (CCA) represents a disease entity that comprises a heterogeneous group of biliary malignant neoplasms, with variable clinical presentation and severity. It may be classified according to its anatomical location and distinguished in intrahepatic (iCCA), perihilar (pCCA), or distal (dCCA), each subtype implying distinct epidemiology, biology, prognosis, and strategy for clinical management. Its incidence has increased globally over the past few decades, and its mortality rate remains high due to both its biological aggressiveness and resistance to medical therapy. Surgery is the only potentially curative treatment and is the standard approach for resectable CCA; however, more than half of the patients have locally advanced or metastatic disease at presentation. For patients with unresectable CCA, the available systemic therapies are of limited effectiveness. However, the advances of the comprehension of the complex molecular landscape of CCA and its tumor microenvironment could provide new keys to better understand the pathogenesis, the mechanisms of resistance and ultimately to identify promising new therapeutic targets. Recently, clinical trials targeting isocitrate dehydrogenase (IDH)-1 mutations and fibroblast growth factor receptor (FGFR)-2 fusions, as well as immunotherapy showed promising results. All these new and emerging therapeutic options are herein discussed.

Published
2020

32. CAPECITABINE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER

Author

Procopio, Giuseppe, Bajetta, Emilio, Catena, Laura, Alù, Massimiliano, Longarini, Raffaella, Buzzoni, Roberto, La Torre, Ignazia, Kalbakis, Kostantinos, Torre, Silvia Della, Platania, Marco, Del Vecchio, Michele, and Lambiase, Antonio

Published
2001

33. Maintenance Therapy With Panitumumab Alone vs Panitumumab Plus Fluorouracil-Leucovorin in Patients With RAS Wild-Type Metastatic Colorectal Cancer

Author

Pietrantonio, Filippo, primary, Morano, Federica, additional, Corallo, Salvatore, additional, Miceli, Rosalba, additional, Lonardi, Sara, additional, Raimondi, Alessandra, additional, Cremolini, Chiara, additional, Rimassa, Lorenza, additional, Bergamo, Francesca, additional, Sartore-Bianchi, Andrea, additional, Tampellini, Marco, additional, Racca, Patrizia, additional, Clavarezza, Matteo, additional, Berenato, Rosa, additional, Caporale, Marta, additional, Antista, Maria, additional, Niger, Monica, additional, Smiroldo, Valeria, additional, Murialdo, Roberto, additional, Zaniboni, Alberto, additional, Adamo, Vincenzo, additional, Tomasello, Gianluca, additional, Giordano, Monica, additional, Petrelli, Fausto, additional, Longarini, Raffaella, additional, Cinieri, Saverio, additional, Falcone, Alfredo, additional, Zagonel, Vittorina, additional, Di Bartolomeo, Maria, additional, and de Braud, Filippo, additional

Published
2019
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34. A randomized phase II trial of second-line CAPTEM versus FOLFIRI in MGMT methylated, RAS mutated metastatic colorectal cancer (mCRC) patients.

Author

Pietrantonio, Filippo, primary, Lobefaro, Riccardo, additional, Antista, Maria, additional, Miceli, Rosalba, additional, Raimondi, Alessandra, additional, Lonardi, Sara, additional, Rimassa, Lorenza, additional, Saggio, Serena, additional, Capone, Iolanda, additional, Farina, Gabriella, additional, Longarini, Raffaella, additional, Mosconi, Stefania, additional, Sartore-Bianchi, Andrea, additional, Tomasello, Gianluca, additional, Perrone, Federica, additional, Barault, Ludovic, additional, Milione, Massimo, additional, Di Nicolantonio, Federica, additional, Di Bartolomeo, Maria, additional, and De Braud, Filippo G., additional

Published
2019
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36. Validation of the Italian version of the full and abbreviated Trust in Oncologist Scale.

Author

Bani, Marco, Rossi, Emanuela, Cortinovis, Diego, Russo, Selena, Gallina, Francesca, Hillen, Marij A., Canova, Stefania, Cicchiello, Federica, Longarini, Raffaella, Cazzaniga, Marina Elena, Bidoli, Paolo, Valsecchi, Maria Grazia, and Strepparava, Maria Grazia

Subjects
CANCER patients, STATISTICAL correlation, FACTOR analysis, HOSPITAL wards, RESEARCH methodology, PATIENT-professional relations, ONCOLOGISTS, PATIENT satisfaction, PSYCHOMETRICS, QUESTIONNAIRES, RESEARCH evaluation, RESEARCH funding, STATISTICS, TRUST, DATA analysis, STATISTICAL reliability, VISUAL analog scale, MULTITRAIT multimethod techniques, RESEARCH methodology evaluation, DATA analysis software, DESCRIPTIVE statistics
Abstract

Introduction: The Trust in Oncologist Scale (TiOS) is an 18‐item questionnaire aimed to assess the cancer patients' trust in their oncologist and has been validated in Dutch and English language. This study aims to validate the Italian version of the TiOS (IT‐TiOS) and the TiOS‐Short Form (IT‐TiOS‐SF). Methods: The IT‐TiOS was administered to 194 patients recruited in an Italian oncology department from April to December 2018. Data collected included socio‐demographic data, health and clinical information, satisfaction with the most recent oncology visit and trust in the regional healthcare system. Internal consistency, test–retest reliability, convergent and the structural validity of both the full and short form were tested. Results: Factor analyses indicated that neither four‐factor nor one‐factor models of the full scale were acceptable. However, confirmatory factor analysis supported the one‐dimensionality of the IT‐TiOS‐SF, and internal consistency assessed with Cronbach's alpha was 0.88. Mean scores on the IT‐TiOS‐SF correlated with satisfaction with the oncologist (rs = 0.64) and willingness to recommend the oncologist to others (rs = 0.67), confirming good construct validity. Conclusion: The IT‐TiOS‐SF demonstrates good psychometric properties and can be used to assess trust for both clinical and research purposes. [ABSTRACT FROM AUTHOR]

Published
2021
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37. First-line FOLFOX plus panitumumab (Pan) followed by 5FU/LV plus Pan or single-agent Pan as maintenance therapy in patients with RAS wild-type metastatic colorectal cancer (mCRC): The VALENTINO study.

Author

Pietrantonio, Filippo, primary, Morano, Federica, additional, Corallo, Salvatore, additional, Lonardi, Sara, additional, Cremolini, Chiara, additional, Rimassa, Lorenza, additional, Sartore-Bianchi, Andrea, additional, Tampellini, Marco, additional, Bustreo, Sara, additional, Clavarezza, Matteo, additional, Murialdo, Roberto, additional, Zaniboni, Alberto, additional, Adamo, Vincenzo, additional, Tomasello, Gianluca, additional, Giordano, Monica, additional, Petrelli, Fausto, additional, Longarini, Raffaella, additional, Zagonel, Vittorina, additional, Di Bartolomeo, Maria, additional, and De Braud, Filippo G., additional

Published
2018
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38. Prospective Evaluation of Health Care Provider and Patient Assessments in Chemotherapy-Induced Peripheral Neurotoxicity

Author

Alberti, Paola, Bernasconi, Davide P., Cornblath, David R., Merkies, Ingemar S.J., Park, Susanna B., Velasco, Roser, Bruna, Jordi, Psimaras, Dimitri, Koeppen, Susanne, Pace, Andrea, Dorsey, Susan G., Argyriou, Andreas A., Kalofonos, Haralabos P., Briani, Chiara, Schenone, Angelo, Faber, Catharina G., Mazzeo, Anna, Grisold, Wolfgang, Valsecchi, MariaGrazia, Cavaletti, Guido, Cazzaniga, Marina Elena, Longarini, Raffaella, Guidi, Alessandro, Postma, Tjeerd J, Goldstein, David, Ricard, Damien, Tafani, Camille, Brooks, DuBose, Renn, Cynthia L, Galiè, Edvina, Campagnolo, Marta, Castellani, Francesca, Grandis, Marina, Lalisang, Roy I, Gentile, Luca, Russo, Massimo, and Toscano, Antonio

Published
2021
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39. First-Line Panitumumab Plus FOLFOX-4 Followed by Maintenance Therapy with Single-Agent Panitumumab or Panitumumab Plus 5-FU/LV in Patients with RAS Wild-Type Metastatic Colorectal Cancer: The Valentino Study

Author

Pietrantonio, Filippo, primary, Morano, Federica, additional, Corallo, Salvatore, additional, Miceli, Rosalba, additional, Lonardi, Sara, additional, Raimondi, Alessandra, additional, Cremolini, Chiara, additional, Rimassa, Lorenza, additional, Bergamo, Francesca, additional, Sartore-Bianchi, Andrea, additional, Tampellini, Marco, additional, Racca, Patrizia, additional, Clavarezza, Matteo, additional, Berenato, Rosa, additional, Caporale, Marta, additional, Antista, Maria, additional, Niger, Monica, additional, Smiroldo, Valeria, additional, Murialdo, Roberto, additional, Zaniboni, Alberto, additional, Adamo, Vincenzo, additional, Tomasello, Gianluca, additional, Giordano, Monica, additional, Petrelli, Fausto, additional, Longarini, Raffaella, additional, Cinieri, Saverio, additional, Falcone, Alfredo, additional, Zagonel, Vittorina, additional, Di Bartolomeo, Maria, additional, and de Braud, Filippo, additional

Published
2018
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40. Open-label, randomized, multicenter, phase II trial designed to compare the efficacy of CAPTEM combination versus FOLFIRI as second line treatment in patients (pts) who have progressed on or after first-line oxaliplatin-containing chemotherapy for advanced, MGMT methylated, RAS mutated colorectal cancer (CRC).

Author

Berenato, Rosa, primary, Pietrantonio, Filippo, additional, Caporale, Marta, additional, Bossi, Ilaria, additional, Tomasello, Gianluca, additional, Mosconi, Stefania, additional, Paterno, Emanuela, additional, Bozzarelli, Silvia, additional, Longarini, Raffaella, additional, Gori, Stefania, additional, Zaniboni, Alberto, additional, Bertolini, Alessandro Stefano, additional, Bergamo, Francesca, additional, Barni, Sandro, additional, Amatu, Alessio, additional, Fagnani, Daniele, additional, Zampino, M. Giulia, additional, Morano, Federica, additional, Di Bartolomeo, Maria, additional, and De Braud, Filippo G., additional

Published
2016
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41. First-line FOLFOX-4 plus panitumumab followed by 5-FU/LV plus panitumumab or single-agent panitumumab as maintenance therapy in patients (pts) with RAS wild-type, metastatic colorectal cancer (mCRC): The VALENTINO study.

Author

Pietrantonio, Filippo, primary, Caporale, Marta, additional, Berenato, Rosa, additional, Lonardi, Sara, additional, Murialdo, Roberto, additional, Paterno, Emanuela, additional, Tampellini, Marco, additional, Bertolini, Alessandro Stefano, additional, Rimassa, Lorenza, additional, Cremolini, Chiara, additional, Giommoni, Elisa, additional, Tomasello, Gianluca, additional, Longarini, Raffaella, additional, Petrelli, Fausto, additional, Zaniboni, Alberto, additional, Cortesi, Enrico, additional, Sartore Bianchi, Andrea, additional, Bossi, Ilaria, additional, Di Bartolomeo, Maria, additional, and De Braud, Filippo G., additional

Published
2016
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42. Single-Agent Panitumumab in Frail Elderly Patients With Advanced RAS and BRAF Wild-Type Colorectal Cancer: Challenging Drug Label to Light Up New Hope

Author

Pietrantonio, Filippo, Cremolini, Chiara, Aprile, Giuseppe, Lonardi, Sara, Orlandi, Armando, Mennitto, Alessia, Berenato, Rosa, Antoniotti, Carlotta, Casagrande, Mariaelena, Marsico, Valentina, Marmorino, Federica, Cardellino, Giovanni Gerardo, Bergamo, Francesca, Tomasello, Gianluca, Formica, Vincenzo, Longarini, Raffaella, Giommoni, Elisa, Caporale, Marta, Di Bartolomeo, Maria, Loupakis, Fotio, De Braud, Filippo, Orlandi, Armando (ORCID:0000-0001-5253-4678), Pietrantonio, Filippo, Cremolini, Chiara, Aprile, Giuseppe, Lonardi, Sara, Orlandi, Armando, Mennitto, Alessia, Berenato, Rosa, Antoniotti, Carlotta, Casagrande, Mariaelena, Marsico, Valentina, Marmorino, Federica, Cardellino, Giovanni Gerardo, Bergamo, Francesca, Tomasello, Gianluca, Formica, Vincenzo, Longarini, Raffaella, Giommoni, Elisa, Caporale, Marta, Di Bartolomeo, Maria, Loupakis, Fotio, De Braud, Filippo, and Orlandi, Armando (ORCID:0000-0001-5253-4678)

Abstract

BACKGROUND: No prospective trials have specifically addressed the efficacy and safety of panitumumab in elderly patients with metastatic colorectal cancer (CRC). We aimed at assessing the efficacy and safety of single agent panitumumab in "frail" elderly patients diagnosed with metastatic RAS and BRAF wild-type CRC. MATERIALS AND METHODS: Forty elderly patients (aged ≥ 75 years) with metastatic RAS-BRAF wild-type CRC received off-label prescriptions of single-agent panitumumab at seven Italian institutions. Treatment was administered as first line in patients with absolute contraindication to any chemotherapy or as second-line treatment after failure of a fluoropyrimidine-based treatment, in the presence of contraindication to irinotecan. The outcome measures included objective response rate (ORR), as well as progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety. RESULTS: The median PFS and OS were 6.4 months (95% confidence interval [CI]: 4.9-8 months) and 14.3 months (95% CI: 10.9-17.7 months), respectively. ORR was 32.5%, and DCR was 72.5%. Dose reductions related to adverse events (AEs) were reported in 9 (23%) patients, but no permanent treatment discontinuation caused by was reported. The most frequent grade 3 AE was skin rash, with an incidence of 20%. CONCLUSION: Panitumumab is effective and well-tolerated in frail elderly patients with RAS-BRAF wild-type metastatic CRC and deemed unfit for chemotherapy. A randomized study is needed to confirm these data. IMPLICATIONS FOR PRACTICE: Treatment of elderly patients with metastatic colorectal cancer represents a difficult challenge in clinical practice. A significant proportion of frail elderly patients do not receive treatment, reflecting ongoing uncertainty of clinical benefit and toxicity of chemotherapy. Unfit condition in this cohort of patients further limits antineoplastic prescription and consequently patient survival. RAS and BRAF wild-type status could help selec

Published
2015

43. Single-Agent Panitumumab in Frail Elderly Patients With Advanced RAS and BRAF Wild-Type Colorectal Cancer: Challenging Drug Label to Light Up New Hope

Author

Pietrantonio, Filippo, primary, Cremolini, Chiara, additional, Aprile, Giuseppe, additional, Lonardi, Sara, additional, Orlandi, Armando, additional, Mennitto, Alessia, additional, Berenato, Rosa, additional, Antoniotti, Carlotta, additional, Casagrande, Mariaelena, additional, Marsico, Valentina, additional, Marmorino, Federica, additional, Cardellino, Giovanni Gerardo, additional, Bergamo, Francesca, additional, Tomasello, Gianluca, additional, Formica, Vincenzo, additional, Longarini, Raffaella, additional, Giommoni, Elisa, additional, Caporale, Marta, additional, Di Bartolomeo, Maria, additional, Loupakis, Fotios, additional, and de Braud, Filippo, additional

Published
2015
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44. Prospective evaluation of estrogen receptor-β in predicting response to neoadjuvant antiestrogen therapy in elderly breast cancer patients

Author

Cappelletti, Vera, primary, Celio, Luigi, additional, Bajetta, Emilio, additional, Allevi, Arianna, additional, Longarini, Raffaella, additional, Miodini, Patrizia, additional, Villa, Raffaella, additional, Fabbri, Alessandra, additional, Mariani, Luigi, additional, Giovanazzi, Riccardo, additional, Galante, Emanuele, additional, Greco, Marco, additional, and Grazia Daidone, Maria, additional

Published
2004
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45. Could exemestane affect insulin-like growth factors, interleukin 6 and bone metabolism in postmenopausal advanced breast cancer patients after failure on aminoglutethimide, anastrozole or letrozole?

Author

Ferrari, Leonardo, primary, Bajetta, Emilio, additional, Martinetti, Antonia, additional, Celio, Luigi, additional, Longarini, Raffaella, additional, La Torre, Ignazia, additional, Buzzoni, Roberto, additional, Gattinoni, Luca, additional, Seregni, Ettore, additional, and Bombardieri, Emilio, additional

Published
2003
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47. Prospective evaluation of estrogen receptor-beta in predicting response to neoadjuvant antiestrogen therapy in elderly breast cancer patients.

Author

Cappelletti V, Celio L, Bajetta E, Allevi A, Longarini R, Miodini P, Villa R, Fabbri A, Mariani L, Giovanazzi R, Galante E, Greco M, and Grazia Daidone M

Subjects
Aged, Aged, 80 and over, Breast Neoplasms pathology, Carcinoma pathology, Estrogen Antagonists therapeutic use, Estrogen Receptor alpha genetics, Estrogen Receptor beta genetics, Female, Gene Expression Regulation, Neoplastic drug effects, Humans, Neoadjuvant Therapy, RNA, Messenger biosynthesis, Treatment Outcome, Tumor Burden, Antineoplastic Agents, Hormonal therapeutic use, Breast Neoplasms drug therapy, Carcinoma drug therapy, Estrogen Receptor alpha metabolism, Estrogen Receptor beta metabolism, Selective Estrogen Receptor Modulators therapeutic use, Toremifene therapeutic use
Abstract

It has been proposed that knowledge of estrogen receptor beta (ER-beta) expression may refine estrogen receptor alpha (ER-alpha) predictivity of response to endocrine therapy. We challenged this hypothesis in ER-alpha-positive breast cancers subjected to preoperative antiestrogen treatment. Forty-seven elderly (> or =65 years old) women with nonmetastatic, ER-alpha-positive (by immunohistochemistry) primary breast cancers (> 2 cm in diameter) entered a neoadjuvant hormone therapy protocol (60 mg/day toremifene for 3 months). ER-alpha and ER-beta (ERs) mRNA was determined by semiquantitative RT-PCR, before (on core needle biopsy) and after (on surgical specimens) neoadjuvant treatment. Study end points included: (1) relation between treatment response and ER mRNA expression; and (2) changes in ER expression after treatment. The response was clinically assessed as tumor size change at the end of the preoperative treatment. ER mRNA expression was assessable before and after treatment in 38 and 20 cases respectively. ER-beta was co-expressed with ER-alpha at variable levels and significantly correlated only with progesterone receptor (P = 0.0285). Objective clinical response, including patients with minor change (> or =25-<50% tumor shrinkage after treatment), was documented in 68.4% of cases and was independent of ER-beta levels or changes. ER-alpha levels were higher in tumors from patients in complete remission than in those from women achieving partial response or minor change compared with non-responsive patients (median expression values: 801 versus 516 versus 320 arbitrary units) and were consistently down-regulated by preoperative treatment. We conclude that in this elderly patient population with ER-alpha-positive tumors, ER-beta mRNA was neither predictive of response to preoperative toremifene nor provided additional information to the knowledge of ER-alpha mRNA levels, which, conversely, were directly correlated with likelihood of response.

Published
2004
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