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1. Intermittent or Continuous Panitumumab Plus Fluorouracil, Leucovorin, and Irinotecan for First-Line Treatment of RAS and BRAF Wild-Type Metastatic Colorectal Cancer: The IMPROVE Trial

Author

Avallone, Antonio, Giuliani, Francesco, De Stefano, Alfonso, Santabarbara, Giuseppe, Nasti, Guglielmo, Montesarchio, Vincenzo, Rosati, Gerardo, Cassata, Antonino, Leo, Silvana, Romano, Carmela, Tamburini, Emiliano, Silvestro, Lucrezia, Lotesoriere, Claudio, Nappi, Anna, Santini, Daniele, Petrillo, Antonella, Colombo, Alfredo, Febbraro, Antonio, Leone, Alessandra, Mannavola, Francesco, Laterza, Maria Maddalena, Izzo, Francesco, Sobrero, Alberto, Delrio, Paolo, Giannarelli, Diana, and Budillon, Alfredo

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. 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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4. 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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5. BRAF mutation in colorectal cancer: An update

Author

Colombo Alfredo, Porretto Concetta Maria, and Rosati Gerardo

Subjects
braf, colorectal cancer, biomarker, oncogene, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Colon cancer is a leading cause of cancer-related deaths worldwide. About 10% of all colon cancer patients are found to have a mutation in BRAF proto-oncogene that arise as a result of a substitution of amino acid valine with glutamate at position 600 (V600E). This specific mutation is also found in melanomas, but at even higher percent - in up to 60% of patients. A particular category of drugs called BRAF inhibitors, have been developed in order to increase survival. But, while in patients with melanoma this class of drugs work well especially when combined with mitogen-activated protein kinase inhibitors, they have low efficacy in patients with metastatic colorectal cancer suggesting different mechanism of action and development of drug resistance. This review summarise recent findings aimed to highlight events in BRAF mutations in metastatic colorectal cancer.

Published
2023

6. A randomized phase III study of fractionated docetaxel, oxaliplatin, capecitabine (low-tox) vs epirubicin, oxaliplatin and capecitabine (eox) in patients with locally advanced unresectable or metastatic gastric cancer: the lega trial

Author

Rosati, Gerardo, Cella, Chiara Alessandra, Cavanna, Luigi, Codecà, Carla, Prisciandaro, Michele, Mosconi, Stefania, Luchena, Giovanna, Silvestris, Nicola, Bernardini, Ilaria, Casaretti, Rossana, Zoratto, Federica, Amoroso, Domenico, Ciarlo, Andrea, Barni, Sandro, Cascinu, Stefano, Davite, Cristina, Di Sanzo, Alessandro, Casolaro, Alessia, Bilancia, Domenico, and Labianca, Roberto

Published
2022
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8. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Bilancia, D., Rosati, G., Montesarchio, V., Iaffaioli, R.V., Nasti, G., Daniele, B., Zagonel, V., Lonardi, S., Pella, N., Aprile, G., Pasini, F., Marchetti, Roma P., Romiti, A., Ciuffreda, L., Ferrari, D., Foa, P., Zaniboni, A., Labianca, R., Mosconi, S., Sobrero, A., Bidoli, P., Cazzaniga, M., Beretta, G.D., Corsi, D.C., Cortesi, E., Barni, S., Petrelli, F., Allione, P., D'Arco, A.M., Valmadre, G., Piazza, E., Veltri, E., Ramus, G. Vietti, Giustini, L., Tumulo, S., Cascinu, S., Granetto, C., Testore, F., Giordano, M., Moroni, M., Di Seri, M., Nuzzo, A., Angelelli, L., Gori, S., Farina, G., Aglietta, M., Franchi, R., Comandé, M., Giordani, P., Tonini, G., Bucci, E., Ballestrero, A., Benasso, M., Graiff, C., Bravi, S., Caffo, O., Silva, R.R., Frontini, L., Rota, S., Cozzi, L., Cantore, M., Maiello, E., Cinieri, S., Silvestris, N., Romito, S., Gebbia, V., Banzi, M., Santoro, A., Artioli, F., Mattioli, R., Contu, A., Di Costanzo, F., Leonardi, F., Cavanna, L., Passalacqua, R., Amoroso, D., Sozzi, P., D'Amico, M., Amadori, D., Frassineti, L., Turci, D., Ravaioli, A., Pasquini, E., Gambi, A., Faedi, M., Cruciani, G., Bajetta, E., Di Bartolomeo, M., Gianni, L., Ronzoni, M., Ionta, M.T., Massidda, B., Scartozzi, M., Zampino, M.G., Bochicchio, A.M., Ciarlo, A., Di Leo, A., Frustaci, S., Rangoni, G., Arizzoia, A., Pavesi, L., Verusio, C., Pinotti, G., Iop, A., De Placido, S., Carlomagno, C., Adamo, V., Ficorella, C., Natale, D., Greco, E., Rulli, E., Galli, F., Poli, D., Porcu, L., Torri, V., Rosati, Gerardo, Lonardi, Sara, Galli, Fabio, Di Bartolomeo, Maria, Ronzoni, Monica, Zampino, Maria G., Banzi, Maria, Zaniboni, Alberto, Pasini, Felice, Bozzarelli, Silvia, Garattini, Silvio K., Ferrari, Daris, Montesarchio, Vincenzo, Mambrini, Andrea, Ciuffreda, Libero, Galli, Francesca, Pusceddu, Valeria, Carlomagno, Chiara, Bidoli, Paolo, Amoroso, Domenico, Bochicchio, Anna M., Frassineti, Luca, Corsi, Domenico, Bilancia, Domenico, Pastorino, Alessandro, De Stefano, Alfonso, and Labianca, Roberto

Published
2021
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9. 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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10. 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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12. Second-line treatment efficacy and toxicity in older vs. non-older patients with advanced gastric cancer: A multicentre real-world study

Author

Fanotto, Valentina, Fornaro, Lorenzo, Bordonaro, Roberto, Rosati, Gerardo, Rimassa, Lorenza, Di Donato, Samantha, Santini, Daniele, Tomasello, Gianluca, Leone, Francesco, Silvestris, Nicola, Stragliotto, Silvia, Scartozzi, Mario, Giampieri, Riccardo, Nichetti, Federico, Antonuzzo, Lorenzo, Cinieri, Saverio, Avallone, Antonio, Pellegrino, Antonio, Melisi, Davide, Vasile, Enrico, Gerratana, Lorenzo, and Aprile, Giuseppe

Published
2019
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13. Quality of life, compliance, safety and effectiveness in fit older metastatic colorectal patients with cancer treated in first-line with chemotherapy plus cetuximab: A restrospective analysis from the ObservEr study

Author

Rosati, Gerardo, Pinto, Carmine, Di Fabio, Francesca, Chiara, Silvana, Lolli, Ivan R., Ruggeri, Enzo M., Ciuffreda, Libero, Ferrara, Raimondo, Antonuzzo, Lorenzo, Adua, Daniela, Racca, Patrizia, Bilancia, Domenico, Benincasa, Elena, Stroppolo, Maria Elena, and Di Costanzo, Francesco

Published
2018
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14. Italian survey on cetuximab-based therapy of elderly patients with metastatic colorectal cancer

Author

Rosati, Gerardo, Addeo, Raffaele, Aprile, Giuseppe, Avallone, Antonio, Bilancia, Domenico, Brugnatelli, Silvia, Buccafusca, Gabriella, Carlomagno, Chiara, Cordio, Stefano, Delfanti, Sara, Dell’Aquila, Emanuela, Di Bisceglie, Maurizio, Di Donato, Samantha, Di Stasi, Antonio, Germano, Domenico, Giuliani, Francesco, Granetto, Cristina, Latiano, Tiziana Pia, Leo, Silvana, Tralongo, Paolo, Stroppolo, Maria Elena, Venturini, Filippo, and Bianco, Salvatore

Published
2019
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15. Treatment sequence with either irinotecan/cetuximab followed by FOLFOX-4 or the reverse strategy in metastatic colorectal cancer patients progressing after first-line FOLFIRI/bevacizumab: An Italian Group for the Study of Gastrointestinal Cancer phase III, randomised trial comparing two sequences of therapy in colorectal metastatic patients

Author

Cascinu, Stefano, Rosati, Gerardo, Bilancia, Domenico, Nasti, Guglielmo, Iaffaioli, Rosario Vincenzo, Lonardi, Sara, Zagonel, Vittorina, Zaniboni, Alberto, Marchetti, Paolo, Romiti, Adriana, Leone, Francesco, Aglietta, Massimo, Giordano, Monica, Corsi, Domenico C., Ferraú, Francesco, Labianca, Roberto, Mosconi, Stefania, Ronzoni, Monica, Gianni, Luca, Rulli, Eliana, Poli, Davide, Galli, Francesca, Torri, Valter, De Simone, Irene, Galli, Fabio, Pasini, Felice, Rangoni, Giovanni, Venezia, Raffaele, Sozzi, Pietro, Nuzzo, Antonio, Berardi, Rossana, Frontini, Luciano, Rota, Silvia, Cozzi, Lorena, and Scartozzi, Mario

Published
2017
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17. 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

20. Prognostic factors in 868 advanced gastric cancer patients treated with second-line chemotherapy in the real world

Author

Fanotto, Valentina, Cordio, Stefano, Pasquini, Giulia, Fontanella, Caterina, Rimassa, Lorenza, Leone, Francesco, Rosati, Gerardo, Santini, Daniele, Giampieri, Riccardo, Di Donato, Samantha, Tomasello, Gianluca, Silvestris, Nicola, Pietrantonio, Filippo, Battaglin, Francesca, Avallone, Antonio, Scartozzi, Mario, Lutrino, Eufemia Stefania, Melisi, Davide, Antonuzzo, Lorenzo, Pellegrino, Antonio, Torri, Valter, and Aprile, Giuseppe

Published
2017
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24. Randomized intermittent or continuous panitumumab plus FOLFIRI (FOLFIRI/PANI) for first-line treatment of patients (pts) with RAS/BRAF wild-type (wt) metastatic colorectal cancer (mCRC): The IMPROVE study.

Author

Avallone, Antonio, primary, Giuliani, Francesco, additional, Nasti, Guglielmo, additional, Montesarchio, Vincenzo, additional, Santabarbara, Giuseppe, additional, Leo, Silvana, additional, De Stefano, Alfonso, additional, Rosati, Gerardo, additional, Lolli, Ivan, additional, Tamburini, Emiliano, additional, Colombo, Alfredo, additional, Santini, Daniele, additional, Silvestro, Lucrezia, additional, Facchini, Gaetano, additional, Mannavola, Francesco, additional, Febbraro, Antonio, additional, Troncone, Giancarlo, additional, Sobrero, Alberto F., additional, Giannarelli, Diana, additional, and Budillon, Alfredo, additional

Published
2022
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25. Phase II study of nivolumab in combination with FOLFOXIRI/bevacizumab as first-line treatment in patients with advanced colorectal cancer RAS/BRAF mutated (mut): NIVACOR trial (GOIRC-03-2018).

Author

Damato, Angela, primary, Bergamo, Francesca, additional, Antonuzzo, Lorenzo, additional, Nasti, Guglielmo, additional, Pietrantonio, Filippo, additional, Tonini, Giuseppe, additional, Maiello, Evaristo, additional, Bordonaro, Roberto, additional, Rosati, Gerardo, additional, Romagnani, Alessandra, additional, Iachetta, Francesco, additional, Larocca, Mario, additional, Maglietta, Giuseppe, additional, Normanno, Nicola, additional, and Pinto, Carmine, additional

Published
2022
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29. Dynamics of RAS/BRAF Mutations in cfDNA from Metastatic Colorectal Carcinoma Patients Treated with Polychemotherapy and Anti-EGFR Monoclonal Antibodies

Author

Rachiglio, Anna Maria, primary, Forgione, Laura, additional, Pasquale, Raffaella, additional, Barone, Carlo Antonio, additional, Maiello, Evaristo, additional, Antonuzzo, Lorenzo, additional, Cassata, Antonino, additional, Tonini, Giuseppe, additional, Bordonaro, Roberto, additional, Rosati, Gerardo, additional, Zaniboni, Alberto, additional, Lonardi, Sara, additional, Ferrari, Daris, additional, Frassineti, Giovanni Luca, additional, Tamberi, Stefano, additional, Pisconti, Salvatore, additional, Di Fabio, Francesca, additional, Roma, Cristin, additional, Orlandi, Armando, additional, Latiano, Tiziana, additional, Damato, Angela, additional, Tortora, Giampaolo, additional, Pinto, Carmine, additional, and Normanno, Nicola, additional

Published
2022
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30. Effect of Bevacizumab in Combination With Standard Oxaliplatin-Based Regimens in Patients With Metastatic Colorectal Cancer

Author

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

Subjects
Adult, Diarrhea, Male, genetic structures, Adolescent, Drug-Related Side Effects and Adverse Reactions, Research, Angiogenesis Inhibitors, Nausea, Middle Aged, Progression-Free Survival, Bevacizumab, Oxaliplatin, Online Only, Young Adult, Treatment Outcome, Oncology, Antineoplastic Combined Chemotherapy Protocols, Quality of Life, Humans, Female, Neoplasm Metastasis, Colorectal Neoplasms, Original Investigation, Aged
Abstract

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

Published
2021

35. 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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37. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Rosati, Gerardo, primary, Lonardi, Sara, additional, Galli, Fabio, additional, Di Bartolomeo, Maria, additional, Ronzoni, Monica, additional, Zampino, Maria G., additional, Banzi, Maria, additional, Zaniboni, Alberto, additional, Pasini, Felice, additional, Bozzarelli, Silvia, additional, Garattini, Silvio K., additional, Ferrari, Daris, additional, Montesarchio, Vincenzo, additional, Mambrini, Andrea, additional, Ciuffreda, Libero, additional, Galli, Francesca, additional, Pusceddu, Valeria, additional, Carlomagno, Chiara, additional, Bidoli, Paolo, additional, Amoroso, Domenico, additional, Bochicchio, Anna M., additional, Frassineti, Luca, additional, Corsi, Domenico, additional, Bilancia, Domenico, additional, Pastorino, Alessandro, additional, De Stefano, Alfonso, additional, Labianca, Roberto, additional, Bilancia, D., additional, Rosati, G., additional, Montesarchio, V., additional, Iaffaioli, R.V., additional, Nasti, G., additional, Daniele, B., additional, Zagonel, V., additional, Lonardi, S., additional, Pella, N., additional, Aprile, G., additional, Pasini, F., additional, Marchetti, Roma P., additional, Romiti, A., additional, Ciuffreda, L., additional, Ferrari, D., additional, Foa, P., additional, Zaniboni, A., additional, Labianca, R., additional, Mosconi, S., additional, Sobrero, A., additional, Bidoli, P., additional, Cazzaniga, M., additional, Beretta, G.D., additional, Corsi, D.C., additional, Cortesi, E., additional, Barni, S., additional, Petrelli, F., additional, Allione, P., additional, D'Arco, A.M., additional, Valmadre, G., additional, Piazza, E., additional, Veltri, E., additional, Ramus, G. Vietti, additional, Giustini, L., additional, Tumulo, S., additional, Cascinu, S., additional, Granetto, C., additional, Testore, F., additional, Giordano, M., additional, Moroni, M., additional, Di Seri, M., additional, Nuzzo, A., additional, Angelelli, L., additional, Gori, S., additional, Farina, G., additional, Aglietta, M., additional, Franchi, R., additional, Comandé, M., additional, Giordani, P., additional, Tonini, G., additional, Bucci, E., additional, Ballestrero, A., additional, Benasso, M., additional, Graiff, C., additional, Bravi, S., additional, Caffo, O., additional, Silva, R.R., additional, Frontini, L., additional, Rota, S., additional, Cozzi, L., additional, Cantore, M., additional, Maiello, E., additional, Cinieri, S., additional, Silvestris, N., additional, Romito, S., additional, Gebbia, V., additional, Banzi, M., additional, Santoro, A., additional, Artioli, F., additional, Mattioli, R., additional, Contu, A., additional, Di Costanzo, F., additional, Leonardi, F., additional, Cavanna, L., additional, Passalacqua, R., additional, Amoroso, D., additional, Sozzi, P., additional, D'Amico, M., additional, Amadori, D., additional, Frassineti, L., additional, Turci, D., additional, Ravaioli, A., additional, Pasquini, E., additional, Gambi, A., additional, Faedi, M., additional, Cruciani, G., additional, Bajetta, E., additional, Di Bartolomeo, M., additional, Gianni, L., additional, Ronzoni, M., additional, Ionta, M.T., additional, Massidda, B., additional, Scartozzi, M., additional, Zampino, M.G., additional, Bochicchio, A.M., additional, Ciarlo, A., additional, Di Leo, A., additional, Frustaci, S., additional, Rangoni, G., additional, Arizzoia, A., additional, Pavesi, L., additional, Verusio, C., additional, Pinotti, G., additional, Iop, A., additional, De Placido, S., additional, Carlomagno, C., additional, Adamo, V., additional, Ficorella, C., additional, Natale, D., additional, Greco, E., additional, Rulli, E., additional, Galli, F., additional, Poli, D., additional, Porcu, L., additional, and Torri, V., additional

Published
2021
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38. Becoming an older caregiver: A study of gender differences in family caregiving at the end of life

Author

Spatuzzi, Roberta, primary, Giulietti, Maria Velia, additional, Romito, Francesca, additional, Reggiardo, Giorgio, additional, Genovese, Carmela, additional, Passarella, Michele, additional, Raucci, Letizia, additional, Ricciuti, Marcello, additional, Merico, Fabiana, additional, Rosati, Gerardo, additional, Attademo, Luigi, additional, and Vespa, Anna, additional

Published
2021
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40. Duration of Adjuvant Doublet Chemotherapy (3 or 6 months) in Patients With High-Risk Stage II Colorectal Cancer

Author

Iveson, Timothy J., primary, Sobrero, Alberto F., additional, Yoshino, Takayuki, additional, Souglakos, Ioannis, additional, Ou, Fang-Shu, additional, Meyers, Jeffrey P., additional, Shi, Qian, additional, Grothey, Axel, additional, Saunders, Mark P., additional, Labianca, Roberto, additional, Yamanaka, Takeharu, additional, Boukovinas, Ioannis, additional, Hollander, Niels H., additional, Galli, Fabio, additional, Yamazaki, Kentaro, additional, Georgoulias, Vassilis, additional, Kerr, Rachel, additional, Oki, Eiji, additional, Lonardi, Sara, additional, Harkin, Andrea, additional, Rosati, Gerardo, additional, and Paul, James, additional

Published
2021
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44. Association of high TUBB3 with resistance to adjuvant docetaxel-based chemotherapy in gastric cancer: translational study of ITACA-S

Author

Di Bartolomeo, Maria, primary, Raimondi, Alessandra, additional, Cecchi, Fabiola, additional, Catenacci, Daniel V.T., additional, Schwartz, Sarit, additional, Sellappan, Shankar, additional, Tian, Yuan, additional, Miceli, Rosalba, additional, Pellegrinelli, Alessandro, additional, Giommoni, Elisa, additional, Aitini, Enrico, additional, Spada, Francesca, additional, Rosati, Gerardo, additional, Marchet, Alberto, additional, Pucci, Francesca, additional, Zaniboni, Alberto, additional, Tamberi, Stefano, additional, Pressiani, Tiziana, additional, Sanna, Gianni, additional, Cantore, Maurizio, additional, Mosconi, Stefania, additional, Bolzoni, Paola, additional, Pinto, Carmine, additional, Landi, Lorenza, additional, Soto Parra, Hector Josè, additional, Cavanna, Luigi, additional, Corallo, Salvatore, additional, Martinetti, Antonia, additional, Hembrough, Todd A., additional, and Pietrantonio, Filippo, additional

Published
2020
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45. From CENTRAL to SENTRAL (SErum aNgiogenesis cenTRAL): Circulating Predictive Biomarkers to Anti-VEGFR Therapy

Author

Giampieri, Riccardo, primary, Ziranu, Pina, additional, Daniele, Bruno, additional, Zizzi, Antonio, additional, Ferrari, Daris, additional, Lonardi, Sara, additional, Zaniboni, Alberto, additional, Cavanna, Luigi, additional, Rosati, Gerardo, additional, Casagrande, Mariaelena, additional, Pella, Nicoletta, additional, Demurtas, Laura, additional, Zampino, Maria Giulia, additional, Sozzi, Pietro, additional, Pusceddu, Valeria, additional, Germano, Domenico, additional, Lai, Eleonora, additional, Zagonel, Vittorina, additional, Codecà, Carla, additional, Libertini, Michela, additional, Puzzoni, Marco, additional, Labianca, Roberto, additional, Cascinu, Stefano, additional, and Scartozzi, Mario, additional

Published
2020
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46. Assessment of Duration and Effects of 3 vs 6 Months of Adjuvant Chemotherapy in High-Risk Stage II Colorectal Cancer

Author

Petrelli, Fausto, primary, Labianca, Roberto, additional, Zaniboni, Alberto, additional, Lonardi, Sara, additional, Galli, Fabio, additional, Rulli, Eliana, additional, Rosati, Gerardo, additional, Corallo, Salvatore, additional, Ronzoni, Monica, additional, Cardellino, Giovanni Gerardo, additional, Mattioli, Rodolfo, additional, Mambrini, Andrea, additional, Ciuffreda, Libero, additional, Banzi, Maria, additional, Pusceddu, Valeria, additional, Maiello, Evaristo, additional, Zampino, Maria, additional, Zagonel, Vittorina, additional, Marchetti, Paolo, additional, Corsi, Domenico, additional, Rimassa, Lorenza, additional, Cinieri, Saverio, additional, and Sobrero, Alberto, additional

Published
2020
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48. Becoming an older caregiver: A study of gender differences in family caregiving at the end of life.

Author

Spatuzzi, Roberta, Giulietti, Maria Velia, Romito, Francesca, Reggiardo, Giorgio, Genovese, Carmela, Passarella, Michele, Raucci, Letizia, Ricciuti, Marcello, Merico, Fabiana, Rosati, Gerardo, Attademo, Luigi, and Vespa, Anna

Subjects
FAMILIES & psychology, CROSS-sectional method, SEX distribution, PSYCHOLOGY of caregivers, ECONOMIC aspects of diseases, DEATH
Abstract

Objectives: Older people are not traditionally expected to become caregivers. For this reason, the experience of caregiving in older persons has not been explored adequately in the research on gender differences. The objective of this study was to assess the caregiver burden among older family members who care for cancer patients facing the end of their lives, in order to compare their differences according to gender (male vs. female).Methods: This is a cross-sectional study. A total of 102 older caregivers (aged ≥65 years) of hospice patients were interviewed through the Caregiver Burden Inventory (CBI). The sample group was divided into two gender subgroups.Results: Compared with male caregivers, the older female group reported significantly higher scores in the CBI-physical subscale (P = 0.028), and in the CBI, the overall score (P = 0.0399) confirmed by the generalized linear model (multivariate) evaluation that included possible predictors in the model. There were no significant differences in the other CBI subscale scores (time-dependent, developmental, social, and emotional).Significance Of Results: Older female caregivers are at higher risk of experiencing burden and worse physical health compared with men. Further research is needed in modern palliative care to assess the role of gender differences in the experience of caregiving when the caregiver is an older person. [ABSTRACT FROM AUTHOR]

Published
2022
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49. Supplementary_Figure_1 – Supplemental material for Association of high TUBB3 with resistance to adjuvant docetaxel-based chemotherapy in gastric cancer: translational study of ITACA-S

Author

Bartolomeo, Maria Di, Raimondi, Alessandra, Cecchi, Fabiola, Catenacci, Daniel V.T., Schwartz, Sarit, Sellappan, Shankar, Tian, Yuan, Miceli, Rosalba, Pellegrinelli, Alessandro, Giommoni, Elisa, Aitini, Enrico, Spada, Francesca, Rosati, Gerardo, Marchet, Alberto, Pucci, Francesca, Zaniboni, Alberto, Tamberi, Stefano, Pressiani, Tiziana, Sanna, Gianni, Cantore, Maurizio, Mosconi, Stefania, Bolzoni, Paola, Pinto, Carmine, Landi, Lorenza, Parra, Hector Josè Soto, Cavanna, Luigi, Corallo, Salvatore, Martinetti, Antonia, Hembrough, Todd A., and Pietrantonio, Filippo

Subjects
Medicine
Abstract

Supplemental material, Supplementary_Figure_1 for Association of high TUBB3 with resistance to adjuvant docetaxel-based chemotherapy in gastric cancer: translational study of ITACA-S by Maria Di Bartolomeo, Alessandra Raimondi, Fabiola Cecchi, Daniel V.T. Catenacci, Sarit Schwartz, Shankar Sellappan, Yuan Tian, Rosalba Miceli, Alessandro Pellegrinelli, Elisa Giommoni, Enrico Aitini, Francesca Spada, Gerardo Rosati, Alberto Marchet, Francesca Pucci, Alberto Zaniboni, Stefano Tamberi, Tiziana Pressiani, Gianni Sanna, Maurizio Cantore, Stefania Mosconi, Paola Bolzoni, Carmine Pinto, Lorenza Landi, Hector Josè Soto Parra, Luigi Cavanna, Salvatore Corallo, Antonia Martinetti, Todd A. Hembrough and Filippo Pietrantonio in Tumori Journal

Published
2020
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