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32 results on '"Moretto R"'

1. Predicting early recurrence after resection of initially unresectable colorectal liver metastases: the role of baseline and pre-surgery clinical, radiological and molecular factors in a real-life multicentre experience

Author

Moretto, R., primary, Germani, M.M., additional, Borelli, B., additional, Conca, V., additional, Rossini, D., additional, Boraschi, P., additional, Donati, F., additional, Urbani, L., additional, Lonardi, S., additional, Bergamo, F., additional, Cerma, K., additional, Ramondo, G., additional, D’Amico, F.E., additional, Salvatore, L., additional, Valente, G., additional, Barbaro, B., additional, Giuliante, F., additional, Di Maio, M., additional, Masi, G., additional, and Cremolini, C., additional

Published
2024
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2. 341P Trop2 and Nectin4 immunohistochemical expression in metastatic colorectal cancer: An exploratory analysis of the TRIBE2 study

Author

Conca, V., primary, Germani, M.M., additional, Moretto, R., additional, Giordano, M., additional, Bergamo, F., additional, Prisciandaro, M., additional, Antoniotti, C., additional, Ugolini, C., additional, Santini, D., additional, Cupini, S., additional, Boccaccino, A., additional, Barsotti, G., additional, Pagani, F., additional, Niccoli, C., additional, Zaniboni, A., additional, Passardi, A., additional, Tamburini, E., additional, Latiano, T.P., additional, Fontanini, G., additional, and Cremolini, C., additional

Published
2022
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3. O-6 Modified FOLFOXIRI plus panitumumab (mFOLFOXIRI/PAN) versus mFOLFOX6/PAN as initial treatment of unresectable RAS/BRAF wild-type metastatic colorectal cancer (mCRC) patients: Results of the phase III randomized TRIPLETE study by GONO

Author

Rossini, D., primary, Antoniotti, C., additional, Lonardi, S., additional, Pietrantonio, F., additional, Marmorino, F., additional, Antonuzzo, L., additional, Boccaccino, A., additional, Randon, G., additional, Giommoni, E., additional, Pozzo, C., additional, Moretto, R., additional, De Grandis, M., additional, Viola, M., additional, Passardi, A., additional, Borelli, B., additional, Buonadonna, A., additional, Masi, G., additional, Formica, V., additional, Aprile, G., additional, Boni, L., additional, and Cremolini, C., additional

Published
2022
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4. Encorafenib plus cetuximab with or without binimetinib in patients with BRAF V600E-mutated metastatic colorectal cancer: real-life data from an Italian multicenter experience

Author

Boccaccino, A., primary, Borelli, B., additional, Intini, R., additional, Antista, M., additional, Bensi, M., additional, Rossini, D., additional, Passardi, A., additional, Tamberi, S., additional, Giampieri, R., additional, Antonuzzo, L., additional, Noto, L., additional, Roviello, G., additional, Zichi, C., additional, Salati, M., additional, Puccini, A., additional, Noto, C., additional, Parisi, A., additional, Rihawi, K., additional, Persano, M., additional, Crespi, V., additional, Libertini, M., additional, Giordano, M., additional, Moretto, R., additional, Lonardi, S., additional, and Cremolini, C., additional

Published
2022
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5. SO-20 Prospective validation of Ang-2 and Tie-2 plasma levels as predictors of benefit from regorafenib in metastatic colorectal cancer patients: REGOLAND study

Author

Antoniotti, C., primary, Marmorino, F., additional, Boccaccino, A., additional, Antista, M., additional, Zaffaroni, N., additional, Zucchelli, G., additional, Martinetti, A., additional, Campi, E., additional, Rossini, D., additional, Sottotetti, E., additional, Borelli, B., additional, Corti, F., additional, Conca, V., additional, Moretto, R., additional, Germani, M., additional, Falcone, A., additional, Giordano, M., additional, Masi, G., additional, Pietrantonio, F., additional, and Cremolini, C., additional

Published
2021
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6. O-18 Tumor mutational load, microsatellite instability, BRCAness, and actionable alterations in metastatic colorectal cancer: Results from the TRIBE2 study

Author

Antoniotti, C., primary, Rossini, D., additional, Marmorino, F., additional, Lonardi, S., additional, Corti, F., additional, Moretto, R., additional, Ugolini, C., additional, Latiano, T., additional, Giordano, M., additional, Tamburini, E., additional, Passardi, A., additional, Santini, D., additional, Zaniboni, A., additional, Aprile, G., additional, Bordonaro, R., additional, Zucchelli, G., additional, Conca, V., additional, Fontanini, G., additional, Lenz, H., additional, Falcone, A., additional, Korn, M., additional, and Cremolini, C., additional

Published
2020
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7. 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., primary, Rossini, D., additional, Lonardi, S., additional, Moretto, R., additional, Zucchelli, G., additional, Aprile, G., additional, Dell’Aquila, E., additional, Ratti, M., additional, Bergamo, F., additional, Masi, G., additional, Urbano, F., additional, Ronzoni, M., additional, Libertini, M., additional, Borelli, B., additional, Randon, G., additional, Buonadonna, A., additional, Allegrini, G., additional, Pella, N., additional, Ricci, V., additional, Boccaccino, A., additional, Latiano, T.P., additional, Cordio, S., additional, Passardi, A., additional, Tamburini, E., additional, Boni, L., additional, Falcone, A., additional, and Cremolini, C., additional

Published
2019
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8. PIK3CA mutation in metastatic colorectal cancer (mCRC): Association with clinico-pathological features and outcome

Author

Fanotto, V., primary, Zucchelli, G., additional, Germani, M.M., additional, Rossini, D., additional, Sensi, E., additional, Lupi, C., additional, Ugolini, C., additional, Antoniotti, C., additional, Marmorino, F., additional, Moretto, R., additional, Boccaccino, A., additional, Borelli, B., additional, Conca, V., additional, Ongaro, E., additional, Masi, G., additional, Fontanini, G., additional, Falcone, A., additional, and Cremolini, C., additional

Published
2019
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9. Evaluation of safety, immunogenicity and preliminary efficacy of PolyPEPI1018 vaccine in subjects with metastatic colorectal cancer (mCRC) with a predictive biomarker

Author

Hubbard, J., primary, Cremolini, C., additional, Graham, R.P., additional, Moretto, R., additional, Mitchell, J., additional, Wessling, J., additional, Tőke, E.R., additional, Csiszovszki, Z., additional, Lorincz, O., additional, Molnar, L., additional, Somogyi, E., additional, Megyesi, M., additional, Pántya, K., additional, Toth, J., additional, Pales, P., additional, Miklos, I., additional, and Falcone, A., additional

Published
2019
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10. Treatments (tx) after progression to first-line FOLFOXIRI + bevacizumab (bev) in metastatic colorectal cancer (mCRC) patients (pts): A pooled analysis of TRIBE and TRIBE-2 studies by GONO

Author

Rossini, D., primary, Lonardi, S., additional, Antoniotti, C., additional, Santini, D., additional, Tomasello, G., additional, Aprile, G., additional, Moretto, R., additional, Prete, A.A., additional, Granetto, C., additional, Urbano, F., additional, Borelli, B., additional, Zaniboni, A., additional, Randon, G., additional, Buonadonna, A., additional, Ritorto, G., additional, Barbara, C., additional, Latiano, T.P., additional, Bordonaro, R., additional, Falcone, A., additional, and Cremolini, C., additional

Published
2019
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11. Efficacy of retreatment with anti-EGFRs in metastatic colorectal cancer is not predictable by clinical factors related to prior lines of therapy: a multi-institutional analysis

Author

Rossini, D., primary, Pagani, F., additional, Pellino, A., additional, Dell’Aquila, E., additional, Liscia, N., additional, Bensi, M., additional, Germani, M., additional, Masi, G., additional, Moretto, R., additional, Santini, D., additional, Salvatore, L., additional, Scartozzi, M., additional, Lonardi, S., additional, Zucchelli, G., additional, Puglisi, F., additional, Vannini, F., additional, Colombo, C., additional, Falcone, A., additional, Pietrantonio, F., additional, and Cremolini, C., additional

Published
2019
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12. Clinical impact of neutropenia and febrile neutropenia in metastatic colorectal cancer patients treated with FOLFOXIRI/bevacizumab: a pooled analysis of TRIBE and TRIBE2 studies

Author

Rossini, D., primary, Sbrana, A., additional, Bergamo, F., additional, Manai, C., additional, Santini, D., additional, Ghidini, M., additional, Antoniotti, C., additional, Moretto, R., additional, Marmorino, F., additional, Urbano, F., additional, Ronzoni, M., additional, Noventa, S., additional, Randon, G., additional, Carlomagno, C., additional, Latiano, T., additional, Cordio, S., additional, Granetto, C., additional, Cremolini, C., additional, Falcone, A., additional, and Antonuzzo, A., additional

Published
2019
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13. Impact of age and gender on safety and efficacy of first-line FOLFOXIRI/bevacizumab in mCRC: a pooled analysis of TRIBE and TRIBE2 studies

Author

Zucchelli, G., primary, Marmorino, F., additional, Rossini, D., additional, Aprile, G., additional, Casagrande, M., additional, Lonardi, S., additional, Murgioni, S., additional, Dell’Aquila, E., additional, Tomasello, G., additional, Moretto, R., additional, Antoniotti, C., additional, Borelli, B., additional, Urbano, F., additional, Ronzoni, M., additional, Zaniboni, A., additional, Manglaviti, S., additional, Buonadonna, A., additional, Ritorto, G., additional, Masi, G., additional, Allegrini, G., additional, Falcone, A., additional, and Cremolini, C., additional

Published
2019
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14. Temozolomide and irinotecan (TEMIRI regimen) as salvage treatment of irinotecan-sensitive advanced colorectal cancer patients bearing MGMT methylation

Author

Morano, F., primary, Corallo, S., additional, Niger, M., additional, Barault, L., additional, Milione, M., additional, Berenato, R., additional, Moretto, R., additional, Randon, G., additional, Antista, M., additional, Belfiore, A., additional, Raimondi, A., additional, Nichetti, F., additional, Martinetti, A., additional, Battaglia, L., additional, Perrone, F., additional, Pruneri, G., additional, Falcone, A., additional, Di Bartolomeo, M., additional, de Braud, F., additional, Di Nicolantonio, F., additional, Cremolini, C., additional, and Pietrantonio, F., additional

Published
2018
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15. Primary tumor sidedness and benefit from FOLFOXIRI plus bevacizumab as initial therapy for metastatic colorectal cancer. Retrospective analysis of the TRIBE trial by GONO

Author

Cremolini, C., primary, Antoniotti, C., additional, Lonardi, S., additional, Bergamo, F., additional, Cortesi, E., additional, Tomasello, G., additional, Moretto, R., additional, Ronzoni, M., additional, Racca, P., additional, Loupakis, F., additional, Zaniboni, A., additional, Tonini, G., additional, Buonadonna, A., additional, Marmorino, F., additional, Allegrini, G., additional, Granetto, C., additional, Masi, G., additional, Zagonel, V., additional, Sensi, E., additional, Fontanini, G., additional, Boni, L., additional, and Falcone, A., additional

Published
2018
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16. Molecular characterization of immune microenvironment in colorectal cancers with microsatellite instability by digital RNA counting

Author

Giordano, M., primary, Moretto, R., additional, Giannini, R., additional, Zucchelli, G., additional, Pietrantonio, F., additional, Antoniotti, C., additional, Ugolini, C., additional, Morano, F., additional, Marmorino, F., additional, Sensi, E., additional, Belfiore, A., additional, Rossini, D., additional, Lupi, C., additional, Masi, G., additional, Borelli, B., additional, Ongaro, E., additional, Boccaccino, A., additional, Falcone, A., additional, Cremolini, C., additional, and Fontanini, G., additional

Published
2018
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17. Clinical and molecular determinants of extrahepatic disease progression (ePD) in initially unresectable, liver-limited metastatic colorectal cancer (mCRC)

Author

Ongaro, E., primary, Rossini, D., additional, Pietrantonio, F., additional, Morano, F., additional, de Braud, F., additional, Mazzaferro, V., additional, Corti, F., additional, Randon, G., additional, Raimondi, A., additional, Battaglia, L., additional, Morelli, L., additional, Urbani, L., additional, Masi, G., additional, Moretto, R., additional, Antoniotti, C., additional, Marmorino, F., additional, Borelli, B., additional, Zucchelli, G., additional, Boccaccino, A., additional, Cremolini, C., additional, and Falcone, A., additional

Published
2018
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18. Negative hyper-selection of metastatic colorectal cancer patients for anti-EGFR monoclonal antibodies: the PRESSING case–control study

Author

Cremolini, C., primary, Morano, F., additional, Moretto, R., additional, Berenato, R., additional, Tamborini, E., additional, Perrone, F., additional, Rossini, D., additional, Gloghini, A., additional, Busico, A., additional, Zucchelli, G., additional, Baratelli, C., additional, Tamburini, E., additional, Tampellini, M., additional, Sensi, E., additional, Fucà, G., additional, Volpi, C., additional, Milione, M., additional, Di Maio, M., additional, Fontanini, G., additional, De Braud, F., additional, Falcone, A., additional, and Pietrantonio, F., additional

Published
2017
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19. Circulating angiogenesis-related markers as predictors of benefit from regorafenib in metastatic colorectal cancer (mCRC) patients (pts)

Author

Antoniotti, C., primary, Marmorino, F., additional, Pennati, M., additional, Zaffaroni, N., additional, Rossini, D., additional, Borelli, B., additional, Zucchelli, G., additional, Moretto, R., additional, Pietrantonio, F., additional, Masi, G., additional, Vannini, F., additional, Colombo, C., additional, Saettini, A., additional, Gini, S., additional, Delliponti, L., additional, Pfanner, E., additional, Brunetti, I., additional, Falcone, A., additional, and Cremolini, C., additional

Published
2017
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20. Dissecting primary resistance to anti-EGFRs in RAS and BRAF wt metastatic colorectal cancer (mCRC): A case-control study

Author

Rossini, D., primary, Cremolini, C., additional, Morano, F., additional, Berenato, R., additional, Tamborini, E., additional, Perrone, F., additional, Moretto, R., additional, Gloghini, A., additional, Busico, A., additional, Zucchelli, G., additional, Baratelli, C., additional, Tamburini, E., additional, Fucà, G., additional, Volpi, C., additional, Milione, M., additional, Di Maio, M., additional, Fontanini, G., additional, de Braud, F., additional, Falcone, A., additional, and Pietrantonio, F., additional

Published
2017
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21. Efficacy of FOLFOXIRI plus bevacizumab in liver-limited metastatic colorectal cancer: A pooled analysis of clinical studies by Gruppo Oncologico del Nord Ovest

Author

Cremolini, Chiara, primary, Casagrande, Mariaelena, additional, Loupakis, Fotios, additional, Aprile, Giuseppe, additional, Bergamo, Francesca, additional, Masi, Gianluca, additional, Moretto R, Roberto, additional, Pietrantonio, Filippo, additional, Marmorino, Federica, additional, Zucchelli, Gemma, additional, Tomasello, Gianluca, additional, Tonini, Giuseppe, additional, Allegrini, Giacomo, additional, Granetto, Cristina, additional, Ferrari, Laura, additional, Urbani, Lucio, additional, Cillo, Umberto, additional, Pilati, Pierluigi, additional, Sensi, Elisa, additional, Pellegrinelli, Alessio, additional, Milione, Massimo, additional, Fontanini, Gabriella, additional, and Falcone, Alfredo, additional

Published
2017
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22. Lactate dehydrogenase (LDH) levels predict benefit from the continuation of bevacizumab (bev) beyond progression in metastatic colorectal cancer (mCRC): subgroup analysis of the randomized BEBYP study

Author

Marmorino, F., primary, Cremolini, C., additional, Loupakis, F., additional, Salvatore, L., additional, Masi, G., additional, Barbara, C., additional, Dargenio, F., additional, Miraglio, E., additional, Ginocchi, L., additional, Antonuzzo, L., additional, Moretto, R., additional, Schirripa, M., additional, Chiara, S., additional, Banzi, C., additional, Amoroso, D., additional, Bonetti, A., additional, Martignetti, A., additional, Paris, M., additional, Boni, L., additional, Tomcikova, D., additional, and Falcone, A., additional

Published
2016
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23. Safety and efficacy of FOLFOXIRI with or without targeted agents as first-line treatment of selected elderly metastatic colorectal cancer patients: a pooled analysis of GONO studies

Author

Rossini, D., primary, Casagrande, M., additional, Moretto, R., additional, Loupakis, F., additional, Cremolini, C., additional, Masi, G., additional, Borelli, B., additional, Lonardi, S., additional, Zagonel, V., additional, Aprile, G., additional, Ricci, V., additional, Grande, R., additional, Tomasello, G., additional, Ronzoni, M., additional, Allegrini, G., additional, Tonini, G., additional, Mancini, M.L., additional, Zaniboni, A., additional, Chiara, S., additional, Carlomagno, C., additional, and Falcone, A., additional

Published
2016
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25. O-011 Modified FOLFOXIRI (mFOLFOXIRI) plus cetuximab (cet), followed by cet or bevacizumab (bev) maintenance, in RAS/BRAF wt metastatic colorectal cancer (mCRC): results of the phase II randomized MACBETH trial by GONO

Author

Antoniotti, C., primary, Cremolini, C., additional, Loupakis, F., additional, Bergamo, F., additional, Grande, R., additional, Tonini, G., additional, Garattini Silvio, K., additional, Masi, G., additional, Battaglin, F., additional, Lucchesi, S., additional, Salvatore, L., additional, Corsi, D., additional, Di Fabio, F., additional, Banzi, M., additional, Moretto, R., additional, Sensi, E., additional, Rossini, D., additional, Tomcikova, D., additional, Fontanini, G., additional, Zagonel, V., additional, Boni, L., additional, and Falcone, A., additional

Published
2016
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26. PD-009 Safety and efficacy of FOLFOXIRI with or without targeted agents as first-line treatment of selected elderly metastatic colorectal cancer patients: a pooled analysis of GONO studies

Author

Casagrande, M., primary, Moretto, R., additional, Loupakis, F., additional, Cremolini, C., additional, Masi, G., additional, Borelli, B., additional, Lonardi, S., additional, Marsico Valentina, A., additional, Salvatore, L., additional, Rossini, D., additional, Ferrari, L., additional, Ricci, V., additional, Grande, R., additional, Tomasello, G., additional, Ronzoni, M., additional, Allegrini, G., additional, Tonini, G., additional, Mancini, M., additional, Zaniboni, A., additional, Chiara, S., additional, Carlomagno, C., additional, and Falcone, A., additional

Published
2016
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27. FOLFOXIRI or FOLFOXIRI plus bevacizumab as first-line treatment of metastatic colorectal cancer: a propensity score-adjusted analysis from two randomized clinical trials

Author

Cremolini, C., primary, Loupakis, F., additional, Masi, G., additional, Lonardi, S., additional, Granetto, C., additional, Mancini, M.L., additional, Chiara, S., additional, Moretto, R., additional, Rossini, D., additional, Vitello, S., additional, Allegrini, G., additional, Tonini, G., additional, Bergamo, F., additional, Tomasello, G., additional, Ronzoni, M., additional, Buonadonna, A., additional, Bustreo, S., additional, Barbara, C., additional, Boni, L., additional, and Falcone, A., additional

Published
2016
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28. BRAF codons 594 and 596 mutations identify a new molecular subtype of metastatic colorectal cancer at favorable prognosis

Author

Cremolini, C., primary, Di Bartolomeo, M., additional, Amatu, A., additional, Antoniotti, C., additional, Moretto, R., additional, Berenato, R., additional, Perrone, F., additional, Tamborini, E., additional, Aprile, G., additional, Lonardi, S., additional, Sartore-Bianchi, A., additional, Fontanini, G., additional, Milione, M., additional, Lauricella, C., additional, Siena, S., additional, Falcone, A., additional, de Braud, F., additional, Loupakis, F., additional, and Pietrantonio, F., additional

Published
2015
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29. Circulating microRNAs in metastatic colorectal cancer (mCRC) patients (pts) treated with regorafenib

Author

Antoniotti, C., primary, Loupakis, F., additional, Schirripa, M., additional, Cremolini, C., additional, Poliseno, L., additional, Salvatore, L., additional, Tuccoli, A., additional, D'Aurizio, R., additional, Marmorino, F., additional, Borelli, B., additional, Rossini, D., additional, Saettini, A., additional, Gini, S., additional, Moretto, R., additional, Rizzo, I., additional, Dell'Aquila, E., additional, Pellegrini, M., additional, and Falcone, A., additional

Published
2015
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30. P-198 Circulating microRNAs in metastatic colorectal cancer (mCRC) patients (pts) treated with regorafenib

Author

Schirripa, M., primary, Loupakis, F., additional, Cremolini, C., additional, Poliseno, L., additional, Salvatore, L., additional, Tuccoli, A., additional, Antoniotti, C., additional, D'Aurzio, R., additional, Marmorino, F., additional, Borelli, B., additional, Rossini, D., additional, Saettini, A., additional, Gini, S., additional, Moretto, R., additional, Rizzo, I., additional, Dell' Aquila, E., additional, Pellegrini, M., additional, and Falcone, A., additional

Published
2015
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31. Effects of SAS 1310, a new calcium antagonist, on isolated myocardial and smooth muscle preparations

Author

Donatella Piovan, Roberto Padrini, Moretto R, Gabriella Cargnelli, and Sergio Bova

Subjects
Inotrope, Contraction (grammar), Guinea Pigs, chemistry.chemical_element, In Vitro Techniques, Pharmacology, Calcium, Muscle, Smooth, Vascular, Contractility, Guinea pig, Diltiazem, medicine, Animals, Heart Atria, Intestine, Large, Aorta, Chemistry, Antagonist, Muscle, Smooth, Calcium Channel Blockers, musculoskeletal system, Taenia coli, Myocardial Contraction, medicine.anatomical_structure, Anesthesia, cardiovascular system, Female, Muscle Contraction, medicine.drug
Abstract

Some features of the effects of the diltiazem derivative SAS 1310 on in vitro myocardial and smooth muscle preparations were compared to those of the effects of diltiazem. Left atria, aortic strips and taenia coli of guinea-pigs were used. SAS 1310 induced a negative inotropic response of the left atria driven at 1 Hz similar to the response to diltiazem (IC50 values: SAS 1310 1.34 microM, diltiazem 0.8 microM). The inotropic effect of diltiazem (5 microM) was clearly rate-dependent whereas the reduction of left atria contractility induced by SAS 1310 (5 microM) was not modified by changes of the stimulation rate (the range of frequencies used was 0.5-2 Hz, with stepwise changes of 0.5 Hz). Diltiazem (0.1-0.5 microM) was more effective than SAS 1310 (0.1-5 microM) in inhibiting the contractile response to calcium of taenia coli depolarized by high K+ as well as in relaxing the aortic strips contracted by high K+ (IC50 SAS 1310 12.3 microM, diltiazem 0.41 microM). The response of aortic strips to norepinephrine (50 microM) in Ca2+-free medium was inhibited by SAS 1310 (50 microM) and was not affected by diltiazem (2 microM). The drug concentrations used were equiactive in inhibiting the high K+-induced contraction of the aortic strips. The different effects of diltiazem and its derivative on left atria contraction at different force-frequency ratios and on aortic strip contraction induced by norepinephrine in a Ca2+-free medium suggest that the actions of the two drugs differ qualitatively.

Published
1987
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32. 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

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

Subjects
Male, 0301 basic medicine, GONO, Organoplatinum Compounds, multicentre, Leucovorin, Colorectal Neoplasm, Gastroenterology, Settore MED/06, Antineoplastic Agents, Immunological, 0302 clinical medicine, Antineoplastic Combined Chemotherapy Protocols, Neoplasm Metastasis, FOLFOXIRI, progression versus mFOLFOX6 plus bevacizumab, mFOLFOX6, metastatic colorectal cancer, Middle Aged, TRIBE2 trial, FOLFIRI plus bevacizumab, Neoplasm Metastasi, Bevacizumab, FOLFOXIRI plus bevacizumab, triplet FOLFOXIRI, Oncology, Fluorouracil, 030220 oncology & carcinogenesis, Disease Progression, FOLFIRI, Female, metastatic colorectal cancer, triplet FOLFOXIRI , FOLFOXIRI plus bevacizumab, FOLFIRI plus bevacizumab, progression versus mFOLFOX6 plus bevacizumab, TRIBE2, Colorectal Neoplasms, Human, medicine.drug, Adult, medicine.medical_specialty, Adolescent, Analogs & derivatives, open-label, NO, Young Adult, 03 medical and health sciences, Folinic acid, Internal medicine, medicine, cancer, Humans, neoplasms, Aged, Antineoplastic Combined Chemotherapy Protocol, Performance status, business.industry, Organoplatinum Compound, randomised controlled, FOLFOXIRI, bevacizumab, mFOLFOX6, FOLFIRI, metastatic colorectal cancer, TRIBE2 trial, multicentre, open-label, phase 3, randomised controlled, GONO, Irinotecan, 030104 developmental biology, phase 3, TRIBE2, Camptothecin, business
Abstract

Summary Background The triplet FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab showed improved outcomes for patients with metastatic colorectal cancer, compared with FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab. However, the actual benefit of the upfront exposure to the three cytotoxic drugs compared with a preplanned sequential strategy of doublets was not clear, and neither was the feasibility or efficacy of therapies after disease progression. We aimed to compare a preplanned strategy of upfront FOLFOXIRI followed by the reintroduction of the same regimen after disease progression versus a sequence of mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) and FOLFIRI doublets, in combination with bevacizumab. Methods TRIBE2 was an open-label, phase 3, randomised study of patients aged 18–75 years with an Eastern Cooperative Oncology Group (ECOG) performance status of 2, with unresectable, previously untreated metastatic colorectal cancer, recruited from 58 Italian oncology units. Patients were stratified according to centre, ECOG performance status, primary tumour location, and previous adjuvant chemotherapy. A randomisation system incorporating a minimisation algorithm was used to randomly assign patients (1:1) via a masked web-based allocation procedure to two different treatment strategies. In the control group, patients received first-line mFOLFOX6 (85 mg/m2 of intravenous oxaliplatin concurrently with 200 mg/m2 of leucovorin over 120 min; 400 mg/m2 intravenous bolus of fluorouracil; 2400 mg/m2 continuous infusion of fluorouracil for 48 h) plus bevacizumab (5 mg/kg intravenously over 30 min) followed by FOLFIRI (180 mg/m2 of intravenous irinotecan over 120 min concurrently with 200 mg/m2 of leucovorin; 400 mg/m2 intravenous bolus of fluorouracil; 2400 mg/m2 continuous infusion of fluorouracil for 48 h) plus bevacizumab after disease progression. In the experimental group, patients received FOLFOXIRI (165 mg/m2 of intravenous irinotecan over 60 min; 85 mg/m2 intravenous oxaliplatin concurrently with 200 mg/m2 of leucovorin over 120 min; 3200 mg/m2 continuous infusion of fluorouracil for 48 h) plus bevacizumab followed by the reintroduction of the same regimen after disease progression. Combination treatments were repeated every 14 days for up to eight cycles followed by fluorouracil and leucovorin (at the same dose administered at the last induction cycle) plus bevacizumab maintenance until disease progression, unacceptable adverse events, or consent withdrawal. Patients and investigators were not masked. The primary endpoint was progression-free survival 2, defined as the time from randomisation to disease progression on any treatment given after first disease progression, or death, analysed by intention to treat. Safety was assessed in patients who received at least one dose of their assigned treatment. Study recruitment is complete and follow-up is ongoing. This trial is registered with Clinicaltrials.gov , NCT02339116 . Findings Between Feb 26, 2015, and May 15, 2017, 679 patients were randomly assigned and received treatment (340 in the control group and 339 in the experimental group). At data cut-off (July 30, 2019) median follow-up was 35·9 months (IQR 30·1–41·4). Median progression-free survival 2 was 19·2 months (95% CI 17·3–21·4) in the experimental group and 16·4 months (15·1–17·5) in the control group (hazard ratio [HR] 0·74, 95% CI 0·63–0·88; p=0·0005). During the first-line treatment, the most frequent of all-cause grade 3–4 events were diarrhoea (57 [17%] vs 18 [5%]), neutropenia (168 [50%] vs 71 [21%]), and arterial hypertension (25 [7%] vs 35 [10%]) in the experimental group compared with the control group. Serious adverse events occurred in 84 (25%) patients in the experimental group and in 56 (17%) patients in the control group. Eight treatment-related deaths were reported in the experimental group (two intestinal occlusions, two intestinal perforations, two sepsis, one myocardial infarction, and one bleeding) and four in the control group (two occlusions, one perforation, and one pulmonary embolism). After first disease progression, no substantial differences in the incidence of grade 3 or 4 adverse events were reported between the control and experimental groups, with the exception of neurotoxicity, which was only reported in the experimental group (six [5%] of 132 patients). Serious adverse events after disease progression occurred in 20 (15%) patients in the experimental group and 25 (12%) in the control group. Three treatment-related deaths after first disease progression were reported in the experimental group (two intestinal occlusions and one sepsis) and four in the control group (one intestinal occlusion, one intestinal perforation, one cerebrovascular event, and one sepsis). Interpretation Upfront FOLFOXIRI plus bevacizumab followed by the reintroduction of the same regimen after disease progression seems to be a preferable therapeutic strategy to sequential administration of chemotherapy doublets, in combination with bevacizumab, for patients with metastatic colorectal cancer selected according to the study criteria. Funding The GONO Cooperative Group, the ARCO Foundation, and F Hoffmann–La Roche.

Published
2020
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