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2. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Mangano, S., Tonato, M., Zucca, E., Valsecchi, M.G., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., Dell'Oro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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3. Discontinuation of first-line bevacizumab in metastatic colorectal cancer: the BEAWARE Italian Observational Study

Author

Lonardi, S., Nasti, G., Fagnani, D., Gemma, D., Ciuffreda, L., Granetto, C., Lucchesi, S., Ballestrero, A., Biglietto, M., Proserpio, I., Bergamo, F., Proietti, E., Tonini, G., and Soto Parra, H

Subjects
Adult, Male, 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Drug-Related Side Effects and Adverse Reactions, Genotype, Bevacizumab, Colorectal cancer, First line, Angiogenesis Inhibitors, Metastatic colorectal cancer, bevacizumab, clinical practice, progression-free survival, therapy interruption, Disease-Free Survival, Proto-Oncogene Proteins p21(ras), 03 medical and health sciences, 0302 clinical medicine, Internal medicine, Humans, Medicine, Progression-free survival, Neoplasm Metastasis, Aged, business.industry, General Medicine, Middle Aged, medicine.disease, Discontinuation, 030104 developmental biology, Italy, 030220 oncology & carcinogenesis, Mutation, Mutation (genetic algorithm), Female, Observational study, Colorectal Neoplasms, business, medicine.drug
Abstract

Aims: BEAWARE investigated the pattern of first-line bevacizumab early interruption in the Italian real-world setting of metastatic colorectal cancer. Methods: A total of 386 patients were followed for 15 months after first-line chemotherapy + bevacizumab start. The rate of bevacizumab interruption for progression or adverse drug reactions (ADRs) constituted the primary endpoint. Results: A total of 78.2% of patients interrupted bevacizumab: 56.6% for progression, 7.3% for ADRs, and 36.1% for other reasons. Median treatment duration was 6.7, 2.5, and 4.6 months, respectively. Median progression-free survival was 10.3 months; however, 35.8% of patients were not progressed and were thus censored at the data cutoff of 15 months, while 21.8% were still receiving bevacizumab. Patients discontinuing for progression/ADRs more frequently had metastases in >1 site ( p = .0001), and a shorter median progression-free survival (6.9 vs 13.9 months, p < .0001). Conclusions: In Italy, first-line bevacizumab is interrupted mainly for progression, only 7.3% due to adverse events, and about one third of cases for other reasons. In clinical practice, the attitude to treat until progression as per guidelines might be implemented. ClinicalTrials.gov Identifier: NCT01609075

Published
2019

4. Early tumor shrinkage and depth of response predict long-term outcome in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab: results from phase III TRIBE trial by the Gruppo Oncologico del Nord Ovest

Author

Cremolini, C., Loupakis, F., Antoniotti, C., Lonardi, S., Masi, G., Salvatore, L., Cortesi, E., Tomasello, G., Spadi, R., Zaniboni, A., Tonini, G., Barone, C., Vitello, S., Longarini, R., Bonetti, A., DʼAmico, M., Di Donato, S., Granetto, C., Boni, L., and Falcone, A.

Published
2015
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7. O-019 Distant-relapse analysis of STAR-01, a randomized phase III trial comparing preoperative chemoradiation with or without oxaliplatin in locally advanced rectal cancer

Author

Lonardi, S., Cionini, L., Pinto, C., Cordio, S., Rosati, G., Sartore Bianchi, A., Tagliagambe, A., Frisinghelli, M., Zagonel, V., Rosetti, P., Negru, M.E., Bonetti, A., Tronconi, M.C., Luppi, G., Marsella, A.R., Corsi, C., Bochicchio, A.M., Aprile, G., Niespolo, R., Granetto, C., Boni, L., and Aschele, C.

Published
2016
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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

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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9. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Bajetta, E., Floriani, I., Di Bartolomeo, M., Labianca, R., Falcone, A., Di Costanzo, F., Comella, G., Amadori, D., Pinto, C., Carlomagno, C., Nitti, D., Daniele, B., Mini, E., Poli, D., Santoro, A., Mosconi, S., Casaretti, R., Boni, C., Pinotti, G., Bidoli, P., Landi, L., Rosati, G., Ravaioli, A., Cantore, M., Di Fabio, F., Aitini, E., Marchet, A., Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Poli, D., Mangano, S., Tonato, M., Zucca, E., Valsecchi, MG., Floriani, I., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Bajetta, E., Di Bartolomeo, M., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., DellʼOro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Labianca, R., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Amadori, D., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Falcone, A., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Di Costanzo, F., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Pinto, C., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Daniele, B., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Nitti, D., Marchet, A., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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11. 1950P TRANSLATE: Activation of immune response in refractory patients to standard treatment

Author

Merlano, M.C., primary, Paccagnella, M., additional, Garrone, O., additional, Falletta, A., additional, Fea, E., additional, Abbona, A., additional, Lo Nigro, C., additional, Gammaitoni, L., additional, Vanella, P., additional, Monteverde, M., additional, Granetto, C., additional, Occelli, M., additional, Denaro, N., additional, Merlotti, A., additional, Reali, A., additional, and Sangiolo, D., additional

Published
2020
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12. Phase II study of preoperative (PREOP) chemoradiotherapy (CTRT) plus avelumab (AVE) in patients (PTS) with locally advanced rectal cancer (LARC): The AVANA Study

Author

Salvatore, L., primary, Bensi, M., additional, Pietrantonio, F., additional, Boccaccino, A., additional, Barbara, C., additional, Auriemma, A., additional, Ratti, M., additional, Tamburini, E., additional, Bordonaro, R., additional, Clavarezza, M., additional, Avallone, A., additional, Bergamo, F., additional, Granetto, C., additional, Bustreo, S., additional, Fabio, F Di, additional, Smiroldo, V., additional, Corvari, B., additional, and Tortora, G., additional

Published
2019
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13. 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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21. The role of interleukin-8 (IL-8) in predicting the outcome of metastatic colorectal cancer patients treated with aflibercept in combination to FOLFIRI: the FLIBER study

Author

D’Arcangelo, M., primary, Buonerba, C., additional, Avallone, A., additional, Dazzi, C., additional, Frassineti, G., additional, Tamberi, S., additional, Tassinari, D., additional, Aprile, G., additional, Granetto, C., additional, Bonetti, A., additional, Vecchiarelli, S., additional, and Cappuzzo, F., additional

Published
2019
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23. Updated results of TRIBE2, a phase III, randomized strategy study by GONO in the 1st- and 2nd-line treatment of unresectable mCRC

Author

Cremolini, C., primary, Antoniotti, C., additional, Lonardi, S., additional, Rossini, D., additional, Morano, F., additional, Cordio, S., additional, Bergamo, F., additional, Marmorino, F., additional, Maiello, E., additional, Passardi, A., additional, Masi, G., additional, Tamburini, E., additional, Santini, D., additional, Grande, R., additional, Zaniboni, A., additional, Granetto, C., additional, Murgioni, S., additional, Aprile, G., additional, Delliponti, L., additional, Boni, L., additional, and Falcone, A., additional

Published
2019
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24. 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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25. TRIBE2: A phase III, randomized strategy study by GONO in the 1st- and 2nd-line treatment of unresectable metastatic colorectal cancer (mCRC) patients (pts)

Author

Cremolini, C., primary, Antoniotti, C., additional, Lonardi, S., additional, Rossini, D., additional, Pietrantonio, F., additional, Cordio, S.S., additional, Murgioni, S., additional, Marmorino, F., additional, Maiello, E., additional, Passardi, A., additional, Masi, G., additional, Tamburini, E., additional, Santini, D., additional, Grande, R., additional, Zaniboni, A., additional, Granetto, C., additional, Loupakis, F., additional, Delliponti, L., additional, Boni, L., additional, and Falcone, A., additional

Published
2018
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26. Corrigendum: Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer (British Journal of Cancer (2016) 115 (789-796) DOI: 10.1038/bjc.2016.271)

Author

Dalgleish AG, Stebbing J, Adamson DJ, Arif SS, Bidoli P, Chang D, Cheeseman S, Diaz-Beveridge R, Fernandez-Martos C, Glynne-Jones R, Granetto C, Massuti B, McAdam K, McDermott R, Martín AJ, Papamichael D, Pazo-Cid R, Vieitez JM, Zaniboni A, Carroll KJ, Wagle S, Gaya A, Mudan SS., Dalgleish, A, Stebbing, J, Adamson, D, Arif, S, Bidoli, P, Chang, D, Cheeseman, S, Diaz-Beveridge, R, Fernandez-Martos, C, Glynne-Jones, R, Granetto, C, Massuti, B, Mcadam, K, Mcdermott, R, Martín, A, Papamichael, D, Pazo-Cid, R, Vieitez, J, Zaniboni, A, Carroll, K, Wagle, S, Gaya, A, and Mudan, S

Subjects
Gemcitabine
Abstract

Upon publication of the above paper in the British Journal of Cancer, the authors identified an error in one of their affiliations. The authors would like to apologise for this mistake. The correct affiliation for Andrés J Munoz Martín is 'Medical Oncology Service, Hospital General Universitario Gregorio Maranón, Madrid, Spain.'

Published
2016

27. 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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28. FOLFOXIRI or FOLFOXIRI plus bevacizumab as first-line treatment of metastatic colorectal cancer: a propensity score-adjusted analysis from two randomized clinical trials.ANNALS OF ONCOLOGY, ISSN: 0923-7534

Author

Cremolini, C, Loupakis, F, Masi, G, Lonardi, S, Granetto, C, Mancini, Marialaura, Chiara, S, Moretto, R, Rossini, Daniela, Vitello, S, Allegrini, G, Tonini, G, Bergamo, F, Tomasello, G, Ronzoni, M, Buonadonna, A, Bustreo, S, Barbara, C, Boni, Maria Luisa, and Falcone, A. 1. 5.

Published
2016

30. 570P - 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., Lonardi, S., Antoniotti, C., Santini, D., Tomasello, G., Aprile, G., Moretto, R., Prete, A.A., Granetto, C., Urbano, F., Borelli, B., Zaniboni, A., Randon, G., Buonadonna, A., Ritorto, G., Barbara, C., Latiano, T.P., Bordonaro, R., Falcone, A., and Cremolini, C.

Published
2019
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31. Phase III Trial of Infusional Fluorouracil, Leucovorin, Oxaliplatin, and Irinotecan (FOLFOXIRI) Compared With Infusional Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) As First-Line Treatment for Metastatic Colorectal Cancer: The Gruppo Oncologico Nord Ovest

Author

Falcone, A., Ricci, S., Brunetti, I., Pfanner, E., Allegrini, G., Barbara, C., Crino, L., Benedetti, G., Evangelista, W., Fanchini, L., Cortesi, Enrico, Picone, V., Vitello, S., Chiara, S., Granetto, C., Porcile, G., Fioretto, L., Orlandini, C., Andreuccetti, M., Masi, G., and Ovest Gruppo Oncologico Nord

Subjects
Adult, Male, Cancer Research, medicine.medical_specialty, Organoplatinum Compounds, Colorectal cancer, Leucovorin, Neutropenia, Irinotecan, Gastroenterology, Recurrence, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Neoplasm Metastasis, Aged, FOLFOXIRI, business.industry, Middle Aged, medicine.disease, Survival Analysis, Surgery, Oxaliplatin, Oncology, Fluorouracil, Quality of Life, FOLFIRI, Camptothecin, Female, Colorectal Neoplasms, business, Febrile neutropenia, medicine.drug
Abstract

Purpose The Gruppo Oncologico Nord Ovest (GONO) conducted a phase III study comparing fluorouracil, leucovorin, oxaliplatin, and irinotecan (FOLFOXIRI [irinotecan 165 mg/m2 day 1, oxaliplatin 85 mg/m2 day 1, leucovorin 200 mg/m2 day 1, fluorouracil 3,200 mg/m2 48-hour continuous infusion starting on day 1, every 2 weeks]) with infusional fluorouracil, leucovorin, and irinotecan (FOLFIRI). Methods Selection criteria included unresectable metastatic colorectal cancer, age 18 to 75 years, and no prior chemotherapy for advanced disease. The primary end point was response rate (RR). Results A total of 244 patients were randomly assigned. An increase of grade 2 to 3 peripheral neurotoxicity (0% v 19%; P < .001), and grade 3 to 4 neutropenia (28% v 50%; P < .001) were observed in the FOLFOXIRI arm. The incidence of febrile neutropenia (3% v 5%) and grade 3 to 4 diarrhea (12% v 20%) were not significantly different. Responses, as assessed by investigators, were, for FOLFIRI and FOLFOXIRI, respectively, complete, 6% and 8%; and partial, 35% and 58%, (RR, 41% v 66%; P = .0002). RR confirmed by an external panel was 34% versus 60% (P < .0001). The R0 secondary resection rate of metastases was greater in the FOLFOXIRI arm (6% v 15%; P = .033, among all 244 patients; and 12% v 36%; P = .017 among patients with liver metastases only). Progression-free survival (PFS) and overall survival (OS) were both significantly improved in the FOLFOXIRI arm (median PFS, 6.9 v 9.8 months; hazard ratio [HR], 0.63; P = .0006; median OS, 16.7 v 22.6 months; HR, 0.70; P = .032). Conclusion The FOLFOXIRI regimen improves RR, PFS, and OS compared with FOLFIRI, with an increased, but manageable, toxicity in patients with metastatic colorectal cancer with favorable prognostic characteristics. Further studies of FOLFOXIRI in combination with targeted agents and in the neoadjuvant setting are warranted.

Published
2007

32. FOLFOXIRI plus bevacizumab (bev) followed by maintenance with bev alone or bev plus metronomic chemotherapy (metroCT) in metastatic colorectal cancer (mCRC): The phase II randomized MOMA trial

Author

Falcone, A., primary, Cremolini, C., additional, Loupakis, F., additional, Lonardi, S., additional, Casagrande, M.E., additional, Murgioni, S., additional, Salvatore, L., additional, Masi, G., additional, Fanotto, V., additional, Granetto, C., additional, Marmorino, F., additional, Ginocchi, L., additional, Ziampiri, S., additional, Grande, R., additional, Tonini, G., additional, Delfanti, S., additional, Di Donato, S., additional, Fontanini, G., additional, Boni, L., additional, and Zagonel, V., additional

Published
2016
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34. Early tumor shrinkage and depth of response predict long-term outcome in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab: results from phase III TRIBE trial by the Gruppo Oncologico del Nord Ovest

Author

Cremolini, C, Loupakis, F, Antoniotti, C, Lonardi, S, Masi, G, Salvatore, L, Cortesi, Enrico, Tomasello, G, Spadi, R, Zaniboni, A, Tonini, G, Barone, C, Vitello, S, Longarini, R, Bonetti, A, D&apos, Amico, M, Di Donato, S, Granetto, C, Boni, L, and Falcone, A.

Subjects
Adult, Oncology, Prognostic variable, medicine.medical_specialty, Time Factors, Organoplatinum Compounds, Bevacizumab, Colorectal cancer, Population, Leucovorin, Angiogenesis Inhibitors, Kaplan-Meier Estimate, Disease-Free Survival, early tumor shrinkage, depth of response, FOLFOXIRI, bevacizumab, Risk Factors, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Neoplasm Metastasis, education, Aged, Proportional Hazards Models, education.field_of_study, Univariate analysis, Chi-Square Distribution, business.industry, Proportional hazards model, Hematology, Middle Aged, medicine.disease, Tumor Burden, Treatment Outcome, Early tumor shrinkage, Italy, Multivariate Analysis, Disease Progression, FOLFIRI, Camptothecin, Fluorouracil, Colorectal Neoplasms, Depth of response, business, medicine.drug
Abstract

Background Early tumor shrinkage (ETS) and depth of response (DoR) predict overall survival (OS) in first-line trials of chemotherapy ± anti-EGFR monoclonal antibodies in metastatic colorectal cancer (mCRC). These associations and the predictive accuracy of response measurements for survival parameters were investigated in the phase III TRIBE trial of FOLFOXIRI plus bevacizumab (bev) versus FOLFIRI plus bev. Patients and methods A landmark approach was adopted to define the assessable population. The distribution of RECIST response rate, ETS and DoR was compared in the two arms. Associations between response measurements and progression-free survival (PFS), post-progression survival (PPS) and OS were tested by univariate and multivariate Cox models. Prediction performance of each factor was estimated by C-index. Results A significantly higher percentage of patients in the FOLFOXIRI plus bev arm achieved ETS ≥20%, when compared with the control arm (62.7% versus 51.9%, P = 0.025). Also the DoR was significantly higher in the triplet plus bev arm (43.4% versus 37.8%, P = 0.003). Both ETS and DoR were associated with PFS, PPS and OS at the univariate analyses and in the multivariate models stratified for other prognostic variables. Both ETS and DoR were able to predict survival as accurately as RECIST response. Conclusion FOLFOXIRI plus bev improves ETS and DoR when compared with FOLFIRI plus bev. Achieving rapid and deep tumor shrinkage consistently delays tumor progression and prolongs survival in patients treated with first-line chemotherapy plus bev. ETS is a promising and valuable end point for clinical trials' design deserving further investigation.

Published
2015

36. PD-015 - 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., Sbrana, A., Bergamo, F., Manai, C., Santini, D., Ghidini, M., Antoniotti, C., Moretto, R., Marmorino, F., Urbano, F., Ronzoni, M., Noventa, S., Randon, G., Carlomagno, C., Latiano, T., Cordio, S., Granetto, C., Cremolini, C., Falcone, A., and Antonuzzo, A.

Published
2019
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40. Metronomic oral cyclophosphamide (CTX) in patients (pts) with heavily pretreated metastatic castration-resistant prostate cancer (mCRPC)

Author

Fea, E., primary, Vanella, P., additional, Miraglio, E., additional, Cauchi, C., additional, Colantonio, I., additional, Denaro, N., additional, Di Costanzo, G., additional, Garrone, O., additional, Granetto, C., additional, Occelli, M., additional, Ricci, V., additional, Vandone, A.M., additional, and Merlano, M.C., additional

Published
2016
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42. Impact on Survival of Timing and Duration of Adjuvant Chemotherapy in Radically Resected Gastric Cancer

Author

Di Bartolomeo, Maria, primary, Pietrantonio, Filippo, additional, Rulli, Eliana, additional, Poli, Davide, additional, Berenato, Rosa, additional, Caporale, Marta, additional, Bajetta, Emilio, additional, Floriani, Irene, additional, Bajetta, E., additional, Di Bartolomeo, M., additional, Catena, L., additional, Schiavo, M., additional, Pinotti, G., additional, Proserpio, I., additional, Rosati, G., additional, Bordonaro, R., additional, Cordio, S., additional, Burrafato, G., additional, Bochicchio, A.M., additional, Aieta, M., additional, Fazio, N., additional, Spada, F., additional, Amoroso, V., additional, Marini, G., additional, Soto Parra, H., additional, Novello, G., additional, Massidda, B., additional, Ionta, M.T., additional, Comandè, M., additional, Venezia, R., additional, Bertolini, A., additional, Menatti, E., additional, Zanlorenzi, L., additional, Colombo, A., additional, Iop, A., additional, Bonura, S., additional, Mazza, E., additional, Viganò, M., additional, Ardizzoia, A., additional, Dell'Oro, S., additional, Lo Re, G., additional, Santeufemia, D., additional, Buonadonna, A., additional, Luisi, D., additional, Ucci, G., additional, Di Lucca, G., additional, Bonetti, A., additional, Bergamo, F., additional, Alù, M., additional, Vastola, F., additional, Marchetti, P., additional, Corsi, D.C., additional, Massa, E., additional, Di Pinto, G., additional, Duro, M., additional, Oliani, C., additional, Franchini, M., additional, Inzoli, A., additional, Gebbia, N., additional, Repetto, L., additional, Rota, S., additional, Frontini, L., additional, Labianca, R., additional, Mosconi, S., additional, Quadri, A., additional, De Grossi, S., additional, Bidoli, P., additional, Cazzaniga, M.E., additional, Villa, F., additional, Foa, P., additional, Ferrari, D., additional, Aitini, E., additional, Rabbi, C., additional, Barni, S., additional, Petrelli, F., additional, Giordano, M., additional, Luchena, G., additional, Pirovano, M., additional, Nasisi, A., additional, Catalano, V., additional, Giordani, P., additional, Zaniboni, A., additional, Leone, F., additional, Ferrario, S., additional, Beretta, G.D., additional, Menichetti, E.T., additional, Conte, D., additional, Mari, D., additional, Giannicola, R., additional, Pierantoni, C., additional, Luporini, A.G., additional, Ragazzini, A., additional, Ravaioli, A., additional, Tassinari, D., additional, Nicolini, M., additional, Amadori, D., additional, Frassineti, G.L., additional, Turci, D., additional, Zumaglini, F., additional, Tamberi, S., additional, Piancastelli, A., additional, Cruciani, G., additional, Bejtja, E., additional, Falcone, A., additional, Landi, L., additional, Minuti, G., additional, Cantore, M., additional, Orlandi, M., additional, Mambrini, A., additional, Ciarlo, A., additional, Cavaciocchi, D., additional, Del Monte, F., additional, Ricci, S., additional, Brunetti, I.M., additional, Lencioni, M., additional, Sisani, M., additional, Sozzi, P., additional, Granetto, C., additional, Chiara, S., additional, Galetto, A.S., additional, Ribecco, A.S., additional, DeCensi, A., additional, Ciuffreda, L., additional, Baldini, E.E., additional, Camisa, R., additional, Todeschini, R., additional, Santoro, A., additional, Rimassa, L., additional, Carnaghi, C., additional, Pressiani, T., additional, Boni, C., additional, Rondini, E., additional, Gnoni, R., additional, Di Costanzo, F., additional, Gasperoni, S., additional, Cavanna, L., additional, Palladino, M.A., additional, Mattioli, R., additional, Laici, G., additional, Pucci, F., additional, Alessio, M.D., additional, Bernardini, I., additional, Tomasello, G., additional, Baldino, G., additional, Rossetti, R., additional, Giaquinta, S., additional, Pinto, C., additional, Di Fabio, F., additional, Rijas Llimpe, F.L., additional, Brandes, A.A., additional, Marzola, M., additional, Rummo Benevento, A.O.G., additional, Competiello, S., additional, Montesarchio, V., additional, Rea, A., additional, Daniele, B., additional, Genua, G., additional, Licenziato, M., additional, Casaretti, R., additional, Silvestro, L., additional, Montano, M., additional, Sarobba, M.G., additional, Sanna, G., additional, Filippelli, G., additional, Dima, G., additional, Greco, E., additional, Roselli, M., additional, Natale, D., additional, Condemi, G., additional, Fumi, G., additional, Tafuto, S., additional, Masullo, P., additional, Nitti, D., additional, Marchet, A., additional, Tiberio, G., additional, de Manzoni, G., additional, Nobili, S., additional, Fiorentini, G., additional, Mazzanti, R., additional, Perrotta, E., additional, Carlomagno, C., additional, De Stefano, A., additional, Cartenì, G., additional, and Otero, M., additional

Published
2016
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44. DPYD c.1905 + 1G > A and c.2846A > T and UGT1A1*28 allelic variants as predictors of toxicity: Pharmacogenetic translational analysis from the phase III TRIBE study in metastatic colorectal cancer

Author

Cremolini, C., primary, Del Re, M., additional, Loupakis, F., additional, Marmorino, F., additional, Citi, V., additional, Palombi, M., additional, Bergamo, F., additional, Schirripa, M., additional, Rossini, D., additional, Cortesi, E., additional, Tomasello, G., additional, Spadi, R., additional, Buonadonna, A., additional, Amoroso, D., additional, Vitello, S., additional, Di Donato, S., additional, Granetto, C., additional, D'Amico, M., additional, Falcone, A., additional, and Danesi, R., additional

Published
2015
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45. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as initial treatment for metastatic colorectal cancer (TRIBE study): updated survival results and final molecular subgroups analyses

Author

Falcone, A., primary, Cremolini, C., additional, Antoniotti, C., additional, Lonardi, S., additional, Ronzoni, M., additional, Zaniboni, A., additional, Tonini, G., additional, Salvatore, L., additional, Masi, G., additional, Mezi, S., additional, Tomasello, G., additional, Carlomagno, C., additional, Allegrini, G., additional, Chiara, S., additional, D'Amico, M., additional, Granetto, C., additional, Lupi, C., additional, Sensi, E., additional, Fontanini, G., additional, Boni, L., additional, and Loupakis, F., additional

Published
2015
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46. Second-line chemotherapy (CT) with or without bevacizumab (BV) in metastatic colorectal cancer (mCRC) patients (pts) who progressed to a first-line treatment containing BV: Updated results of the phase III 'BEBYP'trial by the Gruppo Oncologico Nord Ovest (GONO)

Author

GIANLUCA MASI, Loupakis, F., Salvatore, L., CHIARA CREMOLINI, Fornaro, L., Schirripa, M., Granetto, C., Miraglio, E., Di Costanzo, F., Antonuzzo, L., Marcucci, L., Barbara, C., Boni, C., Banzi, M., Chiara, S., Garbarino, D., Valsuani, C., Bonetti, A., Boni, L., and Alfredo Falcone

Published
2013

47. A multicenter, randomized phase III study of second-line chemotherapy (CT) with or without bevacizumab (BV) in metastatic colorectal cancer (MCRC) patients who progressed to a first-line treatment containing bv: results from the bebyp trial by the Gruppo Oncologico Nord Ovest (GONO)

Author

Salvatore, L., GIANLUCA MASI, Loupakis, F., CHIARA CREMOLINI, Schirripa, M., Fornaro, L., Antoniotti, C., Vivaldi, C., Granetto, C., Fea, E., Antonuzzo, L., Giommoni, E., Boni, C., Banzi, M., Chiara, S., Sonaglio, C., Allegrini, G., Marcucci, L., Valsuani, C., Greco, F., Safina, V., Boni, L., and Alfredo Falcone

Published
2012

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