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

Author

Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, 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, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati G., Lonardi S., Galli F., Di Bartolomeo M., Ronzoni M., Zampino M. G., Banzi M., Zaniboni A., Pasini F., Bozzarelli S., Garattini S. K., Ferrari D., Montesarchio V., Mambrini A., Ciuffreda L., Pusceddu V., Carlomagno C., Bidoli P., Amoroso D., Bochicchio A. M., Frassineti L., Corsi D., Bilancia D., Pastorino A., De Stefano A., Labianca R., Iaffaioli R. V., Nasti G., Daniele B., Zagonel V., Pella N., Aprile G., Marchetti R. P., Romiti A., Foa P., Mosconi S., Sobrero A., Cazzaniga M., Beretta G. D., Cortesi E., Barni S., Petrelli F., Allione P., D'Arco A. M., Valmadre G., Piazza E., Veltri E., Ramus G. V., 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., Comande 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., Santoro A., Artioli F., Mattioli R., Contu A., Di Costanzo F., Leonardi F., Cavanna L., Passalacqua R., Sozzi P., D'Amico M., Amadori D., Turci D., Ravaioli A., Pasquini E., Gambi A., Faedi M., Cruciani G., Bajetta E., Gianni L., Ionta M. T., Massidda B., Scartozzi M., Ciarlo A., Di Leo A., Frustaci S., Rangoni G., Arizzoia A., Pavesi L., Verusio C., Pinotti G., Iop A., De Placido S., Adamo V., Ficorella C., Natale D., Greco E., Rulli E., Poli D., Porcu L., Torri V., Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, 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, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati G., Lonardi S., Galli F., Di Bartolomeo M., Ronzoni M., Zampino M. G., Banzi M., Zaniboni A., Pasini F., Bozzarelli S., Garattini S. K., Ferrari D., Montesarchio V., Mambrini A., Ciuffreda L., Pusceddu V., Carlomagno C., Bidoli P., Amoroso D., Bochicchio A. M., Frassineti L., Corsi D., Bilancia D., Pastorino A., De Stefano A., Labianca R., Iaffaioli R. V., Nasti G., Daniele B., Zagonel V., Pella N., Aprile G., Marchetti R. P., Romiti A., Foa P., Mosconi S., Sobrero A., Cazzaniga M., Beretta G. D., Cortesi E., Barni S., Petrelli F., Allione P., D'Arco A. M., Valmadre G., Piazza E., Veltri E., Ramus G. V., 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., Comande 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., Santoro A., Artioli F., Mattioli R., Contu A., Di Costanzo F., Leonardi F., Cavanna L., Passalacqua R., Sozzi P., D'Amico M., Amadori D., Turci D., Ravaioli A., Pasquini E., Gambi A., Faedi M., Cruciani G., Bajetta E., Gianni L., Ionta M. T., Massidda B., Scartozzi M., Ciarlo A., Di Leo A., Frustaci S., Rangoni G., Arizzoia A., Pavesi L., Verusio C., Pinotti G., Iop A., De Placido S., Adamo V., Ficorella C., Natale D., Greco E., Rulli E., Poli D., Porcu L., and Torri V.

Abstract

Background: Previous studies on oxaliplatin and fluoropyrimidines as adjuvant therapy in older patients with stage III colon cancer (CC) produced conflicting results. Patients and methods: We assessed the impact of age on time to tumour recurrence (TTR), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) in 2360 patients with stage III CC (1667 aged <70 years and 693 ≥ 70 years) randomised to receive 3 or 6 months of FOLFOX or CAPOX within the frame of the phase III, TOSCA study. Results: Older patients compared with younger ones presented more frequently an Eastern Cooperative Oncology Group performance status equal to 1 (10.5% vs 3.3%, p < 0.001), a greater number of right-sided tumours (40.9% vs 26.6%, p < 0.001), and were at higher clinical risk (37.2% vs 33.2%, p = 0.062). The treatments were almost identical in the two cohorts (p = 0.965). We found a greater proportion of dose reductions (46.7% vs 41.4%, p = 0.018), treatment interruptions (26.1% vs 19.3%, p < 0.001) and a higher proportion of recurrences (24.2% vs 20.3%, p = 0.033) in the older patients. The multivariable analysis of the TTR did not indicate a statistically significant effect of age (hazard ratio [HR]: 1.19; 95% confidence interval [CI]: 0.98–1.44; p = 0.082). The HR comparing older with younger patients was 1.34 (95% CI: 1.12–1.59; p = 0.001) for DFS, 1.58 (95% CI: 1.26–1.99; p < 0.001) for OS, and 1.28 (95% CI: 0.96–1.70; p = 0.089) for CSS. Conclusions: Worse prognostic factors and reduced treatment compliance have a negative impact on the efficacy of oxaliplatin-based adjuvant therapy in older patients.

Published
2021

3. 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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4. 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

5. 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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8. 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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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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17. 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, 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, Mudan, S, 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, Mudan, S, 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, and Mudan SS.

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

18. 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, 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, Mudan, S, 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 AG, 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, Mudan, S, 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, and Mudan SS.

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

19. Randomised, open-label, phase II study of gemcitabine with and without IMM-101 for advanced pancreatic cancer

Author

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, Mudan, S, 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, Mudan, S, 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, and Mudan SS

Abstract

Background: Immune Modulation and Gemcitabine Evaluation-1, a randomised, open-label, phase II, first-line, proof of concept study (NCT01303172), explored safety and tolerability of IMM-101 (heat-killed Mycobacterium obuense; NCTC 13365) with gemcitabine (GEM) in advanced pancreatic ductal adenocarcinoma. Methods: Patients were randomised (2: 1) to IMM-101 (10 mg ml -l intradermally)+GEM (1000 mg m -2 intravenously; n=75), or GEM alone (n=35). Safety was assessed on frequency and incidence of adverse events (AEs). Overall survival (OS), progression-free survival (PFS) and overall response rate (ORR) were collected. Results: IMM-101 was well tolerated with a similar rate of AE and serious adverse event reporting in both groups after allowance for exposure. Median OS in the intent-to-treat population was 6.7 months for IMM-101+GEM v 5.6 months for GEM; while not significant, the hazard ratio (HR) numerically favoured IMM-101+GEM (HR, 0.68 (95% CI, 0.44-1.04, P=0.074). In a pre-defined metastatic subgroup (84%), OS was significantly improved from 4.4 to 7.0 months in favour of IMM-101+GEM (HR, 0.54, 95% CI 0.33-0.87, P=0.01). Conclusions: IMM-101 with GEM was as safe and well tolerated as GEM alone, and there was a suggestion of a beneficial effect on survival in patients with metastatic disease. This warrants further evaluation in an adequately powered confirmatory study.

Published
2016

20. 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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22. 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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23. 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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24. 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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25. Effect of Primary Tumor Side on Survival Outcomes in Untreated Patients With Metastatic Colorectal Cancer When Selective Internal Radiation Therapy Is Added to Chemotherapy: Combined Analysis of Two Randomized Controlled Studies.

Author

Helmberger T., Findlay M.P.N., Isaacs R., O'Donnell A., Perez D., Rodriguez J., Vera-Garcia R., Amin P., Bloomgarden D., Bui J., Carlisle J., Chai S., Chen Y.-J., Chuong M., Coveler A., Facchini F., Frenette G., Frick J., Garofalo M., George B., Gordon M., Gulec S., Hannigan J., Holtzman M., Kaubisch A., Kaiser A., Kooy T., Limentani S., Margolis J., Martin R., Ozer H., Padia S., Rilling W., Savin M., Schneiderman E., Seeger G., Shibata S., Smith R., Wang E., Whiting S., Aghmesheh M., Cooray P., Feeney K., Lim L., Singh M., Underhill C., Durand A., Faivre S., Ferru A., Hammel P., Bremer C., De Wit M., Ayala H., Heching N., Shani A., Granetto C., Masi G., Mosconi S., Numico G., Trogu A., Kim Y.H., Sae-Won H., Fragoso M., Tan I., Casado A.R., Liang J.T., Liu J.H., Ades S., Auber M., Boland P., Bowers C., Crain M., Dowling K., Iyer R., Ratner L., Sanchez F., Stoltzfus P., Westcott M., Segelov E., Strickland A., Gibbs P., Heinemann V., Sharma N., Taieb J., Ricke J., Peeters M., Robinson B.A., Jackson C., Gebski V., Van Buskirk M., Zhao H., van Hazel G., Brown M., Burge M., Cardaci G., Clarke S., Eliadis P., Ferguson T., Ganju V., James P., Karapetis C., Liauw W., Marx G., Matos M., Nott L., Pavlakis N., Powell A., Price T., Ransom D., Shannon J., Singhal N., Walpole E., Craninx M., Delaunoit T., Deleporte A., Ferrante M., Geboes K., Hendlisz A., Hendrickx K., De Man M., Monsaert E., Moons V., Polus M., Boucher E., Balosso J., Chevallier P., Louafi S., Pracht M., Rebischung C., Smith D., Terrebonne E., Bruch H.-R., Gehbauer G., Ko Y.-D., Kroning H., Lammert F., Nusch A., Pluntke S., Ridwelski K., Riera-Knorrenschild J., Riess H., Riera J.R., Sauerbruch T., Scheidhauer K., Stotzer O., Tatsch K., Vehling-Kaiser U., Vogl T., Beny A., Geva R., Shacham-Shmueli E., Stemmer S., Tichler T., Wolf I., Angelelli B., Martoni A., Helmberger T., Findlay M.P.N., Isaacs R., O'Donnell A., Perez D., Rodriguez J., Vera-Garcia R., Amin P., Bloomgarden D., Bui J., Carlisle J., Chai S., Chen Y.-J., Chuong M., Coveler A., Facchini F., Frenette G., Frick J., Garofalo M., George B., Gordon M., Gulec S., Hannigan J., Holtzman M., Kaubisch A., Kaiser A., Kooy T., Limentani S., Margolis J., Martin R., Ozer H., Padia S., Rilling W., Savin M., Schneiderman E., Seeger G., Shibata S., Smith R., Wang E., Whiting S., Aghmesheh M., Cooray P., Feeney K., Lim L., Singh M., Underhill C., Durand A., Faivre S., Ferru A., Hammel P., Bremer C., De Wit M., Ayala H., Heching N., Shani A., Granetto C., Masi G., Mosconi S., Numico G., Trogu A., Kim Y.H., Sae-Won H., Fragoso M., Tan I., Casado A.R., Liang J.T., Liu J.H., Ades S., Auber M., Boland P., Bowers C., Crain M., Dowling K., Iyer R., Ratner L., Sanchez F., Stoltzfus P., Westcott M., Segelov E., Strickland A., Gibbs P., Heinemann V., Sharma N., Taieb J., Ricke J., Peeters M., Robinson B.A., Jackson C., Gebski V., Van Buskirk M., Zhao H., van Hazel G., Brown M., Burge M., Cardaci G., Clarke S., Eliadis P., Ferguson T., Ganju V., James P., Karapetis C., Liauw W., Marx G., Matos M., Nott L., Pavlakis N., Powell A., Price T., Ransom D., Shannon J., Singhal N., Walpole E., Craninx M., Delaunoit T., Deleporte A., Ferrante M., Geboes K., Hendlisz A., Hendrickx K., De Man M., Monsaert E., Moons V., Polus M., Boucher E., Balosso J., Chevallier P., Louafi S., Pracht M., Rebischung C., Smith D., Terrebonne E., Bruch H.-R., Gehbauer G., Ko Y.-D., Kroning H., Lammert F., Nusch A., Pluntke S., Ridwelski K., Riera-Knorrenschild J., Riess H., Riera J.R., Sauerbruch T., Scheidhauer K., Stotzer O., Tatsch K., Vehling-Kaiser U., Vogl T., Beny A., Geva R., Shacham-Shmueli E., Stemmer S., Tichler T., Wolf I., Angelelli B., and Martoni A.

Abstract

The primary tumor side is emerging as a prognostic factor for patients with liver metastatic colorectal cancer (mCRC). In a combined analysis of data from 2 randomized studies, the addition of selective internal radiation therapy to first-line chemotherapy in patients with mCRC was associated with statistically and clinically significant overall survival gains for patients with a right-sided primary tumor. Background(s): The primary tumor side is emerging as a major prognostic factor for patients with metastatic colorectal cancer (mCRC). We examined the survival data from 2 randomized studies to determine whether the outcomes differ between patients with mCRC with right-sided primary (RSP) tumors and those with left-sided primary (LSP) tumors after selective internal radiation therapy (SIRT) plus mFOLFOX6 (folinic acid [leucovorin], 5-fluorouracil, oxaliplatin) chemotherapy, versus chemotherapy alone. Patients and Methods: Separate and combined analyses were performed on the data from the SIRFLOX and FOXFIRE global trials, which compared chemotherapy plus SIRT with chemotherapy alone for patients with mCRC liver metastases. The primary tumor side data were prospectively collected. The principal outcome measure was overall survival (OS) stratified by treatment and primary tumor side. Result(s): In the combined analysis of all 739 patients enrolled, SIRT had no effect on OS (median OS, 24.3 vs. 24.6 months; hazard ratio [HR], 1.021; P =.810). For the 179 patients (24.2%) with a RSP tumor, OS was improved with the addition of SIRT (median, 22.0 vs. 17.1 months HR, 0.641; P =.008). The addition of SIRT was not associated with a significant difference in OS among the 540 patients with a LSP tumor (median, 24.6 vs. 26.6 months; HR, 1.120; P =.264). A test of treatment interaction by primary tumor side was statistically significant for RSP and SIRT (P =.002). Conclusion(s): The addition of SIRT for patients with RSP tumors, but not for those with LSP tumors, was associated

Published
2018

26. FOLFOXIRI plus bevacizumab versus FOLFIRI plus bevacizumab as first-line treatment of patients with metastatic colorectal cancer: updated overall survival and molecular subgroup analyses of the open-label, phase 3 TRIBE study

Author

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

Abstract

Background: In the TRIBE study, FOLFOXIRI (fluorouracil, leucovorin, oxaliplatin, and irinotecan) plus bevacizumab significantly improved progression-free survival of patients with metastatic colorectal cancer compared with FOLFIRI (fluorouracil, leucovorin, and irinotecan) plus bevacizumab. In this updated analysis, we aimed to provide mature results for overall survival-a secondary endpoint-and report treatment efficacy in RAS and BRAF molecular subgroups. Methods: TRIBE was an open-label, multicentre, phase 3 randomised study of patients (aged 18-70 years with Eastern Cooperative Oncology Group [ECOG] performance status of 2 or less and aged 71-75 years with an ECOG performance status of 0) with unresectable metastatic colorectal cancer who were recruited from 34 Italian oncology units. Patients were randomly assigned (1:1) via a web-based procedure to receive FOLFIRI plus bevacizumab or FOLFOXIRI plus bevacizumab. Bevacizumab was given as a 5 mg/kg intravenous dose. FOLFIRI consisted of a 180 mg/m2 intravenous infusion of irinotecan for 60 min followed by a 200 mg/m2 intravenous infusion of leucovorin for 120 min, a 400 mg/m2 intravenous bolus of fluorouracil, and a 2400 mg/m2 continuous infusion of fluorouracil for 46 h. FOLFOXIRI consisted of a 165 mg/m2 intravenous infusion of irinotecan for 60 min, followed by an 85 mg/m2 intravenous infusion of oxaliplatin given concurrently with 200 mg/m2 leucovorin for 120 min, followed by a 3200 mg/m2 continuous infusion of fluorouracil for 48 h. Tissue samples for RAS and BRAF mutational status analyses were centrally collected. In this updated analysis, we assessed the secondary endpoint of overall survival in the main cohort and treatment efficacy in RAS and BRAF molecular subgroups. All analyses were by intention to treat. TRIBE was concluded on Nov 30, 2014. The trial is registered with ClinicalTrials.gov, number NCT00719797. Findings: Between July 17, 2008, and May 31, 2011, 508 patients were randomly assigned. At

Published
2015

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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43. 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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44. 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. Folfoxiri with or Without Bevacizumab (Bev) As First-Line Treatment of Metastatic Colorectal Cancer (Mcrc): a Propensity Score-Based Analysis

Author

Cremolini, C., primary, Loupakis, F., additional, Rossini, D., additional, Masi, G., additional, Salvatore, L., additional, Barbara, C., additional, Brunetti, I.M., additional, Antoniotti, C., additional, Granetto, C., additional, Cortesi, E., additional, Chiara, S., additional, Vitello, S., additional, Lonardi, S., additional, Ciuffreda, L., additional, Tomasello, G., additional, Ronzoni, M., additional, Buonadonna, A., additional, Tomcikova, D., additional, Boni, L., additional, and Falcone, A., additional

Published
2014
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47. Subgroup Analyses in RAS Mutant, BRAF Mutant and “ALL WT” Metastatic Colorectal Cancer Patients Treated with Folfoxiri Plus Bevacizumab (BEV) or Folfiri Plus BEV in the Tribe Study

Author

Cremolini, C., primary, Loupakis, F., additional, Lonardi, S., additional, Tomasello, G., additional, Ronzoni, M., additional, Zaniboni, A., additional, Tonini, G., additional, Valsuani, C., additional, Chiara, S., additional, Boni, C., additional, Marcucci, L., additional, Negri, F.V., additional, Barone, C., additional, Vitello, S., additional, D'Amico, M., additional, Granetto, C., additional, Antoniotti, C., additional, Salvatore, L., additional, Fontanini, G., additional, Tomcikova, D., additional, Boni, L., additional, and Falcone, A., additional

Published
2014
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48. LBA21 - 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., Cremolini, C., Loupakis, F., Lonardi, S., Casagrande, M.E., Murgioni, S., Salvatore, L., Masi, G., Fanotto, V., Granetto, C., Marmorino, F., Ginocchi, L., Ziampiri, S., Grande, R., Tonini, G., Delfanti, S., Di Donato, S., Fontanini, G., Boni, L., and Zagonel, V.

Published
2016
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