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2. Bone metastases are associated with worse prognosis in patients affected by metastatic colorectal cancer treated with doublet or triplet chemotherapy plus bevacizumab: a subanalysis of the TRIBE and TRIBE2 trials

Author

Dell’Aquila, E., Rossini, D., Fulgenzi, C.A.M., Passardi, A., Tamburini, E., Vetere, G., Carullo, M., Citarella, F., Antoniotti, C., Zaniboni, A., Pietrantonio, F., Spagnoletti, A., Marmorino, F., Borelli, B., Allegrini, G., Lonardi, S., Nappo, F., Masi, G., Cremolini, C., and Santini, D.

Published
2022
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3. Impact of age and gender on the efficacy and safety of upfront therapy with panitumumab plus FOLFOX followed by panitumumab-based maintenance: a pre-specified subgroup analysis of the Valentino study

Author

Raimondi, A., Fucà, G., Leone, A.G., Lonardi, S., Antoniotti, C., Smiroldo, V., Amatu, A., Tampellini, M., Ritorto, G., Murialdo, R., Clavarezza, M., Zaniboni, A., Berenato, R., Ratti, M., Corallo, S., Morano, F., Di Bartolomeo, M., Di Maio, M., and Pietrantonio, F.

Published
2021
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4. Prognostic and predictive impact of consensus molecular subtypes and CRCAssigner classifications in metastatic colorectal cancer: a translational analysis of the TRIBE2 study

Author

Borelli, B., Fontana, E., Giordano, M., Antoniotti, C., Lonardi, S., Bergamo, F., Pietrantonio, F., Morano, F., Tamburini, E., Boccaccino, A., Santini, D., Zucchelli, G., Pella, N., Maiello, E., Passardi, A., Zaniboni, A., Ugolini, C., Fontanini, G., Falcone, A., Nyamundanda, G., Sadanandam, A., and Cremolini, C.

Published
2021
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5. 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., Antoniotti, C., Lonardi, S., Bergamo, F., Cortesi, E., Tomasello, G., Moretto, R., Ronzoni, M., Racca, P., Loupakis, F., Zaniboni, A., Tonini, G., Buonadonna, A., Marmorino, F., Allegrini, G., Granetto, C., Masi, G., Zagonel, V., Sensi, E., Fontanini, G., Boni, L., and Falcone, A.

Published
2018
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6. Cetuximab as third-line rechallenge plus either irinotecan or avelumab is an effective treatment in metastatic colorectal cancer patients with baseline plasma RAS/BRAF wild-type circulating tumor DNA: Individual patient data pooled analysis of CRICKET and CAVE trials

Author

Martini, G, Ciardiello, D, Famiglietti, V, Rossini, D, Antoniotti, C, Troiani, T, Napolitano, S, Esposito, L, Latiano, T P, Maiello, E, Del Re, M, Lonardi, S, Aprile, G, Santini, D, Masi, G, Avallone, A, Normanno, N, Pietrantonio, F, Pinto, C, Ciardiello, F, Cremolini, C, Martinelli, E, Martini, G, Ciardiello, D, Famiglietti, V, Rossini, D, Antoniotti, C, Troiani, T, Napolitano, S, Esposito, L, Latiano, T P, Maiello, E, Del Re, M, Lonardi, S, Aprile, G, Santini, D, Masi, G, Avallone, A, Normanno, N, Pietrantonio, F, Pinto, C, Ciardiello, F, Cremolini, C, and Martinelli, E

Subjects
metastatic colorectal cancer, cetuximab, rechallenge, immunotherapy
Abstract

The rechallenge strategy is based on the concept that a subset of patients with RAS wild-type (WT) metastatic colorectal cancer (mCRC) could still benefit of epidermal growth factor receptor (EGFR) inhibition, after progression to an anti-EGFR based-therapy. We performed a pooled analysis of two-phase II prospective trials to determine the role of rechallenge in third-line mCRC patients with RAS/BRAF WT baseline circulating tumor DNA (ctDNA). Individual data of 33 and 13 patients from CAVE and CRICKET trials that received as third-line therapy cetuximab rechallenge were collected. Overall survival (OS), Progression-free survival (PFS), Overall response rate (ORR), Stable disease (SD) > 6 months were calculated. Adverse events were reported. For the whole 46 patient population, median PFS (mPFS) was 3.9 months (95% Confidence Interval, CI 3.0-4.9) with median OS (mOS) of 16.9 months (95% CI 11.7-22.1). For CRICKET patients, mPFS was 3.9 months (95% CI 1.7-6.2); mOS was 13.1 months (95% CI 7.3-18.9) with OS rates at 12, 18, and 24 months of 62%, 23%, and 0%, respectively. For CAVE patients, mPFS was 4.1 months (95% CI 3.0-5.2); mOS was 18.6 months (95% CI 11.7-25.4) with OS rates at 12, 18, 24 months of 61%, 52%, 21%, respectively. Skin rash was more frequently reported in CAVE trial (87.9% vs. 30.8%; p = 0.001), whereas a increased incidence of hematological toxicities was observed in CRICKET trial (53.8%% vs. 12.1%; p = 0.003). Third-line cetuximab rechallenge in combination with either irinotecan or avelumab in RAS/BRAF WT ctDNA mCRC patients represents a promising therapy.

Published
2023

7. Cetuximab as third‐line rechallenge plus either irinotecan or avelumab is an effective treatment in metastatic colorectal cancer patients with baseline plasma RAS/BRAF wild‐type circulating tumor DNA : Individual patient data pooled analysis of CRICKET and CAVE trials

Author

Martini, G., primary, Ciardiello, D., additional, Famiglietti, V., additional, Rossini, D., additional, Antoniotti, C., additional, Troiani, T., additional, Napolitano, S., additional, Esposito, L., additional, Latiano, T. P., additional, Maiello, E., additional, Del Re, M., additional, Lonardi, S., additional, Aprile, G., additional, Santini, D., additional, Masi, G., additional, Avallone, A., additional, Normanno, N., additional, Pietrantonio, F., additional, Pinto, C., additional, Ciardiello, F., additional, Cremolini, C., additional, and Martinelli, E., additional

Published
2023
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8. 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., D'Amico, M., Di Donato, S., Granetto, C., Boni, L., and Falcone, A.

Published
2015
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9. Variant alleles in factor V, prothrombin, plasminogen activator inhibitor-1, methylenetetrahydrofolate reductase and risk of thromboembolism in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab

Author

Falvella, F S, Cremolini, C, Miceli, R, Nichetti, F, Cheli, S, Antoniotti, C, Infante, G, Martinetti, A, Marmorino, F, Sottotetti, E, Berenato, R, Caporale, M, Colombo, A, de Braud, F, Di Bartolomeo, M, Clementi, E, Loupakis, F, and Pietrantonio, F

Published
2017
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11. 413P Primary tumor resection (PTR) in metastatic colorectal cancer (mCRC) patients (pts) treated with upfront chemotherapy (CT) + bevacizumab (BEV): A pooled analysis of TRIBE and TRIBE2 studies

Author

Fanotto, V., primary, Boccaccino, A., additional, Casagrande, M., additional, Bergamo, F., additional, Spagnoletti, A., additional, Santini, D., additional, Antoniotti, C., additional, Allegrini, G., additional, Daniel, F., additional, Nasca, V., additional, Rossini, D., additional, Zaniboni, A., additional, Borelli, B., additional, Carullo, M., additional, Conca, V., additional, Passardi, A., additional, Tamburini, E., additional, Masi, G., additional, Cremolini, C., additional, and Pella, N., additional

Published
2022
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12. 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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13. 506O Evaluation of risk of disease progression in first-line therapy of unresected metastatic colorectal cancer to guide intervals of radiological assessment: An analysis of eleven randomized trials by AIO and GONO

Author

Germani, M.M., Heinemann, V., Rossini, D., Fischer von Weikersthal, L., Morano, F., Heinrich, K., Stahler, A., Bergamo, F., Kaiser, F., Decker, T., Salvatore, L., Weiss, L., Russo, A., Fuchs, M., Prete, A.A., Antoniotti, C., Masi, G., Stintzing, S., Cremolini, C., and Modest, D.P.

Published
2024
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14. Variant alleles in factor V, prothrombin, plasminogen activator inhibitor-1, methylenetetrahydrofolate reductase and risk of thromboembolism in metastatic colorectal cancer patients treated with first-line chemotherapy plus bevacizumab

Author

Falvella, F S, Cremolini, C, Miceli, R, Nichetti, F, Cheli, S, Antoniotti, C, Infante, G, Martinetti, A, Marmorino, F, Sottotetti, E, Berenato, R, Caporale, M, Colombo, A, de Braud, F, Di Bartolomeo, M, Clementi, E, Loupakis, F, and Pietrantonio, F

Published
2016
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15. O-7 Evidence of therapeutic effectiveness of third-line cetuximab rechallenge in appropriately selected patients: Findings from long-term follow-up of CRICKET and CAVE trials

Author

Martinelli, E., primary, Martini, G., additional, Ciardiello, D., additional, Famiglietti, V., additional, Rossini, D., additional, Antoniotti, C., additional, Troiani, T., additional, Napolitano, S., additional, Esposito, L., additional, Latiano, T., additional, Maiello, E., additional, Del Re, M., additional, Lonardi, S., additional, Aprile, G., additional, Santini, D., additional, Masi, G., additional, Avallone, A., additional, Normanno, N., additional, Pietrantonio, F., additional, Pinto, C., additional, Ciardiello, F., additional, and Cremolini, C., additional

Published
2022
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16. SO-36 An immune-related gene expression profile predicts the efficacy of adding atezolizumab to first-line FOLFOXIRI/bevacizumab in metastatic colorectal cancer: A translational analysis of the phase II randomized AtezoTRIBE study

Author

Antoniotti, C., primary, Boccaccino, A., additional, Seitz, R., additional, Giordano, M., additional, Rossini, D., additional, Ambrosini, M., additional, Salvatore, L., additional, McGregor, K., additional, Bergamo, F., additional, Conca, V., additional, Leonetti, S., additional, Provenzano, L., additional, Tamberi, S., additional, Ramundo, M., additional, Tortora, G., additional, Rasola, C., additional, Ross, D., additional, Passardi, A., additional, Nielsen, T., additional, Varga, M., additional, and Cremolini, C., additional

Published
2022
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17. 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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20. PD-004 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., Cremolini, C., Loupakis, F., Antoniotti, C., Barbara, C., Dargenio, F., Miraglio, E., Masi, G., Salvatore, L., Schirripa, M., Borelli, B., Marcucci, L., Antonuzzo, L., Chiara, S., Banzi, C., Amoroso, D., Bonetti, A., Martignetti, A., Paris, M., Boni, L., Tomcikova, D., and Falcone, A.

Published
2016
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21. 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., Cremolini, C., Loupakis, F., Bergamo, F., Grande, R., Tonini, G., Garattini Silvio, K., Masi, G., Battaglin, F., Lucchesi, S., Salvatore, L., Corsi, D., Di Fabio, F., Banzi, M., Moretto, R., Sensi, E., Rossini, D., Tomcikova, D., Fontanini, G., Zagonel, V., Boni, L., and Falcone, A.

Published
2016
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22. LBA20 FOLFOXIRI plus bevacizumab (bev) plus atezolizumab (atezo) versus FOLFOXIRI plus bev as first-line treatment of unresectable metastatic colorectal cancer (mCRC) patients: Results of the phase II randomized AtezoTRIBE study by GONO

Author

Cremolini, C., primary, Rossini, D., additional, Antoniotti, C., additional, Pietrantonio, F., additional, Lonardi, S., additional, Salvatore, L., additional, Marmorino, F., additional, Borelli, B., additional, Ambrosini, M., additional, Barsotti, G., additional, Di Stefano, B., additional, Masi, G., additional, Boccaccino, A., additional, Tamberi, S., additional, Tamburini, E., additional, Frassineti, L.G., additional, Simionato, F., additional, Fontanini, G., additional, Boni, L., additional, and Falcone, A., additional

Published
2021
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23. AXL is a predictor of poor survival and of resistance to anti-EGFR therapy in RAS wild-type metastatic colorectal cancer

Author

Cardone C., Blauensteiner B., Moreno-Viedma V., Martini G., Simeon V., Vitiello P. P., Ciardiello D., Belli V., Matrone N., Troiani T., Morgillo F., Zito Marino F., Dentice M., Nappi A., Boccaccino A., Antoniotti C., Cremolini C., Pietrantonio F., Prager G. W., Normanno N., Maiello E., Argiles G., Elez E., Signoriello G., Franco R., Falcone A., Tabernero J., Sibilia M., Ciardiello F., Martinelli E., ZITO MARINO, Federica, Cardone, Claudia, Blauensteiner, Bernadette, Moreno-Viedma, Veronica, Martini, Giulia, Simeon, Vittorio, Vitiello, Pietro P, Ciardiello, Davide, Belli, Valentina, Matrone, Nunzia, Troiani, Teresa, Morgillo, Floriana, Zito Marino, Federica, Dentice, Monica, Nappi, Annarita, Boccaccino, Alessandra, Antoniotti, Carlotta, Cremolini, Chiara, Pietrantonio, Filippo, Prager, Gerald W, Normanno, Nicola, Maiello, Evaristo, Argiles, Guillem, Elez, Elena, Signoriello, Giuseppe, Franco, Renato, Falcone, Alfredo, Tabernero, Josep, Sibilia, Maria, Ciardiello, Fortunato, Martinelli, Erika, Cardone, C., Blauensteiner, B., Moreno-Viedma, V., Martini, G., Simeon, V., Vitiello, P. P., Ciardiello, D., Belli, V., Matrone, N., Troiani, T., Morgillo, F., Zito Marino, F., Dentice, M., Nappi, A., Boccaccino, A., Antoniotti, C., Cremolini, C., Pietrantonio, F., Prager, G. W., Normanno, N., Maiello, E., Argiles, G., Elez, E., Signoriello, G., Franco, R., Falcone, A., Tabernero, J., Sibilia, M., Ciardiello, F., Martinelli, E., and ZITO MARINO, Federica

Subjects
0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Colorectal cancer, Population, 03 medical and health sciences, Mice, 0302 clinical medicine, Growth factor receptor, Internal medicine, Cell Line, Tumor, Proto-Oncogene Proteins, Medicine, Animals, Humans, Epithelial–mesenchymal transition, Neoplasm Metastasis, education, education.field_of_study, Cetuximab, business.industry, AXL, EGFR resistance, RAS WT, Receptor Protein-Tyrosine Kinases, Transfection, medicine.disease, Xenograft Model Antitumor Assays, Axl Receptor Tyrosine Kinase, Blockade, ErbB Receptors, 030104 developmental biology, Genes, ras, Drug Resistance, Neoplasm, 030220 oncology & carcinogenesis, Immunohistochemistry, business, Colorectal Neoplasms, Biomarkers, medicine.drug
Abstract

Background RAS mutations are the only validated biomarkers in metastatic colorectal cancer (mCRC) for anti-epidermal growth factor receptor (EGFR) therapy. Limited clinical information is available on AXL expression, marker of epithelial to mesenchymal transition, in mCRC. Methods AXL was retrospectively assessed by immunohistochemistry in 307 patients. RAS wild-type (WT) patients (N = 136) received first-line anti-EGFR–based therapy; RAS mutant patients (N = 171) received anti-angiogenic–based regimens. Preclinical experiments were performed using human RAS WT CRC cell lines and xenograft models. AXL RNA levels were assessed in a cohort of patients with available samples at baseline and at progression to anti-EGFR treatment and in the GSE5851 dataset. Results AXL was expressed in 55/307 tumour tissues, correlating with worse survival in the overall population (AXL-positive, 23.7 months; AXL-negative, 30.8 months; HR, 1.455, P = 0.032) and in RAS WT patients (AXL-positive, 23.0 months; AXL-negative, 35.8 months; HR,1.780, P = 0.032). Progression-free survival (PFS) in the RAS WT cohort was shorter in the AXL-positive cohort (6.2 months versus 12.1 months; HR, 1.796, P = 0.013). Three-dimensional cultures obtained from a patient following anti-EGFR therapy resulted AXL-positive, showing resistance to anti-EGFR drugs and sensitivity to AXL inhibition. AXL transfection in CRC cell lines induced AXL overexpression and resistance to the EGFR blockade. At progression to cetuximab, 2/10 SW48-tumour xenograft mice showed AXL expression. Consistently, AXL RNA levels increased in 5/7 patients following anti-EGFR therapy. Moreover, in the GSE5851 dataset higher AXL RNA levels correlated with worse PFS with cetuximab in KRAS-exon2 WT chemorefractory patients. Conclusions AXL is a marker of poor prognosis in mCRC with consistent clinical and preclinical evidences of involvement in primary and acquired resistance to anti-EGFR drugs in RAS WT patients.

Published
2020

24. 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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25. SO-24 Circulating tumor DNA variant allelic fraction as a surrogate for disease burden estimation in patients with RAS wild-type metastatic colorectal cancer: A secondary endpoint of the VALENTINO study

Author

Manca, P., primary, Corallo, S., additional, Lonardi, S., additional, Corti, F., additional, Antoniotti, C., additional, Procaccio, L., additional, Smiroldo, V., additional, Tomasello, G., additional, Murialdo, R., additional, Pagani, F., additional, Randon, G., additional, Martinetti, A., additional, Sottotetti, E., additional, Prisciandaro, M., additional, Ambrosini, M., additional, Raimondi, A., additional, Morano, F., additional, and Pietrantonio, F., additional

Published
2021
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27. SO-28 FOLFOXIRI plus bevacizumab and atezolizumab as upfront treatment of unresectable mCRC patients: Updated and overall survival results of the phase II randomized AtezoTRIBE study

Author

Antoniotti, C., Rossini, D., Pietrantonio, F., Salvatore, L., Marmorino, F., Ambrosini, M., Lonardi, S., Bensi, M., Moretto, R., Tamberi, S., Toma, I., Passardi, A., De Grandis, M., Conca, V., Palermo, M., Cappetta, A., Catteau, A., Boni, L., Galon, J., and Cremolini, C.

Published
2023
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28. SO-27 Modified FOLFOXIRI plus cetuximab and avelumab as initial therapy in RAS wild-type unresectable metastatic colorectal cancer: Results of the phase II AVETRIC trial by GONO

Author

Conca, V., Antoniotti, C., Bergamo, F., Pietrantonio, F., Rossini, D., Scartozzi, M., Perissinotto, E., Leone, A., Pusceddu, V., Borelli, B., Cavanna, L., Latiano, T., Santini, D., Masi, G., Salvatore, L., Frassineti, G., Leone, F., Tamberi, S., Boni, L., and Cremolini, C.

Published
2023
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29. SO-22 Gut microbiome composition as predictor of the efficacy of adding atezolizumab to first-line FOLFOXIRI plus bevacizumab in metastatic colorectal cancer: A translational analysis of the AtezoTRIBE study

Author

Marmorino, F., Piccinno, G., Rossini, D., Ghelardi, F., Murgioni, S., Salvatore, L., Nasca, V., Antoniotti, C., Daniel, F., Schietroma, F., Conca, V., Costa Silva, C. Alves, Tamburini, E., Tamberi, S., Passardi, A., Carullo, M., Antonuzzo, L., D'Onofrio, R., Zitvogel, L., Cremolini, C., and Derosa, L.

Published
2023
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30. P-90 Prognostic impact of depth of response (DpR) and early tumour shrinkage (ETS) in patients (pts) with BRAFV600E mutated (mut) metastatic colorectal cancer (mCRC) receiving targeted therapy (TT) as second-line treatment

Author

Vetere, G., Germani, M., Bensi, M., Antoniotti, C., Lonardi, S., Passardi, A., Ghelardi, F., Calegari, M., Borelli, B., Santucci, S., Intini, R., Cristarella, E., Persano, M., Puccini, A., Lavacchi, D., Noto, L., Zichi, C., Giampieri, R., Salati, M., and Cremolini, C.

Published
2023
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32. A validated prognostic classifier for V600EBRAF-mutated metastatic colorectal cancer: the ‘BRAF BeCool’ study

Author

Loupakis F., Intini R., Cremolini C., Orlandi A., Sartore-Bianchi A., Pietrantonio F., Pella N., Spallanzani A., Dell'Aquila E., Scartozzi M., De Luca E., Rimassa L., Formica V., Leone F., Calvetti L., Aprile G., Antonuzzo L., Urbano F., Prenen H., Negri F., Di Donato S., Buonandi P., Tomasello G., Avallone A., Zustovich F., Moretto R., Antoniotti C., Salvatore L., Calegari M. A., Siena S., Morano F., Ongaro E., Cascinu S., Santini D., Ziranu P., Schirripa M., Buggin F., Prete A. A., Depetris I., Biason P., Lonardi S., Zagonel V., Fassan M., Di Maio M., Loupakis, F., Intini, R., Cremolini, C., Orlandi, A., Sartore-Bianchi, A., Pietrantonio, F., Pella, N., Spallanzani, A., Dell'Aquila, E., Scartozzi, M., De Luca, E., Rimassa, L., Formica, V., Leone, F., Calvetti, L., Aprile, G., Antonuzzo, L., Urbano, F., Prenen, H., Negri, F., Di Donato, S., Buonandi, P., Tomasello, G., Avallone, A., Zustovich, F., Moretto, R., Antoniotti, C., Salvatore, L., Calegari, M. A., Siena, S., Morano, F., Ongaro, E., Cascinu, S., Santini, D., Ziranu, P., Schirripa, M., Buggin, F., Prete, A. A., Depetris, I., Biason, P., Lonardi, S., Zagonel, V., Fassan, M., and Di Maio, M.

Subjects
Adult, Male, Proto-Oncogene Proteins B-raf, Scoring system, DNA Mutational Analysis, Metastases, V600E, BRAF, Colorectal cancer, Prognostic markers, Risk Assessment, Young Adult, Predictive Value of Tests, Risk Factors, Biomarkers, Tumor, Humans, Genetic Predisposition to Disease, Neoplasm Metastasis, Aged, Retrospective Studies, Aged, 80 and over, Middle Aged, Prognosis, Phenotype, Italy, Mutation, Female, Colorectal Neoplasms
Abstract

Background: Despite the well-known negative prognostic value of the V600EBRAF mutation in patients with metastatic colorectal cancer (mCRC), its outcome is quite heterogeneous, and the basis for this prognostic heterogeneity should be better defined. Methods: Two large retrospective series of V600EBRAF-mutated mCRC from 22 institutions served as an exploratory and validation set to develop a prognostic score. The model was internally and externally validated. Results: A total of 395 V600EBRAF-mutated mCRCs were included in the exploratory set. Performance status, CA19.9, lactate dehydrogenase, neutrophil/lymphocyte ratio, grading and liver, lung and nodal involvement emerged as independent prognostic factors for overall survival (OS). Two different scoring systems were built: a ‘complete’ score (0–16) including all significant covariates and a ‘simplified’ score (0–9), based only on clinicopathological covariates, and excluding laboratory values. Adopting the complete score, proportions of patients with a low (0–4), intermediate (5–8) and high (9–16) score were 44.7%, 42.6% and 12.6%, respectively. The median OS was 29.6, 15.5 (hazard ratio [HR] for intermediate vs low risk: 2.16, 95% confidence interval [CI]: 1.44–3.22, p < .001) and 6.6 months (HR for high vs low risk: 4.72, 95% CI: 2.72–8.20, p < .001). Similar results were observed also after adjusting for the type of first-line treatment and adopting the simplified score. The simplified prognostic score derived from the exploratory set was then applied to the validation set for external confirmation. Conclusions: These scoring systems are based on easy-to-collect data and defined specific subgroups with relevant differences in their life expectancy. These tools could be useful in clinical practice, would allow better stratification of patients in clinical trials and may be adopted for proper adjustments in exploratory translational analyses.

Published
2019

33. 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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34. SO-20 Consensus molecular subtypes and CRCAssigner classifications in metastatic colorectal cancer (mCRC): Prognostic and predictive impact in the TRIBE2 study

Author

Borelli, B., primary, Fontana, E., additional, Giordano, M., additional, Antoniotti, C., additional, Bergamo, F., additional, Murgioni, S., additional, Pietrantonio, F., additional, Morano, F., additional, Tamburini, E., additional, Boccaccino, A., additional, Santini, D., additional, Conca, V., additional, Pella, N., additional, Maiello, E., additional, Ugolini, C., additional, Fontanini, G., additional, Falcone, A., additional, Nyamundanda, G., additional, Sadanandam, A., additional, and Cremolini, C., additional

Published
2020
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35. 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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36. Prognostic role of blood cell count-based immuno-inflammatory parameters in the Valentino trial

Author

Fuca, G., primary, Guarini, V., additional, Corallo, S., additional, Lonardi, S., additional, Raimondi, A., additional, Peverelli, G., additional, Rimassa, L., additional, Antoniotti, C., additional, Murialdo, R., additional, Zaniboni, A., additional, Sartore-Bianchi, A., additional, Tomasello, G., additional, Racca, P., additional, Clavarezza, M., additional, Adamo, V., additional, Prisciandaro, M., additional, Palermo, F., additional, Bartolomeo, M Di, additional, De Braud, F.G.M., additional, and Pietrantonio, F., additional

Published
2019
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37. 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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38. 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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39. 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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40. 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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41. Class 1, 2, and 3 BRAF-mutated metastatic colorectal cancer: A detailed clinical, pathologic, and molecular characterization

Author

Schirripa, M., Biason, P., Lonardi, S., Pella, N., Simona Pino, M., Urbano, F., Antoniotti, C., Cremolini, C., Corallo, S., Pietrantonio, F., Gelsomino, F., Cascinu, S., Orlandi, Armando, Munari, G., Malapelle, U., Saggio, S., Fontanini, Giovanni, Rugge, M., Mescoli, C., Lazzi, S., Bonetti, L. R., Lanza, Gaetano Antonio, Dei Tos, A. P., De Maglio, G., Martini, Maurizio, Bergamo, F., Zagonel, V., Loupakis, F., Fassan, M., Orlandi A. (ORCID:0000-0001-5253-4678), Fontanini G., Lanza G. (ORCID:0000-0003-2187-6653), Martini M. (ORCID:0000-0002-6260-6310), Schirripa, M., Biason, P., Lonardi, S., Pella, N., Simona Pino, M., Urbano, F., Antoniotti, C., Cremolini, C., Corallo, S., Pietrantonio, F., Gelsomino, F., Cascinu, S., Orlandi, Armando, Munari, G., Malapelle, U., Saggio, S., Fontanini, Giovanni, Rugge, M., Mescoli, C., Lazzi, S., Bonetti, L. R., Lanza, Gaetano Antonio, Dei Tos, A. P., De Maglio, G., Martini, Maurizio, Bergamo, F., Zagonel, V., Loupakis, F., Fassan, M., Orlandi A. (ORCID:0000-0001-5253-4678), Fontanini G., Lanza G. (ORCID:0000-0003-2187-6653), and Martini M. (ORCID:0000-0002-6260-6310)

Abstract

Purpose: BRAF mutations are grouped in activating RASindependent signaling as monomers (class 1-V600E) or as dimers (class 2-codons 597/601), and RAS-dependent with impaired kinase activity (class 3-codons 594/596). Although clinical, pathologic, and molecular features of V600EBRAFmutated metastatic colorectal cancer (mCRC) are well known, limited data are available from the two other classes. Experimental Design: Data from 117 patients with BRAF (92 class 1, 12 class 2, and 13 class 3)-mutated mCRC were collected. A total of 540 BRAF wt mCRCs were included as control. IHC profiling was performed to determine the consensus molecular subtypes (CMS), cytokeratin 7/20 profiles, tumor-infiltrating lymphocyte infiltration, and BM1/BM2 categorization. Overall survival (OS) and progression-free survival were evaluated by Kaplan-Meier and log-rank test. Results: Class 3 BRAF-mutated mCRC was more frequently left sided (P = 0.0028), pN0 (P = 0.0159), and without peritoneal metastases (P = 0.0176) compared with class 1, whereas class 2 cases were similar to class 1. Hazard ratio for OS, as compared with BRAF wt, was 2.38 [95% confidence interval (CI), 1.61-3.54] for class 1, 1.90 (95% CI, 0.85-4.26) for class 2, and 0.93 (95% CI, 0.51-1.69) for class 3 (P < 0.0001). Class 2 and 3 tumors were all assigned to CMS2-3. A higher median CD3/CD8-positive lymphocyte infiltration was observed in BRAF-mutated class 2 (P = 0.033) compared with class 3 cases. Conclusions: For the first time, different clinical and pathologic features and outcome data were reported according to the three BRAF mutation classes in mCRC. Specific targeted treatment strategies should be identified in the near future for such patients.

Published
2019

43. 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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44. Clinico-pathological and molecular characterization of BRAF mutant metastatic colorectal cancer (mCRC): Are all mutations created equal?

Author

Schirripa, M., primary, Biason, P., additional, Cortiula, F., additional, Pino, M., additional, Urbano, F., additional, Antoniotti, C., additional, Corallo, S., additional, Gelsomino, F., additional, Orlandi, A., additional, Lonardi, S., additional, Bergamo, F., additional, Munari, G., additional, Malapelle, U., additional, Rugge, M., additional, Mescoli, C., additional, Reggiani Bonetti, L., additional, Lanza, G., additional, Dei Tos, A., additional, De Maglio, G., additional, Zagonel, V., additional, Loupakis, F., additional, and Fassan, M., additional

Published
2018
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45. FOLFOXIRI plus bevacizumab (bev) followed by maintenance with bev alone or bev plus metronomic chemotherapy (metroCT) in mCRC: Final results of the phase II randomized MOMA trial by GONO

Author

Marmorino, F., primary, Cremolini, C., additional, Bergamo, F., additional, Pella, N., additional, Antoniotti, C., additional, Rossini, D., additional, Dell'Aquila, E., additional, Masi, G., additional, Salvatore, L., additional, Loupakis, F., additional, Marcucci, L., additional, Gemma, D., additional, Cardellino, G., additional, Borelli, B., additional, Ricci, V., additional, Delfanti, S., additional, Mori, E., additional, Tonini, G., additional, Lonardi, S., additional, Fontanini, G., additional, Boni, L., additional, and Falcone, A., additional

Published
2018
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46. P 53 abnormal expression might influence global outcome through EGFR modulation in RAS/BRAF wild type metastatic colorectal cancer patients receiving later-line irinotecan cetuximab

Author

Puzzoni, M., primary, Demurtas, L., additional, Ziranu, P., additional, Lai, E., additional, Giampieri, R., additional, Faloppi, L., additional, Mandolesi, A., additional, Cremolini, C., additional, Masi, G., additional, Gelsomino, F., additional, Mariani, S., additional, Cubeddu, A., additional, Casula, L., additional, Liscia, N., additional, Pusceddu, V., additional, Antoniotti, C., additional, Loretelli, C., additional, Meriggi, F., additional, Zaniboni, A., additional, Falcone, A., additional, Cascinu, S., additional, and Scartozzi, M., additional

Published
2018
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47. 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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48. First-line FOLFOX plus panitumumab followed by 5-FU/LV plus panitumumab or single-agent panitumumab as maintenance therapy in patients with RAS wild-type metastatic colorectal cancer (mCRC): The VALENTINO study

Author

Pietrantonio, F., primary, Morano, F., additional, Corallo, S., additional, Raimondi, A., additional, Loupakis, F., additional, Cremolini, C., additional, Smiroldo, V., additional, Berenato, R., additional, Bianchi, A. Sartore, additional, Tampellini, M., additional, Bustreo, S., additional, Clavarezza, M., additional, Murialdo, R., additional, Zaniboni, A., additional, Tomasello, G., additional, Peverelli, G., additional, Antoniotti, C., additional, Procaccio, L., additional, Cinieri, S., additional, Antonuzzo, L., additional, Di Bartolomeo, M., additional, and de Braud, F., additional

Published
2018
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49. Development of a new clinical nomogram including velocity rate of disease progression to predict outcome in metastatic colorectal cancer patients treated with bevacizumab beyond progression: A subanalysis from tribe trial

Author

Dell'Aquila, E., primary, Pantano, F., additional, Rossini, D., additional, Stellato, M., additional, Lonardi, S., additional, Masi, G., additional, Schirripa, M., additional, Marmorino, F., additional, Antoniotti, C., additional, Murgioni, S., additional, Tomasello, G., additional, Ronzoni, M., additional, Racca, P., additional, Vincenzi, B., additional, Allegrini, G., additional, Urbano, F., additional, Buonadonna, A., additional, Banzi, M., additional, Tonini, G., additional, Cremolini, C., additional, Falcone, A., additional, and Santini, D., additional

Published
2018
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50. 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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