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906 results on '"Ciardiello, F"'

2. Comprehensive genomic profiling by liquid biopsy captures tumor heterogeneity and identifies cancer vulnerabilities in patients with RAS/BRAFV600E wild-type metastatic colorectal cancer in the CAPRI 2-GOIM trial

Author

Ciardiello, Davide, Bielo, Luca Boscolo, Napolitano, Stefania, Martinelli, Erika, Troiani, Teresa, Nicastro, Antonella, Latiano, Tiziana Pia, Parente, Paola, Maiello, Evaristo, Avallone, Antonio, Normanno, Nicola, Pisconti, Salvatore, Nisi, Claudia, Bordonaro, Roberto, Russo, Alessia Erika, Tamburrini, Emiliano, Toma, Ilaria, Lotesoriere, Claudio, Vallarelli, Simona, Zampino, Maria Giulia, Fazio, Nicola, Curigliano, Giuseppe, Ciardiello, Fortunato, Martini, Giulia, Lonardi, Sara, Cremolini, Chiara, Garufi, Carlo, Tagliaferri, Pierosandro, Tortora, Giampaolo, Pietrantonio, Filippo, Febbraro, Antonio, Rosati, Gerardo, Leo, Silvana, Brunetti, Oronzo, Berardi, Rosanna, Cinieri, Saverio, Scartozzi, Mario, Zaniboni, Alberto, Paoletti, Giancarlo, Ciardiello, D., Boscolo Bielo, L., Napolitano, S., Martinelli, E., Troiani, T., Nicastro, A., Latiano, T.P., Parente, P., Maiello, E., Avallone, A., Normanno, N., Pisconti, S., Nisi, C., Bordonaro, R., Russo, A.E., Tamburini, E., Toma, I., Lotesoriere, C., Vallarelli, S., Zampino, M.G., Fazio, N., Curigliano, G., De Vita, F., Ciardiello, F., and Martini, G.

Published
2024
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3. Establishment of patient-derived tumor organoids to functionally inform treatment decisions in metastatic colorectal cancer

Author

Martini, G., Belli, V., Napolitano, S., Ciaramella, V., Ciardiello, D., Belli, A., Izzo, F., Avallone, A., Selvaggi, F., Menegon Tasselli, F., Santaniello, W., Franco, R., Puig, I., Ramirez, L., Chicote, I., Mancuso, F., Caratu, G., Serres, X., Fasani, R., Jimenez, J., Ros, J., Baraibar, I., Mulet, N., Della Corte, C.M., Troiani, T., Vivancos, A., Dienstmann, R., Elez, E., Palmer, H.G., Tabernero, J., Martinelli, E., Ciardiello, F., and Argilés, G.

Published
2023
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4. Regorafenib monotherapy as second-line treatment of patients with RAS-mutant advanced colorectal cancer (STREAM): an academic, multicenter, single-arm, two-stage, phase II study

Author

Cardone, C., De Stefano, A., Rosati, G., Cassata, A., Silvestro, L., Borrelli, M., Di Gennaro, E., Romano, C., Nappi, A., Zanaletti, N., Foschini, F., Casaretti, R., Tatangelo, F., Lastoria, S., Raddi, M., Bilancia, D., Granata, V., Setola, S., Petrillo, A., Vitagliano, C., Gargiulo, P., Arenare, L., Febbraro, A., Martinelli, E., Ciardiello, F., Delrio, P., Budillon, A., Piccirillo, M.C., and Avallone, A.

Published
2023
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5. Fluorouracil and dose-dense adjuvant chemotherapy in patients with early-stage breast cancer (GIM2): end-of-study results from a randomised, phase 3 trial

Author

Venturini, M, Abate, A, Pastorino, S, Canavese, G, Vecchio, C, Guenzi, M, Lambertini, M, Levaggi, A, Giraudi, S, Accortanzo, V, Floris, C.A., Aitini, E, Fornari, G, Miraglia, S, Buonfanti, G, Cherchi, M.C., Petrelli, F, Vaccaro, A, Magnolfi, E, Contu, A, Labianca, R, Parisi, A, Basurto, C, Cappuzzo, F, Merlano, M, Russo, S, Mansutti, M, Poletto, E, Nardi, M, Grasso, D, Fontana, A, Isa, L, Comandè, M, Cavanna, L, Iacobelli, S, Milani, S, Mustacchi, G, Venturini, S, Scinto, A.F., Sarobba, M.G., Pugliese, P, Bernardo, A, Pavese, I, Coccaro, M, Massidda, B, Ionta, M.T., Nuzzo, A, Laudadio, L, Chiantera, V, Dottori, R, Barduagni, M, Castiglione, F, Ciardiello, F, Tinessa, V, Ficorella, A, Moscetti, L, Vallini, I, Giardina, G, Silva, R, Montedoro, M, Seles, E, Morano, F, Cruciani, G, Adamo, V, Pancotti, A, Palmisani, V, Ruggeri, A, Cammilluzzi, E, Carrozza, F, D'Aprile, M, Brunetti, M, Gallotti, P, Chiesa, E, Testore, F, D'Arco, A, Ferro, A, Jirillo, A, Pezzoli, M, Scambia, G, Iacono, C, Masullo, P, Tomasello, G, Gandini, G, Zoboli, A, Bottero, C, Cazzaniga, M, Genua, G, Palazzo, S, D'Amico, M, Perrone, D, Del Mastro, Lucia, Poggio, Francesca, Blondeaux, Eva, De Placido, Sabino, Giuliano, Mario, Forestieri, Valeria, De Laurentiis, Michelino, Gravina, Adriano, Bisagni, Giancarlo, Rimanti, Anita, Turletti, Anna, Nisticò, Cecilia, Vaccaro, Angela, Cognetti, Francesco, Fabi, Alessandra, Gasparro, Simona, Garrone, Ornella, Alicicco, Maria Grazia, Urracci, Ylenia, Mansutti, Mauro, Poletti, Paola, Correale, Pierpaolo, Bighin, Claudia, Puglisi, Fabio, Montemurro, Filippo, Colantuoni, Giuseppe, Lambertini, Matteo, and Boni, Luca

Published
2022
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6. Clinical efficacy of sequential treatments in KRASG12C-mutant metastatic colorectal cancer: findings from a real-life multicenter Italian study (CRC-KR GOIM)

Author

Ciardiello, D., Chiarazzo, C., Famiglietti, V., Damato, A., Pinto, C., Zampino, M.G., Castellano, G., Gervaso, L., Zaniboni, A., Oneda, E., Rapisardi, S., Bordonaro, R., Zichi, C., De Vita, F., Di Maio, M., Parisi, A., Giampieri, R., Berardi, R., Lavacchi, D., Antonuzzo, L., Tamburini, E., Maiorano, B.A., Parrella, P., Latiano, T.P., Normanno, N., De Stefano, A., Avallone, A., Martini, G., Napolitano, S., Troiani, T., Martinelli, E., Ciardiello, F., and Maiello, E.

Published
2022
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12. Three dimensional primary cultures for selecting human breast cancers that are sensitive to the anti-tumor activity of ipatasertib or taselisib in combination with anti-microtubule cytotoxic drugs

Author

Orditura, M., Della Corte, C.M., Diana, A., Ciaramella, V., Franzese, E., Famiglietti, V., Panarese, I., Franco, R., Grimaldi, A., Lombardi, A., Caraglia, M., Santoriello, A., Procaccini, E., Lieto, E., Maiello, E., De Vita, F., Ciardiello, F., and Morgillo, F.

Published
2018
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13. Pan-Asian adapted ESMO consensus guidelines for the management of patients with metastatic colorectal cancer: a JSMO–ESMO initiative endorsed by CSCO, KACO, MOS, SSO and TOS

Author

Yoshino, T., Arnold, D., Taniguchi, H., Pentheroudakis, G., Yamazaki, K., Xu, R.-H., Kim, T.W., Ismail, F., Tan, I.B., Yeh, K.-H., Grothey, A., Zhang, S., Ahn, J.B., Mastura, M.Y., Chong, D., Chen, L.-T., Kopetz, S., Eguchi-Nakajima, T., Ebi, H., Ohtsu, A., Cervantes, A., Muro, K., Tabernero, J., Minami, H., Ciardiello, F., and Douillard, J.-Y.

Published
2018
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14. RAS testing of liquid biopsy correlates with the outcome of metastatic colorectal cancer patients treated with first-line FOLFIRI plus cetuximab in the CAPRI-GOIM trial

Author

Normanno, N., Esposito Abate, R., Lambiase, M., Forgione, L., Cardone, C., Iannaccone, A., Sacco, A., Rachiglio, A.M., Martinelli, E., Rizzi, D., Pisconti, S., Biglietto, M., Bordonaro, R., Troiani, T., Latiano, T.P., Giuliani, F., Leo, S., Rinaldi, A., Maiello, E., and Ciardiello, F.

Published
2018
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18. 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

19. 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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21. ESMO consensus guidelines for the management of patients with metastatic colorectal cancer

Author

Van Cutsem, E., Cervantes, A., Adam, R., Sobrero, A., Van Krieken, J.H., Aderka, D., Aranda Aguilar, E., Bardelli, A., Benson, A., Bodoky, G., Ciardiello, F., D'Hoore, A., Diaz-Rubio, E., Douillard, J.-Y., Ducreux, M., Falcone, A., Grothey, A., Gruenberger, T., Haustermans, K., Heinemann, V., Hoff, P., Köhne, C.-H., Labianca, R., Laurent-Puig, P., Ma, B., Maughan, T., Muro, K., Normanno, N., Österlund, P., Oyen, W.J.G., Papamichael, D., Pentheroudakis, G., Pfeiffer, P., Price, T.J., Punt, C., Ricke, J., Roth, A., Salazar, R., Scheithauer, W., Schmoll, H.J., Tabernero, J., Taïeb, J., Tejpar, S., Wasan, H., Yoshino, T., Zaanan, A., and Arnold, D.

Published
2016
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22. Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX

Author

Iaffaioli, Vincenzo, Nasti, Guglielmo, Botti, Gerardo, Tatangelo, F., Chicchinelli, Nicoletta, Montrone, Mirko, Sebastio, Annamaria, Guarino, Tiziana, Simone, Gianni, Graziano, Paolo, Chiarazzo, Cinzia, Di Maggio, Gabriele, Longhitano, Laura, Manusia, Mario, Cartenì, Giacomo, Nappi, Oscar, Micheli, Pietro, Leo, Luigi, Rossi, Sabrina, Cassano, Alessandra, Tommaselli, Eugenio, Giordano, Guido, Sponziello, Francesco, Marino, Antonella, Rinaldi, Antonio, Romito, Sante, Muda, Andrea Onetti, Lorusso, Vito, Leo, Silvana, Barni, Sandro, Grimaldi, Giuseppe, Aieta, Michele, Ciardiello, F., Normanno, N., Martinelli, E., Troiani, T., Pisconti, S., Cardone, C., Nappi, A., Bordonaro, A.R., Rachiglio, M., Lambiase, M., Latiano, T.P., Modoni, G., Cordio, S., Giuliani, F., Biglietto, M., Montesarchio, V., Barone, C., Tonini, G., Cinieri, S., Febbraro, A., Rizzi, D., De Vita, F., Orditura, M., Colucci, G., and Maiello, E.

Published
2016
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23. Clinical activity and tolerability of FOLFIRI and cetuximab in elderly patients with metastatic colorectal cancer in the CAPRI-GOIM first-line trial

Author

Martinelli, E., Cardone, C., Troiani, T., Normanno, N., Pisconti, S., Sforza, V., Bordonaro, A.R., Rachiglio, A.M., Lambiase, M., Latiano, T.P., Modoni, G., Cordio, S., Giuliani, F., Biglietto, M., Montesarchio, V., Barone, C., Tonini, G., Cinieri, S., Febbraro, A., Rizzi, D., De Vita, F., Orditura, M., Colucci, G., Maiello, E., Ciardiello, F., Iaffaioli, Vincenzo, Nasti, Guglielmo, Nappi, Anna, Botti, Gerardo, Tatangelo, F., Chicchinelli, Nicoletta, Montrone, Mirko, Sebastio, Annamaria, Guarino, Tiziana, Simone, Gianni, Graziano, Paolo, Chiarazzo, Cinzia, Maggio, GabrieleDi, Longhitano, Laura, Manusia, Mario, Cartenì, Giacomo, Nappi, Oscar, Micheli, Pietro, Leo, Luigi, Rossi, Sabrina, Cassano, Alessandra, Tommaselli, Eugenio, Giordano, Guido, Sponziello, Francesco, Marino, Antonella, Rinaldi, Antonio, Romito, Sante, Muda, Andrea Onetti, Lorusso, Vito, Leo, Silvana, Barni, Sandro, Grimaldi, Giuseppe, and Aieta, Michele

Published
2016
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26. Heterogeneity of KRAS, NRAS, BRAF and PIK3CA mutations in metastatic colorectal cancer and potential effects on therapy in the CAPRI GOIM trial

Author

Normanno, N., Rachiglio, A.M., Lambiase, M., Martinelli, E., Fenizia, F., Esposito, C., Roma, C., Troiani, T., Rizzi, D., Tatangelo, F., Botti, G., Maiello, E., Colucci, G., Ciardiello, F., Giuliani, F., Simone, G., Febbraro, A., Tommaselli, E., Cinieri, S., Criscuolo, M., Perrino, A., Rinaldi, A., Bordonaro, R., Manusia, M., Romito, S., Bufo, P., Cartenì, G., Biglietto, M., Nappi, O., Cardarelli, A., Montesarchio, E., Micheli, P., Nasti, G., Chicchinelli, N., Iannaccone, A., Russo, A., Cabibi, D., Giaccone, P., Barone, C., Rindi, G., Tonini, G., Onetti Muda, A., Perrone, G., Latiano, T., Graziano, P., Pisconti, S., and Sebastio, A.

Published
2015
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28. Fluorouracil and dose-dense adjuvant chemotherapy in patients with early-stage breast cancer (GIM2): end-of-study results from a randomised, phase 3 trial

Author

Del Mastro, Lucia, primary, Poggio, Francesca, additional, Blondeaux, Eva, additional, De Placido, Sabino, additional, Giuliano, Mario, additional, Forestieri, Valeria, additional, De Laurentiis, Michelino, additional, Gravina, Adriano, additional, Bisagni, Giancarlo, additional, Rimanti, Anita, additional, Turletti, Anna, additional, Nisticò, Cecilia, additional, Vaccaro, Angela, additional, Cognetti, Francesco, additional, Fabi, Alessandra, additional, Gasparro, Simona, additional, Garrone, Ornella, additional, Alicicco, Maria Grazia, additional, Urracci, Ylenia, additional, Mansutti, Mauro, additional, Poletti, Paola, additional, Correale, Pierpaolo, additional, Bighin, Claudia, additional, Puglisi, Fabio, additional, Montemurro, Filippo, additional, Colantuoni, Giuseppe, additional, Lambertini, Matteo, additional, Boni, Luca, additional, Venturini, M, additional, Abate, A, additional, Pastorino, S, additional, Canavese, G, additional, Vecchio, C, additional, Guenzi, M, additional, Lambertini, M, additional, Levaggi, A, additional, Giraudi, S, additional, Accortanzo, V, additional, Floris, C.A., additional, Aitini, E, additional, Fornari, G, additional, Miraglia, S, additional, Buonfanti, G, additional, Cherchi, M.C., additional, Petrelli, F, additional, Vaccaro, A, additional, Magnolfi, E, additional, Contu, A, additional, Labianca, R, additional, Parisi, A, additional, Basurto, C, additional, Cappuzzo, F, additional, Merlano, M, additional, Russo, S, additional, Mansutti, M, additional, Poletto, E, additional, Nardi, M, additional, Grasso, D, additional, Fontana, A, additional, Isa, L, additional, Comandè, M, additional, Cavanna, L, additional, Iacobelli, S, additional, Milani, S, additional, Mustacchi, G, additional, Venturini, S, additional, Scinto, A.F., additional, Sarobba, M.G., additional, Pugliese, P, additional, Bernardo, A, additional, Pavese, I, additional, Coccaro, M, additional, Massidda, B, additional, Ionta, M.T., additional, Nuzzo, A, additional, Laudadio, L, additional, Chiantera, V, additional, Dottori, R, additional, Barduagni, M, additional, Castiglione, F, additional, Ciardiello, F, additional, Tinessa, V, additional, Ficorella, A, additional, Moscetti, L, additional, Vallini, I, additional, Giardina, G, additional, Silva, R, additional, Montedoro, M, additional, Seles, E, additional, Morano, F, additional, Cruciani, G, additional, Adamo, V, additional, Pancotti, A, additional, Palmisani, V, additional, Ruggeri, A, additional, Cammilluzzi, E, additional, Carrozza, F, additional, D'Aprile, M, additional, Brunetti, M, additional, Gallotti, P, additional, Chiesa, E, additional, Testore, F, additional, D'Arco, A, additional, Ferro, A, additional, Jirillo, A, additional, Pezzoli, M, additional, Scambia, G, additional, Iacono, C, additional, Masullo, P, additional, Tomasello, G, additional, Gandini, G, additional, Zoboli, A, additional, Bottero, C, additional, Cazzaniga, M, additional, Genua, G, additional, Palazzo, S, additional, D'Amico, M, additional, and Perrone, D, additional

Published
2022
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29. 436TiP COLSTAR: Randomized, open-label, multicentre, phase III study comparing futuximab/modotuximab plus trifluridine/tipiracil to trifluridine/tipiracil in KRAS/NRAS and BRAF wild type (wt) metastatic colorectal cancer (mCRC) previously treated with both standard and anti-EGFR treatment

Author

Ciardiello, F., primary, Yoshino, T., additional, Modest, D.P., additional, Martin Fernandez, L., additional, Roby, L., additional, Fougeray, R., additional, Lockhart, B.P., additional, and Tabernero, J., additional

Published
2022
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30. LBA26 BREAKWATER safety lead-in (SLI): Encorafenib (E) + cetuximab (C) + chemotherapy (chemo) for BRAFV600E metastatic colorectal cancer (mCRC)

Author

Tabernero, J., primary, Yoshino, T., additional, Kim, T.W., additional, Yaeger, R., additional, Desai, J., additional, Wasan, H.S., additional, Van Cutsem, E., additional, Ciardiello, F., additional, Maughan, T., additional, Eng, C., additional, Tie, J., additional, Fernandez, M.E. Elez, additional, Lonardi, S., additional, Zhang, X., additional, Chavira, R., additional, Usari, T., additional, Hahn, E., additional, and Kopetz, S., additional

Published
2022
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31. 1092P Clinical potential of circulating tumor DNA (ctDNA)-based molecular response (MR) and baseline blood-based tumor mutational burden (bTMB) for monitoring response to first-line (1L) chemoimmunotherapy in advanced squamous non-small cell lung cancer (sqNSCLC)

Author

Ciardiello, F., primary, Feng, Z., additional, Smith, N.R., additional, Andric, Z.G., additional, Shell, S., additional, Yablonovitch, A., additional, Guezel, G., additional, and Scheuenpflug, J., additional

Published
2022
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32. 316O Genomic mechanisms of acquired resistance of patients (pts) with BRAF V600E-mutant (mt) metastatic colorectal cancer (mCRC) treated in the BEACON study

Author

Kopetz, S., primary, Murphy, D.A., additional, Pu, J., additional, Yaeger, R., additional, Ciardiello, F., additional, Desai, J., additional, Van Cutsem, E., additional, Wasan, H.S., additional, Yoshino, T., additional, Alkuzweny, B., additional, Xie, T., additional, Zhang, X., additional, and Tabernero, J., additional

Published
2022
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37. Clinical efficacy of sequential treatments in KRASG12C-mutant metastatic colorectal cancer: findings from a real-life multicenter Italian study (CRC-KR GOIM)

Author

Ciardiello, D, Chiarazzo, C, Famiglietti, V, Damato, A, Pinto, C, Zampino, M G, Castellano, G, Gervaso, L, Zaniboni, A, Oneda, E, Rapisardi, S, Bordonaro, R, Zichi, C, De Vita, F, Di Maio, M, Parisi, A, Giampieri, R, Berardi, R, Lavacchi, D, Antonuzzo, L, Tamburini, E, Maiorano, B A, Parrella, P, Latiano, T P, Normanno, N, De Stefano, A, Avallone, A, Martini, G, Napolitano, S, Troiani, T, Martinelli, E, Ciardiello, F, Maiello, E, Ciardiello, D, Chiarazzo, C, Famiglietti, V, Damato, A, Pinto, C, Zampino, M G, Castellano, G, Gervaso, L, Zaniboni, A, Oneda, E, Rapisardi, S, Bordonaro, R, Zichi, C, De Vita, F, Di Maio, M, Parisi, A, Giampieri, R, Berardi, R, Lavacchi, D, Antonuzzo, L, Tamburini, E, Maiorano, B A, Parrella, P, Latiano, T P, Normanno, N, De Stefano, A, Avallone, A, Martini, G, Napolitano, S, Troiani, T, Martinelli, E, Ciardiello, F, and Maiello, E

Subjects
KRASG12C mutation, Cancer Research, real-world data, Irinotecan, chemotherapy, first line treatment, Oxaliplatin, Treatment Outcome, Oncology, mCRC, Antineoplastic Combined Chemotherapy Protocols, Colonic Neoplasms, Humans, Fluorouracil, Colorectal Neoplasms, Retrospective Studies
Abstract

Background: The presence of KRASG12C mutation in metastatic colorectal cancer (mCRC) correlates with poor outcome. Although different selective inhibitors are under clinical development, the optimal treatment remains uncertain. Thus, we conducted a retrospective analysis in a large cohort of patients with KRASG12C mCRC treated in 12 Italian oncology units. Patients and methods: Patients with unresectable mCRC harboring KRASG12C mutation receiving a first-line chemotherapy doublet or triplet between 2011 and 2021 were included in the study. Evaluation of overall response rate (ORR), progression-free survival (PFS) and overall survival (OS) analysis was carried out. Results: A total of 256/6952 (3.7%) patients with mCRC displayed KRASG12C mutation; of these, 111 met the inclusion criteria. The ORR of first-line therapy was 38.7% (43/111). Median PFS (mPFS) was 9 months [95% confidence interval (CI) 7.5-10.5 months]. After progression, only 62% and 36% of the patients are fit to receive second or third lines of treatment, with limited clinical benefit. Median OS (mOS) was 21 months (95% CI 17.4-24.6 months). In patients receiving first-line triplet chemotherapy, ORR was 56.3% (9/16), mPFS was 13 months (95% CI 10.3-15.7 months) and mOS was 32 months (95% CI 7.7-56.3 months). For irinotecan-based doublets, ORR was 34.5 (10/29), mPFS was 9 months (95% CI 6.4-11.6 months) and mOS was 22 months (95% CI 16.0-28.0 months). With oxaliplatin-based doublets ORR was 36.4% (24/62), mPFS was 7 months (95% CI 4.6-9.4 months) and mOS was 18 months (95% CI, 13.6-22.4 months). Conclusion: Patients with KRASG12C-mutant mCRC had a disappointing response to standard treatments. Within the limitations of a retrospective study, these results suggest that first-line chemotherapy intensification with FOLFOXIRI is a valid option in fit patients.

Published
2022

38. Is there a role for adjuvant therapy in radiation-induced angiosarcoma of the breast? A case report and review of the literature.

Author

CATERINO, M., DE FELICE, M., POLIERO, L., MAZZARELLA, G., PIROZZI, M., FACCHINI, S., CIARDIELLO, F., and FASANO, M.

Abstract

BACKGROUND: Angiosarcoma (AS) of the breast is very rare, accounting for 1% of all soft tissue breast tumors. AS may present as primary tumors of the breast or as secondary lesions usually associated with previous radiotherapy. Commonly, secondary AS affects older women (median age 67-71 years) with a clinical history of breast cancer. The preferred site of onset of RIAS is the edge of radiation fields, where radiation doses and tumor necrosis may be heterogeneous, resulting in a DNA damage and instability. Radical surgery is the treatment of choice, but no clear consensus exists on surgical management of breast AS. CASE REPORT: We describe an atypical case of relapsed RIAS after radical mastectomy, treated with new surgery and, considering the higher risk of recurrence, subsequent adjuvant chemotherapy with weekly paclitaxel. CONCLUSIONS: The frequency of radiation-induced angiosarcomas (RIAS) after breast-conserving surgery and radiotherapy has been increased to 0.14-0.5% among long survivors. Nevertheless, even if RIAS continues to be prognostically an extremely unfavorable cancer due to a high rate of recurrence, distant spread, and median overall survival (OS) of about 60 months, the benefits of loco-regional breast radiotherapy are clearly higher than the risk in developing angiosarcoma. [ABSTRACT FROM AUTHOR]

Published
2023

39. 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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40. P-68 Regorafenib monotherapy as second-line treatment of patients with RAS-mutant advanced colorectal cancer (STREAM): An academic, multicenter, single-arm, two-stage, phase 2 study

Author

Cardone, C., primary, Piccirillo, M., additional, Rosati, G., additional, De Stefano, A., additional, Romano, C., additional, Nappi, A., additional, Zanaletti, N., additional, Foschini, F., additional, Cassata, A., additional, Casaretti, R., additional, Silvestro, L., additional, Tatangelo, F., additional, Lastoria, S., additional, Raddi, M., additional, Bilancia, D., additional, Febbraro, A., additional, Martinelli, E., additional, Ciardiello, F., additional, Delrio, P., additional, Perrone, F., additional, Budillon, A., additional, and Avallone, A., additional

Published
2022
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41. SO-37 Evaluating age as a factor for survival and quality of life in patients with BRAF V600E-mutant metastatic colorectal cancer treated with encorafenib + cetuximab ± binimetinib: Subanalysis of BEACON CRC

Author

Ng, K., primary, Ciardiello, F., additional, Van Cutsem, E., additional, Yaeger, R., additional, Yoshino, T., additional, Desai, J., additional, Wasan, H., additional, Alkuzweny, B., additional, Zhang, X., additional, Tabernero, J., additional, and Kopetz, S., additional

Published
2022
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43. Overall survival (OS) with encorafenib (enco) + cetuximab (cetux) in BEACON CRC: Effect of prior therapy for BRAF V600E-mutant metastatic colorectal cancer (mCRC).

Author

Desai J., Kopetz S., Aderka D., Grothey A., Van Cutsem E., Yaeger R., Wasan H.S., Yoshino T., Ciardiello F., Chantrill L., Tebbutt N., Strickland A., Price T., Karapetis C., Murphy F., Gollerkeri A., Golden A., Edwards M.L., Tabernero J., Desai J., Kopetz S., Aderka D., Grothey A., Van Cutsem E., Yaeger R., Wasan H.S., Yoshino T., Ciardiello F., Chantrill L., Tebbutt N., Strickland A., Price T., Karapetis C., Murphy F., Gollerkeri A., Golden A., Edwards M.L., and Tabernero J.

Abstract

Background: Enco + cetux (doublet) has been approved in the US, EU, and Japan for the treatment of BRAF V600E-mutant mCRC after progression on 1-2 prior regimens. In the BEACON CRC study (NCT02928224), median OS (95% CI) with the doublet was 9.3 months (8.0-11.3) vs 5.9 months (5.1-7.1) with cetux + irinotecan or FOLFIRI (control) in patients (pts) with BRAF V600E-mutant mCRC (HR 0.61 [95% CI: 0.5-0.8]). This post hoc analysis investigates OS by prior therapies to the doublet treatment in pts with BRAF V600E-mutant mCRC from the BEACON CRC study. Methods : OS of pts treated with the doublet or control were compared according to prior treatment with bevacizumab, oxaliplatin or FOLFOXIRI and duration of prior anticancer therapy (ACT). Results : Sixty-four per cent and 55% of pts in the doublet and control arm respectively received prior bevacizumab. Of pts who had one prior therapy, 95% and 88% received prior oxaliplatin and 20% and 14% received prior FOLFOXIRI, respectively. In the doublet arm, pts who had bevacizumab < 4 months before start of study treatment had a median OS of 8.3 months (95% CI: 6.2-11.2); those who had bevacizumab >=4 months prior had a median OS of 10.7 (95% CI: 7.5-17.7). Within each treatment arm, OS was similar regardless of prior treatment with oxaliplatin or FOLFOXIRI. The duration of prior ACT was similar across study arms, ranging from 5.6 to 5.8 months for the first line of ACT. Conclusions : In the BEACON CRC study, pts treated with the doublet for BRAF V600E-mutant mCRC demonstrated similar OS regardless of prior therapies or duration of prior therapy use. This exploratory post hoc analysis provides data that reflect the prior treatment landscape clinicians may face when deciding subsequent treatment regimens for pts with BRAF V600E-mutant mCRC.

Published
2022

44. Molecular correlates of clinical benefit in previously treated patients (pts) with BRAF V600E-mutant metastatic colorectal cancer (mCRC) from the BEACON study.

Author

Desai J., Kopetz S., Murphy D.A., Pu J., Ciardiello F., Grothey A., Van Cutsem E., Wasan H.S., Yaeger R., Yoshino T., Chantrill L., Tebbutt N., Strickland A., Price T., Karapetis C., Murphy F., Donahue A.C., Golden A., Gollerkeri A., Zhu Z., Tabernero J., Desai J., Kopetz S., Murphy D.A., Pu J., Ciardiello F., Grothey A., Van Cutsem E., Wasan H.S., Yaeger R., Yoshino T., Chantrill L., Tebbutt N., Strickland A., Price T., Karapetis C., Murphy F., Donahue A.C., Golden A., Gollerkeri A., Zhu Z., and Tabernero J.

Abstract

Background: In the BEACON study, encorafenib + binimetinib + cetuximab (enco/bini/cetux; triplet) and enco + cetux (doublet) improved OS and ORR vs standard of care in previously treated BRAF V600E-mutant mCRC pts. Molecular profiling of tumours from this study was performed to identify molecular correlates of outcome. Methods : Baseline tumour samples were analysed by whole-exome sequencing (WES) and whole transcriptome sequencing (WTS). BRAF-mutant (BM) and consensus molecular subtypes (CMS) were determined and pathway activities evaluated with gene set variation analysis. Tumour response was evaluated for each subtype. Additional association and interaction analyses between molecular features and outcomes by treatments are ongoing and will be presented. Results : Baseline tumour samples were analysed by WES and/or WTS for 79.2% of pts. Of the 460 pts analysed by WTS (73.7% in the triplet arm, 66.4% in the doublet arm, 67.4% in the control arm), 84.6% were classified as CMS1 or CMS4. Overall 32.2% of pts were classified as BM1 and the majority (84.5%) of these were CMS4. Many of those classified as BM2 (67.8%) were CMS1 (64.7%). In the BM1 and CMS4 tumours, expression of inflammatory response and epithelial mesenchymal transition genes were elevated, and expression of cell cycle genes was reduced. Response rate in pts with CMS4 and/or BM1 tumors was higher in the triplet arm (CMS4: 33.3% [95% CI: 21.7-46.7]; BM1: 33.3% [95% CI: 21.4-47.1]) vs the doublet arm (CMS4: 19.2% [95% CI: 9.6-32.5]; BM1: 14.9% [95% CI: 6.2-28.3]). Conclusions : Molecular characteristics and biological properties observed in BRAF V600E-mutant mCRC suggest a subset of pts with specific molecular features may derive greater clinical benefit from triplet vs doublet therapy. These findings support further investigating the biological landscape in BRAF-mutant mCRC to enable potential hypotheses for pt selection to improve clinical outcome in future studies.

Published
2022

45. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC.

Author

Kopetz, S, Grothey, A, Van Cutsem, E, Yaeger, R, Wasan, H, Yoshino, T, Desai, J, Ciardiello, F, Loupakis, F, Hong, YS, Steeghs, N, Guren, TK, Arkenau, H-T, Garcia-Alfonso, P, Belani, A, Zhang, X, Tabernero, J, Kopetz, S, Grothey, A, Van Cutsem, E, Yaeger, R, Wasan, H, Yoshino, T, Desai, J, Ciardiello, F, Loupakis, F, Hong, YS, Steeghs, N, Guren, TK, Arkenau, H-T, Garcia-Alfonso, P, Belani, A, Zhang, X, and Tabernero, J

Abstract

BACKGROUND: In the BEACON CRC study (NCT02928224), encorafenib plus cetuximab with binimetinib {9.3 versus 5.9 months; hazard ratio (HR) [95% confidence interval (CI)]: 0.60 [0.47-0.75]} or without binimetinib [9.3 versus 5.9 months; HR (95% CI): 0.61 (0.48-0.77)] significantly improved overall survival (OS) compared with the previous standard of care (control) in patients with BRAF V600E metastatic colorectal cancer (mCRC). Quality of life (QoL) was a secondary endpoint, assessed using validated instruments. PATIENTS AND METHODS: BEACON CRC was a randomized, open-label, phase III study comparing encorafenib plus cetuximab with or without binimetinib and the investigator's choice of irinotecan plus cetuximab or FOLFIRI plus cetuximab (chemotherapy control) in patients with previously treated BRAF V600E mCRC. Patient-reported QoL assessments included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC) and Functional Assessment of Cancer Therapy-Colorectal (FACT-C). The primary outcome for these tools was time to definitive 10% deterioration. RESULTS: Encorafenib plus cetuximab, both with and without binimetinib, was associated with longer median times to definitive 10% deterioration versus the control group in the EORTC Global Health Status scale [HR (95% CI): 0.65 (0.52-0.80) versus 0.61 (0.49-0.75), respectively] and the FACT-C functional well-being subscale [HR (95% CI): 0.62 (0.50-0.76) versus 0.58 (0.47-0.72), respectively]. Consistent results were observed across all subscales of the EORTC and FACT-C instruments. QoL was generally maintained during treatment for the global EORTC and FACT-C scales. CONCLUSIONS: In addition to improving OS, encorafenib plus cetuximab with or without binimetinib delays QoL decline in previously treated patients with BRAF V600E-mutant mCRC.

Published
2022

46. 163P Anti-tumor activity of cetuximab plus avelumab in non-small cell lung cancer patients involves innate immunity activation: Findings from the CAVE-lung trial

Author

Della Corte, C.M., primary, Fasano, M., additional, Ciaramella, V., additional, Cimmino, F., additional, Cardnell, R., additional, Gay, C.M., additional, Ramkumar, K., additional, Diao, L., additional, Di Liello, R., additional, Viscardi, G., additional, Famiglietti, V., additional, Ciardiello, D., additional, Martini, G., additional, Napolitano, S., additional, Troiani, T., additional, Martinelli, E., additional, Wang, J., additional, Byers, L., additional, Morgillo, F., additional, and Ciardiello, F., additional

Published
2022
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47. Clinical management of metastatic colorectal cancer in the era of precision medicine

Author

Ciardiello F, Ciardiello D, Martini G, Napolitano S, Tabernero J, and Cervantes A

Subjects
molecular target therapy, metastatic colorectal cancer, precision medicine, immunotherapy, tumor molecular profiling
Abstract

Colorectal cancer (CRC) represents approximately 10% of all cancers and is the second most common cause of cancer deaths. Initial clinical presentation as metastatic CRC (mCRC) occurs in approximately 20% of patients. Moreover, up to 50% of patients with localized disease eventually develop metastases. Appropriate clinical management of these patients is still a challenging medical issue. Major efforts have been made to unveil the molecular landscape of mCRC. This has resulted in the identification of several druggable tumor molecular targets with the aim of developing personalized treatments for each patient. This review summarizes the improvements in the clinical management of patients with mCRC in the emerging era of precision medicine. In fact, molecular stratification, on which the current treatment algorithm for mCRC is based, although it does not completely represent the complexity of this disease, has been the first significant step toward clinically informative genetic profiling for implementing more effective therapeutic approaches. This has resulted in a clinically relevant increase in mCRC disease control and patient survival. The next steps in the clinical management of mCRC will be to integrate the comprehensive knowledge of tumor gene alterations, of tumor and microenvironment gene and protein expression profiling, of host immune competence as well as the application of the resulting dynamic changes to a precision medicine-based continuum of care for each patient. This approach could result in the identification of individual prognostic and predictive parameters, which could help the clinician in choosing the most appropriate therapeutic program(s) throughout the entire disease journey for each patient with mCRC. CA Cancer J Clin. 2022;72:000-000.

Published
2022

49. Cetuximab continuation after first progression in metastatic colorectal cancer (CAPRI-GOIM): a randomized phase II trial of FOLFOX plus cetuximab versus FOLFOX

Author

Ciardiello, F., Normanno, N., Martinelli, E., Troiani, T., Pisconti, S., Cardone, C., Nappi, A., Bordonaro, A. R., Rachiglio, M., Lambiase, M., Latiano, T. P., Modoni, G., Cordio, S., Giuliani, F., Biglietto, M., Montesarchio, V., Barone, C., Tonini, G., Cinieri, S., Febbraro, A., Rizzi, D., De Vita, F., Orditura, M., Colucci, G., Maiello, E., Iaffaioli, Vincenzo, Nasti, Guglielmo, Botti, Gerardo, Tatangelo, F., Chicchinelli, Nicoletta, Montrone, Mirko, Sebastio, Annamaria, Guarino, Tiziana, Simone, Gianni, Graziano, Paolo, Chiarazzo, Cinzia, Di Maggio, Gabriele, Longhitano, Laura, Manusia, Mario, Cartenì, Giacomo, Nappi, Oscar, Micheli, Pietro, Leo, Luigi, Rossi, Sabrina, Cassano, Alessandra, Tommaselli, Eugenio, Giordano, Guido, Sponziello, Francesco, Marino, Antonella, Rinaldi, Antonio, Romito, Sante, Muda, Andrea Onetti, Lorusso, Vito, Leo, Silvana, Barni, Sandro, Grimaldi, Giuseppe, and Aieta, Michele

Published
2016
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50. 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

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