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1. 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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2. Characteristics of Real-World Patients with High-Risk BRAFV600E/K-Mutated Melanoma Receiving Adjuvant Treatment with Dabrafenib Plus Trametinib After Surgical Resection, Through the Italian Managed Access Program

Author

Quaglino P, Ascierto PA, Consoli F, Queirolo P, Spagnolo F, Morelli MF, Berardi R, Chiarion-Sileni V, Tucci M, Troiani T, Melotti B, Rossi E, Mandala M, Rinaldi G, Marcon IG, Pizzuti M, and Del Vecchio M

Subjects
braf mutation, dabrafenib, melanoma, real-world, trametinib, managed access program, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Pietro Quaglino,1 Paolo A Ascierto,2 Francesca Consoli,3 Paola Queirolo,4 Francesco Spagnolo,5 Maria Francesca Morelli,6 Rossana Berardi,7 Vanna Chiarion-Sileni,8 Marco Tucci,9 Teresa Troiani,10 Barbara Melotti,11 Ernesto Rossi,12 Mario Mandala,13 Gaetana Rinaldi,14 Ilaria Gioia Marcon,15 Matteo Pizzuti,15 Michele Del Vecchio16 1Department of Medical Sciences, Dermatologic Clinic, University of Turin, Turin, Italy; 2Department of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy; 3Department of Oncology, ASST Spedali Civili, Brescia, Italy; 4Oncology Division, Policlinico San Martino IRCCS, Genova, Italy, and Division of Medical Oncology for Melanoma, Sarcoma, and Rare Tumors, IEO, European Institute of Oncology IRCCS, Milan, Italy; 5Skin Cancer Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy; 6Department of Oncology and Dermatological Oncology, Istituto Dermopatico dell’Immacola, Rome, Italy; 7Università Politecnica delle Marche – Azienda Ospedaliero-Universitaria delle Marche, Ancona, Italy; 8Melanoma Oncology Unit, Veneto Institute of Oncology IOV-IRCCS, Padova, Italy; 9Medical Oncology Unit, Department of Interdisciplinary Medicine, University of Bari ‘Aldo Moro’, Bari, Italy; 10Faculty of Medicine, Second University of Naples, Naples, Italy; 11Medical Oncology Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy; 12Medical Oncology, Fondazione Policlinico Universitario A.Gemelli IRCCS, Rome, Italy; 13Division of Oncology, Papa Giovanni XXIII Hospital, Bergamo, Italy, and University of Perugia, Perugia, Italy; 14UOC Oncologia Medica Aoup Paolo Giaccone, Palermo, Italy; 15Novartis Farma S.p.A, Milan, Italy; 16Unit of Melanoma Medical Oncology, Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, ItalyCorrespondence: Michele Del Vecchio, Unit of Melanoma Medical Oncology, Department of Medical Oncology and Hematology, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Giacomo Venezian, 1 20133, Milano, Italy, Tel +39 2.23902557, Email Michele.DelVecchio@istitutotumori.mi.itPurpose: Real-world data from patients with BRAFV600-mutated, resected, stage III melanoma treated with dabrafenib plus trametinib as adjuvant targeted therapy are limited, and it is important to gain an understanding of the characteristics of this patient population, as well as of the patient journey. Here we aimed to describe the characteristics, dosage reductions and discontinuations in patients with BRAFV600E/K-mutated melanoma receiving adjuvant dabrafenib plus trametinib after surgical resection through an Italian managed access program (MAP).Patients and Methods: Eligible patients had completely resected cutaneous melanoma with confirmed BRAF V600E or V600K mutation, or initially resectable lymph node recurrence after a diagnosis of stage I or II melanoma. The starting dose of dabrafenib and trametinib was 150 mg twice daily and 2 mg once daily, respectively.Results: A total of 557 patients received dabrafenib plus trametinib through the MAP (stage III resected disease at inclusion, 554). Median age was 54.0 years, and 40.2% of patients were female. The proportion of all treated patients who required a dose reduction was low (10.8%) as was the proportion of patients who discontinued treatment (13.5%). The main reason for treatment discontinuation was adverse events (36.0%).Conclusion: New treatments, including BRAF-targeted therapies and immunotherapy, have transformed the natural history of melanoma. This is the largest study to date describing patients treated with dabrafenib plus trametinib in routine clinical practice in Italy between 2018 and 2019. Results highlight the characteristics of the patients treated and their journey, as well as the tolerable safety profile of dabrafenib plus trametinib in a real-world patient population.Keywords: BRAF mutation, dabrafenib, melanoma, real-world, trametinib, managed access program

Published
2023

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. 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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10. 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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11. Italian Nivolumab Expanded Access Program (EAP) in Melanoma Adjuvant Setting: patient outcomes and safety profil

Author

Ascierto, P.A., primary, Di Giacomo, A.M., additional, Chiarion Sileni, V., additional, Queirolo, P., additional, Spagnolo, F., additional, De Galitiis, F., additional, Cognetti, F., additional, Mandalà, M., additional, Guidoboni, M., additional, Rinaldi, G., additional, Depenni, R., additional, Consoli, F., additional, Troiani, T., additional, Guida, M., additional, Marconcini, R., additional, Ferrucci, P.F., additional, Strippoli, S., additional, Fava, P., additional, Merelli, B., additional, Simeone, E., additional, Di Guardo, L., additional, Giannarelli, D., additional, Maio, M., additional, Quaglino, P., additional, and Del Vecchio, M., additional

Published
2023
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12. 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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13. 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

14. 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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16. 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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17. 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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18. Clinical activity of FOLFIRI plus cetuximab according to extended gene mutation status by next-generation sequencing: findings from the CAPRI-GOIM trial

Author

Ciardiello, F., Normanno, N., Maiello, E., Martinelli, E., Troiani, T., Pisconti, S., Giuliani, F., Barone, C., Cartenì, G., Rachiglio, A.M., Montesarchio, V., Tonini, G., Rizzi, D., Cinieri, S., Bordonaro, R., Febbraro, A., De Vita, F., Orditura, M., Fenizia, F., Lambiase, M., Rinaldi, A., Tatangelo, F., Botti, G., and Colucci, G.

Published
2014
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19. 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

20. Critical appraisal of the use of regorafenib in the management of colorectal cancer

Author

Festino L, Fabozzi A, Manzo A, Gambardella V, Martinelli E, Troiani T, De Vita F, Orditura M, Ciardiello F, and Morgillo F

Subjects
Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Lucia Festino*, Alessio Fabozzi*, Anna Manzo, Valentina Gambardella, Erika Martinelli, Teresa Troiani, Ferdinando De Vita, Michele Orditura, Fortunato Ciardiello, Floriana Morgillo Division of Medical Oncology, Department of clinical and experimental medicine and surgery "F. Magrassi e A. Lanzara", Second University of Naples, Napoli, Italy*These authors contributed equally to this work Abstract: The lack of valid clinical management options for patients affected by metastatic colorectal cancer, which has progressed after all approved standard treatments, has lead to research into new active molecules. Regorafenib is an oral small-molecule multi kinase inhibitor, binding to several intracellular kinases, with powerful inhibitory activity against vascular endothelial growth factor receptors (VEGFR-1,VEGFR-2, and VEGFR-3), platelet-derived growth factor receptor, fibroblast growth factor receptor 1, Raf, TIE-2, and the kinases KIT, RET, and BRAF. The antitumor activity of regorafenib has been tested in vitro and in vivo, and inhibition of tumor growth has been observed in several cancer models, particularly colorectal cancer and gastrointestinal stromal tumors. The most frequent adverse events of grade 3 or higher related to regorafenib were hand-foot skin reaction, fatigue, diarrhea, hypertension, and rash or desquamation. Only a few Phase I–II trials, and most recently a Phase III trial in pretreated colorectal cancer, have been carried out to date. Several ongoing trials are testing the efficacy of regorafenib in combination with chemotherapy. At this point in time, regorafenib is the first small-molecule tyrosine kinase inhibitor to gain approval by the US Food and Drug Administration for pretreated metastatic colorectal cancer patients. Keywords: colorectal cancer, angiogenesis, regorafenib

Published
2013

21. Corrigendum: “Real world data of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma” (European Journal of Cancer (2021) 157 (250–258), (S0959804921005360), (10.1016/j.ejca.2021.08.018))

Author

Baggi, A., Quaglino, P., Rubatto, M., Depenni, R., Guida, M., Ascierto, P. A., Trojaniello, C., Queirolo, P., Saponara, M., Peris, Ketty, Spagnolo, F., Bianchi, L., De Galitiis, F., Potenza, M. C., Proietti, I., Marconcini, R., Botticelli, A., Barbieri, Pietro Vittorio, Licitra, L., Alfieri, S., Ficorella, C., Cortellini, A., Fargnoli, Maria Concetta, Troiani, T., Tondulli, L., Zamparini, M., Bossi, P., Peris K. (ORCID:0000-0002-5237-0463), Barbieri V., Fargnoli M. C., Baggi, A., Quaglino, P., Rubatto, M., Depenni, R., Guida, M., Ascierto, P. A., Trojaniello, C., Queirolo, P., Saponara, M., Peris, Ketty, Spagnolo, F., Bianchi, L., De Galitiis, F., Potenza, M. C., Proietti, I., Marconcini, R., Botticelli, A., Barbieri, Pietro Vittorio, Licitra, L., Alfieri, S., Ficorella, C., Cortellini, A., Fargnoli, Maria Concetta, Troiani, T., Tondulli, L., Zamparini, M., Bossi, P., Peris K. (ORCID:0000-0002-5237-0463), Barbieri V., and Fargnoli M. C.

Abstract

The authors regret that some Author information was incorrectly given in the published article. Author Manuel Zamparini was missed in the Author list, and the listed affiliation for Paola Queirolo was incorrect. The full and correct details for the Authors are: Paola Queirolo Division of Melanoma, Sarcomas and Rare Tumors, IEO, European Institute of Oncology, IRCCS, Milan, Italy Manuel Zamparini University of Brescia, Department of Medical-Surgical Specialties, Radiological Sciences and Public Health, Medical Oncology, ASST-Spedali Civili, Brescia, Lombardia, ItalyThe Authors also note that values in the first column of Table 4 were mistakenly reversed for ‘Antibiotic intake (within 1 month before therapy)’ and ‘Haemoglobin’. The correct table in full is given here.

Published
2022

23. 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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25. 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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26. Corrigendum to 'Real world data of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma' [Eur J Canc 157 (2021) 250-258]

Author

Baggi, A, Quaglino, P, Rubatto, M, Depenni, R, Guida, M, Ascierto, Pa, Trojaniello, C, Queirolo, P, Saponara, M, Peris, K, Spagnolo, F, Bianchi, L, De Galitiis, F, Potenza, Mc, Proietti, I, Marconcini, R, Botticelli, A, Barbieri, V, Licitra, L, Alfieri, S, Ficorella, C, Cortellini, A, Fargnoli, Mc, Troiani, T, Tondulli, L, Zamparini, M, and Bossi, P

Subjects
Cancer Research, Settore MED/35, Oncology
Published
2022

28. 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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29. The potential diagnostic and predictive role of anaplastic lymphoma kinase (ALK) gene alterations in melanocytic tumors

Author

Ronchi A., Montella M., Cozzolino I., Argenziano G., Moscarella E., Piccolo V., Iovino F., Troiani T., Alfano R., Errico M. E., D'Onofrio V., Berretta M., Franco R., Zito Marino F., ZITO MARINO, Federica, Ronchi, A., Montella, M., Cozzolino, I., Argenziano, G., Moscarella, E., Piccolo, V., Iovino, F., Troiani, T., Alfano, R., Errico, M. E., D'Onofrio, V., Berretta, M., Franco, R., Zito Marino, F., and ZITO MARINO, Federica

Subjects
Skin Neoplasms, hemic and lymphatic diseases, Humans, Anaplastic Lymphoma Kinase, Melanoma
Abstract

OBJECTIVE: Anaplastic lymphoma kinase (ALK) gene has been demonstrated to be rearranged, mutated or amplified in several haematological and solid tumors. Moreover, the use of ALK inhibitors has recently revolutionized the treatment of ALK-rearranged patients affected by non-small cell lung carcinoma. Herein we review the genetic alterations of ALK in melanocytic neoplasms described in literature, focusing on their potential diagnostic and predictive role. MATERIALS AND METHODS: The Authors reviewed the pertinent literature through research on PubMed server was performed typing the terms "ALK", "Anaplastic lymphoma kinase", "ALKATI", "Melanoma", "Spitz", "Spitzoid". RESULTS: ALK translocations were demonstrated in melanocytic neoplasms, particularly in acral melanoma and spitzoid tumors. ALKATI was described in primary and metastatic melanoma, indicating its early occurrence in oncogenesis, with varying immunohistochemical expression of the protein. CONCLUSIONS: The identification of the specific type of ALK mutations could be interesting for planning biologic therapy of melanoma patients. Further studies are needed to evaluate the possibility to introduce an ALK-targeted therapy in patients affected by malignant melanoma.

Published
2020

30. 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

32. P-199 Baseline neutrophil to lymphocyte ratio predicts survival in patients with metastatic colorectal cancer treated with cetuximab plus avelumab (CAVE) as a rechallenge strategy

Author

Ciardiello, D., primary, Famiglietti, V., additional, Napolitano, S., additional, Terminiello, M., additional, Borrelli, C., additional, Vitiello, P., additional, Pietrantonio, F., additional, Avallone, A., additional, Normanno, N., additional, Maiello, E., additional, Latiano, T., additional, Cremolini, C., additional, Santabarbara, G., additional, Pinto, C., additional, Santini, D., additional, Esposito, L., additional, Di Liello, A., additional, Troiani, T., additional, Ciardiello, F., additional, Martinelli, E., additional, and Martini, G., additional

Published
2021
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34. 620P A phase II trial evaluating the activity of cabozantinib in pre-treated patients with metastatic colorectal cancer (mCRC): ABACO trial initial molecular data

Author

Martini, G., Troiani, T., Ciardiello, D., Napolitano, S., Famiglietti, V., Arrichiello, G., Esposito, L., Franco, R., Zito Marino, F., Panarese, I., Cardone, C., Maiello, E., Latiano, T.P., Avallone, A., Vitiello, P.P., Mariella, E., Reginelli, A., Ciardiello, F., and Martinelli, E.

Published
2023
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35. 559MO Rechallenge with EGFR inhibitors in ctDNA RAS/BRAF wild type refractory metastatic colorectal cancer: Individual patients’ data pooled analysis from 4 phase II trials

Author

Ciardiello, D., Mauri, G., Rossini, D., Famiglietti, V., Martini, G., Napolitano, S., Del Tufo, S., Zampino, M.G., Avallone, A., Pietrantonio, F., Lonardi, S., Santini, D., Masi, G., Siena, S., Bardelli, A., Ciardiello, F., Cremolini, C., Sartore Bianchi, A., Troiani, T., and Martinelli, E.

Published
2023
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36. Real world data of cemiplimab in locally advanced and metastatic cutaneous squamous cell carcinoma

Author

Baggi, A., Quaglino, P., Rubatto, M., Depenni, R., Guida, M., Ascierto, P. A., Trojaniello, C., Queirolo, P., Saponara, M., Peris, Ketty, Spagnolo, F., Bianchi, L., De Galitiis, F., Potenza, M. C., Proietti, I., Marconcini, R., Botticelli, A., Barbieri, Pietro Vittorio, Licitra, L., Alfieri, S., Ficorella, C., Cortellini, A., Fargnoli, Maria Concetta, Troiani, T., Tondulli, L., Bossi, P., Peris K. (ORCID:0000-0002-5237-0463), Barbieri V., Fargnoli M. C., Baggi, A., Quaglino, P., Rubatto, M., Depenni, R., Guida, M., Ascierto, P. A., Trojaniello, C., Queirolo, P., Saponara, M., Peris, Ketty, Spagnolo, F., Bianchi, L., De Galitiis, F., Potenza, M. C., Proietti, I., Marconcini, R., Botticelli, A., Barbieri, Pietro Vittorio, Licitra, L., Alfieri, S., Ficorella, C., Cortellini, A., Fargnoli, Maria Concetta, Troiani, T., Tondulli, L., Bossi, P., Peris K. (ORCID:0000-0002-5237-0463), Barbieri V., and Fargnoli M. C.

Abstract

Background: Cutaneous squamous cell carcinoma (cSCC) has an overall favourable outcome, except for patients with an advanced stage disease. The programmed death protein-1 (PD-1) inhibitor cemiplimab has been approved for use in advanced cSCC. We report clinical outcomes from the named patient programme-compassionate use of cemiplimab for patients with advanced cSCC in Italy. Methods: This is a retrospective, observational, multicentre study. We analysed medical records of patients with advanced cSCC treated with cemiplimab between May 2019 and February 2020 in 17 referral Italian centres. We assessed the safety profile according to the Common Terminology Criteria for Adverse Events, version 5.0 (CTCAE v 5.0), the clinical activity in terms of response rate, clinical benefit and duration of response and baseline clinical-pathologic characteristics associated with response. Results: 131 patients were included, with a median age of 79 years. Of them, 9.2% had a concurrent chronic lymphoproliferative disease and 8.5% a concomitant autoimmune disease. Some 42.7% of the total patients had at least one treatment-related adverse events (AEs); out of above, 9.2% had grade 3–4 adverse events, and there were two fatal adverse events. The overall response rate (ORR) was 58%, and the disease control rate (DCR) was 71.7%. Cutaneous squamous cell carcinomas (cSCCs) arising on the head and neck area (p = 0.007) and haemoglobin values in normal range (p = 0.034) were significantly associated with a better response, while cSCCs on the genitalia (p = 0.041), treatment with any systemic antibiotic within 1 month of cemiplimab initiation (p = 0.012), performance status ≥1 (p = 0.012), chronic corticosteroids therapy (p = 0.038), previous radiation therapy to lymph nodes (p = 0.052) and previous chemotherapy (p = 0.0020) were significantly associated with a worse response. Conclusions: Our real-world study showed safety and effectiveness results comparable to those obtained in clinical t

Published
2021

38. Identification of a highly suppressive Treg subset associated to immunotherapy response

Author

ROMANO SIMONA, D’Arrigo P., Troiani T., Rea A., Tufano M., Giunta E. F., Matarese G., Procaccini C., Novizio N., Vigorito V., Faicchia D., Argenziano G., Romano M. F., 34) Romano S., D’Arrigo P., Troiani T., Rea A., Tufano M., Giunta E.F., Matarese G., Procaccini C., Novizio N., Vigorito V., Faicchia D., Argenziano G., Romano M.F., Romano, Simona, D’Arrigo, P., Troiani, T., Rea, A., Tufano, M., Giunta, E. F., Matarese, G., Procaccini, C., Novizio, N., Vigorito, V., Faicchia, D., Argenziano, G., and Romano, M. F.

Published
2018

39. SO-31 Comprehensive genomic profiling of tumor tissue and plasma-circulating tumor DNA in RAS/BRAFV600E wild type metastatic colorectal cancer patients: Initial findings from the CAPRI 2-GOIM trial

Author

Martini, G., Martinelli, E., Ciardiello, D., Nicastro, A., Latiano, T., Maiello, E., Avallone, A., Tamburini, E., Lonardi, S., Cremolini, C., Lolli, I., Tortora, G., Febbraro, A., Leo, S., Zampino, M., Napolitano, S., Normanno, N., Troiani, T., and Ciardiello, F.

Published
2023
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40. SO-24 Panitumumab plus trifluridine/tipiracil as anti-EGFR rechallenge therapy in patients with refractory RAS wild-type metastatic colorectal cancer: Overall survival and subgroup analysis of the randomized phase 2 VELO trial

Author

Ciardiello, D., Napolitano, S., De Falco, V., Martini, G., Martinelli, E., Della Corte, C., Esposito, L., Famiglietti, V., Di Liello, A., Avallone, A., Cardone, C., De Stefano, A., Montesarchio, V., Zampino, M., Fazio, N., Del Tufo, S., Di Maio, M., De Vita, F., Altucci, L., Marrone, F., Ciardiello, F., and Troiani, T.

Published
2023
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42. Diagnostic value/performance of radiological liver imaging during chemoterapy for gastrointestinal malignancy: a critical review

Author

Reginelli A., Vacca G., Zanaletti N., Troiani T., Natella R., Maggialetti N., Palumbo P., Giovagnoni A., Ciardiello F., Cappabianca S., Reginelli, A., Vacca, G., Zanaletti, N., Troiani, T., Natella, R., Maggialetti, N., Palumbo, P., Giovagnoni, A., Ciardiello, F., and Cappabianca, S.

Subjects
liver MR - hepatobiliary phase-Liver CT, steatohepatitis, Antineoplastic Agents, Review, Magnetic Resonance Imaging, sinusoidal obstruction syndrome, Liver, steatosis, Humans, Tomography, X-Ray Computed, Liver MR-hepatobiliary phase-Liver CT, Steatohepatiti, Gastrointestinal Neoplasms, colorectal cancer-chemotherapy-induced focal hepatopathy
Abstract

This article reviews the main toxic effect, complications and relative imaging findings of the liver that may appear during the oncologic follow up among patients affected by gastrointestinal malignancy. Awareness of the causative chemotherapeutic agent and regimens, pathophysiology and relative characteristic imaging findings of hepatic injuries is critical in order to obtain an accurate diagnosis especially when these parenchymal lesions are focal. An accurate synergic radiological diagnosis with Computed Tomography (CT) and Magnetic Resonance (MR) techniques may induce a potential termination of ineffective/toxic chemotherapy during early phases of treatment, changing the therapeutic plan in order to avoid first unnecessary liver biopsy and then invasive treatment as hepatic resection if not required. (www.actabiomedica.it)

Published
2019

44. 13P Synergistic activity of PARP inhibitor and ATR inhibitor in melanoma cell lines may depend on BRAF-V600 mutation status

Author

Giunta, E.F., primary, Belli, V., additional, Napolitano, S., additional, De Falco, V., additional, Vitiello, P.P., additional, Terminiello, M., additional, Caputo, V., additional, Vitale, P., additional, Zanaletti, N., additional, Ciardiello, D., additional, Argenziano, G., additional, Martinelli, E., additional, Martini, G., additional, and Troiani, T., additional

Published
2020
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45. 397O Avelumab plus cetuximab in pre-treated RAS wild type metastatic colorectal cancer patients as a rechallenge strategy: The phase II CAVE (cetuximab-avelumab) mCRC study

Author

Martinelli, E., primary, Martini, G., additional, Troiani, T., additional, Pietrantonio, F., additional, Avallone, A., additional, Normanno, N., additional, Nappi, A., additional, Maiello, E., additional, Falcone, A., additional, Santabarbara, G., additional, Pinto, C., additional, Santini, D., additional, Ciardiello, D., additional, Terminiello, M., additional, Borrelli, C., additional, Napolitano, S., additional, Renato, D., additional, Famiglietti, V., additional, Esposito, L., additional, and Ciardiello, F., additional

Published
2020
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47. 1951P Niraparib and irinotecan combination in ATM-mutated colorectal cancer

Author

Vitiello, P.P., primary, Martini, G., additional, Mele, L., additional, Giunta, E.F., additional, De Falco, V., additional, Ciardiello, D., additional, Belli, V., additional, Cardone, C., additional, Matrone, N., additional, Poliero, L., additional, Tirino, V., additional, Selvaggi, F., additional, Papaccio, G., additional, Troiani, T., additional, Desiderio, V., additional, Ciardiello, F., additional, and Martinelli, E., additional

Published
2020
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48. 461P Real-time PCR-based assessment of RAS/BRAF mutations in the plasma of metastatic colorectal cancer (mCRC) patients: A single institution experience

Author

Vitiello, P.P., primary, De Falco, V., additional, Giunta, E.F., additional, Ciardiello, D., additional, Canciello, M.A., additional, Cardone, C., additional, Vitale, P., additional, Zanaletti, N., additional, Borrelli, C., additional, Poliero, L., additional, Terminiello, M., additional, Arrichiello, G., additional, Caputo, V., additional, Martini, G., additional, Napolitano, S., additional, Lombardi, A., additional, Caraglia, M., additional, Troiani, T., additional, Ciardiello, F., additional, and Martinelli, E., additional

Published
2020
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49. P-200 Bone metastases from colorectal cancer correlate with biological characteristics of primary tumors: A retrospective analysis from a single institution

Author

Giunta, E., primary, De Falco, V., additional, Napolitano, S., additional, Vitale, P., additional, Zanaletti, N., additional, Terminiello, M., additional, Caputo, V., additional, Vitiello, P., additional, Ciardiello, D., additional, Borrelli, C., additional, Poliero, L., additional, Arrichiello, G., additional, Cardone, C., additional, Martini, G., additional, Martinelli, E., additional, Ciardiello, F., additional, and Troiani, T., additional

Published
2020
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50. P-190 A retrospective study of regorafenib versus trifluridine/tipiracil efficacy in chemorefractory metastatic colorectal cancer patients: Multi-institution real-life clinical data

Author

Vitale, P., primary, Zanaletti, N., additional, Lombardi, P., additional, Milanesio, M., additional, Falco, V. De, additional, Terminiello, M., additional, Giunta, E., additional, Vitiello, P., additional, Caputo, V., additional, Borrelli, C., additional, Arrichiello, G., additional, Poliero, L., additional, Ciardiello, D., additional, Napolitano, S., additional, Martini, G., additional, Martinelli, E., additional, Famiglietti, V., additional, Fenocchio, E., additional, Keränen, S. Roselló, additional, Cervantes, A., additional, Ciardiello, F., additional, and Troiani, T., additional

Published
2020
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