Ospedali Riuniti di Pesaro, (Italy) management of patients and clinical research on GI cancers. Chief Laboratory Experimental oncology

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1 Curriculum Vitae PERSONAL INFORMATION Stefano Cascinu WORK EXPERIENCE September 1987 September 1994 Senior registrar Ospedali Riuniti di Pesaro, (Italy) management of patients and clinical research on GI cancers September 1994 March 1997 Deputy director Ancona University, (Italy) management of patients; clinical research; teaching in the University Hospital April 1997 October 1998 Chief Laboratory Experimental oncology Ospedali Riuniti di Pesaro, (Italy) Clinical activity; Translational research November 1998 May 2000 Associate professor of Medical oncology Messina University, (Italy) Clinical activity; translational research, teaching at the School of Medicine April 2000 October 2002 Head of the medical oncology Division Azienda Ospedaliera di Parma, (Italy) Clinicala ctivity; clinical research and teaching at post graduate school of medicine November 2002 Present Full Professor of Medical Oncology and Head of the Department of Medical oncology Università Politecnica delle Marche, (Italy) clinical activity; translational research; teaching at School of Medicine EDUCATION AND TRAINING October 1986 June 1988 post graduate training in medical oncology Università di ancona, (Italy) Management of cancer patients; clinical research 28/4/14 European Union, Page 1 / 6

2 November 1988 June 2002 post graduate training in radiation therapy Università di Bologna, (Italy) ADDITIONAL INFORMATION Expertise GI cancer; tumor biology; target therapy Publications 1. Berardi Rossana, Maccaroni Elena, Mandolesi Alessandra, Mantello Giovanna, Onofri Azzurra, Biscotti Tommasina, Pierantoni Chiara, Siquini Walter, Marmorale Cristina, Mario Guerrieri, Bearzi Italo and Cascinu Stefano. Nuclear factor-k B predicts outcome in locally advanced rectal cancer patients receiving neoadjuvant radio-chemotherapy. Dig Liver Dis Santini D, Tampellini M, Vincenzi B, Ibrahim T, Ortega C, Virzi V, Silvestris N, Berardi R, Masini C, Cascinu S, Barni S, Maiello E, Tonii G. Natural history of bone metastasis in colorectal cancer: final results of a large Italian bone metastases study. Ann Oncol Gasparini G, Torino F, Ueno T, Cascinu S, Troiani T, Ballestrero A, Berardi R, Shishido J, Yoshizawa A, Mori Y, Nagayama S, Morosini P, Toi M. A phase II study of neoadjuvant bevacizumab plus capecitabine and concomitant radiotherapy in patients with locally advanced rectal cancer. Angiogenesis Berardi, S. Miseria, S. Cascinu. Professional failure: how do oncologists feel it? Ann Oncol 2011, 22(12): Scartozzi M, Giampieri R, Maccaroni E, Mandolesi A, Giustizi L, Silva RR, Zaniboni A, Biscotti T, Biagetti S, Galizia E, Loupakis F, Falcone A, Bearzi I, Cascinu S. Analysis of HER-3, insulin growth factor-1, nuclear factor-kb and epidermal growth factor receptor gene copy number in the prediction of clinical outcome for K-RAS wild-type colorectal cancer patients receiving irinotecan-cetuximab. Ann Oncol Nov Scartozzi M, Berazi I, Mandolesi A, Giampieri R, faloppi L, Galizia E, Loupakis F, Zaniboni A, Biscotti T, La bianca R, Falcone A, Cascinu S.Epidermal growth factor receptor (EGFR) gene promoter methylation and cetuximab treatment in colorectal cancer patients. Br J Cancer May 24;104(11): Van Cutsem E, Köhne CH, Láng I, Folprecht G, Nowacki MP, Cascinu S, Shchepotin I, Maurel J, Cunningham D, Tejpar S, Schlichting M, Zubel A, Celik I, Rougier P, Ciardiello F. Cetuximab plus irinotecan, fluorouracil, and leucovorin as first-line treatment for metastatic colorectal cancer: updated analysis of overall survival according to tumor KRAS and BRAF mutation status. J Clin Oncol May 20;29(15): Battelli N, Bittoni A, Pagliacci A, Zepponi L, Scartozzi M, Mariotti C, Cascinu S. Doses of capecitabine and oral vinorelbine are not relevant for efficacy in breast cancer patients: an analysis of dose intensity. Tumori Jul-Aug;97(4): Berardi, Alfredo Santinelli, Alessandro Brunelli, Azzurra Onofri, Chiara Pierantoni, Mario Scartozzi, Eleonora Pisa, Daniela Stramazzotti, Paola Mazzanti, Lina Zuccatosta, Stefano Gasparini, Armando Sabbatini, Stefano Cascinu. Epidermal Growth Factor Receptor (EGFR) status in different stages of resected non-small cell lung cancer (NSCLC): implications for treatment with EGFR inhibitors. Anal Quant Cytol Histol 2011, 33(4): Scartozzi M, Loretelli C, Berardi R, Pierantoni C, Silva RR, Mari D, Giampieri R, Faloppi L, Pistelli M, Maccaroni E, Bittoni A, Del Prete M, Galizia E, Cascinu S. Phase II study of pharmacogenetictailored therapy in elderly colorectal cancer patients. Dig Liver Dis Pistelli M, Scartozzi M, Bittoni A, Galizia E, Berardi R, Cascinu S. Second-line chemotherapy with irinotecan, 5-fluorouracil and leucovorin (FOLFIRI) in relapsed or metastatic gastric cancer: lessons from clinical practice. Tumori 2011;97(3): doi: / Scartozzi M, Bianconi M, Maccaroni E, Giampieri R, Del Prete M, Berardi R, Cascinu S. State of the art and future perspectives for the use of insulin-like growth factor receptor 1 (IGF-1R) targeted treatment strategies in solid tumors. Discov Med 2011;11(57): Scartozzi, Elena Maccaroni, Riccardo Giampieri, Mirco Pistelli, Alessandro Bittoni, Michela Del Prete, Rossana Berardi & Stefano Cascinu. 5-fluorouracil pharmacogenomics: still rocking after all these years? Pharmacogenomics 2011;12(2): Scartozzi M, Mandolesi A, Giampieri R, Bittoni A, Pierantoni C, Zaniboni A, Galizia E, Giustini L, 28/4/14 European Union, Page 2 / 6

3 Silva RR, Bisonni R, Berardi R, Biscotti T, Biagetti S, Bearzi I, Cascinu S. The Role of HER-3 Expression in the Prediction of Clinical Outcome for Advanced Colorectal Cancer Patients Receiving Irinotecan and Cetuximab. Oncologist. 2011;16(1): Rossana Berardi, Azzurra Onofri, Mirco Pistelli, Elena Maccaroni, Mario Scartozzi, Chiara Pierantoni, Stefano Cascinu. Panitumumab: the evidence for its use in the treatment of metastatic colorectal cancer. Core Evidence 2010;5: Loupakis F, Masi G, Fornaro L, Vasile E, Allegrini G, Fontana E, Granetto C, Salvatore L, Mentuccia L, Andreuccetti M, Cortesi E, Merlano M, Cascinu S, Falcone A.Phase II study of sequential cisplatin plus 5-fluorouracil/leucovorin (5-FU/LV) followed by irinotecan plus 5-FU/LV followed by docetaxel plus 5-FU/LV in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma. Cancer Chemother Pharmacol Aug;66(3): Mario Scartozzi, Walter Siquini, Eva Galizia, Pierpaolo Stortoni, Cristina Marmorale, Rossana Berardi, Aroldo Fianchini, Stefano Cascinu. The timing of surgery for resectable metachronous liver metastases from colorectal cancer: Better sooner than later? A retrospective analysis. Dig Liver Dis 2011;43(3): Scartozzi M, Baroni GS, Faloppi L, Paolo MD, Pierantoni C, Candelari R, Berardi R, Antognoli S, Mincarelli C, Risaliti A, Marmorale C, Antico E, Benedetti A, Cascinu S. Trans-arterial chemoembolization (TACE), with either lipiodol (traditional TACE) or drug-eluting microspheres (precision TACE, ptace) in the treatment of hepatocellular carcinoma: efficacy and safety results from a large mono-institutional analysis. J Exp Clin Cancer Res 2010;29: Loupakis F, Masi G, Fornaro L, Vasile E, Allegrini G, Fontana E, Granetto C, Salvatore L, Mentuccia L, Andreuccetti M, Cortesi E, Merlano M, Cascinu S, Falcone A Phase II study of sequential cisplatin plus 5-fluorouracil/leucovorin (5-FU/LV) followed by irinotecan plus 5-FU/LV followed by docetaxel plus 5-FU/LV in patients with metastatic gastric or gastro-oesophageal junction adenocarcinoma. Cancer Chemother Pharmacol Mar Scartozzi M, Mandolesi A, Giampieri R, Pierantoni C, Loupakis F, Zaniboni A, Galizia E, Giustini L, Silva RR, Bisonni R, Berardi R, Biagetti S, Menzo S, Falcone A, Bearzi I, Cascinu S. Insulin-like growth factor 1 expression correlates with clinical outcome in K-RAS wild type colorectal cancer patients treated with cetuximab and irinotecan. Int J Cancer Jan Pinto C, Di Fabio F, Barone C, Siena S, Falcone A, Cascinu S, Rojas Llimpe FL, Stella G, Schinzari G, Artale S, Mutri V, Giaquinta S, Giannetta L, Bardelli A, Martoni AA Phase II study of cetuximab in combination with cisplatin and docetaxel in patients with untreated advanced gastric or gastro-oesophageal junction adenocarcinoma (DOCETUX study). Br J Cancer Oct 20;101(8): Siena S, Crinò L, Danova M, Del Prete S, Cascinu S, Salvagni S, Schiavetto I, Vitali M, Bajetta E.Dose-dense temozolomide regimen for the treatment of brain metastases from melanoma, breast cancer, or lung cancer not amenable to surgery or radiosurgery: a multicenter phase II study. Ann Oncol Mar;21(3): Berardi R, Maccaroni E, Onofri A, Giampieri R, Pistelli M, Bittoni A, Scartozzi M, Pierantoni C, Mandolesi A, Bearzi I, Cascinu S.Locally advanced rectal cancer: from molecular profiling to clinical practice. A literature review: Part 2. Expert Opin Pharmacother Oct;10(15): Scartozzi M, Bearzi I, Mandolesi A, Pierantoni C, Loupakis F, Zaniboni A, Negri F, Quadri A, Zorzi F, Galizia E, Berardi R, Biscotti T, Labianca R, Masi G, Falcone A, Cascinu S. Epidermal Growth Factor Receptor (EGFR) gene copy number (GCN) correlates with clinical activity of irinotecancetuximab in K-RAS wild-type colorectal cancer: a fluorescence in situ (FISH) and chromogenic in situ hybridization (CISH) analysis. BMC Cancer. 2009; 27;9: Cascinu S. Hepatocellular carcinoma: The beginning of a long journey. Dig Liver Dis Oct;41(10): Scartozzi M, Mazzanti P, Giampieri R, Berardi R, Galizia E, Gasparini S, Zuccatosta L, Cascinu S.Clinical predictive factors for advanced non-small cell lung cancer (NSCLC) patients receiving thirdline therapy: Selecting the unselectable? Lung Cancer Aug Berardi R, Maccaroni E, Onofri A, Giampieri R, Bittoni A, Pistelli M, Scartozzi M, Pierantoni C, Bianconi M, Cascinu S. Multidisciplinary treatment of locally advanced rectal cancer: a literature review. Part 1. Expert Opin Pharmacother Oct;10(14): Cascinu S, Jelic S: Pancreatic cancer: ESMO clinical recommendations for diagnosis, treatment and follow-up. Ann Oncol : Scartozzi M, Bittoni A, Pistelli M, Galizia E, Berardi R, Giampieri R, Faloppi L, Cascinu S. Toward molecularly selected chemotherapy for advanced gastric cancer: state of the art and future perspectives. Cancer Treat Rev Aug;35(5): /4/14 European Union, Page 3 / 6

4 30. Loupakis F, Pollina L, Stasi I, Ruzzo A, Scartozzi M, Santini D, Masi G, Graziano F, Cremolini C, Rulli E, Canestrari E, Funel N, Schiavon G, Petrini I, Magnani M, Tonini G, Campani D, Floriani I, Cascinu S, Falcone A. PTEN expression and KRAS mutations on primary tumors and metastases in the prediction of benefit from cetuximab plus irinotecan for patients with metastatic colorectal cancer. J Clin Oncol Jun 1;27(16): Berardi R, Mantello G, Scartozzi M, Del Prete S, Luppi G, Martinelli R, Fumagalli M, Grillo-Ruggieri F, Bearzi I, Mandolesi A, Marmorale C, Cascinu S. Locally advanced rectal cancer patients receiving radio-chemotherapy: a novel clinical-pathologic score correlates with global outcome. Int J Radiat Oncol Biol Phys Dec 1;75(5): Celio L, Sternberg CN, Labianca R, La Torre I, Amoroso V, Barone C, Pinotti G, Cascinu S, Di Costanzo F, Cetto GL, Bajetta E. Pemetrexed in combination with oxaliplatin as a first-line therapy for advanced gastric cancer: a multi-institutional phase II study. Ann Oncol Jun;20(6): Peeters M, Siena S, Van Cutsem E, Sobrero A, Hendlisz A, Cascinu S, Kalofonos H, Devercelli G, Wolf M, Amado RG. Association of progression-free survival, overall survival, and patient-reported outcomes by skin toxicity and KRAS status in patients receiving panitumumab monotherapy. Cancer Apr 1;115(7): Guarneri V, Frassoldati A, Bruzzi P, D'Amico R, Belfiglio M, Molino A, Bertetto O, Cascinu S, Cognetti F, Di Leo A, Pronzato P, Crinó L, Agostara B, Conte P.Multicentric, randomized phase III trial of two different adjuvant chemotherapy regimens plus three versus twelve months of trastuzumab in patients with HER2- positive breast cancer (Short-HER Trial; NCT ). Clin Breast Cancer Oct;8(5): Tiseo M, Gridelli C, Cascinu S, Crinò L, Piantedosi FV, Grossi F, Brandes AA, Labianca R, Siena S, Amoroso D, Belvedere O, Valentino B, Bearz A, Venturino P, Ardizzoni A. An expanded access program of erlotinib (Tarceva) in patients with advanced non-small cell lung cancer (NSCLC): data report from Italy. Lung Cancer May;64(2): Scartozzi M, Galizia E, Chiorrini S, Giampieri R, Berardi R, Pierantoni C, Cascinu S. Arterial hypertension correlates with clinical outcome in colorectal cancer patients treated with first-line bevacizumab. Ann Oncol Feb;20(2): Berardi R, Verdecchia L, Paolo MD, Giampieri R, Scartozzi M, Pierantoni C, Bianconi M, Mazzanti P, Cascinu S. Women and lung cancer: clinical and molecular profiling as a determinate for treatment decisions: a literature review. Crit Rev Oncol Hematol (3): Braconi C, Bracci R, Bearzi I, Bianchi F, Sabato S, Mandolesi A, Belvederesi L, Cascinu S, Valeri N, Cellerino R. Insulin-like growth factor (IGF) 1 and 2 help to predict disease outcome in GIST patients. Ann Oncol Jul;19(7): Pierantoni C, Pagliacci A, Scartozzi M, Berardi R, Bianconi M, Cascinu S. Pancreatic cancer: progress in cancer therapy. Crit Rev Oncol Hematol ;67(1): Cascinu S. Oral treatment for gastric cancer: new choices, better choices? Lancet Oncol Mar;9(3): Braconi C, Bracci R, Bearzi I, Bianchi F, Costagliola A, Catalani R, Mandolesi A, Ranaldi R, Galizia E, Cascinu S, Rossi G, Giustini L, Latini L, Valeri N, Cellerino R. KIT and PDGFRalpha mutations in 104 patients with gastrointestinal stromal tumors (GISTs): a population-based study. Ann Oncol (4): Reni M, Berardi R, Mambrini A, Pasetto L, Cereda S, Ferrari VD, Cascinu S, Cantore M, Mazza E, Grisanti S. A multi-centre retrospective review of second-line therapy in advanced pancreatic adenocarcinoma. Cancer Chemother Pharmacol Sep;62(4): Van Cutsem E, Van de Velde C, Roth A, Lordick F, Köhne CH, Cascinu S, Aapro M; European Organisation for Research and Treatment of Cancer (EORTC)-gastrointestinal cancer group. Expert opinion on management of gastric and gastro-oesophageal junction adenocarcinoma on behalf of the European Organisation for Research and Treatment of Cancer (EORTC)-gastrointestinal cancer group. Eur J Cancer Jan;44(2): Negri FV, Campanini N, Camisa R, Pucci F, Bui S, Ceccon G, Martinelli R, Fumagalli M, Losardo PL, Crafa P, Bordi C, Cascinu S, Ardizzoni A. Biological predictive factors in rectal cancer treated with preoperative radiotherapy or radiochemotherapy. Br J Cancer Jan 15;98(1): Cascinu S, Berardi R, Labianca R, Siena S, Falcone A, Aitini E, Barni S, Di Costanzo F, Dapretto E, Tonini G, Pierantoni C, Artale S, Rota S, Floriani I, Scartozzi M, Zaniboni A; Italian Group for the Study of Digestive Tract Cancer (GISCAD). Cetuximab plus gemcitabine and cisplatin compared with gemcitabine and cisplatin alone in patients with advanced pancreatic cancer: a randomised, multicentre, phase II trial. Lancet Oncol Jan;9(1): Cascinu S, Berardi R, Salvagni S, Beretta GD, Catalano V, Pucci F, Sobrero A, Tagliaferri P, 28/4/14 European Union, Page 4 / 6

5 Labianca R, Scartozzi M, Crocicchio F, Mari E, Ardizzoni A. A combination of gefitinib and FOLFOX-4 as first-line treatment in advanced colorectal cancer patients. A GISCAD multicentre phase II study including a biological analysis of EGFR overexpression, amplification and NF-kB activation. Br J Cancer Jan 15;98(1): Verslype C, Van Cutsem E, Dicato M, Cascinu S, Cunningham D, Diaz-Rubio E, Glimelius B, Haller D, Haustermans K, Heinemann V, Hoff P, Johnston PG, Kerr D, Labianca R, Louvet C, Minsky B, Moore M, Nordlinger B, Pedrazzoli S, Roth A, Rothenberg M, Rougier P, Schmoll HJ, Tabernero J, Tempero M, van de Velde C, Van Laethem JL, Zalcberg J. The management of pancreatic cancer. Current expert opinion and recommendations derived from the 8th World Congress on Gastrointestinal Cancer, Barcelona, Ann Oncol Jun;18 7:vii1-vii Cascinu S, Scartozzi M, Carbonari G, Pierantoni C, Verdecchia L, Mariani C, Squadroni M, Antognoli S, Silva RR, Giampieri R, Berardi R. COX-2 and NF-KB overexpression is common in pancreatic cancer but does not predict for COX-2 inhibitors activity in combination with gemcitabine and oxaliplatin. Am J Clin Oncol Oct;30(5): Grillo-Ruggieri F, Mantello G, Berardi R, Cardinali M, Fenu F, Iovini G, Montisci M, Fabbietti L, Marmorale C, Guerrieri M, Saba V, Bearzi I, Mattioli R, Bonsignori M, Cascinu S. Mucinous rectal adenocarcinoma can be associated to tumor downstaging after preoperative chemoradiotherapy. Dis Colon Rectum Oct;50(10): Scartozzi, Italo Bearzi, Chiara Pierantoni, Alessandra Mandolesi, Fotios Loupakis, Alberto Zaniboni, Vincenzo Catalano, Antonello Quadri, Fausto Zorzi, Rossana Berardi, Tommasina Biscotti, Roberto Labianca, Alfredo Falcone, and Stefano Cascinu. Nuclear Factor-kB (NF-kB) tumor expression predicts response and survival in irinotecan-refractory metastatic colorectal cancer patients treated with cetuximab-irinotecan therapy. J Clin Oncol. 2007;25(25): Grillo-Ruggieri, Giovanna Mantello, Rossana Berardi, Massimo Cardinali, Francesco Fenu, Giuseppina Iovini, Maria Montisci, Letizia Fabbietti, Cristina Marmorale, Mario Guerrieri, Vittorio Saba, Italo Bearzi, Rodolfo Mattioli, Maurizio Bonsignori, Stefano Cascinu. Mucinous rectal adenocarcinoma can be associated to tumor downstaging after preoperative chemoradiotherapy. Dis Colon Rectum 2007;50(10): Cascinu, Mario Scartozzi, Giovanna Carbonari, Chiara Pierantoni, Lorena Verdecchia, Cinzia Mariani, Michela Squadroni, Stefania Antognoli, Rosa Rita Silva, Riccardo Giampieri and Rossana Berardi. COX-2 and NF-KB over-expression is common in pancreatic cancer but does not predict for cox-2 inhibitors activity in combination with gemcitabine and oxaliplatin. Am J Clin Oncol 2007;30(5): Scartozzi M, Bearzi I, Berardi R, Mandolesi A, Pierantoni C, Cascinu S. Epidermal growth factor receptor (EGFR) downstream signalling pathway in primary colorectal tumours and related metastatic sites: optimising EGFR-targeted treatment options. Br J Cancer 2007;97(1): Scartozzi, Eva Galizia, Lorena Verdecchia, Rossana Berardi, Stefania Antognoli, Silvia Chiorrini, Stefano Cascinu. Chemotherapy for advanced gastric cancer: across the years for a standard of care. Expert Opin Pharmacother 2007;8(6): Pinto C, Di Fabio F, Siena S, Cascinu S, Rojas Llimpe F, Ceccarelli C, Mutri V, Giannetta L, Giaquinta S, Funaioli C, Berardi R, Longobardi C, Piana E, Martoni A. Phase II study of cetuximab in combination with FOLFIRI in patients with untreated advanced gastric or gastroesophageal junction adenocarcinoma (FOLCETUX study). Ann Oncol 2007;18(3): Projects Aspetti Molecolari delle Neoplasie Pancreatiche Ministero della Salute 2004 Basi Molecolari della ipossia tumorale in pazienti affetti da neoplasia del retto Università Politecnica delle Marche 2004, Ancona Applicazioni della farmacogenomica nel trattamento chemioterapico CARIVERONA 2005 Farmacogenomica in pazienti affetti da carcinoma del colon-retto Università Politecnica delle Marche 2005 Caratterizzazione molecolare ed approccio terapeutico mirato nelle neoplasie Neuroendocrine PRIN 2005 Identificazione e validazione di marcatori biomolecolari nelle neoplasie del tratto GI Ministero Salute, Regione Marche /4/14 European Union, Page 5 / 6

6 Molecular markers for cancer susceptibility, diagnosis and treatment in gastric and bladder tumours AIRC Regional Grant 2006 Ruolo del recettore per il fattore di crescita epidermoidale (EGFR) Università Politecnica delle Marche 2006 Angiogenesi come bersaglio terapeutico nel carcinoma del colon Università Politecnica delle Marche 2009 TUMOUR ANGIOGENIC PATHWAY AS A THERAPEUTIC TARGET FOR COLORECTAL CANCER PATIENTS-AIRC 2009 Development of effective cancer therapies based on functional proteomics and cancer stem cell targeting-airc 5 x1000, 2010 Prospective selection of colorectal cancer patients for anti-egfr treatment AIRC 2011 Terapia con nanoparticelle contro le integrine AVB3 dell'endotelio dei vasi tumorali di neoplasie pancreatiche- Università Politecnica delle Marche 2010 COLORECTAL CANCER, EGFR INHIBITOR RESISTANCE, Partecipazione scientifica a progetti di ricerca internazionali e nazionali, ammessi al finanziamento sulla base di bandi competitivi che prevedano la revisione tra pari! PATIENT SELECTION FOR PERSONALIZED THERAPIES-PRIN2012 Prospective selection according to LDH serum levels in advanced colorectal cancer patients receiving bevacizumab. GISCAD 2013 Memberships He is a member of several societies including the Italian Association of Medical Oncology, currently serving as President and previously on its Board of Directors twice ( ) and as General Secretary ( ); the European Society of Medical Oncology, serving on the Educational Committee; the American Association of Clinical Oncology and the American Association of Cancer Research. He was a member of the Editorial board of Oncology Reports; Digestive and Liver Disease; Journal of Oncology. Other Relevant Information 28/4/14 European Union, Page 6 / 6