ANNUAL REPORT EDUCATION ACTIVITIES 339 STAFF 341

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2 PREFACE ANNUAL REPORT MARIO NEGRI INSTITUTE, MILAN DEPARTMENTS Department of Oncology.. 7 Department of Environmental Health Sciences Department of Neuroscience.. 77 Department of Cardiovascular Research Department of Molecular Biochemistry and Pharmacology Department of Epidemiology Department of Public Health LABORATORIES AND CENTERS Laboratory of Regulatory Policies Centre of Computer Science Engineering. 247 Italian Cochrane Center The Catullo and Daniela Borgomainerio Center 259 Library NEGRI BERGAMO LABORATORIES DEPARTMENTS Department of Molecular Medicine Department of Biomedical Engineering. 285 Laboratory of Biology and Therapy of Metastasis ALDO and CELE DACCO CENTER DEPARTMENT Department of Renal Medicine. 305 LABORATORIES AND CENTERS Laboratory of Coordination of Diagnosis and Information on Rare Diseases The Transplant Research Center. 337 EDUCATION ACTIVITIES 339 STAFF 341 All the staff of the Institute is listed on its website PUBLICATIONS A comprehensive list of the Institute s publications is available on the website Section Publications 1

3 Edited by Isabella Bordogna printed April

4 PREFACE This booklet provides a brief description of the research and training work done at the Mario Negri Institutes in Milan and Bergamo. It is divided by departments, and in some cases by single laboratories. Details of the results are provided in the text itself, so here we shall just draw a few general remarks. This is our first year in the new Milan Headquarters: during this time we devoted most of our efforts improving the new available technologies. Particularly, we have carried out translational research following the mouse clinic patterns. Nuclear magnetic resonance, micro cat scanner, ultrasound, Doppler, photon microscope are some of the methodologies used to do research on human diseases in mice, following the techniques utilized in medical clinic. This will allow to transfer data in more effective ways, to study more in depth and to use a lower number of animals in experimental research. Imaging will play an important role, thanks to the installation of electronic microscopy, of contrast, time- lapse microscopy and atomic force microscopy. New important technologies will also allow us to develop our proteomics research. The tendency nowadays is towards widespread use of molecular biology techniques, especially for studying the mechanism of action of drugs. In vitro studies are an essential basis for thorough investigations although a significant number of in vivo experiments are still needed as this is the only mean we have of validating in vitro findings and establishing models that resemble human diseases as closely as possible. This has led to a substantial increase in the use of transgenic animals. The Institute is still concentrating on its traditional research lines: oncology, neurosciences, cardiovascular and renal diseases, organ transplants with strong cell biology and molecular biochemistry connotations. Significant work has been carried out on the environment and health as a whole. Experimental, clinical and epidemiological research on rare diseases and orphan drugs is growing all the time. The Mario Negri Institute strives to develop a multifaceted approach to all these research themes, ranging from basic research, to pharmacokinetics, pharmacology, controlled clinical trials, epidemiological analysis and whenever possible the epidemiology of services. So far we have published more than articles on peer reviewed scientific journals. If research is to continue young scientists must be continually trained. Working in the laboratory not only gives them an outlet for their ideas, but enables them to obtain worthwhile qualifications by taking part in the Institute s training schemes, which are recognised by the Lombardy Region in Italy, or by working for a Ph.D. awarded by the Open University, UK. Training courses are also available on biomedical statistics, for general practitioners, family pediatricians, and clinical trial nurses. A vital part of the Institute s work involves providing information, at all levels. This is done, in particular, through the Rare Diseases Information Center, the Center for Information on Medicinal Drugs and the Website (www.marionegri.it). We also provide information to medical doctors, nurses, patients associations and lay people, through the media and through a recently developed website: Because research is going through a very difficult time it is vital to be supported by the Government, by private and public bodies as well as by foundations and private citizens. Silvio Garattini Director 3

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6 Mario Negri INSTITUTE FOR PHARMACOLOGICAL RESEARCH Milan ANNUAL REPORT 2008 departments and laboratories 5

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8 DEPARTMENT OF ONCOLOGY STAFF Chief Maurizio D INCALCI, M.D. Oncological Studies Office and Documentation Scientific Documentalist Stefania FILIPPESCHI, Chemist Laboratory of Cancer Pharmacology Head Biophysics Unit Head Flow Citometry Unit Head Cancer Clinical Pharmacology Unit Head Maurizio D INCALCI, M.D. Paolo UBEZIO, Phys.D. Eugenio ERBA, Biochem.D Massimo ZUCCHETTI, Chem.Pharm.D. Laboratory of Molecular Pharmacology Head DNA Repair Unit Head Massimo BROGGINI, Ph.D. Giovanna DAMIA, M.D. Laboratory of Biology and Therapy of Metastasis Head Tumor Angiogenesis Unit Head Unit located in Bergamo Molecular Cancer Therapeutics Unit Head Raffaella GIAVAZZI, Biol.Sci.D., Ph.D. Giulia TARABOLETTI, Biol.Sci.D. Maria Rosa BANI, Biol.Sci.D., Ph.D. 7

9 Laboratory for the development of new pharmacological strategies Head Valter TORRI, M.D. Laboratory of Clinical Trials Head Irene FLORIANI, Dr.Sci.Biol., Dr.Stat., Ph.D. Laboratory of Translational and Outcome Research in Oncology Head Gynecology Oncology Unit Head Giovanni APOLONE, M.D. Roldano FOSSATI, M.D. CERP: Center for the Evaluation and Research on Pain Head Giovanni APOLONE, M.D. Oscar CORLI, M.D. Laboratory of Medical Research and Consumer Involvement Head Paola MOSCONI, Biol.Sci.D. 8

10 CURRICULA VITAE Maurizio D'Incalci obtained his Medical Degree cum Laude from the University of Milan in After specializing in Pharmacology at the Mario Negri Institute of Milan and in Oncology at the University of Genoa, he worked in the Laboratory of Molecular Pharmacology of the National Cancer Institute in Bethesda, MD, USA. Since 1986 he has been chief of the Laboratory of Cancer Chemotherapy at the Mario Negri Institute and since 1996 he has become chief of the Department of Oncology at the Mario Negri Institute. He has been President of the Pharmacology and Molecular Mechanisms Group of the European Organization for Research and Treatment of Cancer (EORTC). From 1994 to 1997 he was Chairman of the New Drug Development Coordinating Committee and from 1997 to 2000 he was chairman of the Research Division of the EORTC. He has been member of the Board of the EORTC from April 2000 to From 1997 he is the Preclinical Coordinator of the Southern Europe New Drug Organization (SENDO) and since 2006 the Chairman of the New Agents Committee (NAC). He is on the editorial board of many international cancer-related scientific journals and since September 2000 he is Editor for Experimental Oncology of the European Journal of Cancer. Dr D'Incalci is author of more than 440 papers on cancer chemotherapy published in peer reviewed international journals, and of several chapters in books on cancer chemotherapy. Selected publications Grosso F., Jones R.L. Demetri G.D., Judson I.R., Blay J.Y., Le Cesne A., Sanfilippo R., Casieri P., Collini P., Dileo P., Spreafico C., Stacchiotti S., Tamborini E., Tercero J.C., Jimeno J., D Incalci M., Gronchi A., Fletcher J.A., Pilotti S., Casali P.G. Efficacy of Trabectedin (ET-743) in advanced pre-treated myxoid liposarcomas. Lancet Oncology, 2007; 8: Salvati E., Leonetti C., Rizzo A., Scarsella M., Mottolese M., Galati R., Sperduti I., Stevens M., D Incalci M., Blasco M., Chiorino G., Horard B., Gilson E., Zupi G., Biroccio A. Telomere damage promotes antitumoral activity of the G- quadruplex ligand RHPS4. J. Clin. Invest., 2007; 117: Zongaro S., de Stanchina E., Colombo T., D Incalci M., Giulotto E., Mondello C. Stepwise neoplastic transformation of a telomerase immortalized fibroblast cell line. Cancer Research, 2005; 65:(24): Allavena P., Signorelli M., Chieppa M., Erba E., Bianchi G., Marchesi F., Garbi A., Lissoni A., de Braud F., Jimeno J. and D Incalci M. Anti-inflammatory properties of the novel antitumor agent Yondelis (Trabectedin): inhibition of macrophage differentiation and cytokine production. Cancer Res., 2005; 65(7): Tavecchio M., Natoli C., Ubezio P., Erba E., D Incalci M. Dynamics of cell cycle phase perturbations by Trabectedin (ET-743) in nucleotide excision repair (NER)-deficient and NER-proficient cells, unravelled by a novel mathematical simulation approach. Cell proliferation, 2007; 40: Marchini S, Mariani P, Chiorino G, Marrazzo E, Bonomi R, Fruscio R, Clivio L, Garbi A, Torri V, Cinquini M, Dell'Anna T, Apolone G, Broggini M, D'Incalci M Analysis of gene expression in early-stage ovarian cancer Clin Cancer Res : Giovanni Apolone, got his Medical degree in 1982 (Pavia, Italy) and his post-doctoral specializations in Internal Medicine in 1987 (Pavia, Italy) and Pharmacological Research (1992). He is Head of the Laboratory of Translational and Outcome Research. He is also Vice-President of the Ethics Committee of the European Institute of Oncology in Milan (Italy) and listed as National Expert at the European Agency for the Evaluation of Medicinal products (EMEA) in London (UK). His main fields of interest are: Methodological, ethical and regulatory aspects of clinical research, with special emphasis on oncology and the cancer pain. Health care evaluation with special emphasis on oncology; Development and validation of case-mix and patient-reported outcome measures; Education and health promotion research and programs. He has authored or co-authored over 200 publications. Selected publications Trotta F, Apolone G, Garattini S, Tafuri G Stopping a trial early in oncology: for patients or for industry?ann Oncol :

11 Apolone G, Corli O, Greco M T, Zagonel V, CPOR SG Investigators Factors influencing the decision to take or reject opioids for cancer pain: are we on target? Ann Oncol : Deandrea S, Montanari M, Moja L, Apolone G Prevalence of undertreatment in cancer pain. A review of published literature Ann Oncol : Apolone G, Tafuri G, Trotta F, Garattini S A new anti-cancer drug in the market: good news for investors or for patients? Eur J Cancer : Apolone G, Patarnello F The value of a drug: From innovation to the payment via Karl MarxJ Ambul Care Manage : Massimo Broggini followed the faculty of Science of the University of Milan, got the specialization in Biochemistry at Mario Negri Institute, and the PhD degree at the Open University, London,UK. He worked for a period in the laboratory of Molecular Pharmacology of the National Cancer Institute of Bethesda, Md, in From 1991 is the head of the Molecular Pharmacology Unit of the Mario Negri Institute and from 1999 of the Laboratory of Molecular Pharmacology of the same Institute. His main fields of interest are the study of the mechanism of action of new anticancer agents, the search of proteins and genes altered in human cancer and the study of oncosuppressor genes. He is member of the "Pharmacology and Molecular Mechanisms Group" of the European Organisation for the Research and Treatment of Cancer (EORTC) and of the American Association for Cancer Research. He is in the Editorial board of the European Journal of Cancer. He is author of more than 100 articles published in international journals. Selected publications Zangrossi S, Marabese M, Broggini M, Giordano R, D'Erasmo M, Montelatici E, Intini D, Neri A, Pesce M, Rebulla P, Lazzari L. Oct-4 expression in adult human differentiated cells challenges its role as a pure stem cell marker. Stem Cells. 2007;25(7): Marrazzo E, Marchini S, Previdi S, Broggini M. Questioning the oncogenic role of DeltaNp73alpha in different cell lines expressing p53 or not. Cancer Biol Ther. 2006;5(7): Polato F, Codegoni A, Fruscio R, Perego P, Mangioni C, Saha S, Bardelli A, Broggini M. PRL-3 phosphatase is implicated in ovarian cancer growth. Clin Cancer Res : Maffucci T, Piccolo E, Cumashi A, Iezzi M, Riley AM, Saiardi A, Godage HY,Rossi C, Broggini M, Iacobelli S, Potter BV, Innocenti P, Falasca M. Inhibition of the phosphatidylinositol 3-kinase/Akt pathway by inositol pentakisphosphate results in antiangiogenic and antitumor effects. Cancer Res. 2005;65: Marabese M, Marchini S, Sabatino MA, Polato F, Vikhanskaya F, Marrazzo E, Riccardi E, Scanziani E, Broggini M. Effects of inducible overexpression of DNp73alpha on cancer cell growth and response to treatment in vitro and in vivo. Cell Death Differ. 2005;12: Sabatino MA, Colombo T, Geroni C, Marchini S, Broggini M. Enhancement of in vivo antitumor activity of classical anticancer agents by combination with the new, glutathione-interacting DNA minor groove-binder, brostallicin. Clin Cancer Res. 2003;9: Irene Floriani got her degree in Biological Sciences at the University of Milan in 1988, her degree in Biostatistics and Experimental Statistics at the University of Milan in 2003 and her phd in Life Sciences at Open University of London (UK) in After ten-year experience in pharmaceutical industry, in 2002 she became Head of the Biometry and Data Management Unit of the Laboratory of Clinical Research in Oncology and since 2006 she is Head of Laboratory of Clinical Trials. She is also member as bio-statistician of three Italian Ethics Committees. Her main fields of interest are: statistical aspects of methodology of clinical research with focus on Controlled Clinical Trials in Oncology; Systematic Overview of the medical literature and Methodological aspects of diagnostic test evaluation. Selected publications Graziano F, Ruzzo A, Loupakis F, Canestrari E, Santini D, Catalano V, Bisonni R, Torresi U, Floriani I, Schiavon G, Andreuzzi B, Maltese P, Rulli E, Humar B, Falcone A, Giustini L, Tonini G, Fontana A, Masi Gianluca, Magnani M Pharmacogenetic profiling for cetuximab/irinotecan therapy in patients with refractory advanced colorectal cancer. J Clin Oncol 2008 ; 26 : Ludovini V, Gori S, Colozza M, Pistola L, Rulli E, Floriani I, Pacifico E, Tofanetti F R, Sidoni A, Basurto C, Rulli A, Crino' L. Evaluation of serum HER2 extracellular domain in early breast cancer patients: correlation with clinicopathological parameters and survival. Ann Oncol 2008 ; 19 : Di Costanzo F, Gasperoni S, Manzione L, Bisagni G, Labianca R, Bravi S, Cortesi E, Carlini P, Bracci R, Tomao S, Messerini L, Arcangeli F, Torri V, Bilancia D, Floriani I, Tonato M, Italian Oncology Group for Cancer Research. Adjuvant chemotherapy in completely resected gastric cancer: a randomized phase III trial conducted by GOIRC. J Natl Cancer Inst 2008 ; 100 : 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, GISCAD. Cetuximab plus gemcitabine and cisplatin 10

12 compared with gemcitabine and cisplatin alone in patients with advanced pancreatic cancer: a randomised, multicentre, phase II trial. Lancet Oncol 2008 ; 9 : Santini D, Loupakis F, Vincenzi B, Floriani I, Stasi I, Canestrari E, Rulli E, Maltese P, Andreoni F, Masi Gianluca, Graziano F, Baldi G G, Salvatore L, Russo A, Perrone G, Tommasino M R, Magnani M, Falcone A, Tonini G, Ruzzo A. High concordance of KRAS status between primary colorectal tumors and related metastatic sites: implications for clinical practice. Oncologist 2008 ; 13 : Cascinu S, Labianca R, Barone C, Santoro A, Carnaghi C, Cassano A, Beretta GD, Catalano V, Bertetto O, Barni S, Frontini L, Aitini E, Rota S, Torri V, Floriani I. Adjuvant treatment of high-risk, radically resected gastric cancer patients with 5-fluorouracil, leucovorin, cisplatin, and epidoxorubicin in a randomized controlled trial. J Natl Cancer Institute (2007); 99: Raffaella Giavazzi got her Biological Sciences degree (1979) at the University of Milan, and her Ph.D. in Pharmacology at the Mario Negri Institute of Milan (1984), followed by a specialization in pharmacology (1994) at the University of Milan. From 1981 to 1983 she was a Fellow in the Cancer Metastasis and Treatment Laboratory, NCI-FCRDC, Frederick, MD., and from 1983 to 1985 Assistant Professor at the Department of Cell Biology of M.D. Anderson Hospital and Tumour Institute, University of Texas System Cancer Centre in Houston (TX). Raffaella Giavazzi s research interests are in the field of tumour biology and pharmacology. Specifically, she is studying aspects related to the metastatic process and angiogenesis. She is involved in the pre-clinical evaluation of new therapeutic strategies against cancer focusing on the angiogenesis inhibitors and combination therapies. From 1986 to 1993 she was Head of the Cancer Metastasis Treatment Unit and since 1993 she has been the Head of the Laboratory of Biology and Treatment of Metastasis at Mario Negri Institute for Pharmacological Research. She is also adjutant Professor in Oncology, Medical School-University of Brescia, member of the Teaching Committee for the PhD course in Physiology-Pharmacology-Molecular and Cellular Tossicology-University of Siena, member of the Executive Committee at SENDO (South Europe New Drug Development Organization), member of the Pezcoller Foundation Scientific Committee and member of the Executive Committee of the European Association for Cancer Research (EACR). She was consulting scientist for the NCI-Drug Therapeutics Program, USA ( ); She is a member of the American Association for Cancer Research (AACR), International Metastases Research Society, EORTC-Screening and Pharmacology Group, European Association for Cancer Research (EACR), Italian Cancer Society (SIC) of which she was President ( ). She is on the Editorial Board of the European Journal of Cancer, Journal of Clinical Experimental Metastasis, Journal Exp. Therapeutic & Oncology, The International Journal of Biological Markers, Current Cancer Therapy Reviews and Journal of Chemotherapy. She is on the Editorial Board of several international scientific journals. She has published approximately 200 articles on peer reviewed scientific journals. Selected publications Belotti D., Calcagno C., Garofalo A., Caronia D., Riccardi E., Giavazzi R., Taraboletti G. Vascular Endothelial Growth Factor stimulates organ-specific host matrix metalloproteinase-9 expression and ovarian cancer invasion. Molecular Cancer Research, 6(4):525-34, Valentini G., D Andrea C., Ferrari F., Pifferi A., Cobeddu R., Martinelli M., Natoli C., Ubezio P., Giavazzi R. In-vivo measurement of vascular modulation in experimental tumors using a fluorescent contrast agent. Photochemistry and Photobiology, 84(5): , Ghilardi C., Chiorino G., Dossi R., Nagy Z., Giavazzi R., Bani M.R. Identification of novel vascular markers through gene expression profiling of tumor-derived endothelium. BMC Genomics, 30(9), 201, Martinelli M., Bonezzi K., Riccardi E., Kuhn E., Frapolli R., Zucchetti M., Ryan A.J., Taraboletti G., Giavazzi R.: Sequence dependent antitumour efficacy of the vascular disrupting agent ZD6126 in combination with paclitaxel. British Journal of Cancer 97:888-94, Giavazzi R., Bani M.R.,Taraboletti G.: Tumor host interaction in the optimization of paclitaxel-based combination therapies with vascular targeting compounds. Cancer Metastasis Rev. 26:481 88, 2007 Naumova E., Ubezio P., Garofalo A., Borsotti P., Cassis L., Riccardi E., Scanziani E., Eccles S.A., Bani M.R., Giavazzi R.: The vascular targeting property of paclitaxel is enhanced by SU6668, a receptor tyrosine kinase inhibitor, causing apoptosis of endothelial cells and inhibition of angiogenesis. Clin. Cancer Research 12(6): , Paola Mosconi got his Biological Science degree (Milan 1982) and the specialisation in Pharmacological Research (Milan 1984). Her main areas of interest are: development of strategies to involve patients-consumer associations in health debate, and research projects; assessment of quality of life, translation and cultural adaptation of questionnaires for quality of life; 11

13 studies to evaluate the type of information on diseases and treatments received by patients, mainly in cancer patients; set-up of websites targeted on consumers/patients Mattioli.it ; studies to evaluate the consumers level of satisfaction with the health services and cure. Paola Mosconi has participated as a teacher, or coordinator, to the realization of training course on Methodological aspects of clinical research or Evaluation of quality of life for health care professionals and representatives of voluntary associations. Selected publications Lucca U, Tettamanti M, Mosconi P, Apolone G, Gandini F, Nobili A, Tallone MV, Detoma P, Giacomin A, Clerico M, Tempia P, Guala A, Fasolo G, Riva E. Association of mild anemia with cognitive, functional, mood and quality of life outcomes in the elderly: the health and anemia study. PlosONE April 2008, Vol 3, Issue 4, e1920: 1-8 Mosconi P, Apolone G, Mingardi G. Quality of life assessment and instruments in end-stage renal disease. Journal of Nephrology 2008; 21(suppl 13): S107-S112 Mosconi P, Colombo C, Guella F, Pierotti B, Vimercati F. Are Italian medical societies bridging the distance from citizen and patients associations? Result of a survey. Journal of Preventive Medicine and Hygiene 2008: 3 Mosconi P, Colombo C, Satolli R, Liberati A. PartecipaSalute, an Italian project to involve lay people, patients associations and scientific-medical representatives on the health debate. Health Expectations 10: , Mosconi P, Satolli R, Colombo Cinzia, Liberati A, Donati S, Mele A. Hormone replacement therapy and information: in Italy a Consensus Conference to help woman decision. British Medical Journal, Valter Torri got his Medical degree in 1985 and the specialization in medical Oncology in 1989 at the University of Milano. Education: 1985: MD Degree with full honors cum Laude, University of Milano; 1988 Post-Doctoral Degree in Pharmacological Research, Mario Negri Institute, Milano; 1989 Post-Doctoral Degree in Medical Oncology, University of Milano; Research Fellow at the Biometric Research Branch of Cancer Treatment Evaluation Program, NCI, Bethesda, MD (USA) Areas of Interest: Statistical aspects of clinical research methodology with focus on Controlled Clinical Trials in Oncology; Systematic Overview of the medical literature; Methodological aspects of diagnostic test evaluation. Present Position: Head of Laboratory of Clinical Research In Oncology, Oncology Department, Mario Negri Institute, Milano. Chronology of Professional Appointments: : Clinical research Fellow in Internal Medicine at the University Hospital, University of Milan; : Research assistant at the Clinical Trial Unit of the Laboratory of Clinical Epidemiology, Mario Negri Institute for Pharmacological Research, Milano; : Research fellow at the Biometric Research Branch of Cancer Treatment Evaluation Program, NCI, Bethesda, MD (USA); 1994: Head of Biometric Unit of the Laboratory of Cancer Clinical Epidemiology, Oncology Department, Mario Negri Institute for Pharmacological Research, Milano, Italy; 1995 Vice Director of the Italian Cochrane Center; 2001: Head of Laboratory of Clinical Research In Oncology, Oncology Department, Mario Negri Institute, Milano. 2006: Head of Laboratory for the development of new pharmacological strategies, Oncology Department, Mario Negri Institute, Milano.. Selected publications Marchini S, Mariani P, Chiorino G, Marrazzo E, Bonomi R, Fruscio R, Clivio L, Garbi A, Torri V, Cinquini M, Dell'Anna T, Apolone G, Broggini M, D'Incalci M. Analysis of gene expression in early-stage ovarian cancer. Clin Cancer Res Dec 1;14(23): Benedetti Panici P, Basile S, Maneschi F, Alberto Lissoni A, Signorelli M,Scambia G, Angioli R, Tateo S, Mangili G, Katsaros D, Garozzo G, Campagnutta E,Donadello N, Greggi S, Melpignano M, Raspagliesi F, Ragni N, Cormio G, Grassi R, Franchi M, Giannarelli D, Fossati R, Torri V, Amoroso M, Crocè C, Mangioni C. Systematic pelvic lymphadenectomy vs. no lymphadenectomy in early-stage endometrial carcinoma: randomized clinical trial. J Natl Cancer Inst Dec 3;100(23): Mitry E, Fields AL, Bleiberg H, Labianca R, Portier G, Tu D, Nitti D, Torri V,Elias D, O'Callaghan C, Langer B, Martignoni G, Bouché O, Lazorthes F, Van Cutsem E, Bedenne L, Moore MJ, Rougier P. Adjuvant chemotherapy after potentially curative resection of metastases from colorectal cancer: a pooled analysis of two randomized trials. J Clin Oncol Oct 20;26(30): Cascinu S, Labianca R, Barone C, Santoro A, Carnaghi C, Cassano A, Beretta GD, Catalano V, Bertetto O, Barni S, Frontini L, Aitini E, Rota S, Torri V, FlorianiI; Italian Group for the Study of Digestive Tract Cancer, Adjuvant treatment of high-risk, radically resected gastric cancer patients with 5-fluorouracil, leucovorin, cisplatin, and epidoxorubicin in a randomised controlled trial. J Natl Cancer Inst. 2007;99(8):

14 Graziano F, Kawakami K, Ruzzo A, Watanabe G, Santini D, Pizzagalli F, Bisonni R, Mari D, Floriani I, Catalano V, Silva R, Tonini G, Torri V, Giustini L, Magnani M Methylenetetrahydrofolate reductase 677C/T gene polymorphism, gastric cancer susceptibility and genomic DNA hypomethylation in an at-risk Italian population. Int J Cancer : Torri V: Clinical trials and data management In: Oxford textbook of oncology, 2nd. ed. Vol. 1. Oxford Univ. Press, Oxford; 2002 : Maria Rosa Bani got her Biological Sciences degree at the University of Milan in 1998 attaining the Italian Government Qualification to practice as Biologist in She obtained the specialization in Pharmacological Research from the Department of Education of the Regional Government of Lombardia in 1991 and the specialization in Biomedical Research from the Department of Education of the Regional Government of Abruzzo in In 2005 she was awarded the degree of Doctor of Philosophy (PhD), Discipline of Life Sciences of the Open University Research School (UK). From 1991 to 1995 she was a Post Doctoral Fellow in the Cancer Research Division, Sunnybrook Health Science Centre, University of Toronto (Canada); from 2000 to 2001 she was Guest Scientist at the Advance Technology Centre, National Cancer Institute, National Institute of Health (USA). At the MarioNegri Institute for Pharmacological Research she was a Fellow Research Scientist in the Laboratory of Biology and Treatment of Metastasis, Bergamo from 1996 to 2002 and she became a Staff Research Scientist in In April 2004 she became Head of the Molecular Cancer Therapeutics Unit. She is the Scientific Manager of STROMA(since 2004) and ADAMANT(since2008), two Integrated Projects within the 6 th and 7 th Framework Programs of the European Commission. She is a member of the American Association for Cancer Research (AACR), the European Association for Cancer Research (EACR) and the Italian Cancer Society (SIC). Maria Rosa Bani research interests are in the field of cancer biology and molecular therapeutics. She is co-author of 34 peer reviewed publications, 2 book chapters and 65 proceedings of which 15 selected for oral presentation at international meetings. Selected publications Ghilardi C., Chiorino G., Dossi R., Nagy Z., Giavazzi R., Bani M.R. Identification of novel vascular markers through gene expression profiling of tumor-derived endothelium. BMC Genomics, 30(9), 201, Giavazzi R., Bani M.R.,Taraboletti G.: Tumor host interaction in the optimization of paclitaxel-based combination therapies with vascular targeting compounds. Cancer Metastasis Rev. 26:481 88, Naumova E., Ubezio P., Garofalo A., Borsotti P., Cassis L., Riccardi E., Scanziani E., Eccles S.A., Bani M.R. & Giavazzi R. The vascular targeting property of paclitaxel is enhanced by SU6668, a receptor tyrosine kinase inhibitor, causing apoptosis of endothelial cells and inhibition of angiogenesis. Clinical Cancer Research 12: , Bani M.R., Nicoletti M.I., Alkharouf N.W., Ghilardi C., Petersen D., Erba E., Sausville E.A., Liu E.T. and Giavazzi R. Gene expression correlating with response to paclitaxel in ovarian carcinoma xenografts. Molecular Cancer Therapeutics 3: , Vikhanskaya F.*, Bani M.R.*., Borsotti P., Ghilardi C., Ceruti R., Ghisleni G., Marabese M., Giavazzi R., Broggini M. & Taraboletti G. p73 overexpression increases VEGF and reduces thrombospondin-1 production: implication for tumor angiogenesis. Oncogene 20 : , Taraboletti G., Sonzogni L., Vergani V., Hosseini G., Ceruti R., Ghilardi C., Bastone A., Toschi E., Borsotti P., Scanziani E., Giavazzi R., Pepper M.S., Stetler-Stevenson W.G. & Bani M.R. Post-transcriptional stimulation of endothelial cell matrix metalloproteinases 2 and 1 by endothelioma cells. Experimental Cell Research 258 : , Giovanna Damia obtained her Medical Degree cum Laude from the University of Milan in After specializing in Pharmacology at the Mario Negri Institute of Milan and in Oncology at the University of Milan, she worked as a post-doctoral fellow in the Laboratory of Experimental Immunology of the National Cancer Institute, Frederick, USA. She worked as a research fellow in the Laboratory of Cancer Chemotherapy at the Mario Negri Institute and since April 2003 she has become chief of the DNA Repair Unit at the Mario Negri Institute. From 1992 to1995 she has been consultant of the General Secretariat of the Progetto Finalizzato CNR "Applicazioni Cliniche della Ricerca Oncologica". Since September 2005 she is Deputy Editor for Experimental Oncology of the European Journal of Cancer. Her main fields of interest are: mechanism of action of anticancer drugs, cell cycle checkpoints and natural compounds. Selected publications Simone M, Erba E, Damia G, Vikhanskaya F, Di Francesco A M, Riccardi R, Baldeyrou B, Bailly C, Cuevas C, Sousa- Faro J M F, D'Incalci M. Variolin B and its derivate deoxy-variolin B: New marine natural compounds with cyclindependent kinase inhibitor activity. Eur J Cancer 2005; 41:

15 Carrassa L, Broggini M, Erba E, Damia G. Chk1, but not Chk2, is involved in the cellular response to DNA damaging agents. Differential activity in cells expressing or not p53. Cell Cycle 2004; 3: Damia G, Broggini M. Improving the selectivity of cancer treatment by interfering with cell response pathways. Eur J Cancer 2004; 40: Damia G, Broggini M. Cell cycle checkpoint proteins and cellular response to treatment by anticancer agents. Cell Cycle 2004; 3: Carrassa L, Broggini M, Vikhanskaya F, Damia G. Characterization of the 5' flanking region of the human chk1 gene. Identification of E2F1 functional sites. Cell Cycle 2003; 2: Damia G, Sanchez Y, Erba E, Broggini M. DNA damage induces p53-dependent down-regulation of hchk1. J Biol Chem 2001; 276: Eugenio Erba has obtained his Biological and Biochemmistry Analysis Degree at the University of Urbino. He worked as a research fellow in the Laboratory of Cancer Chemotherapy at the Mario Negri Institute and since 1984 he is head of the Flow Cytometry Unit in the Department of Oncology at the Mario Negri Institute of Milan. He has worked as a visiting fellow in the Department of Istochemistry and Cytochemistry of the University of Leiden, The Netherlands in Since 1997 he is Teacher of Post-Graduate Studies in Cytometry at the University of Milan and Co-ordinator and Teacher of Post- Graduate Studies in Cytometry for the Italian Cytometry Group. He has been President of the Italian Cytometry Group from 1999 to Since 2001 he is member of the Executive Board of the Italian Cytometry Group. Scientific areas of interest: studies on the mechanism of action of different compounds with provided antitumoral activity evaluating the mechanism of cell death and cell cycle phase perturbations induced on different human cancer cell lines by using flow cytometry. Co-ordinator of working-group in a quality control study on flow cytometric DNA content analysis in human tumors. Selected publications C. Valli, G. Paroni, A. Di Francesco, R. Riccardi, M. Tavecchio, E. Erba, A. Boldetti, M. Giannì, M. Fratelli, C. Pisano, L. Merlini, A. Antoccia, C. Cenciarelli, M. Terao, E. Garattini. Atypical retinoids ST1926 and CD437 are S-phase specific agents causing DNA double-strand breaks: significance for the cytotoxic and antiproliferative activity. Mol. Ca. Ther. 7(9), , 2008 L. Roncoroni, L. Elli, E. Delfini, E. Erba, E. Dogliotti, C. Terrai, L. Doneda, MG. Grimoldi, MT. Bardella. Resveratrol inhibits cell growth in a human cholangiocarcinoma cell line. Liver Int. 28(10), , 2008 M.Tavecchio, M. Simone, E.Erba, I. Chiolo, G. Liberi, M. Foiani, M. D Incalci, G. Damia. Role of homologous recombination in trabectedin-induced DNA damage. Eur. J. Ca 44: (2008) Paulis M., Bensi M., Orioli D., Mondello C., Mazzini G., D Incalci M., Falcioni C., Radaelli E., Erba E., Raimondi E., De Carli L. Transfer of a Human Chromosomal Vector from a Hamster Cell Line to a Mouse Embryonic Stem Cell Line. Stem Cell, 25: (2007) Tavecchio M., Natoli C., Ubezio P., Erba E., D Incalci M. Dynamics of cell cycle perturbations by trabectedin (ET-743) in nucleotide excision repair (NER) deficient and NER-proficient cells, unravelled by a novel mathematical simulation approach. Cell Prolif., 40: (2007) Tognon G., Bernasconi S., Celli N., Faircloth G.T. Cuevas C., Jimeno J., Erba E., D Incalci M. Induction of resistance to Aplidin in a human ovarian cancer cell line related to MDR expression. Cancer Biology and Therapy, 4(12): (2005). Roldano Fossati got his Medical Degree cum Laude from the University of Milan in 1980, his Post- Doctoral Degree in Endocrinolgy cum Laude from the University of Verona in 1983 and his Post- Doctoral Degree in Medical Statistics from the University of Milan in He has been consultant at the Mario Negri Institute since 1983 and, at present, he is head of the Gynecology and Oncology Unit of the Laboratory of Translational and Outcome Research. Areas of Interest: Statistical and methodologic aspects of clinical research with focus on Controlled Clinical Trials in Oncology; Systematic Overview of the medical literature. Selected publications Labianca R., Fossati R., Zaniboni A., Torri V., Marsoni S., Nitti D., Boffi L., Scatizzi M., Tardio B., Mastrodonato N., Banducci S., Consani G., Pancera G. on behalf of ACOI/GIVIO/GISCAD investigators. Randomized Trial of Intraportal and/or Systemic Adjuvant Chemotherapy in Patients with Colon Carcinoma. J Natl Cancer Inst 96:750-8;2004 P. Benedetti Panici, A. Maggioni, N. Hacker, F. Landoni, S. Ackermann, E. Campagnutta, K. Tamussino, R. Winter, A. Pellegrino, S. Greggi, R. Angioli, N. Manci, G. Scambia, T. Dell'Anna, R. Fossati, I. Floriani, R.S. Rossi, R. Grassi, G. Favalli, F. Raspagliesi, D. Giannarelli, L. Martella, C. Mangioni. Systematic Aortic and Pelvic Lymphadenectomy versus Resection of Bulky Nodes Only in Optimally Debulked Advanced Ovarian Cancer: A Randomized Clinical Trial J Natl Cancer Inst 97:1-6;2005 Buda A, Fossati R, Colombo N, Fei F, Floriani I, Gueli Alletti D, Katsaros D, Landoni F, Lissoni A, Calzoni C, Sartori E, Scollo P, Torri V, Zola P, Mangioni C. Randomized trial of neoadjuvant chemotherapy comparing paclitaxel, ifosfamide, 14

16 and cisplatin with ifosfamide and cisplatin followed by radical surgery in patients with locally advanced squamous cell cervical carcinoma: The SNAP01 (Studio Neo-Adjuvante Por. J Clin Oncol 2005; 23: Maggioni A, Benedetti Panici P, Dell'anna T, Landoni F, Lissoni A, Pellegrino A, Rossi RS, Chiari S, Campagnutta E, Greggi S, Angioli R, Manci N, Calcagno M, Scambia G, Fossati R, Floriani I, Torri V, Grassi R, Mangioni C.Randomised study of systematic lymphadenectomy in patients with epithelial ovarian cancer macroscopically confined to the pelvis. Br J Cancer Sep 18;95(6): Maggi R, Lissoni A, Spina F, Melpignano M, Zola P, Favalli G, Colombo A, Fossati R. Adjuvant chemotherapy vs radiotherapy in high-risk endometrial carcinoma: results of a randomised trial. Br J Cancer Aug 7;95(3): Fruscio R, Colombo N, Lissoni AA, Garbi A, Fossati R, Ieda' N, Torri V, Mangioni C.A phase II randomised clinical trial comparing cisplatin, paclitaxel and ifosfamide with cisplatin, paclitaxel and epirubicin in newly diagnosed advanced epithelial ovarian cancer: long-term survival analysis. Br J Cancer Feb 5. Giulia Taraboletti got her degree cum laude in Biological Sciences at the University of Pavia (Pavia, Italy) in 1983, and the specialization in Pharmacological Research at the Mario Negri Institute, Milano, Italy in From 1986 to 1988 she was a post-doctoral fellow at the Laboratory of Pathology, NCI, NIH, Bethesda, MD, and from research scientist at Mario Negri Institute in Bergamo, Italy. Since 1995 she is Head of the Unit of Tumor Angiogenesis, at Mario Negri Institute, in Bergamo. Research interests include tumor angiogenesis, endogenous inhibitors of angiogenesis (thrombospondin- 1) and preclinical studies of antiangiogenic and vascular disrupting compounds, including tubulintargeting agents. She is member of Metatasis Research Society (MRS), American Association for Cancer Research (AACR), European Association for Cancer Research (EACR), and the Italian Society of Oncology (SIC). She is on the editorial board of European Journal of Cancer. Selected publications Margosio B, Rusnati M, Bonezzi K, Cordes B-lA, Annis DS, Urbinati C, Giavazzi R, Presta M, Ribatti D, Mosher DF, and Taraboletti G. Fibroblast growth factor-2 binding to the thrombospondin-1 type III repeats, a novel antiangiogenic domain. Int J Biochem Cell Biol 40: , Giavazzi R., Bani M.R.,Taraboletti G. Tumor host interaction in the optimization of paclitaxel-based combination therapies with vascular targeting compounds. Cancer Metastasis Rev, 26:481 88, Martinelli M., Bonezzi K., Riccardi E., Kuhn E., Frapolli R., Zucchetti M., Ryan A.J., Taraboletti G., Giavazzi R. Sequence dependent antitumour efficacy of the vascular disrupting agent ZD6126 in combination with paclitaxel. Br J Cancer 97:888-94, Margosio B., Marchetti D., Vergani V., Giavazzi R., Rusnati M., Presta M., and Taraboletti G. Thrombospondin-1 as a scavenger for matrix-associated fibroblast growth factor-2. Blood 102: , Taraboletti G. Micheletti G, Rieppi M, Poli M, Turatto M, Rossi C, Borsotti P, Roccabianca P, Scanziani E, Nicoletti MI, Bombardelli E, Morazzoni P, Riva A, and Giavazzi R. Antiangiogenic and antitumor activity of IDN 5390, a new taxane derivative. Clin Cancer Res. 8: , 2002 Taraboletti G., Morbidelli L., Donnini S., Parenti A., Granger H.J., Giavazzi R., and Ziche M.The heparin binding 25 kda fragment of thrombospondin-1 promotes angiogenesis and modulates gelatinase and TIMP-2 production in endothelial cells. FASEB J., 14: , Paolo Ubezio got his B.Sc. degree in Physics at the University of Milan, in 1982, and the specialisation in Pharmacological Research Specialist" at the Mario Negri Institute for Pharmacological Research in Main activities are: i) Study of cell-cycle mathematical models; ii) Development of flow cytometric methods; iii) Optimization of anticancer drug scheduling. Since 1991 is Head of the Unit of Biophysics at the Mario Negri Institute Selected publications Basse, B., Ubezio, P. (2007) A generalised age and phase structured model of human tumour cell populations both umperturbed and exposed to a range of cancer therapies. Bull. Math. Biol. 69: Lupi, M., Matera, G., Natoli, C., Colombo, V., Ubezio, P. (2007) The Contribution of p53 in the Dynamics of Cell Cycle Response to DNA Damage Interpreted by a Mathematical Model. Cell Cycle 6: Lupi, M., Matera, G., Branduardi, D., D'Incalci M. and Ubezio, P. (2004) Cytostatic and cytotoxic effects of topotecan decoded by a novel mathematical simulation approach. Cancer Res. 64: Matera, G., Lupi, M.,and Ubezio, P. (2004) Heterogeneous cell response to topotecan in a CFSE-based proliferation test. Cytometry 62A: Ubezio, P. (2004) Unraveling the complexity of cell cycle effects of anticancer drugs in cell populations.discrete and Continuous Dynamical Systems-Series B 4: Montalenti, F., Sena, G., Cappella, P., and Ubezio, P. (1998) Simulating cancer-cell kinetics after drug treatment: Application to cisplatin on ovarian carcinoma. Phys. Rev. E, 57: Massimo Zucchetti obtained his Chem. Pharm. Degree from the University of Milan in After specializing in Pharmacology at the Mario Negri Institute of Milan (1988), he worked in the Laboratory 15

17 of Clinical Pharmacology of Department of Oncology at San Giovanni Hospital, Bellinzona, Switzerland ( ). Since 1996 he has been chief of the Cancer Clinical Pharmacology Unit at the Mario Negri Institute. He is member of the Pharmacology and Molecular Mechanisms Group of the European Organization for Research and Treatment of Cancer (EORTC) from 1988 up to date. His main field of interest are: - Clinical pharmacology, phase I and Phase II studies - Analysis of drugs, pharmacokinetic and pharmacodynamic studies in humans in GCP and GLP conditions - Pharmacokinetic and metabolic studies in animals - Pharmacokinetic drug interaction Dr Zucchetti is author of more than 80 papers on pre-clinical and clinical cancer chemotherapy published in peer reviewed international journals. Selected publications Gambacorti-Passerini CB, Tornaghi L, Marangon E, Franceschino A, Pogliani EM, D'Incalci M, Zucchetti M.. Imatinib concentrations in human milk Blood Feb 15;109(4):1790. Marangon E, Sala F, Caffo O, Galligioni E, D'Incalci M, Zucchetti M. Simultaneous determination of gemcitabine and its main metabolite, dfdu, in plasma of patients with advanced non-small-cell lung cancer by high-performance liquid chromatography-tandem mass spectrometry. J Mass Spectrom Feb;43(2): Frapolli R., Marangon E., Zaffaroni M., Colombo T., Falcioni C., Bagnati R., Simone M., D Incalci M., Manzotti C., Fontana G., Morazzoni P., Zucchetti M. Pharmacokinetics and metabolism in mice of IDN 5390 (13-(N-Boc-3-ibutylisoserinoyl)-C-7,8-seco-10-deacetylbaccatin III), a new oral C-seco-taxane derivative with antiangiogenic property effective on paclitaxel-resistant tumors. Drug Metabolism and Disposition, 34(12): (2006). Rizzari C., Citterio M., Zucchetti M., Conter V., Chiesa R., Colombini A., Malguzzi S., D Incalci M. Pharmacological study on pegylated asparaginase used in front-line treatment of children with acute lymphoblastic leukemia. Hematologica, 91: (2006). Fruscio R., Lissoni A.A., Frapolli R., Corso S., Mangioni C., D Incalci M., Zucchetti M. Clindamycin-Paclitaxel pharmacokinetic interaction in ovarian cancer patients. Cancer Chemother. Pharmacol., 58(3): (2006). Gambacorti Passerini C, Zucchetti M, Russo D, Frapolli R, Verga M, Bungaro S, Tornaghi L, Rossi F, Pioltelli P, Pogliani E, Alberti D, Corneo G, D'Incalci M Alpha 1 acid glycoprotein binds to imatinib (STI571) and substantially alters its pharmacokinetics in chronic myeloid leukemia patients Clin Cancer Res 2003; 9:

18 INTRODUCTION TO THE DEPARTMENT'S ACTIVITIES The Oncology Department comprises three preclinical experimental laboratories (Laboratory of Cancer Pharmacology, Laboratory of Molecular Pharmacology and Laboratory of Biology and Therapy of Metastasis) and four laboratories dealing with clinical research and clinical trials (Laboratory for the Development of New Pharmacological Strategies, Laboratory of Clinical Trials, Laboratory of Translational and Outcome Research in Oncology and Laboratory for Medical Research and Consumer Involvement). The Oncology department hosts the coordination center of two networks of hospitals that carry on clinical research in gynecologic cancer (MaNGO: Mario Negri Gynecologic Oncology) and in cancer pain (CPOR-SG: Cancer Pain Outcome Research Study Group) and a center for cancer pain assessment and research (CERP:Center for the Evaluation and Research on Pain). In some cases research projects are carried out by single laboratories or research units, in other cases by collaborations between different laboratories of the Oncology Department or other departments, or other groups outside the Institute (see National and International Collaborations). Preclinical laboratories focus on the discovery and development of new antitumor and antimetastatic drugs and their new combinations; on tumor biology, not only to acquire new scientific knowledge, but particularly as a base for more selective therapeutic approaches and to identify and evaluate experimental models for discovering and studying new drugs or treatments. Clinical new drug development involves close participation in the activity of SENDO (South Europe New Drug Development Organization) and studies driven by the Laboratory of Cancer Pharmacology, the Laboratory of Molecular Pharmacology and the Laboratory of Biology and Therapy of Metastasis. The Laboratory for the Development of New Pharmacological Strategies, the Laboratory of Clinical Trials, the Laboratory of Translational and Outcome Research in Oncology and the Laboratory for Medical Research and Consumer Involvement are involved in the evaluation of the effects of new therapeutic modalities in phase I/II and in phase III comparative and effectiveness outcome studies. Outcome Research implies organizing trials to clarify the results of certain health care practices and interventions in clinical practice. Observational (surveys) and outcome research (effectiveness) studies are carried out, in collaboration with regional and national health authorities and other scientific associations. At the preclinical and clinical level there are studies of various human tumors, with particular emphasis on ovarian tumors and more recently on soft tissue sarcomas. FINDINGS/MAIN RESULTS At nanomolar concentrations, ET-743 (Yondelis, Trabectedin) affects the regulatory mechanisms of the transcription. Nucleotide excision repair deficient cells that are hypersensitive to UV rays and to other DNA damaging drugs are resistant to Trabectedin. The selective activity of ET-743 against human myxoid liposarcoma appears related to the drug ability to modulate the transcription of genes involved in adipocytic differentiation. Use of mathematical models of tumor growth and anticancer treatment to interpret experimental data and to manage the complexity of underlying biological phenomena. 17

19 The theoretical relationship between proliferation, quiescence and cell loss leading to growth control of tumor cell populations was found. Gene profiling analysis shows specific molecular signatures according to the histotype and prognosis of stage I ovarian carcinoma. The expression of a truncated form of p63 (DNp63) increases with the increased malignancy of ovarian cancer. Patients expressing high levels of DNp63 have a worst prognosis. DNp63 represents therefore a new potential target for selective therapies in this malignancy. CHK1 downregulation by specific inhibitors or sirna, increases the antitumor activity of 5- fluorouracil in vivo. This effect is particularly evident in p53 deficient tumors indicating that this combination increases the selectivity of this anticancer agent. An anthracycline derivative, Nemorubicin, has a peculiar mechanism of action and is active against tumors resistant to drugs such as cisplatin. A mechanism of resistance against this drug has been identified, which involves the abrogation of the expression of a nucleotide excision repair gene. Overexpression of a truncated form of p73 (DNp73beta) in human cancer cells lead to growth arrest and formation of tetraploid cells, suggesting a role of this isoform in mitosis. A new mechanism of p73 activation mediated by the protease HtrA2 has been identified. After apoptotic stimuli this protease cleaves p73 in the C-terminal region increasing its apoptotic potential. Inositol pentaphosphate analogues interfere with the PI3-kinase-induced phosphorylation of akt and possess antitumor activity in vitro and in vivo, particularly when combined with other anticancer agents. Human umbilical cord-derived stem cells express checkpoints proteins only in specific differentiation stages. It is likely that this is related to the different susceptibility of the cells. Inhibition of PLC gamma, through sirna technology, reduces the in vivo growth of tumors and reduces the formation of metastasis. Identification of genes preferentially expressed by tumor associated endothelial cells. VEGF released by cancer cells modulatesgene expression in the tumor microenvironment (stroma). VEGF produced by ovarian tumor cells stimulates host MMP9 expression; the anti-vegf antibody bevacizumab (Avastin ) inhibited MMP9 expression and abolished ovarian tumor invasion. Soluble human VEGFC levels in serum and ascites correlate with tumor progression and metastatic capability of ovarian carcinoma models. A new antiangiogenic domain of thrombospondin-1 (an endogenous inhibitor of angiogenesis) that binds the angiogenic factor FGF-2 has been identified and characterized. New antineoplastic compounds directed against the tumor vasculature (vascular disrupting agents) have been identified. 18

20 The histone deacetylase inhibitor SAHA potentiates the cytotoxic effect of paclitaxel in human ovarian carcinoma cells resistant to paclitaxel. The effect is mediated by the acetylation of tubulin. The expression of protease-activated receptor-1 (PAR-1) correlates with the malignant phenotype of human melanomas and is accountable for their motility and invasive features ICON4, a, randomised trial of second-line chemotherapy in advanced ovarian cancer, coordinated by the Mario Negri Institute and by MRC, showed for the first time a reduction in mortality in favour of platinum and paclitaxel chemotherapy. The response to chemotherapy was a good surrogate endpoint of survival in patients with locally advanced cervix carcinoma. Adjuvant chemotherapy with the regimen vindesin, mitomycin C and cisplatin (MVP) did not improve survival of non small cell lung cancer (NSCLC) patients compared with surgery alone. The website of the project PartecipaSalute (www.partecipasalute.it) has a very innovative character in comparison with the other health Italian sites because introduces and develops with ad-hoc instruments the information transfer in an active way. The project PartecipaSalute (www.partecipasalute.it) has an innovative character of the website panorama in Italy. This web - compared to other Italian health websites - introduces and develops ad hoc methods to transfer in an active way information on health. A randomized phase III trial has shown that pelvic systematic lymphadenectomy in early endometrial cancer does not improve overall survival. As pelvic systematic lymphadenectomy is not devoid of side effects, this trial will spare patients with early endometrial cancer important early and late surgical morbidities. A twin trial in ovarian carcinoma, published in 2005, came to similar conclusions. Bupropion more than doubled the odds of continuous abstinence from smoking from week 4 to 7 and from week 4 to 12 months in a way similar to that observed in academic studies. The adherence of GPs and participants to the protocol was excellent, making our findings robust and easy to generalize to the context of primary care. A randomized phase II trial has shown that the efficacy and tolerability of a chemotherapic regimen containing paclitaxel and cisplatin (TP) in the neoadjuvant treatment of locally advanced squamous cell cervical cancer is inferior to the triplet containing also iphosphamide (TIP). Adding up to previous similar findings, the TIP regimen (TP plus ifosfamide) has been proving to be one the best chemotherapic regimen in this setting of patients as it can adequately reduce the cancer volume allowing the surgical ablation with curative intent in most of the patients. An observational longitudinal study carried out in 110 Italian centers and involving about 1800 patients with metastatic cancer and pain have documented that in Italy most patients at the time of study inclusion were still on active anti-cancer treatment (>50%), were not aware of their prognosis (about 70%). In addition, up to 45% did not received an appropriate analgesic treatment (under-treatment), especially in some sub-groups. In terms of analgesics effectiveness, although the observational design, results suggest that each drugs prescribed by investigators (morphine, fentanyl, buprenorphine and oxycodone) were able to reduce the intensity of pain of about 2 points on a 11-eleven point numerical rating scale 19

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