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1. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Mangano, S., Tonato, M., Zucca, E., Valsecchi, M.G., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., Dell'Oro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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3. Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference

Author

Roila, F., Herrstedt, J., Aapro, M., Gralla, R.J., Einhorn, L.H., Ballatori, E., Bria, E., Clark-Snow, R.A., Espersen, B.T., Feyer, P., Grunberg, S.M., Hesketh, P.J., Jordan, K., Kris, M.G., Maranzano, E., Molassiotis, A., Morrow, G., Olver, I., Rapoport, B.L., Rittenberg, C., Saito, M., Tonato, M., and Warr, D.

Published
2010
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5. Randomized trial on adjuvant treatment with FOLFIRI followed by docetaxel and cisplatin versus 5-fluorouracil and folinic acid for radically resected gastric cancer

Author

Bajetta, E., Floriani, I., Di Bartolomeo, M., Labianca, R., Falcone, A., Di Costanzo, F., Comella, G., Amadori, D., Pinto, C., Carlomagno, C., Nitti, D., Daniele, B., Mini, E., Poli, D., Santoro, A., Mosconi, S., Casaretti, R., Boni, C., Pinotti, G., Bidoli, P., Landi, L., Rosati, G., Ravaioli, A., Cantore, M., Di Fabio, F., Aitini, E., Marchet, A., Floriani, I., Rulli, E., Cropalato Di Tullio, M., Poli, D., Galli, F., Biagioli, E., De Simone, I., Poli, D., Mangano, S., Tonato, M., Zucca, E., Valsecchi, MG., Floriani, I., Bajetta, E., Di Bartolomeo, M., Labianca, R., Amadori, D., Falcone, A., Di Costanzo, F., Daniele, B., Pinto, C., Comella, G., Nitti, D., Mini, E., De Placido, S., Marchet, A., Bajetta, E., Di Bartolomeo, M., Catena, L., Schiavo, M., Pinotti, G., Proserpio, I., Rosati, G., Bordonaro, R., Cordio, S., Burrafato, G., Bochicchio, A.M., Aieta, M., Fazio, N., Spada, F., Amoroso, V., Marini, G., Soto Parra, H., Novello, G., Massidda, B., Ionta, M.T., Comandè, M., Venezia, R., Bertolini, A., Menatti, E., Zanlorenzi, L., Colombo, A., Iop, A., Bonura, S., Mazza, E., Viganò, M., Ardizzoia, A., DellʼOro, S., Lo Re, G., Santeufemia, D., Buonadonna, A., Luisi, D., Ucci, G., Di Lucca, G., Bonetti, A., Bergamo, F., Alù, M., Vastola, F., Marchetti, P., Corsi, D.C., Massa, E., Di Pinto, G., Duro, M., Oliani, C., Franchini, M., Inzoli, A., Gebbia, N., Repetto, L., Rota, S., Frontini, L., Labianca, R., Mosconi, S., Quadri, A., De Grossi, S., Bidoli, P., Cazzaniga, M.E., Villa, F., Foa, P., Ferrari, D., Aitini, E., Rabbi, C., Barni, S., Petrelli, F., Giordano, M., Luchena, G., Pirovano, M., Nasisi, A., Catalano, V., Giordani, P., Zaniboni, A., Leone, F., Ferrario, S., Beretta, G.D., Menichetti, E.T., Conte, D., Mari, D., Giannicola, R., Pierantoni, C., Luporini, A.G., Ravaioli, A., Tassinari, D., Nicolini, M., Amadori, D., Frassineti, G.L., Turci, D., Zumaglini, F., Tamberi, S., Piancastelli, A., Cruciani, G., Falcone, A., Landi, L., Minuti, G., Cantore, M., Orlandi, M., Mambrini, A., Ciarlo, A., Cavaciocchi, D., Del Monte, F., Ricci, S., Brunetti, M.I., Lencioni, M., Sisani, M., Sozzi, P., Granetto, C., Chiara, S., Galetto, A.S., Ribecco, A.S., DeCensi, A., Ciuffreda, L., Baldini, E.E., Camisa, R., Todeschini, R., Santoro, A., Rimassa, L., Carnaghi, C., Pressiani, T., Boni, C., Rondini, E., Gnoni, R., Di Costanzo, F., Gasperoni, S., Cavanna, L., Palladino, M.A., Mattioli, R., Laici, G., Pucci, F., Alessio, M.D., Bernardini, I., Tomasello, G., Baldino, G., Rossetti, R., Giaquinta, S., Pinto, C., Di Fabio, F., Rijas Llimpe, F.L., Brandes, A.A., Marzola, M., Montesarchio, V., Rea, A., Daniele, B., Genua, G., Casaretti, R., Silvestro, L., Montano, M., Sarobba, M.G., Sanna, G., Filippelli, G., Dima, G., Greco, E., Roselli, M., Natale, D., Condemi, G., Fumi, G., Tafuto, S., Masullo, P., Nitti, D., Marchet, A., Tiberio, G., de Manzoni, G., Fiorentini, G., Mazzanti, R., Carlomagno, C., De Stefano, A., Cartenì, G., and Otero, M.

Published
2014
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29. 5-Fluorouracil Versus a Combination of BCNU, Adriamycin, 5- FU and Mitomycin C in Advanced Gastric Cancer: A Prospective Randomized Study of the Italian Clinical Research Oncology Group

Author

De Lisi, V., Cocconi, G., Tonato, M., Di Costanzo, F., Leonardi, F., Soldani, M., Herfarth, Ch., editor, Senn, H. J., editor, Baum, M., editor, Diehl, V., editor, von Essen, C., editor, Grundmann, E., editor, Hitzig, W., editor, Rajewsky, M. F., editor, Schlag, Peter, editor, Hohenberger, Peter, editor, and Metzger, Urs, editor

Published
1988
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31. Addition of Either Lonidamine or Granulocyte Colony-Stimulating Factor Does Not Improve Survival in Early Breast Cancer Patients Treated With High-Dose Epirubicin and Cyclophosphamide

Author

Papaldo, P., Lopez, M., Cortesi, Enrico, Cammilluzzi, E., Antimi, M., Terzoli, E., Lepidini, G., Vici, P., Barone, C., Ferretti, G., Di Cosimo, S., Nistico, C., Carlini, P., Conti, F., Di Lauro, L., Botti, C., Vitucci, C., Fabi, A., Giannarelli, D., Marolla, P., Di Maio, M., Perrone, F., Gallo, C., Iaffaioli, R. V., Manzione, L., Piantedosi, F. V., Cigolari, S., Illiano, A., Barbera, S., Robbiati, S. F., Piazza, E., Ianniello, G. P., Frontini, L., Veltri, E., Castiglione, F., Rosetti, F., De Maio, E., Maione, P., Gridelli, C., Rossi, A., Barletta, E., Barzelloni, M. L., Signoriello, G., Bilancia, D., Dinota, A., Rosati, G., Germano, D., Lamberti, A., Pontillo, V., Brancacio, L., Crispino, C., Esposito, M., Battiloro, C., Tufano, G., Cioffi, A., Guardasole, V., Angelini, V., Guidetti, G., Renda, F., Romano, F., Volpintesta, A., Sannicolo, M., Filipazzi, V., Esani, G., Gambaro, A., Ferrario, S., Tinessa, V., Caprio, M. G., Zonato, S., Cabiddu, M., Raina, A., D'Aprile, M., Pistillucci, G., Porcile, G., Ostellino, O., Vinante, O., Azzarello, G., Gebbia, V., Borsellino, N., Testa, A., Gasparini, G., Morabito, A., Gattuso, D., Romito, S., Carrozza, F., Fava, S., Calcagno, A., Grimi, E., Bertetto, O., Ciuffreda, L., Parello, G., Maiorino, L., Santoro, A., Santoro, M., Failla, G., Aiello, R. A., Bearz, A., Sorio, R., Scalone, S., Clerici, M., Bollina, R., Belloni, P., Sacco, C., Sibau, A., Adamo, V., Altavilla, G., Scimone, A., Spatafora, M., Bellia, V., Hopps, M. R., Monfardini, S., Favaretto, A., Stefani, M., Corradini, G. M., Pavia, G., Scagliotti, G., Novello, S., Selvaggi, G., Tonato, M., Darwish, S., Michetti, G., Belometti, M. O., Labianca, R., Quadri, A., De Marinis, F., Migliorino, M. R., Martelli, O., Colucci, G., Galetta, D., Giotta, F., Isa, L., Candido, P., Rossi, N., Calandriello, A., Ferrau, F., Malaponte, E., Barni, S., Cazzaniga, M., Gebbia, N., Valerio, Mr, Belli, M., Colantuoni, G., Capuano, M. A., Angiolillo, M., Sollitto, F., Ardizzoia, A., Luporini, G., Locatelli, M. C., Pari, F., Aitini, E., Pedicini, T., Febbraro, A., Zollo, C., Di Costanzo, F., Bartolucci, R., Gasperoni, S., Gaion, F., Palazzolo, G., Galligioni, E., Caffo, O., Cortesi, E., D'Auria, G., Curcio, C., Vasta, M., Bumma, C., Celano, A., Bretti, S., Nettis, G., Anselmo, A., Mattioli, R., Aschelter, A., and Foa, P.

Subjects
Adult, Cancer Research, medicine.medical_specialty, Indazoles, Filgrastim, Cyclophosphamide, medicine.medical_treatment, Breast Neoplasms, Gastroenterology, Disease-Free Survival, chemistry.chemical_compound, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, Granulocyte Colony-Stimulating Factor, medicine, Humans, Survival rate, Aged, Epirubicin, Chemotherapy, business.industry, Lonidamine, Middle Aged, medicine.disease, Metastatic breast cancer, Recombinant Proteins, Granulocyte colony-stimulating factor, Surgery, Survival Rate, Oncology, chemistry, Female, business, Follow-Up Studies, medicine.drug
Abstract

Purpose: Lonidamine (LND) can enhance the activity of anthracyclines in patients with metastatic breast cancer. A multicenter, prospective, randomized trial was designed to determine whether the association of LND with high-dose epirubicin plus cyclophosphamide (EC) could improve disease-free survival (DFS) in patients with early breast cancer (BC) compared with EC alone. Granulocyte colony-stimulating factor (G-CSF) was added to maintain the EC dose-intensity. Patients and Methods: From October 1991 to April 1994, 506 patients with stage I/II BC were randomly assigned to four groups: (A) epirubicin 120 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 every 21 days for four cycles (124 patients); (B) EC plus LND 450 mg/d administered orally (125 patients); (C) EC plus G-CSF administered subcutaneously (129 patients); (D) EC plus LND plus G-CSF (128 patients). Results: Median follow-up was 55 months. Five-year DFS rate was similar for LND (B+D groups; 69.6%) versus non-LND arms (A+C groups; 70.3%) and G-CSF (C+D groups; 67.2%) versus non–G-CSF arms (A+B groups; 72.9%). Five-year overall survival (OS) was comparable in LND (79.1%) versus non-LND arms (81.3%) and in G-CSF (80.6%) versus non–G-CSF arms (79.6%). DFS and OS distributions in LND and G-CSF arms did not change according to tumor size, node, receptor, and menopausal status. G-CSF dramatically reduced hematologic toxicity without having a significant impact on dose-intensity (98.1% v 95.5% for C+D and A+B groups, respectively). Conclusion: EC is active and well tolerated in patients with early breast cancer. The addition of LND or G-CSF does not improve DFS or OS.

Published
2003

34. Carpal tunnel syndrome and musculoskeletal symptoms in postmenopausal women with early breast cancer treated with exemestane or tamoxifen after 2-3 years of tamoxifen: a retrospective analysis of the Intergroup Exemestane Study

Author

Mieog, Js, Morden, Jp, Bliss, Jm, Coombes, Rc, van de Velde CJ, IES Steering Committee: Delozier, T, Veronesi, A, Vrdoljak, E, Monnier, A, Coombes, C, Nagykalnai, T, Roumen, Rm, Utracka Hutka, B, Pluzanska, A, Porpiglia, M, Genta, F, Benedetto, Chiara, Sozzani, P, Steiner, M, Rubinov, R, Leviov, M, Semiglazov, V, Fox, J, Mayordomo, Ji, Cervek, J, Sleeboom, Hp, Jassem, J, Hinton, Cp, Paulsen, Th, Guleng, Rj, Fein, L, Gutulescu, N, Florián, J, Rosso, R, Rutgers, Ej, Krzakowski, M, Pienkowski, T, Krajina, Z, Siffnerova, H, Pawlicki, M, Drosik, K, Wagnerowa, M, Brunt, M, Vukelja, S, Mitrowic, L, Cataliotti, L, Karnicka Mlodkowska, H, Bonnefoi, H, Tilch, G, Chollet, P, Patel, A, Kamby, C, Giustini, L, Acito, L, Mouridsen, H, Roche, H, De Lafontan, B, Tomczak, P, Petruzelka, L, Lortholary, A, Pacquola, Mg, Skene, A, Rici, S, Michelotti, A, Ghilezan, N, Stewart, A, Beauduin, M, Andersen, J, Vassilaros, S, Celio, L, Bajetta, E, Bastús, R, Marsland, T, Paridaens, R, Tzekova, V, Lichtenegger, W, Piersma, H, Jones, S, Holmberg, S, Verhoeven, D, Hill, A, Porcile, G, Bruno, Mf, Chernozemski, I, Coleman, R, Jadeja, J, Cohn, A, Merlano, M, Perroni, D, Di Costanzo, F, Van Bochove, A, Gerrits, Ma, Malec, V, Balil, A, Mendiola, C, Dodwell, D, Knox, R, Horgan, K, Joannides, T, Leonard, Rc, Cawthorn, Sj, Ghosh, C, Cantrell, J, Campos, D, Orti, R, Diedrich, K, Aas, H, Barnadas, A, Vila, Mm, Makris, A, Anderson, T, Chittor, S, Michel, J, Philip, P, Redmond, P, Mastboom, Wj, Nordenskjöld, B, Simmonds, P, Grieve, Rj, Tomova, A, Piot, G, Borea, G, Ucci, G, Einarsson, E, Nicholson, S, Gardiol, Ea, Kerger, J, Schlosser, J, Namer, M, Pinotti, G, Rutten, Ht, Iversen, T, Nejim, A, Dudov, A, Grundtvig, P, Lang, I, Massidda, B, Van De Velde CH, Gervasio, Mh, Tengrup, I, Tennvall, L, Goodman, S, Modgill, Vk, Vorobiof, Da, Mickiewicz, E, Chirgwin, J, Focan, C, Albin, N, Contu, Aa, Svensson, Jh, Borghede, G, Källström, Ac, Forbes, Jf, Hurtz, Hj, Tubiana Hulin, M, Viens, P, Scanni, A, Arnoldi, E, Nastasi, G, Bottini, A, Alquati, P, Muscat, V, Brincat, S, Holmen, K, Amaral, N, Moreno, I, Trask, C, Robinson, A, Mcintyre, K, Otsuka, A, Hohaus, B, Hoefig, G, Georgoulias, V, Salvagni, S, Bidin, L, Artioli, F, Engan, T, Benedikstsson, Kp, Campbell, I, Harvey, V, Zimbler, H, Mrsic Krmpotic, Z, Canon, Jl, Tchilingirov, Pv, Buser, K, Bolanca, A, Reztke, U, Rhein, U, Jouve, M, Mullins, G, Vesentini, L, Gallo, L, Merlini, L, Decensi, A, Carreca, I, Van Tienhoven, G, Börjesson, B, Hansen, J, Koza, I, Arcusa, A, Inoriza, A, Pelegri, A, Eremin, O, Modiano, Mr, Anthony, S, Donat, D, Richardet, E, Kochli, O, Zeißig, P, Gauch, G, Aabo, K, Fumoleau, P, Erdkamp, Fl, Lovén, L, Jönsson, Pe, Perren, T, Stuart, N, Galindo, E, Marek, Bj, Salmon, Jp, Dohollou, N, Thompson, R, Folco, U, Rosa, A, Tonato, M, Heijmans, Gj, Koralewski, P, Bång, H, Lescure, Ar, Carrato, A, Martin, M, Neave, F, Howell, T, Savin, M, Loesch, D, Hannois, A, Mohr, A, Laube, T, Omar, S, Bonneterre, J, Servent, V, Danese, S, Sertoli, Mr, Butzelaar, Rm, Steller, Ep, Gomez, H, Skoog, P, Alvarez, I, Aguilar, Ea, Giner, Jl, Yosef, Hm, Barrett Lee, P, Buzdar, Au, George, T, Olivaires, J, Vsianska, M, Köhler, U, Lindeløv, B, Toftdahl, Db, Nielsen, Eb, Veyret, C, Castera, D, Kerbrat, P, Vassilaros, P, Yeo, W, Boni, C, Aitini, E, Luporini, G, Herben, Mg, Espelid, H, Dahl, S, Ingvar, C, Meana, A, Pico, C, Garcia, Am, Agrawal, Rk, Gruenberg, D, Nunez de Pierro, A, Gill, G, Nogaret, Jm, Honhon, B, Wassenaar, H, Nielander, R, Warnier, P, Sessa, C, Padrik, P, Guastalla, Jp, Serin, D, Jaubert, D, Dank, M, Given, Fh, Mascia, V, De Fraia, E, Silingardi, V, Conte, Pf, Labianca, R, Tondini, C, Bagnulo, A, Gardani, G, Wils, J, Liem, G, Nuytinck, Jk, Formoe, E, Ambré, T, Alés, J, Aramburo, P, Mansi, J, Graham, J, Joffe, J, Sainsbury, J, Stone, J, Good, Rh, Cartwright, T, Werner, Id, Murray, E, Beith, J, Tigges, Fj, Bojko, P, Sandberg, E, Jensen, B, Lotz, Jp, Carney, D, Shapira, J, Neumann, A, Goldhirsch, A, Dicato, M, de Graaf, H, Maartense, E, Burghouts, J, Cassinello, J, Jones, A, Gaffney, C, Blum, R, Abdi, E, Becquart, D, Dirix, L, Janssens, J, Nmarschner, N, Blaska Jaulerry, B, Prevot, G, Mirah Lev, L, Shani, A, Baruch, Nb, Peretz, T, Gips, M, Cognetti, F, Carlini, P, Nortier, Jw, Huinink D, ten B., Roussel, Jg, Unneberg, K, Kylberg, F, Hovind, H, Nestvold, T, Fogelkvist, R, Due, J, Muller, S, Gilligan, D, Russel, S, Mcaleer, J, Yiangou, C, Foote, L, Schottstaedt, M, Holmes, Fa, Wainstein, R, Contreras, O, Martinez, J, Della Fiorentina, S, Beslija, S, Vermorken, Jb, Thirion, M, Fraikin, J, Castiglione, M, Jäger, W, Fasching, P, Fabriz, H, Neis, K, Kirschbaum, M, Labat, Jp, Dupuis, O, Bernard, J, Datchary, J, Provencal, J, Allain, P, Clerico, M, Lopez, M, Nalli, G, Aspevik, R, Fràguas, A, Curescu, S, Cuevas, Jm, Oltra, A, Bradley, C, Kapoor, R, Akbain, S, Croghan, Mk, Modiano, M, Taetle, R, Beale, P, Gobert, P, Bondue, H, Böhm, R, Møller, Ka, Brettes, Jp, Netter, G, Grogan, L, Klein, B, Botta, M, Barni, S, Van Meerwijk, I, Kåresen, R, Godes, J, Aramburo, A, Jara, C, Zanger, B, Fleagle, Jt, Greenspan, A, Marschke, R, Medgyesy, Dc, Garbo, L., CCA -Cancer Center Amsterdam, and Radiotherapy

Subjects
medicine.medical_specialty, Population, Breast Neoplasms, Disease-Free Survival, chemistry.chemical_compound, Breast cancer, Exemestane, Internal medicine, Surveys and Questionnaires, medicine, Clinical endpoint, Humans, Carpal tunnel syndrome, education, Aged, Retrospective Studies, Aged, 80 and over, education.field_of_study, business.industry, Aromatase Inhibitors, Hazard ratio, Middle Aged, medicine.disease, Carpal Tunnel Syndrome, Surgery, Musculoskeletal Abnormalities, Androstadienes, Postmenopause, Tamoxifen, Treatment Outcome, Oncology, chemistry, Hormonal therapy, Female, business, medicine.drug
Abstract

BACKGROUND: Aromatase inhibitors are more effective than is tamoxifen in prevention of breast-cancer recurrence, but at the expense of increased musculoskeletal side-effects, such as carpal tunnel syndrome. The aim of this study was to assess risk factors and the prognostic value of musculoskeletal symptoms during treatment with the steroidal aromatase inhibitor exemestane or with tamoxifen after 2-3 years of tamoxifen. METHODS: In the Intergroup Exemestane Study, postmenopausal women treated for early invasive breast cancer who remained disease free and on treatment after 2-3 years of tamoxifen were randomised to switch to exemestane or to continue tamoxifen for the remainder of the 5-year period of endocrine treatment. The primary endpoint for this retrospective analysis was occurrence of carpal tunnel syndrome and any musculoskeletal events, analysed in the safety population, which consisted of all patients who had received any trial treatment. As well as case-report forms, questionnaires were distributed retrospectively to gain more details of cases of carpal tunnel syndrome. The relation between musculoskeletal symptoms reported by 6 months from randomisation and survival from 9 months onwards was assessed by Cox proportional hazards models. The trial is registered, number ISRCTN11883920. It has completed accrual and follow-up is continuing for enrolled participants. FINDINGS: After a median follow-up of 91·0 months (IQR 83·0-99·2), carpal tunnel syndrome had been reported for 66 (2·8%) of 2319 patients in the exemestane group compared with 13 (0·6%) of 2338 in the tamoxifen group (odds ratio [OR] 5·23, 99% CI 2·39-11·49; p

Published
2012

35. Guideline update for MASCC and ESMO in the prevention of chemotherapy- and radiotherapy-induced nausea and vomiting: results of the Perugia multinational consensus conference

Author

Roila, F, Herrstedt, J, Aapro, M, Gralla, Rj, Einhorn, L, Ballatori, E, Bria, Emilio, Clark Snow RA, Espersen, Bt, Feyer, P, Grunberg, Sm, Hesketh, Pj, Jordan, K, Kris, M, Maranzano, E, Molassiotis, A, Morrow, G, Olver, I, Rapoport, Bl, Rittenberg, C, Saito, M, Tonato, M, Warr, D, and On behalf of the ESMO/MASCC Guidelines Working Group

Subjects
Guideline, nausea, vomiting, prevention, chemotherapy, Radiotherapy
Published
2010

38. Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study

Author

Agnelli, Giancarlo, Gussoni, G, Bianchini, C, Verso, Melina, Mandalà, M, Cavanna, L, Barni, S, Labianca, R, Buzzi, F, Scambia, G, Passalacqua, R, Ricci, S, Gasparini, G, Lorusso, V, Bonizzoni, E, Tonato, M, Protecht, Investigators, and Mandala', Mario

Subjects
Male, medicine.medical_specialty, Injections, Subcutaneous, Population, Antineoplastic Agents, Placebo, law.invention, Cohort Studies, Randomized controlled trial, Double-Blind Method, Fibrinolytic Agents, law, Neoplasms, Thromboembolism, Medicine, Humans, education, Adverse effect, Aged, education.field_of_study, business.industry, antithrombotic prophylaxis, lung, gastrointestinal, pancreatic, breast, ovarian, head and neck cancer, Nadroparin, Middle Aged, Surgery, Clinical trial, Oncology, Ambulatory, Female, business, Cohort study, Factor Xa Inhibitors
Abstract

Summary Background Clinical trials are needed to assess the clinical benefit of antithrombotic prophylaxis in patients with cancer who are receiving chemotherapy, since these patients are at an increased risk of developing a thromboembolism. We did a trial to assess the clinical benefit of the low-molecular-weight heparin nadroparin for the prophylaxis of thromboembolic events in ambulatory patients receiving chemotherapy for metastatic or locally advanced solid cancer. Methods Between October, 2003, and May, 2007, ambulatory patients with lung, gastrointestinal, pancreatic, breast, ovarian, or head and neck cancer were randomly assigned in a double-blind manner to receive subcutaneous injections of nadroparin (3800 IU anti-Xa once a day, n=779) or placebo (n=387), in a 2:1 ratio. Study treatment was given for the duration of chemotherapy up to a maximum of 4 months. The primary study outcome was the composite of symptomatic venous or arterial thromboembolic events, as assessed by an independent adjudication committee. All randomised patients who received at least one dose of study treatment were included in the efficacy and safety analyses (modified intention-to-treat population). The study is registered with ClinicalTrials.gov, NCT 00951574. Findings 1150 patients were included in the primary efficacy and safety analyses: 769 patients in the nadroparin group and 381 patients in the placebo group. 15 (2·0%) of 769 patients treated with nadroparin and 15 (3·9%) of 381 patients treated with placebo had a thromboembolic event (single-sided p=0·02). Five (0·7%) of 769 patients in the nadroparin group and no patients in the placebo group had a major bleeding event (two-sided p=0·18). The incidences of minor bleeding were 7·4% (57 of 769) with nadroparin and 7·9% (30 of 381) with placebo. There were 121 (15·7%) serious adverse events in the nadroparin goup and 67 (17·6%) serious adverse events in the placebo group. Interpretation Nadroparin reduces the incidence of thromboembolic events in ambulatory patients with metastatic or locally advanced cancer who are receiving chemotherapy. Future studies should focus on patients who are at a high risk for thromboembolic events. Funding Italfarmaco SpA, Milan, Italy.

Published
2009

40. Nadroparin for the prevention of thromboembolic events in ambulatory patients with metastatic or locally advanced solid cancer receiving chemotherapy: a randomised, placebo-controlled, double-blind study

Author

Agnelli, G, Gussoni, G, Bianchini, C, Verso, M, Mandalà, M, Cavanna, L, Barni, S, Labianca, R, Buzzi, F, Scambia, G, Passalacqua, R, Ricci, S, Gasparini, G, Lorusso, V, Bonizzoni, E, Tonato, M, PROTECHT Investigators Agnelli, G, Amadori, D, Barbui, T, Cognetti, F, Crinò, L, Mannucci, Pm, Moia, M, Gianni, L, Prandoni, P, Cesana, B, de Braud, F, Del Favero, A, Lazzaro, A, Anselmi, E, Mordenti, P, Cabiddu, M, Petrelli, F, Ghilardi, M, Poletti, P, Marelli, B, Fumagalli, D, Sabatini, S, Fumi, G, Masi, C, Salutari, V, Malaggese, M, Brighenti, M, Lazzarelli, S, Donati, G, Di Donato, S, Arrighi, G, Orlandini, C, Amici, S, Verì, A, Sarmento, R, Pollera, C, Capomolla, E, Moschetti, L, Garufi, C, Campanella, C, Torsello, A, Misino, A, Ciuffreda, L, Dongiovanni, V, Addeo, A, Vitale, Fv, Ferraù, F, Priolo, D, Muggiano, A, Mulas, C, Tedde, A, Pogliani, Ea, Ardizzoia, A, Villa, F, Montedoro, M, Bravi, S, Biagioni, F, Palazzo, S, Filice, A, Gori, S, Porrozzi, S, Ciccarese, M, Petrucelli, L, Chiuri, Ve, Passardi, A, Ravaioli, E, Ceravolo, R, Crivellari, G, Nicoletto, Mo, Brandes, A, Bertolini, S, Benedetti, G, Bernardo, G, Teragni, C, Jirillo, A, Falci, C, Santoro, A, Masci, G, Monti, M, Casanova, C, Intrivici, C, Rinaldi, G, Massidda, B, Ionta, Mt, Dogliotti, Luigi, Russo, L, Collovà, E, Luoni, M, Maiello, E, Romano, Mp, Molica, S, Battaglia, C, Doni, L, Di Costanzo, F, Giuliodori, L, Silva, Rr, Sarobba, Mg, Pinna, A, Sorarù, M, Gaion, F, Ferrandina, G, Gilli, G, Locatelli, Mc, Zanaboni, F, Bologna, A, Ferretti, G, Chini, C, Farina, G, Bronner, L, Biscottini, B, Tomirotti, M, and Sciacca, V.

Published
2009

41. Adjuvant chemotherapy in completely resected gastric cancer: A Randomized phase III trial conducted by GOIRC

Author

Di Costanzo, F., Gasperoni, S., Manzione, L., Bisagni, G., Labianca, R., Bravi, S., Cortesi, Enrico, Carlini, P., Bracci, R., Tomao, Silverio, Messerini, L., Arcangeli, A., Torri, V., Bilancia, D., Floriani, I., Tonato, M., Italian Oncology Group For Cancer Research, Dinota, A., Strafiuso, G., Corgna, E., Porrozzi, S., Boni, C., Rondini, E., Giunta, A., Monzio Compagnoni, B., Biagioni, F., Cesari, M., Fornarini, G., Nelli, F., Carboni, M., Cognetti, F., Enzo, Mr, Piga, A., Romiti, A., Olivetti, A., Masoni, Luigi, De Stefanis, M., Dalla Mola, A., Camera, S., Recchia, F., De Filippis, S., Scipioni, L., Zironi, S., Luppi, G., Italia, M., Banducci, S., Pisani Leretti, A., Massidda, B., Ionta, M. T., Nicolosi, A., Canaletti, R., Biscottini, B., Grigniani, F., Rovei, R., Croce, E., Carroccio, R., Gilli, G., Cavalli, C., Olgiati, A., Pandolfi, U., Rossetti, R., Natalini, G., Foa, P., Oldani, S., Bruno, L., Cascinu, S., Catalano, G., Catalano, V., Lungarotti, F., Farris, A., Sarobba, M. G., Trignano, M., Muscogiuri, A., Francavilla, F., Figoli, F., Leoni, M., Papiani, G., Orselli, G., Antimi, M., Bellini, V., Cabassi, A., Contu, A., Pazzola, A., Frignano, M., Lastraioli, E., Saggese, M., Bianchini, D., Antonuzzo, L., Mela, M., and Camisa, R.

Subjects
Male, Cancer Research, medicine.medical_treatment, Leucovorin, Kaplan-Meier Estimate, Gastroenterology, Antineoplastic Combined Chemotherapy Protocols, Medicine, Stomach cancer, Adult, Aged, Biomarkers, Tumor, Chemotherapy, Adjuvant, Cisplatin, Diarrhea, Disease-Free Survival, Epirubicin, Female, Fluorouracil, Hematologic Diseases, Humans, Immunohistochemistry, Italy, Lymph Node Excision, Lymphatic Metastasis, Middle Aged, Mucositis, Neoplasm Staging, Patient Compliance, Prognosis, Proportional Hazards Models, Stomach Neoplasms, Treatment Outcome, Vomiting, Gastrectomy, Hazard ratio, Chemotherapy regimen, Oncology, medicine.drug, medicine.medical_specialty, Internal medicine, Survival analysis, Chemotherapy, business.industry, Proportional hazards model, medicine.disease, Surgery, business
Abstract

Background Complete surgical resection of gastric cancer is potentially curative, but long-term survival is poor. Methods Patients with histologically proven adenocarcinoma of the stomach of stages IB, II, IIIA and B, or IV (T4N2M0) and treated with potentially curative surgery were randomly assigned to follow-up alone or to intravenous treatment with four cycles (repeated every 21 days) of PELF (cisplatin [40 mg/m 2 , on days 1 and 5], epirubicin [30 mg/m 2 , days 1 and 5], L-leucovorin [100 mg/m 2 , days 1-4], and 5-fluorouracil [300 mg/m 2 , days 1-4] in a hospital setting. Frequencies and severity of adverse events were determined. Overall survival (OS) and disease-free survival (DFS) were compared between the treatment arms using Kaplan-Meier analysis and a Cox proportional hazards regression model. All statistical tests were two-sided. Results From January 1995 through September 2000, 258 patients were randomly assigned to chemotherapy (n = 130) or surgery alone (n = 128). Patient characteristics were well balanced between the two arms. Among those who received chemotherapy, grade 3 or 4 toxic effects including vomiting, mucositis, and diarrhea were experienced by 21.1%, 8.4%, and 11.8% of patients, respectively. Leucopenia, anemia, and thrombocytopenia of grade 3 or 4 were experienced by 20.3%, 3.3%, and 4.2% of patients, respectively. After a median follow-up of 72.8 months, 128 patients (49.6%) experienced recurrence and 139 (53.9%) deaths were observed, one toxicity-related. Relative to treatment with surgery alone, adjuvant chemotherapy did not increase disease-free survival (hazard ratio [HR] of recurrence = 0.92; 95% confidence interval [Cl] = 0.66 to 1.27) or overall survival (HR of death = 0.90; 95% Cl = 0.64 to 1.26). Conclusions Our results failed to provide proof of an effect of adjuvant chemotherapy with PELF on overall survival or disease-free survival. The estimated effect of chemotherapy (10% reduction in the hazard of death or relapse) is modest and consistent with the results of meta-analyses of adjuvant chemotherapy without platinum agents.

Published
2008

47. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancerreceiving chemotherapy: a prognostic analysis of the multicenter Italian lungcancer in the elderly study

Author

Maione, P, Perrone, F, Gallo, C, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferrau, F, Frontini, L, Bearz, A, Repetto, L, Gridelli, C, Barletta, E, Barzelloni, Ml, Iaffaioli, Rv, DE MAIO, E, DI MAIO, M, DE FEO, G, Sigoriello, G, Chiodini, P, Cioffi, A, Guardasole, V, Angelini, V, Rossi, A, Bilancia, D, Germano, D, Lamberti, A, Pontillo, V, Brancaccio, L, Renda, F, Romano, F, Esani, G, Gambaro, A, Vinante, O, Azzarello, G, Clerici, M, Bollina, R, Belloni, P, Sannicolo, M, Ciuffreda, L, Parello, G, Cabiddu, M, Sacco, C, Sibau, A, Porcile, G, Castiglione, F, Ostellino, O, Monfardini, S, Stefani, M, Scagliotti, G, Selvaggi, G, DE MARINIS, F, Martelli, O, Gasparini, G, Morabito, A, Gattuso, D, Colucci, G, Galetta, D, Giotta, F, Gebbia, V, Borsellino, N, Testa, A, Malaponte, E, Capuano, Ma, Angiolillo, M, Sollitto, F, Tirelli, U, Spazzapan, S, Adamo, Vincenzo, Altavilla, Giuseppe, Scimone, A, Hopps, Mr, Tartamella, F, Ianniello, Gp, Tinessa, V, Failla, G, Bordonaro, R, Gebbia, N, Valerio, Mr, D'Aprile, M, Veltri, E, Tonato, M, Darwish, S, Romito, S, Carrozza, F, Barni, S, Ardizzoia, A, Corradini, Gm, Pavia, G, Belli, M, Colantuoni, G, Galligioni, E, Caffo, O, Labianca, R, Quadri, A, Cortesi, E, D'Auria, G, Fava, S, Calcagno, A, Luporini, G, Locatelli, Mc, DI COSTANZO, F, Gasperoni, S, Isa, L, Candido, P, Gaion, F, Palazzolo, G, Nettis, G, Annamaria, A, Rinaldi, M, Lopez, M, Felletti, R, DI NEGRO GB, Rossi, N, Calandriello, A, Maiorino, L, Mattioli, R, Celano, A, Schiavon, S, Illiano, A, Raucci, Ca, Caruso, M, Foa, P, Tonini, G, Curcio, C, and Cazzaniga, M.

Published
2005

48. Pretreatment quality of life and functional status assessment significantly predict survival of elderly patients with advanced non-small-cell lung cancer receiving chemotherapy: a prognostic analysis of the multicenter Italian lung cancer in the elderly study

Author

Maione, P, Perrone, F, Gallo, C, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferraù, F, Frontini, L, Bearz, A, Repetto, L, Gridelli, C, Barletta, E, Barzelloni, Ml, Iaffaioli, Rv, DE MAIO, E, DI MAIO, M, DE FEO, G, Sigoriello, G, Chiodini, P, Cioffi, A, Guardasole, V, Angelini, V, Rossi, A, Bilancia, D, Germano, D, Lamberti, A, Pontillo, V, Brancaccio, L, Renda, F, Romano, F, Esani, G, Gambaro, A, Vinante, O, Azzarello, G, Clerici, M, Bollina, R, Belloni, P, Sannicolò, M, Ciuffreda, L, Parello, G, Cabiddu, M, Sacco, C, Sibau, A, Porcile, G, Castiglione, F, Ostellino, O, Monfardini, S, Stefani, M, Scagliotti, G, Selvaggi, G, DE MARINIS, F, Martelli, O, Gasparini, G, Morabito, A, Gattuso, D, Colucci, G, Galetta, D, Giotta, F, Gebbia, V, Borsellino, N, Testa, A, Malaponte, E, Capuano, Ma, Angiolillo, M, Sollitto, F, Tirelli, U, Spazzapan, S, Adamo, V, Altavilla, G, Scimone, A, Hopps, Mr, Tartamella, F, Ianniello, Gp, Tinessa, V, Failla, G, Bordonaro, R, Gebbia, N, Valerio, Mr, D'Aprile, M, Veltri, E, Tonato, M, Darwish, S, Romito, S, Carrozza, F, Barni, S, Ardizzoia, A, Corradini, Gm, Pavia, G, Belli, M, Colantuoni, G, Galligioni, E, Caffo, O, Labianca, R, Quadri, A, Cortesi, Enrico, D'Auria, Giuliana, Fava, S, Calcagno, A, Luporini, G, Locatelli, Mc, DI COSTANZO, F, Gasperoni, S, Isa, L, Candido, P, Gaion, F, Palazzolo, G, Nettis, G, Annamaria, A, Rinaldi, M, Lopez, M, Felletti, R, DI NEGRO GB, Rossi, N, Calandriello, A, Maiorino, L, Mattioli, R, Celano, A, Schiavon, S, Illiano, A, Raucci, Ca, Caruso, M, Foa, P, Tonini, G, Curcio, C, Cazzaniga, M., MAIONE P, PERRONE F, GALLO C, MANZIONE L, PIANTEDOSI F, BARBERA S, CIGOLARI, ROSETTI F, PIAZZA E, ROBBIATI SF, BERTETTO O, NOVELLO S, MIGLIORINO MR, FAVARETTO A, SPATAFORA M, FERRAU F, FRONTINI L, BEARZ A, REPETTO L, GRIDELLI C, BARLETTA E, BARZELLONI ML, IAFFAIOLI RV, DE MAIO E, DI MAIO M, DE FEO G, SIGORIELLO G, CHIODINI P, CIOFFI A, GUARDASOLE V, ANGELINI V, ROSSI A, BILANCIA, GERMANO D, LAMBERTI A, PONTILLO V, BRANCACCIO L, RENDA F, ROMANO F, ESANI G, GAMBARO A, VINANTE O, AZZARELLO G, CLERICI M, BOLLINA R, BELLONI P, SANNICOLO M, CIUFFREDA L, PARELLO G, CABIDDU M, SACCO C, SIBAU A, PORCILE G, CASTIGLIONE F, OSTELLINO O, MONFARDINI S, STEFANI M, SCAGLIOTTI G, SELVAGGI G, DE MARINIS F, MARTELLI O, GASPARINI G, MORABITO A, GATTUSO D, COLUCCI G, GALETTA D, GIOTTA F, GEBBIA V, ET AL, Maione, P, Perrone, F, Gallo, Ciro, Manzione, L, Piantedosi, F, Barbera, S, Cigolari, S, Rosetti, F, Piazza, E, Robbiati, Sf, Bertetto, O, Novello, S, Migliorino, Mr, Favaretto, A, Spatafora, M, Ferrau, F, Frontini, L, Bearz, A, Repetto, L, and Gridelli, C.

Subjects
Male, Cancer Research, medicine.medical_specialty, Lung Neoplasms, Activities of daily living, Health Status, carcinoma, Vinblastine, Vinorelbine, Deoxycytidine, older people, Quality of life, Instrumental activitie, Carcinoma, Non-Small-Cell Lung, Internal medicine, Activities of Daily Living, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Lung cancer, Aged, Aged, 80 and over, validation, Proportional hazards model, business.industry, QLQ-C30, Age Factors, Cancer, clinical trial, Prognosis, medicine.disease, Gemcitabine, Comorbidity, humanities, comorbidity, Oncology, Quartile, Quality of Life, Physical therapy, impact, Geriatric oncology, Female, business, Randomized-trial, medicine.drug
Abstract

Purpose To study the prognostic value for overall survival of baseline assessment of functional status, comorbidity, and quality of life (QoL) in elderly patients with advanced non—small-cell lung cancer treated with chemotherapy. Patients and Methods Data from 566 patients enrolled onto the phase III randomized Multicenter Italian Lung Cancer in the Elderly Study (MILES) study were analyzed. Functional status was measured as activities of daily living (ADL) and instrumental ADL (IADL). The presence of comorbidity was assessed with a checklist of 33 items; items 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) core questionnaire QLQ-C30 (EORTC QLQ-C30) were used to estimate QoL. ADL was dichotomized as none versus one or more dependency. For IADL and QoL, three categories were defined using first and third quartiles as cut points. Comorbidity was summarized using the Charlson scale. Analysis was performed by Cox model, and stratified by treatment arm. Results Better values of baseline QoL (P = .0003) and IADL (P = .04) were significantly associated with better prognosis, whereas ADL (P = .44) and Charlson score (P = .66) had no prognostic value. Performance status 2 (P = .006) and a higher number of metastatic sites (P = .02) also predicted shorter overall survival. Conclusions Pretreatment global QoL and IADL scores, but not ADL and comorbidity, have significant prognostic value for survival of elderly patients with advanced non—small-cell lung cancer who were treated with chemotherapy. Using these scores in clinical practice might improve prognostic prediction for treatment planning.

Published
2005

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