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187 results on '"Carteni, G."'

1. Validation of the Meet-URO score in patients with metastatic renal cell carcinoma receiving first-line nivolumab and ipilimumab in the Italian Expanded Access Program

Author

Rebuzzi, S.E., Signori, A., Buti, S., Banna, G.L., Murianni, V., Damassi, A., Maruzzo, M., Giannarelli, D., Tortora, G., Galli, L., Rizzo, M., De Giorgi, U., Antonuzzo, L., Bracarda, S., Cartenì, G., Atzori, F., Tamberi, S., Procopio, G., Fratino, L., Lo Re, G., Santoni, M., Baldessari, C., Astone, A., Calabrò, F., Brunelli, M., Porta, C., Rescigno, P., Basso, U., and Fornarini, G.

Published
2022
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2. Heterogeneity of KRAS, NRAS, BRAF and PIK3CA mutations in metastatic colorectal cancer and potential effects on therapy in the CAPRI GOIM trial

Author

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

Published
2015
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3. Clinical activity of FOLFIRI plus cetuximab according to extended gene mutation status by next-generation sequencing: findings from the CAPRI-GOIM trial

Author

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

Published
2014
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4. 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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11. Safety and efficacy of nivolumab for metastatic renal cell carcinoma: real-world results from an expanded access programme

Author

De Giorgi, U, Carteni, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, Cn, Procopio, G, Falcone, A, Roila, F, Cascinu, S, Tirelli, U, Giustini, L, Sobrero, A, Cappuzzo, F, Tortora, G, Tassinari, D, Passalacqua, R, Pazzola, A, Surico, G, Maio, M, Benedetti, G, Barone, C, Adamo, V, Ricevuto, E, De Censi, A, Spada, M, Tonini, G, Pinto, C, Ciuffreda, L, Ruggeri, Em, Bengala, C, Scotti, V, Fagnani, D, Bonetti, A, Mitterer, M, Castiglione, F, Bidoli, P, Ferrau, F, Crino, L, Frassoldati, A, Marchetti, P, Mini, E, Scoppola, A, Verusio, C, Favaretto, A, Di Costanzo, F, Fasola, G, Merlano, M, Artioli, F, Di Leo, A, Romito, S, Maestri, A, Giorgio, Cg, Ionta, Mt, Verderame, F, Zampa, G, Numico, G, Minelli, M, Tagliaferri, P, Foa, P, Palmiotti, G, De Placido, S, Mattioli, R, Iuliano, F, Defraia, E, Siena, S, Clerico, M, Salvagno, L, Ceresoli, Gl, Bernardo, A, Di Lieto, M, Moroni, M, Maisano, M, Scartozzi, M, Scagliotti, G, Soraru, M, Pepe, S, Scaltriti, A, Gebbia, V, Testa, E, Lorusso, V, Bordonaro, R, De Signoribus, G, Tedde, N, Santoro, A, Francini, G, Aondio, G, De Giorgi, U., Carteni, G., Giannarelli, D., Basso, U., Galli, L., Cortesi, E., Caserta, C., Pignata, S., Sabbatini, R., Bearz, A., Buti, S., Lo Re, G., Berruti, A., Bracarda, S., Cognetti, F., Rastelli, F., Fornarini, G., Porta, C., Turci, D., Sternberg, C. N., Procopio, G., Falcone, A., Roila, F., Cascinu, S., Tirelli, U., Giustini, L., Sobrero, A., Cappuzzo, F., Tassinari, D., Passalacqua, R., Pazzola, A., Surico, G., Maio, M., Benedetti, G., Barone, C., Adamo, V., Ricevuto, E., De Censi, A., Spada, M., Tonini, G., Pinto, C., Ciuffreda, L., Ruggeri, E. M., Bengala, C., Scotti, V., Fagnani, D., Bonetti, A., Mitterer, M., Castiglione, F., Bidoli, P., Ferrau, F., Crino, L., Frassoldati, A., Marchetti, P., Mini, E., Scoppola, A., Verusio, C., Favaretto, A., Di Costanzo, F., Fasola, G., Merlano, M., Artioli, F., Di Leo, A., Romito, S., Maestri, A., Giannitto Giorgio, C., Ionta, M. T., Verderame, F., Zampa, G., Numico, G., Minelli, M., Tagliaferri, P., Foa, P., Palmiotti, G., De Placido, S., Mattioli, R., Iuliano, F., Defraia, E., Siena, S., Clerico, M., Salvagno, L., Ceresoli, G. L., Bernardo, A., Di Lieto, M., Moroni, M., Maisano, M., Scartozzi, M., Scagliotti, G., Soraru, M., Pepe, S., Scaltriti, A., Gebbia, V., Testa, E., Lorusso, V., Bordonaro, R., De Signoribus, G., Tedde, N., Santoro, A., Francini, G., Aondio, G., De Giorgi, U, Cartenì, G, Giannarelli, D, Basso, U, Galli, L, Cortesi, E, Caserta, C, Pignata, S, Sabbatini, R, Bearz, A, Buti, S, Lo Re, G, Berruti, A, Bracarda, S, Cognetti, F, Rastelli, F, Fornarini, G, Porta, C, Turci, D, Sternberg, C, Procopio, G, and Bidoli, P

Subjects
0301 basic medicine, Male, expanded access programme, nivolumab, real-world experience, renal cell cancer, Antineoplastic Agent, 0302 clinical medicine, Antineoplastic Agents, Immunological, 80 and over, Sunitinib, Medicine, Urology, Aged, 80 and over, Sulfonamides, Brain Neoplasms, Kidney Neoplasm, Common Terminology Criteria for Adverse Events, Middle Aged, Kidney Neoplasms, Progression-Free Survival, Survival Rate, Everolimu, Immunological, Response Evaluation Criteria in Solid Tumors, 030220 oncology & carcinogenesis, Retreatment, Female, Nivolumab, medicine.drug, Human, Adult, medicine.medical_specialty, Indazoles, metastatic renal cancer, Response Evaluation Criteria in Solid Tumor, Antineoplastic Agents, Bone Neoplasms, Bone Neoplasm, expanded access programme, nivolumab, real-world experience, renal cell cancer, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Antineoplastic Agents, Immunological, Bone Neoplasms, Brain Neoplasms, Carcinoma, Renal Cell, Everolimus, Female, Humans, Kidney Neoplasms, Male, Middle Aged, Nivolumab, Progression-Free Survival, Pyrimidines, Response Evaluation Criteria in Solid Tumors, Retreatment, Sulfonamides, Sunitinib, Survival Rate, Sulfonamide, Pazopanib, Brain Neoplasm, 03 medical and health sciences, Aged, Carcinoma, Renal Cell, Everolimus, Humans, Pyrimidines, Internal medicine, Progression-free survival, Survival rate, business.industry, Carcinoma, Renal Cell, 030104 developmental biology, Pyrimidine, Expanded access, business
Abstract

Objective: To report the safety and efficacy results of patients enrolled in the Italian Nivolumab Renal Cell Cancer Expanded Access Programme. Patients and Methods: Patients with metastatic renal cell cancer (mRCC) previously treated with agents targeting the vascular endothelial growth factor pathway were eligible to receive nivolumab 3 mg/kg once every 2 weeks. Patients included in the analysis had received ≥1 dose of nivolumab and were monitored for adverse events (AEs) using Common Terminology Criteria for Adverse Events (CTCAE) v.4.0. Results: A total of 389 patients were enrolled between July 2015 and April 2016, of whom 18% were aged ≥75 years, 6.7% had non-clear cell RCC, 49.6% had bone and 8.2% brain metastases, and 79% had received ≥2 previous lines of therapy. The most common any-grade treatment-related AEs were fatigue (13%) and rash (9%). Twenty-two patients (5.7%) discontinued treatment because of AEs. There were no treatment-related deaths. The objective response rate was 23.1%. At a median follow-up of 12 months, the median progression-free survival was 4.5 months (95% confidence interval 3.7–6.2) and the 12-month overall survival rate was 63%. Similar survival rates were reported among patients with non-clear-cell histology, elderly patients, those with bone and/or brain metastases, and those who had received prior first-line sunitinib or pazopanib, or prior everolimus. Conclusion: The safety and efficacy observed were consistent with those reported in the pivotal Checkmate 025 trial. Results in patients with non-clear-cell mRCC who were elderly, pretreated with everolimus, and had bone and/or brain metastases encourage the use of nivolumab in these categories of patients. © 2018 The Authors BJU International

Published
2019

12. Adjuvant anastrozole versus exemestane versus letrozole, upfront or after 2 years of tamoxifen, in endocrine-sensitive breast cancer (FATA-GIM3): a randomised, phase 3 trial

Author

De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., Zoboli A., De Placido, S, Gallo, C, De Laurentiis, M, Bisagni, G, Arpino, G, Sarobba, M, Riccardi, F, Russo, A, Del Mastro, L, Cogoni, A, Cognetti, F, Gori, S, Foglietta, J, Frassoldati, A, Amoroso, D, Laudadio, L, Moscetti, L, Montemurro, F, Verusio, C, Bernardo, A, Lorusso, V, Gravina, A, Moretti, G, Lauria, R, Lai, A, Mocerino, C, Rizzo, S, Nuzzo, F, Carlini, P, Perrone, F, Accurso, A, Agostara, B, Aieta, M, Alabiso, O, Alicicco, M, Amadori, D, Amaducci, L, Amiconi, G, Antuzzi, G, Ardine, M, Ardizzoia, A, Aversa, C, Badalamenti, G, Barni, S, Basurto, C, Berardi, R, Bergamasco, C, Bidoli, P, Bighin, C, Biondi, E, Boni, C, Borgonovo, K, Botta, M, Bravi, S, Bruzzi, P, Buono, G, Butera, A, Caldara, A, Candeloro, G, Cappelletti, C, Cardalesi, C, Carfora, E, Cariello, A, Carrozza, F, Carteni, G, Caruso, M, Casadei, V, Casanova, C, Castori, L, Cavanna, L, Cavazzini, G, Cazzaniga, M, Chilelli, M, Chiodini, P, Chiorrini, S, Ciardiello, F, Ciccarese, M, Cinieri, S, Clerico, M, Coccaro, M, Comande, M, Corbo, C, Cortino, G, Cusenza, S, Daniele, G, D'Arco, A, D'Auria, G, Dazzi, C, De Angelis, C, de Braud, F, De Feo, G, De Matteis, A, De Tursi, M, Di Blasio, A, di Lucca, G, Di Lullo, L, Di Rella, F, Di Renzo, G, Di Stefano, P, Di Stefano, A, Diana, A, Donati, S, Fabbri, A, Fabi, A, Faedi, M, Farina, G, Farris, A, Febbraro, A, Fedele, P, Federico, P, Ferrau, F, Ferretti, G, Ferro, A, Floriani, I, Forcignano, R, Forciniti, S, Forestieri, V, Fornari, G, Frisinghelli, M, Fusco, V, Gallizzi, G, Galvano, A, Gambardella, A, Gambi, A, Gebbia, V, Gervasi, E, Ghilardi, M, Giacobino, A, Giardina, G, Giotta, F, Giraudi, S, Giuliano, M, Grassadonia, A, Grasso, D, Grosso, F, Guizzaro, L, Incoronato, P, Incorvaia, L, Iodice, G, La Verde, N, Labonia, V, Landi, G, Latorre, A, Leonardi, V, Levaggi, A, Limite, G, Lina Bascialla, L, Livi, L, Maiello, E, Mandelli, D, Marcon, I, Menon, D, Montedoro, M, Moraca, L, Moretti, A, Morritti, M, Morselli, P, Mura, A, Mura, S, Musacchio, M, Muzio, A, Natale, D, Natoli, C, Nigro, C, Nistico, C, Nuzzo, A, Orditura, M, Orlando, L, Pacilio, C, Palumbo, G, Palumbo, R, Pasini, F, Paterno, E, Pazzola, A, Pelliccioni, S, Pensabene, M, Perroni, D, Pesenti Gritti, A, Petrelli, F, Piccirillo, M, Pinotti, G, Pogliani, C, Poli, D, Prader, S, Recchia, F, Rizzi, D, Romano, C, Rossello, R, Rossini, C, Salvucci, G, Sanna, V, Santini, A, Saracchini, S, Savastano, C, Scambia, G, Schettini, F, Schiavone, P, Schirone, A, Seles, E, Signoriello, S, Signoriello, G, Silva, R, Silvestri, A, Simeon, V, Spagnoletti, I, Tamberi, S, Teragni, C, Thalmann, V, Thomas, R, Thomas, G, Tienghi, A, Tinari, N, Tinessa, V, Tomei, F, Tonini, G, Torri, V, Traficante, D, Tudini, M, Turazza, M, Vignoli, R, Vitale, M, Zacchia, A, Zagarese, P, Zanni, A, Zavallone, L, Zavettieri, M, Zoboli, A, De Placido S., Gallo C., De Laurentiis M., Bisagni G., Arpino G., Sarobba M. G., Riccardi F., Russo A., Del Mastro L., Cogoni A. A., Cognetti F., Gori S., Foglietta J., Frassoldati A., Amoroso D., Laudadio L., Moscetti L., Montemurro F., Verusio C., Bernardo A., Lorusso V., Gravina A., Moretti G., Lauria R., Lai A., Mocerino C., Rizzo S., Nuzzo F., Carlini P., Perrone F., Accurso A., Agostara B., Aieta M., Alabiso O., Alicicco M. G., Amadori D., Amaducci L., Amiconi G., Antuzzi G., Ardine M., Ardizzoia A., Aversa C., Badalamenti G., Barni S., Basurto C., Berardi R., Bergamasco C., Bidoli P., Bighin C., Biondi E., Boni C., Borgonovo K., Botta M., Bravi S., Bruzzi P., Buono G., Butera A., Caldara A., Candeloro G., Cappelletti C., Cardalesi C., Carfora E., Cariello A., Carrozza F., Carteni G., Caruso M., Casadei V., Casanova C., Castori L., Cavanna L., Cavazzini G., Cazzaniga M., Chilelli M., Chiodini P., Chiorrini S., Ciardiello F., Ciccarese M., Cinieri S., Clerico M., Coccaro M., Comande M., Corbo C., Cortino G., Cusenza S., Daniele G., D'arco A. M., D'auria G., Dazzi C., De Angelis C., de Braud F., De Feo G., De Matteis A., De Tursi M., Di Blasio A., di Lucca G., Di Lullo L., Di Rella F., Di Renzo G., Di Stefano P., Di Stefano A., Diana A., Donati S., Fabbri A., Fabi A., Faedi M., Farina G., Farris A., Febbraro A., Fedele P., Federico P., Ferrau F., Ferretti G., Ferro A., Floriani I., Forcignano R., Forciniti S., Forestieri V., Fornari G., Frisinghelli M., Fusco V., Gallizzi G., Galvano A., Gambardella A., Gambi A., Gebbia V., Gervasi E., Ghilardi M., Giacobino A., Giardina G., Giotta F., Giraudi S., Giuliano M., Grassadonia A., Grasso D., Grosso F., Guizzaro L., Incoronato P., Incorvaia L., Iodice G., La Verde N., Labonia V., Landi G., Latorre A., Leonardi V., Levaggi A., Limite G., Lina Bascialla L., Livi L., Maiello E., Mandelli D., Marcon I., Menon D., Montedoro M., Moraca L., Moretti A., Morritti M. G., Morselli P., Mura A., Mura S., Musacchio M., Muzio A., Natale D., Natoli C., Nigro C., Nistico C., Nuzzo A., Orditura M., Orlando L., Pacilio C., Palumbo G., Palumbo R., Pasini F., Paterno E., Pazzola A., Pelliccioni S., Pensabene M., Perroni D., Pesenti Gritti A., Petrelli F., Piccirillo M. C., Pinotti G., Pogliani C., Poli D., Prader S., Recchia F., Rizzi D., Romano C., Rossello R., Rossini C., Salvucci G., Sanna V., Santini A., Saracchini S., Savastano C., Scambia G., Schettini F., Schiavone P., Schirone A., Seles E., Signoriello S., Signoriello G., Silva R. R., Silvestri A., Simeon V., Spagnoletti I., Tamberi S., Teragni C., Thalmann V., Thomas R., Thomas G., Tienghi A., Tinari N., Tinessa V., Tomei F., Tonini G., Torri V., Traficante D., Tudini M., Turazza M., Vignoli R., Vitale M. G., Zacchia A., Zagarese P., Zanni A., Zavallone L., Zavettieri M., and Zoboli A.

Abstract

Background: Uncertainty exists about the optimal schedule of adjuvant treatment of breast cancer with aromatase inhibitors and, to our knowledge, no trial has directly compared the three aromatase inhibitors anastrozole, exemestane, and letrozole. We investigated the schedule and type of aromatase inhibitors to be used as adjuvant treatment for hormone receptor-positive early breast cancer. Methods: FATA-GIM3 is a multicentre, open-label, randomised, phase 3 trial of six different treatments in postmenopausal women with hormone receptor-positive early breast cancer. Eligible patients had histologically confirmed invasive hormone receptor-positive breast cancer that had been completely removed by surgery, any pathological tumour size, and axillary nodal status. Key exclusion criteria were hormone replacement therapy, recurrent or metastatic disease, previous treatment with tamoxifen, and another malignancy in the previous 10 years. Patients were randomly assigned in an equal ratio to one of six treatment groups: oral anastrozole (1 mg per day), exemestane (25 mg per day), or letrozole (2·5 mg per day) tablets upfront for 5 years (upfront strategy) or oral tamoxifen (20 mg per day) for 2 years followed by oral administration of one of the three aromatase inhibitors for 3 years (switch strategy). Randomisation was done by a computerised minimisation procedure stratified for oestrogen receptor, progesterone receptor, and HER2 status; previous chemotherapy; and pathological nodal status. Neither the patients nor the physicians were masked to treatment allocation. The primary endpoint was disease-free survival. The minimum cutoff to declare superiority of the upfront strategy over the switch strategy was assumed to be a 2% difference in disease-free survival at 5 years. Primary efficacy analyses were done by intention to treat; safety analyses included all patients for whom at least one safety case report form had been completed. Follow-up is ongoing. This trial is regist

Published
2018

13. Abiraterone plus Prednisone in Metastatic, Castration-Sensitive Prostate Cancer

Author

Fizazi, Karim, Tran, Namphuong, Fein, Luis, Matsubara, Nobuaki, Rodriguez Antolin, Alfredo, Alekseev, Boris Y., Özgã¼roglu, Mustafa, Dingwei, Ye, Feyerabend, Susan, Protheroe, Andrew, De Porre, Peter, Kheoh, Thian, Park, Youn C., Todd, Mary B., Chi, Korbenfeld E, Kim N., Metrebian, S, Kaen, L, Staneloni, E, Batagelj, E, Tan, H, Hovey, E, Woo, H, Frydenberg, M, Chua, W, D’Hondt, L, Evaraert, E, Verschaeve, V, Wynendaele, W, Schrijvers, D, Waltregny, D, Whenham, N, Demey, W, Franke, F, Panhoca, R, Damião, R, Zucca, L, Da Rosa, V, Reis, R, Scalabrini, A, Nahas, W, Girotto, G, Nogueira, A, Gomes, A, Coradazzi, A, Kurteva, G, Siemens, R, Gingerich, J, Fleshner, N, Fradet, Y, Morgan, S, North, S, Saad, F, Shayegan, B, Zalewski, P, Pinochet, R, Orellana, N, Ding, Q, Ye, Z, Xie, L, Du, C, Chen, Z, Huang, Y, Sun, Z, Li, H, Jin, J, Li, C, Wan, B, Tian, Y, Zhou, F, Xie, K, Yao, X, Qiu, M, Zou, Q, Na, Y, Sun, Y, Xue, B, Ma, L, Martinez, C, Salazar, M, Larios, C, Solano, S, Pavlik, I, Brodak, M, Hora, M, Büchler, T, Borre, M, Johansen, J, Mejlholm, I, Poulsen, M, Wittendorf, He, Tammela, T, Vaarala, M, Theodore, C, Staudacher, L, Villers, A, Laplaige, P, Suttman, H, Steuber, T, Natale, S, Jones, R, Tran, A, Mazhar, D, Mills, J, Nyirady, P, Salamon, C, Torzsok, F, Feher, J, Géczi, L, Lakatos, A, Keizman, D, Sella, A, Frank, S, Peer, A, Rosenbaum, E, Berger, R, Mermershtain, W, Carteni, G, Tonini, G, De Giorgi, U, Facchini, G, Berruti, Alfredo, Bracarda, S, Basso, U, Galli, L, Tortora, G, Alietta, M, Fukasawa, S, Suzuki, H, Hasumi, H, Tsuchiya, T, Uemura, H, Kanayama, H, Hashine, K, Sato, F, Matsumoto, H, Oya, M, Lee, Jl, Park, S, Keam, B, Yun, H, Kim, Y, Kang, B, Lee, K, Kim, C, Saad, M, Sundram, M, Calvo, D, Moreno, R, Rodriquez, J, Hernandez, C, van den Berg, H, De La Rosett, J, Van Moorse, R, Hunting, J, Hendriks, M, Kueppers, F, Gilling, P, Beaven, A, Holmes, M, Jassem, J, Oszukowska, E, Niezabitowski, J, Jaxa Larecka, D, Chwalinski, M, Swiniarski, P, Silva, C, Conceicãoa, P, Fraga, A, Mauricio, J, Rodrigues, T, Pinheiro, L, Lima, E, Palma Dos Reis, J, Volovat, C, Jinga, V, Harza, M, Alyasova, A, Budnik, N, Bychkov, Y, Izmaylov, A, Khvorosten, D, Matveev, V, Novsov, A, Vladimirov, V, Tevs, D, Sheveleva, L, Bulanov, A, Semenov, A, Fadeeva, N, Kulikov, E, Emelyanov, S, Karyakin, O, Shirinkin, V, Shkolnik, M, Lykov, A, Skopin, P, Kopyltsov, E, Mincik, I, Mir, O, Kliment, J, Mikurcik, E, Gajdos, M, Milichovsky, I, Malan, J, Bahlmann, J, Moshokoa, E, Madlala, T, Coetzee, L, Ribal, M, Miñana, B, Martinez Breijo, S, Carballido, J, Olmos, D, Requena, M, Morote, J, Damber, Je, Haggman, M, Nyman, C, Ljungberg, B, Bjartell, A, Ozen, H, Beduk, Y, Sozen, S, Cetinkaya, M, Ozyurt, M, Tansug, Z, Mungan, A, Tanidir, Y, Toktas, M, Hotko, E, Stus, V, Lyulko, O, Vinnyk, Y, Shparyk, Y, Sakalo, V, Bondarenko, I, Paramonov, V, Khareba, G, Hodos, V., Lääketieteen ja biotieteiden tiedekunta - Faculty of Medicine and Life Sciences, Tampere University, UCL - SSS/IREC/MONT - Pôle Mont Godinne, and UCL - (MGD) Service d'oncologie médicale

Subjects
Adult, Male, medicine.medical_specialty, Prednisolone, Kirurgia, anestesiologia, tehohoito, radiologia - Surgery, anesthesiology, intensive care, radiology, Abiraterone Acetate, 030232 urology & nephrology, Urology, 03 medical and health sciences, Prostate cancer, chemistry.chemical_compound, 0302 clinical medicine, Prednisone, Antineoplastic Combined Chemotherapy Protocols, 80 and over, medicine, Humans, Aged, Aged, 80 and over, Androgen Antagonists, Middle Aged, Neoplasm Metastasis, Prostatic Neoplasms, Steroid 17-alpha-Hydroxylase, Survival Analysis, Medicine (all), Gynecology, business.industry, Apalutamide, Abiraterone acetate, General Medicine, medicine.disease, Interim analysis, Clinical trial, Darolutamide, chemistry, 030220 oncology & carcinogenesis, business, medicine.drug
Abstract

Abiraterone acetate, a drug that blocks endogenous androgen synthesis, plus prednisone is indicated for metastatic castration-resistant prostate cancer. We evaluated the clinical benefit of abiraterone acetate plus prednisone with androgen-deprivation therapy in patients with newly diagnosed, metastatic, castration-sensitive prostate cancer. In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 1199 patients to receive either androgen-deprivation therapy plus abiraterone acetate (1000 mg daily, given once daily as four 250-mg tablets) plus prednisone (5 mg daily) (the abiraterone group) or androgen-deprivation therapy plus dual placebos (the placebo group). The two primary end points were overall survival and radiographic progression-free survival. After a median follow-up of 30.4 months at a planned interim analysis (after 406 patients had died), the median overall survival was significantly longer in the abiraterone group than in the placebo group (not reached vs. 34.7 months) (hazard ratio for death, 0.62; 95% confidence interval [CI], 0.51 to 0.76; P

Published
2017

15. Prospective Observational Study of Pazopanib in Patients with Advanced Renal Cell Carcinoma (PRINCIPAL Study)

Author

Schmidinger, M. Bamias, A. Procopio, G. Hawkins, R. Sanchez, A.R. Vázquez, S. Srihari, N. Kalofonos, H. Bono, P. Pisal, C.B. Hirschberg, Y. Dezzani, L. Ahmad, Q. Jonasch, E. Gimeno, R.A. Herranz, U.A. Ardavanis, A. Ashraf, S.A. Bamias, A. Barone, C. Bella, S.R. Belz, H. Companario, E.B. Bolling, C. Bono, P. Bothe, K. Carteni, G. Espinosa, J.C. Clausse, M. Confente, C. Coskun, H. Herrero, G.C. Demey, W. D'hondt, R. Santasusana, M.D. Doshi, G. Elkiran, E. Facchini, G. Fein, L. Calvo, O.F. Flaherty, A. Fountzilas, G. Fruehauf, J. Díaz, E.G. Garcia, R. Domínguez, R.G. Ghosn, M. Glorieux, P. Goebell, P.J. Gutierrez, L.G.-A. Gonzalez, M. Green, N.B. Arnau, M.G. Harich, H.-D. Hawkins, R. Hegele, A. Pérez, C.H. Herrmann, E. Horniniger, W.J. Hutson, T.E. Janetschek, G. Kalantari, H. Kalofonos, H. Klausmann, M. Kolin, M. Krause, S. Kroening, H. Sorrosal, J.J.L. Lázaro, M. Lema, M. Lema, M.L. Lin, J. Lueck, A. Lybaert, W. Magi, A. Marina, V.A. Rey, J.P.M. Matus, G. Melear, J. Gonzalez, B.M. Milella, M. Montalar, J. Ferrandis, J.M. Nathan, P. Nechushtan, H. Nusch, A. Ojamaa, K. Oksuzoglu, B. Ozkan, M. Papazisis, K. Passalacqua, R. Pe'er, A. Gracia, J.L.P. Pichler, A. Pokker, H. Porta, C. Rauchenwald, M. Richardet, M.E. Richey, S.L. Garcia, J.M.R. Sánchez, A.R. Rudolph, R. Sabbatini, R. Salmon, J.-P. Lobera, C.S. Sarid, D.L. Saylors, G.B. Schmidinger, M. Schrijvers, D. Schulze, M. Sevilay, A. Shumaker, G.G. Siemer, S. de Prado y Otero, D.S. Srihari, N. Stoiber, F. Rodriguez, C.S. Varela, M.S. Vasanthan, S. Estevez, S.V. Vehling-Kaiser, U. Vogelzang, N. Weiss, H. Whenham, N. Wyendaele, W. Yildiz, R. Yucel, I. Zarba, J.J. Zarkar, A. Zhong, W. Ziem, P. the PRINCIPAL Study Group

Abstract

Background: Real-world data are essential to accurately assessing efficacy and toxicity of approved agents in everyday practice. PRINCIPAL, a prospective, observational study, was designed to confirm the real-world safety and efficacy of pazopanib in patients with advanced renal cell carcinoma (RCC). Subjects, Materials, and Methods: Patients with clear cell advanced/metastatic RCC and a clinical decision to initiate pazopanib treatment within 30 days of enrollment were eligible. Primary objectives included progression-free survival (PFS), overall survival (OS), objective response rate (ORR), relative dose intensity (RDI) and its effect on treatment outcomes, change in health-related quality of life (HRQoL), and safety. We also compared characteristics and outcomes of clinical-trial-eligible (CTE) patients, defined using COMPARZ trial eligibility criteria, with those of non-clinical-trial-eligible (NCTE) patients. Secondary study objectives were to evaluate clinical efficacy, safety, and RDI in patient subgroups. Results: Six hundred fifty-seven patients were enrolled and received ≥1 dose of pazopanib. Median PFS and OS were 10.3 months (95% confidence interval [CI], 9.2–12.0) and 29.9 months (95% CI, 24.7 to not reached), respectively, and the ORR was 30.3%. HRQoL showed no or little deterioration over time. Treatment-related serious adverse events (AEs) and AEs of special interest occurred in 64 (9.7%), and 399 (60.7%) patients, respectively. More patients were classified NCTE than CTE (85.2% vs. 14.8%). Efficacy of pazopanib was similar between the two groups. Conclusion: PRINCIPAL confirms the efficacy and safety of pazopanib in patients with advanced/metastatic RCC in a real-world clinical setting. Implications for Practice: PRINCIPAL is the largest (n = 657) prospective, observational study of pazopanib in patients with advanced/metastatic renal cell carcinoma, to the authors’ knowledge. Consistent with clinical trial results that often contain specific patient types, the PRINCIPAL study demonstrated that the effectiveness and safety of pazopanib is similarly safe and effective in patients with advanced kidney cancer in a real-world clinical setting. The PRINCIPAL study showed that patients with advanced kidney cancer who are treated with first-line pazopanib generally do not show disease progression for approximately 10 months and generally survive for nearly 30 months. © AlphaMed Press 2019

Published
2019

16. Summary of the International Conference on Onco-Nephrology: an emerging field in medicine

Author

Capasso, A., Benigni, A., Capitanio, U., Danesh, F. R., Di Marzo, V., Gesualdo, L., Grandaliano, Giuseppe, Jaimes, E. A., Malyszko, J., Perazella, M. A., Qian, Q., Ronco, P., Rosner, M. H., Trepiccione, F., Viggiano, D., Zoccali, C., Capasso, G., Akitaka, A., Alahoti, A., Alexander, T. R., Altucci, L., Amer, H., Barone, V., Biancone, L., Bonventre, J. V., Camussi, G., Ciardiello, F., Caraglia, M., Carteni, G., Cervantes, A., Citterio, Franco, Cosmai, L., Daniele, B., D'Errico, A., De Vita, F., Ereditato, A., Falco, G., Fouque, D., Franco, R., Gallieni, M., Gambaro, G., Kuo, C., Launay-Vacher, V., Maiello, E., Mallamaci, F., Malysxko, J., Marino, G., Martinelli, E., Matarese, G., Matsubara, T., Messa, P., Messina, C., Mirone, V., Morgillo, F., Costa, A. N., Orditura, M., Pani, A., Perna, A., Pisano, C., Pitts, T., Porta, C., Procopio, G., Remuzzi, G., Russo, D., Siu, L. L., Stadler, W., Troiani, T., Weisz, A., Wiecek, A., Xiaoqiang, D., Zecchino, O., Grandaliano G. (ORCID:0000-0003-1213-2177), Citterio F. (ORCID:0000-0003-0489-6337), Capasso, A., Benigni, A., Capitanio, U., Danesh, F. R., Di Marzo, V., Gesualdo, L., Grandaliano, Giuseppe, Jaimes, E. A., Malyszko, J., Perazella, M. A., Qian, Q., Ronco, P., Rosner, M. H., Trepiccione, F., Viggiano, D., Zoccali, C., Capasso, G., Akitaka, A., Alahoti, A., Alexander, T. R., Altucci, L., Amer, H., Barone, V., Biancone, L., Bonventre, J. V., Camussi, G., Ciardiello, F., Caraglia, M., Carteni, G., Cervantes, A., Citterio, Franco, Cosmai, L., Daniele, B., D'Errico, A., De Vita, F., Ereditato, A., Falco, G., Fouque, D., Franco, R., Gallieni, M., Gambaro, G., Kuo, C., Launay-Vacher, V., Maiello, E., Mallamaci, F., Malysxko, J., Marino, G., Martinelli, E., Matarese, G., Matsubara, T., Messa, P., Messina, C., Mirone, V., Morgillo, F., Costa, A. N., Orditura, M., Pani, A., Perna, A., Pisano, C., Pitts, T., Porta, C., Procopio, G., Remuzzi, G., Russo, D., Siu, L. L., Stadler, W., Troiani, T., Weisz, A., Wiecek, A., Xiaoqiang, D., Zecchino, O., Grandaliano G. (ORCID:0000-0003-1213-2177), and Citterio F. (ORCID:0000-0003-0489-6337)

Abstract

Onco-nephrology is an emerging field in medicine. Patients with cancer may suffer from kidney diseases because of the cancer itself and cancer-related therapy. It is critical for nephrologists to be knowledgeable of cancer biology and therapy in order to be fully integrated in the multidisciplinary team and optimally manage patients with cancer and kidney diseases. In a recent international meeting, the key issues in this challenging clinical interface were addressed, including many unresolved basic science questions, such as the high tumor incidence in kidney transplant recipients. To this end, 70 highly qualified faculty members were gathered from all over the world to discuss these issues in 8 plenary sessions, including 5 keynote lectures. In addition, 48 young nephrologists and oncologists were invited to present their original observations that were highlighted in 2 large poster sessions.

Published
2019

18. Synchronous Mammary Metastasis Mimicking a Primary Breast Cancer: A Case Report and Review of Literature

Author

Savastano C, Riccardi F, Giuliano M, Mocerino C, Pirozzi A, Campione S, and Carteni G

Subjects
0301 basic medicine, Oncology, medicine.medical_specialty, business.industry, medicine.disease, Metastasis, 03 medical and health sciences, 030104 developmental biology, 0302 clinical medicine, 030220 oncology & carcinogenesis, Internal medicine, medicine, business, Primary breast cancer
Published
2018

19. Immune-related adverse events correlate with clinical outcomes in non-small cell lung cancer (NSCLC) patients treated with nivolumab in the Italian expanded access programme

Author

Baldini, E., primary, Lunghi, A., additional, Cortesi, E., additional, Turci, D., additional, Garassino, M.C., additional, Stati, V., additional, Ardizzoni, A., additional, Ricciuti, B., additional, Frassoldati, A., additional, Romano, G., additional, Illiano, A., additional, Verderame, F., additional, Fasola, G., additional, Marchetti, P., additional, Pinto, C., additional, Carteni, G., additional, Scotti, V., additional, Tibaldi, C., additional, Fioretto, L., additional, and Giannarelli, D., additional

Published
2018
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20. 696P Is it possible to improve the prognostic ability of the IMDC score? Validation of the Meet-URO score in metastatic renal cell carcinoma (mRCC) patients (pts) receiving first-line nivolumab plus ipilimumab in the Italian Expanded Access Program (EAP)

Author

Rebuzzi, S.E., Signori, A., Maruzzo, M., Tortora, G., Galli, L., Rizzo, M., De Giorgi, U., Antonuzzo, L., Bracarda, S., Cartenì, G., Atzori, F., Tamberi, S., Procopio, G., Fratino, L., Santoni, M., Baldessari, C., Astone, A., Calabro', F., Buti, S., and Fornarini, G.

Published
2021
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21. Erratum to: Breakthrough pain and its treatment: critical review and recommendations of IOPS (Italian Oncologic Pain Survey) expert group

Author

Mercadante, Sebastiano, Marchetti, Paolo, Cuomo, Arturo, Mammucari, Massimo, Caraceni, Augusto, Mediati, RD, Caruselli, A, Costanzi, A, Bracchi, P, Dodaro, L, Contu, V, Fora, G, Veronese, B, Alu, M, Chiurazzi, B, Sgarlata, M, Kasa, A, Donelli, E, Silvestro, S, Romano, C, Ghidoni, S, Palermo, L, Pisanu, GM, Imperatori, L, Diacciati, S, Bruno, E, Saulle, S, Bonotto, M, De Santis, S, Tammaro, D, Ginocchi, L, Zampieri, M, Fioroni, I, Gallo, G, Saber, B, Dauri, M, Airoldi, M, Azzarello, G, Bandera, M, Blasi, L, Carteni, G, Costanzo, V, Degiovanni, D, Fusco, F, Guardamagna, V, Iaffaioli, V, Lazzari, M, Liguori, S, Lorusso, V, Mameli, S, Mattioli, R, Mazzei, T, Menardo, V, Miotti, D, Moroso, S, Natoli, S, Orsetti, R, Papa, A, Ricci, S, Sabato, AF, Scelzi, E, Sofia, M, Tonini, G, Valle, A., SAMOLSKY DEKEL, BOAZ GEDALIAHU, MELOTTI, RITA MARIA, Mercadante, Sebastiano, Marchetti, Paolo, Cuomo, Arturo, Mammucari, Massimo, Caraceni, Augusto, Mediati, RD, Caruselli, A, Costanzi, A, Bracchi, P, Dodaro, L, Contu, V, Fora, G, Veronese, B, Alu, M, Chiurazzi, B, Sgarlata, M, Kasa, A, Donelli, E, Silvestro, S, Romano, C, Ghidoni, S, Palermo, L, Pisanu, GM, Imperatori, L, Diacciati, S, Samolsky Dekel, Boaz Gedaliahu, Bruno, E, Saulle, S, Bonotto, M, De Santis, S, Tammaro, D, Ginocchi, L, Zampieri, M, Fioroni, I, Gallo, G, Saber, B, Dauri, M, Airoldi, M, Azzarello, G, Bandera, M, Blasi, L, Carteni, G, Costanzo, V, Degiovanni, D, Fusco, F, Guardamagna, V, Iaffaioli, V, Lazzari, M, Liguori, S, Lorusso, V, Mameli, S, Mattioli, R, Mazzei, T, Melotti, RM, Menardo, V, Miotti, D, Moroso, S, Natoli, S, Orsetti, R, Papa, A, Ricci, S, Sabato, AF, Scelzi, E, Sofia, M, Tonini, G, and Valle, A

Subjects
Fentanyl, Opioids, Morphine, Oncology, Breakthrough pain
Abstract

Controversies exist about the definition and epidemiology of breakthrough cancer pain (BTcP), the pharmacological treatment options, drug dosing, and how to select the medications for BTcP among the new fentanyl products. Existing data were critically evaluated to provide recommendations by an expert group. An algorithm to diagnose BTcP should be used followed by a careful assessment. Fentanyl products provide efficacy and rapidity of action to counteract the temporal pattern of BTcP. The doses of opioids used for background pain should guide the choice of the doses of fentanyl products. The choice of fentanyl products should be based on individual clinical conditions.

Published
2017

22. Prevalence of malnutrition in patients at first medical oncology visit: The PreMiO study

Author

Muscaritoli, M, Lucia, S, Farcomeni, A, Lorusso, V, Saracino, V, Barone, C, Plastino, F, Gori, S, Magarotto, R, Carteni, G, Chiurazzi, B, Pavese, I, Marchetti, L, Zagonel, V, Bergo, E, Tonini, G, Imperatori, M, Iacono, C, Maiorana, L, Pinto, C, Rubino, D, Cavanna, L, Di Cicilia, R, Gamucci, T, Quadrini, S, Palazzo, S, Minardi, S, Merlano, M, Colucci, G, Marchetti, P, Fioretto, L, Cipriani, G, Barni, S, Lonati, V, Frassoldati, A, Surace, Gc, Porzio, G, Martella, F, Altavilla, G, Santarpia, Mc, Pronzato, P, Levaggi, A, Contu, A, Contu, M, Adamo, V, Berenato, R, Marchetti, F, Pellegrino, A, Violante, S, and Guida, M

Subjects
Oncology, medicine.medical_specialty, Sarcopenia, Cachexia, Cachexia, Cancer, Malnutrition, Oncology, Sarcopenia, Socio-culturale, Teaching hospital, 03 medical and health sciences, 0302 clinical medicine, Physical functioning, Internal medicine, Cancer centre, Cancer, Malnutrition, medicine, In patient, Appetite status, 030212 general & internal medicine, business.industry, Public health, medicine.disease, humanities, 030220 oncology & carcinogenesis, Clinical Research Paper, business, Settore SECS-S/01 - Statistica, FAACT Questionnaire
Abstract

// Maurizio Muscaritoli 1 , Simone Lucia 1 , Alessio Farcomeni 2 , Vito Lorusso 3 , Valeria Saracino 3 , Carlo Barone 4 , Francesca Plastino 4 , Stefania Gori 5 , Roberto Magarotto 5 , Giacomo Carteni 6 , Bruno Chiurazzi 6 , Ida Pavese 7 , Luca Marchetti 7 , Vittorina Zagonel 8 , Eleonora Bergo 8 , Giuseppe Tonini 9 , Marco Imperatori 9 , Carmelo Iacono 10 , Luigi Maiorana 10 , Carmine Pinto 11 , Daniela Rubino 11 , Luigi Cavanna 12 , Roberto Di Cicilia 12 , Teresa Gamucci 13 , Silvia Quadrini 13 , Salvatore Palazzo 14 , Stefano Minardi 14 , Marco Merlano 15 , Giuseppe Colucci 16 and Paolo Marchetti 17, 18 , on behalf of the PreMiO Study Group 19 1 Department of Clinical Medicine, Sapienza University of Rome, Rome, Italy 2 Department of Public Health and Infectious Diseases, Sapienza University of Rome, Rome, Italy 3 Department of Medical Oncology, National Cancer Research Centre Giovanni Paolo II, Bari, Italy 4 Department of Medical Oncology, Catholic University of Sacred Heart, Largo A. Gemelli, Rome, Italy 5 Medical Oncology Unit, Ospedale Sacro Cuore Don Calabria, Verona, Italy 6 Oncology Unit, Antonio Cardarelli Hospital, Naples, Italy 7 Oncology Unit, San Pietro Fatebenefratelli Hospital, Rome, Italy 8 Department of Clinical and Experimental Oncology, Medical Oncology 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy 9 Department of Oncology, University Campus Bio-Medico of Rome, Rome, Italy 10 Department of Medical Oncology, Azienda Ospedaliera Civile - Maria Paterno Arezzo, Ragusa, Italy 11 Medical Oncology, Clinical Cancer Centre, IRCCS-Arcispedale S. Maria Nuova, Reggio Emilia, Italy 12 Department of Oncology-Hematology, Guglielmo da Saliceto Hospital, Piacenza, Italy 13 Medical Oncology Unit, S.S. Trinita Hospital, Sora, Italy 14 Division of Medical Oncology, Mariano Santo Hospital, Azienda Ospedaliera, Cosenza, Italy 15 Medical Oncology, Oncology Department, S. Croce & Carle Teaching Hospital, Cuneo, Italy 16 Medical Oncology Department, National Cancer Research Centre Giovanni Paolo II, Bari, Italy 17 Department of Clinical and Molecular Medicine, Faculty of Medicine and Psychology Sapienza, St. Andrea Hospital, Rome, Italy 18 IDI-IRCCS, Rome, Italy 19 The PreMiO Study group also included investigators who contributed to patients’ enrollment Correspondence to: Maurizio Muscaritoli, email: maurizio.muscaritoli@uniroma1.it Keywords: malnutrition, cancer, cachexia, sarcopenia, oncology Received: April 27, 2017 Accepted: June 20, 2017 Published: August 10, 2017 ABSTRACT Background: In cancer patients, malnutrition is associated with treatment toxicity, complications, reduced physical functioning, and decreased survival. The Prevalence of Malnutrition in Oncology (PreMiO) study identified malnutrition or its risk among cancer patients making their first medical oncology visit. Innovatively, oncologists, not nutritionists, evaluated the nutritional status of the patients in this study. Methods: PreMiO was a prospective, observational study conducted at 22 medical oncology centers across Italy. For inclusion, adult patients (>18 years) had a solid tumor diagnosis, were treatment-naive, and had a life expectancy >3 months. Malnutrition was identified by the Mini Nutritional Assessment (MNA), appetite status with a visual analog scale (VAS), and appetite loss with a modified version of Anorexia-Cachexia Subscale (AC/S-12) of the Functional Assessment of Anorexia-Cachexia Therapy (FAACT). Findings: Of patients enrolled ( N= 1,952), 51% had nutritional impairment; 9% were overtly malnourished, and 43% were at risk for malnutrition. Severity of malnutrition was positively correlated with the stage of cancer. Over 40% of patients were experiencing anorexia, as reported in the VAS and FAACT questionnaire. During the prior six months, 64% of patients lost weight (1–10 kg). Interpretation: Malnutrition, anorexia, and weight loss are common in cancer patients, even at their first visit to a medical oncology center.

Published
2017

23. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy

Author

Ravaud, A, Motzer, Rj, Pandha, Hs, George, Dj, Pantuck, Aj, Patel, A, Chang, Yh, Escudier, B, Donskov, F, Magheli, A, Carteni, G, Laguerre, B, Tomczak, P, Breza, J, Gerletti, P, Lechuga, M1, Lin, X, Martini, Jf, Ramaswamy, K, Casey, M, Staehler, M, Patard, Jj, Gruenwald, V, Link, K, Doehn, C, Heinzer, H, Grimm, M-O, Wirth, M, Stoeckle, M, Heidenreich, A, Garcia del Muro Solans, X, Mellado, Bo, Castellano, Dg, Frydenberg, M, Schobinger, Sr, Dimopoulos, Ma, Rothermundt, C, Climent Duran MA, Melotti, B, Procopio, G, Boccardo, F, Sella, A, Stewart, S, Adenis, A, Jones, Rj, Chevreau, C, Prausova, J, Vyzula, R, Oudard, S, Jacqmin, D, Gravis, G, Varela, R, Herrmann, E, Lim, Hy, Lee, J-L, Kim, Yh, Kim, Jh, Y-C, Ou, Papakotoulas, P, Iacobelli, S, Chowdhury, S, Passalacqua, R, Tomasek, J, Anton Aparicio LM, Linassier, C, Hauser, S, Bergmann, L, Hawkins, Re, Szczylik, C, Zdrojowy, R, Sosnowski, M, Koralewski, P, Wiechnio, Pj, Schraml, J, Mardiak, J, Laurinc, P, Kliment, J, Rosenbaum, E, Lundstam, S, Flodgren, P, Ljungberg, B, Stenzl, A, Schnoeller, Tj, Mcdermott, Sr, Breathnach, Os, Mccaffrey, Ja, Donnellan, P, The, G-C, Rolland, F, Brekkan, E, Nilsson, C, Kim, Wy, Bishoff, J, Chung, J, Shore, Nd, Master, V, Tang Chen DY, Ye, D, Huang, Y, Jin, J, Song, B, Zhou, F, Galceran, Jc, Yao, X, and Zhang, X.

Subjects
Male, Indoles, medicine.medical_treatment, Clinical Trial, Phase III, 030232 urology & nephrology, Nephrectomy, 0302 clinical medicine, Renal cell carcinoma, Clinical endpoint, 80 and over, Adjuvant, Aged, 80 and over, Adolescent, Adult, Aged, Antineoplastic Agents, Carcinoma, Renal Cell, Chemotherapy, Adjuvant, Double-Blind Method, Drug Administration Schedule, Female, Humans, Kidney Neoplasms, Middle Aged, Pyrroles, Survival Analysis, Young Adult, Medicine (all), Sunitinib, General Medicine, Multicenter Study, 030220 oncology & carcinogenesis, Randomized Controlled Trial, medicine.drug, medicine.medical_specialty, Urology, Placebo, 03 medical and health sciences, Journal Article, Carcinoma, medicine, Chemotherapy, Survival analysis, business.industry, Renal Cell, medicine.disease, Surgery, Clinical trial, business
Abstract

BACKGROUNDSunitinib, a vascular endothelial growth factor pathway inhibitor, is an effectivetreatment for metastatic renal-cell carcinoma. We sought to determine the efficacyand safety of sunitinib in patients with locoregional renal-cell carcinoma athigh risk for tumor recurrence after nephrectomy.METHODSIn this randomized, double-blind, phase 3 trial, we assigned 615 patients withlocoregional, high-risk clear-cell renal-cell carcinoma to receive either sunitinib(50 mg per day) or placebo on a 4-weeks-on, 2-weeks-off schedule for 1 year oruntil disease recurrence, unacceptable toxicity, or consent withdrawal. The primaryend point was disease-free survival, according to blinded independent central review.Secondary end points included investigator-assessed disease-free survival,overall survival, and safety.RESULTSThe median duration of disease-free survival was 6.8 years (95% confidence interval[CI], 5.8 to not reached) in the sunitinib group and 5.6 years (95% CI, 3.8 to6.6) in the placebo group (hazard ratio, 0.76; 95% CI, 0.59 to 0.98; P=0.03). Overallsurvival data were not mature at the time of data cutoff. Dose reductions becauseof adverse events were more frequent in the sunitinib group than in theplacebo group (34.3% vs. 2%), as were dose interruptions (46.4% vs. 13.2%) anddiscontinuations (28.1% vs. 5.6%). Grade 3 or 4 adverse events were more frequentin the sunitinib group (48.4% for grade 3 events and 12.1% for grade 4 events)than in the placebo group (15.8% and 3.6%, respectively). There was a similarincidence of serious adverse events in the two groups (21.9% for sunitinib vs.17.1% for placebo); no deaths were attributed to toxic effects.CONCLUSIONSAmong patients with locoregional clear-cell renal-cell carcinoma at high risk fortumor recurrence after nephrectomy, the median duration of disease-free survivalwas significantly longer in the sunitinib group than in the placebo group, at a costof a higher rate of toxic events. (Funded by Pfizer; S-TRAC ClinicalTrials.gov number,NCT00375674.)

Published
2016

26. 721P Ipilimumab and nivolumab compassionate use program in metastatic renal cell carcinoma patients with intermediate or poor IMDC risk score: The large multicenter Italian study

Author

Basso, U., Paolieri, F., Porta, C.G., De Giorgi, U., Bracarda, S., Antonuzzo, L., Atzori, F., Cartenì, G., Procopio, G., Fratino, L., D'Arcangelo, M., Fornarini, G., Zucali, P.A., Cusmai, A., Santoni, M., Baldessari, C., Naglieri, E., Panni, S., Zagonel, V., and Tortora, G.

Published
2020
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27. S-TRAC adjuvant sunitinib phase 3 trial in patients with high risk renal cell carcinoma: Subgroups analyses by risk factors

Author

Staehler, M., primary, Patard, J.-J., additional, Pantuck, A., additional, Ravaud, A., additional, Motzer, R., additional, Pandha, H., additional, George, D., additional, Chang, Y.-H., additional, Escudier, B., additional, Donskov, F., additional, Magheli, A., additional, Carteni, G., additional, Laguerre, B., additional, Tomczak, P., additional, Breza, J., additional, Gerletti, P., additional, Lechuga, M., additional, Lin, X., additional, Casey, M., additional, and Patel, A., additional

Published
2017
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28. System Dynamics modeling of tumor growth: a possible tool for optimization of pharmacological treatment?

Author

CARTENI', FABRIZIO, GIANNINO, FRANCESCO, MAZZOLENI, STEFANO, Rizzo M, Carteni G, Virginia Lanzotti, Carteni', Fabrizio, Rizzo, M, Giannino, Francesco, Carteni, G, and Mazzoleni, Stefano

Abstract

Process-based modeling has been widely used to simulate the behavior of all kinds of biological systems. Recent modeling studies on plants, proposed a new concept of autotoxicity as a main driver, along environmental gradients, of plant systems development (Mazzoleni et al., 2010). The release of autotoxic compounds was showed to be responsible for the generation of ring-like spatial patterns of individual plants, presenting an increase of dead biomass in their central growth zone (Cartenì et al., 2012). This has been recently associated to the levels of washing out of turnover products, showing that the occurrence of spatial patterns is dependent on the balance between positive and negative feedbacks by nutrients and toxic products respectively (Marasco et al., 2013). In oncology, simulation modeling was used to understand and predict tumor growth and also to anticipate the effects of different therapies (Anderson and Quaranta, 2008). In this work we discuss the possible application of the autotoxicity hypothesis on modeling the growth of solid tumors. In particular, simulations are implemented showing the development and the spatial arrangement, in relation to different levels of vascularization, of 3 different layers: (i) proliferating, (ii) quiescent and (iii) necrotic cells

Published
2013

30. Prevalence and treatment of cancer pain in Italian oncological wards centres: a cross-sectional survey

Author

MERCADANTE, S, ROILA, F, BERRETTO, O, LABIANCA, R, CASILINI, S, BOTTERO, G, TROVA, V, CASCINU, S, DI VITO, F, LORUSSO, V, TROCCOLI, G, ENDRIZZI, L, DANIELE, B, MARTONI, A, MARINI, G, VITELLO, S, ROMITO, S, SBALZARINI, G, SERRAVEZZA, G, MANENTE, P, MOLICA, S, PALAZZO, S, PRANTERA, T, MERLANO, M, DI GIROLAMO, G, AMADORI, D, SOBRERO, A, ALGERI, R, BRETTI, S, GRECO, E, D'APRILE, M, FORCIGNANO, C, BONETTI, A, AITINI, E, PIAZZA, E, PIVA, L, TABBIADON, D, CARTENI', G, CATALANO, G, ALABISO, O, LANDRISCINA, G, DOGLIOTTI, L, FILIPPELLI, G, BERTE', R, RICCI, S, MANZIONE, L, IACONO, C, MARANGOLO, M., GEBBIA, Nicolo', PALMERI, Sergio, MERCADANTE, S, ROILA, F, BERRETTO, O, LABIANCA, R, CASILINI, S, BOTTERO, G, TROVA, V, CASCINU, S, DI VITO, F, LORUSSO, V, TROCCOLI, G, ENDRIZZI, L, DANIELE, B, MARTONI, A, MARINI, G, VITELLO, S, ROMITO, S, SBALZARINI, G, SERRAVEZZA, G, MANENTE, P, MOLICA, S, PALAZZO, S, PRANTERA, T, MERLANO, M, DI GIROLAMO, G, AMADORI, D, SOBRERO, A, ALGERI, R, BRETTI, S, GRECO, E, D'APRILE, M, FORCIGNANO, C, BONETTI, A, AITINI, E, PIAZZA, E, PIVA, L, TABBIADON, D, CARTENI', G, CATALANO, G, ALABISO, O, LANDRISCINA, G, DOGLIOTTI, L, GEBBIA, N, PALMERI, S, FILIPPELLI, G, BERTE', R, RICCI, S, MANZIONE, L, IACONO, C, and MARANGOLO, M

Subjects
Adult, Male, medicine.medical_specialty, Settore MED/06 - Oncologia Medica, Cross-sectional study, Pain medicine, MEDLINE, Pain, Severity of Illness Index, Neoplasms, Oncology Service, Hospital, Epidemiology, Severity of illness, medicine, Prevalence, Humans, Aged, Aged, 80 and over, Primary Health Care, business.industry, Cancer pain,Epidemiology,Opioids, Nursing research, Physicians, Family, Middle Aged, Large sample, Analgesics, Opioid, Cross-Sectional Studies, Oncology, Italy, Family medicine, Health Care Surveys, Physical therapy, Female, Cancer pain, business
Abstract

The aim of this national cross-sectional survey was to draw information on pain prevalence and intensity from a large sample of patients who were admitted to oncologic centres for different reasons and to evaluate the pain treatment and possible influencing factors.A total of 2,655 patients completed the study. Nine hundred and one patients (34%) reported pain.Higher pain levels were observed in inpatients, in the presence of bone metastases, and with low levels of Eastern Cooperative Oncology Group status. The number of patients receiving strong opioids increased with the highest levels of pain. However, a significant part of patients with moderate-severe pain were not receiving appropriate medication, patients being predominantly administered non-opioid drugs. General practitioners' attitudes did not negatively influence the opioid prescription.The results of this survey indicate a need for continuing educational and informative program in pain management for oncologists and more generally for any physician dealing with cancer patients.

Published
2008

31. 53P - Immune-related adverse events correlate with clinical outcomes in non-small cell lung cancer (NSCLC) patients treated with nivolumab in the Italian expanded access programme

Author

Baldini, E., Lunghi, A., Cortesi, E., Turci, D., Garassino, M.C., Stati, V., Ardizzoni, A., Ricciuti, B., Frassoldati, A., Romano, G., Illiano, A., Verderame, F., Fasola, G., Marchetti, P., Pinto, C., Carteni, G., Scotti, V., Tibaldi, C., Fioretto, L., and Giannarelli, D.

Published
2018
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32. Preliminary efficacy and safety data of nivolumab in never smoker patients with advanced squamous NSCLC: Experience from Italian sites participating in the Expanded Access Programme (EAP)

Author

Vitali, M., primary, Crinò, L., additional, Logroscino, A.F., additional, Ardizzoni, A., additional, Caponnetto, S., additional, Landi, L., additional, Bordi, P., additional, Luana, C., additional, Barbieri, F., additional, Santo, A., additional, Santarpia, M., additional, Carteni, G., additional, Mini, E., additional, Vasile, E., additional, Morgillo, F., additional, De Galitiis, F., additional, Conca, R., additional, Macerelli, M., additional, Tedde, N., additional, and Vitiello, F., additional

Published
2016
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33. genitourinary tumours, non prostate Phase III trial of sunitinib (SU) vs placebo (PBO) as adjuvant treatment for high-risk renal cell carcinoma (RCC) after nephrectomy (S-TRAC)

Author

Ravaud, A., primary, Motzer, R.J., additional, Pandha, H.S., additional, Staehler, M., additional, George, D., additional, Pantuck, A.J., additional, Patel, A., additional, Chang, Y.-H., additional, Escudier, B., additional, Donskov, F., additional, Magheli, A., additional, Carteni, G., additional, Laguerre, B., additional, Tomczak, P., additional, Breza, J., additional, Gerletti, P., additional, Lin, X., additional, Lechuga, M., additional, Martini, J.-F., additional, and Patard, J.-J., additional

Published
2016
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34. Topotecan compared with no terapy and carboplatin/paclitaxel in patients with ovarian cancer: Multicenter Italian Trials in Ovarian Cancer (MITO-1) randomized study

Author

DE PLACIDO S, SCAMBIA G, DI VAGNO G, NAGLIERI E, LOMBARDI A. V, BIAMONTE R, MARINACCIO M, CARTENI G, MANZIONE L, FEBBRARO A, DE MATTEIS A, DANESE S, PERRONE F, LAURIA R, DE LAURENTIS M, GREGGI S, GALLO C, PIGNATA S., VALERIO, Maria Rosaria, DE PLACIDO S, SCAMBIA G, DI VAGNO G, NAGLIERI E, LOMBARDI A V, BIAMONTE R, MARINACCIO M, CARTENI G, MANZIONE L, FEBBRARO A, DE MATTEIS A, VALERIO MR, DANESE S, PERRONE F, LAURIA R, DE LAURENTIS M, GREGGI S, GALLO C, and PIGNATA S

Published
2004

36. An international expanded-access programme of everolimus: Addressing safety and efficacy in patients with metastatic renal cell carcinoma who progress after initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor therapy

Author

Grünwald, V, Karakiewicz, P, Bavbek, S, Miller, K, Machiels, J, Lee, S, Larkin, J, Bono, P, Rha, S, Castellano, D, Blank, C, Knox, J, Hawkins, R, Anak, O, Rosamilia, M, Booth, J, Pirotta, N, Bodrogi, I, Romedi, M, Ferrandini, S, Rondinon, M, Pittman, K, Goldstein, D, Shapiro, J, Troon, S, Yip, D, Mainwaring, P, Zigeuner, R, Loidl, W, Greil, R, Schmidinger, M, De Grève, J, Rottey, S, Vermorken, J, Gil, T, Gennigens, C, Roumeguere, T, Barrios, C, Mathias, C, Assi, H, Hotte, S, Spadafora, S, Wood, L, Zalewski, P, Mackensie, M, Bjarnason, G, Lalancette, A, Chan, A, Higgins, B, North, S, Soulieres, D, Asselah, J, Sperlich, C, Miller, W, Yadav, S, El Maraghi, R, Godoy, J, Prausová, J, Katolicka, J, Petruzelka, L, Kiss, I, Lapela, M, Bergmann, L, Beck, J, Jäger, E, Kindler, M, Overkamp, F, Wirth, M, Hölzer, W, Gschwend, J, Stenzl, A, Gauler, T, Niederwieser, D, Marschner, N, Lück, A, Tessen, H, Eichelberg, C, Steiner, T, Goebell, P, Kettner, E, Bakhshandeh Bath, A, Wilhelm, M, Schmitz, S, Jacob, A, Bierer, S, Kube, U, Staehler, M, Engel, E, Frambach, M, Schellenberger, U, Albers, P, Simon, J, Gleissler, M, Klotz, T, Repp, R, Kröning, H, Westermann, J, Rebmann, U, Brehmer, B, Niederle, N, Grund, C, Verpoort, K, Fonara, P, Rassweiler, J, Bamias, A, Fountzilas, G, Razis, E, Mouratidou, D, Georgoulias, V, Samantas, E, Mangel, L, Szanto, J, Berger, R, Pe'Er, A, Sella, A, Ben Yosef, R, Nechushtan, H, Crinò, L, Bracarda, S, Ciuffreda, L, Graiff, C, Falcone, A, Roselli, M, Sternberg, C, Santoro, A, Ruggeri, E, Bearz, A, Venturini, M, Aglietta, M, Amadori, D, Di Costanzo, F, Bari, M, Gebbia, N, Conte, P, Bonetti, A, Bordonaro, R, Cascinu, S, Contu, A, Cruciani, G, Gasparro, D, Nardi, M, Lelli, G, Lo Re, G, Boccardo, F, Lorusso, V, Maiello, E, Manente, P, Passalacqua, R, Piantedosi, F, Porta, C, Sacco, C, Tondini, C, De Placido, S, Carteni, G, Dogliotto, L, Rosti, G, Milella, M, Roila, F, Amoroso, D, Farina, G, Al Khatib, H, Kim, T, Ahn, J, Lim, H, Chung, I, Kim, J, Chung, J, Ghosn, M, Shameseddine, A, Lugo, R, Cabrera, P, Osanto, S, Groenewegen, G, van den Eertwegh, F, van Herpen, C, Oosting, S, Soetekouw, P, Lilleby, W, Klepp, O, Guren, T, Alcedo, J, Karlov, P, Nosov, D, Roman, L, Rusakov, I, Bazarbashi, S, Toh, C, Mardiak, J, del Muro Solans, F, Ray, J, Mollins, J, Martinez, I, Gonzalez, B, Santasusana, M, Piqueras, M, Fuentes, J, Larriba, J, Caro, R, Garcia, A, Aparicio, L, Lopez, N, Aragon, V, Morales, C, Figueiras, M, Ibanez, J, Billalabeitia, G, Estrada, E, Arranz, J, Sorrosal, J, Lozano, A, de Villena, M, Espinosa, E, Lopez, R, Perez, J, Laurell, A, Stierner, U, Cwikiel, M, Borner, M, Dietrich, P, Rothermundt, C, Pu, Y, Chang, Y, Ou, Y, Chuang, C, Liao, Y, Srimuninnimit, V, Sriuranpong, V, Buyukberber, S, Yalcin, B, Goker, E, Yalcin, S, Geldart, T, Wagstaff, J, Nicholson, S, Chowdhury, S, Bahl, A, Jones, R, Azzabi, A, Chao, D, Fife, K, Mead, G, Nathan, P, Pandha, H, Hajdenberg, J, Gabrail, N, Nimeh, N, Logan, T, Flaig, T, Schraeder, R, Rini, B, O'Rourke, M, Alemany, C, Kessinger, A, Amin, A, Arriaga, M, Rodriguez, J, Gauler, Thomas (Beitragende*r), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, Interne Geneeskunde, and Laboratory of Molecular and Medical Oncology

Subjects
Nephrology, Oncology, Male, Cancer Research, mTOR inhibitor, Settore MED/06 - Oncologia Medica, Medizin, Advanced kidney cancer, RAD001, REACT, 0302 clinical medicine, Renal cell carcinoma, Receptors, 80 and over, Treatment Failure, Neoplasm Metastasis, Aged, 80 and over, 0303 health sciences, Vascular Endothelial Growth Factor, Sirolimus, Young Adult, Antineoplastic Agents, Humans, Aged, Immunosuppressive Agents, Protein Kinase Inhibitors, Receptors, Vascular Endothelial Growth Factor, Kidney Neoplasms, Adult, Carcinoma, Renal Cell, Middle Aged, Female, 3. Good health, 030220 oncology & carcinogenesis, Safety, medicine.drug, medicine.medical_specialty, SECOND LINE THERPAY, Second-line therapy, Everolimus, 03 medical and health sciences, Internal medicine, medicine, Adverse effect, 030304 developmental biology, business.industry, Carcinoma, Renal Cell, medicine.disease, Surgery, Clinical trial, Expanded access, business, Kidney cancer
Abstract

BACKGROUND AND OBJECTIVES: The RECORD-1 trial established the clinical benefit of everolimus in patients with metastatic renal cell carcinoma (mRCC) after failure of initial vascular endothelial growth factor receptor-tyrosine kinase inhibitor (VEGFr-TKI) therapy. The REACT (RAD001 Expanded Access Clinical Trial in RCC) study was initiated to address an unmet medical need by providing everolimus prior to commercial availability, and also to further assess the safety and efficacy of everolimus in patients with VEGFr-TKI-refractory mRCC. PATIENTS AND METHODS: REACT (Clinicaltrials.gov: NCT00655252) was a global, open-label, expanded-access programme in patients with mRCC who were intolerant of, or who had progressed on or after stopping treatment with, any available VEGFr-TKI therapy. Patients received everolimus 10mg once daily, with dose and schedule modifications allowed for toxicity. Patients were closely monitored for the development of serious and grades 3/4 adverse events (AEs). Response was assessed by RECIST every 3months for the first year and every 6months thereafter. RESULTS: A total of 1367 patients were enroled. Safety findings and tumour responses were consistent with those observed in RECORD-1, with no new safety issues identified. The most commonly reported serious AEs were dyspnoea (5.0%), pneumonia (4.7%) and anaemia (4.1%), and the most commonly reported grades 3/4 AEs were anaemia (13.4%), fatigue (6.7%) and dyspnoea (6.5%). Best overall response was stable disease in 51.6% and partial response in 1.7% of patients. Median everolimus treatment duration was 14weeks. CONCLUSION: Everolimus is well tolerated in patients with mRCC and demonstrates a favourable risk-benefit ratio.

Published
2012

37. Time to response (TTR) and early tumor shrinkage (ETS) in recurrent glioblastoma patients treated with bevacizumab: an exploratory analysis of the prospective randomized AVAREG (ML25739) phase II study

Author

Franceschi, E., primary, Finocchiaro, G., additional, Zagonel, V., additional, Reni, M., additional, Fabi, A., additional, Caserta, C., additional, Clavarezza, M., additional, Maiello, E., additional, Carteni, G., additional, Rosti, G., additional, Agati, R., additional, Tosoni, A., additional, Proietti, E., additional, Paccapelo, A., additional, and Brandes, A.A., additional

Published
2015
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38. 2143 Regorafenib for previously treated metastatic colorectal cancer (mCRC): Results from 683 Italian patients treated in the open-label phase 3B CONSIGN study

Author

Ciardiello, F., primary, Falcone, A., additional, Cascinu, S., additional, Sobrero, A., additional, Boni, C., additional, Barone, C., additional, Luppi, G., additional, Maiello, E., additional, Siena, S., additional, Zagonel, V., additional, Carteni, G., additional, Constanzo, F. Di, additional, Bartolomeo, M. Di, additional, Santoro, A., additional, Russo, A., additional, Moscovici, M., additional, Van Cutsem, E., additional, and Zaniboni, A., additional

Published
2015
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39. Final results from the large sunitinib global expanded-access trial in metastatic renal cell carcinoma

Author

Gore, M E, primary, Szczylik, C, additional, Porta, C, additional, Bracarda, S, additional, Bjarnason, G A, additional, Oudard, S, additional, Lee, S-H, additional, Haanen, J, additional, Castellano, D, additional, Vrdoljak, E, additional, Schöffski, P, additional, Mainwaring, P, additional, Hawkins, R E, additional, Crinò, L, additional, Kim, T M, additional, Carteni, G, additional, Eberhardt, W E E, additional, Zhang, K, additional, Fly, K, additional, Matczak, E, additional, Lechuga, M J, additional, Hariharan, S, additional, and Bukowski, R, additional

Published
2015
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40. NI-26 * COMPARATIVE ANALYSIS OF THE RANO AND MACDONAD'S CRITERIA IN RECURRENT GLIOBLASTOMA TREATED IN THE RANDOMIZED PHASE II TRIAL AVAREG WITH BEVACIZUMAB OR FOTEMUSTINE.

Author

Franceschi, E., primary, Agati, R., additional, Finocchiaro, G., additional, Zagonel, V., additional, Fabi, A., additional, Reni, M., additional, Caserta, C., additional, Maiello, E., additional, Carteni, G., additional, Clavarezza, M., additional, Rosti, G., additional, Eoli, M., additional, Lombardi, G., additional, Bacci, A., additional, Monteforte, M., additional, Doria, S., additional, Galli, A., additional, and Brandes, A. A., additional

Published
2014
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41. AT-11 * FINAL RESULTS FROM THE RANDOMIZED PHASE II TRIAL AVAREG (ML25739) WITH BEVACIZUMAB (BEV) OR FOTEMUSTINE (FTM) IN RECURRENT GBM

Author

Brandes, A. A., primary, Finocchiaro, G., additional, Zagonel, V., additional, Reni, M., additional, Fabi, A., additional, Caserta, C., additional, Clavarezza, M., additional, Maiello, E., additional, Carteni, G., additional, Rosti, G., additional, Eoli, M., additional, Lombardi, G., additional, Monteforte, M., additional, Agati, R., additional, Eusebi, V., additional, Galli, A., additional, Doria, S., additional, and Franceschi, E., additional

Published
2014
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46. 904P - Inflammatory indexes strongly predict clinical outcome in patients (pts) with metastatic renal cell cancer (mRCC) treated with nivolumab: results from the Italian expanded access program (EAP)

Author

De Giorgi, U., Procopio, G., Guida, A., Bearz, A., Buti, S., Basso, U., Mitterer, M., Ortega, C., Bidoli, P., Ferrau, F., Crinò, L., Frassoldati, A., Marchetti, P., Mini, E., Scoppola, A., Verusio, C., Fornarini, G., Cartenì, G., Caserta, C., and Sternberg, C.N.

Published
2017
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50. Bone Metastases from Rcc are not Always Associated with a Poor Prognosis

Author

Santini, D., primary, Santoni, M., additional, Conti, A., additional, Procopio, G., additional, Porta, C., additional, Ibrahim, T., additional, Barni, S., additional, Fontana, A., additional, Berruti, A., additional, Vincenzi, B., additional, Ortega, C., additional, Carteni, G., additional, Fedeli, S.L., additional, Adamo, V., additional, Maiello, E., additional, Sabbatini, R., additional, Felici, A., additional, Tonini, G., additional, Bracarda, S., additional, and Cascinu, S., additional

Published
2014
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