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1. Indices of healthy and unhealthy plant-based diets and the risk of selected digestive cancers.

Author

Turati, Federica, Mignozzi, Silvia, Esposito, Giovanna, Bravi, Francesca, D'Angelo, Angela, Alicandro, Gianfranco, Garavello, Werner, Augustin, Livia S.A., Vitale, Sara, Giacosa, Attilio, Bidoli, Ettore, Polesel, Jerry, Negri, Eva, Ferraroni, Monica, and La Vecchia, Carlo

Abstract

The relation between various types of plant-based diets and cancer risk is still unclear. We examined the association of the overall plant-based diet index (PDI) and healthy (hPDI) and unhealthy plant-based diet indices (uPDI) with the risk of selected digestive cancers. We used data from a network of hospital-based case–control studies including 942 oral/pharyngeal, 304 esophageal, 230 stomach, 1953 colorectal, and 326 pancreatic cancer cases. We calculated PDI, hPDI, and uPDI from a validated food frequency questionnaire. We used multivariable logistic regression models to estimate the odds ratios (OR) of selected digestive cancers across the three indices (in quintiles, Q, or tertiles, T, and in continuous). The PDI was significantly inversely associated with oral/pharyngeal (OR Q5 vs Q1 =0.63, 95% confidence interval, CI, 0.47–0.84) and esophageal cancer risk (OR T3 vs T1 =0.47, 95% CI 0.31–0.72). The inverse associations appeared stronger for the hPDI (oral cavity/pharynx: OR Q5 vs Q1 =0.52; 95% CI 0.39–0.70; esophagus: OR T3 vs T1 =0.59, 95% CI 0.39–0.91; stomach: OR T3 vs T1 =0.42, 95% CI 0.27–0.67; colorectum: OR Q5 vs Q1 =0.69; 95% CI 0.57–0.84; pancreas: OR T3 vs T1 =0.60; 95% CI 0.41–0.89). In contrast, the uPDI was directly associated with the risk of oral/pharyngeal (OR Q5 vs Q1 =1.43, 95% CI 1.06-1.94), colorectal (OR Q5 vs Q1 =2.28, 95% CI 1.86–2.81), and pancreatic cancer (OR T3 vs T1 =1.74, 95% CI 1.14–2.65). Esophageal and stomach cancer risks were non-significantly increased by 34% and 46% respectively in the highest uPDI quantile. A plant-based diet, especially a healthy plant-based diet, may reduce the risk of various digestive cancers, whereas an unhealthy plant-based diet may increase the risk. The quality of plant-based diets is important for digestive cancer risk evaluation and prevention. [ABSTRACT FROM AUTHOR]

Published
2025
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3. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Bilancia, D., Rosati, G., Montesarchio, V., Iaffaioli, R.V., Nasti, G., Daniele, B., Zagonel, V., Lonardi, S., Pella, N., Aprile, G., Pasini, F., Marchetti, Roma P., Romiti, A., Ciuffreda, L., Ferrari, D., Foa, P., Zaniboni, A., Labianca, R., Mosconi, S., Sobrero, A., Bidoli, P., Cazzaniga, M., Beretta, G.D., Corsi, D.C., Cortesi, E., Barni, S., Petrelli, F., Allione, P., D'Arco, A.M., Valmadre, G., Piazza, E., Veltri, E., Ramus, G. Vietti, Giustini, L., Tumulo, S., Cascinu, S., Granetto, C., Testore, F., Giordano, M., Moroni, M., Di Seri, M., Nuzzo, A., Angelelli, L., Gori, S., Farina, G., Aglietta, M., Franchi, R., Comandé, M., Giordani, P., Tonini, G., Bucci, E., Ballestrero, A., Benasso, M., Graiff, C., Bravi, S., Caffo, O., Silva, R.R., Frontini, L., Rota, S., Cozzi, L., Cantore, M., Maiello, E., Cinieri, S., Silvestris, N., Romito, S., Gebbia, V., Banzi, M., Santoro, A., Artioli, F., Mattioli, R., Contu, A., Di Costanzo, F., Leonardi, F., Cavanna, L., Passalacqua, R., Amoroso, D., Sozzi, P., D'Amico, M., Amadori, D., Frassineti, L., Turci, D., Ravaioli, A., Pasquini, E., Gambi, A., Faedi, M., Cruciani, G., Bajetta, E., Di Bartolomeo, M., Gianni, L., Ronzoni, M., Ionta, M.T., Massidda, B., Scartozzi, M., Zampino, M.G., Bochicchio, A.M., Ciarlo, A., Di Leo, A., Frustaci, S., Rangoni, G., Arizzoia, A., Pavesi, L., Verusio, C., Pinotti, G., Iop, A., De Placido, S., Carlomagno, C., Adamo, V., Ficorella, C., Natale, D., Greco, E., Rulli, E., Galli, F., Poli, D., Porcu, L., Torri, V., Rosati, Gerardo, Lonardi, Sara, Galli, Fabio, Di Bartolomeo, Maria, Ronzoni, Monica, Zampino, Maria G., Banzi, Maria, Zaniboni, Alberto, Pasini, Felice, Bozzarelli, Silvia, Garattini, Silvio K., Ferrari, Daris, Montesarchio, Vincenzo, Mambrini, Andrea, Ciuffreda, Libero, Galli, Francesca, Pusceddu, Valeria, Carlomagno, Chiara, Bidoli, Paolo, Amoroso, Domenico, Bochicchio, Anna M., Frassineti, Luca, Corsi, Domenico, Bilancia, Domenico, Pastorino, Alessandro, De Stefano, Alfonso, and Labianca, Roberto

Published
2021
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8. In-flight performances of SilEye-2 Experiment and cosmic ray abundances inside space station Mir

Author

Avdeev, S., Bidoli, V., Bonvicini, W., Boezio, M., Carlson, P., Casolino, M., Castellini, G., De Grandis, E., De Pascale, M. P., Fuglesang, C., Furano, G., Galper, A., Khodarovich, A., Korotkov, M., Mazzenga, G., Morselli, A., Narici, L., Papini, P., Picozza, P., Popov, A., Reali, E., Ricci, M., Sparvoli, R., Spillantini, P., Vacchi, A., Vavilov, N., and Zampa, N.

Subjects
Astrophysics
Abstract

Cosmic ray measurements performed with the instrument SilEye-2 on Mir space station are presented. SilEye-2 is a silicon detector telescope for the study of the causes of Light Flashes perception by astronauts. As a stand-alone device, it monitors in the short and long term the radiation composition inside Mir. The cosmic ray detector consists of an array of 6 active silicon strip detectors which allow nuclear identification of cosmic rays up to Iron. The device was operational for more than 1000 hours in the years 1998-2000, measuring also several Solar Particle Events. In this work we present the in-flight performance of the instrument and nuclear abundance data from Boron to Silicon above ~150 MeV/n inside Mir., Comment: 18 pages, 8 figures

Published
2001

9. Light Isotope Abundances in Solar Energetic Particles measured by the Space Instrument NINA

Author

The NINA Collaboration, Bakaldin, A., Galper, A., Koldashov, S., Korotkov, M., Leonov, A., Mikhailov, V., Murashov, A., Voronov, S., Bidoli, V., Casolino, M., De Pascale, M., Furano, G., Iannucci, A., Morselli, A., Picozza, P., Sparvoli, R., Boezio, M., Bonvicini, V., Cirami, R., Vacchi, A., Zampa, N., Ambriola, M., Bellotti, R., Cafagna, F., Ciacio, F., Circella, M., De Marzo, C., Adriani, O., Papini, P., Piccardi, S., Spillantini, P., Straulino, S., Vannuccini, E., Bartalucci, S., Ricci, M., and Castellini, G.

Subjects
Astrophysics
Abstract

This article reports nine Solar Energetic Particle events detected by the instrument NINA between October 1998 and April 1999. NINA is a silicon-based particle detector mounted on-board the Russian satellite Resurs-01-N4, which has flown at an altitude of about 800 km in polar inclination since July 1998. For every solar event the power-law He4 spectrum across the energy interval 10--50 MeV/n was reconstructed, and spectral indexes, gamma, from 1.8 to 6.8 extracted. Data of He3 and He4 were used to determine the He3/He4 ratio, that for some SEP events indicated an enrichment in He3. For the 1998 November 7 event the ratio reached a maximum value of 0.33+- 0.06, with spectral indexes of gamma = 2.5 +- 0.6 and gamma = 3.7 +- 0.3 for He3 and He4, respectively. The He3/He4 ratio averaged over the remaining events was 0.011 +- 0.004. For all events the deuterium-to-proton ratio was determined. The average value over all events was (3.9+-1.4) 10^{-5} across the energy interval 9--12 MeV/n. For one event (1998 November 24) this ratio yielded approximately 10 times higher than normal coronal values. Upper limits on the H3/H1 counting ratio for all events were determined. For the 1998 November 14 SEP event the high flux of heavy particles detected made it possible to reconstruct the carbon and oxygen flux., Comment: 42 pages, 14 figures, submitted to Journal of Geophysical Research

Published
2001
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10. In-Orbit Performance of the Space Telescope NINA and GCR Flux Measurements

Author

The NINA Collaboration, Bidoli, V., Canestro, A., Casolino, M., DePascale, M. P., Furano, G., Iannucci, A., Morselli, A., Picozza, P., Reali, E., Sparvoli, R., Bakaldin, A., Galper, A., Koldashov, S., Korotkov, M., Leonov, A., Mikhailov, V., Murashov, A., Voronov, S., Boezio, M., Bonvicini, V., Cirami, R., Vacchi, A., Zampa, N., Ambriola, M., Bellotti, R., Cafagna, F., Ciacio, F., Circella, M., De Marzo, C., Adriani, O., Papini, P., Piccardi, S., Spillantini, P., Straulino, S., Bartalucci, S., Mazzenga, G., Ricci, M., and Castellini, G.

Subjects
Astrophysics
Abstract

The NINA apparatus, on board the Russian satellite Resurs-01 n.4, has been in polar orbit since 1998 July 10, at an altitude of 840 km. Its main scientific task is to study the galactic, solar and anomalous components of cosmic rays in the energy interval 10--200 MeV/n. In this paper we present a description of the instrument and its basic operating modes. Measurements of Galactic Cosmic Ray spectra will also be shown., Comment: 38 pages, 10 figures, accepted for publication in the ApJS

Published
2000
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12. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer. A phase II–III trial

Author

Ghi, M.G., Paccagnella, A., Ferrari, D., Foa, P., Alterio, D., Codecà, C., Nolè, F., Verri, E., Orecchia, R., Morelli, F., Parisi, S., Mastromauro, C., Mione, C.A., Rossetto, C., Polsinelli, M., Koussis, H., Loreggian, L., Bonetti, A., Campostrini, F., Azzarello, G., D’Ambrosio, C., Bertoni, F., Casanova, C., Emiliani, E., Guaraldi, M., Bunkheila, F., Bidoli, P., Niespolo, R.M., Gava, A., Massa, E., Frattegiani, A., Valduga, F., Pieri, G., Cipani, T., Da Corte, D., Chiappa, F., and Rulli, E.

Published
2017
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13. The Historical Relationship between Triestine Sign Language and Austrian Sign Language

Author

Dotter, Franz and Bidoli, Cynthia J. Kellett

Abstract

The high degree of comprehensibility between the signed languages in Trieste (present-day Italy) and Austria is very probably due to their joint history of deaf schools within the Austro-Hungarian Empire. Investigation undertaken in archives in Trieste and Klagenfurt has revealed interesting similarities in the education of deaf children there since the mid-nineteenth century, which may explain present-day affinities. General background information is provided regarding sign language in Italy and Austria, and a detailed description of schools and teaching methodologies, which are the probable source of a historical connection, is then presented.

Published
2017
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14. Efficacy of nivolumab in pre-treated non-small-cell lung cancer patients harbouring KRAS mutations

Author

Passiglia, Francesco, Cappuzzo, Federico, Alabiso, Oscar, Bettini, Anna Cecilia, Bidoli, Paolo, Chiari, Rita, Defferrari, Carlotta, Delmonte, Angelo, Finocchiaro, Giovanna, Francini, Guido, Gelsomino, Francesco, Giannarelli, Diana, Giordano, Monica, Illiano, Alfonso, Livi, Lorenzo, Martelli, Olga, Natoli, Clara, Puppo, Gianfranco, Ricevuto, Enrico, Roca, Elisa, Turci, Daniele, and Galetta, Domenico

Published
2019
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17. Phase III trial comparing 3–6 months of adjuvant FOLFOX4/XELOX in stage II–III colon cancer: safety and compliance in the TOSCA trial

Author

Bilancia, D., Rosati, G., Montesarchio, V., Iaffaioli, R.V., Nasti, G., Daniele, B., Zagonel, V., Lonardi, S., Pella, N., Aprile, G., Pasini, F., Marchetti, P., Romiti, A., Ciuffreda, L., Ferrari, D., Foa, P., Zaniboni, A., Labianca, R., Mosconi, S., Sobrero, A., Bidoli, P., Cazzaniga, M., Beretta, G.D., Corsi, D.C., Cortesi, E., Barni, S., Petrelli, F., Cantore, M., Maiello, E., Cinieri, S., Banzi, M., Santoro, A., Artioli, F., Mattioli, R., Amoroso, D., Amadori, D., Frassineti, L., Turci, D., Ravaioli, A., Bajetta, E., Di Bartolomeo, M., Gianni, L., Ronzoni, M., Ionta, M.T., Massidda, B., Scartozzi, M., Zampino, M.G., Bochicchio, A., Ciarlo, A., Di Leo, A., De Placido, S., Carlomagno, C., Adamo, V., Natale, D., Rulli, E., Galli, F., Poli, D., Torri, V., and Rimassa, L.

Published
2016
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18. Vanishing bile duct syndrome following pembrolizumab infusion: case report and review of the literature

Author

Gemelli, M, Carbone, M, Abbate, M, Mancin, M, Zucchini, N, Colonese, F, Invernizzi, P, Bidoli, P, Cortinovis, D, Gemelli M., Carbone M., Abbate M. I., Mancin M., Zucchini N., Colonese F., Invernizzi P., Bidoli P., Cortinovis D., Gemelli, M, Carbone, M, Abbate, M, Mancin, M, Zucchini, N, Colonese, F, Invernizzi, P, Bidoli, P, Cortinovis, D, Gemelli M., Carbone M., Abbate M. I., Mancin M., Zucchini N., Colonese F., Invernizzi P., Bidoli P., and Cortinovis D.

Abstract

Plain language summary Immunotherapy has demonstrated high efficacy in lung cancer and is commonly used in clinical practice. Despite the good tolerability, severe immune-related adverse events may occur, requiring hospitalization and possibly leading to death. We present a case of vanishing bile duct syndrome (a rare and potentially lethal condition characterized by progressive destruction of small bile ducts) which arose a few days after the first pembrolizumab infusion. Laboratory tests and radiological imaging were performed to orient diagnosis and monitor disease; a histological sample was required for vanishing bile duct syndrome diagnosis. High-dose steroid therapy and immunosuppressors were administered, with scarce efficacy. Prompt recognition and management of similar conditions is crucial to avoid fatal events. Further studies are needed to investigate new drugs for steroid-refractory conditions.

Published
2022

19. Bone metastases and immunotherapy in patients with advanced non-small-cell lung cancer

Author

Landi, Lorenza, D’Incà, Federica, Gelibter, Alain, Chiari, Rita, Grossi, Francesco, Delmonte, Angelo, Passaro, Antonio, Signorelli, Diego, Gelsomino, Francesco, Galetta, Domenico, Giannarelli, Diana, Soto Parra, Hector, Minuti, Gabriele, Tiseo, Marcello, Migliorino, Maria Rita, Cognetti, Francesco, Toschi, Luca, Bidoli, Paolo, Piantedosi, Francovito, Calabro’, Luana, and Cappuzzo, Federico

Published
2019
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21. Thymus neuroendocrine tumors with CTNNB1 gene mutations, disarrayed ß-catenin expression, and dual intra-tumor Ki-67 labeling index compartmentalization challenge the concept of secondary high-grade neuroendocrine tumor: a paradigm shift

Author

Fabbri, Alessandra, Cossa, Mara, Sonzogni, Angelica, Bidoli, Paolo, Canova, Stefania, Cortinovis, Diego, Abbate, Maria Ida, Calabrese, Fiorella, Nannini, Nazarena, Lunardi, Francesca, Rossi, Giulio, La Rosa, Stefano, Capella, Carlo, Tamborini, Elena, Perrone, Federica, Busico, Adele, Capone, Iolanda, Valeri, Barbara, Pastorino, Ugo, Albini, Adriana, and Pelosi, Giuseppe

Published
2017
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22. Evaluation of the psychometric properties of the EORTC chemotherapy-induced peripheral neuropathy questionnaire (QLQ-CIPN20)

Author

Kieffer, Jacobien M., Postma, Tjeerd J., van de Poll-Franse, Lonneke, Mols, Floortje, Heimans, Jan J., Cavaletti, Guido, Aaronson, Neil K., Cavaletti, G., Cornblath, D. R., Merkies, I. S. J., Postma, T. J., Valsecchi, M. G., Galimberti, S., Rossi, E., Cavaletti, G., Frigeni, B., Lanzani, F., Mattavelli, L., Piatti, M. L., Alberti, P., Binda, D., Bidoli, P., Cazzaniga, M., Cortinovis, D., Bruna, J., Velasco, R., Argyriou, A. A., Kalofonos, H. P., Psimaras, D., Ricard, D., Pace, A., Galiè, E., Briani, C., Lucchetta, M., Campagnolo, M., Torre, C. Dalla, Faber, C. G., Merkies, I. S. J., Vanhoutte, E. K., Bakkers, M., Brouwer, B., Boogerd, M., Lalisang, R. I., Boogerd, W., Brandsma, D., Koeppen, S., Hense, J., Grant, R., Storey, D., Kerrigan, S., Schenone, A., Reni, L., Piras, B., Fabbri, S., Pessino, A., Padua, L., Granata, G., Leandri, M., Ghignotti, I., Plasmati, R., Pastorelli, F., Postma, T. J., Heimans, J. J., Eurelings, M., Meijer, R. J., Grisold, W., Pozza, E. Lindeck, Mazzeo, A., Toscano, A., Russo, M., Tomasello, C., Altavilla, G., Prado, M. Penas, Gonzalez, C. Dominguez, Dorsey, S. G., and In Collaboration with the CI-PeriNomS Group

Published
2017
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23. 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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24. Physician-assessed and patient-reported outcome measures in chemotherapy-induced sensory peripheral neurotoxicity: two sides of the same coin

Author

Cavaletti, G., Cornblath, D.R., Merkies, I.S.J., Postma, T.J., Valsecchi, M.G, Galimberti, S., Rossi, E., Frigeni, B., Lanzani, F., Mattavelli, L., Piatti, M.L., Alberti, P., Binda, D., Bidoli, P., Cazzaniga, M., Cortinovis, D., Bruna, J., Velasco, R., Argyriou, A.A., Kalofonos, H.P., Psimaras, D., Ricard, D., Pace, A., Galiè, E., Briani, C., Lucchetta, M., Campagnolo, M., Dalla Torre, C., Faber, C.G., Vanhoutte, E.K., Bakkers, M., Brouwer, B., Lalisang, R.I., Boogerd, W., Brandsma, D., Koeppen, S., Hense, J., Grant, R., Storey, D., Kerrigan, S., Schenone, A., Reni, L., Piras, B., Fabbri, S., Padua, L., Granata, G., Leandri, M., Ghignotti, I., Plasmati, R., Pastorelli, F., Heimans, J.J., Eurelings, M., Meijer, R.J., Grisold, W., Lindeck Pozza, E., Mazzeo, A., Toscano, A., Tomasello, C., Altavilla, G., Penas Prado, M., Dominguez Gonzalez, C., Dorsey, S.G., Brell, J.M., and Valsecchi, M.G.

Published
2014
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27. Novel cytotoxic chemotherapies in small cell lung carcinoma

Author

Cortinovis, D, Bidoli, P, Canova, S, Colonese, F, Gemelli, M, Lavitrano, M, Banna, G, Liu, S, Morabito, A, Cortinovis D., Bidoli P., Canova S., Colonese F., Gemelli M., Lavitrano M. L., Banna G. L., Liu S. V., Morabito A., Cortinovis, D, Bidoli, P, Canova, S, Colonese, F, Gemelli, M, Lavitrano, M, Banna, G, Liu, S, Morabito, A, Cortinovis D., Bidoli P., Canova S., Colonese F., Gemelli M., Lavitrano M. L., Banna G. L., Liu S. V., and Morabito A.

Abstract

Small cell lung cancer (SCLC) is one of the deadliest thoracic neoplasms, in part due to its fast doubling time and early metastatic spread. Historically, cytotoxic chemotherapy consisting of platinum–etoposide or anthracycline-based regimens has demonstrated a high response rate, but early chemoresistance leads to a poor prognosis in advanced SCLC. Only a fraction of patients with limited-disease can be cured by chemo-radiotherapy. Given the disappointing survival rates in advanced SCLC, new cytotoxic agents are eagerly awaited. Unfortunately, few novel chemotherapy drugs have been developed in the latest decades. This review describes the results and potential application in the clinical practice of novel chemotherapy agents for SCLC.

Published
2021

28. Trabectedin in Malignant Pleural Mesothelioma: Results From the Multicentre, Single Arm, Phase II ATREUS Study

Author

Cortinovis, D, Grosso, F, Carlucci, L, Zucali, P, Pasello, G, Tiseo, M, Sperandi, F, Hollander, L, Galli, F, Torri, V, Rulli, E, Canova, S, Maconi, A, Bidoli, P, Ceresoli, G, D'Incalci, M, Cortinovis D., Grosso F., Carlucci L., Zucali P. A., Pasello G., Tiseo M., Sperandi F., Hollander L., Galli F., Torri V., Rulli E., Canova S., Maconi A., Bidoli P., Ceresoli G. L., D'Incalci M., Cortinovis, D, Grosso, F, Carlucci, L, Zucali, P, Pasello, G, Tiseo, M, Sperandi, F, Hollander, L, Galli, F, Torri, V, Rulli, E, Canova, S, Maconi, A, Bidoli, P, Ceresoli, G, D'Incalci, M, Cortinovis D., Grosso F., Carlucci L., Zucali P. A., Pasello G., Tiseo M., Sperandi F., Hollander L., Galli F., Torri V., Rulli E., Canova S., Maconi A., Bidoli P., Ceresoli G. L., and D'Incalci M.

Abstract

ATREUS was a phase II, single arm, multicenter study aimed at exploring the activity and safety of trabectedin in 78 epithelioid patients and 67 nonepithelioid patients with unresectable malignant pleural mesothelioma. Trabectedin showed modest clinical activity, at the expense of relevant liver toxicity. Introduction: New therapeutic approaches in unresectable malignant pleural mesothelioma (MPM) are eagerly awaited. Trabectedin is an antitumor agent with an effect on cancer cell proliferation and a modulating action on tumor microenvironment. The ATREUS study explored the activity and safety of trabectedin in patients with unresectable MPM. Methods: Epithelioid patients with MPM received trabectedin as second-line while biphasic/sarcomatoid patients with MPM as first- or second-line therapy. Treatment was given intravenously at an initially planned dose of 1.3 mg/m(2) every 3 weeks, until progression or unacceptable toxicity. The primary endpoint was progression-free survival rate at 12 weeks (PFS12wks). Results: Overall, 78 patients (54%) had epithelioid and 67 (46%) nonepithelioid MPM. PFS12wks in 62 evaluable patients with epithelioid MPM was 43.5% (80% confidence interval 34.9%-52.5%); median progression-free and overall survival were 2.4 and 9.0 months, respectively. PFS12wks in 52 evaluable patients with nonepithelioid MPM was 30.8% (90% confidence interval 20.3%-42.9%); median progression-free and overall survival were 1.7 and 5.4 months. Trabectedin starting dose was amended due to excess of liver toxicity. Eighty-four (64%) and 48 (36%) patients received 1.3 mg/m(2 )and 1.1. mg/m(2), respectively. The most common grade 3-4 toxicities were hepatotoxicity, leukopenia/neutropenia, and fatigue. Grade 3-4 hepatotoxicity was reported in 59 (70%) patients treated at 1.3 mg/m(2), and in 19 (40%) treated at 1.1 mg/m(2). Conclusions: Trabectedin showed modest clinical activity, at the expense of relevant liver toxicity. Further development of this drug in MPM at fu

Published
2021

29. Oxaliplatin plus fluoropyrimidines as adjuvant therapy for colon cancer in older patients: A subgroup analysis from the TOSCA trial

Author

Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, Giustini, L, Tumulo, S, Cascinu, S, Granetto, C, Testore, F, Giordano, M, Moroni, M, Di Seri, M, Nuzzo, A, Angelelli, L, Gori, S, Farina, G, Aglietta, M, Franchi, R, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati G., Lonardi S., Galli F., Di Bartolomeo M., Ronzoni M., Zampino M. G., Banzi M., Zaniboni A., Pasini F., Bozzarelli S., Garattini S. K., Ferrari D., Montesarchio V., Mambrini A., Ciuffreda L., Pusceddu V., Carlomagno C., Bidoli P., Amoroso D., Bochicchio A. M., Frassineti L., Corsi D., Bilancia D., Pastorino A., De Stefano A., Labianca R., Iaffaioli R. V., Nasti G., Daniele B., Zagonel V., Pella N., Aprile G., Marchetti R. P., Romiti A., Foa P., Mosconi S., Sobrero A., Cazzaniga M., Beretta G. D., Cortesi E., Barni S., Petrelli F., Allione P., D'Arco A. M., Valmadre G., Piazza E., Veltri E., Ramus G. V., Giustini L., Tumulo S., Cascinu S., Granetto C., Testore F., Giordano M., Moroni M., Di Seri M., Nuzzo A., Angelelli L., Gori S., Farina G., Aglietta M., Franchi R., Comande M., Giordani P., Tonini G., Bucci E., Ballestrero A., Benasso M., Graiff C., Bravi S., Caffo O., Silva R. R., Frontini L., Rota S., Cozzi L., Cantore M., Maiello E., Cinieri S., Silvestris N., Romito S., Gebbia V., Santoro A., Artioli F., Mattioli R., Contu A., Di Costanzo F., Leonardi F., Cavanna L., Passalacqua R., Sozzi P., D'Amico M., Amadori D., Turci D., Ravaioli A., Pasquini E., Gambi A., Faedi M., Cruciani G., Bajetta E., Gianni L., Ionta M. T., Massidda B., Scartozzi M., Ciarlo A., Di Leo A., Frustaci S., Rangoni G., Arizzoia A., Pavesi L., Verusio C., Pinotti G., Iop A., De Placido S., Adamo V., Ficorella C., Natale D., Greco E., Rulli E., Poli D., Porcu L., Torri V., Rosati, G, Lonardi, S, Galli, F, Di Bartolomeo, M, Ronzoni, M, Zampino, M, Banzi, M, Zaniboni, A, Pasini, F, Bozzarelli, S, Garattini, S, Ferrari, D, Montesarchio, V, Mambrini, A, Ciuffreda, L, Pusceddu, V, Carlomagno, C, Bidoli, P, Amoroso, D, Bochicchio, A, Frassineti, L, Corsi, D, Bilancia, D, Pastorino, A, De Stefano, A, Labianca, R, Iaffaioli, R, Nasti, G, Daniele, B, Zagonel, V, Pella, N, Aprile, G, Marchetti, R, Romiti, A, Foa, P, Mosconi, S, Sobrero, A, Cazzaniga, M, Beretta, G, Cortesi, E, Barni, S, Petrelli, F, Allione, P, D'Arco, A, Valmadre, G, Piazza, E, Veltri, E, Ramus, G, Giustini, L, Tumulo, S, Cascinu, S, Granetto, C, Testore, F, Giordano, M, Moroni, M, Di Seri, M, Nuzzo, A, Angelelli, L, Gori, S, Farina, G, Aglietta, M, Franchi, R, Comande, M, Giordani, P, Tonini, G, Bucci, E, Ballestrero, A, Benasso, M, Graiff, C, Bravi, S, Caffo, O, Silva, R, Frontini, L, Rota, S, Cozzi, L, Cantore, M, Maiello, E, Cinieri, S, Silvestris, N, Romito, S, Gebbia, V, Santoro, A, Artioli, F, Mattioli, R, Contu, A, Di Costanzo, F, Leonardi, F, Cavanna, L, Passalacqua, R, Sozzi, P, D'Amico, M, Amadori, D, Turci, D, Ravaioli, A, Pasquini, E, Gambi, A, Faedi, M, Cruciani, G, Bajetta, E, Gianni, L, Ionta, M, Massidda, B, Scartozzi, M, Ciarlo, A, Di Leo, A, Frustaci, S, Rangoni, G, Arizzoia, A, Pavesi, L, Verusio, C, Pinotti, G, Iop, A, De Placido, S, Adamo, V, Ficorella, C, Natale, D, Greco, E, Rulli, E, Poli, D, Porcu, L, Torri, V, Rosati G., Lonardi S., Galli F., Di Bartolomeo M., Ronzoni M., Zampino M. G., Banzi M., Zaniboni A., Pasini F., Bozzarelli S., Garattini S. K., Ferrari D., Montesarchio V., Mambrini A., Ciuffreda L., Pusceddu V., Carlomagno C., Bidoli P., Amoroso D., Bochicchio A. M., Frassineti L., Corsi D., Bilancia D., Pastorino A., De Stefano A., Labianca R., Iaffaioli R. V., Nasti G., Daniele B., Zagonel V., Pella N., Aprile G., Marchetti R. P., Romiti A., Foa P., Mosconi S., Sobrero A., Cazzaniga M., Beretta G. D., Cortesi E., Barni S., Petrelli F., Allione P., D'Arco A. M., Valmadre G., Piazza E., Veltri E., Ramus G. V., Giustini L., Tumulo S., Cascinu S., Granetto C., Testore F., Giordano M., Moroni M., Di Seri M., Nuzzo A., Angelelli L., Gori S., Farina G., Aglietta M., Franchi R., Comande M., Giordani P., Tonini G., Bucci E., Ballestrero A., Benasso M., Graiff C., Bravi S., Caffo O., Silva R. R., Frontini L., Rota S., Cozzi L., Cantore M., Maiello E., Cinieri S., Silvestris N., Romito S., Gebbia V., Santoro A., Artioli F., Mattioli R., Contu A., Di Costanzo F., Leonardi F., Cavanna L., Passalacqua R., Sozzi P., D'Amico M., Amadori D., Turci D., Ravaioli A., Pasquini E., Gambi A., Faedi M., Cruciani G., Bajetta E., Gianni L., Ionta M. T., Massidda B., Scartozzi M., Ciarlo A., Di Leo A., Frustaci S., Rangoni G., Arizzoia A., Pavesi L., Verusio C., Pinotti G., Iop A., De Placido S., Adamo V., Ficorella C., Natale D., Greco E., Rulli E., Poli D., Porcu L., and Torri V.

Abstract

Background: Previous studies on oxaliplatin and fluoropyrimidines as adjuvant therapy in older patients with stage III colon cancer (CC) produced conflicting results. Patients and methods: We assessed the impact of age on time to tumour recurrence (TTR), disease-free survival (DFS), cancer-specific survival (CSS), and overall survival (OS) in 2360 patients with stage III CC (1667 aged <70 years and 693 ≥ 70 years) randomised to receive 3 or 6 months of FOLFOX or CAPOX within the frame of the phase III, TOSCA study. Results: Older patients compared with younger ones presented more frequently an Eastern Cooperative Oncology Group performance status equal to 1 (10.5% vs 3.3%, p < 0.001), a greater number of right-sided tumours (40.9% vs 26.6%, p < 0.001), and were at higher clinical risk (37.2% vs 33.2%, p = 0.062). The treatments were almost identical in the two cohorts (p = 0.965). We found a greater proportion of dose reductions (46.7% vs 41.4%, p = 0.018), treatment interruptions (26.1% vs 19.3%, p < 0.001) and a higher proportion of recurrences (24.2% vs 20.3%, p = 0.033) in the older patients. The multivariable analysis of the TTR did not indicate a statistically significant effect of age (hazard ratio [HR]: 1.19; 95% confidence interval [CI]: 0.98–1.44; p = 0.082). The HR comparing older with younger patients was 1.34 (95% CI: 1.12–1.59; p = 0.001) for DFS, 1.58 (95% CI: 1.26–1.99; p < 0.001) for OS, and 1.28 (95% CI: 0.96–1.70; p = 0.089) for CSS. Conclusions: Worse prognostic factors and reduced treatment compliance have a negative impact on the efficacy of oxaliplatin-based adjuvant therapy in older patients.

Published
2021

30. Talactoferrin alfa versus placebo in patients with refractory advanced non-small-cell lung cancer (FORTIS-M trial)

Author

Della-Fiorentina, S., Begbie, S., Jennens, R., Dass, J., Pittman, K., Ivanova, N., Koynova, T., Petrov, P., Tomova, A., Tzekova, V., Couture, F., Hirsh, V., Burkes, R., Sangha, R., Ambrus, M., Janaskova, T., Musil, J., Novotny, J., Zatloukal, P., Jakesova, J., Klenha, K., Roubec, J., Vanasek, J., Fayette, J., Barlesi, F., Bennouna-Louridi, J., Chouaid, C., Mazières, J., Vallerand, H., Robinet, G., Souquet, P.-J., Spaeth, D., Schott, R., Lena, H., Martinet, Y., El Kouri, C., Baize, N., Scherpereel, A., Molinier, O., Fuchs, F., Josten, K.M., Manegold, C., Marschner, N., Schneller, F., Overbeck, T., Thomas, M., von Pawel, J., Reck, M., Schuette, W., Hagen, V., Schneider, C.-P., Georgoulias, V., Varthalitis, I., Zarogoulidis, K., Syrigos, K., Papandreou, C., Bocskei, C., Csanky, E., Juhasz, E., Losonczy, G., Mark, Z., Molnar, I., Papai-Szekely, Z., Tehenes, S., Vinkler, I., Almel, S., Bakshi, A., Bondarde, S., Maru, A., Pathak, A., Pedapenki, R.M., Prasad, K., Prasad, S.V.S.S., Kilara, N., Gorijavolu, D., Deshmukh, C.D., John, S., Sharma, L.M., Amoroso, D., Bajetta, E., Bidoli, P., Bonetti, A., De Marinis, F., Maio, M., Passalacqua, R., Cascinu, S., Bearz, A., Bitina, M., Brize, A., Purkalne, G., Skrodele, M., Baba, A.A., Ratnavelu, K., Saw, M.H., Samson-Fernando, M.C., Ladrera, G.E., Jassem, J., Koralewski, P., Serwatowski, P., Krzakowski, M., Cebotaru, C., Filip, D., Ganea-Motan, D.E., Ianuli, C.H., Manolescu, I.G., Udrea, A., Burdaeva, O., Byakhov, M., Filippov, A., Lazarev, S., Mosin, I., Orlov, S., Udovitsa, D., Khorinko, A., Protsenko, S., Chang, A., Lim, H.L., Tan, Y.O., Tan, E.H., Bastus Piulats, R., Garcia-Foncillas, J., Valdivia, J., de Castro, J., Domine Gomez, M., Kim, S.W., Lee, J.-S., Kim, H.K., Lee, J.S., Shin, S.W., Kim, D.-W., Kim, Y.-C., Park, K.C., Chang, C.-S., Chang, G.-C., Goan, Y.-G., Su, W.-C., Tsai, C.-M., Kuo, H.-P., Benekli, M., Demir, G., Gokmen, E., Sevinc, A., Crawford, J., Giaccone, G., Haigentz, M., Owonikoko, T., Agarwal, M., Pandit, S., Araujo, R., Vrindavanam, N., Bonomi, P., Berg, A., Wade, J., Bloom, R., Amin, B., Camidge, R., Hill, D., Rarick, M., Flynn, P., Klein, L., Lo Russo, K., Neubauer, M., Richards, P., Ruxer, R., Savin, M., Weckstein, D., Rosenberg, R., Whittaker, T., Richards, D., Berry, W., Ottensmeier, C., Dangoor, A., Steele, N., Summers, Y., Rankin, E., Rowley, K., Giridharan, S., Kristeleit, H., Humber, C., Taylor, P., Ramalingam, S., Perez-Soler, R., Douillard, J.-Y., Thatcher, N., Wang, Y., Pultar, P., Zhu, J., and Malik, R.

Published
2013
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31. Rasch-built Overall Disability Scale for patients with chemotherapy-induced peripheral neuropathy (CIPN-R-ODS)

Author

Galimberti, S., Lanzani, F., Mattavelli, L., Piatti, M.L., Bidoli, P., Cazzaniga, M., Cortinovis, D., Lucchetta, M., Campagnolo, M., Bakkers, M., Brouwer, B., Boogerd, W., Grant, R., Reni, L., Piras, B., Pessino, A., Padua, L., Granata, G., Leandri, M., Ghignotti, I., Plasmati, R., Pastorelli, F., Heimans, J.J., Eurelings, M., Meijer, R.J., Grisold, W., Lindeck Pozza, E., Mazzeo, A., Toscano, A., Russo, M., Tomasello, C., Altavilla, G., Penas Prado, M., Dominguez Gonzalez, C., Dorsey, S.G., Binda, D., Vanhoutte, E.K., Cavaletti, G., Cornblath, D.R., Postma, T.J., Frigeni, B., Alberti, P., Bruna, J., Velasco, R., Argyriou, A.A., Kalofonos, H.P., Psimaras, D., Ricard, D., Pace, A., Galiè, E., Briani, C., Dalla Torre, C., Lalisang, R.I., Brandsma, D., Koeppen, S., Hense, J., Storey, D., Kerrigan, S., Schenone, A., Fabbri, S., Rossi, E., Valsecchi, M.G., Faber, C.G., and Merkies, I.S.J.

Published
2013
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32. The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings

Author

Cavaletti, G., Cornblath, D.R., Merkies, I.S.J., Postma, T.J., Rossi, E., Frigeni, B., Alberti, P., Bruna, J., Velasco, R., Argyriou, A.A., Kalofonos, H.P., Psimaras, D., Ricard, D., Pace, A., Galiè, E., Briani, C., Dalla Torre, C., Faber, C.G., Lalisang, R.I., Boogerd, W., Brandsma, D., Koeppen, S., Hense, J., Storey, D., Kerrigan, S., Schenone, A., Fabbri, S., Valsecchi, M.G., Mazzeo, A., Pessino, A., Toscano, A., Brouwer, B., Piras, B., Dominguez Gonzalez, C., Tomasello, C., Binda, D., Cortinovis, D., Lindeck Pozza, E., Vanhoutte, E.K., Lanzani, F., Pastorelli, F., Altavilla, G., Granata, G., Ghignotti, I., Heimans, J.J., Mattavelli, L., Padua, L., Reni, L., Bakkers, M., Boogerd, M., Campagnolo, M., Cazzaniga, M., Eurelings, M., Leandri, M., Lucchetta, M., Penas Prado, M., Russo, M., Piatti, M.L., Bidoli, P., Grant, R., Plasmati, R., Meijer, R.J., Dorsey, S.G., Galimberti, S., and Grisold, W.

Published
2013
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34. Patients' and physicians' interpretation of chemotherapy-induced peripheral neurotoxicity

Author

Cavaletti, G., Cornblath, D. R., Merkies, I. S. J., Postma, T. J., Rossi, E., Alberti, Paola, Bruna, J., Argyriou, A. A., Briani, C., Velasco, Riccardo, Kalofonos, H. P., Psimaras, D., Ricard, D., Pace, A., Faber, C. G., Lalisang, R. I., Brandsma, D., Koeppen, S., Kerrigan, S., Schenone, A., Grisold, W., Mazzeo, A., Padua, L., Dorsey, S. G., Penas-Prado, M., Valsecchi, M. G., Frigeni, B., Lanzani, F., Mattavelli, L., Piatti, M. L., Binda, D., Bidoli, P., Cazzaniga, M., Cortinovis, D., Galie, E., Campagnolo, M., Salvalaggio, A., Ruiz, M., Vanhoutte, E. K., Boogerd, W., Hense, J., Grant, R., Storey, D., Reni, L., Demichelis, C., Pessino, A., Granata, G., Leandri, Martina, Ghigliotti, I., Plasmati, R., Pastorelli, Federica, Heimans, J. J., Eurelings, M., Meijer, R. J., Pozza, E. L., Toscano, A., Gentile, L., Santarpia, M., Gonzalez, C. D., Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Interne Geneeskunde, MUMC+: MA Medische Oncologie (9), RS: GROW - R3 - Innovative Cancer Diagnostics & Therapy, MUMC+: DA KG Polikliniek (9), Cavaletti, G, Cornblath, D, Merkies, I, Postma, T, Rossi, E, Alberti, P, Bruna, J, Argyriou, A, Briani, C, Velasco, R, Kalofonos, H, Psimaras, D, Ricard, D, Pace, A, Faber, C, Lalisang, R, Brandsma, D, Koeppen, S, Kerrigan, S, Schenone, A, Grisold, W, Mazzeo, A, Padua, L, Dorsey, S, Penas-Prado, M, Valsecchi, M, Bidoli, P, Cazzaniga, M, Neurology, and CCA - Cancer Treatment and quality of life

Subjects
Adult, medicine.medical_specialty, Activities of daily living, side effect, media_common.quotation_subject, medicine.medical_treatment, assessment, chemotherapy, neurotoxicity, patient reported outcome measures, side effects, Medizin, NEUROPATHY CIPN, Neurological examination, Severity of Illness Index, 03 medical and health sciences, Vibration perception, 0302 clinical medicine, Perception, Internal medicine, Activities of Daily Living, medicine, Humans, VALIDITY, media_common, Oncologists, Neuroscience (all), Neurology (clinical), Chemotherapy, medicine.diagnostic_test, business.industry, General Neuroscience, Neurotoxicity, Outcome measures, Peripheral Nervous System Diseases, assessment, chemotherapy, neurotoxicity, patient reported outcome measures, side effects, Adult, Humans, Neurotoxicity Syndromes, Peripheral Nervous System Diseases, Activities of Daily Living, Oncologists, Patient Reported Outcome Measures, Severity of Illness Index, OUTCOME MEASURES, medicine.disease, Peripheral, patient reported outcome measure, 030220 oncology & carcinogenesis, Neurotoxicity Syndromes, business, 030217 neurology & neurosurgery
Abstract

To test if and how chemotherapy-induced peripheral neurotoxicity (CIPN) is perceived differently by patients and physicians, making assessment and interpretation challenging. We performed a secondary analysis of the CI-PeriNomS study which included 281 patients with stable CIPN. We tested: (a) the association between patients' perception of activity limitation in performing eight common tasks and neurological impairment and (b) how the responses to questions related to these daily activities are interpreted by the treating oncologist. To achieve this, we compared patients' perception of their activity limitation with neurological assessment and the oncologists' blind interpretation. Distribution of the scores attributed by oncologists to each daily life maximum limitation ("impossible") generated three groups: Group 1 included limitations oncologists attributed mainly to motor impairment; Group 2 ones mainly attributed to sensory impairment and Group 3 ones with uncertain motor and sensory impairment. Only a subset of questions showed a significant trend between severity in subjective limitation, reported by patients, and neurological impairment. In Group 1, neurological examination confirmed motor impairment in only 51%-65% of patients; 76%-78% of them also had vibration perception impairment. In Group 2, sensory impairment ranged from 84% to 100%; some degree of motor impairment occurred in 43%-56% of them. In Group 3 strength reduction was observed in 49%-50% and sensory perception was altered in up to 82%. Interpretation provided by the panel of experienced oncologists was inconsistent with the neurological impairment. These observations highlight the need of a core set of outcome measures for future CIPN trials.

Published
2019
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36. 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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38. High Prevalence and Early Occurrence of Skeletal Complications in EGFR Mutated NSCLC Patients With Bone Metastases

Author

Lagana, M, Gurizzan, C, Roca, E, Cortinovis, D, Signorelli, D, Pagani, F, Bettini, A, Bonomi, L, Rinaldi, S, Berardi, R, Filetti, M, Giusti, R, Pilotto, S, Milella, M, Intagliata, S, Baggi, A, Cortellini, A, Soto Parra, H, Brighenti, M, Petrelli, F, Bennati, C, Bidoli, P, Garassino, M, Berruti, A, Lagana M., Gurizzan C., Roca E., Cortinovis D., Signorelli D., Pagani F., Bettini A., Bonomi L., Rinaldi S., Berardi R., Filetti M., Giusti R., Pilotto S., Milella M., Intagliata S., Baggi A., Cortellini A., Soto Parra H., Brighenti M., Petrelli F., Bennati C., Bidoli P., Garassino M. C., Berruti A., Lagana, M, Gurizzan, C, Roca, E, Cortinovis, D, Signorelli, D, Pagani, F, Bettini, A, Bonomi, L, Rinaldi, S, Berardi, R, Filetti, M, Giusti, R, Pilotto, S, Milella, M, Intagliata, S, Baggi, A, Cortellini, A, Soto Parra, H, Brighenti, M, Petrelli, F, Bennati, C, Bidoli, P, Garassino, M, Berruti, A, Lagana M., Gurizzan C., Roca E., Cortinovis D., Signorelli D., Pagani F., Bettini A., Bonomi L., Rinaldi S., Berardi R., Filetti M., Giusti R., Pilotto S., Milella M., Intagliata S., Baggi A., Cortellini A., Soto Parra H., Brighenti M., Petrelli F., Bennati C., Bidoli P., Garassino M. C., and Berruti A.

Abstract

Objectives: The prevalence of Skeletal Related Adverse Events (SREs) in EGFR mutated non-small cell lung cancer (NSCLC) patients with bone metastases, treated with modern tyrosine kinase inhibitors (TKIs), has been scarcely investigated. Materials and Methods: We retrospectively evaluated the data of EGFR mutated NSCLC patients with bone metastases treated with TKIs in 12 Italian centers from 2014 to 2019, with the primary aim to explore type and frequency of SREs. Results: Seventy-seven out of 274 patients enrolled (28%) developed at least one major SRE: 55/274 (20%) bone fractures, 30/274 (11%) spinal cord compression, 5/274 (2%) hypercalcemia. Median time to the onset of SRE was 3.63 months. Nine patients (3%) underwent bone surgery and 150 (55%) radiation therapy on bone. SREs were more frequently observed within the 12 months from TKI start than afterwards (71 vs 29%, p 0.000). Patient Performance Status and liver metastases where independently associated with the risk of developing SREs. Median TKI exposure and overall survival were 11 and 28 months, respectively. Bone resorption inhibitors were associated with a lower risk of death (HR 0.722, 95% CI: 0.504–1.033, p = 0.075) although not statistically significant at multivariate analysis. Conclusion: Bone metastatic NSCLC patients with EGFR mutated disease, treated with EGFR TKIs, have a relatively long survival expectancy and are at high risk to develop SREs. The early SRE occurrence after the TKI start provides the rationale to administer bone resorption inhibitors.

Published
2020

39. Aplastic anemia in a patient with advanced lung adenocarcinoma during first line osimertinib: A case report and literature review

Author

Sala, L, Mancin, M, Pastore, A, Seminati, D, Cortinovis, D, Bidoli, P, Alberti, A, Sala L., Mancin M., Pastore A., Seminati D., Cortinovis D., Bidoli P., Alberti A., Sala, L, Mancin, M, Pastore, A, Seminati, D, Cortinovis, D, Bidoli, P, Alberti, A, Sala L., Mancin M., Pastore A., Seminati D., Cortinovis D., Bidoli P., and Alberti A.

Abstract

Objectives: Osimertinib is a third-generation, irreversible tyrosine kinase inhibitor of the epidermal growth factor receptor (EGFR-TKI) showing longer progression free survival and overall survival than other EGFR-TKI with an improvement in tolerability. Materials and methods: We report about an advanced lung adenocarcinoma patient with severe aplastic anemia during first line osimertinib. Results and conclusion: Severe hematologic toxicity is extremely rare but possible with osimertinib and clinicians should be careful about changes in blood cell count during the use of it.

Published
2020

40. Final overall survival and safety update for durvalumab in third- or later-line advanced NSCLC: The phase II ATLANTIC study

Author

Garassino, M, Cho, B, Kim, J, Mazieres, J, Vansteenkiste, J, Lena, H, Jaime, J, Gray, J, Powderly, J, Chouaid, C, Bidoli, P, Wheatley-Price, P, Park, K, Soo, R, Poole, L, Wadsworth, C, Dennis, P, Rizvi, N, Garassino M. C., Cho B. -C., Kim J. -H., Mazieres J., Vansteenkiste J., Lena H., Jaime J. C., Gray J. E., Powderly J., Chouaid C., Bidoli P., Wheatley-Price P., Park K., Soo R. A., Poole L., Wadsworth C., Dennis P. A., Rizvi N. A., Garassino, M, Cho, B, Kim, J, Mazieres, J, Vansteenkiste, J, Lena, H, Jaime, J, Gray, J, Powderly, J, Chouaid, C, Bidoli, P, Wheatley-Price, P, Park, K, Soo, R, Poole, L, Wadsworth, C, Dennis, P, Rizvi, N, Garassino M. C., Cho B. -C., Kim J. -H., Mazieres J., Vansteenkiste J., Lena H., Jaime J. C., Gray J. E., Powderly J., Chouaid C., Bidoli P., Wheatley-Price P., Park K., Soo R. A., Poole L., Wadsworth C., Dennis P. A., and Rizvi N. A.

Abstract

Introduction: In the phase II ATLANTIC study, durvalumab provided durable responses with acceptable tolerability in heavily pretreated patients with advanced NSCLC, across three independent patient cohorts defined by EGFR/ALK status and tumour PD-L1 expression. Preliminary overall survival (OS) data were encouraging. We now report final OS and updated safety data. Methods: Patients with advanced NSCLC with disease progression following ≥2 previous systemic regimens received durvalumab 10 mg/kg every 2 weeks. The primary endpoint was objective response rate among patients with increased PD-L1 expression (defined as ≥25 % or ≥90 % of tumour cells [TCs], cohort-dependent). Secondary endpoints included OS and safety. Results: 444 patients received durvalumab: 111 in Cohort 1 (EGFR+/ALK+), 265 in Cohort 2 (EGFR−/ALK−), and 68 in Cohort 3 (EGFR−/ALK−; TC ≥ 90 %). Median (95 % CI) OS was 13.3 months (6.3–24.5) in patients with EGFR+/ALK+ NSCLC with TC ≥ 25 %, 10.9 months (8.6–13.6) in patients with EGFR–/ALK– NSCLC with TC ≥ 25 %, and 13.2 months (5.9–not reached) in patients with EGFR–/ALK– NSCLC with TC ≥ 90 %. Median (95 % CI) OS was slightly shorter in patients with TC < 25 % (9.9 months [4.2–13.3] in patients with EGFR+/ALK+ NSCLC and 9.3 months [5.9–10.8] in those with EGFR–/ALK– NSCLC). Treatment-related adverse events of special interest occurred with similar incidences as reported previously. Conclusions: After additional follow-up, final OS data remain encouraging across all cohorts, further supporting the clinical activity of durvalumab in patients with heavily pretreated advanced NSCLC, including those with EGFR+/ALK+ tumours. There were no new safety signals.

Published
2020

41. Disseminated intravascular coagulation in advanced lung adenocarcinoma during first-line pembrolizumab

Author

Alberti, A, Mancin, M, Cortinovis, D, Bidoli, P, Sala, L, Alberti A., Mancin M., Cortinovis D., Bidoli P., Sala L., Alberti, A, Mancin, M, Cortinovis, D, Bidoli, P, Sala, L, Alberti A., Mancin M., Cortinovis D., Bidoli P., and Sala L.

Abstract

Aim: Every year 1.6 million people worldwide die from lung cancer, making it one of the most frequent and deadly tumors. Pembrolizumab is a humanized monoclonal antibody against PD-1 that has antitumor activity in advanced non-small-cell lung cancer, with increased activity in tumors that express programmed death ligand 1. Methods &results: We report the first case of pembrolizumab-related disseminated intravascular coagulation (DIC). After excluding other causes of DIC, a diagnosis of pembrolizumab-related DIC was performed and the patient was treated with corticosteroid therapy until signs resolution. Conclusion: Disorders of coagulation-fibrinolysis system related to immunotherapy are rare, but often clinically serious and life threatening, so it is necessary to pay close attention to the various symptoms and signs during immunotherapy.

Published
2020

42. Efficacy and Safety of Anti-PD-1 Immunotherapy in Patients Aged ≥ 75 Years With Non–small-cell Lung Cancer (NSCLC): An Italian, Multicenter, Retrospective Study

Author

Luciani, A, Marra, A, Toschi, L, Cortinovis, D, Fava, S, Filipazzi, V, Tuzi, A, Cerea, G, Rossi, S, Perfetti, V, Rossi, A, Giannetta, L, Sala, L, Finocchiaro, G, Pizzutilo, E, Carelli, S, Agustoni, F, Cergnul, M, Zonato, S, Siena, S, Bidoli, P, Ferrari, D, Luciani A., Marra A., Toschi L., Cortinovis D., Fava S., Filipazzi V., Tuzi A., Cerea G., Rossi S., Perfetti V., Rossi A., Giannetta L., Sala L., Finocchiaro G., Pizzutilo E. G., Carelli S., Agustoni F., Cergnul M., Zonato S., Siena S., Bidoli P., Ferrari D., Luciani, A, Marra, A, Toschi, L, Cortinovis, D, Fava, S, Filipazzi, V, Tuzi, A, Cerea, G, Rossi, S, Perfetti, V, Rossi, A, Giannetta, L, Sala, L, Finocchiaro, G, Pizzutilo, E, Carelli, S, Agustoni, F, Cergnul, M, Zonato, S, Siena, S, Bidoli, P, Ferrari, D, Luciani A., Marra A., Toschi L., Cortinovis D., Fava S., Filipazzi V., Tuzi A., Cerea G., Rossi S., Perfetti V., Rossi A., Giannetta L., Sala L., Finocchiaro G., Pizzutilo E. G., Carelli S., Agustoni F., Cergnul M., Zonato S., Siena S., Bidoli P., and Ferrari D.

Abstract

This study was conducted in the setting of advanced non–small-cell lung cancer in older patients. It is a multicenter retrospective analysis on very old persons that explores the efficacy and the safety of anti-programmed cell death protein 1 therapy. Older patients seem to tolerate immunotherapy as well as younger patients with comparable efficacy. This is a relevant message for everyday clinical practice.

Published
2020

43. Khorana score and thromboembolic risk in stage II–III colorectal cancer patients: a post hoc analysis from the adjuvant TOSCA trial

Author

Barni, S, Rosati, G, Lonardi, S, Pella, N, Banzi, M, Zampino, M, Dotti, K, Rimassa, L, Marchetti, P, Maiello, E, Artioli, F, Ferrari, D, Labianca, R, Bidoli, P, Zaniboni, A, Sobrero, A, Iaffaioli, V, De Placido, S, Frassineti, G, Ciarlo, A, Buonadonna, A, Silvestris, N, Piazza, E, Pavesi, L, Moroni, M, Clerico, M, Aglietta, M, Giordani, P, Galli, F, Petrelli, F, Barni S., Rosati G., Lonardi S., Pella N., Banzi M., Zampino M. G., Dotti K. F., Rimassa L., Marchetti P., Maiello E., Artioli F., Ferrari D., Labianca R., Bidoli P., Zaniboni A., Sobrero A., Iaffaioli V., De Placido S., Frassineti G. L., Ciarlo A., Buonadonna A., Silvestris N., Piazza E., Pavesi L., Moroni M., Clerico M., Aglietta M., Giordani P., Galli F., Petrelli F., Barni, S, Rosati, G, Lonardi, S, Pella, N, Banzi, M, Zampino, M, Dotti, K, Rimassa, L, Marchetti, P, Maiello, E, Artioli, F, Ferrari, D, Labianca, R, Bidoli, P, Zaniboni, A, Sobrero, A, Iaffaioli, V, De Placido, S, Frassineti, G, Ciarlo, A, Buonadonna, A, Silvestris, N, Piazza, E, Pavesi, L, Moroni, M, Clerico, M, Aglietta, M, Giordani, P, Galli, F, Petrelli, F, Barni S., Rosati G., Lonardi S., Pella N., Banzi M., Zampino M. G., Dotti K. F., Rimassa L., Marchetti P., Maiello E., Artioli F., Ferrari D., Labianca R., Bidoli P., Zaniboni A., Sobrero A., Iaffaioli V., De Placido S., Frassineti G. L., Ciarlo A., Buonadonna A., Silvestris N., Piazza E., Pavesi L., Moroni M., Clerico M., Aglietta M., Giordani P., Galli F., and Petrelli F.

Abstract

Background: The risk of venous thromboembolic events (VTE) during adjuvant chemotherapy for colorectal cancer (CRC) is unknown. We aim to evaluate if the Khorana score (KS) can predict this risk, and if it represents a prognostic factor for overall survival (OS) through a post hoc analysis of the phase III TOSCA trial of different durations (3- versus 6-months) of adjuvant chemotherapy. Methods: A logistic regression model was used to test the associations between the risk of VTE and the KS. The results are expressed as odds ratios (OR) with 95% confidence intervals (95% CI). To assess the effect of the KS on OS, multivariable analyses using Cox regression models were performed. The results are expressed as hazard ratios (HR) with 95% CI. Results: Among 1380 CRC patients with available data, the VTE risk (n = 72 events: 5.2%) was similar in the two duration arms (5.5% versus 4.9%), with 0.2% of patients belonging to the high-risk KS group. Rates of VTE were similar in the low- and intermediate-risk groups (4.8% versus 6.4%). KS did not represent an independent predictive factor for VTE occurrence. Chemotherapy duration was not associated with VTE risk. In addition, KS was not prognostic for OS in multivariate analysis (HR: 0.92, 95% CI, 0.63–1.36; p = 0.6835). Conclusions: The use of the KS did not predict VTEs in a low–moderate thromboembolic risk population as CRC. These data did not support the use of KS to predict VTE during adjuvant chemotherapy, and suggest that other risk assessment models should be researched.

Published
2020

44. Molecular and immune biomarkers for cutaneous melanoma: Current status and future prospects

Author

Pilla, L, Alberti, A, Mauro, P, Gemelli, M, Cogliati, V, Cazzaniga, M, Bidoli, P, Maccalli, C, Pilla L., Alberti A., Mauro P. D., Gemelli M., Cogliati V., Cazzaniga M. E., Bidoli P., Maccalli C., Pilla, L, Alberti, A, Mauro, P, Gemelli, M, Cogliati, V, Cazzaniga, M, Bidoli, P, Maccalli, C, Pilla L., Alberti A., Mauro P. D., Gemelli M., Cogliati V., Cazzaniga M. E., Bidoli P., and Maccalli C.

Abstract

Advances in the genomic, molecular and immunological make-up of melanoma allowed the development of novel targeted therapy and of immunotherapy, leading to changes in the paradigm of therapeutic interventions and improvement of patients’ overall survival. Nevertheless, the mechanisms regulating either the responsiveness or the resistance of melanoma patients to therapies are still mostly unknown. The development of either the combinations or of the sequential treatment of different agents has been investigated but without a strongly molecularly motivated rationale. The need for robust biomarkers to predict patients’ responsiveness to defined therapies and for their stratification is still unmet. Progress in immunological assays and genomic techniques as long as improvement in designing and performing studies monitoring the expression of these markers along with the evolution of the disease allowed to identify candidate biomarkers. However, none of them achieved a definitive role in predicting patients’ clinical outcomes. Along this line, the cross-talk of melanoma cells with tumor microenvironment plays an important role in the evolution of the disease and needs to be considered in light of the role of predictive biomarkers. The overview of the relationship between the molecular basis of melanoma and targeted therapies is provided in this review, highlighting the benefit for clinical responses and the limitations. Moreover, the role of different candidate biomarkers is described together with the technical approaches for their identification. The provided evidence shows that progress has been achieved in understanding the molecular basis of melanoma and in designing advanced therapeutic strategies. Nevertheless, the molecular determinants of melanoma and their role as biomarkers predicting patients’ responsiveness to therapies warrant further investigation with the vision of developing more effective precision medicine.

Published
2020

46. The use of PSA testing over more than 20 years: A population-based study in North-Eastern Italy

Author

Taborelli, Martina, Toffolutti, Federica, Bidoli, Ettore, Dal Maso, Luigino, Del Zotto, Stefania, Clagnan, Elena, Gobbato, Michele, Serraino, Diego, and Franceschi, Silvia

Abstract

Objective: To describe the practice of prostate-specific antigen (PSA) testing over more than 20 years in Friuli Venezia Giulia (FVG), North-Eastern Italy.Methods: A population-based, ecological study was conducted using information derived from regional administrative health-related databases. Data on PSA and prostate biopsies performed on resident men aged ⩾45 years from 1998 to 2019 were retrieved. PSA and biopsy rates were calculated as the number of men who had at least one such procedure in each calendar year over the mean resident male population of the same year. Temporal trends were analyzed using joinpoint regression (annual percentage change –APC).Results: A total of 2,502,670 PSA were made between 1998 to 2019 in men aged ⩾45 years. The number of PSA steadily increased from 51,055 in 1998-1999 to 134,504 in 2010-2011, then dropped to 122,080 in 2018-2019. Significant changes in the slopes of PSA rates emerged in 2002 and 2009: the largest increase occurred during 1998-2002 (APC 18.4), followed by a smaller increase in 2002-2009 (APC 3.4) and a subsequent reduction (APC -2.5). Similar patterns emerged for all ages, but the decrease since 2009 was smaller for men aged ⩾65 years. An upward trend emerged in biopsy rate from 1998 to 2001 (APC 13.0), followed by a smaller increase until 2007 (APC 5.7) and a subsequent decrease. Biopsies as percentage of PSA decreased from 3.2% to 2.2%, particularly in those aged ⩾75 years.Conclusions: Although overall declining PSA rates have been observed in FVG since 2009, rates remained higher in the ⩾65-year-old group than in the 45-64–year-old group.

Published
2023
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47. Breast cancer deaths attributable to alcohol consumption: Italy, 2015–2019.

Author

Driutti, Marco, Dal Maso, Luigino, Toffolutti, Federica, Valdi, Giulia, Bidoli, Ettore, Giudici, Fabiola, Parpinel, Maria, and Serraino, Diego

Subjects
ALCOHOL drinking, BREAST cancer, CANCER-related mortality
Abstract

A study was conducted to assess the fraction of female breast cancer (BC) deaths attributable to alcohol consumption in Italy. National mortality data for the period 2015–2019 were used along with national estimates of women from the general population exposed to moderate (11–20 gr/day) or heavy (>20 gr/day) alcohol consumption. From 2015 to 2019, 2918 (4.6%) out of 63,428 BC| deaths were attributable to alcohol consumption, including 1269 deaths (2.0%) caused by moderate consumption. Study findings could help stakeholders to prioritize programs aimed at reducing alcohol consumption, and to improve ways to effectively communicate alcohol-related health risks, including moderate consumption. • Alcohol is a well-established risk factor for seven cancers, but its impact on breast cancer mortality is poorly known; • The aim of this study was to estimate, in Italy for the period 2015–2019, the fraction of female breast cancer deaths attributable to moderate or heavy alcohol consumption. • Out of 63,428 of breast cancer deaths, 2.0% (i.e., 1269) were attributable to moderate alcohol consumption and 2.6% (i.e., 1649) to heavy consumption. [ABSTRACT FROM AUTHOR]

Published
2023
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50. 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

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