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1. Safety and Efficacy of Atezolizumab and Bevacizumab Combination as a First Line Treatment of Advanced Hepatocellular Carcinoma

Author

Zanuso V, Pirozzi A, Balsano R, Pressiani T, and Rimassa L

Subjects
hcc, immune checkpoint inhibitors, atezolizumab, bevacizumab, safety, efficacy., Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Valentina Zanuso,1,2 Angelo Pirozzi,1,2 Rita Balsano,2 Tiziana Pressiani,2 Lorenza Rimassa1,2 1Department of Biomedical Sciences, Humanitas University, Milan, Italy; 2Medical Oncology and Hematology Unit, IRCCS Humanitas Research Hospital, Milan, ItalyCorrespondence: Lorenza Rimassa, Humanitas University, Via Rita Levi Montalcini 4, 20072 Pieve Emanuele, Milan, Italy, Tel +39 02 82244573, Fax +39 02 82244590, Email lorenza.rimassa@hunimed.euAbstract: Hepatocellular carcinoma (HCC) is one of the most common leading causes of cancer death worldwide. As most patients are diagnosed with advanced disease, systemic therapy remains the backbone of treatment. In recent years, we have witnessed the transformation of advanced HCC treatment landscapes from single-agent targeted therapies to immunotherapy combinations, with atezolizumab plus bevacizumab becoming the new first-line standard of care with an increase in overall survival, progression-free survival, and objective response rate compared to sorafenib, and a positive impact on quality of life. Although the efficacy and safety of this combination have been confirmed regardless of ethnicity, age, and etiology, only a subgroup of patients seems to benefit the most from this treatment. Currently, predictive serum and tissue biomarkers to select patients who are most likely to respond to atezolizumab plus bevacizumab are lacking. Moreover, the optimal subsequent therapy for patients who progress on first-line atezolizumab plus bevacizumab remains unknown, clinical trials are ongoing, and real-world data are needed to determine the most effective treatment sequence. Importantly, careful evaluation of bleeding risk and preservation of adequate liver function are fundamental to improve patients’ prognosis, especially when subsequent treatments are administered.Keywords: HCC, immune checkpoint inhibitors, atezolizumab, bevacizumab, safety, efficacy

Published
2023

2. Assessment and Monitoring of Response to Systemic Treatment in Advanced Hepatocellular Carcinoma: Current Insights

Author

Cammarota A, Zanuso V, Pressiani T, Personeni N, and Rimassa L

Subjects
afp, hcc, recist, mrecist, surrogate endpoints, systemic therapy., Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Antonella Cammarota,1,2 Valentina Zanuso,1,2 Tiziana Pressiani,2 Nicola Personeni,1,2,* Lorenza Rimassa1,2,* 1Department of Biomedical Sciences, Humanitas University, Milan, Pieve Emanuele, Italy; 2Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Milan, Rozzano, Italy*These authors contributed equally to this workCorrespondence: Lorenza Rimassa, Department of Biomedical Sciences, Humanitas University, Via Rita Levi Montalcini 4, Milan, Pieve Emanuele, 20072, Italy, Tel +39 02 82244573, Fax +39 02 82244590, Email lorenza.rimassa@hunimed.euAbstract: Advanced hepatocellular carcinoma (HCC) management has become more complex as novel therapies have been proven effective. After sorafenib, the approval of other multikinase inhibitors (MKIs) and immune checkpoints inhibitors (ICIs) has considerably increased the number of systemic therapies available. Therefore, careful assessment and monitoring of response to systemic treatment are essential to identify surrogate endpoints of overall survival (OS) in clinical trials and reliable tools to gauge treatment benefit in clinical practice. Progression-free survival (PFS) and objective response rate (ORR) are early informative parameters of efficacy that are not influenced by further lines of therapy. However, none of them has shown sufficient surrogacy to be recommended in place of OS in phase 3 trials. With such a wealth of therapeutic options, the prime intent of tumor assessments is no longer limited to identifying progressive disease to spare ineffective treatments to non-responders. Indeed, the early detection of responders could also help tailor treatment sequencing. Tumor assessment relies on the Response Evaluation Criteria for Solid Tumors (RECIST), which are easy to interpret – being based on dimensional principles – but could misread the activity of targeted agents. The HCC-specific modified RECIST (mRECIST), considering both the MKI-induced biological modifications and some of the cirrhosis-induced liver changes, better capture tumor response. Yet, mRECIST could not be considered a standard in advanced HCC. Further prognosticators including progression patterns, baseline and on-treatment liver function deterioration, and baseline alpha-fetoprotein (AFP) levels and AFP response have been extensively evaluated for MKIs. However, limited information is available for patients receiving ICIs and regarding their predictive role. Finally, there is increasing interest in incorporating novel imaging techniques which go beyond sizes and novel serum biomarkers in the advanced HCC framework. Hopefully, multiparametric models grouping dimensional and functional radiological parameters with biochemical markers will most precisely reflect treatment response.Keywords: AFP, HCC, RECIST, mRECIST, surrogate endpoints, systemic therapy

Published
2022

3. Lenvatinib for the treatment of unresectable hepatocellular carcinoma: evidence to date

Author

Personeni N, Pressiani T, and Rimassa L

Subjects
Hepatocellular carcinoma, unresectable, first-line, lenvatinib, angiogenesis, immunotherapy, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Nicola Personeni,1,2 Tiziana Pressiani,1 Lorenza Rimassa1 1Medical Oncology and Hematology Unit, Humanitas Cancer Center, Humanitas Clinical and Research Center – IRCCS, Rozzano 20089, Milan, Italy; 2Department of Biomedical Sciences, Humanitas University, Pieve Emanuele 20090, Milan, Italy Abstract: During the last 10 years, the multikinase inhibitor sorafenib has emerged as the only systemic treatment for unresectable hepatocellular carcinoma (HCC). More recently, data from the Phase III REFLECT trial showed that another multikinase inhibitor, namely, lenvatinib, was non-inferior to sorafenib in terms of overall survival (OS). In contrast, with respect to OS, previous randomized Phase III trials have been negative, and several agents tested have failed to prove non-inferiority (or superiority) when compared with sorafenib in a first-line setting. Furthermore, the REFLECT trial demonstrated that lenvatinib, in comparison with sorafenib, significantly increased progression-free survival, time to progression, and objective response rate. Overall, the incidence of grade ≥3 treatment-emergent adverse events (TEAEs) was similar in the two treatment arms of the trial, with a higher incidence of serious TEAEs in the lenvatinib arm. Encouraging efficacy signals had already been reported for immune checkpoint inhibitors in HCC, and different synergisms have been postulated in the frame of interplay between vascular endothelial growth factor receptor-2 inhibitors and immunotherapy. Given these premises, future approaches are being developed in Phase I trials testing lenvatinib in combination with pembrolizumab or nivolumab. As the treatment landscape of HCC is expanding with novel agents being approved for patients who are intolerant or are progressing on prior sorafenib, we will discuss current challenges pertaining to the optimal sequencing of active agents in first- and second-line setting. Keywords: hepatocellular carcinoma, unresectable, first line, lenvatinib, angiogenesis, immunotherapy

Published
2019

4. Atezolizumab plus bevacizumab versus lenvatinib or sorafenib in non-viral unresectable hepatocellular carcinoma: an international propensity score matching analysis

Author

Rimini, M., Rimassa, L., Ueshima, K., Burgio, V., Shigeo, S., Tada, T., Suda, G., Yoo, C., Cheon, J., Pinato, D.J., Lonardi, S., Scartozzi, M., Iavarone, M., Di Costanzo, G.G., Marra, F., Soldà, C., Tamburini, E., Piscaglia, F., Masi, G., Cabibbo, G., Foschi, F.G., Silletta, M., Pressiani, T., Nishida, N., Iwamoto, H., Sakamoto, N., Ryoo, B.-Y., Chon, H.J., Claudia, F., Niizeki, T., Sho, T., Kang, B., D’Alessio, A., Kumada, T., Hiraoka, A., Hirooka, M., Kariyama, K., Tani, J., Atsukawa, M., Takaguchi, K., Itobayashi, E., Fukunishi, S., Tsuji, K., Ishikawa, T., Tajiri, K., Ochi, H., Yasuda, S., Toyoda, H., Ogawa, C., Nishimur, T., Hatanaka, T., Kakizaki, S., Shimada, N., Kawata, K., Tanaka, T., Ohama, H., Nouso, K., Morishita, A., Tsutsui, A., Nagano, T., Itokawa, N., Okubo, T., Arai, T., Imai, M., Naganuma, A., Koizumi, Y., Nakamura, S., Joko, K., Iijima, H., Hiasa, Y., Pedica, F., De Cobelli, F., Ratti, F., Aldrighetti, L., Kudo, M., Cascinu, S., and Casadei-Gardini, A.

Published
2022
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5. Clinical impact of relative dose intensity of cabozantinib during the first 8 weeks and of subsequent dose reductions in patients with unresectable hepatocellular carcinoma

Author

Tovoli, F., primary, Dadduzio, V., additional, De Lorenzo, S., additional, Rimassa, L., additional, Masi, G., additional, Iavarone, M., additional, Marra, F., additional, Garajova, I., additional, Brizzi, M.P., additional, Daniele, B., additional, Trevisani, F., additional, Messina, C., additional, Clemente, F. Di, additional, Pini, S., additional, Cabibbo, G., additional, Granito, A., additional, Rizzato, M.D., additional, Zagonel, V., additional, Brandi, G., additional, Pressiani, T., additional, Federico, P., additional, Vivaldi, C., additional, Bergna, I., additional, Campani, C., additional, and Piscaglia, F., additional

Published
2023
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8. 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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9. Wirksamkeit und Sicherheit einer zweiten Behandlung mit Immun-Checkpoint-Inhibitoren bei PatientInnen mit hepatozellulärem Karzinom

Author

Scheiner, B, additional, Pomej, K, additional, Pressiani, T, additional, Cammarota, A, additional, Fründt, TW, additional, von Felden, J, additional, Schulze, K, additional, Rössler, D, additional, Himmelsbach, V, additional, Finkelmeier, F, additional, Deibel, A, additional, Siebenhüner, AR, additional, Shmanko, K, additional, Radu, P, additional, Schwacha, B, additional, Ebert, MP, additional, Teufel, A, additional, Djanani, A, additional, Hucke, F, additional, Balcar, L, additional, Venerito, M, additional, Sinner, F, additional, Trauner, M, additional, D'Alessio, A, additional, Pinato, DJ, additional, Peck-Radosavljevic, M, additional, Dufour, J, additional, Weinmann, A, additional, Kremer, AE, additional, Toni, ENDe, additional, Rimassa, L, additional, and Pinter, M, additional

Published
2022
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10. A randomized, multicenter, phase II study of vandetanib monotherapy versus vandetanib in combination with gemcitabine versus gemcitabine plus placebo in subjects with advanced biliary tract cancer: the VanGogh study

Author

Santoro, A., Gebbia, V., Pressiani, T., Testa, A., Personeni, N., Arrivas Bajardi, E., Foa, P., Buonadonna, A., Bencardino, K., Barone, C., Ferrari, D., Zaniboni, A., Tronconi, M. C., Cartenì, G., Milella, M., Comandone, A., Ferrari, S., and Rimassa, L.

Published
2015
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13. 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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14. Real-life clinical data of cabozantinib for unresectable hepatocellular carcinoma: efficacy, safety and prognostic factors

Author

Tovoli, F., primary, Dadduzio, V., additional, De Lorenzo, S., additional, Rimassa, L., additional, Masi, G., additional, Iavarone, M., additional, Marra, F., additional, Garajova, I., additional, Brizzi, M.P., additional, Daniele, B., additional, Trevisani, F., additional, Messina, C., additional, Clemente, F. Di, additional, Pini, S., additional, Cabibbo, G., additional, Granito, A., additional, Rizzato, M.D., additional, Zagonel, V., additional, Brandi, G., additional, Pressiani, T., additional, Federico, P., additional, Vivaldi, C., additional, Bergna, I., additional, Campani, C., additional, and Piscaglia, F., additional

Published
2021
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15. P-57 Atezolizumab in combination with bevacizumab in patients with unresectable HCC previously untreated with systemic therapy: Interim analysis results from phase IIIb Italian AMETHISTA trial

Author

Martinelli, E., Masi, G., Piscaglia, F., Cabibbo, G., Di Maio, M., Gasbarrini, A., Iavarone, M., Pellegrini, E., Mazzaferro, V., Ballestrero, A., Garufi, C., Bergamo, F., Celsa, C., Marino, D., Tovoli, F., Ponziani, F., Pressiani, T., Astolfi, C., Ciardiello, F., Daniele, B., and Rimassa, L.

Published
2023
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17. Sorafenib in patients with Child-Pugh class A and B advanced hepatocellular carcinoma: a prospective feasibility analysis

Author

Pressiani, T., Boni, C., Rimassa, L., Labianca, R., Fagiuoli, S., Salvagni, S., Ferrari, D., Cortesi, E., Porta, C., Mucciarini, C., Latini, L., Carnaghi, C., Banzi, M., Fanello, S., De Giorgio, M., Lutman, F. R., Torzilli, G., Tommasini, M. A., Ceriani, R., Covini, G., Tronconi, M. C., Giordano, L., Locopo, N., Naimo, S., and Santoro, A.

Published
2013
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18. 1838P Do irinotecan (IRI) dose reductions driven by UGT1A1*28 genotyping prevent IRI-related severe neutropenia? A real-world study

Author

Personeni, N., primary, Mineri, R., additional, D'Alessio, A., additional, Cammarota, A., additional, Michelini, A., additional, Bozzarelli, S., additional, Smiroldo, V., additional, Pressiani, T., additional, Giordano, L., additional, Sandri, M.T., additional, Santoro, A., additional, and Rimassa, L., additional

Published
2020
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20. PO-0811 SBRT compared to sorafenib in locally advanced hepatocellular carcinoma: a propensity score analysis

Author

Gkika, E., primary, Brunner, T., additional, Abbasi-Senger, N., additional, Alheit, H., additional, Baus, W., additional, Blanck, O., additional, Gerum, S., additional, Guckenberger, M., additional, Habermehl, D., additional, Ostheimer, C., additional, Riesterer, O., additional, Tamihardja, J., additional, Pinato, D.J., additional, Rimassa, L., additional, Pressiani, T., additional, Schultheiss, M., additional, Sharma, R., additional, Burlone, M.E., additional, Pirisi, M., additional, Kudo, M., additional, Park, J.W., additional, Neumann-Haefelin, C., additional, Grosu, A., additional, Thimme, R., additional, and Bettinger, D., additional

Published
2019
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21. Supplementary Material for: Treatment Stage Migration Maximizes Survival Outcomes in Patients with Hepatocellular Carcinoma Treated with Sorafenib: An Observational Study

Author

Yen, C., Sharma, R., Rimassa, L., Arizumi, T., Bettinger, D., Choo, H.Y., Pressiani, T., Burlone, M.E., Pirisi, M., Giordano, L., Abdulrahman, A., Kudo, M., Thimme, R., Park, J.W., and Pinato, D.J.

Abstract

Background: Level I evidence supports the use of sorafenib in patients with Barcelona Clinic Liver Cancer (BCLC) stage C hepatocellular carcinoma, where heterogeneity in efficacy exists due to varying clinicopathologic features of the disease. Aim: We evaluated whether prior treatment with curative or locoregional therapies influences sorafenib-specific survival. Methods: From a prospective data set of 785 consecutive patients from international specialist centres, 264 patients (34%) were treatment naïve (TN) and 521 (66%) were pre-treated (PT), most frequently with transarterial chemoembolization (n = 413; 79%). The primary endpoint was overall survival (OS) from sorafenib initiation with prognostic factors tested on uni- and multivariate analyses. Results: Median OS for the entire cohort was 9 months; the median sorafenib duration was 2.8 months, with discontinuation being secondary to progression (n = 454; 58%) or toxicity (n = 149; 19%). PT patients had significantly longer OS than TN patients (10.5 vs. 6.6 months; p < 0.001). Compared to TN patients, PT patients had a better Child-Pugh (CP) class (CP A: 57 vs. 47%; p < 0.001) and a lower BCLC stage (BCLC A-B, 40 vs. 30%; p = 0.007). PT status preserved an independent prognostic role (p = 0.002) following adjustment for BCLC stage, α-fetoprotein, CP class, aetiology, and post-sorafenib treatment status. PT patients were more likely to receive further anticancer treatment after sorafenib (31 vs. 9%; p < 0.001). Conclusion: Patients receiving sorafenib after having failed curative or locoregional therapies survive longer and are more likely to receive further treatment after sorafenib. This suggests an incremental benefit to OS from sequential exposure to multiple lines of therapy, justifying treatment stage migration in eligible patients.

Published
2017
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22. Risk-stratified management of advanced hepatocellular carcinoma (HCC)

Author

Pinato, D.J., primary, Kaplan, D.E., additional, Yen, C., additional, Rimassa, L., additional, Dominik, B., additional, Pressiani, T., additional, Thimme, R., additional, Pirisi, M., additional, Burlone, M., additional, Arizumi, T., additional, Kudo, M., additional, Park, J.W., additional, Taddei, T.H., additional, Johnson, P., additional, and Sharma, R., additional

Published
2018
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24. A Phase II Randomized Dose Escalation Trial of Sorafenib in Patients With Advanced Hepatocellular Carcinoma

Author

Rimassa, L, Pressiani, T, Boni, C, Carnaghi, C, Rota Caremoli, E, Fagiuoli, S, Foa, P, Salvagni, S, Cortesi, E, Chiara Tronconi, M, Personeni, N, Bozzarelli, S, Chiara Banzi, M, Fanello, S, Romano Lutman, F, Giordano, L, Santoro, A, Rimassa L, Pressiani T, Boni C, Carnaghi C, Rota Caremoli E, Fagiuoli S, Foa P, Salvagni S, Cortesi E, Chiara Tronconi M, Personeni N, Bozzarelli S, Chiara Banzi M, Fanello S, Romano Lutman F, Giordano L, Santoro A., Rimassa, L, Pressiani, T, Boni, C, Carnaghi, C, Rota Caremoli, E, Fagiuoli, S, Foa, P, Salvagni, S, Cortesi, E, Chiara Tronconi, M, Personeni, N, Bozzarelli, S, Chiara Banzi, M, Fanello, S, Romano Lutman, F, Giordano, L, Santoro, A, Rimassa L, Pressiani T, Boni C, Carnaghi C, Rota Caremoli E, Fagiuoli S, Foa P, Salvagni S, Cortesi E, Chiara Tronconi M, Personeni N, Bozzarelli S, Chiara Banzi M, Fanello S, Romano Lutman F, Giordano L, and Santoro A.

Abstract

Background. Sorafenib has proven survival benefits in patients with advanced hepatocellular carcinoma (HCC). The viability of continuing sorafenib at a higher dosage in patients who experienced radiologic disease progression was investigated. Methods. Patients who experienced disease progression while on sorafenib 400 mg twice daily were randomized to sorafenib 600mgtwice daily (n49) or best supportive care (n52). The primary end point was progression-free survival (PFS). Time to progression, overall survival,andsafetywerealso evaluated. Results. The study did not meet its primary end point. The difference in PFS between the sorafenib arm (3.91 months) and the best supportive care arm (2.69 months) did not reach statistical significance (p = 0.086). Adverse events were mainly grade 1-2 and similar across both groups. In the sorafenib arm, the most frequent events were diarrhea (80%), weight loss (75%), fatigue (67%), hand-foot-skin reaction (49%), abdominal pain (37%), and stomatitis (26%). Conclusions. Escalated-dose sorafenib in patients with advanced HCC who progressed while on sorafenib, failed to provide any clinical benefit. Second-line treatment still remains an open issue to be explored in appropriate clinical trials

Published
2013

25. Sorafenib in patients with Child-Pugh class A and B advanced hepatocellular carcinoma: a prospective feasibility analysis.

Author

Pressiani, T, Boni, C, Rimassa, L, Labianca, R, Fagiuoli, S, Salvagni, S, Ferrari, D, Cortesi, E, Porta, C, Mucciarini, C, Latini, L, Carnaghi, C, Banzi, M, Fanello, S, De Giorgio, M, Lutman, F, Torzilli, G, Tommasini, M, Ceriani, R, Covini, G, Tronconi, M, Giordano, L, Locopo, N, Naimo, S, Santoro, A, Pressiani T, Boni C, Rimassa L, Labianca R, Fagiuoli S, Salvagni S, Ferrari D, Cortesi E, Porta C, Mucciarini C, Latini L, Carnaghi C, Banzi M, Fanello S, De Giorgio M, Lutman FR, Torzilli G, Tommasini MA, Ceriani R, Covini G, Tronconi MC, Giordano L, Locopo N, Naimo S, Santoro A., Pressiani, T, Boni, C, Rimassa, L, Labianca, R, Fagiuoli, S, Salvagni, S, Ferrari, D, Cortesi, E, Porta, C, Mucciarini, C, Latini, L, Carnaghi, C, Banzi, M, Fanello, S, De Giorgio, M, Lutman, F, Torzilli, G, Tommasini, M, Ceriani, R, Covini, G, Tronconi, M, Giordano, L, Locopo, N, Naimo, S, Santoro, A, Pressiani T, Boni C, Rimassa L, Labianca R, Fagiuoli S, Salvagni S, Ferrari D, Cortesi E, Porta C, Mucciarini C, Latini L, Carnaghi C, Banzi M, Fanello S, De Giorgio M, Lutman FR, Torzilli G, Tommasini MA, Ceriani R, Covini G, Tronconi MC, Giordano L, Locopo N, Naimo S, and Santoro A.

Abstract

Background: Sorafenib has shown survival benefits in patients with advanced hepatocellular carcinoma (HCC) and Child-Pugh (CP) class A liver function. There are few prospective data on sorafenib in patients with HCC and CP class B. Patients and methods: A consecutive prospective series of 300 patients with CP class A or B HCC were enrolled in a dual-phase trial to determine survival and safety data according to liver function (class A or B) in patients receiving oral sorafenib 800 mg daily. [Results of this study were presented in part at the ASCO 2012 Gastrointestinal Cancers Symposium, 19-21 January 2012. J Clin Oncol 2012; 30 (Suppl 4): abstract 306.]. Results: Overall progression-free survival (PFS), time to progression (TTP) and overall survival (OS) were 3.9, 4.1 and 9.1 months, respectively. For patients with CP class A versus B status, PFS was 4.3 versus 2.1 months, TTP was 4.2 versus 3.8 months and OS was 10.0 versus 3. 8 months. Extrahepatic spread was associated with worse outcomes but taken together with CP class, liver function played a greater role in reducing survival. Adverse events for the two CP groups were similar. Conclusion: Although patients with HCC and CP class B liver function have poorer outcomes than those with CP class A function, data suggest that patients with CP class B liver function can tolerate treatment and may still benefit from sorafenib.

Published
2013

26. Treatment-stage migration maximizes survival outcomes in patients with hepatocellular carcinoma treated with sorafenib: an observational study

Author

Yen, C., primary, Sharma, R., additional, Rimassa, L., additional, Arizumi, T., additional, Bettinger, D., additional, Evans, J., additional, Pressiani, T., additional, Burlone, M.E., additional, Pirisi, M., additional, Giordano, L., additional, Howell, J., additional, Kudo, M., additional, Thimme, R., additional, Park, J.-W., additional, and Pinato, D.J., additional

Published
2017
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27. Management of cirrhotic patients with hepatocellular carcinoma treated with sorafenib

Author

Cabibbo, G, Rolle, E, De Giorgio, M, Genco, C, Pressiani, T, Spada, F, Sacco, R, Fagiuoli, S, Cabibbo G, Rolle E, De Giorgio M, Genco C, Pressiani T, Spada F, Sacco R, Fagiuoli S, Cabibbo, G, Rolle, E, De Giorgio, M, Genco, C, Pressiani, T, Spada, F, Sacco, R, Fagiuoli, S, Cabibbo G, Rolle E, De Giorgio M, Genco C, Pressiani T, Spada F, Sacco R, and Fagiuoli S

Abstract

Sorafenib (Nexavar®, Bayer), a multi-targeted tyrosine kinase inhibitor, was the first systemic agent that demonstrated a significant improvement in the overall survival in patients with advanced hepatocellular carcinoma and well-preserved liver function. This drug is now recommended in patients with advanced hepatocellular carcinoma as first-line therapy and for patients not suitable for locoregional treatment. This brief article, produced by a multidisciplinary panel including specialists in gastroenterology and oncology, provides an overview of the major issues related to systemic treatment of hepatocellular carcinoma with sorafenib, including staging and prognostic strategies, assessment of liver disease and its complications, and efficacy and safety of this molecule. Particular emphasis is given on how to improve tolerability of sorafenib in difficult-to-treat patients.

Published
2011

28. Learning from critical internationalisation events. Insights from two fast growing Italian SMEs

Author

S. Albertini, G. Antonelli, B. Balboni, A. Berni, S. Bonesso, G. Bortoluzzi, M. Brumana, D. Campagnolo, L. Cassia, A. Comacchio, S. Consiglio, F. Crisci, C. Dossena, C.E. De Marco, V. Finotto, A. Francesconi, D. Gamba, D. Giacomini, M. Gianecchini, P. Gubitta, M.P. Iacono, F. Izzo, G. Lauto, G. Magnani, M. Martine, B. Masiello, P.A.M. Mazzurana, T. Minola, C. Muzzi, A. Onetti, A. Piccaluga, A. Pisoni, D. Pittino, P. Pressiani, T. Pucci, M. Talaia, A. Tognazzo, A. Tracogna, F. Visintin, L. Zanni, A. Zucchella, Visintin, F, Pittino, D, Francesconi, A., Dossena, Claudia, Magnani, Giacomo, Talaia, M., Pisoni, A., Onetti, A., Zucchella, A., Dossena, C. (ORCID:0000-0002-3657-8782), Magnani, G., S. Albertini, G. Antonelli, B. Balboni, A. Berni, S. Bonesso, G. Bortoluzzi, M. Brumana, D. Campagnolo, L. Cassia, A. Comacchio, S. Consiglio, F. Crisci, C. Dossena, C.E. De Marco, V. Finotto, A. Francesconi, D. Gamba, D. Giacomini, M. Gianecchini, P. Gubitta, M.P. Iacono, F. Izzo, G. Lauto, G. Magnani, M. Martine, B. Masiello, P.A.M. Mazzurana, T. Minola, C. Muzzi, A. Onetti, A. Piccaluga, A. Pisoni, D. Pittino, P. Pressiani, T. Pucci, M. Talaia, A. Tognazzo, A. Tracogna, F. Visintin, L. Zanni, A. Zucchella, Visintin, F, Pittino, D, Francesconi, A., Dossena, Claudia, Magnani, Giacomo, Talaia, M., Pisoni, A., Onetti, A., Zucchella, A., Dossena, C. (ORCID:0000-0002-3657-8782), and Magnani, G.

Abstract

At present, Europe lacks innovative companies, which grow quickly and end up big. This book examines SME growth, innovation and success, to suggest that fast-growing firms could offer a major contribution to the recovery of a European economy. The contributors examine eleven case studies from Italian firms, breaking the book up into three parts: context, actors and strategy. The topics discussed include entrepreneurship and technological clusters, innovative start-ups and growth factors, and family firms as the incubators of new ventures. Students and scholars of entrepreneurship and other related disciplines will find this book to be of interest. It will also be of use to practitioners in the field, working with and alongside SMEs.

Published
2016

29. Management of cirrhotic patients with hepatocellular carcinoma treated with sorafenib

Author

Cabibbo G, Rolle E, De Giorgio M, Genco C, Pressiani T, Spada F, Sacco R, Fagiuoli S, Cabibbo, G, Rolle, E, De Giorgio, M, Genco, C, Pressiani, T, Spada, F, Sacco, R, and Fagiuoli, S

Subjects
Oncology, Sorafenib, Liver Cirrhosis, Niacinamide, medicine.medical_specialty, Cirrhosis, Carcinoma, Hepatocellular, medicine.drug_class, Pyridines, Antineoplastic Agents, Gastroenterology, Tyrosine-kinase inhibitor, systemic therapy, liver cancer, Liver disease, Internal medicine, medicine, Humans, Pharmacology (medical), treatment, business.industry, Phenylurea Compounds, Benzenesulfonates, Liver Neoplasms, Disease Management, hepatocellular carcinoma, medicine.disease, hepatocellular carcinoma, sorafenb, cirrhosis, digestive system diseases, Tolerability, Hepatocellular carcinoma, sorafenib, Liver function, Liver cancer, business, management, medicine.drug, cirrhosi
Abstract

Sorafenib (Nexavar®, Bayer), a multi-targeted tyrosine kinase inhibitor, was the first systemic agent that demonstrated a significant improvement in the overall survival in patients with advanced hepatocellular carcinoma and well-preserved liver function. This drug is now recommended in patients with advanced hepatocellular carcinoma as first-line therapy and for patients not suitable for locoregional treatment. This brief article, produced by a multidisciplinary panel including specialists in gastroenterology and oncology, provides an overview of the major issues related to systemic treatment of hepatocellular carcinoma with sorafenib, including staging and prognostic strategies, assessment of liver disease and its complications, and efficacy and safety of this molecule. Particular emphasis is given on how to improve tolerability of sorafenib in difficult-to-treat patients.

Published
2011

34. Impact on Survival of Timing and Duration of Adjuvant Chemotherapy in Radically Resected Gastric Cancer

Author

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

Published
2016
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35. MicroRNA-425-3p predicts response to sorafenib therapy in patients with hepatocellular carcinoma

Author

Vaira, V, Roncalli, M, Carnaghi, C, Faversani, A, Maggioni, M, Augello, C, Rimassa, L, Pressiani, T, Spagnuolo, G, Di Tommaso, L, Fagiuoli, S, Rota Caremoli, E, Barberis, M, Labianca, R, Santoro, A, Bosari, S, Bosari, S., SPAGNUOLO, GAIA, Vaira, V, Roncalli, M, Carnaghi, C, Faversani, A, Maggioni, M, Augello, C, Rimassa, L, Pressiani, T, Spagnuolo, G, Di Tommaso, L, Fagiuoli, S, Rota Caremoli, E, Barberis, M, Labianca, R, Santoro, A, Bosari, S, Bosari, S., and SPAGNUOLO, GAIA

Abstract

Background & Aims: Sorafenib is the standard of care in advanced hepatocellular carcinoma (HCC), however no criteria have been established to select patients likely to benefit from this therapy. In this study, we evaluated the predictive role of microRNAs (miRNAs) in this setting of patients. Methods: We profiled 522 miRNA in a series of 26 HCC patients treated with sorafenib (training set) and validated the results in an independent series of 58 patients (validation set). Formalin-fixed paraffin-embedded tumour and cirrhotic liver biopsies were used for RNA extraction and miRNAs profiling with TaqMan Arrays technology. Statistical analyses were used to correlate miRNA levels with clinical outcome, including time to progression (TTP), progression free (PFS), and overall survival. Cell viability and cell motility of HuH-7 or HepG2 HCC cells were tested in vitro after transfection with specific miRNA precursor, inhibitor or controls and sorafenib treatment. Results: Six miRNAs were significantly associated with clinical variables in the training set and only miR-425-3p could be further validated. Higher levels of miR-425-3p were associated with longer TTP and PFS (P = 0.0008; HR = 0.4; 95% CI = 0.2-0.7 and P = 0.007; HR = 0.5; 95% CI = 0.3-0.9 respectively). Multivariate analysis confirmed the predictive significance of miR-425-3p. Furthermore, an association between increased miR-425-3p, cell death and reduced cell motility was defined in vitro in HCC cell lines treated with sorafenib. Conclusions: Assessment of miR-425-3p levels in liver biopsies could help in stratifying patients with advanced HCC for sorafenib treatment. These promising results need to be confirmed in a large prospective study.

Published
2015

38. ONC-2014-001: An open-label phase II study of regorafenib in patients with metastatic solid tumors who have progressed after standard therapy - RESOUND

Author

Bozzarelli, S., primary, Rimassa, L., additional, Giordano, L., additional, Garassino, I., additional, Marrari, A., additional, Tronconi, M.C., additional, De Sanctis, R.M., additional, Cavina, R., additional, Baretti, M., additional, Personeni, N., additional, Pressiani, T., additional, and Santoro, A., additional

Published
2015
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39. ITACA-S (Intergroup trial of adjuvant chemotherapy in adenocarcinoma of the stomach) trial: comparison of a sequential treatment versus a 5-FU/LV regimen for radically resecate gastric cancer. Tolerability and feasibility of a randomized study

Author

Bajetta, E., Floriani, I., Di Bartolomeo, M., Pressiani, T., Labianca, R., Sandomenico, C., Rondini, E., Pinotti, G., Bidoli, P., Alfredo Falcone, Rosati, G., Oliverio, G., Membrini, A., Di Fabio, F., Ciarlo, A., Cordio, S., Ricci, S., Calpona, S., and Study Group, F. Di Costanzo On Behalf Of Itaca S.

Published
2010

44. Phase II randomized trial on dose-escalated sorafenib (S) versus best supportive care (BSC) in patients with advanced hepatocellular carcinoma (HCC) with disease progression on prior S treatment.

Author

Pressiani, T., primary, Rimassa, L., additional, Boni, C., additional, Labianca, R., additional, Fagiuoli, S., additional, Ardizzoni, A., additional, Foa, P., additional, Cortesi, E., additional, Porta, C., additional, Artioli, F., additional, Latini, L., additional, Carnaghi, C., additional, Lutman, R. F., additional, Torzilli, G., additional, Tommasini, M., additional, Ceriani, R., additional, Covini, G., additional, Giordano, L., additional, Locopo, N., additional, and Santoro, A., additional

Published
2011
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45. Activity and safety of NGR-hTNF, a selective vascular-targeting agent, in previously treated patients with advanced hepatocellular carcinoma

Author

Santoro, A, primary, Pressiani, T, additional, Citterio, G, additional, Rossoni, G, additional, Donadoni, G, additional, Pozzi, F, additional, Rimassa, L, additional, Personeni, N, additional, Bozzarelli, S, additional, Colombi, S, additional, De Braud, F G, additional, Caligaris-Cappio, F, additional, Lambiase, A, additional, and Bordignon, C, additional

Published
2010
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