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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. PD-1 Blockade for Hepatocellular Carcinoma: Current Research and Future Prospects

Author

D'Alessio A, Rimassa L, Cortellini A, and Pinato DJ

Subjects
liver cancer, immunotherapy, advanced, immune checkpoint inhibition, pd-1, angiogenesis, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Antonio D’Alessio,1,2 Lorenza Rimassa,2,3 Alessio Cortellini,1,4 David James Pinato1,5 1Department of Surgery & Cancer, Imperial College London, Hammersmith Hospital, London, W120HS, UK; 2Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; 3Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano, Milan, Italy; 4Department of Biotechnology and Applied Clinical Sciences, University of L’Aquila, L’Aquila, Italy; 5Division of Oncology, Department of Translational Medicine, University of Piemonte Orientale, Novara, ItalyCorrespondence: David James PinatoDepartment of Surgery & Cancer, Imperial College London, Hammersmith Hospital, Du Cane Road, London, W12 0HS, UKTel +44 20 83833720Email david.pinato@imperial.ac.ukAbstract: The treatment of hepatocellular carcinoma (HCC) has witnessed radical changes over the last few years, with the introduction of immune checkpoint inhibitors (ICI) in clinical practice, namely the combination of atezolizumab plus bevacizumab as the standard of care for first-line treatment of advanced HCC. The immunosuppressive microenvironment of the chronically inflamed liver makes HCC a fertile ground for the use of ICI. This review focuses on anti-programmed cell death-1 (PD-1) monoclonal antibodies (mAb), which have been extensively studied, as monotherapy, in combination with other ICI or with antiangiogenic agents. Currently, anti-PD-1 agents are approved by the United States Food and Drug Administration for second-line treatment in advanced HCC: nivolumab, alone or in combination with ipilimumab, and pembrolizumab. Lack of demonstration of survival benefit in first and second line led to the investigation of PD-1 agents in combination with multi-kinase inhibitors, with a number of first-line treatment regimens being actively investigated. Mounting evidence suggests a potential role of PD-1 blockade as adjuvant or neoadjuvant therapies. A key challenge remains the identification of biomarkers of response, since only a minority of patients appear to benefit from ICI.Keywords: liver cancer, immunotherapy, advanced, immune checkpoint inhibition, PD-1, angiogenesis

Published
2021

4. The Role of Cabozantinib as a Therapeutic Option for Hepatocellular Carcinoma: Current Landscape and Future Challenges

Author

D'Alessio A, Prete MG, Cammarota A, Personeni N, and Rimassa L

Subjects
liver cancer, advanced, metastatic, second-line, third-line, special populations, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Antonio D’Alessio,1,2 Maria Giuseppina Prete,1,2 Antonella Cammarota,1,2 Nicola Personeni,1,2 Lorenza Rimassa1,2 1Department of Biomedical Sciences, Humanitas University, Pieve Emanuele (Milan), 20090, Italy; 2Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Rozzano (Milan), 20089, ItalyCorrespondence: Lorenza Rimassa; Nicola PersoneniDepartment of Biomedical Sciences, Humanitas University, Pieve Emanuele (Milan), 20090, ItalyTel +39 02 82244573; +39 02 82244573Fax +39 02 82244590Email lorenza.rimassa@hunimed.eu; nicola.personeni@hunimed.euAbstract: The systemic treatment of advanced hepatocellular carcinoma (HCC) has significantly changed over the last years, with the introduction of two new standard-of-care first-line treatments (lenvatinib and the combination of atezolizumab and bevacizumab) and the success of several new agents in second line. In particular, after the approval of regorafenib, ramucirumab and cabozantinib, the landscape of second-line treatment has become notably complex, providing a serious challenge in clinical practice. In this review, we focus on cabozantinib, a multikinase inhibitor which was proven effective in improving overall and progression-free survival of patients previously treated with sorafenib in the randomized Phase III CELESTIAL trial. CELESTIAL is the only phase III study to have included patients in the third-line setting and cabozantinib efficacy was confirmed in several post hoc analyses, irrespective of alpha-fetoprotein levels, albumin-bilirubin score, age, and duration of previous sorafenib treatment. The safety profile of cabozantinib in the CELESTIAL trial was comparable with other multikinase inhibitors used for HCC and the most frequent grade ≥ 3 adverse events were diarrhea, palmar-plantar erythrodysesthesia, fatigue, hypertension, and aspartate aminotransferase increase. Tolerability did not differ between younger and older patients and quality of life was significantly improved compared to placebo during the treatment. In this review, we also make a particular mention to the use of cabozantinib in populations which are normally excluded from clinical trials, such as older patients and Child-Pugh B patients. Finally, we present the new treatment strategies in which cabozantinib is being tested, most notably the combination of cabozantinib and atezolizumab in the first-line setting in the phase III COSMIC-312 trial and the use of cabozantinib after progression on immune-checkpoint inhibitors.Keywords: liver cancer, advanced, metastatic, second-line, third-line, special populations

Published
2021

5. 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

6. Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Azevedo, Sergio, Braghiroli, Maria Ignez, Girotto, Gustavo, Bragagnoli, Arinilda, Branco, Ricardo, Faccio, Adilson, Moretto, Andrea, Skare, Nils, Dutra, Jamille, Viola, Luciana, Vianna, Karina, Meton, Fernando, Sette, Claudia, Faulhaber, Amanda, Tam, Vincent C., Couture, Felix, Biagi, Jim, Castel, Helene, Mulder, Karen, Ko, Yoo-Joung, Zbuk, Kevin, Welch, Stephen, Beaudoin, Annie, Heurgué, Alexandra, Assenat, Eric, Archambeaud, Isabelle, Tougeron, David, Peron, Jean-Marie, Gilabert, Marine, Bronowicki, Jean-Pierre, Cattan, Stephane, Blanc, Jean-Frederic, Bouattour, Mohamed, Phelip, Jean-Marc, Boige, Valerie, Michel, Pierre, Frin, Anne-Claire, De Toni, Enrico N., Berres, Marie-Luise, Vogel, Arndt, Berg, Thomas, Ettrich, Thomas, Waldschmidt, Dirk, Wedemeyer, Hans Heinrich, Worns, Marcus-Alexander, Bitzer, Michael, Weiss, Karl-Heinz, Lau, George, Chan, Stephen L., Yau, Thomas, Tai, Yin Ping, Lee, Ann Shing, Thungappa, Satheesh Chiradoni, N, Lokesh K., Sureshchand Ostwal, Vikas, Ashok, Kattimani Kiran, Mittal, Sushant, Goyal, Hari, Srinivasan, Sankar, Biswas, Ghanashyam, Mohan, Mallavarapu, Limaye, Sewanti, Asarawala, Nirav, Rimassa, Lorenza, Falcone, Alfredo, Gianni, Luca, Gasbarrini, Antonio, Daniele, Bruno, Avallone, Antonio, Paolo Frassineti, Giovanni Luca, Roila, Fausto, Kudo, Masatoshi, Kawaoka, Tomokazu, Morimoto, Manabu, Takikawa, Yasuhiro, Kato, Naoya, Yamashita, Tatsuya, Osaki, Yukio, Motomura, Kenta, Tateishi, Ryosuke, Ohkawa, Kazuyoshi, Wada, Yoshiyuki, Onishi, Hideki, Sasahira, Naoki, Inaba, Yoshitaka, Kurosaki, Masayuki, Tsuji, Kunihiko, Takei, Yoshiyuki, Aramaki, Takeshi, Hagihara, Atsushi, Furuse, Junji, Kioka, Kiyohide, Koga, Hironori, Sasaki, Yutaka, Numata, Kazushi, Tada, Toshifumi, Kawaguchi, Yasunori, Nadano, Seijin, Vasilyev, Alexander, Breder, Valery, Lipatov, Oleg, Dvorkin, Mikhail, Zarubenkov, Oleg, Kutukova, Svetlana, Ponomarev, Roman, Shostka, Kirill, Alyasova, Anna, Topuzov, Eldar, Severtsev, Alexey, Petrov, Yuryi, Erygin, Dmitriy, Berdov, Boris, Kang, Yoon-Koo, Tak, Won-Young, Park, Joong-Won, Lim, Ho Yeong, Heo, Jeong, Kim, Jee Hyun, Kim, Tae-You, Choi, Hye Jin, Varela, María, Reig Monzon, María Elisa, Sangro, Bruno, Martin, Carlos Gómez, Ponce, Carmen Guillén, López, Carlos, Cheng, Ann-Lii, Chao, Yee, Feng, Yin-Hsun, Jeng, Long-Bin, Hung, Chao-Hung, Hou, Ming-Mo, Wang Tsang-En Wang, Jing-Houng, Yen, Chia-Jui, Sukeepaisarnjaroen, Wattana, Sunpaweravong, Patrapim, Charoentum, Chaiyut, Tanasanvimon, Suebpong, Sirachainan, Ekaphop, Ungtrakul, Teerapat, Prasongsook, Naiyarat, Maneenil, Kunlatida, Jitpewngarm, Wittawat, Ostapenko, Yurii, Skoryi, Denys, Bondarenko, Igor, Shparyk, Yaroslav, Trukhin, Dmytro, Hotko, Yevhen, Ursol, Grygorii, Kryzhanivska, Anna, Abou-Alfa, Ghassan K., Mody, Kabir, Dayyani, Farshid, Al-Rajabi, Raed, Yarchoan, Mark, Gandhi, Sunil, Crysler, Oxana, He, Aiwu Ruth, Reeves, James, Bahary, Nathan, Mahipal, Amit, Kelley, Robin Kate, Dasgupta, Anirudha, Rowe, Julie, Thota, Ramya, Beg, Muhammad, Morse, Michael, Choi, Sung-hee, Crocenzi, Todd, Somer, Bradley, Abrams, Thomas, Denlinger, Crystal, Zhang, Yue, Sharma, Nisha, Dao, Tu V., Thinh, Nguyen Tien, Tuyet Phuong, Le Thi, Sangro, B., Chan, S.L., Kelley, R.K., Lau, G., Kudo, M., Sukeepaisarnjaroen, W., Yarchoan, M., De Toni, E.N., Furuse, J., Kang, Y.K., Galle, P.R., Rimassa, L., Heurgué, A., Tam, V.C., Van Dao, T., Thungappa, S.C., Breder, V., Ostapenko, Y., Reig, M., Makowsky, M., Paskow, M.J., Gupta, C., Kurland, J.F., Negro, A., and Abou-Alfa, G.K.

Published
2024
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7. 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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10. OC.04.2: EFFECT OF PREOPERATIVE CHEMO-RADIATION ON TUMORINFILTRATING LYMPHOCYTES IN LOCALLY ADVANCED RECTAL CANCER AND TUMOR RESPONSE: RESULTS FROM THE STAR-01 COHORT

Author

Negri, F., primary, Gnetti, L., additional, Campanini, N., additional, Azzoni, C., additional, Bottarelli, L., additional, Negru, E., additional, Bergamo, F., additional, Frisinghelli, M., additional, Chiaulon, G., additional, Tamberi, S., additional, Masi, G., additional, Petric, M., additional, Tagliagambe, A., additional, Morabito, A., additional, Siena, S., additional, Corsi, D., additional, Rimassa, L., additional, Frassineti, G.L., additional, De'Angelis, G.L., additional, Laghi, L., additional, Boni, L., additional, and Aschele, C., additional

Published
2024
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11. OC.16.6: APPLICATION OF MACHINE LEARNING MODEL-3P TO PREDICT PORTAL HYPERTENSION IN PATIENT WITH HEPATOCELLULAR CARCINOMA

Author

Soleri, M., primary, Berardi, F., additional, Bertazzoni, A., additional, Fortunato, M., additional, Ceriani, R., additional, Colapietro, F., additional, Pugliese, N., additional, Masetti, C., additional, Torzilli, G., additional, Pedicini, V., additional, Poretti, D., additional, Rimassa, L., additional, Comito, T., additional, De Nalda, A. Lleo, additional, Aghemo, A.M.G., additional, and De Nicola, S., additional

Published
2024
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13. T.07.3: CHARACTERISTICS AND OUTCOMES OF IMMUNOTHERAPYRELATED LIVER INJURY IN PATIENTS WITH HEPATOCELLULAR CARCINOMA COMPARED TO PATIENTS WITH ADVANCED SOLID TUMOURS

Author

Celsa, C., primary, Cabibbo, G., additional, Fulgenzi, C.A.M., additional, Scheiner, B., additional, D'Alessio, A., additional, Manfredi, G.F., additional, Stefanini, B., additional, Marron, T., additional, Saeed, A., additional, Pinter, M., additional, Huang, Y., additional, Pillai, A., additional, Schönlein, M., additional, Von Felden, J., additional, Galle, P.R., additional, Kudo, M., additional, Rimassa, L., additional, Singal, A.G., additional, Chon, H.J., additional, Hsu, W., additional, Vogel, A., additional, Brunetti, L., additional, Pinto, C., additional, Bersanelli, M., additional, Cortellini, A., additional, Cammà, C., additional, and Pinato, D.J., additional

Published
2024
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17. Four-year overall survival update from the phase III HIMALAYA study of tremelimumab plus durvalumab in unresectable hepatocellular carcinoma

Author

Sangro, B., primary, Chan, S.L., additional, Kelley, R.K., additional, Lau, G., additional, Kudo, M., additional, Sukeepaisarnjaroen, W., additional, Yarchoan, M., additional, De Toni, E.N., additional, Furuse, J., additional, Kang, Y.K., additional, Galle, P.R., additional, Rimassa, L., additional, Heurgué, A., additional, Tam, V.C., additional, Van Dao, T., additional, Thungappa, S.C., additional, Breder, V., additional, Ostapenko, Y., additional, Reig, M., additional, Makowsky, M., additional, Paskow, M.J., additional, Gupta, C., additional, Kurland, J.F., additional, Negro, A., additional, Abou-Alfa, G.K., additional, Azevedo, Sergio, additional, Braghiroli, Maria Ignez, additional, Girotto, Gustavo, additional, Bragagnoli, Arinilda, additional, Branco, Ricardo, additional, Faccio, Adilson, additional, Moretto, Andrea, additional, Skare, Nils, additional, Dutra, Jamille, additional, Viola, Luciana, additional, Vianna, Karina, additional, Meton, Fernando, additional, Sette, Claudia, additional, Faulhaber, Amanda, additional, Tam, Vincent C., additional, Couture, Felix, additional, Biagi, Jim, additional, Castel, Helene, additional, Mulder, Karen, additional, Ko, Yoo-Joung, additional, Zbuk, Kevin, additional, Welch, Stephen, additional, Beaudoin, Annie, additional, Heurgué, Alexandra, additional, Assenat, Eric, additional, Archambeaud, Isabelle, additional, Tougeron, David, additional, Peron, Jean-Marie, additional, Gilabert, Marine, additional, Bronowicki, Jean-Pierre, additional, Cattan, Stephane, additional, Blanc, Jean-Frederic, additional, Bouattour, Mohamed, additional, Phelip, Jean-Marc, additional, Boige, Valerie, additional, Michel, Pierre, additional, Frin, Anne-Claire, additional, Enrico N De Toni, Germany, additional, Berres, Marie-Luise, additional, Vogel, Arndt, additional, Berg, Thomas, additional, Ettrich, Thomas, additional, Waldschmidt, Dirk, additional, Wedemeyer, Hans Heinrich, additional, Worns, Marcus-Alexander, additional, Bitzer, Michael, additional, Weiss, Karl-Heinz, additional, Lau, George, additional, Chan, Stephen L., additional, Yau, Thomas, additional, Tai, Yin Ping, additional, Lee, Ann Shing, additional, Thungappa, Satheesh Chiradoni, additional, N, Lokesh K., additional, Ostwal, Vikas Sureshchand, additional, Ashok, Kattimani Kiran, additional, Mittal, Sushant, additional, Goyal, Hari, additional, Srinivasan, Sankar, additional, Biswas, Ghanashyam, additional, Mohan, Mallavarapu, additional, Limaye, Sewanti, additional, Asarawala, Nirav, additional, Rimassa, Lorenza, additional, Falcone, Alfredo, additional, Gianni, Luca, additional, Gasbarrini, Antonio, additional, Daniele, Bruno, additional, Avallone, Antonio, additional, Paolo Frassineti, Giovanni Luca, additional, Roila, Fausto, additional, Kudo, Masatoshi, additional, Kawaoka, Tomokazu, additional, Morimoto, Manabu, additional, Takikawa, Yasuhiro, additional, Kato, Naoya, additional, Yamashita, Tatsuya, additional, Osaki, Yukio, additional, Motomura, Kenta, additional, Tateishi, Ryosuke, additional, Ohkawa, Kazuyoshi, additional, Wada, Yoshiyuki, additional, Onishi, Hideki, additional, Sasahira, Naoki, additional, Inaba, Yoshitaka, additional, Kurosaki, Masayuki, additional, Tsuji, Kunihiko, additional, Takei, Yoshiyuki, additional, Aramaki, Takeshi, additional, Hagihara, Atsushi, additional, Furuse, Junji, additional, Kioka, Kiyohide, additional, Koga, Hironori, additional, Sasaki, Yutaka, additional, Numata, Kazushi, additional, Tada, Toshifumi, additional, Kawaguchi, Yasunori, additional, Nadano, Seijin, additional, Alexander Vasilyev, Russian Federation, additional, Breder, Valery, additional, Lipatov, Oleg, additional, Dvorkin, Mikhail, additional, Zarubenkov, Oleg, additional, Kutukova, Svetlana, additional, Ponomarev, Roman, additional, Shostka, Kirill, additional, Alyasova, Anna, additional, Topuzov, Eldar, additional, Severtsev, Alexey, additional, Petrov, Yuryi, additional, Erygin, Dmitriy, additional, Berdov, Boris, additional, Kang, Yoon-Koo, additional, Tak, Won-Young, additional, Park, Joong-Won, additional, Lim, Ho Yeong, additional, Heo, Jeong, additional, Kim, Jee Hyun, additional, Kim, Tae-You, additional, Choi, Hye Jin, additional, Varela, María, additional, Reig Monzon, María Elisa, additional, Sangro, Bruno, additional, Martin, Carlos Gómez, additional, Ponce, Carmen Guillén, additional, López, Carlos, additional, Cheng, Ann-Lii, additional, Chao, Yee, additional, Feng, Yin-Hsun, additional, Jeng, Long-Bin, additional, Hung, Chao-Hung, additional, Hou, Ming-Mo, additional, Wang Tsang-En Wang, Jing-Houng, additional, Yen, Chia-Jui, additional, Sukeepaisarnjaroen, Wattana, additional, Sunpaweravong, Patrapim, additional, Charoentum, Chaiyut, additional, Tanasanvimon, Suebpong, additional, Sirachainan, Ekaphop, additional, Ungtrakul, Teerapat, additional, Prasongsook, Naiyarat, additional, Maneenil, Kunlatida, additional, Jitpewngarm, Wittawat, additional, Ostapenko, Yurii, additional, Skoryi, Denys, additional, Bondarenko, Igor, additional, Shparyk, Yaroslav, additional, Trukhin, Dmytro, additional, Hotko, Yevhen, additional, Ursol, Grygorii, additional, Kryzhanivska, Anna, additional, Abou-Alfa, Ghassan K., additional, Mody, Kabir, additional, Dayyani, Farshid, additional, Al-Rajabi, Raed, additional, Yarchoan, Mark, additional, Gandhi, Sunil, additional, Crysler, Oxana, additional, He, Aiwu Ruth, additional, Reeves, James, additional, Bahary, Nathan, additional, Mahipal, Amit, additional, Kelley, Robin Kate, additional, Dasgupta, Anirudha, additional, Rowe, Julie, additional, Thota, Ramya, additional, Beg, Muhammad, additional, Morse, Michael, additional, Choi, Sung-hee, additional, Crocenzi, Todd, additional, Somer, Bradley, additional, Abrams, Thomas, additional, Denlinger, Crystal, additional, Zhang, Yue, additional, Sharma, Nisha, additional, Dao, Tu V., additional, Thinh, Nguyen Tien, additional, and Tuyet Phuong, Le Thi, additional

Published
2024
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18. 111P Characteristics and outcomes of immunotherapy-related liver injury in patients with hepatocellular carcinoma compared to patients with advanced solid tumours

Author

Celsa, C., primary, Cabibbo, G., additional, Marron, T.U., additional, Saeed, A., additional, Pinter, M., additional, Huang, Y-H., additional, Pillai, A., additional, Schoenlein, M., additional, von Felden, J., additional, Galle, P.R., additional, Kudo, M., additional, Rimassa, L., additional, Singal, A., additional, Chon, H., additional, Hsu, W-F., additional, Brunetti, L., additional, Pinto, C., additional, Bersanelli, M., additional, Cortellini, A., additional, and Pinato, D.J., additional

Published
2023
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19. 93P The survival impact of the addition of durvalumab to cisplatin/gemcitabine in advanced biliary tract cancer: A real-world, retrospective, multicentric study

Author

Rimini, M., primary, Persano, M., additional, Fornaro, L., additional, Antonuzzo, L., additional, Lonardi, S., additional, Rimassa, L., additional, Niger, M., additional, Silletta, M., additional, Tamburini, E., additional, Giordano, G., additional, Scartozzi, M., additional, Pastorino, A., additional, Martinelli, E., additional, Rizzato, M.D., additional, and Gardini, A. Casadei, additional

Published
2023
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20. 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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21. Estimating 12-week death probability in patients with refractory metastatic colorectal cancer: the Colon Life nomogram

Author

Pietrantonio, F., Miceli, R., Rimassa, L., Lonardi, S., Aprile, G., Mennitto, A., Marmorino, F., Bozzarelli, S., Antonuzzo, L., Tamburini, E., Morano, F., Rossini, D., Battaglin, F., Baretti, M., Berenato, R., Formica, V., Mosconi, S., Petrelli, F., Ghidini, M., Loupakis, F., Spada, D., Cinieri, S., Beretta, G., Falcone, A., de Braud, F., and Cremolini, C.

Published
2017
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23. OC.12.5 MYOSTEATOSIS IS NOT ASSOCIATED WITH COMPLICATIONS OR SURVIVAL IN HCC PATIENTS UNDERGOING TRANS ARTERIAL EMBOLIZATION

Author

De Marco, A., primary, Masetti, C., additional, Pugliese, N., additional, Lofino, L., additional, Colapietro, F., additional, Ceriani, R., additional, Lleo, A., additional, Poretti, D., additional, Pedicini, V., additional, De Nicola, S., additional, Torzilli, G., additional, Rimassa, L., additional, Aghemo, A., additional, and Lanza, E., additional

Published
2023
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24. Regret affects the choice between neoadjuvant therapy and upfront surgery for potentially resectable pancreatic cancer

Author

Cucchetti, A., Djulbegovic, B., Crippa, S., Hozo, I., Sbrancia, M., Tsalatsanis, A., Binda, C., Fabbri, C., Salvia, R., Falconi, M., Ercolani, G., Alfieri, Sergio, Amato, A., Amisano, M., Anderloni, A., Maestri, A., Coluccio, C., Brandi, G., Casadei-Gardini, A., Cennamo, V., Crino, S. F., Valle, R. D., De Angelis, C., Di Battista, M., Di Maio, M., Di Marco, M., Di Matteo, F., Di Mitri, R., Ettorre, G. M., Facciorusso, A., Farina, G., Ferrari, G., Fornaro, L., Frigerio, I., Frisone, D., Fuccio, L., Gardini, A., Garufi, C., Giampieri, R., Grazi, G. L., Jovine, E., Kauffmann, E., Langella, S., Larghi, Alberto Leonardo, Manno, M., Marciano, E., Marzioni, M., Merighi, A., Mutignani, M., Nardo, B., Niger, M., Palmisano, V., Partelli, S., Pinto, C., Piras, E., Rapposelli, I. G., Reni, M., Ricci, C., Rimassa, L., Siena, S., Spada, Cristiano, Sperti, E., Spezzaferro, M., Sposito, C., Tamberi, S., Troisi, R., Veneroni, L., Vivarelli, M., Zerbi, A., Alfieri S. (ORCID:0000-0002-0404-724X), Larghi A., Spada C. (ORCID:0000-0002-5692-0960), Cucchetti, A., Djulbegovic, B., Crippa, S., Hozo, I., Sbrancia, M., Tsalatsanis, A., Binda, C., Fabbri, C., Salvia, R., Falconi, M., Ercolani, G., Alfieri, Sergio, Amato, A., Amisano, M., Anderloni, A., Maestri, A., Coluccio, C., Brandi, G., Casadei-Gardini, A., Cennamo, V., Crino, S. F., Valle, R. D., De Angelis, C., Di Battista, M., Di Maio, M., Di Marco, M., Di Matteo, F., Di Mitri, R., Ettorre, G. M., Facciorusso, A., Farina, G., Ferrari, G., Fornaro, L., Frigerio, I., Frisone, D., Fuccio, L., Gardini, A., Garufi, C., Giampieri, R., Grazi, G. L., Jovine, E., Kauffmann, E., Langella, S., Larghi, Alberto Leonardo, Manno, M., Marciano, E., Marzioni, M., Merighi, A., Mutignani, M., Nardo, B., Niger, M., Palmisano, V., Partelli, S., Pinto, C., Piras, E., Rapposelli, I. G., Reni, M., Ricci, C., Rimassa, L., Siena, S., Spada, Cristiano, Sperti, E., Spezzaferro, M., Sposito, C., Tamberi, S., Troisi, R., Veneroni, L., Vivarelli, M., Zerbi, A., Alfieri S. (ORCID:0000-0002-0404-724X), Larghi A., and Spada C. (ORCID:0000-0002-5692-0960)

Abstract

Background: When treating potentially resectable pancreatic adenocarcinoma, therapeutic decisions are left to the sensibility of treating clinicians who, faced with a decision that post hoc can be proven wrong, may feel a sense of regret that they want to avoid. A regret-based decision model was applied to evaluate attitudes to-ward neoadjuvant therapy versus upfront surgery for potentially resectable pancreatic adenocarcinoma.Methods: Three clinical scenarios describing high-, intermediate-, and low-risk disease-specific mortality after upfront surgery were presented to 60 respondents (20 oncologists, 20 gastroenterologists, and 20 surgeons). Respondents were asked to report their regret of omission and commission regarding neo-adjuvant chemotherapy on a scale between 0 (no regret) and 100 (maximum regret). The threshold model and a multilevel mixed regression were applied to analyze respondents' attitudes toward neo-adjuvant therapy.Results: The lowest regret of omission was elicited in the low-risk scenario, and the highest regret in the high-risk scenario (P < .001). The regret of the commission was diametrically opposite to the regret of omission (P < .001). The disease-specific threshold mortality at which upfront surgery is favored over the neoadjuvant therapy progressively decreased from the low-risk to the high-risk scenarios (P <=.001). The nonsurgeons working in or with lower surgical volume centers (P = .010) and surgeons (P = .018) accepted higher disease-specific mortality after upfront surgery, which resulted in the lower likelihood of adopting neoadjuvant therapy.Conclusion: Regret drives decision making in the management of pancreatic adenocarcinoma. Being a surgeon or a specialist working in surgical centers with lower patient volumes reduces the likelihood of recommending neoadjuvant therapy.(c) 2023 Elsevier Inc. All rights reserved.

Published
2023

27. 67P Real-world data for atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma

Author

Persano, M., primary, Rimini, M., additional, Tada, T., additional, Suda, G., additional, Shimose, S., additional, Kudo, M., additional, Cheon, J., additional, Finkelmeier, F., additional, Rimassa, L., additional, Presa, J., additional, Masi, G., additional, Yoo, C., additional, Lonardi, S., additional, Piscaglia, F., additional, Burgio, V., additional, Scartozzi, M., additional, Cascinu, S., additional, and Casadei Gardini, A., additional

Published
2022
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28. 65P Atezolizumab plus bevacizumab versus lenvatinib for unresectable hepatocellular carcinoma: A large real life worldwide population

Author

Rimini, M., primary, Casadei Gardini, A., additional, Persano, M., additional, Suda, G., additional, Tada, T., additional, Shimose, S., additional, Kudo, M., additional, Cheon, J., additional, Finkelmeier, F., additional, Rimassa, L., additional, Presa, J., additional, Masi, G., additional, Yoo, C., additional, Lonardi, S., additional, Tovoli, F., additional, Piscaglia, F., additional, Iavarone, M.A., additional, Scartozzi, M., additional, Burgio, V., additional, Cascinu, S., additional, and Cucchetti, A., additional

Published
2022
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30. 84P Atezolizumab plus bevacizumab versus lenvatinib for unresectable hepatocellular carcinoma: A large real life worldwide population

Author

Rimini, M., primary, Casadei-Gardini, A., additional, Tada, T., additional, Suda, G., additional, Shimose, S., additional, Kudo, M., additional, Cheon, J., additional, Finkelmeier, F., additional, Lim, H.Y., additional, Rimassa, L., additional, Presa, J., additional, Masi, G., additional, Yoo, C., additional, Lonardi, S., additional, Tovoli, F., additional, Cascinu, S., additional, and Cucchetti, A., additional

Published
2022
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31. NMS-01940153E, an MPS1 inhibitor with anti-tumor activity in relapsed or refractory unresectable Hepatocellular carcinoma

Author

Reig, M., primary, Damian, S., additional, Roberti, D., additional, Maruzzelli, S., additional, Crivori, P., additional, Gianellini, L., additional, De Pietro, M.T., additional, Personeni, N., additional, Sanduzzi-Zamparelli, M., additional, Duca, M., additional, Disconzi, L., additional, Montagnoli, A., additional, Galvani, A., additional, Ardini, E., additional, Isacchi, A., additional, Colajori, E., additional, Davite, C., additional, Mahnke, L., additional, and Rimassa, L., additional

Published
2022
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32. 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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37. 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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38. P-19 Subgroup analysis of the number of prior lines of systemic therapy and clinical outcomes associated with tislelizumab in patients with previously treated advanced hepatocellular carcinoma (HCC)

Author

Merle, P., primary, Edeline, J., additional, Fang, W., additional, Assenat, E., additional, Pan, H., additional, Rimassa, L., additional, Li, Z., additional, Blanc, J., additional, Yen, C., additional, Ross, P., additional, Hu, S., additional, Zhang, T., additional, Tran, A., additional, Shao, G., additional, Bouattour, M., additional, Chen, Y., additional, Wu, J., additional, Li, B., additional, Chica-Duque, S., additional, and Ren, Z., additional

Published
2022
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39. SO-14 Atezolizumab plus bevacizumab versus lenvatinib or sorafenib in non-viral unresectable hepatocellular carcinoma: An international study

Author

Rimini, M., primary, Rimassa, L., additional, Kudo, M., additional, Shigeo, S., additional, Toshifumi, T., additional, Suda, G., additional, Yoo, C., additional, Cheon, J., additional, Lonardi, S., additional, Scartozzi, M., additional, Tamburini, E., additional, Masi, G., additional, Cascinu, S., additional, and Casadei-Gardini, A., additional

Published
2022
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40. 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

41. Outcomes of the SARS-CoV-2 omicron (B.1.1.529) variant outbreak among vaccinated and unvaccinated patients with cancer in Europe: results from the retrospective, multicentre, OnCovid registry study

Author

Pinato, DJ, Aguilar-Company, J, Ferrante, D, Hanbury, G, Bower, M, Salazar, R, Mirallas, O, Sureda, A, Plaja, A, Cucurull, M, Mesia, R, Townsend, S, Jackson, A, Dalla Pria, A, Newsom-Davis, T, Handford, J, Sita-Lumsden, A, Apthorp, E, Vincenzi, B, Bertuzzi, A, Brunet, J, Lambertini, M, Maluquer, C, Pedrazzoli, P, Biello, F, Sinclair, A, Bawany, S, Khalique, S, Rossi, S, Rogers, L, Murphy, C, Belessiotis, K, Carmona-Garcia, MC, Sharkey, R, Garcia-Illescas, D, Rizzo, G, Perachino, M, Saoudi-Gonzalez, N, Doonga, K, Fox, L, Roldan, E, Gaidano, G, Ruiz-Camps, I, Bruna, R, Patriarca, A, Martinez-Vila, C, Cantini, L, Zambelli, A, Giusti, R, Mazzoni, F, Caliman, E, Santoro, A, Grosso, F, Parisi, A, Queirolo, P, Aujayeb, A, Rimassa, L, Prat, A, Tucci, M, Libertini, M, Grisanti, S, Mukherjee, U, Diamantis, N, Fusco, V, Generali, D, Provenzano, S, Gennari, A, Tabernero, J, and Cortellini, A

Abstract

Background The omicron (B.1.1.529) variant of SARS-CoV-2 is highly transmissible and escapes vaccine-induced immunity. We aimed to describe outcomes due to COVID-19 during the omicron outbreak compared with the prevaccination period and alpha (B.1.1.7) and delta (B.1.617.2) waves in patients with cancer in Europe. Methods In this retrospective analysis of the multicentre OnCovid Registry study, we recruited patients aged 18 years or older with laboratory-confirmed diagnosis of SARS-CoV-2, who had a history of solid or haematological malignancy that was either active or in remission. Patient were recruited from 37 oncology centres from UK, Italy, Spain, France, Belgium, and Germany. Participants were followed up from COVID-19 diagnosis until death or loss to follow-up, while being treated as per standard of care. For this analysis, we excluded data from centres that did not actively enter new data after March 1, 2021 (in France, Germany, and Belgium). We compared measures of COVID-19 morbidity, which were complications from COVID-19, hospitalisation due to COVID-19, and requirement of supplemental oxygen and COVID-19-specific therapies, and COVID-19 mortality across three time periods designated as the prevaccination (Feb 27 to Nov 30, 2020), alpha-delta (Dec 1, 2020, to Dec 14, 2021), and omicron (Dec 15, 2021, to Jan 31, 2022) phases. We assessed all-cause case-fatality rates at 14 days and 28 days after diagnosis of COVID-19 overall and in unvaccinated and fully vaccinated patients and in those who received a booster dose, after adjusting for country of origin, sex, age, comorbidities, tumour type, stage, and status, and receipt of systemic anti-cancer therapy. This study is registered with ClinicalTrials.gov, NCT04393974, and is ongoing. Findings As of Feb 4, 2022 (database lock), the registry included 3820 patients who had been diagnosed with COVID-19 between Feb 27, 2020, and Jan 31, 2022. 3473 patients were eligible for inclusion (1640 [47.4%] were women and 1822 [52.6%] were men, with a median age of 68 years [IQR 57-77]). 2033 (58.5%) of 3473 were diagnosed during the prevaccination phase, 1075 (31.0%) during the alpha-delta phase, and 365 (10.5%) during the omicron phase. Among patients diagnosed during the omicron phase, 113 (33.3%) of 339 were fully vaccinated and 165 (48.7%) were boosted, whereas among those diagnosed during the alpha-delta phase, 152 (16.6%) of 915 were fully vaccinated and 21 (2.3%) were boosted. Compared with patients diagnosed during the prevaccination period, those who were diagnosed during the omicron phase had lower case-fatality rates at 14 days (adjusted odds ratio [OR] 0.32 [95% CI 0.19-0.61) and 28 days (0.34 [0.16-0.79]), complications due to COVID-19 (0.26 [0.17-0.46]), and hospitalisation due to COVID-19 (0.17 [0.09-0.32]), and had less requirements for COVID-19-specific therapy (0.22 [0.15-0.34]) and oxygen therapy (0.24 [0.14-0.43]) than did those diagnosed during the alpha-delta phase. Unvaccinated patients diagnosed during the omicron phase had similar crude case-fatality rates at 14 days (ten [25%] of 40 patients vs 114 [17%] of 656) and at 28 days (11 [27%] of 40 vs 184 [28%] of 656) and similar rates of hospitalisation due to COVID-19 (18 [43%] of 42 vs 266 [41%] of 652) and complications from COVID-19 (13 [31%] of 42 vs 237 [36%] of 659) as those diagnosed during the alpha-delta phase. Interpretation Despite time-dependent improvements in outcomes reported in the omicron phase compared with the earlier phases of the pandemic, patients with cancer remain highly susceptible to SARS-CoV-2 if they are not vaccinated against SARS-CoV-2. Our findings support universal vaccination of patients with cancer as a protective measure against morbidity and mortality from COVID-19. Copyright (C) 2022. Published by Elsevier Ltd. All rights reserved.

Published
2022

43. VP10-2021: Cabozantinib (C) plus atezolizumab (A) versus sorafenib (S) as first-line systemic treatment for advanced hepatocellular carcinoma (aHCC): Results from the randomized phase III COSMIC-312 trial

Author

Kelley, R.K., primary, Yau, T., additional, Cheng, A.-L., additional, Kaseb, A., additional, Qin, S., additional, Zhu, A.X., additional, Chan, S., additional, Sukeepaisarnjaroen, W., additional, Breder, V., additional, Verset, G., additional, Gane, E., additional, Borbath, I., additional, Gomez Rangel, J.D., additional, Merle, P., additional, Benzaghou, F.M., additional, Banerjee, K., additional, Hazra, S., additional, Fawcett, J., additional, and Rimassa, L., additional

Published
2022
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46. 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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50. O-1 Results from a global phase 2 study of tislelizumab, an investigational PD-1 antibody, in patients with unresectable hepatocellular carcinoma

Author

Ducreux, M., primary, Abou-Alfa, G., additional, Ren, Z., additional, Edeline, J., additional, Li, Z., additional, Assenat, E., additional, Rimassa, L., additional, Blanc, J., additional, Ross, P., additional, Fang, W., additional, Hu, S., additional, Zhang, T., additional, Tran, A., additional, Pan, H., additional, Yen, C., additional, Wu, J., additional, Li, V., additional, Chica-Duque, S., additional, Merle, P., additional, and Cheng, A., additional

Published
2021
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