205 results on '"Shimose S"'
Search Results
2. Immunological inflammatory biomarkers as prognostic predictors for advanced hepatocellular carcinoma
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Nakano, M., Kuromatsu, R., Niizeki, T., Okamura, S., Iwamoto, H., Shimose, S., Shirono, T., Noda, Y., Kamachi, N., Koga, H., and Torimura, T.
- Published
- 2021
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3. 88P Adverse events (AEs) as potential predictive factors of activity in patients with advanced hepatocellular carcinoma (HCC) treated with atezolizumab plus bevacizumab (AB)
- Author
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Persano, M., primary, Rimini, M., additional, Tada, T., additional, Suda, G., additional, Shimose, S., additional, Kudo, M., additional, Yoo, C., additional, Cheon, J., additional, Finkelmeier, F., additional, Lim, H.Y., additional, Presa, J., additional, Masi, G., additional, Bergamo, F., additional, Iavarone, M.A., additional, Cabibbo, G., additional, Foschi, F.G., additional, Piscaglia, F., additional, Cascinu, S., additional, Scartozzi, M., additional, and Gardini, A. Casadei, additional
- Published
- 2023
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4. Incidence and risk factors of esophagogastric varices bleeding in cirrhotic patients with advanced hepatocellular carcinoma treated with lenvatinib
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Iavarone, M., primary, Alimenti, E., additional, Tada, T., additional, Shimose, S., additional, Suda, G., additional, Yoo, C., additional, Soldà, C., additional, Piscaglia, F., additional, Casadei-Gardini, A., additional, Marra, F., additional, Vivaldi, C., additional, Conti, F., additional, Schirripa, M., additional, Iwamoto, H., additional, Sho, T., additional, Lee, So Heun, additional, Rizzato, M.D., additional, Tonnini, M., additional, Rimini, M., additional, Campani, C., additional, Masi, G., additional, Foschi, F., additional, Bruccoleri, M., additional, Kawaguchi, T., additional, Kumada, T., additional, Hiraoka, A., additional, Atsukawa, M., additional, Fukunishi, S., additional, Ishikawa, T., additional, Tajiri, K., additional, Ochi, H., additional, Yasuda, S., additional, Toyoda, H., additional, Hatanaka, T., additional, Kakizaki, S., additional, Kawata, K., additional, Tada, F., additional, Ohama, H., additional, Itokawa, N., additional, Okubo, T., additional, Arai, T., additional, Imai, M., additional, Naganuma, A., additional, Tosetti, G., additional, and Lampertico, P., additional
- Published
- 2023
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5. 67P Real-world data for atezolizumab plus bevacizumab in unresectable hepatocellular carcinoma
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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
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- 2022
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6. 65P Atezolizumab plus bevacizumab versus lenvatinib for unresectable hepatocellular carcinoma: A large real life worldwide population
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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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7. 84P Atezolizumab plus bevacizumab versus lenvatinib for unresectable hepatocellular carcinoma: A large real life worldwide population
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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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8. 972P Sequential therapies after atezolizumab plus bevacizumab or lenvatinib first-line treatments in advanced hepatocellular carcinoma
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Persano, M., Rimini, M., Tada, T., Suda, G., Shimose, S., Kudo, M., Cheon, J., Finkelmeier, F., Presa, J., Masi, G., Yoo, C., Lonardi, S., Piscaglia, F., iavarone, M.A., TAMBURINI, E., Cabibbo, G., Silletta, M., Cascinu, S., Scartozzi, M., and Casadei Gardini, A.
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- 2023
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9. Origami Medial Femoral Condyle Flap for Finger Joint Reconstruction
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Hachisuka, H, Hamada, N, Shimose, S, Hamasaki, T, Izuta, Y, Fujimori, J, Mori, R, Okawa, S, and Ishibashi, S
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Finger joint ,Microsurgery ,ddc: 610 ,Medial femoral condyle ,Reconstruction ,610 Medical sciences ,Medicine - Abstract
Objectives/Interrogation: Finger joint reconstruction is challenging for hand surgeons, especially when accompanied by severe soft tissue damage. Accordingly, we adopted use of a vascularized medial femoral condyle (MFC) flap. In our procedure, a finger joint is fabricated with origami-like folding[for full text, please go to the a.m. URL], 14th Triennial Congress of the International Federation of Societies for Surgery of the Hand (IFSSH), 11th Triennial Congress of the International Federation of Societies for Hand Therapy (IFSHT), 11th Triennial Congress of the International Federation of Societies for Hand Therapy (IFSHT)
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- 2020
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10. Evaluating the effect of intrahepatic lesion status on the prognosis of advanced hepatocellular carcinoma patients with extrahepatic metastasis: A prospective multicenter cohort study
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Nakano M, Kuromatsu R, Niizeki T, Okamura S, Iwamoto H, Shimose S, Shirono T, Noda Y, Kamachi N, Koga H, and Torimura T
- Published
- 2020
11. Expression of hypoxia-inducible factor-1α and its relationship to tumour angiogenesis and cell proliferation in cartilage tumours
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Kubo, T., Sugita, T., Shimose, S., Matsuo, T., Arihiro, K., and Ochi, M.
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- 2008
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12. 367P Detecting circulating tumor cells by hTERT-specific replication-selective adenovirus in postoperative sarcoma patients
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Matsuo, T., primary, Sugita, T., additional, Shimose, S., additional, Hamada, N., additional, Deie, M., additional, and Urata, Y., additional
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- 2015
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13. Long-Term Results of Postoperative 3-Dimensional High-Dose-Rate Brachytherapy for Soft-Tissue Sarcomas
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Kenjo, M., primary, Kubo, T., additional, Shimose, S., additional, Fujimori, J., additional, Nakashima, T., additional, Doi, Y., additional, Okabe, T., additional, Murakami, Y., additional, Kimura, T., additional, Kaneyasu, Y., additional, and Nagata, Y., additional
- Published
- 2014
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14. Minodronate for the treatment of osteoporosis
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Kubo, T., primary, Shimose, S., additional, Matsuo, T., additional, Fujimori, J., additional, and Ochi, M., additional
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- 2010
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15. Differential diagnosis between osteomyelitis and bone tumors
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Shimose, S., primary, Sugita, T., additional, Kubo, T., additional, Matsuo, T., additional, Nobuto, H., additional, and Ochi, M., additional
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- 2008
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16. Major-nerve schwannomas versus intramuscular schwannomas
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Shimose, S., primary, Sugita, T., additional, Kubo, T., additional, Matsuo, T., additional, Nobuto, H., additional, Tanaka, K., additional, Arihiro, K., additional, and Ochi, M., additional
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- 2007
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17. Damage-free wafer cleaning by water and gas mixture jet
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Hirota, Y., primary, Kanno, I., additional, Fujiwara, K., additional, Nagayasu, H., additional, and Shimose, S., additional
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- 2005
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18. Targeted systemic chemotherapy using magnetic liposomes with incorporated adriamycin for osteosarcoma in hamsters.
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Kubo, T, primary, Sugita, T, additional, Shimose, S, additional, Nitta, Y, additional, Ikuta, Y, additional, and Murakami, T, additional
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- 2001
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19. Targeted delivery of anticancer drugs with intravenously administered magnetic liposomes in osteosarcoma-bearing hamsters.
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Kubo, T, primary, Sugita, T, additional, Shimose, S, additional, Nitta, Y, additional, Ikuta, Y, additional, and Murakami, T, additional
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- 2000
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20. Interferon-α/β receptor as a prognostic marker in osteosarcoma.
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Kubo T, Shimose S, Matsuo T, Fujimori J, Arihiro K, Ochi M, Kubo, Tadahiko, Shimose, Shoji, Matsuo, Toshihiro, Fujimori, Jun, Arihiro, Koji, and Ochi, Mitsuo
- Abstract
Background: A large-scale randomized trial of adjuvant interferon-α therapy for patients with osteosarcoma has been initiated as a joint protocol by the European and American Osteosarcoma Study Group. Because the expression of functional interferon-α/β receptor is necessary for interferon-α agents to interact with osteosarcoma cells, we examined the expression of interferon-α/β receptor in a series of osteosarcoma specimens.Methods: Forty patients with high-grade resectable osteosarcoma, from whom surgical specimens had been obtained at the time of biopsy, were included in this retrospective study. Biopsy specimens were immunohistochemically stained with anti-interferon-α/β receptor antibodies. Survival was estimated with the Kaplan-Meier method. The Cox proportional hazards model was used for multivariate analysis to determine the independent prognostic factors. Furthermore, we used Holm and Benjamini-Hochberg procedures to adjust for multiple comparisons in setting the level of significance. The median follow-up period was five years and two months (range, four to 195 months).Results: The expression of interferon-α/β receptor was positive in eighteen (45%) of the forty patients with high-grade osteosarcoma. American Joint Committee on Cancer surgical stage IIA, a good histologic response to chemotherapy, and expression of interferon-α/β receptor correlated significantly with better disease-free survival (p < 0.05). Multivariate analysis showed that interferon-α/β receptor expression alone retained its power to predict an improved prognosis (p = 0.042). There were no significant variables after corrections for multiple comparisons.Conclusions: Interferon-α/β receptor may be a useful marker for assessing tumor prognosis in patients with osteosarcoma and may play an important role in tumor progression. These findings are encouraging and support the ongoing clinical trials of adjuvant interferon-α therapy by the multinational Osteosarcoma Study Group. Our pilot study was based on a small sample size, and larger trials are needed to confirm this finding.Level Of Evidence: Prognostic Level II. See Instructions to Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]- Published
- 2011
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21. 182P A real-world, multicenter study of atezolizumab plus bevacizumab in viral and non-viral advanced hepatocellular carcinoma patients from Asia and Europe.
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Rossari, F., Tada, T., Shimose, S., Kudo, M., Yoo, C., Cheon, J., Finkelmeier, F., Lim, H.Y., Presa, J., Masi, G., Bergamo, F., Amadeo, E., Vitiello, F., Foti, S., Camera, S., Persano, M., Stefanini, B., Scartozzi, M., Rimini, M., and Gardini, A. Casadei
- Subjects
- *
HEPATOCELLULAR carcinoma , *ATEZOLIZUMAB , *BEVACIZUMAB - Published
- 2024
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22. Control of multi modal structural vibration using digital self-powered device
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Shimose, S., kanjuro makihara, Onoda, J., and Takeuchi, S.
23. Digital self-powered semi-active unit for advanced energy-recycling vibration suppression
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Makihara, K., Takeuchi, S., Shimose, S., Junjiro Onoda, and Minesugi, K.
24. Enhancement of energy-harvesting from random vibration by switched shunt circuit
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Shimose, S., Onoda, J., and kanjuro makihara
25. Practical application of energy-recycling semi-active vibration suppression method to an actual satellite structural model
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Minesugi, K., Junjiro Onoda, Shimose, S., Makihara, K., and Yabu, T.
26. Investigation of vibration suppressuon capabirity of switching techniques by multiple piezoelectric actuators
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Shimose, S., Minesugi, K., Makihara, K., and Junjiro Onoda
27. 185P Disease etiology impact on outcomes of hepatocellular carcinoma patients treated with atezolizumab plus bevacizumab: A real-world, multicenter study.
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Rossari, F., Tada, T., Shimose, S., Kudo, M., Yoo, C., Cheon, J., Finkelmeier, F., Lim, H.Y., Presa, J., Masi, G., Bergamo, F., Amadeo, E., Vitiello, F., Foti, S., Persano, M., Piscaglia, F., Scartozzi, M., Cascinu, S., Rimini, M., and Casadei Gardini, A.
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- *
ETIOLOGY of diseases , *BEVACIZUMAB , *ATEZOLIZUMAB - Published
- 2023
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28. Correlation between p38 mitogen-activated protein kinase and human telomerase reverse transcriptase in sarcomas
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Matsuo Toshihiro, Shimose Shoji, Kubo Tadahiko, Fujimori Jun, Yasunaga Yuji, Sugita Takashi, and Ochi Mitsuo
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p38 mitogen-activated protein kinase ,human telomerase reverse transcriptase ,malignant fibrous histiocytoma ,liposarcoma ,Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background One of the major components of telomerase is the human telomerase reverse transcriptase (hTERT) as the catalytic protein. hTERT mRNA expression are reported to be associated with prognosis and tumor progression in several sarcomas. However, there is no clear understanding of the mechanisms of hTERT in human sarcomas. Recent studies have suggested that signals transmitted through p38 mitogen-activated protein kinase (MAPK) can increase or decrease hTERT transcription in human cells. The purpose of this study was to analyse the correlation between p38 MAPK and hTERT in sarcoma samples. Methods We investigated 36 soft tissue malignant fibrous histiocytomas (MFH), 24 liposarcomas (LS) and 9 bone MFH samples for hTERT and p38 MAPK expression. Quantitative detection of hTERT and p38 MAPK was performed by RT-PCR. Results There was a significant positive correlation between the values of hTERT and p38 MAPK in all samples (r = 0.445, p = 0.0001), soft tissue MFH (r = 0.352, p = 0.0352), LS (r = 0.704, p = 0.0001) and bone MFH samples (r = 0.802, p = 0.0093). Patients who had a higher than average expression of p38 MAPK had a significantly worse prognosis than other patients (p = 0.0036). Conclusions p38 MAPK may play a role in up-regulation of hTERT, and therefore, p38 MAPK may be a useful marker in the assessment of hTERT and patients' prognosis in sarcomas.
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- 2012
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29. Immunohistochemical expression of promyelocytic leukemia body in soft tissue sarcomas
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Yasunaga Yuji, Ishikawa Masataka, Kubo Tadahiko, Shimose Shoji, Sugita Takashi, Matsuo Toshihiro, and Ochi Mitsuo
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background The function of promyelocytic leukemia (PML) bodies is not well known but plays an important role in controlling cell proliferation, apoptosis and senescence. This study was undertaken to analyze the clinical significance of PML body expression in primary tumor samples from malignant fibrous histiocytoma (MFH) and liposarcoma patients. Methods We studied MFH and liposarcoma samples from 55 patients for PML bodies. Fluorescent immunostaining of PML bodies was performed in the paraffin-embedded tumor sections. Results PML body immunostaining was identified in 63.9% of MFH and 63.2% of liposarcoma samples. PML body expression rates of all sarcoma cells were 1.5 ± 1.8% (range: 0–7.0) in MFH and 1.3 ± 1.4% (0–5.2) in liposarcoma samples. PML body expression (p = 0.0053) and a high rate of PML body expression (p = 0.0012) were significantly greater prognostic risk factors for death than the other clinical factors in MFH patients. All liposarcoma patients without expression of PML were disease free at the end of the study. Conclusion Our study suggests that the presence of PML bodies may indicate a poor prognosis for MFH and liposarcoma patients.
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- 2008
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30. Nerve tolerance to high-dose-rate brachytherapy in patients with soft tissue sarcoma: a retrospective study
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Kimura Hiroaki, Hirao Ken, Matsuo Toshihiro, Shimose Shoji, Sugita Takashi, Kubo Tadahiko, Kenjo Masahiro, and Ochi Mitsuo
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Neoplasms. Tumors. Oncology. Including cancer and carcinogens ,RC254-282 - Abstract
Abstract Background Brachytherapy, interstitial tumor bed irradiation, following conservative surgery has been shown to provide excellent local control and limb preservation in patients with soft tissue sarcomas (STS), whereas little is known about the tolerance of peripheral nerves to brachytherapy. In particular, nerve tolerance to high-dose-rate (HDR) brachytherapy has never been properly evaluated. In this study, we examined the efficacy and radiation neurotoxicity of HDR brachytherapy in patients with STS in contact with neurovascular structures. Methods Between 1995 and 2000, seven patients with STS involving the neurovascular bundle were treated in our institute with limb-preserving surgery, followed by fractionated HDR brachytherapy. Pathological examination demonstrated that 6 patients had high-grade lesions with five cases of negative margins and one case with positive margins, and one patient had a low-grade lesion with a negative margin. Afterloading catheters placed within the tumor bed directly upon the preserved neurovascular structures were postoperatively loaded with Iridium-192 with a total dose of 50 Gy in 6 patients. One patient received 30 Gy of HDR brachytherapy combined with 20 Gy of adjuvant external beam radiation. Results With a median follow-up of 4 years, the 5-year actuarial overall survival, disease-free survival, and local control rates were 83.3, 68.6, and 83.3%, respectively. None of the 7 patients developed HDR brachytherapy-induced peripheral neuropathy. Of 5 survivors, 3 evaluable patients had values of motor nerve conduction velocity of the preserved peripheral nerve in the normal range. Conclusion In this study, there were no practical and electrophysiological findings of neurotoxicity of HDR brachytherapy. Despite the small number of patients, our encouraging results are valuable for limb-preserving surgery of unmanageable STS involving critical neurovascular structures.
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- 2005
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31. 967P Lenvatinib (L) versus sorafenib (S) second-line therapy in hepatocellular carcinoma (HCC) patients (P) progressed to atezolizumab plus bevacizumab (AB).
- Author
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Persano, M., Rimini, M., Tada, T., Suda, G., Shimose, S., Kudo, M., Yoo, C., Cheon, J., Finkelmeier, F., Lim, H.Y., Presa, J., Rossari, F., Amadeo, E., Vitiello, F., Camera, S., Foti, S., Mascia, L., Scartozzi, M., Cascinu, S., and Casadei Gardini, A.
- Published
- 2024
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32. Identification of lenvatinib prognostic index via recursive partitioning analysis in advanced hepatocellular carcinoma
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Marianna Silletta, V. Burgio, Gianluca Masi, A. Takata, M.G. Viola, Mario Domenico Rizzato, Kazuto Tajiri, H. Toyoda, M. Scartozzi, Francesca Salani, Syusuke Okamura, Francesco Giuseppe Foschi, Takashi Kumada, G. Astara, I.G. Rapposelli, Fabio Conti, Emiliano Tamburini, Claudia Campani, Kazuhito Kawata, Fabio Marra, A. Forgione, A. Hiraoka, Giovanni Luca Frassineti, R. Tortora, Takuji Torimura, Shigeo Shimose, Masahito Nakano, Masanori Atsukawa, Stefano Cascinu, Andrea Casadei-Gardini, H. Shibata, G.G. Di Costanzo, Caterina Vivaldi, Antonio Pellino, Claudia Angela Maria Fulgenzi, Toshifumi Tada, Eleonora Lai, Fabio Piscaglia, S. Lonardi, Margherita Rimini, Rapposelli, I. G., Shimose, S., Kumada, T., Okamura, S., Hiraoka, A., Di Costanzo, G. G., Marra, F., Tamburini, E., Forgione, A., Foschi, F. G., Silletta, M., Lonardi, S., Masi, G., Scartozzi, M., Nakano, M., Shibata, H., Kawata, K., Pellino, A., Vivaldi, C., Lai, E., Takata, A., Tajiri, K., Toyoda, H., Tortora, R., Campani, C., Viola, M. G., Piscaglia, F., Conti, F., Fulgenzi, C. A. M., Frassineti, G. L., Rizzato, M. D., Salani, F., Astara, G., Torimura, T., Atsukawa, M., Tada, T., Burgio, V., Rimini, M., Cascinu, S., Casadei-Gardini, A., Rapposelli I.G., Shimose S., Kumada T., Okamura S., Hiraoka A., Di Costanzo G.G., Marra F., Tamburini E., Forgione A., Foschi F.G., Silletta M., Lonardi S., Masi G., Scartozzi M., Nakano M., Shibata H., Kawata K., Pellino A., Vivaldi C., Lai E., Takata A., Tajiri K., Toyoda H., Tortora R., Campani C., Viola M.G., Piscaglia F., Conti F., Fulgenzi C.A.M., Frassineti G.L., Rizzato M.D., Salani F., Astara G., Torimura T., Atsukawa M., Tada T., Burgio V., Rimini M., Cascinu S., and Casadei-Gardini A.
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Oncology ,Cancer Research ,medicine.medical_specialty ,lenvatinib prognostic index ,Carcinoma, Hepatocellular ,hepatocellular carcinoma ,recursive partitioning analysis ,Humans ,Phenylurea Compounds ,Prognosis ,Quinolines ,Chemoembolization, Therapeutic ,Liver Neoplasms ,Recursive partitioning ,Prognostic score ,chemistry.chemical_compound ,Internal medicine ,medicine ,Original Research ,business.industry ,Carcinoma ,Treatment options ,Hepatocellular ,medicine.disease ,chemistry ,Hepatocellular carcinoma ,Cohort ,Chemoembolization ,Therapeutic ,Medium Risk ,Lenvatinib ,business - Abstract
Background After the advent of new treatment options for advanced hepatocellular carcinoma (HCC), the identification of prognostic factors is crucial for the selection of the most appropriate therapy for each patient. Patients and methods With the aim to fill this gap, we applied recursive partitioning analysis (RPA) to a cohort of 404 patients treated with lenvatinib. Results The application of RPA resulted in a classification based on five variables that originated a new prognostic score, the lenvatinib prognostic index (LEP) index, identifying three groups: low risk [patients with prognostic nutritional index (PNI) >43.3 and previous trans-arterial chemoembolization (TACE)]; medium risk [patients with PNI >43.3 but without previous TACE and patients with PNI, Highlights • This study shows a new prognostic index (LEP index) for patients undergoing systemic therapy for hepatocellular carcinoma. • LEP index is an easy-to-use tool, based on clinical and laboratory features, that identifies three risk groups. • LEP index may be used to stratify hepatocellular carcinoma patients in order to select the most appropriate treatment.
- Published
- 2021
33. Lenvatinib versus sorafenib in first-line treatment of unresectable hepatocellular carcinoma: An inverse probability of treatment weighting analysis
- Author
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Andrea Casadei‐Gardini, Mario Scartozzi, Toshifumi Tada, Changhoon Yoo, Shigeo Shimose, Gianluca Masi, Sara Lonardi, Luca Giovanni Frassineti, Silvestris Nicola, Fabio Piscaglia, Takashi Kumada, Hyung‐Don Kim, Hironori Koga, Caterina Vivaldi, Caterina Soldà, Atsushi Hiraoka, Yeonghak Bang, Masanori Atsukawa, Takuji Torimura, Kunihiko Tsuj, Ei Itobayashi, Hidenori Toyoda, Shinya Fukunishi, Lorenza Rimassa, Margherita Rimini, Stefano Cascinu, Alessandro Cucchetti, Shinichiro Nakamura, Kojiro Michitaka, Norio Itokawa, Korenobu Hayama, Masashi Hirooka, Yohei Koizumi, Yoichi Hiasa, Toru Ishikawa, Michitaka Imai, Koichi Takaguchi, Akemi Tsutsui, Takuya Nagano, Kazuya Kariyama, Kazuhiro Nouso, Kazuto Tajiri, Noritomo Shimada, Hiroshi Shibata, Hironori Ochi, Kouji Joko, Satoshi Yasuda, Hideko Ohama, Kazuhito Kawata, Casadei-Gardini A., Scartozzi M., Tada T., Yoo C., Shimose S., Masi G., Lonardi S., Frassineti L.G., Nicola S., Piscaglia F., Kumada T., Kim H.-D., Koga H., Vivaldi C., Solda C., Hiraoka A., Bang Y., Atsukawa M., Torimura T., Tsuj K., Itobayashi E., Toyoda H., Fukunishi S., Rimassa L., Rimini M., Cascinu S., Cucchetti A., Nakamura S., Michitaka K., Itokawa N., Hayama K., Hirooka M., Koizumi Y., Hiasa Y., Ishikawa T., Imai M., Takaguchi K., Tsutsui A., Nagano T., Kariyama K., Nouso K., Tajiri K., Shimada N., Shibata H., Ochi H., Joko K., Yasuda S., Ohama H., Kawata K., Casadei-Gardini, A., Scartozzi, M., Tada, T., Yoo, C., Shimose, S., Masi, G., Lonardi, S., Frassineti, L. G., Nicola, S., Piscaglia, F., Kumada, T., Kim, H. -D., Koga, H., Vivaldi, C., Solda, C., Hiraoka, A., Bang, Y., Atsukawa, M., Torimura, T., Tsuj, K., Itobayashi, E., Toyoda, H., Fukunishi, S., Rimassa, L., Rimini, M., Cascinu, S., Cucchetti, A., Nakamura, S., Michitaka, K., Itokawa, N., Hayama, K., Hirooka, M., Koizumi, Y., Hiasa, Y., Ishikawa, T., Imai, M., Takaguchi, K., Tsutsui, A., Nagano, T., Kariyama, K., Nouso, K., Tajiri, K., Shimada, N., Shibata, H., Ochi, H., Joko, K., Yasuda, S., Ohama, H., and Kawata, K.
- Subjects
Sorafenib ,Oncology ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,Antineoplastic Agents ,lenvatinib ,survival ,trans-arterial chemoembolization ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,medicine ,Clinical endpoint ,performance status ,Humans ,Adverse effect ,Probability ,Hepatology ,Performance status ,business.industry ,Phenylurea Compounds ,Carcinoma ,Liver Neoplasms ,Hepatocellular ,medicine.disease ,extrahepatic disease ,sorafenib ,Quinolines ,chemistry ,030220 oncology & carcinogenesis ,Hepatocellular carcinoma ,Cohort ,030211 gastroenterology & hepatology ,Lenvatinib ,business ,medicine.drug ,performance statu - Abstract
Purpose Data from common clinical practice were used to generate balanced cohorts of patients receiving either sorafenib or lenvatinib, for unresectable hepatocellular carcinoma, with the final aim to investigate their declared equivalence. Methods Clinical features of lenvatinib and sorafenib patients were balanced through inverse probability of treatment weighting (IPTW) methodology, which weights patients' characteristics and measured outcomes of each patient in both treatment arms. Overall survival was the primary endpoint and occurrence of adverse events was the secondary. Results The analysis included 385 patients who received lenvatinib, and 555 patients who received sorafenib. In the unadjusted cohort, lenvatinib did not show a survival advantage over sorafenib (HR: 0.85, 95% CI 0.70-1.02). After IPTW adjustment, lenvatinib still not returned a survival advantage over sorafenib (HR: 0.82, 95% CI: 0.62-1.07) even in presence of balanced baseline characteristics. Lenvatinib provided longer survival than sorafenib in patients previously submitted to TACE (HR: 0.69), with PS of 0 (HR: 0.73) or without extrahepatic disease (HR: 0.69). Conclusion Present results confirmed randomized controlled trial in the real-life setting, but also suggests that in earlier stages some benefit can be expected.
- Published
- 2021
34. Adverse events as potential predictive factors of activity in patients with advanced hepatocellular carcinoma treated with lenvatinib
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Joji Tani, Noritomo Shimada, Taeang Arai, Massimo Iavarone, Valentina Burgio, Koichi Takaguchi, Masanori Atsukawa, Marianna Silletta, Hideko Ohama, Takaaki Tanaka, Hironori Koga, Masashi Hirooka, Emiliano Tamburini, Stefano Cascinu, Ei Itobayashi, Luca Aldrighetti, Gianluca Masi, Takashi Kumada, Kazuhito Kawata, Yoichi Hiasa, Toshifumi Tada, Atsushi Hiraoka, Raffaella Tortora, Shinichiro Nakamura, Kouji Joko, Takuji Torimura, Sara Lonardi, Takuya Nagano, Hironori Ochi, Ilario Giovanni Rapposelli, Francesco Giuseppe Foschi, Akemi Tsutsui, Hideki Iwamoto, Shigeo Shimose, Satoshi Yasuda, Tomomi Okubo, Hiroshi Shibata, Takashi Niizeki, Hidenori Toyoda, Giuseppe Cabibbo, Margherita Rimini, Toru Ishikawa, Shinya Fukunishi, Claudia Campani, Kazuya Kariyama, Kazuto Tajiri, Kunihiko Tsuji, Fabio Piscaglia, Andrea Casadei-Gardini, Kazuhiro Nouso, Yohei Koizumi, Francesca Ratti, Norio Itokawa, Michitaka Imai, Rapposelli I.G., Tada T., Shimose S., Burgio V., Kumada T., Iwamoto H., Hiraoka A., Niizeki T., Atsukawa M., Koga H., Hirooka M., Torimura T., Iavarone M., Tortora R., Campani C., Lonardi S., Tamburini E., Piscaglia F., Masi G., Cabibbo G., Giuseppe Foschi F., Silletta M., Tsuji K., Ishikawa T., Takaguchi K., Kariyama K., Itobayashi E., Tajiri K., Shimada N., Shibata H., Ochi H., Yasuda S., Toyoda H., Fukunishi S., Ohama H., Kawata K., Tani J., Nakamura S., Nouso K., Tsutsui A., Nagano T., Tanaka T., Itokawa N., Okubo T., Arai T., Imai M., Joko K., Koizumi Y., Hiasa Y., Rimini M., Ratti F., Aldrighetti L., Cascinu S., Casadei-Gardini A., Rapposelli, I. G., Tada, T., Shimose, S., Burgio, V., Kumada, T., Iwamoto, H., Hiraoka, A., Niizeki, T., Atsukawa, M., Koga, H., Hirooka, M., Torimura, T., Iavarone, M., Tortora, R., Campani, C., Lonardi, S., Tamburini, E., Piscaglia, F., Masi, G., Cabibbo, G., Giuseppe Foschi, F., Silletta, M., Tsuji, K., Ishikawa, T., Takaguchi, K., Kariyama, K., Itobayashi, E., Tajiri, K., Shimada, N., Shibata, H., Ochi, H., Yasuda, S., Toyoda, H., Fukunishi, S., Ohama, H., Kawata, K., Tani, J., Nakamura, S., Nouso, K., Tsutsui, A., Nagano, T., Tanaka, T., Itokawa, N., Okubo, T., Arai, T., Imai, M., Joko, K., Koizumi, Y., Hiasa, Y., Rimini, M., Ratti, F., Aldrighetti, L., Cascinu, S., and Casadei-Gardini, A.
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Phenylurea Compound ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,Multivariate analysis ,predictive factors ,adverse event ,lenvatinib ,Gastroenterology ,predictive factor ,chemistry.chemical_compound ,Quality of life ,Internal medicine ,medicine ,Humans ,Adverse effect ,Retrospective Studies ,adverse events ,hepatocellular carcinoma ,Settore MED/12 - Gastroenterologia ,Hepatology ,business.industry ,Phenylurea Compounds ,Liver Neoplasms ,Hazard ratio ,medicine.disease ,Confidence interval ,Discontinuation ,chemistry ,Liver Neoplasm ,Hepatocellular carcinoma ,Quality of Life ,Quinolines ,Lenvatinib ,business - Abstract
Background and Aim: Lenvatinib is a standard of care option in first-line therapy of advanced hepatocellular carcinoma (HCC). In the present study, we aim to identify, in patients with HCC treated with lenvatinib, a possible association between occurrence and grading of adverse events (AEs) and outcome. Methods: We performed a retrospective analysis of 606 Japanese and Italian patients treated with lenvatinib in first-line setting and investigated the possible correlation between the onset of AEs, toxicity grade (G) and outcome measures such as overall survival (OS) and progression-free survival (PFS). Results: The appearance of arterial hypertension G≥2 independently predicted prolonged OS [hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.46–0.93, P=.0188], whereas decreased appetite G≥2 independently predicted decreased OS (HR 1.70, 95% CI 1.25–2.32, P=.0007) by multivariate analysis. Appearance of hand-foot skin reaction independently predicted prolonged PFS (HR 0.72, 95% CI 0.56–0.93, P=.0149), whereas decreased appetite G≥2 predicted decreased PFS (HR 1.36, 95% CI 1.04–1.77, P=.0277). Conclusions: Our main findings are that the occurrence of arterial hypertension G≥2 is a predictor of longer survival, whereas decreased appetite G≥2 predicts for a poor prognosis. A careful management of AEs under lenvatinib treatment for HCC is required, to improve patients’ quality of life, minimize the need for treatment discontinuation and achieve optimal outcome.
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- 2021
35. 165P BMI impact on the prognosis of unresectable HCC patients receiving first-line lenvatinib or atezolizumab plus bevacizumab.
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Amadeo, E., Persano, M., Tada, T., Suda, G., Shimose, S., Kudo, M., Yoo, C., Rossari, F., Vitiello, F., Casadei Gardini, A., and Rimini, M.
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BEVACIZUMAB , *ATEZOLIZUMAB , *PROGNOSIS - Published
- 2023
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36. 188P Impact of metformin, statin, aspirin and insulin on the prognosis of unresectable HCC patients receiving first-line lenvatinib or atezolizumab plus bevacizumab.
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Rimini, M., Amadeo, E., Vitiello, F., Foti, S., Persano, M., Tada, T., Suda, G., Shimose, S., Kudo, M., Cheon, J., Finkelmeier, F., Lim, H.Y., Piscaglia, F., Masi, G., Yoo, C., Lonardi, S., Rossari, F., Camera, S., Casadei Gardini, A., and Presa, J.
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BEVACIZUMAB , *ATEZOLIZUMAB , *INSULIN , *ASPIRIN , *STATINS (Cardiovascular agents) - Published
- 2023
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37. 173P Lenvatinib (L) versus sorafenib (S) second-line therapy in hepatocellular carcinoma (HCC) patients progressed to atezolizumab plus bevacizumab (AB).
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Persano, M., Rimini, M., Tada, T., Suda, G., Shimose, S., Kudo, M., Yoo, C., Cheon, J., Finkelmeier, F., Lim, H.Y., Presa, J., Masi, G., Bergamo, F., Iavarone, M.A., Cabibbo, G., Foschi, F.G., Piscaglia, F., Cascinu, S., Scartozzi, M., and Casadei Gardini, A.
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HEPATOCELLULAR carcinoma , *BEVACIZUMAB , *ATEZOLIZUMAB , *SORAFENIB - Published
- 2023
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38. 154P Adverse events (AEs) as potential predictive factors of activity in patients with advanced hepatocellular carcinoma (HCC) treated with atezolizumab plus bevacizumab (AB).
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Persano, M., Rimini, M., Tada, T., Suda, G., Shimose, S., Kudo, M., Yoo, C., Cheon, J., Finkelmeier, F., Lim, H.Y., Presa, J., Masi, G., Bergamo, F., Iavarone, M.A., Cabibbo, G., Foschi, F.G., Piscaglia, F., Cascinu, S., Scartozzi, M., and Casadei Gardini, A.
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HEPATOCELLULAR carcinoma , *BEVACIZUMAB , *ATEZOLIZUMAB - Published
- 2023
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39. 170P Atezolizumab plus bevacizumab (A+B) versus lenvatinib for BCLC-B stage of patients with hepatocellular carcinoma (HCC): A large real-life worldwide population.
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Vitiello, F., Rimini, M., Persano, M., Suda, G., Shimose, S., Finkelmeier, F., Masi, G., Rossari, F., Amadeo, E., Casadei Gardini, A., Tada, T., Kudo, M., Cheon, J., Lim, H.Y., and Yoo, C.
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ATEZOLIZUMAB , *HEPATOCELLULAR carcinoma , *BEVACIZUMAB - Published
- 2023
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40. Global multi-stakeholder endorsement of the MAFLD definition
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Nahum Méndez-Sánchez, Elisabetta Bugianesi, Robert G Gish, Frank Lammert, Herbert Tilg, Mindie H Nguyen, Shiv K Sarin, Núria Fabrellas, Shira Zelber-Sagi, Jian-Gao Fan, Gamal Shiha, Giovanni Targher, Ming-Hua Zheng, Wah-Kheong Chan, Shlomo Vinker, Takumi Kawaguchi, Laurent Castera, Yusuf Yilmaz, Marko Korenjak, C Wendy Spearman, Mehmet Ungan, Melissa Palmer, Mortada El-Shabrawi, Hans-Juergen Gruss, Jean-François Dufour, Anil Dhawan, Heiner Wedemeyer, Jacob George, Luca Valenti, Yasser Fouad, Manuel Romero‐Gomez, Mohammed Eslam, Maria Lorena Abate, Bahaa Abbas, Ahmed Amr Abbassy, Waleed Abd El Ghany, Amira Abd Elkhalek, Emad Abd ElMajeed, Mohammad Abdalgaber, Mohamed AbdAllah, Marwa Abdallah, Nourhan Abdallah, Shereen Abdelaleem, Yasser Abdelghani, Wael Abdelghany, Safaa Mohamed Abdelhalim, Wafaa Abdelhamid, Nehal Abdelhamid, Nadia A. Abdelkader, Elsayed Abdelkreem, Aly Mohamed Abdelmohsen, Awny Ali Abdelrahman, Sherief M Abd-elsalam, Doaa Abdeltawab, Abdulbaset Abduh, Nada Abdulhakam, Maheeba Abdulla, Navid Abedpoor, Ludovico Abenavoli, Fredrik Åberg, Omala Ablack, Mostafa Abo elftouh, Yousry Esam-Eldin Abo-Amer, Ashraf Aboubkr, Alaa Aboud, Amr M. Abouelnaga, Galal A. Aboufarrag, Ashraf Aboutaleb, Leticia Abundis, Gupse Adalı, Enrique Adames, Leon Adams, Danjuma Adda, Noor Adel, Nada Adel, Muhammad Adel Sayed, Taiba Jibril Afaa, Nawal Afredj, Gulnara Aghayeva, Alessio Aghemo, Carlos A. Aguilar-Salinas, Golo Ahlenstiel, Walid Ahmady, Wafaa Ahmed, Amira Ahmed, Samah Nasser Ahmed, Heba Mostafa Ahmed, Rasha Ahmed, Elmar Aigner, Mesut Akarsu, Maisam Akroush, Umit Akyuz, Mamun Al Mahtab, Tahani Al Qadiri, Yusriya Al Rawahi, Razzaq AL rubaee, Muna Al Saffar, Shahinul Alam, Zaid Al-Ani, Agustín Albillos, Mohamed Alboraie, Said Al-Busafi, Mohamed Al-Emam, Jawaher Alharthi, Kareem Ali, Basma Abdelmoez Ali, Mohammad Ali, Raja Affendi Raja Ali, Anna Alisi, Ali Raad AL-Khafaji, Maryam Alkhatry, Rocio Aller, Yahya Almansoury, Khalid Al-Naamani, Alaa Alnakeeb, Anna Alonso, Saleh A. Alqahtani, Leina Alrabadi, Khalid Alswat, Mahir Altaher, Turki Altamimi, Jose Altamirano, Mario R. Alvares-da-Silva, Elsragy Adel M. Aly, Amgad Alzahaby, Ahmed Alzamzamy, Keisuke Amano, Maysa A. Amer, Mona A. Amin, Sayed A. Amin, Ashraf A. Amir, Javier Ampuero, Noha Anas, Pietro Andreone, Soa Fy Andriamandimby, Mahmoud Anees, Peltec Angela, Manal Antonios, Wael Arafat, Jose Moreno Araya, Juan Armendariz-Borunda, Matthew J. Armstrong, Hassan Ashktorab, Patricia Aspichueta, Fathia Assal, Mira Atef, Dina Attia, Hoda Atwa, Reham Awad, Mohyeldeen Abd Elaziz Awad, Sally Awny, Obafemi Awolowo, Yaw Asante Awuku, Ibrahim Ayada, Than Than Aye, Sherif Ayman, Hedy Ayman, Hesham Ayoub, Hosny M. Azmy, Romiro P. Babaran, Omneya Badreldin, Ahmed Badry, İbrahim Halil Bahçecioğlu, Amira Bahour, Jiajia Bai, Yasemin Balaban, Muthuswamy Balasubramanyam, Khaled Bamakhrama, Jesus M Banales, Babu Bangaru, Jianfeng Bao, Jorge Suazo Barahona, Salma Barakat, Sandra Maria Barbalho, Bikwa Barbra, Beatriz Barranco, Francisco Barrera, Ulrich Baumann, Shamardan Bazeed, Eva Bech, Aourarh Benayad, Andreas Benesic, David Bernstein, Fernando Bessone, Susie Birney, Cyrille Bisseye, Martin Blake, Bilal Bobat, Leonilde Bonfrate, Dmitry S Bordin, Francisco Bosques-Padilla, Jerome Boursier, Boushab Mohamed Boushab, David Bowen, Patricia Medina Bravo, Paul N Brennan, Bisi Bright, Ilse Broekaert, Xabier Buque, Diego Burgos-Santamaría, Julio Burman, Luca Busetto, Chris D. Byrne, Patricia Anne I. Cabral-Prodigalidad, Guillermo Cabrera-Alvarez, Wei Cai, Francesca Cainelli, Ali Riza Caliskan, Ali Canbay, Ana Cano-Contreras, Hai-Xia Cao, Zhujun Cao, Andres Carrion, Francesca Carubbi, Teresa Casanovas, Marlen Ivón Castellanos Fernández, Jin Chai, Siew Pheng Chan, Phunchai Charatcharoenwitthaya, Norberto Chavez-Tapia, Kazuaki Chayama, Jinjun Chen, Lin Chen, Zhong-Wei Chen, Huiting Chen, Sui-Dan Chen, Qiang Chen, Yaxi Chen, Gang Chen, En-Quang Chen, Fei Chen, Pei-Jer Chen, Robert Cheng, Wendy Cheng, Jack Tan Wei Chieh, Imad Chokr, Evangelos Cholongitas, Ashok Choudhury, Abhijit Chowdhury, Evaristus Sunday Chukwudike, Stefano Ciardullo, Michelle Clayton, Karine Clement, Marie Michelle Cloa, Cecilia Coccia, Cristina Collazos, Massimo Colombo, Arif Mansur Cosar, Helma Pinchemel Cotrim, Joris Couillerot, Alioune Coulibaly, Gonzalo Crespo, Javier Crespo, Maria Cruells, Ian Homer Y. Cua, Hesham K. Dabbous, George N Dalekos, Patricia D'Alia, Li Dan, Viet Hang Dao, Mostafa Darwish, Christian Datz, Milagros B Davalos-Moscol, Heba Dawoud, Blanca Olaechea de Careaga, Robert de Knegt, Victor de Ledinghen, Janaka de Silva, Nabil Debzi, Marie Decraecker, Elvira Del Pozo, Teresa C Delgado, Manuel Delgado-Blanco, Łukasz Dembiński, Adilson Depina, Moutaz Derbala, Hailemichael Desalegn, Christèle Desbois-Mouthon, Mahmoud Desoky, Anouk Dev, Agostino Di Ciaula, Moisés Diago, Ibrahima Diallo, Luis Antonio Díaz, Melisa Dirchwolf, Paola Dongiovanni, Andrriy Dorofeyev, Xiaoguang Dou, Mark W. Douglas, Michael Doulberis, Cecil K. Dovia, Adam Doyle, Ivana Dragojević, Joost PH Drenth, Xuefei Duan, Audrius Dulskas, Dan L Dumitrascu, Oliver Duncan, Vincent Dusabejambo, Rev. Shem N.A. Dwawhi, Sho Eiketsu, Doaa El Amrousy, Ahmed El Deeb, Ghada El Deriny, Hesham Salah El Din, Salwa El Kamshishy, Mohamed El Kassas, Maissa El Raziky, Osama A Elagamy, Wafaa Elakel, Dina Elalfy, Hanaa Elaraby, Heba ElAwady, Reda Elbadawy, Hanaa Hassan Eldash, Manal S. Eldefrawy, Carol Lezama Elecharri, Amel Elfaramawy, Mohammed Elfatih, Mahmoud Elfiky, Mohamed Elgamsy, Mohamed Elgendy, Mohamed A. El-Guindi, Nagi Elhussieny, Ahmed Maher Eliwa, Zeineb Elkabbany, Hesham El-Khayat, Nehal M. El-Koofy, Alaa Elmetwalli, Amr Elrabat, Fathiya El-Raey, Fatma Elrashdy, Medhat Elsahhar, Esraa M. Elsaid, Shimaa Elsayed, Hany Elsayed, Aly Elsayed, Amr M. Elsayed, Hamdy Elsayed, Magdy El-Serafy, Ahmed M. Elsharkawy, Reem Yehia Elsheemy, Eman Elsayed Elshemy, Sara Elsherbini, Naglaa Eltoukhy, Reda Elwakil, Ola Emad, Shaimaa Emad, Mohamed Embabi, Ilkay Ergenç, Tatiana Ermolova, Gamal Esmat, Doaa M. Esmat, Enrique Carrera Estupiñan, Said Ettair, Tcaciuc Eugen, Mohammed Ezz-Eldin, Lidia Patricia Valdivieso Falcón, Yu-Chen Fan, Samah Fandari, Mahmoud Farag, Taghreed Mohamed Farahat, Eman M. Fares, Michael Fares, Eduardo Fassio, Hayam Fathy, Dina Fathy, Wael Fathy, Soheir Fayed, Dan Feng, Gong Feng, Miguel Fernández-Bermejo, Cristina Targa Ferreira, Javier Díaz Ferrer, Alastair Forbes, Rabab Fouad, Hanan M. Fouad, Tove Frisch, Hideki Fujii, Shuhei Fukunaga, Shinya Fukunishi, Hacer Fulya, Masato Furuhashi, Yasmine Gaber, Augusto Jose G. Galang, Jacqueline Cordova Gallardo, Rocío Galloso, Mahmoud Gamal, Reham Gamal, Hadeel Gamal, Jian Gan, Anar Ganbold, Xin Gao, George Garas, Tony Garba, Miren García-Cortes, Carmelo García-Monzón, Javier García-Samaniego, Amalia Gastaldelli, Manuel Gatica, Elizabeth Gatley, Tamar Gegeshidze, Bin Geng, Hasmik Ghazinyan, Salma Ghoneem, Luca Giacomelli, Gianluigi Giannelli, Edoardo G. Giannini, Matthew Giefer, Pere Ginès, Marcos Girala, Pablo J Giraudi, George Boon-Bee Goh, Ahmed Ali Gomaa, Benbingdi Gong, Dina Hilda C. Gonzales, Humberto C. Gonzalez, Maria Saraí Gonzalez-Huezo, Isabel Graupera, Ivica Grgurevic, Henning Grønbæk, Xuelian Gu, Lin Guan, Ibrahima Gueye, Alice Nanelin Guingané, Ozen Oz Gul, Cuma Bulent Gul, Qing Guo, Pramendra Prasad Gupta, Ahmet Gurakar, Juan Carlos Restrepo Gutierrez, Ghada Habib, Azaa Hafez, Emilia Hagman, Eman Halawa, Osama Hamdy, Abd Elkhalek Hamed, Dina H. Hamed, Saeed Hamid, Waseem Hamoudi, Yu Han, James Haridy, Hanan Haridy, David C H Harris Harris, Michael Hart, Fuad Hasan, Almoutaz Hashim, Israa Hassan, Ayman Hassan, Essam Ali Hassan, Adel Ahmed Hassan, Magda Shehata Hassan, Fetouh Hassanin, Alshymaa Hassnine, John Willy Haukeland, Amr Ismael M. Hawal, Jinfan He, Qiong He, Yong He, Fang-Ping He, Mona Hegazy, Adham Hegazy, Osama Henegil, Nelia Hernández, Manuel Hernández-Guerra, Fatima Higuera-de-la-Tijera, Ibrahim Hindy, Keisuke Hirota, Lee Chi Ho, Alexander Hodge, Mohamed Hosny, Xin Hou, Jiao-Feng Huang, Yan Huang, Zhifeng Huang, Yuan Huang, Ang Huang, Xiao-Ping Huang, Sheng Hui-ping, Bela Hunyady, Mennatallah A. Hussein, Osama Hussein, Shahinaz Mahmoud Hussien, Luis Ibáñez-Samaniego, Jamal Ibdah, Luqman Ibrahim, Miada Ibrahim, Ibrahim Ibrahim, Maria E. Icaza-Chávez, Sahar Idelbi, Ramazan Idilman Idilman, Mayumi Ikeda, Giuseppe Indolfi, Federica Invernizzi, Iram Irshad, Hasan Mohamed Ali Isa, Natacha Jreige Iskandar, Abdulrahman Ismaiel, Mariam Ismail, Zulkifli Ismail, Faisal Ismail, Hideki Iwamoto, Kathryn Jack, Rachael Jacob, Fuad Jafarov, Wasim Jafri, Helen Jahshan, Prasun K Jalal, Ligita Jancoriene, Martin Janicko, Hiruni Jayasena, Meryem Jefferies, Vivekanand Jha, Fanpu Ji, Yaqiu Ji, Jidong Jia, Changtao Jiang, Ni Jiang, Zong-zhe Jiang, Xing Jin, Yi Jin, Xu Jing, Qian Jingyu, Maia Jinjolava, FX Himawan Haryanto Jong, Alina Jucov, Ibecheole Julius, Mona Kaddah, Yoshihiro Kamada, Abobakr kamal, Enas Mohamed Kamal, Ashraf Sayed Kamel, Jia-Horng Kao, Maja Karin, Thomas Karlas, Mohammad Kashwaa, Leolin Katsidzira, Eda Kaya, M.Azzam Kayasseh, Bernadette Keenan, Caglayan Keklikkiran, William Keml, Deia K. Khalaf, Rofida Khalefa, Sherin Khamis, Doaa Khater, Hamed khattab, Anatoly Khavkin, Olga Khlynova, Nabil Khmis, Nazarii Kobyliak, Apostolos Koffas, Kazuhiko Koike, Kenneth Y.Y. Kok, Tomas Koller, Narcisse Patrice Komas, Nataliya V. Korochanskaya, Yannoula Koulla, Shunji Koya, Colleen Kraft, Bledar Kraja, Marcin Krawczyk, Mohammad Shafi Kuchay, Anand V Kulkarni, Ashish Kumar, Manoj Kumar, Sulaiman Lakoh, Philip Lam, Ling Lan, Naomi F. Lange, Kamran Bagheri Lankarani, Nicolas Lanthier, Kateryna Lapshyna, Sameh A. Lashen, Konang Nguieguia Justine Laure, Leonid Lazebnik, Didier Lebrec, Samuel S. Lee, Way Seah Lee, Yeong Yeh Lee, Diana Julie Leeming, Nathalie Carvalho Leite, Roberto Leon, Cosmas Rinaldi Adithya Lesmana, Junfeng Li, Qiong Li, Jun Li, Yang-Yang Li, Yufang Li, Lei Li, Min Li, Yiling li, Huiqing Liang, Tang Lijuan, Seng Gee Lim, Lee-Ling Lim, Shumei Lin, Han-Chieh Lin, Rita Lin, Rania Lithy, Yaru Liu, Yuanyuan Liu, Xin Liu, Wen-Yue Liu, Shourong Liu, Ken Liu, Tian Liu, Amedeo Lonardo, Mariana Bravo López, Eva López-Benages, Patricio Lopez-Jaramillo, Huimin Lu, Lun Gen Lu, Yan Lu, John Lubel, Rashid Lui, Iulianna Lupasco, Elena Luzina, Xiao-Hui Lv, Kate Lynch, Hong-Lei Ma, Mariana Verdelho Machado, Nonso Maduka, Katerina Madzharova, Russellini Magdaong, Sanjiv Mahadeva, Amel Mahfouz, Nik Ritza Kosai Nik Mahmood, Eman Mahmoud, Mohamed Mahrous, Rakhi Maiwall, Ammar Majeed, Avik Majumdar, Loey Mak, Madiha M Maklouf, Reza Malekzadeh, Claudia Mandato, Alessandra Mangia, Jake Mann, Hala Hussien Mansour, Abdellah Mansouri, Alessandro Mantovani, Jun qian Mao, Flor Maramag, Giulio Marchesini, Claude Marcus, Rui António Rocha Tato Marinho, Maria L Martinez-Chantar, Antonieta A. Soares Martins, Rana Marwan, Karen Frances Mason, Ghadeer Masoud, Mohamed Naguib Massoud, Maria Amalia Matamoros, Rosa Martín Mateos, Asmaa Mawed, Jean Claude Mbanya, Charles Mbendi, Lone McColaugh, Duncan McLeod, Juan Francisco Rivera Medina, Ahmed Megahed, Mai Mehrez, Iqbal Memon, Shahin Merat, Randy Mercado, Ahmed Mesbah, Taoufik Meskini, Mayada Metwally, Rasha Metwaly, Lei Miao, Eileen Micah, Luca Miele, Vladimir Milivojevic, Tamara Milovanovic, Yvonne L. Mina, Milan Mishkovik, Amal Mishriki, Tim Mitchell, Alshaimaa Mohamed, Mona Mohamed, Sofain Mohamed, Shady Mohammed, Ahmed Mohammed, Viswanathan Mohan, Sara Mohie, Aalaa Mokhtar, Reham Moniem, Mabel Segura Montilla, Jose Antonio Orozco Morales, María María Sánchez Morata, Jose Maria Moreno-Planas, Silvia Morise, Sherif Mosaad, Mohamed Moselhy, Alaa Mohamed Mostafa, Ebraheem Mostafa, Nezha Mouane, Nasser Mousa, Hamdy Mahfouz Moustafa, Abeer Msherif, Kate Muller, Christopher Munoz, Ana Beatriz Muñoz-Urribarri, Omar Alfaro Murillo, Feisul Idzwan Mustapha, Emir Muzurović, Yehia Nabil, Shaymaa Nafady, Ayu Nagamatsu, Atsushi Nakajima, Dan Nakano, Yuemin Nan, Fabio Nascimbeni, Mirella S. Naseef, Nagwa Nashat, Taran Natalia, Francesco Negro, Alexander V. Nersesov, Manuela Neuman, Masolwa Ng'wanasayi, Yan Ni, Amanda Nicoll, Takashi Niizeki, Dafina Nikolova, Wang Ningning, Madunil Niriella, K.A Nogoibaeva, Rozeena Nordien, Catherine O Sullivan, James O'Beirne, Solomon Obekpa, Ponsiano Ocama, Missiani Ochwoto, Michael Promise Ogolodom, Olusegun Ojo, Nana Okrostsvaridze, Claudia P. Oliveira, Raul Contreras Omaña, Omneya M. Omar, Hanaa Omar, Mabroka Omar, Salma Omran, Reham Omran, Marian Muse Osman, Nevin Owise, Theobald Owusu-Ansah, P. Martín Padilla- Machaca, Sirish Palle, Ziyan Pan, Xiao-Yan Pan, Qiuwei Pan, Apostolis Papaefthymiou, Feliciano Chanana Paquissi, Gabriella Par, Arit Parkash, Diana Payawal, Kevork M. Peltekian, Xuebin Peng, Liang Peng, Ying Peng, Rahul Pengoria, Martina Perez, José Luis Pérez, Norma Marlene Pérez, Marcello Persico, Mário Guimarães Pessoa, Salvatore Petta, Mathew Philip, Maria Corina Plaz Torres, Naveen Polavarapu, Jaime Poniachik, Piero Portincasa, Chunwen Pu, Tuğrul Pürnak, Edhie Purwanto, Xiaolong Qi, Xingshun Qi, Zibing Qian, Zhao Qiang, Zengpei Qiao, Liang Qiao, Alberto Queiroz, Atoosa Rabiee, Manal Radwan, Alain Marcel Rahetilahy, Yasmin Ramadan, Dina Ramadan, Anis Safura Ramli, Grant A. Ramm, Ao Ran, Ivan Rankovic, Huiying RAO, Sara Raouf, Sayantan Ray, Nancy Reau, Ahmed Refaat, Thomas Reiberger, Jose M Remes-Troche, Eira Cerda Reyes, Ben Richardson, Ezequiel Ridruejo, Sergio Riestra Jimenez, Ibrahim Rizk, Stuart Roberts, Juan Pablo Roblero, Jorge Alberto Prado Robles, Don Rockey, Manuel Rodríguez, Heriberto Rodríguez Hernández, Eva Román, Fernando Gomes Romeiro, Stefano Romeo, Jose Miguel Rosales-Zabal, Georgina R. Roshdi, Natalia Rosso, Andres Ruf, Patricia Cordero Ruiz, Nelia R. Runes, Andrea Ruzzenente, Marno Ryan, Ahmed Saad, Eman BE Sabbagh, Meriam Sabbah, Shimaa Saber, Reham Sabrey, Ramy Sabry, Maysaa Abdallah Saeed, Dina Said, Ebada M Said, Mohammad Amin Sakr, Yara Salah, Rabab Maamoun Salama, Asmaa Salama, Hussein Saleh, Ahmed Saleh, Ahmed Salem, Ahmed Thabet Salem, Alkassoum Salifou, Aso Faeq Salih, Abdallah Salman, Hanen Samouda, Faisal Sanai, Juan Francisco Sánchez-Ávila, Lakshumanan Sanker, Tomoya Sano, Miquel Sanz, Tobokalova Saparbu, Rohit Sawhney, Fatma Sayed, Sayed A. Sayed, Ashraf Othman Sayed, Manar Sayed, Giada Sebastiani, Laura Secadas, Khawaja Qamaruddin Sediqi, Sameh Seif, Nady Semida, Ebubekir Şenateş, Elena Daniela Serban, Lawrence Serfaty, Wai-Kay Seto, Ikram Sghaier, Min Sha, Hamada M. Shabaan, Lobna Shalaby, Inass Shaltout, Ala I. 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Xu, A, Xu, C, Yan, H, Yang, J, Yang, R, Yang, Y, Yang, Q, Yang, N, Yao, J, Yara, J, Yaras, S, Yilmaz, N, Younes, R, Younes, H, Young, S, Youssef, F, Yu, Y, Yu, M, Yuan, J, Yue, Z, Yuen, M, Yun, W, Yurukova, N, Zakaria, S, Zaky, S, Zaldastanishvili, M, Zapata, R, Zare, N, Zerem, E, Zeriban, N, Zeshuai, X, Zhang, H, Zhang, X, Zhang, Y, Zhang, W, Zhang, Z, Zhao, J, Zhao, R, Zhao, H, Zheng, C, Zheng, Y, Zheng, R, Zheng, T, Zheng, K, Zhou, X, Zhou, Y, Zhou, H, Zhou, L, Zhu, L, Zhu, Y, Zhu, P, Ziada, E, Ziring, D, Ziyi, L, Zou, S, Zou, Z, Zou, H, Zuart Ruiz, R, and Global Multi-Stakeholder Consensus on the Redefinition of Fatty Liver Disease
- Subjects
Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11] ,Hepatology ,Non-alcoholic Fatty Liver Disease ,NAFLD ,consensu ,Gastroenterology ,MAFLD ,definition ,Humans ,MAFLD, NAFLD ,Human medicine - Abstract
Contains fulltext : 252162.pdf (Publisher’s version ) (Closed access)
- Published
- 2022
41. Is Atezolizumab Plus Bevacizumab for Unresectable Hepatocellular Carcinoma Superior Even to Lenvatinib? A Matching-Adjusted Indirect Comparison
- Author
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Takashi Kumada, Stefano Cascinu, Andrea Casadei-Gardini, Alessandro Cucchetti, Takashi Niizeki, Shigeo Shimose, Toshifumi Tada, Casadei-Gardini, A., Tada, T., Shimose, S., Kumada, T., Niizeki, T., Cascinu, S., and Cucchetti, A.
- Subjects
0301 basic medicine ,Oncology ,Sorafenib ,Male ,Cancer Research ,medicine.medical_specialty ,Carcinoma, Hepatocellular ,Bevacizumab ,Antibodies, Monoclonal, Humanized ,law.invention ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,Atezolizumab ,law ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Pharmacology (medical) ,business.industry ,Phenylurea Compounds ,Hazard ratio ,Liver Neoplasms ,Survival Analysis ,Confidence interval ,030104 developmental biology ,chemistry ,030220 oncology & carcinogenesis ,Number needed to treat ,Quinolines ,Female ,Lenvatinib ,business ,medicine.drug - Abstract
Background: Atezolizumab plus bevacizumab showed superior progression-free and overall survival compared to sorafenib in the IMbrave150 trial. It would therefore be useful to compare the efficacy of lenvatinib and that of atezolizumab plus bevacizumab to determine if a benefit of one therapy against the other exists. Objective: The aim of the present report was to apply a matching-adjusted indirect comparison (MAIC) to individual participant data (IPD) from patients treated with lenvatinib outside of randomized trials, to aggregate results derived from the IMbrave150 trial. Patients and methods: Data from 455 patients who received lenvatinib as first-line systemic therapy for unresectable HCC represented the present IPD. Data inclusion were adapted to those reported in the IMbrave150 trial. Results: Overall survival on atezolizumab plus bevacizumab proved to be superior to lenvatinib (log-rank: 0.001) with a hazard ratio of 0.59 (95% confidence interval 0.46–0.75). The number needed to treat ranged between seven in the first 12 months and five at the 15th month. Conclusions: The present MAIC highlights that the combination of atezolizumab plus bevacizumab is superior to lenvatinib. However, updated data or sub-analyses of the IMbrave150 trial would provide more robust estimates for such a treatment comparison.
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- 2021
42. Dose-reduction of bevacizumab in atezolizumab plus bevacizumab therapy extends treatment duration with disease control in patients with hepatocellular carcinoma.
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Sakai M, Iwamoto H, Shimose S, Niizeki T, Nakano M, Shirono T, Noda Y, Moriyama E, Suzuki H, Koga H, Kuromatsu R, and Kawaguchi T
- Abstract
Introduction: Atezolizumab (ATZ) and bevacizumab (BEV) combination therapy is widely used in patients with unresectable hepatocellular carcinoma (HCC). However, combination therapy is typically interrupted or discontinued owing to BEV-related adverse events. In this study, we examined the effects of BEV dose-reduction on the treatment of unresectable HCC using propensity score matching (PSM)., Method: Overall, 119 patients with HCC who were treated with ATZ + BEV between November 2020 and October 2022 were enrolled retrospectively at our institute. The therapeutic effects and safety of BEV dose-reduction and non-dose reduction after PSM were compared. Decision-tree analysis was used to investigate treatment duration in the patients., Results: Significant differences were not observed between the two groups after PSM. The objective response rate (ORR) and disease control rate (DCR) assessed by modified RECIST did not differ significantly between the two groups (BEV non-dose-reduction/dose-reduction: ORR; 46/34%, DCR; 80/91%). Progression-free survival (PFS) and overall survival (OS) also did not differ significantly between the two groups (BEV non-dose-reduction /dose-reduction: PFS; 5.6/8.6 months, OS; 18.6/15.5 months). The median duration of treatment in the BEV dose-reduction group was significantly longer than that in the non-dose-reduction group (BEV non-dose-reduction /dose-reduction: 4.8/9.1 months, P = 0.038). Decision-tree analysis revealed that dose-reduction of BEV was the first distinguishae factor for the extension of treatment duration with ATZ + BEV., Conclusion: BEV dose-reduction can be effectively used in maintaining the treatment duration of ATZ + BEV while maintaining therapeutic effects and safety in real-world clinical practice., (S. Karger AG, Basel.)
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- 2024
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43. Impact of metformin, statin, aspirin and insulin on the prognosis of uHCC patients receiving first line Lenvatinib or Atezolizumab plus Bevacizumab.
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Rimini M, Montes M, Amadeo E, Vitiello F, Kudo M, Tada T, Suda G, Shimose S, Lonardi S, Finkelmeier F, Salani F, Antonuzzo L, Marra F, Iavarone M, Cabibbo G, Foschi FG, Silletta M, Sacco R, Rapposelli IG, Scartozzi M, Nicoletta P, Aldrighetti L, Persano M, Camera S, Rossari F, Foti S, Kumada T, Hiraoka A, Iwamoto H, Rizzato MD, Himmelsbach V, Masi G, Corradi M, Celsa C, Fabio C, Frassineti GL, Cascinu S, Casadei-Gardini A, and Presa J
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- Humans, Male, Female, Aged, Middle Aged, Prognosis, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Retrospective Studies, Aged, 80 and over, Metformin therapeutic use, Metformin administration & dosage, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized administration & dosage, Bevacizumab therapeutic use, Bevacizumab administration & dosage, Quinolines therapeutic use, Quinolines administration & dosage, Liver Neoplasms drug therapy, Liver Neoplasms mortality, Carcinoma, Hepatocellular drug therapy, Carcinoma, Hepatocellular mortality, Insulin therapeutic use, Phenylurea Compounds therapeutic use, Phenylurea Compounds administration & dosage, Hydroxymethylglutaryl-CoA Reductase Inhibitors therapeutic use, Hydroxymethylglutaryl-CoA Reductase Inhibitors administration & dosage, Aspirin therapeutic use, Aspirin administration & dosage
- Abstract
Recently, in Hepatocellular carcinoma (HCC) setting, the use of metformin has been associated to a trend toward worse response rate, overall survival and progression free survival in patients who received immunotherapy. The study population included individuals from both Eastern and Western regions with a confirmed diagnosis of HCC and receiving first line treatment with Atezolizumab plus bevacizumab or Lenvatinib. Univariate and multivariate analyses were performed by Cox proportional. For the analysis, patients were stratified based on their use of concomitant medication or not. At the time of database lock, 319 deaths were observed: 209 in the Lenvatinib cohort, 110 in the Atezolizumab plus bevacizumab cohort. In the Atezolizumab plus Bevacizumab arm, 50 (16.5%) patients were on chronic metformin use. At the univariate analysis for OS, patients who used metformin showed significantly shorter OS compared to patients who did not use metformin (HR 1.9, 95% CI 1.1-3.2). Multivariate analysis confirmed that patients in metformin group had significantly shorter OS compared to patients in no-metformin group (HR 1.9; 95% CI 1.1-3.1). At the univariate analysis for PFS, patients in metformin group had significantly shorter PFS compared to patients in no-metformin group (HR 1.6, 95% CI 1.0-2.6). Multivariate analysis confirmed that patients in metformin group had significantly shorter PFS compared to patients in no-metformin group (HR 1.7; 95% CI 1.1-2.7; p = 0.0147). No differences were reported in terms of ORR and DCR between patients in metformin group and those in no-metformin group. In the Lenvatinib cohort, 65 (15%) patients were recorded to chronically use metformin. No statistically significant differences in terms of both OS and PFS were found between patients in metformin group and patients in no-metformin group. This analysis unveils a negative prognostic role associated with metformin use specifically within the Atezolizumab plus Bevacizumab group., (© 2024. The Author(s).)
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- 2024
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44. A Multidisciplinary Therapeutic Approach Proposal for Huge Hepatocellular Carcinomas Exceeding 10 cm in Diameter.
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Goto Y, Niizeki T, Sakai H, Akashi M, Fukutomi S, Hashimoto K, Iwamoto H, Shimose S, Shirono T, Yoshida T, Isobe T, Mori N, Kawaguchi T, Ishibashi N, Fujita F, and Hisaka T
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- Humans, Male, Female, Middle Aged, Aged, Combined Modality Therapy, Adult, Infusions, Intra-Arterial, Retrospective Studies, Aged, 80 and over, Treatment Outcome, Survival Rate, Carcinoma, Hepatocellular pathology, Carcinoma, Hepatocellular surgery, Carcinoma, Hepatocellular therapy, Carcinoma, Hepatocellular mortality, Liver Neoplasms pathology, Liver Neoplasms surgery, Liver Neoplasms therapy, Liver Neoplasms mortality, Hepatectomy
- Abstract
Background/aim: The outcome of hepatectomy for a hepatocellular carcinoma (HCC) exceeding 10 cm (i.e., huge HCC) remains unfavorable. The aim of the current study was to evaluate the optimal therapeutic approach for huge HCCs., Patients and Methods: Between 2008 and 2018, patients with a huge HCC who underwent treatment at our institution were enrolled. Cases not meeting the criteria (Child-Pugh grade A or performance status 0/1) and patients with distant metastases were excluded. Patients were stratified into three groups: a) upfront hepatectomy (Upfront); b) hepatectomy subsequent to hepatic arterial infusion chemotherapy (HAIC-Hr); and c) HAIC alone (HAIC). Survival rates, including overall survival (OS) and progression-free survival (PFS), were analyzed. The cancer-specific mortality attributed to recurrence within one year after surgery was defined as "futile surgery"; the rate of futile surgery was also assessed., Results: A total of 70 cases were censored (Upfront/HAIC-Hr/HAIC: 28/13/29). The 5-year PFS and OS rates for Upfront, HAIC-Hr, and HAIC were 7.7%, 69.2%, and 6.9%, and 37.1%, 79.1%, and 19.7%, respectively. The number of futile surgeries was 6 (21.4%) in the Upfront group, whereas no such cases occurred in the HAIC-Hr group., Conclusion: Although hepatectomy was advocated in the Upfront group due to the potential resectability, the outcomes were comparable to those of the HAIC group. Conversely, the HAIC-Hr group had promising outcomes, marked by a decreased prevalence of futile surgeries. Huge HCCs should be regarded as borderline resectable, even when deemed potentially resectable. Therefore, a multidisciplinary therapeutic approach might be reasonable., (Copyright © 2024 International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.)
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- 2024
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45. Japanese orthopaedic association (JOA) clinical practice guidelines on the management of malignant bone tumors - Secondary publication.
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Tsuchiya K, Akisue T, Ehara S, Kawai A, Kawano H, Hiraga H, Hosono A, Hutani H, Morii T, Morioka H, Nishida Y, Oda Y, Ogose A, Shimose S, Yamaguchi T, Yamamoto T, and Yoshida M
- Abstract
Background: In Japan, there are currently no general guidelines for the treatment of primary malignant bone tumors. Therefore, the Japanese Orthopaedic Association established a committee to develop guidelines for the appropriate diagnosis and treatment of primary malignant bone tumors for medical professionals in clinical practice., Methods: The guidelines were developed in accordance with "Minds Clinical Practice Guideline Development Handbook 2014″ and "Minds Clinical Practice Guideline Development Manual 2017". The Japanese Orthopaedic Association's Bone and Soft Tissue Tumor Committee established guideline development and systematic review committees, drawing members from orthopedic specialists leading the diagnosis and treatment of bone and soft tissue tumors. Pediatricians, radiologists, and diagnostic pathologists were added to both committees because of the importance of multidisciplinary treatment. Based on the diagnosis and treatment algorithm for primary malignant bone tumors, important decision-making points were selected, and clinical questions (CQ) were determined. The strength of recommendation was rated on two levels and the strength of evidence was rated on four levels. The recommendations published were selected based on agreement by 70% or more of the voters., Results: The guideline development committee examined the important clinical issues in the clinical algorithm and selected 22 CQs. The systematic review committee reviewed the evidence concerning each CQ and a clinical value judgment was added by experts. Eventually, 25 questions were published and the text of each recommendation was determined., Conclusion: Since primary malignant bone tumors are rare, there is a dearth of strong evidence based on randomized controlled trials, and recommendations cannot be applied to all the patients. In clinical practice, appropriate treatment of patients with primary malignant bone tumors should be based on the histopathological diagnosis and degree of progression of each case, using these guidelines as a reference., (Copyright © 2024. Published by Elsevier B.V.)
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- 2024
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46. Evaluation of the associations of interlukin-7 genetic variants with toxicity and efficacy of immune checkpoint inhibitors: A replication study of a Japanese population, based on the findings of a European genome-wide association study.
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Miyamoto H, Kondo Y, Itobayashi E, Uehara M, Hiraoka A, Kudo M, Kakizaki S, Kagawa T, Miuma S, Suzuki T, Sugi K, Suyama K, Beppu T, Toyoda H, Yoshiji H, Uojima H, Miyase S, Inoue K, Tamori A, Ito T, Shimose S, Suda G, Hayashi T, Onishi M, Narahara S, Watanabe T, Iwatsuki M, Fukushima S, and Tanaka Y
- Abstract
Aim: Recent genome-wide association studies of European populations have identified rs16906115, a single-nucleotide polymorphism in the interleukin-7 gene, as a predictor of immune-related adverse events (irAEs) and the therapeutic efficacy of immune checkpoint inhibitors. We evaluated this single-nucleotide polymorphism in a Japanese population., Methods: From January 2021, we stored host DNA from individuals who received various types of immune checkpoint inhibitors. From this population, we categorized 510 participants into cases (grade ≥2 irAEs) and controls (received ≥3 immune checkpoint inhibitor doses, follow-up ≥12 weeks, no irAEs), and divided 339 hepatocellular carcinoma patients treated with atezolizumab/bevacizumab into responders and non-responders, evaluated using the modified response evaluation criteria in solid tumors. We compared the minor allele frequencies of rs16906115 between cases and controls, and responders and non-responders., Results: In the irAE prediction analysis of 234 cases and 276 controls, the minor allele frequency was 0.244 in the case group and 0.265 in the control group. This difference is not significant. In the analysis predicting the therapeutic efficacy for hepatocellular carcinoma patients, the responders had a significantly lower minor allele frequency of 0.220, compared with 0.300 for the non-responders (p = 0.022). Univariate and multivariate analyses identified the minor allele homozygosity as a significant predictor of treatment response, with odds ratios of 0.292 (p = 0.015) in the univariate analysis and 0.315 (p = 0.023) in the multivariate analysis., Conclusions: In our Japanese cohort, no association was found between the rs16906115 minor allele and irAEs or treatment efficacy. The minor allele homozygosity may be associated with a negative therapeutic outcome., Clinical Trial Registration: UMIN Clinical Trials Registry with the number UMIN000043798., (© 2024 Japan Society of Hepatology.)
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- 2024
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47. Adverse Events as Potential Predictive Factors of Activity in Patients with Advanced HCC Treated with Atezolizumab Plus Bevacizumab.
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Persano M, Rimini M, Tada T, Suda G, Shimose S, Kudo M, Rossari F, Yoo C, Cheon J, Finkelmeier F, Lim HY, Presa J, Masi G, Bergamo F, Amadeo E, Vitiello F, Kumada T, Sakamoto N, Iwamoto H, Aoki T, Chon HJ, Himmelsbach V, Iavarone MA, Cabibbo G, Montes M, Foschi FG, Vivaldi C, Soldà C, Sho T, Niizeki T, Nishida N, Steup C, Bruccoleri M, 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, Nishimura T, Hatanaka T, Kakizaki S, Shimada N, Kawata K, Hiraoka A, Tada F, Ohama H, Nouso K, Morishita A, Tsutsui A, Nagano T, Itokawa N, Okubo T, Imai M, Kosaka H, Naganuma A, Koizumi Y, Nakamura S, Kaibori M, Iijima H, Hiasa Y, Foti S, Camera S, Piscaglia F, Scartozzi M, Cascinu S, and Casadei-Gardini A
- Subjects
- Humans, Male, Female, Retrospective Studies, Aged, Middle Aged, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols pharmacology, Aged, 80 and over, Adult, Prognosis, Bevacizumab therapeutic use, Bevacizumab pharmacology, Antibodies, Monoclonal, Humanized therapeutic use, Antibodies, Monoclonal, Humanized pharmacology, Antibodies, Monoclonal, Humanized adverse effects, Liver Neoplasms drug therapy, Liver Neoplasms pathology, Carcinoma, Hepatocellular drug therapy, Carcinoma, Hepatocellular pathology
- Abstract
Background: In the context of patients with hepatocellular carcinoma (HCC) treated with systemic therapy, the correlation between the appearance of adverse events (AEs) and reported efficacy outcomes is well-known and widely investigated. From other pathological settings, we are aware of the prognostic and predictive value of the occurrence of immune-related AEs in patients treated with immune-checkpoint inhibitors., Objective: This retrospective multicenter real-world study aims to investigate the potential prognostic value of AEs in patients with HCC treated with atezolizumab plus bevacizumab in the first-line setting., Patients and Methods: The study population consisted of 823 patients from five countries (Italy, Germany, Portugal, Japan, and the Republic of Korea)., Results: Of the patients, 73.3% presented at least one AE during the study period. The most common AEs were proteinuria (29.6%), arterial hypertension (27.2%), and fatigue (26.0%). In all, 17.3% of the AEs were grade (G) 3. One death due to bleeding was reported. The multivariate analysis confirmed the appearance of decreased appetite G < 2 [versus G ≥ 2; hazard ratio (HR) 0.60; 95% confidence interval (CI) 0.13-0.90; p < 0.01] and immunotoxicity G < 2 (versus G ≥ 2; HR: 0.70; 95% CI 0.24-0.99; p = 0.04) as independent prognostic factors for overall survival, and the appearance of decreased appetite G < 2 (versus G ≥ 2; HR: 0.73; 95% CI 0.43-0.95; p = 0.01), diarrhea (yes versus no; HR: 0.57, 95% CI 0.38-0.85; p = 0.01), fatigue (yes versus no; HR: 0.82, 95% CI 0.65-0.95; p < 0.01), arterial hypertension G < 2 (versus G ≥ 2; HR: 0.68, 95% CI 0.52-0.87; p < 0.01), and proteinuria (yes versus no; HR: 0.79, 95% CI 0.64-0.98; p = 0.03) as independent prognostic factors for progression-free survival., Conclusions: As demonstrated for other therapies, there is also a correlation between the occurrence of AEs and outcomes for patients with HCC for the combination of atezolizumab plus bevacizumab., (© 2024. The Author(s).)
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- 2024
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48. Initial clinical experience with durvalumab plus tremelimumab in patients with unresectable hepatocellular carcinoma in real‑world practice.
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Shimose S, Saeki I, Tomonari T, Ito T, Tani J, Takeuchi Y, Yoshioka N, Naito T, Takeuchi M, Kakizaki S, Hatanaka T, Sasaki K, Yasunaka T, Sakata M, Iwamoto H, Itano S, Shirono T, Tanabe N, Yamamoto T, Naganuma A, Nishina S, Otsuka M, Kawashima H, Takayama T, Takami T, and Kawaguchi T
- Abstract
Although durvalumab plus tremelimumab (Dur/Tre) has been approved as first-line therapy for patients with unresectable hepatocellular carcinoma (u-HCC), its outcomes in real-world clinical practice are unclear. The present study aimed to evaluate the efficacy and safety of Dur/Tre treatment. This multicenter study was conducted between March 2023 and January 2024, and included 120 patients with u-HCC treated with Dur/Tre. Among the patients, 44 had no history of systemic treatment. Progression-free survival (PFS), therapeutic response and adverse events (AEs) were assessed. The objective response rate (ORR) and disease control rates (DCR) were 15.8 and 53.3%, respectively. The median PFS was 3.9 months. The incidence rates of AEs of any grade and those grade 3 or higher were 83.3 and 36.7%, respectively. Liver injury was the most frequent AE of any grade and grade 3 or higher. Although there was no significant difference in ORR and PFS between the first and later line groups (ORR 15.8 vs. 15.7%, P=0.986; PFS 4.5 vs. 3.6 months, P=0.213), there was a significant difference in DCR between the two groups (65.8 vs. 45.9%, P=0.034). No significant differences were noted between the first- and later-line treatment groups regarding the incidence rate of AEs. Decision tree analysis revealed that poor liver function and advanced age were significant variables for discontinuation owing to AEs. In conclusion, Dur/Tre as first-line therapy had better disease control responses compared with later-line therapy; however, this regimen should be carefully administered to patients with deteriorating hepatic function or advanced age., Competing Interests: The authors declare that they have no competing interests., (Copyright: © 2024 Shimose et al.)
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- 2024
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49. Impact of body mass index on the prognosis of unresectable HCC patients receiving first-line Lenvatinib or atezolizumab plus bevacizumab.
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Rimini M, Stefanini B, Tada T, Suda G, Shimose S, Kudo M, Finkelmeier F, Yoo C, Presa J, Amadeo E, Genovesi V, De Grandis MC, Iavarone M, Marra F, Foschi F, Tamburini E, Rossari F, Vitiello F, Bartalini L, Soldà C, Tovoli F, Vivaldi C, Lonardi S, Silletta M, Kumada T, Sakamoto N, Iwamoto H, Aoki T, Himmelsbach V, Montes M, Hiraoka A, Sho T, Niizeki T, Nishida N, Steup C, 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, Nishimura T, Hatanaka T, Kakizaki S, Shimada N, Kawata K, Tada F, Ohama H, Nouso K, Morishita A, Tsutsui A, Nagano T, Itokawa N, Okubo T, Arai T, Imai M, Kosaka H, Naganuma A, Koizumi Y, Nakamura S, Kaibori M, Iijima H, Hiasa Y, Persano M, Camera S, Foti S, Aldrighetti L, Cascinu S, Casadei-Gardini A, and Piscaglia F
- Subjects
- Humans, Bevacizumab therapeutic use, Body Mass Index, Overweight, Prognosis, Thinness, Antibodies, Monoclonal, Humanized therapeutic use, Carcinoma, Hepatocellular, Liver Neoplasms, Phenylurea Compounds therapeutic use, Quinolines therapeutic use
- Abstract
Introduction: Overweight is a negative prognostic factor in the general population in the long term. However, the role of body mass index (BMI) in the short-mid term in advanced tumours is unclear. The present analysis investigates the role of BMI weight classes in a large sample of patients affected by HCC and receiving atezolizumab plus bevacizumab or lenvatinib as first-line treatment., Methods and Material: The cohort included consecutive patients affected by BCLC-c and BCLC-B HCC patients from a multicenter international study group who received atezolizumab plus bevacizumab or lenvatinib as first-line therapy. Population was stratified according to the BMI in under-, over- and normal-weight according to the conventional thresholds. The primary objective of the study was to evaluate the prognostic and predictive impact of BMI in patients affected by advanced or intermediate HCC. Survival curves were estimated using the product-limit method of Kaplan-Meier. The role of stratification factors was analysed with log-rank tests., Results: 1292 consecutive patients with HCC were analysed. 466 (36%) patients were treated with lenvatinib and 826 (64%) patients were treated with atezolizumab plus bevacizumab. In the atezolizumab plus bevacizumab arm, 510 (62%) patients were normal-weight, 52 (6%) underweight and 264 (32%) overweight. At the univariate analysis for OS, underweight patients had significantly shorter OS compared to normal-weight patients, whereas no differences were found between normal-weight versus overweight. Multivariate analysis confirmed that underweight patients had significantly shorter OS compared to normal-weight patients (HR: 1.7; 95% CI: 1.0-2.8; p = .0323). In the lenvatinib arm, 26 patients (5.6%) were categorized as underweight, 256 (54.9%) as normal-weight, and 184 (39.5%) as overweight. At the univariate analysis for OS, no significant differences were found between normal-weight versus underweight and between normal-weight versus overweight, which was confirmed at multivariate analysis., Conclusion: Our analysis highlighted a prognostic role of BMI in a cohort of patients with advanced HCC who received atezolizumab plus bevacizumab, while no prognostic role for low BMI was apparent in patients who received lenvatinib., (© 2024 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)
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- 2024
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50. Disease Etiology Impact on Outcomes of Hepatocellular Carcinoma Patients Treated with Atezolizumab plus Bevacizumab: A Real-World, Multicenter Study.
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Rossari F, Tada T, Suda G, Shimose S, Kudo M, Yoo C, Cheon J, Finkelmeier F, Lim HY, Presa J, Masi G, Bergamo F, Amadeo E, Vitiello F, Kumada T, Sakamoto N, Iwamoto H, Aoki T, Chon HJ, Himmelsbach V, Iavarone M, Cabibbo G, Montes M, Foschi FG, Vivaldi C, Soldà C, Sho T, Niizeki T, Nishida N, Steup C, 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, Nishimura T, Hatanaka T, Kakizaki S, Shimada N, Kawata K, Hiraoka A, Tada F, Ohama H, Nouso K, Morishita A, Tsutsui A, Nagano T, Itokawa N, Okubo T, Imai M, Kosaka H, Naganuma A, Koizumi Y, Nakamura S, Kaibori M, Iijima H, Hiasa Y, Persano M, Foti S, Camera S, Stefanini B, Scartozzi M, Cascinu S, Casadei-Gardini A, and Rimini M
- Abstract
Introduction: The impact of etiology on response to immunotherapy in advanced hepatocellular carcinoma (HCC) is being debated, with contrasting findings between early and recent post hoc analyses of IMbrave-150 and metanalyses of clinical trials of PD-1/PD-L1 blockers. As a results, it is not clear whether the first-line systemic treatment atezolizumab plus bevacizumab (A + B) is equally effective in viral and nonviral patients., Methods: We retrospectively analyzed 885 HCC patients treated with the first-line A + B from multiple centers from Eastern and Western countries, 53.9% having viral and 46.1% nonviral etiology. Baseline clinical and laboratory characteristics were analyzed with uni- and multivariate models to explore potential differences on overall survival (OS), time-to-progression (TTP), disease control rates (DCRs) based on etiology and to identify putative prognostic factors in etiology subgroups. Treatment toxicities and access to the second-line treatments and outcomes were also reported and compared between etiologies., Results: Overall, no statistically significant differences were found in median OS (mOS: viral 15.9 months; nonviral 16.3 months), TTP (mTTP: viral 8.3 months; nonviral 7.2 months), and DCRs (viral 78.1%; nonviral 80.8%) based on etiology. Prognostic factors of survival and progression were mainly shared between viral and nonviral etiologies, including alpha-fetoprotein, aspartate transaminase, neutrophil-to-lymphocyte ratio (NLR) and ALBI score. Exploratory analyses highlighted a possible stronger association of immunological factors, i.e., NLR and eosinophil count, to treatment outcomes in viral patients. The toxicity profile, the access to and type of the second-line treatments and their outcome in terms of OS almost overlap in the two etiology subgroups., Conclusion: Atezolizumab plus bevacizumab efficacy does not vary according to underlying etiology of HCC in a multicenter, real-world population, matching recent post hoc findings from the IMbrave-150 trial. Preliminary analyses suggest that some prognostic factors differ between viral and nonviral patients, potentially due to biological and immunological differences. Prospective and comparative trials stratifying by etiology are warranted to validate these findings and guide clinical practice., Competing Interests: Andrea Casadei-Gardini has received grants and personal fees from MSD, Eisai, Bayer and is an advisor for MSD, Eisai, Bayer, Bristol-Myers Squibb, AstraZeneca and GSK. Atsushi Hiraoka received lecture’s fees from Chugai, Lilly, AstraZeneca. Fabian Finkelmeier has received travel support from Ipsen, and speaker’s fees from AbbVie, MSD, Ipsen, Eisai and Fresenius. Gianluca Masi is an advisor for Roche, MSD, Eisai. Giuseppe Cabibbo is a consultant for Roche, AstraZeneca, Eisai, MSD. Hidenori Toyoda has received grants and personal fees from Gilead, AbbVie, Eisai, Fujifilm, Teruma, Kowa, Takeda. Ho Yeong Lim is an advisor for Roche, Eisai, AstraZeneca, Bayer. Hong Jae Chon has advisory role for Roche, Eisai, Bayer, ONO, MDS, BMS, Sanofi, Servier, AstraZeneca, Silajen, Menarini, GreenCross Cell; received speaker’s fee and research grants from Roche, Eisai, Bayer, BMS, Sanofi, Dong-A ST, BORYUNG, Inno.N, Hanmi, YUHAN. Josè Presa is an advisor for Gilead, AbbVie, Roche, AstraZeneca, Giszi, Advaus. Mario Scartozzi received grants and personal fees from MSD, Merck, Servier, Novartis, AstraZeneca. Masatoshi Kudo received lecture’s fees from Chugai Pharmaceutical, Eisai, Eli Lilly Japan, Takeda Pharmaceutical; is an advisor for F. Hoffmann-La Roche, AstraZeneca, Chugai Pharmaceutical, Eisai; and received grants from Otsuka Pharmaceutical, Taiho Pharmaceutical, Chugai Pharmaceutical, GE Healthcare Japan Corporation, Eisai, AbbVie, EA Pharma. Massimo Iavarone received grants and personal fees from MSD, Gilead, AstraZeneca, Bayer, Roche, Ipsen, Eisai. Takeshi Hatanaka received lecture’s fees from Eisai. The other coauthors have no conflict of interest to disclose., (© 2024 The Author(s). Published by S. Karger AG, Basel.)
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- 2024
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