REal life study of LEnVAtiNib therapy for HepAtocellular carcinoma: RELEVANT study
Introduction: In the REFLECT trial, lenvatinib was found to be non-inferior compared to sorafenib in terms of Overall Survival. Here, we analyze the effects of lenvatinib in the real-life experience of several centers across the world, and to identify clinical factors that could be significantly ass...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Karger Publishers
2022-07-01
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| Series: | Liver Cancer |
| Online Access: | https://beta.karger.com/Article/FullText/525145 |
| _version_ | 1818491332601053184 |
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| author | Andrea Casadei-Gardini Margherita Rimini Masatoshi Kudo Shigeo Shimose Toshifumi Tada Goki Suda Myung Ji Goh Andre Jefremow Mario Scartozzi Giuseppe Cabibbo Claudia Campani Emiliano Tamburini Francesco Tovoli Kazuomi Ueshima Tomoko Aoki Hideki Iwamoto Takuji Torimura Takashi Kumada Atsushi Hiraoka Masanori Atsukawa Ei Itobayashi Hidenori Toyoda Naoya Sakamoto Takuya Sho Wonseok Kang Jürgen Siebler Markus Friedrich Neurath Valentina Burgio Stefano Cascinu |
| author_facet | Andrea Casadei-Gardini Margherita Rimini Masatoshi Kudo Shigeo Shimose Toshifumi Tada Goki Suda Myung Ji Goh Andre Jefremow Mario Scartozzi Giuseppe Cabibbo Claudia Campani Emiliano Tamburini Francesco Tovoli Kazuomi Ueshima Tomoko Aoki Hideki Iwamoto Takuji Torimura Takashi Kumada Atsushi Hiraoka Masanori Atsukawa Ei Itobayashi Hidenori Toyoda Naoya Sakamoto Takuya Sho Wonseok Kang Jürgen Siebler Markus Friedrich Neurath Valentina Burgio Stefano Cascinu |
| author_sort | Andrea Casadei-Gardini |
| collection | DOAJ |
| description | Introduction: In the REFLECT trial, lenvatinib was found to be non-inferior compared to sorafenib in terms of Overall Survival. Here, we analyze the effects of lenvatinib in the real-life experience of several centers across the world, and to identify clinical factors that could be significantly associated with survival outcomes.
Methods: The study population derived from retrospectively collected data of HCC patients treated with lenvatinib. The overall cohort included Western and Eastern populations from 23 centres in five countries.
Results:
We included 1325 patients with HCC and treated with lenvatinib in our analysis. Median OS was 16.1 months. Overall response rate was 38.5%. Multivariate analysis for OS highlighted that HBsAg positive, NLR >3 and AST >38 were independently associated with poor prognosis in all models. Conversely, NAFLD/NASH related aetiology was independently associated with good prognosis.
Median progression free survival was 6.3 months. Multivariate analysis for Progression Free survival revealed that NAFLD/NASH, BCLC, NLR and AST as independent prognostic factors for progression free survival.
A proportion of 75.2% of patients suffered from at least one adverse effect during the study period. Multivariate analysis exhibited that the appearance of decreased appetite Grade ≥ 2 versus Grade 0-1 as an independent prognostic factor for worse Progression Free Survival.
924 patients on 1325 progressed during lenvatinib (69.7%), and 827 of them had a follow-up over two-months from the beginning of second line treatment. From first line therapy the longest median OS was obtained with the sequence lenvatinib and immunotherapy (47.0 months), followed by TACE (24.7 months), ramucirumab (21.2 months), sorafenib (15.7 months), regorafenib (12.7 months) and best supportive care (10.8 months).
Conclusions:
Our study confirms in a large and global population of patients with advanced HCC not candidate to locoregional treatment the OS reported in the registration study and a high response rate with lenvatinib. |
| first_indexed | 2024-12-10T17:29:26Z |
| format | Article |
| id | doaj.art-08c68969bf5f4251a200dc0cdcbbbea5 |
| institution | Directory Open Access Journal |
| issn | 2235-1795 1664-5553 |
| language | English |
| last_indexed | 2024-12-10T17:29:26Z |
| publishDate | 2022-07-01 |
| publisher | Karger Publishers |
| record_format | Article |
| series | Liver Cancer |
| spelling | doaj.art-08c68969bf5f4251a200dc0cdcbbbea52022-12-22T01:39:44ZengKarger PublishersLiver Cancer2235-17951664-55532022-07-0110.1159/000525145525145REal life study of LEnVAtiNib therapy for HepAtocellular carcinoma: RELEVANT studyAndrea Casadei-Gardinihttps://orcid.org/0000-0001-6289-7202Margherita RiminiMasatoshi Kudohttps://orcid.org/0000-0002-4102-3474Shigeo ShimoseToshifumi Tadahttps://orcid.org/0000-0002-0976-6761Goki SudaMyung Ji GohAndre Jefremowhttps://orcid.org/0000-0002-2041-269XMario ScartozziGiuseppe Cabibbohttps://orcid.org/0000-0002-0946-3859Claudia CampaniEmiliano TamburiniFrancesco Tovolihttps://orcid.org/0000-0002-8350-1155Kazuomi Ueshimahttps://orcid.org/0000-0002-7577-5789Tomoko AokiHideki IwamotoTakuji TorimuraTakashi Kumadahttps://orcid.org/0000-0003-2211-495XAtsushi Hiraokahttps://orcid.org/0000-0003-1989-0480Masanori AtsukawaEi ItobayashiHidenori Toyodahttps://orcid.org/0000-0002-1652-6168Naoya Sakamotohttps://orcid.org/0000-0003-0061-059XTakuya ShoWonseok Kanghttps://orcid.org/0000-0001-9578-8424Jürgen SieblerMarkus Friedrich NeurathValentina Burgiohttps://orcid.org/0000-0002-0146-4136Stefano CascinuIntroduction: In the REFLECT trial, lenvatinib was found to be non-inferior compared to sorafenib in terms of Overall Survival. Here, we analyze the effects of lenvatinib in the real-life experience of several centers across the world, and to identify clinical factors that could be significantly associated with survival outcomes. Methods: The study population derived from retrospectively collected data of HCC patients treated with lenvatinib. The overall cohort included Western and Eastern populations from 23 centres in five countries. Results: We included 1325 patients with HCC and treated with lenvatinib in our analysis. Median OS was 16.1 months. Overall response rate was 38.5%. Multivariate analysis for OS highlighted that HBsAg positive, NLR >3 and AST >38 were independently associated with poor prognosis in all models. Conversely, NAFLD/NASH related aetiology was independently associated with good prognosis. Median progression free survival was 6.3 months. Multivariate analysis for Progression Free survival revealed that NAFLD/NASH, BCLC, NLR and AST as independent prognostic factors for progression free survival. A proportion of 75.2% of patients suffered from at least one adverse effect during the study period. Multivariate analysis exhibited that the appearance of decreased appetite Grade ≥ 2 versus Grade 0-1 as an independent prognostic factor for worse Progression Free Survival. 924 patients on 1325 progressed during lenvatinib (69.7%), and 827 of them had a follow-up over two-months from the beginning of second line treatment. From first line therapy the longest median OS was obtained with the sequence lenvatinib and immunotherapy (47.0 months), followed by TACE (24.7 months), ramucirumab (21.2 months), sorafenib (15.7 months), regorafenib (12.7 months) and best supportive care (10.8 months). Conclusions: Our study confirms in a large and global population of patients with advanced HCC not candidate to locoregional treatment the OS reported in the registration study and a high response rate with lenvatinib.https://beta.karger.com/Article/FullText/525145 |
| spellingShingle | Andrea Casadei-Gardini Margherita Rimini Masatoshi Kudo Shigeo Shimose Toshifumi Tada Goki Suda Myung Ji Goh Andre Jefremow Mario Scartozzi Giuseppe Cabibbo Claudia Campani Emiliano Tamburini Francesco Tovoli Kazuomi Ueshima Tomoko Aoki Hideki Iwamoto Takuji Torimura Takashi Kumada Atsushi Hiraoka Masanori Atsukawa Ei Itobayashi Hidenori Toyoda Naoya Sakamoto Takuya Sho Wonseok Kang Jürgen Siebler Markus Friedrich Neurath Valentina Burgio Stefano Cascinu REal life study of LEnVAtiNib therapy for HepAtocellular carcinoma: RELEVANT study Liver Cancer |
| title | REal life study of LEnVAtiNib therapy for HepAtocellular carcinoma: RELEVANT study |
| title_full | REal life study of LEnVAtiNib therapy for HepAtocellular carcinoma: RELEVANT study |
| title_fullStr | REal life study of LEnVAtiNib therapy for HepAtocellular carcinoma: RELEVANT study |
| title_full_unstemmed | REal life study of LEnVAtiNib therapy for HepAtocellular carcinoma: RELEVANT study |
| title_short | REal life study of LEnVAtiNib therapy for HepAtocellular carcinoma: RELEVANT study |
| title_sort | real life study of lenvatinib therapy for hepatocellular carcinoma relevant study |
| url | https://beta.karger.com/Article/FullText/525145 |
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