Andrea Casadei-Gardini1,2, Mario Scartozzi3, Toshifumi Tada4, Changhoon Yoo5, Shigeo Shimose6, Gianluca Masi7, Sara Lonardi8, Luca Giovanni Frassineti9, Silvestris Nicola10,11, Fabio Piscaglia12,13, Takashi Kumada14, Hyung-Don Kim4, Hironori Koga5, Caterina Vivaldi7, Caterina Soldà8, Atsushi Hiraoka15, Yeonghak Bang4, Masanori Atsukawa16, Takuji Torimura4, Kunihiko Tsuj17, Ei Itobayashi18, Hidenori Toyoda19, Shinya Fukunishi20, Lorenza Rimassa21,22, Margherita Rimini1, Stefano Cascinu1,2, Alessandro Cucchetti12. 1. Vita-Salute San Rafaele University, Milan, Italy. 2. Department of Medical Oncology, San Rafaele Scientifc Institute IRCCS, Milan, Italy. 3. Department of Medical Oncology, University Hospital of Cagliari, Cagliari, Italy. 4. Department of Internal Medicine, Japanese Red Cross Society Himeji Hospital, Himeji, Japan. 5. Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea. 6. Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan. 7. Department of Translational Research and New Surgical and Medical Technologies, University of Pisa, Pisa, Italy. 8. Medical Oncology Unit 1, Veneto Institute of Oncology IOV - IRCCS, Padova, Italy. 9. Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy. 10. Medical Oncology Unit, IRCCS IstitutoTumori "Giovanni Paolo II" of Bari, Bari, Italy. 11. Department of Biomedical Sciences and Human Oncology, University of Bari "Aldo Moro", Bari, Italy. 12. Division of Internal Medicine, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy. 13. Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy. 14. Faculty of Nursing, Gifu Kyoritsu University, Ogaki, Japan. 15. Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan. 16. Division of Gastroenterology and Hepatology, Department of Internal Medicine, Nippon Medical School, Tokyo, Japan. 17. Center of Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan. 18. Department of Gastroenterology, Asahi General Hospital, Asahi, Japan. 19. Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan. 20. Second Department of Internal Medicine, Osaka Medical College, Takatsuki, Japan. 21. Department of Biomedical Sciences, Humanitas University, Milan, Italy. 22. Medical Oncology and Hematology Unit, Humanitas Cancer Center, IRCCS Humanitas Research Hospital, Milan, Italy.
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.
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 sorafenibpatients 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.
Authors: I G Rapposelli; S Shimose; T Kumada; S Okamura; A Hiraoka; G G Di Costanzo; F Marra; E Tamburini; A Forgione; F G Foschi; M Silletta; S Lonardi; G Masi; M Scartozzi; M Nakano; H Shibata; K Kawata; A Pellino; C Vivaldi; E Lai; A Takata; K Tajiri; H Toyoda; R Tortora; C Campani; M G Viola; F Piscaglia; F Conti; C A M Fulgenzi; G L Frassineti; M D Rizzato; F Salani; G Astara; T Torimura; M Atsukawa; T Tada; V Burgio; M Rimini; S Cascinu; A Casadei-Gardini Journal: ESMO Open Date: 2021-06-15
Authors: Na Ryung Choi; Ju Yeon Kim; Ji Hoon Hong; Moon Haeng Hur; Heejin Cho; Min Kyung Park; Jihye Kim; Yun Bin Lee; Eun Ju Cho; Jeong-Hoon Lee; Su Jong Yu; Jung-Hwan Yoon; Yoon Jun Kim Journal: BMC Gastroenterol Date: 2022-03-25 Impact factor: 3.067