Margherita Rimini1, Wonseok Kang2, Valentina Burgio1, Mara Persano3, Tamoko Aoki4, Shigeo Shimose5, Toshifumi Tada6, Takashi Kumada7, Takuya Sho8, Eleonora Lai3, Ciro Celsa9, Claudia Campani10, Matteo Tonnini11, Emiliano Tamburini12, Atsushi Hiraoka13, Koichi Takaguchi14, Naoshi Nishida4, Hideki Iwamoto5, Ei Itobayashi15, Kunihiko Tsuji16, Naoya Sakamoto8, Toru Ishikawa17, Hidenori Toyoda18, Masatoshi Kudo4, Takumi Kawaguchi5, Takeshi Hatanaka19, Kazugiro Nouso20, Goki Suda8, Giuseppe Cabibbo9, Fabio Marra10, Angelo Della Corte21,22, Francesca Ratti23, Federica Pedica24, Francesco De Cobelli21,22, Luca Aldrighetti23, Mario Scartozzi3, Stefano Cascinu22, Andrea Casadei-Gardini22. 1. Medical Oncology Department, IRCCS San Raffaele Hospital, Milan, Italy. 2. Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. 3. Medical Oncology Department, University and University Hospital, Cagliari, Italy. 4. Department of Gastroenterology and Hepatology, Kindai University, Faculty of Medicine, Osaka-Sayama, Osaka, Japan. 5. Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan. 6. Department of Internal Medicine, Japanese Red Cross Himeji Hospital, Himeji, Japan. 7. Department of Nursing, Gifu Kyoritsu University, Ogaki, Japan. 8. Department of Gastroenterology and Hepatology, Hokkaido University Graduate School of Medicine, Hokkaido, Japan. 9. Section of Gastroenterology & Hepatology, University of Palermo, Palermo, Italy. 10. Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy. 11. Department of Medical and Surgical Sciences, University of Bologna, Bologna, Italy. 12. Department of Oncology and Palliative Care, Cardinale G Panico, Tricase City Hospital, Tricase, Italy. 13. Gastroenterology Center, Ehime Prefectural Central Hospital, Matsuyama, Japan. 14. Department of Hepatology, Kagawa Prefectural Central Hospital, Takamatsu, Japan. 15. Department of Gastroenterology, Asahi General Hospital, Asahi, Japan. 16. Center of Gastroenterology, Teine Keijinkai Hospital, Sapporo, Japan. 17. Department of Gastroenterology, Saiseikai Niigata Hospital, Niigata, Japan. 18. Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan. 19. Department of Gastroenterology, Gunma Saiseikai Maebashi Hospital, Maebashi, Japan. 20. Department of Gastroenterology, Okayama City Hospital, Okayama, Japan. 21. Department of Radiology, IRCCS San Rafaele Hospital, Milan, Italy. 22. Vita-Salute San Raffaele, University of Medicine, Milan, Italy. 23. Hepatobiliary Surgery Division, Liver Center, Vita-Salute San Raffaele University, IRCCS San Raffaele Scientific Institute, Milan, Italy. 24. Department of Experimental Oncology, Pathology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
Abstract
AIM: The identification of new prognostic factors able to stratify hepatocellular carcinoma patients candidate to first-line therapy is urgent. In the present work we validated the prognostic value of the lenvatinib prognostic index. METHODS: Data of Eastern and Western patients treated with lenvatinib as first-line for Barcelona Clinic Liver Cancer stage B or C hepatocellular carcinoma were recollected. The lenvatinib prognostic index was composed by three classes of risk according with our previous study. The "low risk" group includes patients with prognostic nutritional index (PNI) >43.3 and with previous transarterial chemoembolization. The "medium risk" group includes patients with PNI >43.3, but without previous transarterial chemoembolization and patients with PNI <43.3, albumin-bilirubin grade 1 and Barcelona Clinic Liver Cancer stage B. The "high risk" group includes patients with PNI <43.3, albumin-bilirubin grade 2, and patients with PNI <43.3, albumin-bilirubin grade 1 and Barcelona Clinic Liver Cancer stage C. RESULTS: A total of 717 patients were included. The median overall survival was 20.7 months (95% CI 16.1-51.6) in patients with low risk (n = 223), 16.7 months (95% CI 13.3-47.0) in patients with medium risk (n = 264), and 10.7 months (95% CI 9.3-12.2) in patients with high risk (n = 230; HR 1, 1.29, and 1.92, respectively; p < 0.0001). Median progression-free survival was 7.3 months (95% CI 6.3-46.5) in patients with low risk, 6.4 months (95% CI 5.3-8.0) in patients with medium risk ,and 4.9 months (95% CI 4.3-5.5) in patients with high risk (HR 1, 1.07, 1.47 respectively; p = 0.0009). CONCLUSION: The lenvatinib prognostic index confirms its prognostic value on an external cohort of hepatocellular carcinoma patients treated with Lenvatinib.
AIM: The identification of new prognostic factors able to stratify hepatocellular carcinoma patients candidate to first-line therapy is urgent. In the present work we validated the prognostic value of the lenvatinib prognostic index. METHODS: Data of Eastern and Western patients treated with lenvatinib as first-line for Barcelona Clinic Liver Cancer stage B or C hepatocellular carcinoma were recollected. The lenvatinib prognostic index was composed by three classes of risk according with our previous study. The "low risk" group includes patients with prognostic nutritional index (PNI) >43.3 and with previous transarterial chemoembolization. The "medium risk" group includes patients with PNI >43.3, but without previous transarterial chemoembolization and patients with PNI <43.3, albumin-bilirubin grade 1 and Barcelona Clinic Liver Cancer stage B. The "high risk" group includes patients with PNI <43.3, albumin-bilirubin grade 2, and patients with PNI <43.3, albumin-bilirubin grade 1 and Barcelona Clinic Liver Cancer stage C. RESULTS: A total of 717 patients were included. The median overall survival was 20.7 months (95% CI 16.1-51.6) in patients with low risk (n = 223), 16.7 months (95% CI 13.3-47.0) in patients with medium risk (n = 264), and 10.7 months (95% CI 9.3-12.2) in patients with high risk (n = 230; HR 1, 1.29, and 1.92, respectively; p < 0.0001). Median progression-free survival was 7.3 months (95% CI 6.3-46.5) in patients with low risk, 6.4 months (95% CI 5.3-8.0) in patients with medium risk ,and 4.9 months (95% CI 4.3-5.5) in patients with high risk (HR 1, 1.07, 1.47 respectively; p = 0.0009). CONCLUSION: The lenvatinib prognostic index confirms its prognostic value on an external cohort of hepatocellular carcinoma patients treated with Lenvatinib.