Safety and Efficacy of Lenvatinib in Very Old Patients with Unresectable Hepatocellular Carcinoma

Silvia Camera; Margherita Rimini; Federico Rossari; Toshifumi Tada; Goki Suda; Shigeo Shimose; Masatoshi Kudo; Changhoon Yoo; Jaekyung Cheon; Fabian Finkelmeier; Ho Yeong Lim; José Presa; Gianluca Masi; Francesca Bergamo; Francesca Salani; Mariarosaria Marseglia; Elisabeth Amadeo; Francesco Vitiello; Takashi Kumada; Naoya Sakamoto; Hideki Iwamoto; Tomoko Aoki; Hong Jae Chon; Vera Himmelsbach; Massimo Iavarone; Giuseppe Cabibbo; Margarida Montes; Francesco Giuseppe Foschi; Caterina Vivaldi; Sara Lonardi; Takuya Sho; Takashi Niizeki; Naoshi Nishida; Christoph Steup; Masashi Hirooka; Kazuya Kariyama; Joji Tani; Masanori Atsukawa; Koichi Takaguchi; Ei Itobayashi; Shinya Fukunishi; Kunihiko Tsuji; Toru Ishikawa; Kazuto Tajiri; Hironori Ochi; Satoshi Yasuda; Hidenori Toyoda; Chikara Ogawa; Takashi Nishimura; Takeshi Hatanaka; Satoru Kakizaki; Noritomo Shimada; Kazuhito Kawata; Atsushi Hiraoka; Fujimasa Tada; Hideko Ohama; Kazuhiro Nouso; Asahiro Morishita; Akemi Tsutsui; Takuya Nagano; Norio Itokawa; Tomomi Okubo; Michitaka Imai; Hisashi Kosaka; Atsushi Naganuma; Yohei Koizumi; Shinichiro Nakamura; Masaki Kaibori; Hiroko Iijima; Yoichi Hiasa; Mara Persano; Silvia Foti; Fabio Piscaglia; Mario Scartozzi; Stefano Cascinu; Andrea Casadei-Gardini

doi:10.1007/s11523-023-01029-6

Safety and Efficacy of Lenvatinib in Very Old Patients with Unresectable Hepatocellular Carcinoma

Silvia Camera, Margherita Rimini^*, Federico Rossari, Toshifumi Tada, Goki Suda, Shigeo Shimose, Masatoshi Kudo, Changhoon Yoo, Jaekyung Cheon, Fabian Finkelmeier, Ho Yeong Lim, José Presa, Gianluca Masi, Francesca Bergamo, Francesca Salani, Mariarosaria Marseglia, Elisabeth Amadeo, Francesco Vitiello, Takashi Kumada, Naoya SakamotoHideki Iwamoto, Tomoko Aoki, Hong Jae Chon, Vera Himmelsbach, Massimo Iavarone, Giuseppe Cabibbo, Margarida Montes, Francesco Giuseppe Foschi, Caterina Vivaldi, Sara Lonardi, Takuya Sho, Takashi Niizeki, Naoshi Nishida, Christoph Steup, Masashi Hirooka, Kazuya Kariyama, Joji Tani, Masanori Atsukawa, Koichi Takaguchi, Ei Itobayashi, Shinya Fukunishi, Kunihiko Tsuji, Toru Ishikawa, Kazuto Tajiri, Hironori Ochi, Satoshi Yasuda, Hidenori Toyoda, Chikara Ogawa, Takashi Nishimura, Takeshi Hatanaka, Satoru Kakizaki, Noritomo Shimada, Kazuhito Kawata, Atsushi Hiraoka, Fujimasa Tada, Hideko Ohama, Kazuhiro Nouso, Asahiro Morishita, Akemi Tsutsui, Takuya Nagano, Norio Itokawa, Tomomi Okubo, Michitaka Imai, Hisashi Kosaka, Atsushi Naganuma, Yohei Koizumi, Shinichiro Nakamura, Masaki Kaibori, Hiroko Iijima, Yoichi Hiasa, Mara Persano, Silvia Foti, Fabio Piscaglia, Mario Scartozzi, Stefano Cascinu, Andrea Casadei-Gardini

^*Corresponding author for this work

Internal Medicine （3）

Research output: Contribution to journal › Article › peer-review

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Abstract

Background: Data concerning the use of lenvatinib in very old patients (≥ 80 years) are limited, although the incidence of hepatocellular carcinoma (HCC) in this patient population is constantly increasing. Objective: This analysis aimed to evaluate the efficacy and safety of lenvatinib in a large cohort of very old patients (≥ 80 years) with unresectable HCC. Patients and Methods: The study was conducted on a cohort of 1325 patients from 46 centers in four Western and Eastern countries (Italy, Germany, Japan, and the Republic of Korea) who were undergoing first-line treatment with lenvatinib between July 2010 and February 2022. Patients were stratified according to age as very old (≥ 80 years) and not very old (< 80 years). Results: The median overall survival (OS) was 15.7 months for patients < 80 years old and 18.4 months for patients ≥ 80 years old [hazard ratio (HR) = 1.02, 95% confidence interval (CI) 0.84–1.25, p = 0.8281]. Median progression free survival (PFS) was 6.3 months for patients < 80 years old and 6.5 months for patients ≥ 80 years old (HR = 1.07, 95% CI 0.91–1.25, p = 0.3954). No differences between the two study groups were found in terms of disease control rate (DCR; 80.8% versus 78.8%; p = 0.44) and response rate (RR; 38.2% versus 37.9%; p = 0.88). Patients < 80 years old experienced significantly more hand–foot skin reaction (HFSR) grade ≥ 2 and decreased appetite grade ≥ 2. Conversely, patients ≥ 80 years old experienced significantly more fatigue grade ≥ 2. In the very old group, parameters associated with prognosis were AFP, albumin–bilirubin (ALBI) grade, Barcelona Clinic Liver Cancer (BCLC), and Child–Pugh score. BCLC stage was the only independent predictor of overall survival (OS; HR = 1.59, 95% CI 1.11–2.29, p = 0.01115). Conclusions: Our study highlights the same efficacy and safety of lenvatinib between very old and not very old patients.

Original language	English
Pages (from-to)	29-39
Number of pages	11
Journal	Targeted Oncology
Volume	19
Issue number	1
DOIs	https://doi.org/10.1007/s11523-023-01029-6
State	Published - 2024/01

ASJC Scopus subject areas

Oncology
Cancer Research
Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s11523-023-01029-6

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Camera, S., Rimini, M., Rossari, F., Tada, T., Suda, G., Shimose, S., Kudo, M., Yoo, C., Cheon, J., Finkelmeier, F., Lim, H. Y., Presa, J., Masi, G., Bergamo, F., Salani, F., Marseglia, M., Amadeo, E., Vitiello, F., Kumada, T., ... Casadei-Gardini, A. (2024). Safety and Efficacy of Lenvatinib in Very Old Patients with Unresectable Hepatocellular Carcinoma. Targeted Oncology, 19(1), 29-39. https://doi.org/10.1007/s11523-023-01029-6

@article{d2553e01a6c84cc08b1b9baca6039201,

title = "Safety and Efficacy of Lenvatinib in Very Old Patients with Unresectable Hepatocellular Carcinoma",

abstract = "Background: Data concerning the use of lenvatinib in very old patients (≥ 80 years) are limited, although the incidence of hepatocellular carcinoma (HCC) in this patient population is constantly increasing. Objective: This analysis aimed to evaluate the efficacy and safety of lenvatinib in a large cohort of very old patients (≥ 80 years) with unresectable HCC. Patients and Methods: The study was conducted on a cohort of 1325 patients from 46 centers in four Western and Eastern countries (Italy, Germany, Japan, and the Republic of Korea) who were undergoing first-line treatment with lenvatinib between July 2010 and February 2022. Patients were stratified according to age as very old (≥ 80 years) and not very old (< 80 years). Results: The median overall survival (OS) was 15.7 months for patients < 80 years old and 18.4 months for patients ≥ 80 years old [hazard ratio (HR) = 1.02, 95% confidence interval (CI) 0.84–1.25, p = 0.8281]. Median progression free survival (PFS) was 6.3 months for patients < 80 years old and 6.5 months for patients ≥ 80 years old (HR = 1.07, 95% CI 0.91–1.25, p = 0.3954). No differences between the two study groups were found in terms of disease control rate (DCR; 80.8% versus 78.8%; p = 0.44) and response rate (RR; 38.2% versus 37.9%; p = 0.88). Patients < 80 years old experienced significantly more hand–foot skin reaction (HFSR) grade ≥ 2 and decreased appetite grade ≥ 2. Conversely, patients ≥ 80 years old experienced significantly more fatigue grade ≥ 2. In the very old group, parameters associated with prognosis were AFP, albumin–bilirubin (ALBI) grade, Barcelona Clinic Liver Cancer (BCLC), and Child–Pugh score. BCLC stage was the only independent predictor of overall survival (OS; HR = 1.59, 95% CI 1.11–2.29, p = 0.01115). Conclusions: Our study highlights the same efficacy and safety of lenvatinib between very old and not very old patients.",

author = "Silvia Camera and Margherita Rimini and Federico Rossari and Toshifumi Tada and Goki Suda and Shigeo Shimose and Masatoshi Kudo and Changhoon Yoo and Jaekyung Cheon and Fabian Finkelmeier and Lim, {Ho Yeong} and Jos{\'e} Presa and Gianluca Masi and Francesca Bergamo and Francesca Salani and Mariarosaria Marseglia and Elisabeth Amadeo and Francesco Vitiello and Takashi Kumada and Naoya Sakamoto and Hideki Iwamoto and Tomoko Aoki and Chon, {Hong Jae} and Vera Himmelsbach and Massimo Iavarone and Giuseppe Cabibbo and Margarida Montes and Foschi, {Francesco Giuseppe} and Caterina Vivaldi and Sara Lonardi and Takuya Sho and Takashi Niizeki and Naoshi Nishida and Christoph Steup and Masashi Hirooka and Kazuya Kariyama and Joji Tani and Masanori Atsukawa and Koichi Takaguchi and Ei Itobayashi and Shinya Fukunishi and Kunihiko Tsuji and Toru Ishikawa and Kazuto Tajiri and Hironori Ochi and Satoshi Yasuda and Hidenori Toyoda and Chikara Ogawa and Takashi Nishimura and Takeshi Hatanaka and Satoru Kakizaki and Noritomo Shimada and Kazuhito Kawata and Atsushi Hiraoka and Fujimasa Tada and Hideko Ohama and Kazuhiro Nouso and Asahiro Morishita and Akemi Tsutsui and Takuya Nagano and Norio Itokawa and Tomomi Okubo and Michitaka Imai and Hisashi Kosaka and Atsushi Naganuma and Yohei Koizumi and Shinichiro Nakamura and Masaki Kaibori and Hiroko Iijima and Yoichi Hiasa and Mara Persano and Silvia Foti and Fabio Piscaglia and Mario Scartozzi and Stefano Cascinu and Andrea Casadei-Gardini",

note = "Publisher Copyright: {\textcopyright} 2024, The Author(s), under exclusive licence to Springer Nature Switzerland AG.",

year = "2024",

month = jan,

doi = "10.1007/s11523-023-01029-6",

language = "英語",

volume = "19",

pages = "29--39",

journal = "Targeted Oncology",

issn = "1776-2596",

publisher = "Springer Paris",

number = "1",

}

Camera, S, Rimini, M, Rossari, F, Tada, T, Suda, G, Shimose, S, Kudo, M, Yoo, C, Cheon, J, Finkelmeier, F, Lim, HY, Presa, J, Masi, G, Bergamo, F, Salani, F, Marseglia, M, 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, Lonardi, S, 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, Piscaglia, F, Scartozzi, M, Cascinu, S & Casadei-Gardini, A 2024, 'Safety and Efficacy of Lenvatinib in Very Old Patients with Unresectable Hepatocellular Carcinoma', Targeted Oncology, vol. 19, no. 1, pp. 29-39. https://doi.org/10.1007/s11523-023-01029-6

TY - JOUR

T1 - Safety and Efficacy of Lenvatinib in Very Old Patients with Unresectable Hepatocellular Carcinoma

AU - Camera, Silvia

AU - Rimini, Margherita

AU - Rossari, Federico

AU - Tada, Toshifumi

AU - Suda, Goki

AU - Shimose, Shigeo

AU - Kudo, Masatoshi

AU - Yoo, Changhoon

AU - Cheon, Jaekyung

AU - Finkelmeier, Fabian

AU - Lim, Ho Yeong

AU - Presa, José

AU - Masi, Gianluca

AU - Bergamo, Francesca

AU - Salani, Francesca

AU - Marseglia, Mariarosaria

AU - Amadeo, Elisabeth

AU - Vitiello, Francesco

AU - Kumada, Takashi

AU - Sakamoto, Naoya

AU - Iwamoto, Hideki

AU - Aoki, Tomoko

AU - Chon, Hong Jae

AU - Himmelsbach, Vera

AU - Iavarone, Massimo

AU - Cabibbo, Giuseppe

AU - Montes, Margarida

AU - Foschi, Francesco Giuseppe

AU - Vivaldi, Caterina

AU - Lonardi, Sara

AU - Sho, Takuya

AU - Niizeki, Takashi

AU - Nishida, Naoshi

AU - Steup, Christoph

AU - Hirooka, Masashi

AU - Kariyama, Kazuya

AU - Tani, Joji

AU - Atsukawa, Masanori

AU - Takaguchi, Koichi

AU - Itobayashi, Ei

AU - Fukunishi, Shinya

AU - Tsuji, Kunihiko

AU - Ishikawa, Toru

AU - Tajiri, Kazuto

AU - Ochi, Hironori

AU - Yasuda, Satoshi

AU - Toyoda, Hidenori

AU - Ogawa, Chikara

AU - Nishimura, Takashi

AU - Hatanaka, Takeshi

AU - Kakizaki, Satoru

AU - Shimada, Noritomo

AU - Kawata, Kazuhito

AU - Hiraoka, Atsushi

AU - Tada, Fujimasa

AU - Ohama, Hideko

AU - Nouso, Kazuhiro

AU - Morishita, Asahiro

AU - Tsutsui, Akemi

AU - Nagano, Takuya

AU - Itokawa, Norio

AU - Okubo, Tomomi

AU - Imai, Michitaka

AU - Kosaka, Hisashi

AU - Naganuma, Atsushi

AU - Koizumi, Yohei

AU - Nakamura, Shinichiro

AU - Kaibori, Masaki

AU - Iijima, Hiroko

AU - Hiasa, Yoichi

AU - Persano, Mara

AU - Foti, Silvia

AU - Piscaglia, Fabio

AU - Scartozzi, Mario

AU - Cascinu, Stefano

AU - Casadei-Gardini, Andrea

PY - 2024/1

Y1 - 2024/1

N2 - Background: Data concerning the use of lenvatinib in very old patients (≥ 80 years) are limited, although the incidence of hepatocellular carcinoma (HCC) in this patient population is constantly increasing. Objective: This analysis aimed to evaluate the efficacy and safety of lenvatinib in a large cohort of very old patients (≥ 80 years) with unresectable HCC. Patients and Methods: The study was conducted on a cohort of 1325 patients from 46 centers in four Western and Eastern countries (Italy, Germany, Japan, and the Republic of Korea) who were undergoing first-line treatment with lenvatinib between July 2010 and February 2022. Patients were stratified according to age as very old (≥ 80 years) and not very old (< 80 years). Results: The median overall survival (OS) was 15.7 months for patients < 80 years old and 18.4 months for patients ≥ 80 years old [hazard ratio (HR) = 1.02, 95% confidence interval (CI) 0.84–1.25, p = 0.8281]. Median progression free survival (PFS) was 6.3 months for patients < 80 years old and 6.5 months for patients ≥ 80 years old (HR = 1.07, 95% CI 0.91–1.25, p = 0.3954). No differences between the two study groups were found in terms of disease control rate (DCR; 80.8% versus 78.8%; p = 0.44) and response rate (RR; 38.2% versus 37.9%; p = 0.88). Patients < 80 years old experienced significantly more hand–foot skin reaction (HFSR) grade ≥ 2 and decreased appetite grade ≥ 2. Conversely, patients ≥ 80 years old experienced significantly more fatigue grade ≥ 2. In the very old group, parameters associated with prognosis were AFP, albumin–bilirubin (ALBI) grade, Barcelona Clinic Liver Cancer (BCLC), and Child–Pugh score. BCLC stage was the only independent predictor of overall survival (OS; HR = 1.59, 95% CI 1.11–2.29, p = 0.01115). Conclusions: Our study highlights the same efficacy and safety of lenvatinib between very old and not very old patients.

AB - Background: Data concerning the use of lenvatinib in very old patients (≥ 80 years) are limited, although the incidence of hepatocellular carcinoma (HCC) in this patient population is constantly increasing. Objective: This analysis aimed to evaluate the efficacy and safety of lenvatinib in a large cohort of very old patients (≥ 80 years) with unresectable HCC. Patients and Methods: The study was conducted on a cohort of 1325 patients from 46 centers in four Western and Eastern countries (Italy, Germany, Japan, and the Republic of Korea) who were undergoing first-line treatment with lenvatinib between July 2010 and February 2022. Patients were stratified according to age as very old (≥ 80 years) and not very old (< 80 years). Results: The median overall survival (OS) was 15.7 months for patients < 80 years old and 18.4 months for patients ≥ 80 years old [hazard ratio (HR) = 1.02, 95% confidence interval (CI) 0.84–1.25, p = 0.8281]. Median progression free survival (PFS) was 6.3 months for patients < 80 years old and 6.5 months for patients ≥ 80 years old (HR = 1.07, 95% CI 0.91–1.25, p = 0.3954). No differences between the two study groups were found in terms of disease control rate (DCR; 80.8% versus 78.8%; p = 0.44) and response rate (RR; 38.2% versus 37.9%; p = 0.88). Patients < 80 years old experienced significantly more hand–foot skin reaction (HFSR) grade ≥ 2 and decreased appetite grade ≥ 2. Conversely, patients ≥ 80 years old experienced significantly more fatigue grade ≥ 2. In the very old group, parameters associated with prognosis were AFP, albumin–bilirubin (ALBI) grade, Barcelona Clinic Liver Cancer (BCLC), and Child–Pugh score. BCLC stage was the only independent predictor of overall survival (OS; HR = 1.59, 95% CI 1.11–2.29, p = 0.01115). Conclusions: Our study highlights the same efficacy and safety of lenvatinib between very old and not very old patients.

UR - http://www.scopus.com/inward/record.url?scp=85182829355&partnerID=8YFLogxK

U2 - 10.1007/s11523-023-01029-6

DO - 10.1007/s11523-023-01029-6

M3 - 学術論文

C2 - 38252195

AN - SCOPUS:85182829355

SN - 1776-2596

VL - 19

SP - 29

EP - 39

JO - Targeted Oncology

JF - Targeted Oncology

IS - 1

ER -

Safety and Efficacy of Lenvatinib in Very Old Patients with Unresectable Hepatocellular Carcinoma

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