Adverse events as potential predictive factors of activity in patients with advanced hepatocellular carcinoma treated with lenvatinib

Ilario Giovanni Rapposelli, Toshifumi Tada, Shigeo Shimose, Valentina Burgio, Takashi Kumada, Hideki Iwamoto, Atsushi Hiraoka, Takashi Niizeki, Masanori Atsukawa, Hironori Koga, Masashi Hirooka, Takuji Torimura, Massimo Iavarone, Raffaella Tortora, Claudia Campani, Sara Lonardi, Emiliano Tamburini, Fabio Piscaglia, Gianluca Masi, Giuseppe CabibboFrancesco Giuseppe Foschi, Marianna Silletta, Kunihiko Tsuji, Toru Ishikawa, Koichi Takaguchi, Kazuya Kariyama, Ei Itobayashi, Kazuto Tajiri, Noritomo Shimada, Hiroshi Shibata, Hironori Ochi, Satoshi Yasuda, Hidenori Toyoda, Shinya Fukunishi, Hideko Ohama, Kazuhito Kawata, Joji Tani, Shinichiro Nakamura, Kazuhiro Nouso, Akemi Tsutsui, Takuya Nagano, Takaaki Tanaka, Norio Itokawa, Tomomi Okubo, Taeang Arai, Michitaka Imai, Francesca Ratti, Luca Aldrighetti, Stefano Cascinu, Andrea Casadei-Gardini

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
JournalLiver International
DOIs
Publication statusAccepted/In press - 2021

Keywords

  • adverse events
  • hepatocellular carcinoma
  • lenvatinib
  • predictive factors

ASJC Scopus subject areas

  • Hepatology

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