Prognostic factor of lenvatinib for unresectable hepatocellular carcinoma in real‐world conditions—Multicenter analysis

• Main Authors: Atsushi Hiraoka, Takashi Kumada, Masanori Atsukawa, Masashi Hirooka, Kunihiko Tsuji, Toru Ishikawa, Koichi Takaguchi, Kazuya Kariyama, Ei Itobayashi, Kazuto Tajiri, Noritomo Shimada, Hiroshi Shibata, Hironori Ochi, Toshifumi Tada, Hidenori Toyoda, Kazuhiro Nouso, Akemi Tsutsui, Takuya Nagano, Norio Itokawa, Korenobu Hayama, Michitaka Imai, Kouji Joko, Yohei Koizumi, Yoichi Hiasa, Kojiro Michitaka, Masatoshi Kudo, the Real‐life Practice Experts for HCC (RELPEC) Study Group, HCC 48 Group (hepatocellular carcinoma experts from 48 clinics in Japan)
• Format: Article
• Language: English
• Published: Wiley 2019-07-01
• Series: Cancer Medicine
• Subjects: adverse event; hand‐foot skin reaction; hepatic function; hepatocellular carcinoma; lenvatinib; modified albumin‐bilirubin grade
• Online Access: https://doi.org/10.1002/cam4.2241

Abstract Background/aim We assessed suitable factors indicating newly developed lenvatinib (LEN) treatment for unresectable hepatocellular carcinoma (u‐HCC) by investigating real‐world clinical features of patients. Materials/methods One hundred fifty two u‐HCC patients, who receive LEN treatment from March to December 2018, were enrolled. (Child‐Pugh score [CPS] 5/6/7/8 = 76/61/13/2, modified albumin‐bilirubin grade [mALBI] 1/2a/2b/3 = 53/35/60/4). Clinical features were evaluated retrospectively. Results Overall‐response rate (ORR)/disease control rate (DCR) at 1 month after starting LEN were 38.7%/86.0%, respectively. Estimated median time to progression (TTP) was 7.0 months, while median survival time was not reached within the observation period. CPS (≥7) and past history of tyrosine‐kinase inhibitor (TKI) were not significant prognostic factors. mALBI ≥2b was an only significant prognostic factor (HR 4.632, 95%CI 1.649‐13.02, P = 0.004) in Cox‐hazard multivariate analysis. In patients with Child‐Pugh A, c‐index/Akaike's information criterion (AIC) of prognostic predictive value of mALBI were superior to CPS (0.682/135.6 vs 0.652/138.7), while those of stopping LEN also showed that mALBI was better (0.575/447.3 vs 0.562/447.8). Additional analysis of patients with good mALBI (1/2a) revealed that time to stopping LEN was significantly shorter in those with the adverse event (AE) of appetite loss (any grade) than those without (P = 0.006) and body mass index (BMI) was also lower in patients with that AE (20.3 ± 3.0 vs 23.6 ± 4.0kg/m2, P < 0.001), while patients with a hand‐foot skin reaction (any grade) showed good ORR/DCR (59.1%/86.4%) and longer TTP as compared to patients without (P = 0.007). Conclusion Good hepatic function (mALBI 1/2a) is the best indication for LEN, while potential appetite loss in association with low BMI should be kept in mind in such cases.