Abstract
Background/aimWe assessed suitable factors indicating newly developed lenvatinib (LEN) treatment for unresectable hepatocellular carcinoma (u‐HCC) by investigating real‐world clinical features of patients.Materials/methodsOne 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.ResultsOverall‐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).ConclusionGood 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.
Highlights
Tyrosine‐kinase inhibitors (TKIs), including sorafenib (SOR)[1,2] and regorafenib (REG),[3,4] have been developed for treatment of patients with unresectable hepatocellular carcinoma (u‐HCC)
CPS (≥7) and past history of tyrosine‐kinase inhibitor (TKI) were not significant prognostic factors. modified albumin‐ bilirubin (ALBI) grade (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 showed that mALBI was better (0.575/447.3 vs 0.562/447.8)
Summary
Tyrosine‐kinase inhibitors (TKIs), including sorafenib (SOR)[1,2] and regorafenib (REG),[3,4] have been developed for treatment of patients with unresectable hepatocellular carcinoma (u‐HCC). In our recent reports of findings obtained in real‐world practice, LEN showed good therapeutic potential as a first‐line drug, and for second‐ and third‐line therapy.[7,8] TKI naïve and TKI experienced patients who received the drug showed a similar good therapeutic response,[7] with similar findings for overall survival (OS) and progression‐free survival (PFS) in each of those groups.[8] These results revealed that clinical physicians have a powerful and useful tool in addition to SOR and REG, and the clinical importance and therapeutic efficacy of LEN for u‐HCC is increasingly becoming recognized Based on these factors, LEN use in clinical practice in Japan is steadily increasing. Prognostic factors in u‐HCC patients, who receive LEN treatment, as well as clinical meaning of adverse events (AEs) of its usage have yet to be fully elucidated
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