In:
Clinical Cancer Research, American Association for Cancer Research (AACR), ( 2023-10-5)
Kurzfassung:
Background and Aims: This study aimed to investigate the safety and efficacy of lenvatinib in real-world settings, including patients excluded from the REFLECT trial. Methods: This multicenter, nonrandomized, open-label prospective study was conducted at 10 medical facilities in Japan (jRCTs031190017). Eligible patients had advanced HCC and were suitable for lenvatinib therapy. The study included patients with high tumor burden (with & gt;50% intrahepatic tumor volume, main portal vein invasion, or bile duct invasion), Child–Pugh B status, and receiving lenvatinib as second-line therapy following atezolizumab plus bevacizumab. Results: From Dec 2019 to Sep 2021, 59 patients were analyzed (47 and 12 patients with Child–Pugh A and B, respectively). In patients with Child–Pugh A, the frequency of aspartate aminotransferase elevation was high (72.7%) in high-burden group. No other significant adverse events (AEs) were observed even in second-line treatment. However, patients with Child–Pugh B had high incidence of grade ≥3 AEs (100.0%) and high discontinuation rates caused by AEs (33.3%) compared to patients with Child–Pugh A (80.9% and 17.0%, respectively). Median PFS was 6.4 and 2.5 months and median OS was 19.7 and 4.1 months in Child–Pugh A and B, respectively. Lenvatinib plasma concentration was higher in Child–Pugh B patients on days 8 and 15 and correlated with dose modifications and lower relative dose intensity. Conclusion: Lenvatinib is safe and effective for advanced HCC in patients with Child–Pugh A, even with high tumor burden. However, it carries a higher risk of AEs and may not provide adequate efficacy for patients with Child–Pugh B.
Materialart:
Online-Ressource
ISSN:
1078-0432
,
1557-3265
DOI:
10.1158/1078-0432.CCR-23-1462
Sprache:
Englisch
Verlag:
American Association for Cancer Research (AACR)
Publikationsdatum:
2023
ZDB Id:
1225457-5
ZDB Id:
2036787-9
