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Association between overall survival and adverse events with lenvatinib treatment in patients with hepatocellular carcinoma (REFLECT)

Journal of Clinical Oncology Feb 05, 2019

Sung MW, et al. - Whether lenvatinib (LEN)-related adverse events (AEs) correlated with longer overall survival (OS), was investigated in this post hoc analysis of phase 3 REFLECT study, wherein a treatment effect on OS was shown by LEN by statistical confirmation of non-inferiority to sorafenib (SOR) in patients (pts) with unresectable hepatocellular carcinoma (uHCC), who had not received prior treatment for advanced disease. A total of 478 Pts were randomly administered LEN (12 mg/d for actual body weight ≥ 60 kg or 8 mg/d for actual body weight < 60 kg) and depending on whether pts treated with LEN experienced any-grade AEs of interest (AEIs), subgroup analyses were carried out. Hypertension (42%), diarrhea (38%), proteinuria (24%), dysphonia (24%), and hypothyroidism (16%) were documented as LEN-related AEIs. In pts treated with LEN, generally longer OS was observed in association with the occurrence of hypertension, diarrhea, proteinuria, or hypothyroidism in pts with uHCC.
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