The Journal of Clinical Endocrinology & Metabolism
Background Lenvatinib is a multikinase inhibitor approved to treat radioiodine-refractory differe... more Background Lenvatinib is a multikinase inhibitor approved to treat radioiodine-refractory differentiated thyroid cancer (RR-DTC) at a starting dose of 24 mg/day. This study explored, in a double-blinded fashion, whether a starting dose of 18 mg/day would provide comparable efficacy with reduced toxicity. Methods Patients with RR-DTC were randomized to lenvatinib 24 mg/day or 18 mg/day. The primary efficacy endpoint was objective response rate as of Week 24 (ORRwk24); odds ratio noninferiority margin: 0.4. The primary safety endpoint was frequency of grade ≥3 treatment-emergent adverse events (TEAEs) as of Week 24. Tumors were assessed using RECIST v1.1. TEAEs were monitored and recorded. Results The ORRwk24 was 57.3% (95% confidence interval [CI] 46.1–68.5) in the lenvatinib 24-mg arm and 40.3% (95% CI 29.3–51.2) in the lenvatinib 18-mg arm, with an odds ratio [18/24 mg] of 0.50 (95% CI 0.26–0.96). As of Week 24, the rates of TEAEs grade ≥3 were 61.3% in the lenvatinib 24-mg arm and...
The Journal of Clinical Endocrinology & Metabolism
Background Lenvatinib is a multikinase inhibitor approved to treat radioiodine-refractory differe... more Background Lenvatinib is a multikinase inhibitor approved to treat radioiodine-refractory differentiated thyroid cancer (RR-DTC) at a starting dose of 24 mg/day. This study explored, in a double-blinded fashion, whether a starting dose of 18 mg/day would provide comparable efficacy with reduced toxicity. Methods Patients with RR-DTC were randomized to lenvatinib 24 mg/day or 18 mg/day. The primary efficacy endpoint was objective response rate as of Week 24 (ORRwk24); odds ratio noninferiority margin: 0.4. The primary safety endpoint was frequency of grade ≥3 treatment-emergent adverse events (TEAEs) as of Week 24. Tumors were assessed using RECIST v1.1. TEAEs were monitored and recorded. Results The ORRwk24 was 57.3% (95% confidence interval [CI] 46.1–68.5) in the lenvatinib 24-mg arm and 40.3% (95% CI 29.3–51.2) in the lenvatinib 18-mg arm, with an odds ratio [18/24 mg] of 0.50 (95% CI 0.26–0.96). As of Week 24, the rates of TEAEs grade ≥3 were 61.3% in the lenvatinib 24-mg arm and...
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Papers by Yury Panaseykin