Taylor MH, Leboulleux S, Panaseykin Y, Konda B, de La Fouchardiere C, Hughes BGM, Gianoukakis AG, Park YJ, Romanov I, Krzyzanowska MK, Garbinsky D, Sherif B, Pan JJ, Binder TA, Sauter N, Xie R, Brose MS. Health-related quality-of-life analyses from a multicenter, randomized, double-blind phase 2 study of patients with differentiated thyroid cancer treated with lenvatinib 18 or 24 mg/day. Cancer Med. 2023 Feb;12(4):4332-42. doi: 10.1002/cam4.5308

BACKGROUND: In the phase 2 double-blind Study 211, a starting dose of lenvatinib 18mg/day was compared to the approved starting dose of 24mg/day in patients with radioiodine-refractory differentiated thyroid cancer (RR-DTC). Predefined criteria for noninferiority for efficacy in the 18mg arm were not met; safety was similar in both arms. Impact of lenvatinib treatment on health-related quality-of-life (HRQoL) was a secondary endpoint of Study 211.

METHODS: Patients with RR-DTC were randomly assigned to a blinded starting dose of lenvatinib 18mg/day or 24mg/day. HRQoL was assessed at baseline, every 8 weeks until week 24, then every 16 weeks, and at the off-treatment visit, using the EQ-5D-3L and FACT-G instruments. Completion and compliance rates, mean change from baseline, and times to first and definitive deterioration were evaluated.

RESULTS: Baseline EQ-5D and FACT-G scores, and overall changes from baseline, were comparable between patients in the lenvatinib 18mg/day (n=77) and 24mg/day arms (n=75). For the 18mg versus 24mg arms, least squares mean differences were −0.42 (95% CI −4.88, 4.03) for EQ-5D-VAS and 0.47 (95% CI −3.45, 4.39) for FACT-G total. Time to first deterioration did not significantly favor either arm; EQ-5D-VAS HR [18mg/24mg] 0.93 (95% CI 0.61–1.40), EQ-5D-HUI HR [18mg/24mg] 0.68 (95% CI 0.44–1.05), FACT-G total HR [18mg/24mg] 0.73 (95% CI 0.48–1.12). Time to definitive deterioration did not significantly favor either arm, though EQ-5D-VAS showed a trend in favor of the 24mg arm (HR [18mg/24mg] 1.72; 95% CI 0.99–3.01); EQ-5D-HUI HR [18mg/24mg] was 0.96 (95% CI 0.57–1.63), FACT-G total HR [18mg/24mg] was 0.72 (95% CI 0.43–1.21).

CONCLUSIONS: In Study 211, HRQoL for patients in the lenvatinib 18mg/day arm was not statistically different from that of patients in the 24mg/day arm. These data further support the use of the approved lenvatinib starting dose of 24mg/day in patients with RR-DTC.

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