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Table 2 Summary of efficacy findings from the SELECT and DECISION trials

From: A systematic review of lenvatinib and sorafenib for treating progressive, locally advanced or metastatic, differentiated thyroid cancer after treatment with radioactive iodine

Outcome SELECT trial DECISION trial
Lenvatinib
N = 261
Placebo
N = 131
Sorafenib
N = 207
Placebo
N = 210
OSa
Median, months 41.6 34.5 39.4 42.8
(95% CI) (31.2-NE) (21.7-NE) (32.7–51.4) (34.7–52.6)
Unadjusted HR (95% CI) 0.84 (0.62–1.13) 0.92 (0.71–1.21)
RPSFTM adjusted OS HR 0.54 0.77
(95% CI) b (0.36–0.80) (0.42–1.79)
PFSc
Median, months 18.3 3.6 10.8 5.8
(95% CI) (15.1-NE) (2.2–3.7) (CIs NR) (CIs NR)
Stratified HR (95% CI) 0.21 (0.14–0.31) 0.59 (0.45–0.76)
Objective tumour response
ratec, d (%) 64.8 1.5 12.2 0.5
(95% CI) (59–70.5) (0–3.6) (8–17.7) (0–2.7)
Odds Ratio (95% CI) 28.87 (12.46–66.86) NR
P value p < 0.0001 p < 0.0001
  1. CI Confidence interval, HR Hazard ratio, IPE Iterative Parameter Estimation, NE Not estimable, NR Not reported, OS Overall survival, PFS Progression-free survival, RPSFTM Rank Preserving Structural Failure Time Model
  2. aData from final data-cut
  3. bBootstrapping CIs
  4. cAssessed by blinded independent review at primary data-cut
  5. dUnlike the SELECT trial, patients who were unevaluable for response were excluded from the analyses in the DECISION trial. There were 18 (4.3%) patients who were excluded from the objective tumour response analyses in the DECISION trial, 9 (4.3%) patients in each arm [27]
  6. Source: [26, 27] with additional OS data from Eisai Ltd. 2017 [24] and Bayer HealthCare 2017 [25] and additional ORR data (95% CIs) from European public assessment report (EPAR) for lenvatinib [51] and EPAR for sorafenib [56]