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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]
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BMC Cancer

ISSN: 1471-2407

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