Lenvatinib (LEN) in Patients With Radioiodine-Refractory Differentiated Thyroid Cancer (RR-DTC) in SELECT: Post Hoc Analysis of Neutrophil-to-Lymphocyte Ratio (NLR)

  • Background: Elevated NLR serves as a biomarker for systemic inflammation and has been associated with poor survival outcomes in DTC. LEN is a multikinase inhibitor of VEGFR 1–3, FGFR 1–4, PDGFR?, RET, and KIT.  Phase 3 SELECT enrolled patients with metastatic RR-DTC and demonstrated that LEN was superior to placebo in objective response rate (ORR; 64.8% vs 1.5%) and median progression-free survival (PFS; 18.3 months vs 3.6 months). This post hoc analysis assessed influence of NLR on SELECT outcomes.

    Methods: In SELECT, patients with RR-DTC were randomly assigned (2:1) to LEN (24 mg/day in 28-day cycles; n=261) or placebo (n=131). At disease progression, patients in the placebo group could receive LEN. For this analysis, SELECT patients were stratified by baseline NLR of ?3 or >3.

    Results: Median baseline NLRs were 3.1 (LEN) and 3.2 (placebo). Median PFS was significantly longer for NLR ?3 vs NLR >3 (HR 0.43, 95% CI: 0.29-0.65) as was overall survival (OS; HR 0.48 95% CI: 0.29-0.78). In the placebo arm, PFS and OS were also significantly improved for the NLR ?3 group. In the LEN arm, ORR was 70% (95% CI, 61-78) for NLR ?3 and 60% (95% CI, 51-68) for NLR >3.

    Conclusions: PFS and OS were significantly longer for the NLR ?3 group. ORRs were consistent with overall SELECT results and similar between NLR groups. This hypothesis-generating analysis suggests that NLR may be prognostic of outcomes. Further study is needed on association of NLR and clinical outcomes in DTC.

 

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