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Correlation of Performance Status and Neutrophil-Lymphocyte Ratio with Efficacy in Radioiodine-Refractory Differentiated Thyroid Cancer Treated with Lenvatinib.

Earle A. Chiles Research Institute, Providence Portland Medical Center, Portland, Oregon, USA. Department of Medical Oncology, The Cancer Institute Hospital of JFCR, Tokyo, Japan. Medical Oncology Department, University Hospital Vall d'Hebron, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain. Division of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan. Department of Nuclear Medicine and Endocrine Oncology, Gustave Roussy, Villejuif, France. Department of Medical Oncology and Hematology and Cancer Center, Kobe University Hospital, Kusunoki Cho, Chuo-ku, Japan. Eisai Inc., Woodcliff Lake, New Jersey, USA. Department of Biostatistics, Eisai Inc., Woodcliff Lake, New Jersey, USA. Royal North Shore Hospital, University of Sydney, Australia. Department of Endocrine Neoplasia and Hormonal Disorders, Division of Internal Medicine, University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA. Endocrine Unit, Department of Clinical and Experimental Medicine, University of Pisa, Pisa, Italy. Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, Massachusetts, USA.

Thyroid : official journal of the American Thyroid Association. 2021;(8):1226-1234
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Abstract

Background: Radioiodine-refractory differentiated thyroid cancer (RR-DTC) has a low 10-year patient-survival rate and is challenging to treat. Lenvatinib is a multikinase inhibitor approved for the treatment of RR-DTC. This study aims to assess Eastern Cooperative Oncology Group performance status (ECOG PS) and neutrophil-to-lymphocyte ratio (NLR) as prognostic markers for patients with RR-DTC treated with lenvatinib. Methods: In this retrospective analysis of the Study of (E7080) LEnvatinib in Differentiated Cancer of the Thyroid (SELECT), patients randomly assigned to receive lenvatinib were classified according to baseline ECOG PS (0 or 1) or baseline NLR (≤3 or >3). The effects of baseline ECOG PS and NLR on progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) were evaluated. In addition, the effects of baseline ECOG PS on the change in diameter of target lesions and correlations between baseline NLR and the sums of the diameters of target lesions were calculated. Results: Among patients who received lenvatinib, patients with a baseline ECOG PS of 0 had statistically improved PFS (hazard ratio [HR] 0.52; 95% confidence interval [CI 0.35-0.77]; p = 0.001), OS (HR 0.42 [CI 0.26-0.69]; p = 0.0004), and ORR (odds ratio [OR] 3.51 [CI 2.02-6.10]; p < 0.0001) compared with patients with a baseline ECOG PS of 1. Patients who received lenvatinib with a baseline NLR ≤3 also had improved PFS (HR 0.43 [CI 0.29-0.65]; p < 0.0001) and OS (HR 0.48 [CI 0.29-0.78]; p = 0.0029) versus patients with a baseline NLR >3. Moreover, patients with a baseline NLR ≤3 had a trend toward increased ORR (OR 1.57 [CI 0.94-2.64]; p = 0.08) compared with patients with a baseline NLR >3. Treatment-emergent adverse events were generally similar among patients who received lenvatinib, irrespective of patients' ECOG PS at baseline. Conclusion: Lower ECOG PS and NLR may provide prognostic value for improved efficacy in patients with RR-DTC. ClinicalTrials.gov no. NCT01321554.

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