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      Improvement of lenvatinib-induced nephrotic syndrome after adaptation to sorafenib in thyroid cancer: A case report

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          Abstract

          BACKGROUND

          Target therapy is licensed by United States Food and Drug Administration on certain cancers. Both sorafenib and lenvatinib are tyrosine kinase inhibitor and indicated on radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). Lenvatinib is more effective in cancers' control than sorafenib, but causes more nephrotoxicity than sorafenib does. This case is the second published case about the serial adaptions from lenvatinib to sorafenib for improving the proteinuria and, meanwhile, achieving the therapeutic goal.

          CASE SUMMARY

          A 56-year-old man suffered from bilateral edematous lower extremities after 1-mo prescription of lenvatinib of 20 mg/d for RAI-refractory DTC. Aside from this symptom, he also developed hypertension. His laboratory showed grade-3 proteinuria (estimated 24-h urine protein: 9993 mg), hypoalbuminemia and hypercholesterolemia. Anti-vascular endothelial growth factor (VEGF) therapy-induced nephrotic syndrome was impressed. After reduced dosage of lenvatinib of 10 mg/d and related symptomatic drugs, limited improvement was observed in both adverse effects and caner control. Under this condition, we substituted sorafenib of 400 mg/d for lenvatinib of 10 mg/d. After a 5-mo prescription, not only hypertension and peripheral edema were greatly improved, but also proteinuria was improved from grade three to grade one (estimated 24-h urine protein: 962 mg). At the same time the cancer control was achieved, judged from computed tomography and laboratory evidence [thyroglobulin (Tg) before prescription of sorafenib: 354.7 ng/mL; Tg after prescription of sorafenib: 108.9 ng/mL].

          CONCLUSION

          Adaption from lenvatinib to sorafenib is a feasible method to improve the anti-VEGF therapy-induced nephrotic syndrome and achieve the therapeutic goal at the same time.

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          Most cited references17

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          Lenvatinib versus sorafenib in first-line treatment of patients with unresectable hepatocellular carcinoma: a randomised phase 3 non-inferiority trial

          In a phase 2 trial, lenvatinib, an inhibitor of VEGF receptors 1-3, FGF receptors 1-4, PDGF receptor α, RET, and KIT, showed activity in hepatocellular carcinoma. We aimed to compare overall survival in patients treated with lenvatinib versus sorafenib as a first-line treatment for unresectable hepatocellular carcinoma.
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            Lenvatinib versus placebo in radioiodine-refractory thyroid cancer.

            Lenvatinib, an oral inhibitor of vascular endothelial growth factor receptors 1, 2, and 3, fibroblast growth factor receptors 1 through 4, platelet-derived growth factor receptor α, RET, and KIT, showed clinical activity in a phase 2 study involving patients with differentiated thyroid cancer that was refractory to radioiodine (iodine-131).
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              Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial.

              Patients with radioactive iodine ((131)I)-refractory locally advanced or metastatic differentiated thyroid cancer have a poor prognosis because of the absence of effective treatment options. In this study, we assessed the efficacy and safety of orally administered sorafenib in the treatment of patients with this type of cancer. In this multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (DECISION), we investigated sorafenib (400 mg orally twice daily) in patients with radioactive iodine-refractory locally advanced or metastatic differentiated thyroid cancer that had progressed within the past 14 months. Adult patients (≥18 years of age) with this type of cancer were enrolled from 77 centres in 18 countries. To be eligible for inclusion, participants had to have at least one measurable lesion by CT or MRI according to Response Evaluation Criteria In Solid Tumors (RECIST); Eastern Cooperative Oncology Group performance status 0-2; adequate bone marrow, liver, and renal function; and serum thyroid-stimulating hormone concentration lower than 0·5 mIU/L. An interactive voice response system was used to randomly allocate participants in a 1:1 ratio to either sorafenib or matching placebo. Patients, investigators, and the study sponsor were masked to treatment assignment. The primary endpoint was progression-free survival, assessed every 8 weeks by central independent review. Analysis was by intention to treat. Patients in the placebo group could cross over to open-label sorafenib upon disease progression. Archival tumour tissue was examined for BRAF and RAS mutations, and serum thyroglobulin was measured at baseline and at each visit. This study is registered with ClinicalTrials.gov, number NCT00984282, and with the EU Clinical Trials Register, number EudraCT 2009-012007-25. Patients were randomly allocated on a 1:1 basis to sorafenib or placebo. The intention-to-treat population comprised 417 patients (207 in the sorafenib group and 210 in the placebo group) and the safety population was 416 patients (207 in the sorafenib group and 209 in the placebo group). Median progression-free survival was significantly longer in the sorafenib group (10·8 months) than in the placebo group (5·8 months; hazard ratio [HR] 0·59, 95% CI 0·45-0·76; p<0·0001). Progression-free survival improved in all prespecified clinical and genetic biomarker subgroups, irrespective of mutation status. Adverse events occurred in 204 of 207 (98·6%) patients receiving sorafenib during the double-blind period and in 183 of 209 (87·6%) patients receiving placebo. Most adverse events were grade 1 or 2. The most frequent treatment-emergent adverse events in the sorafenib group were hand-foot skin reaction (76·3%), diarrhoea (68·6%), alopecia (67·1%), and rash or desquamation (50·2%). Sorafenib significantly improved progression-free survival compared with placebo in patients with progressive radioactive iodine-refractory differentiated thyroid cancer. Adverse events were consistent with the known safety profile of sorafenib. These results suggest that sorafenib is a new treatment option for patients with progressive radioactive iodine-refractory differentiated thyroid cancer. Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals (an Amgen subsidiary). Copyright © 2014 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                Journal
                World J Clin Cases
                WJCC
                World Journal of Clinical Cases
                Baishideng Publishing Group Inc
                2307-8960
                26 October 2020
                26 October 2020
                : 8
                : 20
                : 4883-4894
                Affiliations
                Division of Urology, Department of Surgery, Tungs' Taichung MetroHarbor Hospital, Taichung City 435403, Taiwan
                Division of General Surgery, Department of Surgery, Tungs' Taichung MetroHarbor Hospital, Taichung City 435403, Taiwan
                Division of Urology, Department of Surgery, Tungs' Taichung MetroHarbor Hospital, Taichung City 435403, Taiwan. tung12197@ 123456gmail.com
                Division of Urology, Department of Surgery, Tungs' Taichung MetroHarbor Hospital, Taichung City 435403, Taiwan
                Division of Urology, Department of Surgery, Tungs' Taichung MetroHarbor Hospital, Taichung City 435403, Taiwan
                Division of Urology, Department of Surgery, Tungs' Taichung MetroHarbor Hospital, Taichung City 435403, Taiwan
                Author notes

                Author contributions: Yang CH was the primary care of this case and responsible for the original draft; Chen KT was the primary surgeon of him and consulted Lin YS, urologist, for adverse effects from lenvatinib; Chen KT and Lin YS were both responsible for reviewing this draft; Ou YC provided comments to this literature; Hsu CY and Tung MC were responsible for the important intellectual content and supervisor; informed consent was conducted by Chen KT.

                Corresponding author: Yi Sheng Lin, MD, Attending Doctor, Surgeon, Surgical Oncologist, Division of Urology, Department of Surgery, Tungs' Taichung Metroharbor Hospital, No. 699 Sec. 8, Taiwan Blvd., Wuqi District, Taichung City 435403, Taiwan. tung12197@ 123456gmail.com

                Article
                jWJCC.v8.i20.pg4883
                10.12998/wjcc.v8.i20.4883
                7642543
                33195657
                b557a2df-d99f-4a6f-a0fe-330a97c59017
                ©The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights reserved.

                This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial.

                History
                : 17 July 2020
                : 28 August 2020
                : 16 September 2020
                Categories
                Case Report

                molecular targeted therapy/methods,receptors,vascular endothelial growth factor/drug effects,vascular endothelial growth factor/therapeutic use,vascular endothelial growth factor a/drug effects,nephrotic syndrome/drug therapy,case report

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