Real-World Data for Lenvatinib in Radioiodine-Refractory Differentiated Thyroid Cancer (RELEVANT): A Retrospective Multicentric Analysis of Clinical Practice in Austria
Background. Lenvatinib has proven efficacy in progressive, radioiodine- (RAI-) refractory thyroid cancer (TC). Dose reductions are commonly performed due to decreased tolerability and adverse effects. This retrospective multicenter study analyzed overall survival (OS) and progression-free survival (...
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| Published in | International journal of endocrinology Vol. 2020; no. 2020; pp. 1 - 8 |
|---|---|
| Main Authors | , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Cairo, Egypt
Hindawi Publishing Corporation
2020
Hindawi John Wiley & Sons, Inc Wiley |
| Subjects | |
| Online Access | Get full text |
| ISSN | 1687-8337 1687-8345 |
| DOI | 10.1155/2020/8834148 |
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| Abstract | Background. Lenvatinib has proven efficacy in progressive, radioiodine- (RAI-) refractory thyroid cancer (TC). Dose reductions are commonly performed due to decreased tolerability and adverse effects. This retrospective multicenter study analyzed overall survival (OS) and progression-free survival (PFS) and tolerability in the Austrian patient population treated with lenvatinib. Methods. Clinical data of 43 patients (25 males and 18 females) with a median age of 70 years (range: 39–91 years) and RAI-refractory TC with metastases to the lymph nodes (74%), lungs (86%), bone (35%), liver (16%), and brain (12%) were analyzed. The mean duration of treatment with lenvatinib was 26.6 ± 15.4 months with dosage reductions required in 39 patients (91%). Results. PFS after 24 months was 71% (95% CI: 56–87), and overall survival (OS) was 74% (95% CI: 60–88), respectively. OS was significantly shorter (p=0.048) in patients with a daily maintenance dosage ≤ 10 mg (63%) (95% CI: 39–86) as compared to patients on ≥ 14 mg lenvatinib (82%) (95% CI: 66–98) daily. Dose reduction was noted in 39 patients (91%). Grade ≥3 toxicities (hypertension, diarrhea, weight loss, and palmar-plantar erythrodysesthesia syndrome) were most common leading to discontinuation of lenvatinib in 7 patients (16%). Conclusion. Lenvatinib showed sustained clinical efficacy in patients with metastatic RAI-refractory TC even with reduced maintenance dosages over years. The effects were comparable to the registration trial, although patients had a higher median age and, more commonly, dose reductions. |
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| AbstractList | Background. Lenvatinib has proven efficacy in progressive, radioiodine- (RAI-) refractory thyroid cancer (TC). Dose reductions are commonly performed due to decreased tolerability and adverse effects. This retrospective multicenter study analyzed overall survival (OS) and progression-free survival (PFS) and tolerability in the Austrian patient population treated with lenvatinib. Methods. Clinical data of 43 patients (25 males and 18 females) with a median age of 70 years (range: 39–91 years) and RAI-refractory TC with metastases to the lymph nodes (74%), lungs (86%), bone (35%), liver (16%), and brain (12%) were analyzed. The mean duration of treatment with lenvatinib was 26.6 ± 15.4 months with dosage reductions required in 39 patients (91%). Results. PFS after 24 months was 71% (95% CI: 56–87), and overall survival (OS) was 74% (95% CI: 60–88), respectively. OS was significantly shorter (p=0.048) in patients with a daily maintenance dosage ≤ 10 mg (63%) (95% CI: 39–86) as compared to patients on ≥ 14 mg lenvatinib (82%) (95% CI: 66–98) daily. Dose reduction was noted in 39 patients (91%). Grade ≥3 toxicities (hypertension, diarrhea, weight loss, and palmar-plantar erythrodysesthesia syndrome) were most common leading to discontinuation of lenvatinib in 7 patients (16%). Conclusion. Lenvatinib showed sustained clinical efficacy in patients with metastatic RAI-refractory TC even with reduced maintenance dosages over years. The effects were comparable to the registration trial, although patients had a higher median age and, more commonly, dose reductions. Lenvatinib has proven efficacy in progressive, radioiodine- (RAI-) refractory thyroid cancer (TC). Dose reductions are commonly performed due to decreased tolerability and adverse effects. This retrospective multicenter study analyzed overall survival (OS) and progression-free survival (PFS) and tolerability in the Austrian patient population treated with lenvatinib. Clinical data of 43 patients (25 males and 18 females) with a median age of 70 years (range: 39-91 years) and RAI-refractory TC with metastases to the lymph nodes (74%), lungs (86%), bone (35%), liver (16%), and brain (12%) were analyzed. The mean duration of treatment with lenvatinib was 26.6 ± 15.4 months with dosage reductions required in 39 patients (91%). PFS after 24 months was 71% (95% CI: 56-87), and overall survival (OS) was 74% (95% CI: 60-88), respectively. OS was significantly shorter ( =0.048) in patients with a daily maintenance dosage ≤ 10 mg (63%) (95% CI: 39-86) as compared to patients on ≥ 14 mg lenvatinib (82%) (95% CI: 66-98) daily. Dose reduction was noted in 39 patients (91%). Grade ≥3 toxicities (hypertension, diarrhea, weight loss, and palmar-plantar erythrodysesthesia syndrome) were most common leading to discontinuation of lenvatinib in 7 patients (16%). Lenvatinib showed sustained clinical efficacy in patients with metastatic RAI-refractory TC even with reduced maintenance dosages over years. The effects were comparable to the registration trial, although patients had a higher median age and, more commonly, dose reductions. Background. Lenvatinib has proven efficacy in progressive, radioiodine- (RAI-) refractory thyroid cancer (TC). Dose reductions are commonly performed due to decreased tolerability and adverse effects. This retrospective multicenter study analyzed overall survival (OS) and progression-free survival (PFS) and tolerability in the Austrian patient population treated with lenvatinib. Methods. Clinical data of 43 patients (25 males and 18 females) with a median age of 70 years (range: 39-91 years) and RAI-refractory TC with metastases to the lymph nodes (74%), lungs (86%), bone (35%), liver (16%), and brain (12%) were analyzed. The mean duration of treatment with lenvatinib was 26.6±15.4 months with dosage reductions required in 39 patients (91%). Results. PFS after 24 months was 71% (95% CI: 56-87), and overall survival (OS) was 74% (95% CI: 60-88), respectively. OS was significantly shorter (p=0.048) in patients with a daily maintenance dosage≤10mg (63%) (95% CI: 39-86) as compared to patients on≥14mg lenvatinib (82%) (95% CI: 66-98) daily. Dose reduction was noted in 39 patients (91%). Grade ≥3 toxicities (hypertension, diarrhea, weight loss, and palmar-plantar erythrodysesthesia syndrome) were most common leading to discontinuation of lenvatinib in 7 patients (16%). Conclusion. Lenvatinib showed sustained clinical efficacy in patients with metastatic RAI-refractory TC even with reduced maintenance dosages over years. The effects were comparable to the registration trial, although patients had a higher median age and, more commonly, dose reductions. Lenvatinib has proven efficacy in progressive, radioiodine- (RAI-) refractory thyroid cancer (TC). Dose reductions are commonly performed due to decreased tolerability and adverse effects. This retrospective multicenter study analyzed overall survival (OS) and progression-free survival (PFS) and tolerability in the Austrian patient population treated with lenvatinib.BACKGROUNDLenvatinib has proven efficacy in progressive, radioiodine- (RAI-) refractory thyroid cancer (TC). Dose reductions are commonly performed due to decreased tolerability and adverse effects. This retrospective multicenter study analyzed overall survival (OS) and progression-free survival (PFS) and tolerability in the Austrian patient population treated with lenvatinib.Clinical data of 43 patients (25 males and 18 females) with a median age of 70 years (range: 39-91 years) and RAI-refractory TC with metastases to the lymph nodes (74%), lungs (86%), bone (35%), liver (16%), and brain (12%) were analyzed. The mean duration of treatment with lenvatinib was 26.6 ± 15.4 months with dosage reductions required in 39 patients (91%).METHODSClinical data of 43 patients (25 males and 18 females) with a median age of 70 years (range: 39-91 years) and RAI-refractory TC with metastases to the lymph nodes (74%), lungs (86%), bone (35%), liver (16%), and brain (12%) were analyzed. The mean duration of treatment with lenvatinib was 26.6 ± 15.4 months with dosage reductions required in 39 patients (91%).PFS after 24 months was 71% (95% CI: 56-87), and overall survival (OS) was 74% (95% CI: 60-88), respectively. OS was significantly shorter (p=0.048) in patients with a daily maintenance dosage ≤ 10 mg (63%) (95% CI: 39-86) as compared to patients on ≥ 14 mg lenvatinib (82%) (95% CI: 66-98) daily. Dose reduction was noted in 39 patients (91%). Grade ≥3 toxicities (hypertension, diarrhea, weight loss, and palmar-plantar erythrodysesthesia syndrome) were most common leading to discontinuation of lenvatinib in 7 patients (16%).RESULTSPFS after 24 months was 71% (95% CI: 56-87), and overall survival (OS) was 74% (95% CI: 60-88), respectively. OS was significantly shorter (p=0.048) in patients with a daily maintenance dosage ≤ 10 mg (63%) (95% CI: 39-86) as compared to patients on ≥ 14 mg lenvatinib (82%) (95% CI: 66-98) daily. Dose reduction was noted in 39 patients (91%). Grade ≥3 toxicities (hypertension, diarrhea, weight loss, and palmar-plantar erythrodysesthesia syndrome) were most common leading to discontinuation of lenvatinib in 7 patients (16%).Lenvatinib showed sustained clinical efficacy in patients with metastatic RAI-refractory TC even with reduced maintenance dosages over years. The effects were comparable to the registration trial, although patients had a higher median age and, more commonly, dose reductions.CONCLUSIONLenvatinib showed sustained clinical efficacy in patients with metastatic RAI-refractory TC even with reduced maintenance dosages over years. The effects were comparable to the registration trial, although patients had a higher median age and, more commonly, dose reductions. Background. Lenvatinib has proven efficacy in progressive, radioiodine- (RAI-) refractory thyroid cancer (TC). Dose reductions are commonly performed due to decreased tolerability and adverse effects. This retrospective multicenter study analyzed overall survival (OS) and progression-free survival (PFS) and tolerability in the Austrian patient population treated with lenvatinib. Methods. Clinical data of 43 patients (25 males and 18 females) with a median age of 70 years (range: 39–91 years) and RAI-refractory TC with metastases to the lymph nodes (74%), lungs (86%), bone (35%), liver (16%), and brain (12%) were analyzed. The mean duration of treatment with lenvatinib was 26.6 ± 15.4 months with dosage reductions required in 39 patients (91%). Results. PFS after 24 months was 71% (95% CI: 56–87), and overall survival (OS) was 74% (95% CI: 60–88), respectively. OS was significantly shorter ( p = 0.048 ) in patients with a daily maintenance dosage ≤ 10 mg (63%) (95% CI: 39–86) as compared to patients on ≥ 14 mg lenvatinib (82%) (95% CI: 66–98) daily. Dose reduction was noted in 39 patients (91%). Grade ≥3 toxicities (hypertension, diarrhea, weight loss, and palmar-plantar erythrodysesthesia syndrome) were most common leading to discontinuation of lenvatinib in 7 patients (16%). Conclusion. Lenvatinib showed sustained clinical efficacy in patients with metastatic RAI-refractory TC even with reduced maintenance dosages over years. The effects were comparable to the registration trial, although patients had a higher median age and, more commonly, dose reductions. |
| Audience | Academic |
| Author | Pirich, C. Trummer, C. Hitzl, W. Ardelt, M. Rendl, G. Raderer, M. Sipos, B. Sorko, S. Gallowitsch, H. J. Becherer, A. |
| AuthorAffiliation | 7 Department of Ophthalmology and Optometry, University Hospital Salzburg, Paracelsus Medical University Salzburg, Salzburg, Austria 8 Research Program Experimental Ophthalmology and Glaucoma Research, University Hospital Salzburg, Paracelsus Medical University Salzburg, Salzburg, Austria 6 Research Office (Biostatistics), Paracelsus Medical University Salzburg, Salzburg, Austria 2 Department of Nuclear Medicine, Academic Teaching Hospital Feldkirch, Feldkirch, Austria 1 Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Paracelsus Medical University Salzburg, Salzburg, Austria 4 Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria 5 Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria 9 Institute of Pharmacy, Paracelsus Medical University Salzburg, Salzburg, Austria 3 Department of Nuclear Medicine and Endocrinology, PET/CT Centre, Klinikum Klagenfurt |
| AuthorAffiliation_xml | – name: 7 Department of Ophthalmology and Optometry, University Hospital Salzburg, Paracelsus Medical University Salzburg, Salzburg, Austria – name: 9 Institute of Pharmacy, Paracelsus Medical University Salzburg, Salzburg, Austria – name: 5 Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, Vienna, Austria – name: 1 Department of Nuclear Medicine and Endocrinology, University Hospital Salzburg, Paracelsus Medical University Salzburg, Salzburg, Austria – name: 8 Research Program Experimental Ophthalmology and Glaucoma Research, University Hospital Salzburg, Paracelsus Medical University Salzburg, Salzburg, Austria – name: 2 Department of Nuclear Medicine, Academic Teaching Hospital Feldkirch, Feldkirch, Austria – name: 6 Research Office (Biostatistics), Paracelsus Medical University Salzburg, Salzburg, Austria – name: 3 Department of Nuclear Medicine and Endocrinology, PET/CT Centre, Klinikum Klagenfurt am Wörthersee, Klagenfurt, Austria – name: 4 Division of Endocrinology and Diabetology, Department of Internal Medicine, Medical University of Graz, Graz, Austria |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/33312196$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | Copyright © 2020 G. Rendl et al. COPYRIGHT 2020 John Wiley & Sons, Inc. Copyright © 2020 G. Rendl et al. This work is licensed under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. Copyright © 2020 G. Rendl et al. 2020 |
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| References_xml | – ident: 2 – ident: 26 doi: 10.1089/thy.2019.0221 – ident: 36 doi: 10.1007/s10637-014-0181-7 – ident: 31 doi: 10.1089/thy.2019.0355 – ident: 34 doi: 10.1002/jcph.917 – ident: 39 doi: 10.1007/s00280-015-2899-0 – volume: 54 start-page: 125 year: 2015 ident: 6 article-title: Treatment of patients with radioiodine refractory, differentiated thyroid carcinoma. A Consensus Statement] publication-title: Nuklearmedizin – ident: 35 doi: 10.1007/s10637-016-0342-y – ident: 28 doi: 10.7150/jca.22318 – ident: 41 doi: 10.1038/srep28081 – ident: 7 doi: 10.1007/s00259-008-0883-1 – ident: 18 doi: 10.1056/nejmoa1406470 – ident: 10 doi: 10.1210/jc.2005-2838 – ident: 37 doi: 10.1158/1078-0432.ccr-15-1354 – ident: 21 doi: 10.2967/jnumed.108.057307 – ident: 33 doi: 10.1016/s0140-6736(18)30207-1 – ident: 15 doi: 10.1155/2014/638747 – ident: 11 doi: 10.1089/thy.2015.0020 – ident: 25 doi: 10.1089/thy.2017.0205 – volume: 30 start-page: 639 issue: 8 year: 2013 ident: 43 article-title: Value of 18F-FDG-PET/PET-CT in differentiated thyroid carcinoma with radioiodine-negative whole-body scan: a meta-analysis publication-title: Nucl Med Commun doi: 10.1097/MNM.0b013e32832dcfa7 – ident: 8 doi: 10.1155/2012/618985 – volume-title: Lenvima (Lenvatinib) Capsules, for Oral Use [Package Insert] year: 2017 ident: 17 – ident: 22 – ident: 44 doi: 10.1210/jc.2005-1534 – ident: 32 doi: 10.1007/s12020-017-1233-5 – ident: 9 doi: 10.1016/s2213-8587(13)70215-8 – ident: 4 doi: 10.1016/s0140-6736(16)30172-6 – ident: 23 doi: 10.1530/erc-18-0049 – ident: 24 doi: 10.1016/j.ejca.2019.05.031 – ident: 1 – ident: 12 doi: 10.1007/s40618-018-0884-2 – ident: 42 doi: 10.1016/j.ejca.2017.01.013 – ident: 3 doi: 10.1155/2012/847108 – ident: 5 doi: 10.1007/s00508-017-1207-x – ident: 13 doi: 10.1016/s0140-6736(14)60421-9 – volume-title: Lenvima 4 Mg Hard Capsules [Summary of Product Characteristics] ident: 16 – ident: 38 doi: 10.1158/1078-0432.ccr-10-2638 – ident: 27 doi: 10.1530/eje-19-0763 – ident: 29 doi: 10.1007/s002590050234 – ident: 14 doi: 10.1002/ijc.23131 – volume: 7 issue: 1 year: 2016 ident: 19 article-title: A risk-adapted approach to follow-up in differentiated thyroid cancer publication-title: Rambam Maimonides Medical Journal doi: 10.5041/RMMJ.10231 – ident: 30 doi: 10.1200/jco.2016.71.6472 – ident: 40 doi: 10.1507/endocrj.ej17-0104 – ident: 20 doi: 10.1016/j.ejca.2008.10.026 |
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| Snippet | Background. Lenvatinib has proven efficacy in progressive, radioiodine- (RAI-) refractory thyroid cancer (TC). Dose reductions are commonly performed due to... Lenvatinib has proven efficacy in progressive, radioiodine- (RAI-) refractory thyroid cancer (TC). Dose reductions are commonly performed due to decreased... |
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| SubjectTerms | Ablation Age Blood pressure Cancer therapies Care and treatment Data collection Drug dosages Endocrinology Growth factors Hypertension Laboratories Liver cancer Lymphatic system Metastasis Nuclear medicine Patients Pazopanib Radiation therapy Survival analysis Thyroid cancer |
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| Title | Real-World Data for Lenvatinib in Radioiodine-Refractory Differentiated Thyroid Cancer (RELEVANT): A Retrospective Multicentric Analysis of Clinical Practice in Austria |
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