Long-term management of lenvatinib-treated thyroid cancer patients: a real-life experience at a single institution.
Lenvatinib
Long-term management
Real-life
Thyroid cancer
Tyrosine kinase inhibitors
Journal
Endocrine
ISSN: 1559-0100
Titre abrégé: Endocrine
Pays: United States
ID NLM: 9434444
Informations de publication
Date de publication:
08 2021
08 2021
Historique:
received:
05
11
2020
accepted:
18
01
2021
pubmed:
5
2
2021
medline:
20
7
2021
entrez:
4
2
2021
Statut:
ppublish
Résumé
The efficacy of lenvatinib for advanced and progressive radioactive iodine refractory differentiated thyroid cancer is well established. Herein, we retrospectively evaluated the long-term safety and efficacy of lenvatinib in 23 patients treated at a single Institution. Clinical data of all patients treated for a differentiated thyroid cancer with lenvatinib from April 2015 to September 2020 were retrospectively analyzed. A total of 23 patients were included. In all, 21 patients received lenvatinib as first-line systemic therapy. Median age at initiation of lenvatinib treatment was 68 (44-90) years. Median duration of the study from initiation of lenvatinib to study end was 23 (2-65) months. The indication for lenvatinib treatment was documented progression of distant metastases in 20 patients and of locally advanced disease in the other 3 and median duration of lenvatinib therapy was 15 (2-64) months. Best treatment responses were: partial response in 6 patients, stable disease in 14, progressive disease in 1, and not evaluable in 2. Median progression-free survival was 25 months (95% CI: 12-40) and median overall survival was 46 months (95% CI: 28-65). Three patients had to discontinue lenvatinib treatment due to serious adverse events and no drug-related death was observed. Ten patients continued lenvatinib for more than 24 months and the only newly registered adverse event after this period of time was one case of G2 proteinuria. Six patients continued lenvatinib treatment beyond documented tumor progression due to oligoprogression or slowly progressive disease (median time 18.5 months, 8-42 months). A total of 14 patients were alive at the end of the study: 11 showed partial response/stable disease on lenvatinib, including 3 who had a stable disease after local ablative therapy for oligoprogressive metastases; 3 had to change treatment, including 2 for lenvatinib-related serious adverse events and 1 for progressive disease. Long-term lenvatinib treatment is safe and some patients may experience persistent long-term control of the disease. Late treatment-related AEs rarely occurred. Oligoprogressive and slowly progressive disease can be managed without treatment withdrawal as long as there are some clinical benefits.
Identifiants
pubmed: 33537956
doi: 10.1007/s12020-021-02634-z
pii: 10.1007/s12020-021-02634-z
doi:
Substances chimiques
Antineoplastic Agents
0
Iodine Radioisotopes
0
Phenylurea Compounds
0
Protein Kinase Inhibitors
0
Quinolines
0
lenvatinib
EE083865G2
Banques de données
ClinicalTrials.gov
['NCT02303444']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
358-366Références
B.R. Haugen, E.K. Alexander, K.C. Bible, G. Doherty, S.J. Mandel, Y.E. Nikiforov, F. Pacini, G. Randolph, A. Sawka, M. Schlumberger, K.G. Schuff, S.I. Sherman, J.A. Sosa, D. Steward, R.M. Tuttle, L. Wartofsky, 2015 American Thyroid Association management guidelines for adult patients with thyroid nodules and differentiated thyroid cancer. Thyroid 26, 1–133 (2016)
doi: 10.1089/thy.2015.0020
L.J. Wirth, E. Sherman, B. Robinson, B. Solomon, H. Kang, J. Lorch, F. Worden, M. Brose, J. Patel, S. Leboulleux, Y. Godbert, F. Barlesi, J.C. Morris, T.K. Owonikoko, D.S.W. Tan, O. Gautschi, J. Weiss, C. de la Fouchardière, M.E. Burkard, J. Laskin, M.H. Taylor, M. Kroiss, J. Medioni, J.W. Goldman, T.M. Bauer, B. Levy, V.W. Zhu, N. Lakhani, V. Moreno, K. Ebata, M. Nguyen, D. Heirich, E.Y. Zhu, X. Huang, L. Yang, J. Kherani, S.M. Rothenberg, A. Drilon, V. Subbiah, M.H. Shah, M.E. Cabanillas, Efficacy of selpercatinib in RET-altered thyroid cancers. N. Engl. J. Med. 383, 825–835 (2020)
doi: 10.1056/NEJMoa2005651
S.P. Weitzman, S.I. Sherman, Novel drug treatments of progressive radioiodine-refractory differentiated thyroid cancer. Endocrinol. Metab. Clin. North Am. 48, 253–268 (2019)
doi: 10.1016/j.ecl.2018.10.009
M.S. Brose, C.M. Nutting, B. Jarzab, R. Elisei, S. Siena, L. Bastholt, C. de la Fouchardiere, F. Pacini, R. Paschke, Y.K. Shong, S.I. Sherman, J.W.A. Smit, J. Chung, C. Kappeler, C. Peña, I. Molnár, M. Schlumberger, Sorafenib in radioactive iodine-refractory, locally advanced or metastatic differentiated thyroid cancer: a randomised, double-blind, phase 3 trial. Lancet 384, 319–328 (2014)
doi: 10.1016/S0140-6736(14)60421-9
M. Schlumberger, M. Tahara, L.J. Wirth, B. Robinson, M.S. Brose, R. Elisei, M.A. Habra, K. Newbold, M.H. Shah, A.O. Hoff, A.G. Gianoukakis, N. Kiyota, M.H. Taylor, S.B. Kim, M.K. Krzyzanowska, C.E. Dutcus, B. de las Heras, J. Zhu, S.I. Sherman, Lenvatinib versus placebo in radioiodine-refractory thyroid cancer. N. Engl. J. Med. 372, 621–630 (2015)
doi: 10.1056/NEJMoa1406470
M.S. Brose, F.P. Worden, K.L. Newbold, M. Guo, A. Hurria, Effect of age on the efficacy and safety of lenvatinib in radioiodine-refractory differentiated thyroid cancer in the phase III SELECT trial. J. Clin. Oncol. 35, 2692–2699 (2017)
doi: 10.1200/JCO.2016.71.6472
L.D. Locati, A. Piovesan, C. Durante, M. Bregni, M.G. Castagna, S. Zovato, M. Giusti, T. Ibrahim, E. Puxeddu, G. Fedele, G. Pellegriti, G. Rinaldi, D. Giuffrida, F. Verderame, F. Bertolini, C. Bergamini, A. Nervo, G. Grani, S. Rizzati, S. Morelli, I. Puliafito, R. Elisei, Real-world efficacy and safety of lenvatinib: data from a compassionate use in the treatment of radioactive iodine-refractory differentiated thyroid cancer patients in Italy. Eur. J. Cancer 118, 35–40 (2019)
doi: 10.1016/j.ejca.2019.05.031
A. Berdelou, I. Borget, Y. Godbert, T. Nguyen, M.E. Garcia, C.N. Chougnet, A. Ferru, C. Buffet, O. Chabre, O. Huillard, S. Leboulleux, M. Schlumberger, Lenvatinib for the treatment of radioiodine-refractory thyroid cancer in real-life practice. Thyroid 28, 72–78 (2018)
doi: 10.1089/thy.2017.0205
E.K. Lee, S.M. Kim, B.H. Kim, M.J. Kim, D.J. Lim, M.H. Kim, D.Y. Shin, H.C. Kang, B.C. Ahn, S.W. Kim, H.Y. Ahn, Y.J. Park, Lesion-based evaluation predicts treatment response to lenvatinib for radioactive iodine-refractory differentiated thyroid cancer: a Korean Multicenter Retrospective Study. Thyroid 29, 1811–1819 (2019)
doi: 10.1089/thy.2019.0022
C. Masaki, K. Sugino, N. Saito, J. Akaishi, K. Hames, C. Tomoda, A. Suzuki, K. Matsuzu, T. Uruno, K. Ohkuwa, W. Kitagawa, M. Nagahama, K. Ito, Efficacy and limitations of lenvatinib therapy for radioiodine-refractory differentiated thyroid cancer: real-world experiences. Thyroid 30, 214–221 (2020)
doi: 10.1089/thy.2019.0221
M.D. Aydemirli, E. Kapiteijn, K.R.M. Ferrier, N. Ottevanger, T.P. Links, A.N.A. van der Horst-Schrivers, K.E. Broekman, R.H.H. Groenwold, J. Zwaveling, Effectiveness and toxicity of lenvatinib in refractory thyroid cancer: Dutch real-life data. Eur. J. Endocrinol. 182, 131–138 (2020)
doi: 10.1530/EJE-19-0763
E. Song, M. Kim, E.Y. Kim, B.H. Kim, D.Y. Shin, H.C. Kang, B.C. Ahn, W.B. Kim, Y.K. Shong, M.J. Jeon, D.J. Lim, Lenvatinib for radioactive iodine‐refractory differentiated thyroid carcinoma and candidate biomarkers associated with survival: a multicenter study in Korea. Thyroid 30, 732–738 (2020)
doi: 10.1089/thy.2019.0476
F. Jerkovich, I. Califano, F. Bueno, J.M. Carrera, R. Giglio, E. Abelleira, F. Pitoia, Real-life use of lenvatinib in patients with differentiated thyroid cancer: experience from Argentina. Endocrine 69, 142–148 (2020)
doi: 10.1007/s12020-020-02290-9
S. De Leo, M. Di Stefano, L. Persani, L. Fugazzola, C. Colombo, Lenvatinib as first-line treatment for advanced thyroid cancer: long progression-free survival. Endocrine. (2020). [Online ahead of print]
E.A. Eisenhauer, P. Therasse, J. Bogaerts, L.H. Schwartz, D. Sargent, R. Ford, J. Dancey, S. Arbuck, S. Gwyther, M. Mooney, L. Rubinstein, L. Shankar, L. Dodd, R. Kaplan, D. Lacombe, J. Verweij, New response evaluation criteria in solid tumors: revised RECIST guideline (version 1.1). Eur. J. Cancer 45, 228–247 (2009)
doi: 10.1016/j.ejca.2008.10.026
C. Resteghini, S. Cavalieri, D. Galbiati, R. Granata, S. Alfieri, C. Bergamini, P. Bossi, L. Licitra, L. Locati, Management of tyrosine kinase inhibitors (TKI) side effects in differentiated and medullary thyroid cancer patients. Best. Pract. Res. Clin. Endocrinol. Metab. 31, 349–361 (2017)
doi: 10.1016/j.beem.2017.04.012
T. Porcelli, F. Sessa, A. Caputo, C. Catalini, D. Salvatore, Teriparatide replacement therapy for hypoparathyroidism during treatment with lenvatinib for advanced thyroid cancer: a case report. Front. Endocrinol. (Lausanne) 9, 244 (2018)
doi: 10.3389/fendo.2018.00244
A.G. Gianoukakis, C.E. Dutcus, N. Batty, M. Guo, M. Baig, Prolonged duration of response in lenvatinib responders with thyroid cancer. Endocr. Relat. Cancer 25, 699–704 (2018)
doi: 10.1530/ERC-18-0049
B. Robinson, M. Schlumberger, L.J. Wirth, C.E. Dutcus, J. Song, M.H. Taylor, S.B. Kim, M.K. Krzyzanowska, J. Capdevila, S.I. Sherman, M. Tahara, Characterization of tumor size changes over time from the phase 3 study of lenvatinib in thyroid cancer. J. Clin. Endocrinol. Metab. 101, 4103–4109 (2016)
doi: 10.1210/jc.2015-3989
L. Fugazzola, R. Elisei, D. Fuhrer, B. Jarzab, S. Leboulleux, K. Newbold, J. Smit, 2019 European Thyroid Association guidelines for the treatment and follow-up of advanced radioiodine-refractory thyroid cancer. Eur. Thyroid J. 8, 227–245 (2019)
doi: 10.1159/000502229
M. Tahara, M.S. Brose, L.J. Wirth, T. Suzuki, H. Miyagishi, K. Fujino, C.E. Dutcus, A. Gianoukakis, Impact of dose interruption on the efficacy of lenvatinib in a phase 3 study in patients with radioiodine-refractory differentiated thyroid cancer. Eur. J. Cancer 106, 61–68 (2019)
doi: 10.1016/j.ejca.2018.10.002
R.I. Haddad, M. Schlumberger, L.J. Wirth, E.J. Sherman, M.H. Shah, B. Robinson, C.E. Dutcus, A. Teng, A.G. Gianoukakis, S.I. Sherman, Incidence and timing of common adverse events in Lenvatinib-treated patients from the SELECT trial and their association with survival outcomes. Endocrine 56, 121–128 (2017)
doi: 10.1007/s12020-017-1233-5
M.S. Brose, J. Smit, C.C. Lin, F. Pitoia, M. Fellous, Y. DeSanctis, M. Schlumberger, M. Tori, I. Sugitani, Timing of multikinase inhibitor initiation in differentiated thyroid cancer. Endocr. Relat. Cancer 24, 237–242 (2017)
doi: 10.1530/ERC-17-0016
D.R. Camidge, W. Pao, L.V. Sequist, Acquired resistance to TKIs in solid tumours: learning from lung cancer. Nat. Rev. Clin. Oncol. 11, 473–481 (2014)
doi: 10.1038/nrclinonc.2014.104
C. Giani, L. Valerio, A. Bongiovanni, C. Durante, G. Grani, T. Ibrahim, S. Mariotti, M. Massa, F. Pani, G. Pellegriti, T. Porcelli, D. Salvatore, M. Tavarelli, M. Torlontano, L. Locati, E. Molinaro, R. Elisei, Safety and quality of life data from an Italian expanded access program of lenvatinib for treatment of thyroid cancer. Thyroid. (2020). [Online ahead of print]
T. Porcelli, F. Sessa, C. Luongo, D. Salvatore, Local ablative therapy of oligoprogressive TKI-treated thyroid cancer. J. Endocrinol. Invest. 42, 871–879 (2019)
doi: 10.1007/s40618-019-1001-x