Efficacy and safety of anlotinib-based chemotherapy for locally advanced or metastatic anaplastic thyroid carcinoma

R.C. Smallridge, J.A. Copland, Anaplastic thyroid carcinoma: pathogenesis and emerging therapies. Clin. Oncol. (R. Coll. Radio.) 22, 486–497 (2010)

S.A. Hundahl, I.D. Fleming, A.M. Fremgen, H.R. Menck, A National Cancer Data Base report on 53,856 cases of thyroid carcinoma treated in the U.S., 1985-1995 [see commetns]. Cancer 83, 2638–2648 (1998)

H. Lim, S.S. Devesa, J.A. Sosa, D. Check, C.M. Kitahara, Trends in thyroid cancer incidence and mortality in the United States, 1974-2013. Jama 317, 1338–1348 (2017)

E. Kebebew, F.S. Greenspan, O.H. Clark, K.A. Woeber, A. McMillan, Anaplastic thyroid carcinoma. Treatment outcome and prognostic factors. Cancer 103, 1330–1335 (2005)

M.L. Carcangiu, T. Steeper, G. Zampi, J. Rosai, Anaplastic thyroid carcinoma. A study of 70 cases. Am. J. Clin. Pathol. 83, 135–158 (1985)

J. Akaishi, K. Sugino, W. Kitagawa, M. Nagahama, K. Kameyama et al. Prognostic factors and treatment outcomes of 100 cases of anaplastic thyroid carcinoma. Thyroid 21, 1183–1189 (2011)

R.C. Smallridge, K.B. Ain, S.L. Asa, K.C. Bible, J.D. Brierley et al. American Thyroid Association guidelines for management of patients with anaplastic thyroid cancer. Thyroid 22, 1104–1139 (2012)

B. Salehian, S.Y. Liem, H. Mojazi Amiri, E. Maghami, Clinical trials in management of anaplastic thyroid carcinoma; progressions and set backs: a systematic review. Int J. Endocrinol. Metab. 17, e67759 (2019)

E. Molinaro, C. Romei, A. Biagini, E. Sabini, L. Agate et al. Anaplastic thyroid carcinoma: from clinicopathology to genetics and advanced therapies. Nat. Rev. Endocrinol. 13, 644–660 (2017)

M.K. Gule, Y. Chen, D. Sano, M.J. Frederick, G. Zhou et al. Targeted therapy of VEGFR2 and EGFR significantly inhibits growth of anaplastic thyroid cancer in an orthotopic murine model. Clin. Cancer Res 17, 2281–2291 (2011)

K.C. Bible, E. Kebebew, J. Brierley, J.P. Brito, M.E. Cabanillas et al. 2021 American thyroid association guidelines for management of patients with anaplastic thyroid cancer. Thyroid 31, 337–386 (2021)

G. Shen, F. Zheng, D. Ren, F. Du, Q. Dong et al. Anlotinib: a novel multi-targeting tyrosine kinase inhibitor in clinical development. J. Hematol. Oncol. 11, 120 (2018)

Y. Gao, P. Liu, R. Shi, Anlotinib as a molecular targeted therapy for tumors. Oncol. Lett. 20, 1001–1014 (2020)

Q. Xu, J. Wang, Y. Sun, Y. Lin, J. Liu et al. Efficacy and safety of sintilimab plus anlotinib for PD-L1-positive recurrent or metastatic cervical cancer: a multicenter, single-arm, prospective phase II trial. J. Clin. Oncol. 40, 1795–1805 (2022)

B. Han, K. Li, Q. Wang, L. Zhang, J. Shi et al. Effect of anlotinib as a third-line or further treatment on overall survival of patients with advanced non-small cell lung cancer: the ALTER 0303 phase 3 randomized clinical trial. JAMA Oncol. 4, 1569–1575 (2018)

Z.M. Wang, R.Y. Zhuang, X. Guo, C.L. Zhang, Y. You et al. Anlotinib plus epirubicin followed by anlotinib maintenance as first-line treatment for advanced soft tissue sarcoma: an open-label, single-arm, phase 2 trial. Clin. Cancer Res. 28, 5290–5296 (2022).

Y. Sun, F. Du, M. Gao, Q. Ji, Z. Li et al. Anlotinib for the treatment of patients with locally advanced or metastatic medullary thyroid cancer. Thyroid 28, 1455–1461 (2018)

I. Landa, T. Ibrahimpasic, L. Boucai, R. Sinha, J.A. Knauf et al. Genomic and transcriptomic hallmarks of poorly differentiated and anaplastic thyroid cancers. J. Clin. Invest. 126, 1052–1066 (2016)

H. Duan, Y. Li, P. Hu, J. Gao, J. Ying et al. Mutational profiling of poorly differentiated and anaplastic thyroid carcinoma by the use of targeted next-generation sequencing. Histopathology 75, 890–899 (2019)

N. Pozdeyev, L.M. Gay, E.S. Sokol, R. Hartmaier, K.E. Deaver et al. Genetic analysis of 779 advanced differentiated and anaplastic thyroid cancers. Clin. Cancer Res. 24, 3059–3068 (2018)

X. Shi, R. Liu, S. Qu, G. Zhu, J. Bishop et al. Association of TERT promoter mutation 1,295,228 C>T with BRAF V600E mutation, older patient age, and distant metastasis in anaplastic thyroid cancer. J. Clin. Endocrinol. Metab. 100, E632–637 (2015)

K.T. Flaherty, J.R. Infante, A. Daud, R. Gonzalez, R.F. Kefford et al. Combined BRAF and MEK inhibition in melanoma with BRAF V600 mutations. N. Engl. J. Med 367, 1694–1703 (2012)

S.G. Waguespack, A. Drilon, J.J. Lin, M.S. Brose, R. McDermott et al. Efficacy and safety of larotrectinib in patients with TRK fusion-positive thyroid carcinoma. Eur. J. Endocrinol. 186, 631–643 (2022)

I. Damásio, J. Simões-Pereira, S. Donato, M. Horta, B.M. Cavaco et al. Entrectinib in the neoadjuvant setting of anaplastic thyroid cancer: a case report. Eur. Thyroid J. 12, e220179 (2022)

D. Hanahan, Hallmarks of cancer: new dimensions. Cancer Disco. 12, 31–46 (2022)

A. Sharma, J.F. Arambula, S. Koo, R. Kumar, H. Singh et al. Hypoxia-targeted drug delivery. Chem. Soc. Rev. 48, 771–813 (2019)

J. Folkman, Angiogenesis. Annu. Rev. Med. 57, 1–18 (2006)

M. Shibuya, Vascular endothelial growth factor (VEGF) and its receptor (VEGFR) signaling in angiogenesis: a crucial target for anti- and pro-angiogenic therapies. Genes Cancer 2, 1097–1105 (2011)

K. Sato, Vascular endothelial growth factors and thyroid disorders. Endocr. J. 48, 635–646 (2001)

R.K. Jain, Normalizing tumor vasculature with anti-angiogenic therapy: a new paradigm for combination therapy. Nat. Med. 7, 987–989 (2001)

R.T. Kloos, M.D. Ringel, M.V. Knopp, N.C. Hall, M. King et al. Phase II trial of sorafenib in metastatic thyroid cancer. J. Clin. Oncol. 27, 1675–1684 (2009)

V. Gupta-Abramson, A.B. Troxel, A. Nellore, K. Puttaswamy, M. Redlinger et al. Phase II trial of sorafenib in advanced thyroid cancer. J. Clin. Oncol. 26, 4714–4719 (2008)

P. Savvides, G. Nagaiah, P. Lavertu, P. Fu, J.J. Wright et al. Phase II trial of sorafenib in patients with advanced anaplastic carcinoma of the thyroid. Thyroid 23, 600–604 (2013)

Y. Ito, N. Onoda, K.I. Ito, I. Sugitani, S. Takahashi et al. Sorafenib in Japanese patients with locally advanced or metastatic medullary thyroid carcinoma and anaplastic thyroid carcinoma. Thyroid 27, 1142–1148 (2017)

E.J. Sherman, L.A. Dunn, A.L. Ho, S.S. Baxi, R.A. Ghossein et al. Phase 2 study evaluating the combination of sorafenib and temsirolimus in the treatment of radioactive iodine-refractory thyroid cancer. Cancer 123, 4114–4121 (2017)

O. Tohyama, J. Matsui, K. Kodama, N. Hata-Sugi, T. Kimura et al. Antitumor activity of lenvatinib (e7080): an angiogenesis inhibitor that targets multiple receptor tyrosine kinases in preclinical human thyroid cancer models. J. Thyroid Res. 2014, 638747 (2014)

S. Takahashi, N. Kiyota, T. Yamazaki, N. Chayahara, K. Nakano et al. A Phase II study of the safety and efficacy of lenvatinib in patients with advanced thyroid cancer. Future Oncol. 15, 717–726 (2019)

A. Ravaud, C. de la Fouchardière, P. Caron, A. Doussau, C. Do Cao et al. A multicenter phase II study of sunitinib in patients with locally advanced or metastatic differentiated, anaplastic or medullary thyroid carcinomas: mature data from the THYSU study. Eur. J. Cancer 76, 110–117 (2017)

C. Xie, X. Wan, H. Quan, M. Zheng, L. Fu et al. Preclinical characterization of anlotinib, a highly potent and selective vascular endothelial growth factor receptor-2 inhibitor. Cancer Sci. 109, 1207–1219 (2018)

X. Ruan, X. Shi, Q. Dong, Y. Yu, X. Hou et al. Antitumor effects of anlotinib in thyroid cancer. Endocr. Relat. Cancer 26, 153–164 (2019)

N.S. Huang, W.J. Wei, J. Xiang, J.Y. Chen, Q. Guan et al. The efficacy and safety of anlotinib in neoadjuvant treatment of locally advanced thyroid cancer: a single-arm phase II clinical trial. Thyroid 31, 1808–1813 (2021)

R.O. Wein, R.S. Weber, Anaplastic thyroid carcinoma: palliation or treatment? Curr. Opin. Otolaryngol. Head. Neck Surg. 19, 113–118 (2011)

R.K. Jain, Antiangiogenesis strategies revisited: from starving tumors to alleviating hypoxia. Cancer Cell 26, 605–622 (2014)