Phase II Trial of Sorafenib in Metastatic Thyroid Cancer

Kloos, Richard T.; Ringel, Matthew D.; Knopp, Michael V.; Hall, Nathan C.; King, Mark A.; Stevens, Robert C.; Ji, Liang; Wakely, Paul E.; Vasko, Vasyl; Saji, Motoyasu; Rittenberry, Jennifer; Wei, Lai; Arbogast, Daria; Collamore, Minden; Wright, John J.; Grever, Michael R.; Shah, Manisha H.

doi:10.1200/jco.2008.18.2717

Cited by 505 publications

(361 citation statements)

References 31 publications

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“…New smallmolecule protein-kinase inhibitors including axitinib [259], sorafenib [260,284,285], motesanib [262] and pazopanib [264] have shown promise in clinical trials on thyroid cancer. PLX4032 (also known as vemurafenib), a BRAF-V600E-specific inhibitor, has been recently approved by the FDA for the treatment of BRAFV600E-positive melanoma [286].…”

Section: Discussionmentioning

confidence: 99%

An update on molecular biology of thyroid cancers

Ömür

Baran

2014

Critical Reviews in Oncology/Hematology

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Section: Discussionmentioning

confidence: 99%

An update on molecular biology of thyroid cancers

Ömür

Baran

2014

Critical Reviews in Oncology/Hematology

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“…Our study results might also be pertinent to therapeutic decision-making. There is growing evidence that BRAF mutation-targeted therapy (sorafenib) is effective in metastatic or advanced thyroid cancer [26][27][28]. There was also a report that in iodine-refractory differentiated thyroid cancer, an early 18 F-FDG PET response was useful for identifying sorafenib non-responders, although no BRAF mutation analysis was performed in those patients [29].…”

Section: Discussionmentioning

confidence: 99%

Association Between 18F-FDG Avidity and the BRAF Mutation in Papillary Thyroid Carcinoma

Lee

Han

Lee

et al. 2015

Nucl Med Mol Imaging

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Purpose The BRAF mutation, a potential prognostic factor in papillary thyroid carcinoma (PTC), is associated with a high expression of the glucose transporter gene. We investigated which clinicopathologic factors, including BRAF mutation status, influence 18 F-fluoro-2-deoxyglucose ( 18 F-FDG) avidity. Methods We retrospectively reviewed 55 patients who underwent BRAF analysis from biopsy-confirmed PTC and 18 F-FDG positron emission tomography/computed tomography within 6 months before undergoing thyroid surgery from September 2008 to August 2014. Tumors were considered to be 18 F-FDG avid if the uptake was greater than that of the liver. 18 F-FDG uptake of PTCs was also analyzed semiquantitatively using SUV max . The association between 18 F-FDG avidity and clinicopathologic variables (age, tumor size, perithyroidal extension, cervical lymph node status, and BRAF mutation status) was investigated. Results Twenty-nine (52.7 %) of 55 patients had 18 F-FDGavid PTCs. PTCs with the BRAF mutation showed higher 18 F-FDG avidity (24/38, 63.2 %) than those without (5/17, 29.4 %). The BRAF mutation (p=0.025) and tumor size (p= 0.003) were significantly associated with 18 F-FDG avidity in univariate analysis, and the BRAF mutation status remained significant after adjusting for tumor size in multivariate analysis (p=0.015). In the subgroup of tumor size≥1 cm, the BRAF mutation was the only factor significantly associated with 18 F-FDG avidity (p=0.021). The mean SUV max of PTCs with the BRAF mutation was significantly higher than that of those without (4.89±6.12 vs. 1.96±1.10, p=0.039). Conclusions The BRAF mutation must be one of the most important factors influencing 18 F-FDG avidity in PTCs, especially in those with a tumor size≥1 cm.

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“…These findings have suggested that sorafenib may significantly improve outcomes in patients with DTC. Several Phase II trials have assessed the effects of sorafenib monotherapy in over 200 patients with thyroid cancer, most with DTC, with other patients having medullary and anaplastic carcinomas (14)(15)(16)(17)(18)(19)(20). The median progression-free survival (PFS) ranged from 14 to 24 months, with PR rates as high as 38%, and disease control rates (defined as SD plus PR) of 59%-100%.…”

Section: Adverse Eventsmentioning

confidence: 99%

Response to sorafenib treatment in advanced metastatic thyroid cancer

Pitoia

2014

Arq Bras Endocrinol Metab

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Objective: To investigate the efficacy of sorafenib in progressive radioiodine resistant metastatic thyroid carcinoma. Subjects and methods: Off-label observational study. Sorafenib 400 mg twice daily was evaluated. Therapy duration was 12 ± 3 months (range 6-16 months). Results: Eight patients were included (seven papillary, one insular variant). The eight patients meeting study criteria received sorafenib 400 mg orally twice a day until disease progression or unacceptable toxicity developed. One patient showed a partial response with tumor regression of -35%, six months after the beginning of the treatment; five patients exhibited stable disease and two patients had progressive disease and died. Thyroglobulin decreased within 4 weeks in all patients by 50% ± 23%. Adverse events: one patient had heart failure, and recovered after sorafenib withdrawal. However, she died five months later of sudden death. Conclusion: These data suggest a possible role for sorafenib in the treatment of progressive metastatic DTC. Adverse event are usually manageable, but severe ones may appear and these patients should be strictly controlled. Arq Bras Endocrinol Metab. 2014;58(1):37-41 Keywords Metastasis; sorafenib; thyroid; cancer RESUMO Objetivo: Investigar a eficácia do sorafenibe no carcinoma de tireoide metastático progressivo e refratário à iodoterapia. Sujeitos e métodos: Estudo observacional do efeito do sorafenibe off-label administrado 400 mg duas vezes ao dia. A duração da terapia foi de 12 ± 3 meses (variação de 6-16 meses). Resultados: Oito pacientes foram incluídos (sete com variante papilífera e um com variante insular). Os oito pacientes que preencheram os critérios do estudo receberam o sorafenibe 400 mg por via oral duas vezes por dia até progressão da doença ou toxicidade inaceitável. Um paciente apresentou uma resposta parcial com regressão tumoral da lesão alvo de 35% seis meses após o início do tratamento; cinco pacientes apresentaram doença estável e dois pacientes progrediram e morreram. A tireoglobulina diminuiu 50% ± 23% em 4 semanas em todos os pacientes. Eventos adversos: um paciente teve insuficiência cardíaca e morreu por morte súbita cinco meses após a retirada do sorafenibe. Conclusão: Esses dados sugerem um possível papel para sorafenibe para o tratamento do CDT metastático progressivo. Arq Bras Endocrinol Metab. 2014;58(1):37-41Descritores

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Phase II Trial of Sorafenib in Metastatic Thyroid Cancer

Abstract: Sorafenib is reasonably well-tolerated therapy with clinical and biologic antitumor activity in metastatic PTC.

Cited by 505 publications

References 31 publications

An update on molecular biology of thyroid cancers

An update on molecular biology of thyroid cancers

Association Between 18F-FDG Avidity and the BRAF Mutation in Papillary Thyroid Carcinoma

Response to sorafenib treatment in advanced metastatic thyroid cancer

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