Phase II trial of sorafenib in patients with advanced thyroid cancer.

Keefe, Stephen Michael; Troxel, Andrea B.; Rhee, Sang Youl; Puttaswamy, Kanchan; O’Dwyer, P. J.; Loevner, Laurie A.; Brose, Marcia S.

doi:10.1200/jco.2011.29.15_suppl.5562

Cited by 24 publications

(23 citation statements)

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“…Tumor response, however, was not affected by dose reductions. Toxicities observed in our study were mostly grades 1 and 2 and similar to those reported in the other phase II trials of sorafenib (21,22,23,28,29). A long-term safety evaluation of sorafenib in advanced renal cell carcinoma showed similar results, supporting our findings (30).…”

Section: Discussionsupporting

confidence: 92%

“…Results of an update of a phase II study on sorafenib, reported at the 2011 ASCO Annual Meeting by Brose et al, showed a PFS of 24 months and an OS of 35 months in 47 patients with DTC and poorly differentiated thyroid cancer (PD; nZ55). A PR was achieved in 38% of patients and 47% had SD (21). Another phase II study in mainly patients with advanced DTC (nZ30) reported a PR rate of 23%, an SD rate of 53%, and a median PFS of 20 months (22).…”

Section: Introductionmentioning

confidence: 97%

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Long-term analysis of the efficacy and tolerability of sorafenib in advanced radio-iodine refractory differentiated thyroid carcinoma: final results of a phase II trial

Schneider

Abdulrahman

Corssmit

et al. 2012

European Journal of Endocrinology

116

123

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Objective: We conducted a prospective phase II clinical trial to determine the efficacy of sorafenib in patients with advanced radio-iodine refractory differentiated thyroid cancer. In this article, the long-term results are presented. Patients and methods: Thirty-one patients with progressive metastatic or locally advanced radioactive iodine refractory differentiated thyroid cancer received sorafenib 400 mg orally twice daily. The study end points included response rate, progression-free survival (PFS), overall survival (OS), best response by Response Evaluation Criteria in Solid Tumors criteria 1.0, and toxicity. Results: Median PFS was 18 months (95% confidence interval (95% CI): 7-29 months) and median OS was 34.5 months (95% CI: 19-50 months). Eight patients (31%) achieved a partial response and 11 patients (42%) showed stable disease after a median follow-up of 25 months (range 3.5-39 months). Toxicity mostly included hand foot syndrome, weight loss, diarrhea, and rash. Conclusion: Sorafenib has clinically relevant antitumor activity in patients with progressive metastatic or locally advanced radio-iodine refractory differentiated thyroid cancer. Sorafenib can nowadays be considered as the standard option in these patients.

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Section: Discussionsupporting

confidence: 92%

Section: Introductionmentioning

confidence: 97%

Long-term analysis of the efficacy and tolerability of sorafenib in advanced radio-iodine refractory differentiated thyroid carcinoma: final results of a phase II trial

Schneider

Abdulrahman

Corssmit

et al. 2012

European Journal of Endocrinology

116

123

View full text Add to dashboard Cite

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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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“…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 (Table 1) [100][101][102][103][104]. The median PFS ranged from 58 to 96 weeks, with PR rates as high as 38% and disease control rates (defined as SD plus PR) of 59-100%.…”

Section: Sorafenibmentioning

confidence: 99%