Abstract | BACKGROUND: METHODS: In this single-institution, phase 2 study, 36 patients with metastatic, radioactive iodine-refractory thyroid carcinoma of follicular origin received treatment with the combination of oral sorafenib (200 mg twice daily) and intravenous temsirolimus (25 mg weekly). The receipt of prior systemic treatment with cytotoxic chemotherapy and targeted therapy, including sorafenib, was permitted. The primary endpoint was the radiographic response rate. RESULTS: The best response was a partial response in 8 patients (22%), stable disease in 21 (58%), and progressive disease in 1 (3%). Six patients were not evaluable for a response. Patients who had received any prior systemic treatment had a response rate of 10% compared with 38% of those who had not received prior systemic treatment. One of 2 patients with anaplastic thyroid cancer had an objective response. The progression-free survival rate at 1 year was 30.5%. The most common grade 3 and 4 toxicities associated with sorafenib and temsirolimus included hyperglycemia, fatigue, anemia, and oral mucositis. CONCLUSIONS:
Sorafenib and temsirolimus appear to be an active combination in patients with radioactive iodine-refractory thyroid carcinoma, especially in patients who received no prior treatment compared with historic data from single-agent sorafenib. Activity is also observed in patients who previously received sorafenib. This regimen warrants further investigation. Cancer 2017;123:4114-4121. © 2017 American Cancer Society.
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Authors | Eric J Sherman, Lara A Dunn, Alan L Ho, Shrujal S Baxi, Ronald A Ghossein, Matthew G Fury, Sofia Haque, Cami S Sima, Grace Cullen, James A Fagin, David G Pfister |
Journal | Cancer
(Cancer)
Vol. 123
Issue 21
Pg. 4114-4121
(Nov 01 2017)
ISSN: 1097-0142 [Electronic] United States |
PMID | 28662274
(Publication Type: Clinical Trial, Phase II, Journal Article)
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Copyright | © 2017 American Cancer Society. |
Chemical References |
- Antineoplastic Agents
- Iodine Radioisotopes
- Phenylurea Compounds
- Niacinamide
- temsirolimus
- Sorafenib
- BRAF protein, human
- Proto-Oncogene Proteins B-raf
- Sirolimus
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Topics |
- Adenocarcinoma, Follicular
(drug therapy, genetics, pathology, radiotherapy)
- Adult
- Aged
- Aged, 80 and over
- Antineoplastic Agents
(adverse effects, therapeutic use)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Disease-Free Survival
- Drug Administration Schedule
- Female
- Humans
- Iodine Radioisotopes
(therapeutic use)
- Male
- Middle Aged
- Mutation
- Niacinamide
(administration & dosage, adverse effects, analogs & derivatives)
- Phenylurea Compounds
(administration & dosage, adverse effects)
- Proto-Oncogene Proteins B-raf
(genetics)
- Radiation Tolerance
- Sirolimus
(administration & dosage, adverse effects, analogs & derivatives)
- Sorafenib
- Thyroid Neoplasms
(drug therapy, genetics, pathology, radiotherapy)
- Treatment Outcome
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