Sorafenib for the treatment of Progressive Metastatic Medullary Thyroid Cancer: Efficacy and Safety Analysis.

Sorafenib for the treatment of Progressive Metastatic Medullary Thyroid Cancer: Efficacy and Safety Analysis.

Thyroid. 2015 Dec 23;

Authors: Castroneves LA, Negrao MV, Freitas RM, Papadia C, Lima Junior JV, Fukushima J, Simao EF, Kulcsar MA, Tavares M, Jorge AA, Castro G, Hoff PM, Hoff AO

Abstract
BACKGROUND: Treatment of advanced medullary thyroid carcinoma (MTC) was recently improved with the approval of vandetanib and cabozantinib. However, there is still a need to explore sequential therapy with more than one tyrosine kinase inhibitor (TKI) and to explore alternative therapies when vandetanib and cabozantinib are not available. In this paper, we report our experience with sorafenib as a treatment for advanced medullary thyroid cancer.
METHODS: This is a retrospective longitudinal study of thirteen patients with progressive metastatic MTC treated with sorafenib 400 mg twice daily between December 2011 and January 2015. The primary endpoints were to evaluate response and progression free survival (PFS) in patients treated with sorafenib outside a clinical trial. Secondary endpoint was assessment of toxicity profile. One patient was excluded because of a serious allergic skin rash after 1 week of starting sorafenib.
RESULTS: The analysis included 12 patients with metastatic MTC (median age 48 years), 10 with sporadic and 2 with hereditary disease. The median duration of treatment was 11 months and the median follow-up was 15.5 months. At data cutoff, 2 (16%) of 12 patients were still on treatment for 16 and 34 months. According to RECIST analysis, 10 patients (83.3%) showed stable disease and 2 (16.6%) had progression of disease, no partial response was observed. The median PFS was 9 months; however, three patients with extensive and rapidly progressive disease died within 3 months of sorafenib treatment. The median PFS excluding these 3 patients was 12 months. Adverse events (AE) occurred in 9 patients (75%). The main AEs were skin toxicity, weight loss and fatigue. Five (41.6%) patients needed dose reduction, and one patient discontinued treatment for toxicity.
CONCLUSIONS: Treatment with sorafenib in progressive metastatic MTC is well tolerated and resulted in disease control and durable clinical benefit in 75% of patients. Sorafenib treatment could be considered when vandetanib and cabozantinib are not available or after failing these drugs.

PMID: 26701095 [PubMed - as supplied by publisher]

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