Tertiary Care Experience of Sorafenib in the Treatment of Progressive Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Korean Multicenter Study.

Tertiary Care Experience of Sorafenib in the Treatment of Progressive Radioiodine-Refractory Differentiated Thyroid Carcinoma: A Korean Multicenter Study.

Thyroid. 2018 Jan 19;:

Authors: Kim M, Kim TH, Shin DY, Lim DJ, Kim EY, Kim WB, Chung JH, Shong Y, Kim BH, Kim WG

Abstract
BACKGROUND: Sorafenib, a multi-kinase inhibitor, is approved for the treatment of patients with radioactive iodine (RAI)-refractory differentiated thyroid cancer (DTC). In this study, we evaluated the efficacy and safety of sorafenib in real-world clinical practice and compared the results with those of the DECISION trial. We also evaluated the clinical features associated with better clinical outcomes after sorafenib treatment.
METHODS: This multicenter, retrospective cohort study evaluated 98 patients with progressive RAI-refractory DTC who were treated with sorafenib in six tertiary hospitals in Korea. The primary objective was the progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1. Overall survival (OS), response rate (defined as the best objective response according to RECIST), and safety were also evaluated.
RESULTS: The median PFS was 9.7 months; median OS was not reached during follow-up. Partial responses and stable disease (SD) were achieved in 25 (25%) and 64 (65%) patients, respectively. A SD more than 6 months was achieved by 41 patients (42%). In subgroup analysis, we identified several prognostic indicators of a better PFS: absence of disease-related symptoms (hazard ratio [HR]=0.5, p=0.041), lung-only metastasis (HR=0.4, p =0.048); a daily maintenance dose ≥ 600 mg (HR=0.3, p=0.005), and a thyroglobulin (Tg) reduction ≥ 60% (HR=0.4, p=0.012). The mean daily dose of sorafenib was 666 ± 114 mg and drug withdrawals due to adverse events (AEs) occurred in 13% of patients. AEs and serious AEs were reported in 93 (95%) and 40 (41%) patients, respectively. The most frequent AE was hand-foot skin reaction (76%).
CONCLUSIONS: The PFS of progressive RAI-refractory DTC patients treated with sorafenib was consistent with the findings of the DECISION trial. Disease-related symptom, lung-only metastasis, a daily maintenance dose, and Tg reduction were significantly associated with PFS. These results suggest that sorafenib is an effective treatment option for patients with progressive RAI-refractory DTC.

PMID: 29350109 [PubMed - as supplied by publisher]

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