Luis Felipe Fierro-Maya1, Gloria Garavito González2,3, Leonardo Javier Rojas Melo2,4, Andrés Arturo Cuéllar Cuéllar2, Alexander Carreño5, Claudia Córdoba6. 1. Unidad de Endocrinología Oncológica, Instituto Nacional de Cancerología, Bogotá, Colombia, ffierro@cancer.gov.co. 2. Unidad de Endocrinología Oncológica, Instituto Nacional de Cancerología, Bogotá, Colombia. 3. Instituto Nacional de Cancerología, Endocrinóloga en Colsanitas, Bogotá, Colombia. 4. Servicio de Endocrinología, Hospital Universitario San Ignacio, Bogotá, Colombia. 5. Unidad de Investigaciones, Instituto Nacional de Cancerología, Bogotá, Colombia. 6. Unidad de Imágenes Diagnósticas, Instituto Nacional de Cancerología, Bogotá, Colombia.
Abstract
OBJECTIVE: Sorafenib significantly prolonged progression-free survival in patients with iodine-refractory advanced thyroid cancer. The present study was initiated before sorafenib was approved in Colombia and therefore represents an effort by an oncology institution to evaluate its efficacy and safety in this population. METHODS: This phase II clinical trial had a single treatment arm. We included adult patients with progressive metastatic iodine-refractory thyroid cancer who received treatment with sorafenib 800 mg/day (400 mg every 12 hours) up to a maximum of 24 months or until the occurrence of limiting related toxicity, the progression of the disease, or voluntary withdrawal. RESULTS: Nineteen patients received the treatment and were included in the safety analysis. However, for the efficacy analysis, 6 patients were excluded because they received only one month of therapy. Thirteen (68%) patients were women, and the mean age at diagnosis was 61.8 years. No complete responses were observed; 5 patients had a partial response (35.7%), 6 patients had stable disease, and 3 showed progression. Mean progression-free survival was calculated at 18 months (95% CI 10.7-20.3). Overall survival was estimated at 21.3 months (95% CI 17.8-24.8). CONCLUSION: For the first time in Colombia, the efficacy of sorafenib was evaluated in patients with advanced and progressive thyroid carcinoma refractory to radioactive iodine, with an efficacy and a safety profile similar to those previously reported.
OBJECTIVE: Sorafenib significantly prolonged progression-free survival in patients with iodine-refractory advanced thyroid cancer. The present study was initiated before sorafenib was approved in Colombia and therefore represents an effort by an oncology institution to evaluate its efficacy and safety in this population. METHODS: This phase II clinical trial had a single treatment arm. We included adult patients with progressive metastatic iodine-refractory thyroid cancer who received treatment with sorafenib 800 mg/day (400 mg every 12 hours) up to a maximum of 24 months or until the occurrence of limiting related toxicity, the progression of the disease, or voluntary withdrawal. RESULTS: Nineteen patients received the treatment and were included in the safety analysis. However, for the efficacy analysis, 6 patients were excluded because they received only one month of therapy. Thirteen (68%) patients were women, and the mean age at diagnosis was 61.8 years. No complete responses were observed; 5 patients had a partial response (35.7%), 6 patients had stable disease, and 3 showed progression. Mean progression-free survival was calculated at 18 months (95% CI 10.7-20.3). Overall survival was estimated at 21.3 months (95% CI 17.8-24.8). CONCLUSION: For the first time in Colombia, the efficacy of sorafenib was evaluated in patients with advanced and progressive thyroid carcinoma refractory to radioactive iodine, with an efficacy and a safety profile similar to those previously reported.
Authors: Anne Christine Kaae; Michael C Kreissl; Marcus Krüger; Manfred Infanger; Daniela Grimm; Markus Wehland Journal: Int J Mol Sci Date: 2021-11-12 Impact factor: 5.923